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Saturday, 18 August 2012

Eporatio 10,000 IU

1. Name Of The Medicinal Product

Eporatio 10,000 IU/1 ml solution for injection in pre

2. Qualitative And Quantitative Composition

One pre-filled syringe contains 10,000 international units (IU) (83.3 µg) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.

Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection (injection) in pre

The solution is clear and colourless.

4. Clinical Particulars

4.1 Therapeutic Indications

- Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.

- Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

4.2 Posology And Method Of Administration

Special requirements

Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications.

Routes of administration

The solution can be administered subcutaneously (SC) or intravenously (IV). Subcutaneous use is preferable in patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins. If epoetin theta is substituted for another epoetin, the same route of administration should be used. Epoetin theta should be administered by the subcutaneous route to cancer patients with non

Posology

Symptomatic anaemia associated with chronic renal failure

Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary. Epoetin theta should be administered either subcutaneously or intravenously in order to increase haemoglobin level to not greater than 12 g/dl (7.45 mmol/l).

Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l). A sustained haemoglobin level of greater than 12 g/dl (7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment if haemoglobin values exceeding 12 g/dl (7.45 mmol/l) are observed are described below.

A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four week period should be avoided. If the rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) in 4 weeks or the haemoglobin value exceeds 12 g/dl (7.45 mmol/l), the dose should be reduced by 25 to 50%. It is recommended that haemoglobin be monitored every two weeks until levels have stabilised and periodically thereafter. If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.

In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the increase in haemoglobin and the target haemoglobin value should be determined individually taking into account the clinical picture.

Treatment with epoetin theta is divided into two stages.

Correction phase

Subcutaneous administration: The initial posology is 20 IU/kg body weight 3 times per week. The dose may be increased after 4 weeks to 40 IU/kg, 3 times per week, if the increase in haemoglobin is not adequate (< 1 g/dl [0.62 mmol/l] within 4 weeks). Further increases of 25% of the previous dose may be made at monthly intervals until the individual target haemoglobin level is obtained.

Intravenous administration: The initial posology is 40 IU/kg body weight 3 times per week. The dose may be increased after 4 weeks to 80 IU/kg, 3 times per week, and by further increases of 25% of the previous dose at monthly intervals, if needed.

For both routes of administration, the maximum dose should not exceed 700 IU/kg body weight per week.

Maintenance phase

The dose should be adjusted as necessary to maintain the individual target haemoglobin level between 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l), whereby a haemoglobin level of 12 g/dl (7.45 mmol/l) should not be exceeded. If a dose adjustment is required to maintain the desired haemoglobin level, it is recommended that the dose be adjusted by approximately 25%.

Subcutaneous administration: The weekly dose can be given as one injection per week or three times per week.

Intravenous administration: Patients who are stable on a three times weekly dosing regimen may be switched to twice-weekly administration.

If the frequency of administration is changed, haemoglobin level should be monitored closely and dose adjustments may be necessary.

The maximum dose should not exceed 700 IU/kg body weight per week.

If epoetin theta is substituted for another epoetin, haemoglobin level should be monitored closely and the same route of administration should be used.

Patients should be monitored closely to ensure that the lowest approved dose of epoetin theta is used to provide adequate control of the symptoms of anaemia.

Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy

Epoetin theta should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration

The recommended initial dose is 20,000 IU, independent of bodyweight, given once-weekly. If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued. If the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l) a doubling of the weekly dose to 40,000 IU should be considered. If, after an additional 4 weeks of therapy, the haemoglobin increase is still insufficient an increase of the weekly dose to 60,000 IU should be considered.

The maximum dose should not exceed 60,000 IU per week.

If, after 12 weeks of therapy, the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), response is unlikely and treatment should be discontinued.

If the rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) in 4 weeks or the haemoglobin level exceeds 12 g/dl (7.45 mmol/l), the dose should be reduced by 25 to 50%. Treatment with epoetin theta should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.07 mmol/l). Therapy should be reinitiated at approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/dl (7.45 mmol/l) or below.

Therapy should be continued up to 4 weeks after the end of chemotherapy.

Patients should be monitored closely to ensure that the lowest approved dose of epoetin theta is used to provide adequate control of the symptoms of anaemia.

Special populations

Paediatric patients

There is no experience in children and adolescents.

Method of administration

The solution can be administered subcutaneously or intravenously. Subcutaneous use is preferable in patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins. If epoetin theta is substituted for another epoetin, the same route of administration should be used. In cancer patients with non

Subcutaneous injections should be given into the abdomen, arm or thigh.

Eporatio is supplied in a single use pre-filled syringe. The solution should be visually inspected prior to use. Only clear, colourless solutions without particles should be used. The solution for injection should not be shaken. It should be allowed to reach a comfortable temperature (15 °C

Eporatio must not be mixed with other medicinal products (see section 6.2).

The injection sites should be rotated and the injection performed slowly to avoid discomfort at the site of injection.

4.3 Contraindications

- Hypersensitivity to the active substance, other epoetins and derivatives or to any of the excipients.

- Uncontrolled hypertension.

4.4 Special Warnings And Precautions For Use

General

Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l or with transferrin saturation below 20%. To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment.

Non-response to therapy with epoetin theta should prompt a search for causative factors. Deficiencies of iron, folic acid or vitamin B₁₂ reduce the effectiveness of epoetins and should therefore be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, aluminium intoxication, underlying haematological diseases or bone marrow fibrosis may also compromise the erythropoietic response. A reticulocyte count should be considered as part of the evaluation.

Pure red cell aplasia (PRCA)

If typical causes of non-response are excluded, and the patient has a sudden drop in haemoglobin associated with reticulocytopenia, an examination of anti-erythropoietin antibodies and the bone marrow for diagnosis of pure red cell aplasia should be considered. Discontinuation of treatment with epoetin theta should be taken into account.

PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy. These antibodies have been shown to cross-react with all epoetins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to epoetin theta (see section 4.8).

Hypertension

Patients on epoetin theta therapy can experience an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase.

Therefore, in patients treated with epoetin theta, special care should be taken to monitor closely and control blood pressure. Blood pressure should be controlled adequately before initiation and during therapy to avoid acute complications, such as hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke), which may also occur in individual patients with otherwise normal or low blood pressure. If these reactions occur, they require the immediate attention of a physician and intensive medical care. Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal.

Increases in blood pressure may require treatment with antihypertensive medicinal products or a dose increase of existing antihypertensive medicinal products. In addition, a reduction of the administered dose of epoetin theta needs to be considered. If blood pressure values remain high, temporary interruption of epoetin theta therapy may be required. Once hypertension has been controlled with more intensified therapy, epoetin theta therapy should be re-started at a reduced dose.

Misuse

Misuse of epoetin theta by healthy persons may lead to an excessive increase in haemoglobin and haematocrit. This may be associated with life-threatening cardiovascular complications.

Special populations

Due to limited experience, the efficacy and safety of epoetin theta could not be assessed in patients with impaired liver function or homozygous sickle cell anaemia.

In clinical trials, patients over 75 years of age had a higher incidence of serious and severe adverse events irrespective of a causal relationship to treatment with epoetin theta. Furthermore, deaths were more frequent in this patient group compared to younger patients.

Laboratory monitoring

It is recommended that haemoglobin measurement, a complete blood count and platelet count be performed regularly.

Symptomatic anaemia associated with chronic renal failure

The use of epoetin theta in nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible accelerated progression of renal failure cannot be ruled out with certainty.

During haemodialysis, patients treated with epoetin theta may require increased anticoagulation treatment to prevent clotting of the arterio-venous shunt.

In patients with chronic renal failure, the maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2. In clinical trials, an increased risk of death and serious cardiovascular events was observed when epoetins were administered to target a haemoglobin level in excess of 12 g/dl (7.45 mmol/l). Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when the haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.

Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy

Effect on tumour growth

Epoetins are growth factors that primarily stimulate red blood cell production. Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy (see section 5.1).

In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer. In controlled clinical studies, use of epoetins has shown:

- shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin level in excess of 14 g/dl (8.69 mmol/l),

- shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin value of 12

- increased risk of death when administered to target a haemoglobin value of 12 g/dl (7.45 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.

Epoetins are not indicated for use in this patient population.

In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer. The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context. Factors that should be considered in this assessment should include the type of tumour and its stage, the degree of anaemia, life

Excipients

This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially 'sodium-free'.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

4.6 Pregnancy And Lactation

For epoetin theta no clinical data on exposed pregnancies are available. Animal studies with other epoetins do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant women.

It is unknown whether epoetin theta is excreted in human breast milk, but data in neonates show no absorption or pharmacological activity of erythropoietin when given together with breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with epoetin theta should be made taking into account the benefit of breast-feeding to the child and the benefit of epoetin theta therapy for the woman.

4.7 Effects On Ability To Drive And Use Machines

Epoetin theta has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

The safety of epoetin theta has been evaluated based on results from clinical studies including 972 patients.

Approximately 9% of patients can be expected to experience an adverse reaction. The most frequent undesirable effects are hypertension, influenza-like illness and headache.

Adverse reactions listed below are classified according to System Organ Class. Frequency groupings are defined according to the following convention:

Very common:
Common:
Uncommon:
Rare:
Very rare:	< 1/10,000;
Not known:	cannot be estimated from the available data.

System organ class	Adverse reaction	Frequency
Symptomatic anaemia associated with chronic renal failure	Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy
Blood and lymphatic system disorders	Thromboembolic events	—	Not known
Shunt thrombosis	Common	—
Immune system disorders	Hypersensitivity reactions	Not known
Nervous system disorders	Headache	Common
Vascular disorders	Hypertension	Common
Hypertensive crisis	Common	—
Skin and subcutaneous tissue disorders	Skin reactions	Common
Musculoskeletal and connective tissue disorders	Arthralgia	—	Common
General disorders and administration site conditions	Influenza-like illness	Common

Shunt thrombosis may occur, especially in patients who have a tendency to hypotension or whose arterio-venous fistulae exhibit complications (e.g. stenoses, aneurisms) (see section 4.4).

One of the most frequent adverse reactions during treatment with epoetin theta is an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase. Hypertension occurs in chronic renal failure patients more often during the correction phase than during the maintenance phase. Hypertension can be treated with appropriate medicinal products (see section 4.4).

Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).

Skin reactions such as rash, pruritus or injection site reactions may occur.

Symptoms of influenza-like illness such as fever, chills and asthenic conditions have been reported.

Certain adverse reactions have not yet been observed with epoetin theta, but are generally accepted as being attributable to epoetins:

In isolated cases in patients with chronic renal failure, neutralising anti-erythropoietin antibody-mediated PRCA associated with therapy with other epoetins has been reported. If PRCA is diagnosed, therapy with epoetin theta must be discontinued and patients should not be switched to another recombinant epoetin (see section 4.4).

4.9 Overdose

The therapeutic margin of epoetin theta is very wide. In the case of overdose, polycythaemia can occur. In the event of polycythaemia, epoetin theta should be temporarily withheld.

If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to reduce the haemoglobin level.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other anti-anaemic preparations, ATC code: B03XA01

Mechanism of action

Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow. It acts as a mitosis-stimulating factor and differentiation hormone. The production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes in tissue oxygenation. Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is erythropoietin deficiency. In patients with cancer receiving chemotherapy the aetiology of anaemia is multifactorial. In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.

Epoetin theta is identical in its amino acid sequence and similar in its carbohydrate composition (glycosylation) to endogenous human erythropoietin.

Preclinical efficacy

The biological efficacy of epoetin theta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (mice, rats, dogs). After administration of epoetin theta, the number of erythrocytes, the haematocrit values and reticulocyte counts increase.

Clinical efficacy and safety

Symptomatic anaemia associated chronic renal failure

Data from correction phase studies in 284 chronic renal failure patients show that the haemoglobin response rates (defined as haemoglobin levels above 11 g/dl at two consecutive measurements) in the epoetin theta group (88.4% and 89.4% in studies in patients on dialysis and not yet undergoing dialysis, respectively) were comparable to epoetin beta (86.2% and 81.0%, respectively). The median time to response was similar in the treatment groups with 56 days in haemodialysis patients and 49 days in patients not yet undergoing dialysis.

Two randomised controlled studies were conducted in 270 haemodialysis patients and 288 patients not yet undergoing dialysis, who were on stable treatment with epoetin beta. Patients were randomised to continue their current treatment or to be converted to epoetin theta (same dose as epoetin beta) in order to maintain their haemoglobin levels. During the evaluation period (weeks 15 to 26), the mean and median level of haemoglobin in patients treated with epoetin theta was virtually identical to their baseline haemoglobin level. In these two studies, 180 haemodialysis patients and 193 patients not undergoing dialysis were switched from maintenance phase treatment with epoetin beta to treatment with epoetin theta for a period of six months showing stable haemoglobin values and a similar safety profile as epoetin beta. In the clinical studies, patients not yet undergoing dialysis (subcutaneous administration) discontinued the study more frequently than haemodialysis patients (intravenous administration) as they had to terminate the study when starting dialysis.

In two long-term studies, the efficacy of epoetin theta was evaluated in 124 haemodialysis patients and 289 patients not yet undergoing dialysis. The haemoglobin levels remained within the desired target range and epoetin theta was well tolerated over a period of up to 15 months.

In the clinical studies, pre-dialysis patients were treated once-weekly with epoetin theta, 174 patients in the maintenance phase study and 111 patients in the long-term study.

Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy

409 cancer patients receiving chemotherapy were included in two prospective, randomised double

Effect on tumour growth

Erythropoietin is a growth factor that primarily stimulates red cell production. Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.

Survival and tumour progression have been examined in five large controlled studies involving a total of 2,833 patients, of which four were double-blind placebo-controlled studies and one was an open-label study. Two of the studies recruited patients who were being treated with chemotherapy. The target haemoglobin concentration in two studies was> 13 g/dl; in the remaining three studies it was 12

Data from three placebo-controlled clinical studies in 586 anaemic cancer patients conducted with epoetin theta, showed no negative effect of epoetin theta on survival. During the studies, mortality was lower in the epoetin theta group (6.9%) compared to placebo (10.3%).

A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials. Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8,167 patients). An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06; 35 trials and 6,769 patients) was observed in patients treated with recombinant human erythropoietin. There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin. The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dl, is unclear because few patients with these characteristics were included in the data reviewed.

5.2 Pharmacokinetic Properties

General

The pharmacokinetics of epoetin theta have been examined in healthy volunteers, in patients with chronic renal failure and in cancer patients receiving chemotherapy. The pharmacokinetics of epoetin theta are independent of age or gender.

Subcutaneous administration

Following subcutaneous injection of 40 IU/kg body weight epoetin theta at three different sites (upper arm, abdomen, thigh) in healthy volunteers, similar plasma level profiles were observed. The extent of absorption (AUC) was slightly greater after injection in the abdomen in comparison to the other sites. The maximum concentration is reached after an average of 10 to 14 hours and the average terminal half-life ranges from approximately 22 to 41 hours.

Average bioavailability of epoetin theta after subcutaneous administration is approximately 31% compared with intravenous administration.

In pre-dialysis patients with chronic renal failure following subcutaneous injection of 40 IU/kg body weight, the protracted absorption results in a concentration plateau, whereby the maximum concentration is reached after an average of approximately 14 hours. The terminal half-life is higher than after intravenous administration, with an average of 25 hours after single dosing and 34 hours in steady state after repeated dosing three times weekly, without leading to an accumulation of epoetin theta.

In cancer patients receiving chemotherapy, after repeated subcutaneous administration of 20,000 IU epoetin theta once-weekly, the terminal half-life is 29 hours after the first dose and 28 hours in steady state. No accumulation of epoetin theta was observed.

Intravenous administration

In patients with chronic renal failure undergoing haemodialysis, the elimination half-life of epoetin theta is 6 hours after single dosing and 4 hours in steady state after repeated intravenous administration of 40 IU/kg body weight epoetin theta three times weekly. No accumulation of epoetin theta was observed. Following intravenous administration, the volume of distribution approximates to total blood volume.

5.3 Preclinical Safety Data

Non-clinical data with epoetin theta reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated-dose toxicity.

Non-clinical data with other epoetins reveal no special hazard for humans based on conventional studies of genotoxicity and toxicity to reproduction.

In reproductive toxicity studies performed with other epoetins, effects interpreted as being secondary to decreased maternal body weight were observed at doses sufficiently in excess to the recommended human dose.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium dihydrogen phosphate dihydrate

Sodium chloride

Polysorbate 20

Trometamol

Hydrochloric acid (6 M) (for pH adjustment)

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at a temperature not above 25 °C for a single period of up to 7 days without exceeding the expiry date. Once removed from the refrigerator, the medicinal product must be used within this period or disposed of.

6.5 Nature And Contents Of Container

1 ml of solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber), an injection needle (stainless steel) and with or without a pre

Pack sizes of 1, 4 and 6 pre-filled syringes with or without safety device.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The pre

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

info@ratiopharm.de

8. Marketing Authorisation Number(S)

EMEA/H/C/0010350000/15

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 29 October 2009

10. Date Of Revision Of The Text

Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.

Thursday, 16 August 2012

Boots Mild Vapour Rub 3 Months Plus

1. Name Of The Medicinal Product

Boots Mild Vapour Rub 3 Months Plus or

Boots Children's 3 Months Plus Vapour Rub

2. Qualitative And Quantitative Composition

Active ingredient	% w/w
Racemic Camphor	6.0
Levomenthol natural or synthetic	1.0
Eucalyptus oil	1.5

3. Pharmaceutical Form

Ointment

4. Clinical Particulars

4.1 Therapeutic Indications

For head colds, stuffy nose, cough and chest colds.

4.2 Posology And Method Of Administration

For children over 3 months and adults

To be used on the chest and back particularly at bedtimes. Massage gently. Use sparingly on infants and young children. Apply a moderate amount on older children and adults.

Elderly

There is no need for dosage reduction.

Children under 3 months

Not recommended for children under 3 months of age.

For topical application.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

For external use only.

Keep all medicines out of the reach of children.

Not recommended for children under 3 months.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of vapour rub during pregnancy and lactation has not been established but its use during these periods is not considered to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasional hypersensitivity and irritant skin reactions.

4.9 Overdose

Overdosage may result in skin irritation.

Misuse:

Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.

Following oral ingestion, symptoms of overdosage may include colic, dizziness, delirium, muscle twitching, epileptiform convulsions and depression of the central nervous system. Breathing may be difficult. There may also be haematuria and albuminuria.

Acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain and headache, vertigo, feeling hot/flushing, convulsions, respiratory depression and coma.

Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.

Convulsions may be controlled by the intravenous administration of diazepam 5-10 mg.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Eucalyptus oil, camphor, levomenthol are volatile substances and are thought to produce an irritant effect on the respiratory tract, probably via a nasal/pulmonary arc.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White soft paraffin

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months in amber glass jar.

20 months in polystyrene jar.

6.4 Special Precautions For Storage

Amber glass jar - None.

Polystyrene jar - Do not store above 25°C.

6.5 Nature And Contents Of Container

Amber glass jar with either a tin plate cap with waxed aluminium faced pulpboard liner containing 45g or a thermoset plastic cap

or A polystyrene jar with an unlined polypropylene cap containing 25g or 45g.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/0562

9. Date Of First Authorisation/Renewal Of The Authorisation

31 May 1996

10. Date Of Revision Of The Text

August 2010

Tuesday, 14 August 2012

pentazocine and acetaminophen

a-seet-a-MIN-oh-fen, pen-TAZ-oh-seen hye-droe-KLOR-ide

Oral route(Tablet)

Talacen(R) contains pentazocine hydrochloride and acetaminophen. Acetaminophen has been associated with acute liver failure, with some cases resulting in liver transplant and death. Most cases of liver injury were associated with acetaminophen use at doses exceeding 4000 mg/day, and often involved more than 1 acetaminophen-containing product

Commonly used brand name(s)

In the U.S.

APAP/Pentazocine HCl

Talacen

Available Dosage Forms:

Tablet

Therapeutic Class: Opioid Agonist/Antagonist/Acetaminophen Combination

Pharmacologic Class: Pentazocine

Uses For pentazocine and acetaminophen

Pentazocine and acetaminophen combination is used to relieve mild to moderate pain. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Pentazocine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain. When pentazocine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

pentazocine and acetaminophen is available only with your doctor's prescription.

Before Using pentazocine and acetaminophen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pentazocine and acetaminophen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pentazocine and acetaminophen or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pentazocine and acetaminophen combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pentazocine and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving pentazocine and acetaminophen combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking pentazocine and acetaminophen, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using pentazocine and acetaminophen with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfentanil

Alphaprodine

Codeine

Dihydrocodeine

Fentanyl

Fospropofol

Hydrocodone

Hydromorphone

Levorphanol

Meperidine

Methadone

Morphine

Morphine Sulfate Liposome

Oxycodone

Oxymorphone

Propoxyphene

Selegiline

Sibutramine

Sufentanil

Tapentadol

Using pentazocine and acetaminophen with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Carbamazepine

Fluoxetine

Isoniazid

Phenytoin

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using pentazocine and acetaminophen with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use pentazocine and acetaminophen, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using pentazocine and acetaminophen with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use pentazocine and acetaminophen, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

Ethanol

Proper Use of pentazocine and acetaminophen

Take pentazocine and acetaminophen only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of pentazocine and acetaminophen is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdosage. Liver damage can occur if large amounts of acetaminophen are taken for a long time.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

You may take pentazocine and acetaminophen with or without food.

Dosing

The dose of pentazocine and acetaminophen will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pentazocine and acetaminophen. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For mild to moderate pain:
  - Adults, teenagers, and children 12 years of age and older—One tablet every 4 hours as needed. Your doctor may adjust your dose if needed. However, the dose is usually not more than 6 tablets per day.
  - Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of pentazocine and acetaminophen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Precautions While Using pentazocine and acetaminophen

It is very important that your doctor check the progress of you or your child while you are using pentazocine and acetaminophen. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

pentazocine and acetaminophen may cause allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using pentazocine and acetaminophen.

pentazocine and acetaminophen will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before you or your child take any of the medicines listed above while you are using pentazocine and acetaminophen.

Make sure your doctor knows if you or your child have received narcotic medicines (e.g., methadone) in the past. Some patients who have had received narcotic pain medicines, have experienced withdrawal symptoms after receiving pentazocine.

Check with your doctor if you or your child have confusion about identity, place, and time; mood or mental changes; or seeing things that are not there while taking pentazocine and acetaminophen.

pentazocine and acetaminophen may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

pentazocine and acetaminophen may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to pentazocine and acetaminophen before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you or your child have been using pentazocine and acetaminophen regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Make sure any doctor or dentist who treats you knows that you are using pentazocine and acetaminophen. You or your child may need to stop using pentazocine and acetaminophen several days before having surgery.

Using pentazocine and acetaminophen while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using pentazocine and acetaminophen.

Tell your doctor if you smoke tobacco. Smoking may change how well pentazocine and acetaminophen works.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

pentazocine and acetaminophen Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Back, leg, or stomach pains

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

chills

cough or hoarseness

dark urine

decrease in the frequency of urination

decrease in urine volume

diarrhea

difficult or troubled breathing

difficulty in passing urine (dribbling)

difficulty with swallowing

dizziness

fast heartbeat

fever

fever with or without chills

general body swelling

general feeling of tiredness or weakness

headache

hives

irregular, fast or slow, or shallow breathing

itching

joint or muscle pain

loss of appetite

lower back or side pain

nausea or vomiting

nosebleeds

painful or difficult urination

pale or blue lips, fingernails, or skin

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

shakiness in the legs, arms, hands, or feet

shortness of breath

skin rash

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling or puffiness of the face

swollen glands

tightness in the chest

trembling or shaking of the hands or feet

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

yellowing of the eyes or skin

Incidence not known

Blood in the urine

bloody nose

fainting

fast, pounding, or irregular heartbeat or pulse

feeling of warmth

heavier menstrual periods

pinpoint red spots on the skin

redness of the face, neck, arms, and occasionally, upper chest

sweating

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach pain or tenderness

bleeding gums

bloody or cloudy urine

blurred vision

clay-colored stools

cold sweats

confusion

cool, pale skin

decreased appetite

depression

drowsiness

fear or nervousness

increased hunger

muscle tremors

nightmares

rapid, deep breathing

restlessness

seeing, hearing, or feeling things that are not there

seizures

slurred speech

stomach cramps

strange thoughts

sudden decrease in the amount of urine

sugar in the urine

swelling of the feet or lower legs

unpleasant breath odor

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

vomiting of blood

weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Continuing ringing or buzzing or other unexplained noise in the ears

excitement

hearing loss

hives or welts

irritability

redness of the skin

Incidence not known

Confusion about identity, place, and time

constipation

difficulty in focusing the eyes

disturbed dreams

drowsiness

false or unusual sense of well-being

relaxed and calm feeling

sleepiness

sleeplessness

trouble sleeping

unable to sleep

weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pentazocine and acetaminophen side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More pentazocine and acetaminophen resources

Pentazocine and acetaminophen Side Effects (in more detail)
Pentazocine and acetaminophen Dosage
Pentazocine and acetaminophen Use in Pregnancy & Breastfeeding
Drug Images
Pentazocine and acetaminophen Drug Interactions
Pentazocine and acetaminophen Support Group
1 Review for Pentazocine and acetaminophen - Add your own review/rating

Compare pentazocine and acetaminophen with other medications

Pain

Monday, 13 August 2012

PrimaCare

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are PrimaCare (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More PrimaCare resources

PrimaCare Side Effects (in more detail)
PrimaCare Use in Pregnancy & Breastfeeding
PrimaCare Drug Interactions
PrimaCare Support Group
0 Reviews for PrimaCare - Add your own review/rating

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Concept DHA Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

Folcal DHA Prescribing Information (FDA)

Folcaps Care One Prescribing Information (FDA)

Gesticare DHA Prescribing Information (FDA)

Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Inatal Advance Prescribing Information (FDA)

Inatal Ultra Prescribing Information (FDA)

Multi-Nate DHA Prescribing Information (FDA)

Multi-Nate DHA Extra Prescribing Information (FDA)

MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Natelle One Prescribing Information (FDA)

Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

PreNexa Prescribing Information (FDA)

PreferaOB Prescribing Information (FDA)

Prenatal Plus Prescribing Information (FDA)

Prenatal Plus Iron Prescribing Information (FDA)

Prenate Elite Prescribing Information (FDA)

Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

Prenate Elite tablets

Prenate Essential Prescribing Information (FDA)

PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

PrimaCare ONE capsules

PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

Renate DHA Prescribing Information (FDA)

Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Se-Natal 19 Prescribing Information (FDA)

Tandem DHA Prescribing Information (FDA)

Tandem OB Prescribing Information (FDA)

TriAdvance Prescribing Information (FDA)

Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

Compare PrimaCare with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

See also: PrimaCare side effects (in more detail)

Spasmonal 60mg

1. Name Of The Medicinal Product

SPASMONAL 60 mg

2. Qualitative And Quantitative Composition

Each capsule contains 60mg alverine citrate.

3. Pharmaceutical Form

An opaque size 3 capsule with a grey cap and blue body, marked “SP 60”.

4. Clinical Particulars

4.1 Therapeutic Indications

The relief of smooth muscle spasm, in conditions such as irritable bowel syndrome, painful diverticular disease of the colon and primary dysmenorrhoea

4.2 Posology And Method Of Administration

Recommended dose and dosage schedules:

Adults (including the elderly): 1or 2 capsules one to three times daily.

Children below the age of 12 years: not recommended.

4.3 Contraindications

Paralytic ileus or known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Additional warnings to be included in the Patient Information Leaflet:

If this is the first time you have had these symptoms, consult your doctor before using any treatment.

If any of the following apply do not use SPASMONAL 60 mg; it may not be the right treatment for you. See your doctor as soon as possible if:

- you are aged 40 years or over

- you have passed blood from the bowel

- you are feeling sick or vomiting

- you have lost your appetite or lost weight

- you are looking pale and feeling tired

- you are suffering from severe constipation

- you have a fever

- you have recently travelled abroad

- you are or may be pregnant

- you have abnormal vaginal bleeding or discharge

- you have difficulty or pain passing urine.

Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in Preclinical studies is limited.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Possible side effects may include nausea, headache, dizziness, itching, rash, and allergic reactions. There have been isolated reports of jaundice due to hepatitis, which may have been immune-mediated; but this adverse reaction resolved on cessation of alverine treatment.

4.9 Overdose

Can produce hypotension and atropine-like toxic effects. Management is as for atropine poisoning with supportive therapy for hypotension.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Alverine citrate is a spasmolytic, which has a specific action on the smooth muscle of the alimentary tract and uterus, without affecting the heart, blood vessels and tracheal muscle at therapeutic doses.

5.2 Pharmacokinetic Properties

After oral administration, alverine is rapidly converted to its primary active metabolite, which is then further converted to two secondary metabolites. There is a high renal clearance of all metabolites indicating that they are eliminated by active renal secretion. The peak plasma level of the most active metabolite occurs between 1 and 1½ hours after oral dosing. The plasma half-life averages 0.8 hours for alverine and 5.7 hours for the active primary metabolite.

5.3 Preclinical Safety Data

Preclinical studies provide evidence that alverine citrate has no significant systemic toxicity potential at the proposed dosage.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize Starch

Magnesium Stearate

Capsule Shell:

Gelatin, E132, E171, E172

6.2 Incompatibilities

None stated.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store in a dry place. Do not store above 25°C.

6.5 Nature And Contents Of Container

Plastic containers of 20 or 100 capsules; foil/UPVC blister packs containing 3, 10, 12, 20, 90 or 100 capsules.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Norgine Limited

Chaplin House

Widewater Place

Moorhall Road

Harefield

UXBRIDGE

Middlesex UB9 6NS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00322/5014R

9. Date Of First Authorisation/Renewal Of The Authorisation

June 1998

10. Date Of Revision Of The Text

Date: June 2009

Legal category: P

Friday, 10 August 2012

Tuberculin

Class: Tuberculosis
VA Class: DX300
Brands: Aplisol, Tubersol

Introduction

Skin-test antigen for diagnosis of Mycobacterium tuberculosis infection.^a ^b ^c

Uses for Tuberculin

Diagnosis of Tuberculosis (TB) Infection

Aids in identifying Mycobacterium tuberculosis-infected individuals at high risk for developing active TB who may benefit from treatment of latent TB infection.^b ^c ^d ^e

Treatment of latent TB infection previously referred to as “preventive therapy” or “chemoprophylaxis”.¹⁴⁴ ^d ^e

ATS and CDC recommend tuberculin testing in high-risk groups and generally discourage such testing in those at low risk to maximize use of resources and minimize false-positive results.¹⁴⁴

ATS, CDC, and IDSA recommend tuberculin testing in the following high-risk individuals or groups:¹⁴⁴ ^f

Close contacts (i.e., those sharing same household or other closed environment) of known cases of clinical TB or individuals suspected of having TB¹⁴⁴ ^b ^e ^f

HIV-infected individuals;¹⁰⁷ ¹¹⁷ ¹²¹ ¹³² ¹⁴⁴ ¹⁴⁵ ¹⁴⁶ ^b ^c ^e ^f consider annual testing in such individuals at high risk of continued exposure to TB, beginning at 3–12 months of age¹⁴⁵ ^c ^e ^k

Other individuals with medical conditions or factors that increase risk of latent TB infection progressing to active TB, including diabetes mellitus,¹⁴⁴ ^c ^e ^f chronic renal failure,¹⁴⁴ ^c ^e ^f certain hematologic or reticuloendothelial disorders (e.g., leukemias, lymphomas),¹⁴⁴ ^b certain other malignancies (e.g., head and neck or lung cancer),¹⁴⁴ ^b ^f immunosuppression (e.g., organ transplant recipients, individuals receiving prolonged high-dose corticosteroid therapy, tumor necrosis factor, or other immunosuppressive agents),¹⁴⁴ ^e ^f ^j silicosis,¹⁴⁴ ^b ^f weight >10% below ideal body weight,¹⁴⁴ ^f gastrectomy or jejunoileal bypass¹⁴⁴ ^b ^f

Illicit-drug users and other locally identified high-risk substance users (e.g., crack cocaine users);¹⁴⁴ ^b ^f required in all individuals enrolled in methadone detoxification or maintenance treatment program¹²⁹ ¹³⁰ ^f

Residents and employees of high-risk congregate settings (e.g., correctional facilities, nursing homes, mental institutions, other long-term residential facilities [e.g., for HIV-infected patients], homeless shelters);¹⁴⁴ ¹⁴⁶ ^b ^f routine (at least annual) testing recommended^c ^g

Foreign-born individuals (e.g., legal immigrants and refugees with class B1 and B2 TB notification status),^f including children who recently arrived (≤5 years) from countries with high incidence or prevalence of TB and those adopted from outside US¹⁴⁴ ^b ^e ^f

Certain medically underserved, low-income populations (e.g., migrant farm workers, homeless persons)¹²¹ ^b ^f

Individuals with pulmonary fibrotic lesions on chest radiographs (consistent with healed TB)¹⁴⁴ ^b ^e ^f

Children <5 years^f of age or infants, children, and adolescents exposed to adults in high-risk categories;¹²¹ ^e ^f annual testing recommended in high-risk pediatric patients (e.g., individuals from countries with high prevalence of TB, low-income groups, children infected with HIV, incarcerated adolescents)^b ^e

All health-care workers (baseline and postexposure screening); ongoing periodic screening recommended according to risk^c ^f ^h

History of BCG vaccination does not rule out use of tuberculin testing to aid diagnosis of TB infection.^b ^c (See False-positive Reactions under Cautions.)

Tuberculin Dosage and Administration

General

Document test result in permanent medical record.^c Include name of preparation, manufacturer and lot number, administration technique (i.e., Mantoux method), date and dose administered, date of test reading, and extent of induration in mm (including 0).^c ¹²¹ Recording result only as “negative” or “positive” is not adequate.^c

Administration

Intradermal Administration

Administer by intradermal injection using Mantoux method.^b ^c Avoid administering by IV, IM, or sub-Q.^b ^c Sub-Q injection lacks diagnostic value and may result in adverse reactions (e.g., general febrile reaction, acute inflammation around old tuberculous lesions) in highly sensitive individuals.^c

Use tuberculin syringe with short (0.25–0.5 inch) 26- or 27-gauge needle.^b ^c Use a separate sterile, single-use disposable syringe and needle for each individual patient to prevent transmission of infectious agents (e.g., HIV, hepatitis virus).^b ^c To avoid contamination of vial content (and subsequent transmission of infectious agents to other individuals), never use the same needle and/or syringe to re-enter multidose vial, even when used for the same individual.^c

To prepare dose, wipe vial stopper with suitable germicide (e.g., 70% alcohol) and use aseptic technique to draw exact dose into syringe, taking care to exclude air bubbles.^a ^b ^c .

Prior to intradermal injection, cleanse administration site with 70% alcohol or other antiseptic and allow to dry.^b ^c Usual injection site is volar (preferred) or dorsal surface of forearm, approximately 4 inches below elbow.^b ^c ¹²¹ Avoid hairy areas, areas with lesions, areas near veins, swollen or red areas,^b ^c ¹²¹ and areas without adequate subcutaneous tissue (e.g., concavities over tendon or bone).^a

Potential for a drop of blood when needle withdrawn from injection site.^c Remove any blood at injection site gently with gauze to avoid squeezing out tuberculin.^c

Avoid recapping needle following use; properly dispose of used needles and syringes.^c

Mantoux Method

With needle bevel pointing upward, insert needle into the most superficial layers of the skin and inject slowly.^b ^c

A pale bleb about 6–10 mm in diameter should form at injection site.^b ^c Bleb is absorbed within minutes; no dressing required.^b ^c

If improperly administered (i.e., no bleb formed) or if dose leaks from injection site, repeat test immediately at another site at least 5 cm (2 inches) from original injection site; indicate site used for second test in patient’s record or by circling second site.^b ^c ¹²¹

In individuals requiring routine periodic testing (e.g., health-care professionals, residents and workers in hospitals, nursing homes, mental institutions, prisons), perform 2-step testing method initially (using Mantoux method) to avoid misinterpreting a booster effect as a conversion.^b ^c ^g ^h ¹²¹ (See Booster Effect and Two-Step Testing under Dosage and Administration.) If a small or negative reaction is observed after the first test, administer second test 1–4 weeks later.^c ^g ^h ¹²¹

Examine test site 48–72 hours after administration.^b ^c ^e ¹²¹ (See Interpretation of Tuberculin Reaction under Dosage and Administration.)

Interpretation of Tuberculin Reaction

Only trained health professionals should interpret tuberculin skin test; interpretation by untrained individuals or family member not reliable.^c ^e

At 48–72 hours after administration, visually inspect and palpate test site to determine extent of induration.^b ^c ¹²¹ Disregard finding of erythema (no diagnostic value); in absence of induration, an area of erythema with diameter >10 mm indicates too deep an injection and requires retesting.^b ^c Note and record presence and extent of necrosis and edema, although these findings have no diagnostic value.^b ^c

Measure diameter of palpable induration transversely to long axis of forearm.^b ^c ^e Record in mm (including 0) and interpret reaction using guidelines from manufacturer, ATS, and CDC.^b ^c ¹²¹ (See Table 1.)

Table 1. Guidelines for Interpreting Tuberculin Reactionbcei121144
Induration	Interpretation
≥5 mm	Positive in the following groups: Individuals with fibrotic changes on chest radiographs consistent with prior TB Recent contacts of individuals with active TB Individuals with known or suspected HIV-infection Other immunosuppressed patients (patients receiving ≥15 mg of prednisone, or its equivalent, daily for ≥1 month; organ or bone marrow transplant patients; patients taking tumor necrosis factor-alpha antagonists)^b ^c ^e ¹²¹ ¹⁴⁴ ⁱ
≥10 mm	Positive in the following groups who do not meet above criteria: IV drug users who are HIV-negative Individuals with medical conditions that increase risk of progressing from latent TB infection to active TB (e.g., diabetes mellitus, chronic renal failure, malignancies [e.g., leukemias, lymphomas, head/neck/lung cancer], weight loss of ≥10% of ideal body weight, silicosis, gastrectomy, jejunoileal bypass) Residents/employees of high-risk congregate settings (e.g., prisons, nursing homes, long-term care/health-care facilities, homeless shelters, residential facilities for AIDS patients) Foreign-born persons arriving within the last 5 years from areas with high prevalence/incidence of TB (e.g., Asia, Africa, the Caribbean, Latin America) Some medically underserved, low-income populations (e.g., migrant farm workers, homeless persons) High-risk racial or ethnic minority populations, as defined locally Personnel in mycobacteriology laboratories Children <4 years of age Children (including infants) and adolescents exposed to adults in high-risk categories Children who travel to areas with high prevalence of TB^b ^c ^e ⁱ ¹²¹ ¹⁴⁴
≥15 mm	Positive in individuals (including children ≥4 years of age) with no risk factors for TB^b ^c ^e ⁱ ¹²¹ ¹⁴⁴
<15 mm	Negative in normal, healthy individuals with no risk factors for TB (lack of hypersensitivity to tuberculin);^b ^c TB highly unlikely^b

When of diagnostic importance, accept negative reaction as proof that sensitivity is absent only after normal reactivity to nonspecific irritants has been demonstrated.^b In individuals suspected of being TB positive who exhibit negative reaction to tuberculin testing, perform second test to exclude possibility of active TB.^c Individuals with negative reaction to initial and second test may be considered tuberculin negative.^c

To establish diagnosis of latent or active TB infection, rule out possible false-positive reaction (see False-positive Reactions under Cautions) and perform further medical and diagnostic evaluation (e.g., medical history, chest radiograph, sputum smear, culture examination).^b ^c ¹⁴⁴

A positive reaction may indicate latent infection, prior infection, and/or M. tuberculosis disease and may not indicate active TB;^c ^d individuals with a positive reaction should be considered positive by current public health guidelines and referred for further medical evaluation.^c ^d

A negative tuberculin skin test should not be used to exclude active TB in individuals with symptoms compatible with TB (see False-negative Reactions under Cautions).^b ^e

Booster Effect and Two-Step Testing

If tuberculin sensitivity has waned (see Actions), initial testing will produce a small or negative reaction.^b ^c ¹²¹ Repeated testing may boost size of reaction (booster effect), which can be misinterpreted as a conversion (i.e., positive reaction indicative of recent infection with M. tuberculosis).^b ^c ¹²¹ ¹⁴⁴

Therefore, individuals requiring routine periodic testing (e.g., health-care professionals, residents and workers in hospitals, nursing homes, mental institutions, prisons) should initially receive 2-step testing (i.e., a repeat tuberculin test after an initial negative reaction)ⁱ to permanently document infectivity status (e.g., uninfected, previously infected).^b ^c ¹²¹ If first test is negative, use result of second test performed 1–4 weeks later to determine TB status.¹²¹ ^c If reaction to second test is positive, individual is considered previously infected; if reaction is negative, individual is considered uninfected.^c ¹²¹ In these uninfected individuals, a reaction size of ≥10 mm upon repeat testing within a 2-year period is considered a conversion.^c ¹²¹ ¹⁴⁴

Individuals whose second test is negative, but whose reaction is positive after one year, are considered to have newly acquired TB infection and should be managed accordingly.^c

Dosage

Each dose (0.1 mL) is bioequivalent to 5 US units (TU) of the US reference standard (PPD-S).^b ^c

Pediatric Patients

Diagnosis of TB Infection

Intradermal

0.1 mL.^b ^c

Adults

Diagnosis of TB Infection

Intradermal

0.1 mL.^b ^c

Cautions for Tuberculin

Contraindications

Known hypersensitivity or previous severe reaction (e.g., anaphylaxis, vesiculation, ulceration, necrosis, blistering) to tuberculin or any ingredient in the formulation.^b ^c

Individuals with previous positive reactions;^c severe reactions (vesiculation, ulceration, necrosis) may occur in these patients.^c

Individuals with documented active TB or a history of treatment for TB infection or disease.^c

Individuals with extensive burns or eczema.^c

Defer testing for patients with major viral infections or live-virus vaccination (e.g., measles, mumps, rubella, oral polio, yellow fever) in previous month;^c common cold is not contraindication to test (see False-negative Reactions under Cautions).^c

Warnings/Precautions

Warnings

Previous Severe Reaction

Risk of severe reaction at test site in individuals who previously experienced a severe reaction (e.g., vesiculation, ulceration, necrosis).^b Use not recommended in such individuals.^b (See Contraindications under Cautions.)

False-negative Reactions

Possible decreased ability to respond to test (resulting in false-negative reaction) in individuals with any condition that impairs or attenuates cell-mediated immunity, including viral infections (e.g., HIV, infectious mononucleosis, influenza, measles, mumps, rubella, varicella), overwhelming TB or tuberculous pleurisy, other bacterial infections (e.g., brucellosis, leprosy, pertussis, typhoid fever, typhus), fungal infections (e.g., blastomycosis), diseases affecting lymphoid organs (e.g., Hodgkin’s disease, chronic leukemia, lymphoma, sarcoidosis), or malignancy.^a ^b ^c

Possible temporarily decreased ability to respond to test (resulting in false-negative reaction) caused by live virus vaccines (e.g., measles, mumps, rubella, oral polio, yellow fever).^b ^c Administer skin test and vaccine at separate sites when tuberculin screening required at same time as live-virus vaccine.^c Delay tuberculin skin test for ≥4–6 weeks after live virus vaccination if live virus vaccine recently administered.^b ^c

Possible decreased ability to respond to test (resulting in false-negative reaction) in individuals with metabolic derangements (e.g., chronic renal failure), low protein states, malnutrition, stress (e.g., surgery, burns, mental illness, graft-versus-host reactions), or with immunosuppressive therapy.^b ^c (See Interactions.)

Reactivity to test possibly depressed or suppressed for 5–6 weeks following viral infections, immunization with certain live virus vaccines, or discontinuance of corticosteroid or immunosuppressive therapy.^b (See Interactions.)

Possible decreased ability to respond to test (resulting in false-negative reaction) in newborns and geriatric patients.^b ^c (See Specific Populations under Cautions.)

In HIV-infected individuals, test becomes less reliable as CD4⁺ T-cell count declines; therefore, perform tuberculin testing as soon as possible after HIV infection develops.^b ^c ^k

Possible false-negative reaction if performed too soon after infection with M. tuberculosis.^a (See Actions.)

False-positive Reactions

Possible false-positive reaction in individuals infected with nontuberculous mycobacteria or in individuals previously vaccinated with BCG vaccine.^b ^c ¹²¹ ¹⁴⁴

Cannot reliably distinguish between reactions caused by BCG vaccination and those caused by natural mycobacterial infections.^c ¹⁴⁴ In individuals with prior BCG vaccination, indurations ≥20 mm in diameter not likely caused by BCG vaccination.¹⁴⁴

Test reaction of ≥10 mm probably attributable to M. tuberculosis infection in a BCG-vaccinated individual from a country with a high prevalence of TB or who is in close contact with another person with infectious TB (especially if contact has spread M. tuberculosis to others) or if individual continually exposed to groups with a high TB prevalence.^c

Sensitivity gradually wanes with time (period of years) but may be boosted/prolonged by periodic tuberculin testing.^b ^c ¹⁴⁴ (See Booster Effect and Two-Step Testing under Dosage and Administration.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactic/anaphylactoid reactions manifested by angioedema, upper respiratory stridor, dyspnea, rash, generalized rash and/or urticaria reported within 24 hours after injection; manifestations resolved following treatment with epinephrine, diphenhydramine, and/or corticosteroids.^c Allergic reactions may occur in individuals with no prior history of hypersensitivity to tuberculin skin test components.^c

Ensure immediate availability of epinephrine and other appropriate agents in case of anaphylactic/anaphylactoid or acute hypersensitivity reaction.^b ^c

Major Toxicities

Strongly Positive Reactions

Possible vesiculation, ulceration, or necrosis in highly sensitive individuals; may result in scarring at test site.^b ^c

ATS recommends using a dry dressing to prevent secondary infection.^a

Some manufacturers recommend using cold packs or topical corticosteroid preparations for symptomatic relief of pain, pruritus, and discomfort at injection site.^b However, topical 1% hydrocortisone ointment shown to be ineffective in reducing extent or rate of resolution of induration reaction.^a

General Precautions

Improper Storage and Handling

Possible loss of potency and inaccurate test results if improperly stored or handled.^b ^c (See Storage under Stability.)

Specific Populations

Pregnancy

Category C.^b ^c Tuberculin skin testing considered valid and safe throughout pregnancy.^b Weigh benefit against risk, particularly in high-risk groups.^b

Pediatric Use

Due to an immature immune system, infants <6 weeks of age infected with M. tuberculosis may not react to test.^b ¹⁰⁵ In older infants and children, tuberculin sensitivity develops 2–12 weeks (median: 3–6 weeks) after initial infection.^c ^e

Very young children infected with M. tuberculosis at increased risk for active tuberculosis.^c During contact investigations, give high priority to skin testing and treatment in young children and infants exposed to individuals with active TB.^c

Geriatric Use

Skin test sensitivity may wane with advancing age;^b skin test reaction may develop slowly and not be maximal until >72 hours.^b ^c

Common Adverse Effects

Erythema, pain, pruritus, discomfort at test site.^b ^c (See Major Toxicities under Cautions.)

Occasionally, localized redness or rash (without induration) within 12 hours of skin test;^c reaction does not indicate TB infection.^c (See Major Toxicities under Cautions.)

Interactions for Tuberculin

Specific Drugs

Drug	Interaction	Comments
Corticosteroids	Possible depressed or suppressed reactivity, persisting up to 5–6 weeks following discontinuance of corticosteroid^b ^c
Immunosuppressive agents	Possible depressed or suppressed reactivity, persisting up to 5–6 weeks following discontinuance of immunosuppressive agent^b ^c
Vaccine, BCG	Possible false-positive reaction^c ¹⁴⁴	Sensitivity in BCG-vaccinated individuals gradually wanes with time (over a period of years) or advancing age;^b ^c unlikely to persist for ≥10 years^a Sensitivity may be boosted/prolonged by periodic tuberculin testing^b ^c ¹⁴⁴
Vaccines, live virus (oral polio, measles, mumps, rubella, smallpox, yellow fever, varicella)	Possible depressed reactivity^b ^c	Administer test before or simultaneously with vaccine(s) (at separate sites) or postpone test for 4–6 weeks^b ^c

Tuberculin Pharmacokinetics

Absorption

Onset

In sensitive individuals, delayed hypersensitivity reaction is evident within 5–6 hours and is maximal within 48–72 hours.^b ^c

In geriatric individuals or first-time recipients, reaction develops more slowly and may not be maximal until after 72 hours.^b ^c

Duration

In tuberculin-sensitive individuals, delayed hypersensitivity reaction subsides over a period of days.¹⁰⁵ ¹⁴⁴ Positive reaction may persist for up to 1 week.¹⁴⁴

Stability

Storage

Parenteral

Injection

2–8°C; do not freeze.^b ^c Protect from light.^b ^c Due to possible oxidation and degradation (which may affect potency), discard vials in use for ≥30 days.^b ^c ^b ^c

ActionsActions

Purified protein fraction isolated from a human strain of M. tuberculosis.^b ^c

Produces delayed hypersensitivity response (e.g., local vasodilation, edema, infiltration of leukocytes) in individuals with tuberculin sensitivity (e.g., those infected with M. tuberculosis or other mycobacteria, those with history of BCG vaccination).^b ^c Test not specific for M. tuberculosis; other nontuberculous mycobacteria may cross-react.^a ^b ^c

Delayed hypersensitivity develops 2–12 weeks (median: 3–4 weeks) following infection and manifests as palpable induration (and occasional vesiculation and necrosis) at injection site.^a ^b ^c

Tuberculin sensitivity generally persists throughout life but may gradually diminish or disappear with time (over a period of years) or advancing age.^b ^c ¹²¹ Upon initial testing after sensitivity has waned, reactivity may be small or absent.^b ^c ¹²¹ (See Booster Effect and Two-Step Testing under Dosage and Administration.)

Advice to Patients

Risk of pain, pruritus, and discomfort at injection site.^b ^c Importance of informing clinician if vesiculation, ulceration, or necrosis occurs.^b ^c

Importance of patient returning to clinician 48–72 hours after skin test administration for interpretation of test.^b ^c

Importance of maintaining personal immunization record.^b ^c

Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^b ^c

Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.^b ^c

Importance of informing patients of other important precautionary information.^b ^c (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Purified Protein Derivative
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for intradermal use only	5 TU/0.1 mL	Aplisol (with phenol)	Parkedale
			Tubersol (with phenol)	Aventis Pasteur

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

Only references cited for selected revisions after 1984 are available electronically.

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123. Okwera A, Eriki PP, Guay LA et al. Tuberculin reactions in apparently healthy HIV-seropositive and HIV-seronegative women—Uganda. MMWR Morb Mortal Wkly Rep. 1990; 39:638-9,645-6. [IDIS 271074] [PubMed 2118590]

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a. AHFS drug information 2004. McEvoy GK, ed. Tuberculin Purified Protein Derivative. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2486-91.

b. Parkdale Pharmaceuticals. Aplisol (tuberculin purified protein derivative, diluted [stabilized solution]) diagnostic antigen prescribing information. Rochester, MI; 2002 May.

c. Aventis Pasteur. Tubersol (tuberculin purified protein derivative [Mautoux]) diagnostic antigen prescribing information. Swiftwater, PA; 2007 Jan.

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f. Centers for Disease Control and Prevention. Controlling tuberculosis in the United States: recommendations from the American Thoracic Society, CDC, and the Infectious Diseases Society of America. MMWR Morb Mortal Wkly Rep. 2005; 54(RR-12): 1-81.

g. Centers for Disease Control and Prevention. Prevention and control of tuberculosis in correctional and detention facilities: recommendations from the CDC. MMWR Morb Mortal Wkly Rep 2006; 55: (RR-9) 1-54.

h. Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR Morb Mortal Wkly Rep 2005; 54: (RR-17) 1-140.

i. Centers for Disease Control and Prevention. Tuberculin skin testing fact sheet. 2007 May. From CDC website

Saturday, 18 August 2012

Eporatio 10,000 IU

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

Thursday, 16 August 2012

Boots Mild Vapour Rub 3 Months Plus

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

Tuesday, 14 August 2012

pentazocine and acetaminophen

Commonly used brand name(s)

Uses For pentazocine and acetaminophen

Before Using pentazocine and acetaminophen

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of pentazocine and acetaminophen

Dosing

Missed Dose

Storage

Precautions While Using pentazocine and acetaminophen

pentazocine and acetaminophen Side Effects

More pentazocine and acetaminophen resources