Nandrolone

Dosage Form: injection, solution
Nandrolone DECANOATE INJECTION, USP

Rx Only

DESCRIPTION

A sterile oleaginous solution containing per mL: Nandrolone Decanoate 200 mg with Benzyl Alcohol 5% as solubilizer/preservative, in Sesame Oil q.s. Nandrolone decanoate (C28H44O3) occurs as a fine, white to creamy white, crystalline powder. It is odorless, or may have a slight odor.  Nandrolone decanoate is soluble in chloroform, in alcohol, in acetone, and in vegetable oils.  It is practically insoluble in water.

CLINICAL PHARMACOLOGY

Anabolic steroids are synthetic derivatives of testosterone.  Certain clinical effects and adverse reactions demonstrate the androgenic properties of this class of drugs.  Complete dissociation of anabolic and androgenic effects has not been achieved.  The actions of anabolic steroids are therefore similar to those of male sex hormones with the possibility of causing serious disturbances of growth and sexual development if given to young children.  Anabolic steroids suppress the gonadotropic functions of the pituitary and may exert a direct effect upon the testis.  Anabolic steroids have been reported to increase low-density lipoproteins and decrease high-density lipoproteins.  These changes revert to normal on discontinuation of treatment.

INDICATIONS AND USAGE

Nandrolone decanoate is indicated for the management of the anemia of renal insufficiency and has been shown to increase hemoglobin and red cell mass. Surgically induced anephric patients have been reported to be less responsive.

CONTRAINDICATIONS

1. Male patients with carcinoma of the breast or with known or suspected carcinoma of the prostate.


2. Carcinoma of the breast in females with hypercalcemia: androgenic anabolic steroids may stimulate osteolytic resorption of bones.


3. Pregnancy, because of masculinization of the fetus.


4. Nephrosis or the nephrotic phase of nephritis.

WARNINGS

PELIOSIS HEPATIS, A CONDITION IN WHICH LIVER AND SOMETIMES SPLENIC TISSUE IS REPLACED WITH BLOOD-FILLED CYSTS, HAS BEEN REPORTED IN PATIENTS RECEIVING ANDROGENIC ANABOLIC STEROID THERAPY.  THESE CYSTS ARE SOMETIMES PRESENT WITH MINIMAL HEPATIC DYSFUNCTION, BUT AT OTHER TIMES THEY HAVE BEEN ASSOCIATED WITH LIVER FAILURE.  THEY ARE OFTEN NOT RECOGNIZED UNTIL LIFE-THREATENING LIVER FAILURE OR INTRA-ABDOMINAL HEMORRHAGE DEVELOPS.  WITHDRAWAL OF DRUG USUALLY RESULTS IN COMPLETE DISAPPEARANCE OF LESIONS.   LIVER CELL TUMORS ARE ALSO REPORTED.  MOST OFTEN THESE TUMORS ARE BENIGN AND ANDROGEN-DEPENDENT, BUT FATAL MALIGNANT TUMORS HAVE BEEN REPORTED.  WITHDRAWAL OF DRUG OFTEN RESULTS IN REGRESSION OR CESSATION OF PROGRESSION OF THE TUMOR.  HOWEVER, HEPATIC TUMORS ASSOCIATED WITH ANDROGENS OR ANABOLIC STEROIDS ARE MUCH MORE VASCULAR THAN OTHER HEPATIC TUMORS AND MAY BE SILENT UNTIL LIFE-THREATENING INTRA-ABDOMINAL HEMORRHAGE DEVELOPS.  BLOOD LIPID CHANGES THAT ARE KNOWN TO BE ASSOCIATED WITH INCREASED RISK OF ATHEROSCLEROSIS ARE SEEN IN PATIENTS TREATED WITH ANDROGENS AND ANABOLIC STEROIDS.  THESE CHANGES INCLUDE DECREASED HIGH-DENSITY LIPOPROTEIN AND SOMETIMES INCREASED LOW-DENSITY LIPOPROTEIN.  THE CHANGES MAY BE VERY MARKED AND COULD HAVE A SERIOUS IMPACT ON THE RISK OF ATHEROSCLEROSIS AND CORONARY ARTERY DISEASE.

Hypercalcemia may develop both spontaneously and as a result of androgen therapy in women with disseminated breast carcinoma.  If it develops while on this agent, the drug should be discontinued. Caution is required in administering these agents to patients with cardiac, renal or hepatic disease.  Cholestatic jaundice is associated with therapeutic use of anabolic and androgenic steroids.  Edema may occur occasionally with or without congestive heart failure.  Concomitant administration of adrenal steroids or ACTH may add to the edema.  In children, anabolic steroid treatment may accelerate bone maturation without producing compensatory gain in linear growth.  This adverse effect may result in compromised adult stature.  The younger the child the greater the risk of compromising final mature height.   The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months.  This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

PRECAUTIONS

General

Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitorimegaly and menstrual irregularities).  Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization.  Such virilization is usual following anabolic steroid use in high doses.  The insulin or oral hypoglycemic dosage may need adjustment in diabetic patients who receive anabolic steroids.

Information for Patients

The physician should instruct patients to report any of the following side effects of androgenic anabolic steroids: Hoarseness, acne, changes in menstrual periods, more hair on the face, nausea, vomiting, changes in skin color, or ankle swelling.

Laboratory Tests

Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of anabolic therapy (see WARNINGS section).  If children are treated, periodic (every six months) X-ray examinations of bone age should be made during treatment to determine the rate of bone maturation and the effects of anabolic therapy on the epiphyseal centers.  Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of anabolic steroids.  Serum lipids and high-density lipoprotein cholesterol should be determined periodically.  Because of the hepatotoxicity associated with the use of 17-alpha-alkylated anabolic steroids, liver function tests should be obtained periodically.

Drug Interactions

Anticoagulants. Anabolic steroids may increase sensitivity to oral anticoagulants.  Dosage of the anticoagulant may have to be decreased in order to maintain the prothrombin time at the desired therapeutic level.  Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.

DRUG & OR LABORATORY TEST INTERACTIONS

Anabolic steroid therapy may decrease thyroxine-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4.  Free thyroid hormone levels remain unchanged.  Anabolic steroids may cause an increase in prothrombin time.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Nandrolone decanoate has not been tested in laboratory animals for carcinogenic or mutagenic effects.  Liver cell tumors have been reported in patients receiving androgenic anabolic steroid therapy (see WARNINGS section).  Geriatric patients treated with anabolics may be at an increased risk for prostatic hypertrophy and prostatic carcinoma.

Pregnancy

Pregnancy Category X.

See CONTRAINDICATIONS section.

Nursing Mothers

It is not known whether anabolic steroids are excreted in human milk.  Many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from anabolic steroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of Nandrolone decanoate in children with metastatic breast cancer (rarely found) has not been established. Anabolic agents may accelerate epiphyseal maturation more rapidly than linear growth in children, and the effect may continue for six months after the drug has been stopped.  Therefore, therapy should be monitored by X-ray studies at six month intervals in order to avoid the risk of compromising the adult height.

ADVERSE REACTIONS

Hepatic:

Hepatocellular neoplasms and peliosis hepatis have been reported in association with long-term androgenic anabolic steroid therapy (see WARNINGS section).

Genitourinary System:

In men.

1. Prepubertal: Phallic enlargement and increased frequency of erections.


2. Postpubertal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis and bladder irritability.

In women: Clitoral enlargement, menstrual irregularities. In both sexes: Increased or decreased libido.

CNS:

Habituation, excitation, insomnia, depression.

Gastrointestinal:

Nausea, vomiting, diarrhea.

Hematologic:

Bleeding in patients on concomitant anticoagulant therapy (see PRECAUTIONS, Drug Interactions).

Breast:

Gynecomastia.

Larynx:

Deepening of the voice in women.

Hair:

Hirsutism and male pattern of baldness in women.

Skin:

Acne (especially in women and prepubertal boys.)

Skeletal:

Premature closure of epiphyses in children (see PRECAUTIONS, Pediatric use).

Fluid and Electrolytes:

Edema, retention of serum electrolytes (sodium, chloride, potassium, phosphate, calcium).

Metabolic/Endocrine:

Decreased glucose tolerance (see PRECAUTIONS, General), increased serum levels of low-density lipoprotein and decreased levels of high-density lipoprotein (see PRECAUTIONS, Laboratory tests), increased creatine and creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens (see PRECAUTIONS).

DRUG ABUSE AND DEPENDENCE

Nandrolone decanoate injection is classified as a Schedule III controlled substance under the Anabolic Steroids Control Act of 1990.

DOSAGE AND ADMINISTRATION

Nandrolone decanoate injection is intended for deep intramuscular injection only, into the gluteal muscle preferably.  Dosage should be based on therapeutic response and consideration of the benefit to risk ratio.  Duration of therapy will depend on the response of the condition and the appearance of adverse reactions.  If possible, therapy should be intermittent.  Nandrolone decanoate should be regarded as adjunctive therapy and adequate quantities of nutrients should be consumed in order to obtain maximal therapeutic effects.  For example, when it is used in the treatment of refractory anemia, adequate iron intake is required for a maximal response.

Anemia of Renal Disease

A dose of 50 to 100 mg per week is recommended for women and 100 to 200 mg per week for men. Drug therapy should be discontinued if no hematologic improvement is seen within the first six months. For children from 2 to 13 years of age, the average dose is 25 to 50 mg every 3 to 4 weeks.  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

HOW SUPPLIED

Nandrolone Decanoate Injection USP, 200 mg per mL is available in vials of 1 mL, in cartons of 20.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

PROTECT FROM LIGHT. Store in carton until contents are used.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Revised: September 2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nandrolone DECANOATE  Nandrolone decanoate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0517-0790 Route of Administration INTRAMUSCULAR DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nandrolone DECANOATE (Nandrolone) Nandrolone DECANOATE 200 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL   SESAME OIL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0517-0790-20 20 VIAL In 1 CARTON contains a VIAL 1 1 mL In 1 VIAL This package is contained within the CARTON (0517-0790-20)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091252	01/01/2000

Labeler - American Regent, Inc. (622781813)

Revised: 09/2010American Regent, Inc.

More Nandrolone resources

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

• Nandrolone MedFacts Consumer Leaflet (Wolters Kluwer)

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• Anemia Associated with Chronic Renal Failure
• Breast Cancer
• Breast Cancer, Metastatic

Lidex Cream

Pronunciation: floo-oh-SIN-oh-nide
Generic Name: Fluocinonide
Brand Name: Examples include Lidex and Lidex-E

Lidex Cream is used for:

Treating inflammation and itching due to certain skin conditions. It may also be used for other conditions as determined by your doctor.

Lidex Cream is a topical adrenocortical steroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation) by a way that is not clearly understood.

Do NOT use Lidex Cream if:

• you are allergic to any ingredient in Lidex Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lidex Cream:

Some medical conditions may interact with Lidex Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test


• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Lidex Cream. Because little, if any, of Lidex Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Lidex Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lidex Cream:

Use Lidex Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Lidex Cream, unless your hands are part of the treated area.


• Do not bandage or cover the treated skin area unless directed by your doctor.


• If you miss a dose of Lidex Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Lidex Cream.

Important safety information:

• Lidex Cream is for external use only. Do not get Lidex Cream in your eyes. If contact is made with the eyes, flush them immediately with tap water.


• If Lidex Cream is applied to the diaper area, apply a very small amount and do not use tight-fitting diapers or plastic pants.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Talk with your doctor before you receive any vaccine while you are using Lidex Cream.


• Do not use Lidex Cream for other skin conditions at a later time.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Lidex Cream.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lidex Cream while you are pregnant. It is not known if Lidex Cream is found in breast milk. If you are or will be breast-feeding while you use Lidex Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Lidex Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Lidex Cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lidex side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Lidex Cream may be harmful if swallowed.

Proper storage of Lidex Cream:

Store Lidex Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lidex Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Lidex Cream, please talk with your doctor, pharmacist, or other health care provider.


• Lidex Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lidex Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Lidex resources

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

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Nulecit

Generic Name: sodium ferric gluconate complex (Intravenous route)

SOE-dee-um FER-rik Gloo-koe-nate KOM-plex

Commonly used brand name(s)

In the U.S.

• Ferrlecit


• Nulecit

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Mineral-Trace Mineral

Uses For Nulecit

Sodium ferric gluconate complex injection is used to treat iron deficiency anemia (not enough iron in the blood). It is used in patients with kidney disease who are receiving dialysis and a medicine called epoetin to prevent anemia. Sodium ferric gluconate complex is an iron replacement product.

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, the number of red blood cells is lower than normal. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using Nulecit

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sodium ferric gluconate complex injection in children. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 receiving this medicine, 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 this medicine 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.

• Eltrombopag

Using this medicine 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.

• Minocycline


• Mycophenolic Acid


• Zinc

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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Phytic Acid Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

• Iron overload—Use is not recommended in patients with this condition.

Proper Use of sodium ferric gluconate complex

This section provides information on the proper use of a number of products that contain sodium ferric gluconate complex. It may not be specific to Nulecit. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital or dialysis clinic. This medicine is given through a needle placed in one of your veins.

Precautions While Using Nulecit

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of 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; lightheadedness, dizziness, or fainting; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you or your child begin using this medicine, or when the dose is increased.

This medicine contains benzyl alcohol which may cause serious reactions (e.g., gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.

Nulecit 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 or nurse immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• anxiety


• arm, back, or jaw pain


• bladder pain


• bloating or swelling of the face, arms, hands, lower legs, or feet


• bloody or cloudy urine


• bloody, black, or tarry stools


• blue lips and fingernails


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• cold sweats


• confusion


• convulsions


• cool, pale skin


• cough or hoarseness


• coughing that sometimes produces a pink frothy sputum


• decreased level of consciousness


• decreased urine


• depression


• diarrhea


• difficult or labored breathing


• difficult, burning, or painful urination


• difficult, fast, or noisy breathing, sometimes with wheezing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• dry mouth


• eye pain


• fainting


• fast or slow heartbeat


• fast, pounding, or irregular heartbeat or pulse


• feeling of warmth or heat


• fever or chills


• flushing or redness of the skin, especially on the face and neck


• frequent urge to urinate


• general feeling of discomfort or illness


• headache


• increased hunger


• increased sweating


• increased thirst


• irregular heartbeat


• joint pain


• leg cramps


• lightheadedness


• loss of appetite


• lower back or side pain


• mood changes


• muscle aches and pains


• muscle cramps


• nausea or vomiting


• nervousness


• nightmares


• numbness or tingling in the hands, feet, or lips


• pain or discomfort in the arms, jaw, back, or neck


• pale skin


• pounding in the ears


• rapid weight gain


• rapid, shallow breathing


• runny nose


• shakiness


• shivering


• shortness of breath


• slow or irregular heartbeat


• slurred speech


• sore throat


• sweating


• swelling in the legs and ankles


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area


• trouble sleeping


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• weakness or heaviness of the legs


• weight gain


• wheezing

Incidence not known

• Bleeding gums


• bluish color


• changes in skin color


• cold, clammy skin


• coughing up blood


• excessive muscle tone


• face is warm or hot to touch


• fast, weak pulse


• hives


• increased menstrual flow or vaginal bleeding


• itching


• muscle stiffness


• muscle tension or tightness


• nosebleeds


• paralysis


• prolonged bleeding from cuts


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


• red or black, tarry stools


• red or dark brown urine


• skin rash


• sweating


• tenderness

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:

More common

• Accumulation of pus


• acid or sour stomach


• anxiety


• belching


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• body aches or pain


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


• burning, dry, or itching eyes


• cramps


• deafness


• difficulty with moving


• discharge or excessive tearing


• double vision


• ear congestion


• excess air or gas in the stomach or intestines


• feeling unusually cold


• full feeling


• heartburn


• hyperventilation


• increased sweating


• indigestion


• irritability


• longer or heavier menstrual periods


• loss of appetite


• loss of voice


• passing of gas


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• restlessness


• rolling of the eyes


• seeing double


• shivering


• sleepiness or unusual drowsiness


• sneezing


• stomach discomfort or upset


• swollen, red, or tender area of infection


• voice changes


• watery eyes


• weight loss

Incidence not known

• Change in taste


• loss of taste

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.

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.

Entex Pac Liquid

Pronunciation: DEX-troe-meth-OR-fan/gwye-FEN-e-sin/SOO-doe-e-FED-rin
Generic Name: Guaifenesin/Pseudoephedrine
Brand Name: Entex Pac

Entex Pac Liquid is used for:

Relieving congestion, cough, and throat and airway irritation caused by colds, hay fever, or other respiratory allergies. It may also be used for other conditions as determined by your doctor.

Entex Pac Liquid is a kit containing a decongestant and expectorant tablet combination and a cough suppressant liquid. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The expectorant works by loosening mucus and lung secretions in the chest, making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Entex Pac Liquid if:

• you are allergic to any ingredient in Entex Pac Liquid


• you have severe or uncontrolled high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you are taking droxidopa or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Entex Pac Liquid:

Some medical conditions may interact with Entex Pac Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of glaucoma or increased pressure in the eye, enlarged prostate gland or other prostate problems, heart problems (eg, fast, slow, or irregular heartbeat; heart disease), diabetes, high blood pressure, blood vessel problems, adrenal gland problems (eg, pheochromocytoma), mental or mood problems (eg, depression), trouble sleeping, an overactive thyroid, seizures, or stroke


• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema); chronic cough; or if your cough produces large amounts of mucus


• if you are in poor health or are very overweight


• if you take medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Entex Pac Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Abiraterone, beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, linezolid, MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Entex Pac Liquid's side effects


• Bromocriptine because the risk of its side effects may be increased by Entex Pac Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Entex Pac Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Entex Pac Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Entex Pac Liquid:

Use Entex Pac Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Entex Pac Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• To measure the liquid: Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Drink plenty of water while taking Entex Pac Liquid.


• If you miss a dose of Entex Pac Liquid and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Entex Pac Liquid.

Important safety information:

• Entex Pac Liquid may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Entex Pac Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Entex Pac Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take appetite suppressants while you are taking Entex Pac Liquid without checking with your doctor.


• Before you start any new medicine, check the label to see if it has a decongestant, cough suppressant, or an expectorant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 7 days, if they get worse, or if they occur with a fever, check with your doctor. If your cough goes away and comes back, or occurs with a fever, rash, or persistent headache, check with your doctor.


• Do not use Entex Pac Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Entex Pac Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Entex Pac Liquid.


• Tell your doctor or dentist that you take Entex Pac Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Entex Pac Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Entex Pac Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Entex Pac Liquid should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Entex Pac Liquid while you are pregnant. It is not known if Entex Pac Liquid is found in breast milk. Do not breast-feed while taking Entex Pac Liquid.

Possible side effects of Entex Pac Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; excitability; headache; irritability; nausea; stomach upset; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, anxiety, nervousness); paleness; persistent trouble sleeping; restlessness; seizures; severe or persistent dizziness, drowsiness, light-headedness, or headache; tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Entex Pac side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; difficulty urinating; fast or shallow breathing; hallucinations; paleness; restlessness; seizures; severe dizziness, light-headedness, or headache; severe drowsiness; tremor; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Entex Pac Liquid:

Store Entex Pac Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Entex Pac Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Entex Pac Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Entex Pac Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Entex Pac Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Entex Pac resources

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

Compare Entex Pac with other medications

• Cough and Nasal Congestion

asparaginase

Generic Name: asparaginase (as PAR a jin ase)

Brand Names: Elspar

What is asparaginase?

Asparaginase is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Asparaginase is used to treat acute lymphocytic lymphoma.

Asparaginase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about asparaginase?

Do not receive this medication if you are allergic to asparaginase or pegaspargase (Oncaspar), or if you have a history of liver disease or pancreas problems. Tell your doctor about all other cancer medications you are receiving. Get emergency medical help if you think you have received too much of this medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Even if you have received asparaginase without reaction in the past, you may have an allergic reaction to the medication when you receive it again.

Call your doctor at once if you have any of the following side effects during your treatment with asparaginase:

• 
  

  severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  sudden headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  agitation, hallucinations, seizure (convulsions); or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Asparaginase is highly toxic and both the powder and solution must be handled with care. Avoid inhaling vapors from the medicine, or allowing the medicine to come into contact with your skin, eyes, nose, or mouth. If the medicine gets on your skin, wash the area right away with soap and water. If the medicine gets into your eyes, rinse them for at least 15 minutes with water, saline, or other irrigating solution and seek emergency medical attention.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

What should I discuss with my health care provider before receiving asparaginase?

Do not receive this medication if you are allergic to asparaginase or pegaspargase (Oncaspar), or if you have a history of pancreas problems.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• 
  

  liver disease;

  
  


• 
  

  gout;

  
  


• 
  

  diabetes (asparaginase can raise blood sugar); or

  
  


• 
  

  if you are being treated with other cancer medications.

  
  

FDA pregnancy category C. It is not known whether asparaginase is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether asparaginase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is asparaginase given?

Asparaginase is given as an injection through an IV needle placed into a vein, or as a shot into a muscle. You will receive this injection in a clinic or hospital setting. The IV medicine must be given slowly, and it can take up to 30 minutes to complete.

Before you receive your first treatment with this medication, you may need a skin test to make sure you are not allergic to asparaginase.

Asparaginase can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain thyroid tests. Tell any doctor who treats you that you are receiving asparaginase.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your asparaginase injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Overdose symptoms may include easy bruising or bleeding, unusual weakness, fever, chills, flu symptoms, confusion, agitation, hallucinations, urinating less than usual or not at all, and seizure (convulsions).

What should I avoid while receiving asparaginase?

Asparaginase is highly toxic and both the powder and solution must be handled with care. Avoid inhaling vapors from the medicine, or allowing the medicine to come into contact with your skin, eyes, nose, or mouth. If the medicine gets on your skin, wash the area right away with soap and water. If the medicine gets into your eyes, rinse them for at least 15 minutes with water, saline, or other irrigating solution and seek emergency medical attention.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Asparaginase 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. Even if you have received asparaginase without reaction in the past, you may have an allergic reaction to the medication when you receive it again. Call your doctor at once if you have any of these serious side effects:

• 
  

  severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  sudden headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  increased thirst or urination;

  
  


• 
  

  agitation, hallucinations, seizure (convulsions);

  
  


• 
  

  tremors, muscle stiffness; or

  
  


• 
  

  urinating more or less than usual, or not at all.

  
  

Less serious side effects may include:

• 
  

  mild skin rash or itching;

  
  


• 
  

  depression, drowsiness;

  
  


• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  nausea, vomiting, loss of appetite, weight loss;

  
  


• 
  

  stomach cramps; or

  
  


• 
  

  headache, feeling tired or irritable.

  
  

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.

Asparaginase Dosing Information

Usual Adult Dose for Acute Lymphocytic Leukemia:

Intradermal Skin Test:

Because of the occurrence of allergic reactions, an intradermal skin test should be performed prior to the initial administration of asparaginase and when asparaginase is given after an interval of a week or more has elapsed between doses.

Use approximately two international units for the intradermal skin test. The skin test site should be observed for at least one hour for the appearance of a wheal or erythema either of which indicates a positive reaction. An allergic reaction even to the skin test dose in certain sensitized individuals may rarely occur. A negative skin test reaction does not preclude the possibility of the development of an allergic reaction.

Clinical data are insufficient for a recommendation concerning the use of combination regimens in adults. However, the use of asparaginase as the sole induction agent should be undertaken only in an unusual situation when a combined regimen is inappropriate because of toxicity or other specific patient-related factors, or in cases refractory to other therapy.

As a sole induction agent: 200 international units/kg/day intravenously for 28 days.

(When complete remissions were obtained with this regimen, they were of short duration, 1 to 3 months.)

Usual Pediatric Dose for Acute Lymphocytic Leukemia:

Intradermal Skin Test:

Because of the occurrence of allergic reactions, an intradermal skin test should be performed prior to the initial administration of asparaginase and when asparaginase is given after an interval of a week or more has elapsed between doses.

Use approximately two international units for the intradermal skin test. The skin test site should be observed for at least one hour for the appearance of a wheal or erythema either of which indicates a positive reaction. An allergic reaction even to the skin test dose in certain sensitized individuals may rarely occur. A negative skin test reaction does not preclude the possibility of the development of an allergic reaction.

Recommended Induction Regimens:

Combination regimens recommended for acute lymphocytic leukemia:

Regimen I

Prednisone 40 mg/m2 per day orally in three divided doses for 15 days, followed by tapering of the dosage as follows: 20 mg/square meter for 2 days, 10 mg/square meter for 2 days, 5 mg/square meter for 2 days, 2.5 mg/square meter for 2 days and then discontinue.

Vincristine sulfate 2 mg/m2 intravenously once weekly on days 1, 8, and 15 of the treatment period. The maximum single dose should not exceed 2 mg.

Asparaginase 1,000 international units/kg/day intravenously for ten successive days beginning on day 22 of the treatment period.

Regimen II

Prednisone 40 mg/m2 per day orally in three divided doses for 28 days (the total daily dose should be to the nearest 2.5 mg), following which the dosage of prednisone should be discontinued gradually over a 14 day period.

Vincristine sulfate 1.5 mg/m2 intravenously weekly for four doses, on days 1, 8, 15, and 22 of the treatment period. The maximum single dose should not exceed 2 mg.

Asparaginase 6,000 international units/m2 intramuscularly on days 4, 7, 10, 13, 16, 19, 22, 25, and 28 of the treatment period. When a remission is obtained with either of the above regimens, appropriate maintenance therapy must be instituted. asparaginase should not be used as part of a maintenance regimen. The above regimens do not preclude a need for special therapy directed toward the prevention of central nervous system leukemia.

Use of asparaginase as the sole induction agent should be undertaken only in an unusual situation when a combined regimen is inappropriate because of toxicity or other specific patient-related factors, or in cases refractory to other therapy.

As a sole induction agent: 200 international units/kg/day intravenously for 28 days.

(When complete remissions were obtained with this regimen, they were of short duration, 1 to 3 months.)

What other drugs will affect asparaginase?

Before receiving asparaginase, tell your doctor if you are using any of the following drugs:

• 
  

  vincristine (Oncovin, Vincasar);

  
  


• 
  

  prednisone (Deltasone, Meticorten, Orasone, and others); or

  
  


• 
  

  methotrexate (Folex, Rheumatrex, Trexall).

  
  

This list is not complete and there may be other drugs that can interact with asparaginase. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More asparaginase resources

• Asparaginase Use in Pregnancy & Breastfeeding
• Asparaginase Drug Interactions
• Asparaginase Support Group
• 0 Reviews for Asparaginase - Add your own review/rating

Compare asparaginase with other medications

• Acute Lymphocytic Leukemia

Where can I get more information?

• Your doctor or pharmacist can provide more information about asparaginase.

Alka-Seltzer Plus Cold and Sinus

Generic Name: acetaminophen and phenylephrine (a SEET a MIN oh fen and FEN il EFF rin)

Brand Names: Alka-Seltzer Plus Cold and Sinus, Excedrin Sinus Headache Caplet, Mapap Sinus Congestion and Pain, Robitussin Nasal Relief, Sinus Congestion and Pain Daytime Cool Ice, Sinus Pain & Pressure, Sudafed PE Sinus Headache, Theraflu Daytime Severe Cold, Tylenol Sinus Congestion Daytime

What is Alka-Seltzer Plus Cold and Sinus (acetaminophen and phenylephrine)?

Acetaminophen is a pain reliever and a fever reducer.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen and phenylephrine is used to treat headache, fever, body aches, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Acetaminophen and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Alka-Seltzer Plus Cold and Sinus (acetaminophen and phenylephrine)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not use acetaminophen and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other pain, cold, allergy, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking Alka-Seltzer Plus Cold and Sinus (acetaminophen and phenylephrine)?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  enlarged prostate or urination problems; or

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor).

  
  

It is not known whether acetaminophen and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

How should I take Alka-Seltzer Plus Cold and Sinus (acetaminophen and phenylephrine)?

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. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling. If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Alka-Seltzer Plus Cold and Sinus (acetaminophen and phenylephrine)?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Alka-Seltzer Plus Cold and Sinus (acetaminophen and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain, fast, slow, or uneven heart rate;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, weakness;

  
  


• 
  

  mild headache;

  
  


• 
  

  mild nausea, diarrhea, upset stomach;

  
  


• 
  

  runny nose;

  
  


• 
  

  feeling nervous, restless, or anxious; or

  
  


• 
  

  sleep problems (insomnia).

  
  

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 Alka-Seltzer Plus Cold and Sinus (acetaminophen and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take acetaminophen and phenylephrine if you are also using any of the following drugs:

• 
  

  leflunomide (Arava);

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen and phenylephrine. 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 Alka-Seltzer Plus Cold and Sinus resources

• Alka-Seltzer Plus Cold and Sinus Use in Pregnancy & Breastfeeding
• Alka-Seltzer Plus Cold and Sinus Drug Interactions
• 0 Reviews for Alka-Seltzer Plus Cold and Sinus - Add your own review/rating

Compare Alka-Seltzer Plus Cold and Sinus with other medications

• Headache
• Nasal Congestion
• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and phenylephrine.

Cuprofen Tablets

1. Name Of The Medicinal Product

Cuprofen Tablets and Ibuprofen Tablets 200mg BP

Own label: Dr White's Well Woman Tablets 200mg BP, Ibrufhalal, Lloyd's Ibuprofen Tablets, Peels Ibuprofen Tablets 200mg BP and Drummond Ibuprofen Tablets 200mg

2. Qualitative And Quantitative Composition

Each Cuprofen Tablet contains:

Ibuprofen BP 200mg

3. Pharmaceutical Form

Film Coated Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of rheumatic, muscular, dental and period pains and pain in backache, neuralgia, migraine and headache, and for the symptomatic relief of colds, flu and feverishness.

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

Adults, the elderly and children over 12 years:

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

One to two tablets up to three times as day as required.

Leave at least four hours between doses and do not take more than 6 tablets in any 24 hour period.

To be taken preferably after food.

Children under 12 years:

Not to be given to children under 12 years of age.

4.3 Contraindications

Hypersensitivity to ibuprofen or any of the excipients in the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non steroidal anti-inflammatory drugs.

Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, relating to previous NSAIDs therapy.

Severe heart failure, renal failure or hepatic failure (see section 4.4).

Last trimester of pregnancy (see section 4.6).

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Other NSAIDs:

The use of Cuprofen Maximum Strength Tablets with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

SLE and mixed connective tissue disease:

Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8)

Renal:

Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8)

Hepatic:

Hepatic dysfunction (see sections 4.3 and 4.8)

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.

Impaired female fertility:

There is limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

Gastrointestinal:

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDSs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Cuprofen Maximum Strength Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will include:

Read the enclosed leaflet before taking this product.

Do not take if you:

• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding

• are allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers

• are taking other NSAID painkillers, or aspirin with a daily dose above 75mg

Speak to a pharmacist or your doctor before taking if you

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

• are a smoker

• are pregnant

If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ibuprofen should be avoided in combination with:

Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.4). Experimental data suggests that ibuprofen may inhibit the effect of low does aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

Other NSAIDS including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4).

Ibuprofen should be used with caution in combination with:

Anticoagulants: NSAIDS may enhance the effects of anti-coagulants, such as warfarin (see section 4.4).

Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4)

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Lithium: There is evidence for potential increases in plasma levels of lithium.

Methotrexate: There is a potential for an increase in plasma methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

4.6 Pregnancy And Lactation

Whilst no teratogenic effects have been demonstrated in animal studies, the use of Cuprofen Maximum Strength Tablets should be avoided during the first 6 months of pregnancy.

During the 3rd trimester, ibuprofen is contraindicated as there is there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and duration of labour increased with an increased bleeding tendency in both the mother and child. (see section 4.3).

In limited studies, ibuprofen appears in the breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.

See section 4.4 regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

None expected at recommended doses and duration of therapy.

4.8 Undesirable Effects

Hypersensitivity reactions have been reported and these may consist of:

(a) non-specific allergic reactions and anaphylaxis

(b) respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm, dyspnoea

(c) various skin reactions, e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)

The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Hypersensitivity reactions:

Uncommon: Hypersensitivity reactions with urticaria and pruritus.

Very rare: severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).

Exacerbation of asthma and bronchospasm.

Gastrointestinal:

The most commonly-observed adverse events are gastrointestinal in nature.

Uncommon: abdominal pain, nausea, dyspepsia.

Rare: diarrhoea, flatulence, constipation and vomiting

Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis.

Exacerbation of colitis and Crohn's disease (see section 4.4).

Nervous System:

Uncommon: Headache

Very rare: Aseptic meningitis – single cases have been reported very rarely.

Renal:

Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.

Hepatic:

Very rare: liver disorders.

Haematological:

Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

Dermatological:

Uncommon: Various skin rashes

Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur.

Immune System:

In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4).

Cardiovascular and Cerebrovascular:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke), (see section 4.4).

4.9 Overdose

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Experimental data suggests that ibuprofen may inhibit the effect of low does aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single does of ibuprofen 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be like for occasional ibuprofen use.

5.2 Pharmacokinetic Properties

Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys.

Maximum plasma concentrations are reached 45 minutes after ingestion if taken on an empty stomach. When taken with food, peak levels are observed after 1 to 2 hours. These times may vary with different dosage forms.

The half-life of ibuprofen is about 2 hours.

In limited studies, ibuprofen appears in the breast milk in very low concentrations.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Core

Lactose EP

Ac-di-sol HSE

Methylcellulose (Celacol M1000) BP

Magnesium Stearate BP

Coating

Methylcellulose (Methocel E15) BP

Polyethylene Glycol 400 HSE

Sepisperse Rose AP 5002 HSE or

Mastercote Pink FA0430 HSE

6.2 Incompatibilities

None stated.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

In a glass bottle - normal storage conditions.

In blister pack - store below 25°C in a dry place.

6.5 Nature And Contents Of Container

15ml Amber Glass Universal Tablet containing 18 tablets.

30ml Amber Glass Universal Tablet containing 36 tablets.

60ml Amber Glass Universal Tablet containing 50/96 tablets.

All above fitted with child resistant cap.

Thermoformed blister pack of 6 tablets constructed of :-

(a) Plain 250µ white rigid UPVC

(b) 20µ hard temper aluminium foil containing 12, 24, 36, 48 or 96 tablets

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

SSL International PLC

Venus

1 Old Park Lane

Trafford Park

Manchester

M41 7HA

8. Marketing Authorisation Number(S)

PL 00338/0055

9. Date Of First Authorisation/Renewal Of The Authorisation

24/10/1985 / 17/06/2010

10. Date Of Revision Of The Text

16/07/2010