Web Article Directory Curaçao

Sunday, 23 September 2012

ChiRhoStim

Dosage Form: injection
FULL PRESCRIBING INFORMATION

Indications and Usage for ChiRhoStim

ChiRhoStim® is indicated for:

Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction,

Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, and

Facilitation of the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).

ChiRhoStim Dosage and Administration

Stimulation of Pancreatic Secretions, Including Bicarbonate to Aid in the Diagnosis of Exocrine Pancreas Dysfunction:

0.2 mcg/kg body weight by intravenous injection over 1 minute.

Gastroduodenal (Dreiling) Tube Collection Method(1):

A radiopaque, double-lumen tube is passed through the mouth following a 12-15 hour fast. Under fluoroscopic control, the opening of the proximal lumen of the tube is placed in the gastric antrum and the opening of the distal lumen just beyond the papilla of Vater. The positioning of the tube must be confirmed and the tube secured prior to synthetic human secretin testing. Intermittent negative pressure of 25-40 mmHg is applied to both lumens and maintained throughout the test. When duodenal contents have a pH of ≥ 6, a baseline sample of duodenal fluids is collected for a 10 minute period. A test dose of ChiRhoStim® 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. After one minute, if there are no signs of allergic reaction, ChiRhoStim® at a dose of 0.2 mcg/kg of body weight is injected intravenously over 1 minute. Duodenal fluid is collected for 60 minutes thereafter. The aspirate is divided into four collection periods of fifteen minutes each. The duodenal lumen of the tube is cleared with an injection of air after collection of each sample. Wide variation in volume of the aspirate is indicative of incomplete aspiration. Each sample of duodenal fluid is to be chilled and subsequently analyzed for volume and bicarbonate concentration. Exocrine pancreas dysfunction typically associated with chronic pancreatitis is indicated if the peak bicarbonate concentration for any sample ≤ 80 mEq/L.

Endoscopic Collection Method: Endoscopic Pancreatic Function Test (ePFT)(2-4):

After assessment of patients for sedation and analgesia, a test dose of ChiRhoStim® 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. After one minute, if there are no signs of allergic reaction, ChiRhoStim® at a dose of 0.2 mcg/kg of body weight is injected intravenously over 1 minute. An upper endoscopy is performed with conscious sedation, after topical anesthetic. All gastric fluid is aspirated through the endoscope and discarded. After small bowel intubation to the junction of the second and third portion of the duodenum, fluid is aspirated for 1 to 3 minutes and collected in 5 separate specimen traps at baseline (0), 15, 30, 45, and 60 minutes after secretin injection. The patients remain intubated with the upper endoscope for one hour in the left lateral decubitus position. Boluses of meperidine and midazolam in a 25:1 mg ratio are administered to maintain analgesia and sedation during the 1-hour procedure. Each sample of duodenal fluid is to be chilled and subsequently analyzed for volume and bicarbonate concentration. Exocrine pancreas dysfunction typically associated with chronic pancreatitis is indicated if the peak bicarbonate concentration for any sample ≤ 80 mEq/L.

Stimulation of Gastrin Secretion to Aid in Diagnosis of Gastrinoma:

0.4 mcg/kg body weight by intravenous injection over 1 minute.

The patient should fast for at least 12 hours prior to beginning the test. Prior to injection of ChiRhoStim®, two blood samples are drawn for determination of fasting serum gastrin levels (baseline values). Subsequently, a test dose of ChiRhoStim® 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. If there are no signs of allergic reaction, ChiRhoStim® at a dose of 0.4 mcg/kg of body weight is injected intravenously over 1 minute; post-injection blood samples are collected after 1, 2, 5, 10, and 30 minutes for determination of serum gastrin concentrations.

Gastrinoma is strongly indicated in patients who show an increase in serum gastrin concentrations of 110 pg/mL over basal level on any of the post injection samples.

Facilitation of the Identification of the Ampulla of Vater and Accessory Papilla During Endoscopic Retrograde Cholangiopancreatography (ERCP) to aid in cannulation of the pancreatic duct:

0.2 mcg/kg body weight by intravenous injection over 1 minute.

Administration of ChiRhoStim® may be given when difficulty is encountered by the endoscopist in identifying the ampulla of Vater for various reasons including: anatomic deformity secondary to prior surgery, radiation therapy, peptic ulcer disease, tumors, etc. or in identifying the accessory papilla in patients with pancreas divisum. A test dose of ChiRhoStim® 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. If there are no signs of allergic reaction, a dose of 0.2 mcg/kg of body weight intravenously over 1 minute may be administered and will result in visible excretion of pancreatic fluid from the orifices of these papillae enabling their identification and facilitating their cannulation.

ADMINISTRATION

ChiRhoStim® 16 mcg vial:

Dissolve the contents of the ChiRhoStim® 16 mcg vial in 8 mL of Sodium Chloride Injection USP, to yield a concentration of 2 mcg/mL. Shake vigorously to ensure dissolution. Use immediately after reconstitution and discard any unused portion.

ChiRhoStim® 40 mcg vial:

Dissolve the contents of the ChiRhoStim® 40 mcg vial in 10 mL of Sodium Chloride Injection USP, to yield a concentration of 4 mcg/mL. Shake vigorously to ensure dissolution. Use immediately after reconstitution and discard any unused portion.

For both strengths, the reconstituted drug product should be inspected visually prior to administration. If particulate matter or discoloration is seen, the product should be discarded.

Dosage Forms and Strengths

ChiRhoStim® is available in two strengths:

As a lyophilized sterile powder in 10 mL vials containing 16 mcg of human secretin.

As a lyophilized sterile powder in 10 mL vials containing 40 mcg of human secretin.

Contraindications

Patients suffering from acute pancreatitis should not receive ChiRhoStim® until the acute episode has subsided.

Warnings and Precautions

Allergic Reactions

Because of a potential allergic reaction to ChiRhoStim® patients should receive an intravenous test dose of 0.1 mL of the respective reconstituted vial. If no signs of allergic reaction are noted after one minute, the recommended dose may be injected slowly over 1 minute. A test dose is especially important in patients with a history of atopic allergy and/or asthma. Appropriate measures for the treatment of acute hypersensitivity reactions should be immediately available. No allergic reactions were observed after the test dose or full dose of synthetic human secretin in 584 patients and volunteers.

Vagotomy or Inflammatory Bowel Disease

Patients who have undergone vagotomy or who have inflammatory bowel disease may be hyporesponsive to secretin stimulation. This response does not indicate pancreatic disease, and results of secretin stimulation tests in these patients should be interpreted with caution.

Alcoholic or Other Liver Disease

A greater than normal volume response to secretin stimulation, which may mask coexisting pancreatic disease, is occasionally encountered in patients with alcoholic or other liver disease. Results of secretin stimulation tests in these patients should thus be interpreted with caution.

Adverse Reactions

Mild to moderate adverse reactions have been noted for synthetic human secretin in clinical studies in 533 patients and 51 healthy volunteers. Two severe adverse reactions, nausea and abdominal pain, occurred in one patient. Table 1 details the type and number of patients with adverse reactions.

TABLE 1 ADVERSE REACTIONS WITH ChiRhoStim®
Adverse Reaction	N = 584 Incidence (Patients)
Nausea	11 (11)
Flushing	4 (4)
Early removal of Dreiling tube	3 (3)
Abdominal pain	3 (3)
Vomiting	3 (3)
Increased heart rate	2 (2)
Mild Pancreatitis	2 (2)
Upset stomach	2 (2)
Anxiety	1 (1)
Burning in stomach or abdomen	1 (1)
Clammy skin	1 (1)
Decreased O2 saturation	1 (1)
Diarrhea	1 (1)
Faintness	1 (1)
Hypotension	1 (1)
Infiltrated IV	1 (1)
Oral secretions increased	1 (1)
Sedation	1 (1)
Slow heart rate (57bpm)	1 (1)
Tingling in legs	1 (1)
Unresponsive	1 (1)
Warm sensation in abdomen	1 (1)
Warm sensation in face	1 (1)

Of the 584 patients and healthy volunteers treated with ChiRhoStim®, a total of 29 patients (5%) had at least one adverse reaction.

Drug Interactions

The concomitant use of anticholinergic agents may make patients hyporesponsive to secretin stimulation and may produce a false result. Any results of secretin stimulation tests in these patients should thus be interpreted with caution.

USE IN SPECIAL POPULATIONS

Pregnancy

Animal reproduction studies have not been conducted with synthetic human secretin. It is also not known whether synthetic human secretin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Synthetic human secretin should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether synthetic human secretin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when synthetic human secretin is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Among the 533 patients who have received ChiRhoStim® in clinical trials 18% were 65 years of age or older and 6% were 75 years of age or older. Dosing was the same as that for the overall population of patients. No overall differences in safety, pharmacologic response, or diagnostic effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and the younger patients, but greater sensitivity of some older individuals to ChiRhoStim® cannot be ruled out.

ChiRhoStim Description

Human secretin is a gastrointestinal peptide hormone produced by cells in the duodenum in response to acidification. ChiRhoStim® (human secretin as the acetate) is a purified synthetic peptide with an amino acid sequence identical to the naturally occurring hormone. Synthetic human secretin is chemically defined as follows:

Molecular Weight 3039.44

Empirical Formula: C130H220N44O39

CAS # 108153-74-8

Structural Formula:

His - Ser - Asp - Gly - Thr - Phe - Thr - Ser - Glu - Leu - Ser - Arg - Leu - Arg - Glu - Gly - Ala - Arg - Leu - Gln - Arg - Leu - Leu - Gln - Gly - Leu - Val - NH2

ChiRhoStim® is available in two strengths:

As a 10 ml vial which contains 16 mcg of purified synthetic human secretin, 1.5 mg of L-cysteine hydrochloride, 20 mg of mannitol, and 9 mg of sodium chloride per vial. When reconstituted in 8 mL of Sodium Chloride Injection USP, each mL of solution contains 2 mcg synthetic human secretin for intravenous use. The pH of the reconstituted solution has a range of 3 to 6.5.

As a 10 ml vial which contains 40 mcg of purified synthetic human secretin, 3.75 mg of L-cysteine hydrochloride, 50 mg of mannitol, and 22.5 mg of sodium chloride per vial. When reconstituted in 10 mL of Sodium Chloride Injection USP, each mL of solution contains 4 mcg synthetic human secretin for intravenous use. The pH of the reconstituted solution has a range of 3 to 6.5.

ChiRhoStim - Clinical Pharmacology

The primary action of ChiRhoStim® is to increase the volume and bicarbonate content of secreted pancreatic juices. The standard unit of activity used for ChiRhoStim® is the clinical unit as defined in the literature.(5) Synthetic human secretin (sHS), synthetic porcine secretin (sPS) and biologically derived porcine secretin (bPS) have been evaluated and compared in the validated cat bioassay used for release of bPS. sHS and sPS were found to have similar pharmacological activity in terms of stimulating the exocrine pancreas to secrete juice and bicarbonate. The potency correlation with bPS for both sHS and sPS was 0.2 mcg (sHS or sPS) corresponding to 1 CU (bPS). The biological activity of sHS and sPS was approximately 5.0 CU per mcg as opposed to 3.0 CU per mcg for bPS.

Mechanism of Action

Secretin is a hormone that is normally released from the duodenum upon exposure of the proximal intestinal lumen to gastric acid, fatty acids and amino acids. Secretin is released from enterochromaffin cells in the intestinal mucosa. Secretin receptors have been identified in the pancreas, stomach, liver, colon and other tissues. When secretin binds to secretin receptors on pancreatic duct cells it opens cystic fibrosis transmembrane conductance regulator (CFTR) channels, leading to secretion of bicarbonate-rich-pancreatic fluid. Secretin may also work through vagal-vagal neural pathways since stimulation of the efferent vagus nerve stimulates bicarbonate secretion and atropine blocks secretin-stimulated pancreatic secretion. See references 6 and 7 for additional details on mechanism of action of secretin and feedback controls.

Pharmacokinetics

The PK profile for synthetic human secretin was evaluated in 12 normal subjects. After intravenous bolus administration of 0.4 mcg/kg, synthetic human secretin concentration rapidly declines to baseline secretin levels within 90 to 120 minutes. The elimination half-life of synthetic human secretin is 45 minutes. The clearance of synthetic human secretin is 580.9 ± 51.3 mL/min and the volume of distribution is 2.7 L.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of synthetic human secretin. Studies to evaluate the potential for impairment of fertility or mutagenicity of synthetic human secretin have not been performed.

Animal Toxicology and/or Pharmacology

A single intravenous dose of synthetic human secretin at 20 mcg/kg was not lethal to mice or rabbits.

Clinical Studies

Stimulation of pancreatic secretions, including bicarbonate to aid in the diagnosis of Exocrine Pancreas Dysfunction:

ChiRhoStim® administered intravenously stimulates the exocrine pancreas to secrete pancreatic juice, which can assist in the diagnosis of exocrine pancreas dysfunction. Normal ranges for pancreatic secretory response to intravenous secretin in patients with defined pancreatic disease have been shown to vary. One source of variation is related to the inter-investigator differences in operative technique.

In two crossover studies (CRC98-2 and CRC99-9), a total of 18 patients with a documented history of chronic pancreatitis were given sHS, sPS and bPS. The results appear in Figures 1 and 2. In another study, 35 normal volunteers were given sHS. The results appear in Figures 1 and 2.

The values obtained for Figures 1 and 2 were performed by investigators skilled in performing secretin stimulation testing and are to be taken only as guidelines. These results should not be generalized to results of secretin stimulation testing conducted in other laboratories. However, a volume response of less than 2 mL/kg/hr, bicarbonate concentration of less than 80 mEq/L, and a bicarbonate output of less than 0.2 mEq/kg/hr are consistent with impaired pancreatic function.

A physician or institution planning to perform secretin stimulation testing as an aid to the diagnosis of pancreatic disease should begin by assessing enough normal subjects (>5) to develop proficiency in proper techniques and to generate normal response ranges for the commonly assessed parameters for pancreatic exocrine response to ChiRhoStim®.

In three crossover studies (CRC 98-1, CRC 98-2, and CRC 99-9) evaluating 21 different patients with a documented history of chronic pancreatitis, synthetic human secretin (sHS) was compared to synthetic porcine secretin (sPS) and biologically derived secretin (bPS). All of the patients treated with these drugs had peak bicarbonate concentrations of < 80 mEq/L.

Pancreatic secretory response to intravenous synthetic human secretin in 35 normal healthy subjects demonstrated a mean peak bicarbonate concentration of 100 mEq/L and a mean total volume over one hour of 260.7 mL. All 35 subjects had peak bicarbonate concentrations ≥ 80 mEq/L.

Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma

ChiRhoStim® administered intravenously stimulates gastrin release in patients with gastrinoma (Zollinger-Ellison Syndrome), whereas no or only small changes in serum gastrin concentrations occur in normal subjects and in patients with duodenal ulcer disease. Deveney, et al. established the high sensitivity and specificity of the secretin stimulation test to aid in the diagnosis of gastrinoma and found using discriminant analysis that an increase from baseline of ≥ 110 pg/mL was the optimal point separating positive and negative tests.(8) This gastrin response is the basis for the use of synthetic human secretin as a provocative test in the evaluation of patients in whom gastrinoma is a diagnostic consideration.

In a three way crossover study of 6 patients with tissue diagnosed gastrinoma, there was agreement among synthetic human secretin (ChiRhoStim®), synthetic porcine secretin and biologically derived porcine secretin regarding gastrin levels. Serum gastrin levels were reported to be >110 pg/mL for all secretin products tested after stimulation with 0.4 mcg/kg secretin. Testing of ChiRhoStim® in 12 healthy volunteers demonstrated completely negative results for gastrinoma.

Facilitation of identification of the ampulla of Vater and the accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP) to assist in cannulation of the pancreatic ducts

In a randomized, placebo controlled crossover study in 24 patients with pancreas divisum undergoing ERCP, synthetic human secretin administration at a dose of 0.2 mcg/kg resulted in 16 of 24 successful cannulations of the minor duct compared to 2 of 24 for placebo.

REFERENCES

Dreiling DA. Pancreatic secretory testing in 1974. Gut. 1975;16(8):653-7.

Stevens T, Conwell DL, Zuccaro G Jr, Van Lente F, Purich E, Khandwala F, Fein S. A randomized crossover study of secretin-stimulated endoscopic and dreiling tube pancreatic function test methods in healthy subjects. Am J Gastroenterol. 2006 Feb;101(2):351-5.

Yadav D, Chari ST. The Endoscopic Pancreatic Exocrine Function Test (ePFT): Can it be the New “Gold Standard”? Gastroenterology 2006 Oct;131(4):1349-1350.

Conwell DL, Zuccaro G, Purich E, Fein S, Vanlente F, Vargo J, Dumot J, O'laughlin C, Trolli P. The effect of moderate sedation on exocrine pancreas function in normal healthy subjects: a prospective, randomized, cross-over trial using the synthetic porcine secretin stimulated Endoscopic Pancreatic Function Test (ePFT). Am J Gastroenterol. 2005 May;(5):1161-6.

Jorpes, E. and Mutt V. On the biological assay of secretin. The reference standard. Acta Physiol Scand. 1966 Mar;66(3):316-25.

Chey WY, Chang T-M, Secretin. In: Kasin AJ. Editor. Handbook of Biologically Active Peptides. Elsevier, Amsterdam. 2006;1115-1122.

Whitcomb DC. Neurohormonal Control of the Exocrine Pancreas. In:Greeley JR G, editor. Endocrinology of the Gastrointestinal System. Totowa NJ:Humana Press. 1998;239-258.

Deveney, C.W., et al. Use of Calcium and Secretin in the Diagnosis of Gastrinoma (Zollinger-Ellison Syndrome). Ann Intern Med. 1977 Dec;87(6):680-6.

How Supplied/Storage and Handling

: ChiRhoStim ® 16 mcg vial NDC # 67066-005-01
: ChiRhoStim ®40 mcg vial NDC # 67066-007-01

Supplied

ChiRhoStim® is supplied in two strengths:

As a lyophilized sterile powder in vials containing 16 mcg of human secretin.

As a lyophilized sterile powder in vials containing 40 mcg of human secretin.

Storage

The unreconstituted product should be stored at -20°C (freezer). Expiration date is marked on the label. Protect from light.

Patient Counseling Information

Since there is no data on pregnant or nursing mothers, physicians should discuss these matters with the patient before using this product.

ChiRhoStim® is a registered trademark of ChiRhoClin, Inc.

Manufactured for:

ChiRhoClin, Inc

Burtonsville, MD 20866-6129

Manufactured by:

Bell-More Labs, Inc.

Hampstead, Maryland 21074-0179

005PI504

ChiRhoStim
secretin human injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	67066-005
Route of Administration	INTRAVENOUS	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Secretin human (Secretin human)	Active	16 MICROGRAM In 8 MILLILITER
L-cysteine hydrochloride	Inactive	1.5 MILLIGRAM In 8 MILLILITER
mannitol	Inactive	20 MILLIGRAM In 8 MILLILITER
sodium chloride	Inactive	9 MILLIGRAM In 8 MILLILITER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	67066-005-01	8 mL (MILLILITER) In 1 VIAL, SINGLE-USE	None

ChiRhoStim
secretin human injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	67066-007
Route of Administration	INTRAVENOUS	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Secretin human (Secretin human)	Active	40 MICROGRAM In 10 MILLILITER
L-cysteine hydrochloride	Inactive	3.75 MILLIGRAM In 10 MILLILITER
mannitol	Inactive	50 MILLIGRAM In 10 MILLILITER
sodium chloride	Inactive	22.5 MILLIGRAM In 10 MILLILITER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	67066-007-01	10 mL (MILLILITER) In 1 VIAL, SINGLE-USE	None

Revised: 08/2007ChiRhoClin, Inc

More ChiRhoStim resources

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

Secretin Professional Patient Advice (Wolters Kluwer)

Human Secretin Consumer Overview

Compare ChiRhoStim with other medications

Diagnosis and Investigation

Saturday, 22 September 2012

Glycopyrrolate Injection USP 200 micrograms / ml, 1ml & 3ml

1. Name Of The Medicinal Product

Glycopyrrolate Injection U.S.P. 200 micrograms/ml, 1ml & 3ml.

2. Qualitative And Quantitative Composition

Each ml of solution contains 200 micrograms of glycopyrrolate USP.

3. Pharmaceutical Form

Clear, colourless, sterile solution intended for parenteral administration to human beings.

4. Clinical Particulars

4.1 Therapeutic Indications

(1) To protect against the peripheral muscarinic actions of anticholinesterases such as neostigmine and pyridostigmine used to reverse residual neuromuscular blockade produced by non-depolarising muscle relaxants.

(2) As a pre-operative antimuscarinic agent to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric contents.

(3) As a pre-operative or intra-operative antimuscarinic to attenuate or prevent intraoperative bradycardia associated with the use of suxamethonium, cardiac vagal reflexes or that associated with the use of the non-depolarising relaxants atracurium and vecuronium.

4.2 Posology And Method Of Administration

For intravenous or intramuscular use.

A.) Premedication

Adults and older Patients

200 to 400 micrograms (0.2 to 0.4mg) intravenously or intramuscularly before the induction of anaesthesia. Alternatively, a dose of 4 to 5 micrograms/kg (0.004 to 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. Larger doses may result in a marked and prolonged antisialogogue action which may be unpleasant for the patient.

Children

4 to 8 micrograms/kg (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) intravenously or intramuscularly before the induction of anaesthesia. Larger doses may result in a marked and prolonged antisialogogue action which may be unpleasant for the patient.

B.) Intra-operative Use

Adults and Older Patients

A single dose of 200 to 400 micrograms (0.2 to 0.4mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 5 micrograms/kg (0.004 - 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. This dose may be repeated as necessary.

Children

When indicated, a single dose of 200 micrograms (0.2mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 8 micrograms per kg (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) may be used. This dose may be repeated if necessary.

Reversal of non-depolarising neuromuscular block

Adults and Older Patients

200 micrograms (0.2mg) intravenously per 1000 micrograms (1mg) neostigmine or the equivalent dose of pyridostigmine. Alternatively, a dose of 10 - 15 micrograms/kg (0.01 to 0.015mg/kg) intravenously with 50 micrograms/kg (0.05mg/kg) of neostigmine or the equivalent dose of pyridostigmine.

Glycopyrrolate may be mixed with either neostigmine or pyridostigmine in the same syringe and administered simultaneously; greater cardiovascular stability results from this method of administration.

Children

10 micrograms/kg (0.01mg/kg) intravenously with 50 micrograms/kg (0.05mg/kg) neostigmine or equivalent doses of pyridostigmine. Glycopyrrolate may be mixed in the same syringe as neostigmine or pyridostigmine and administered simultaneously; greater cardiovascular stability results from this method of administration.

4.3 Contraindications

Apart from established hypersensitivity to glycopyrrolate, there are no absolute contraindications.

4.4 Special Warnings And Precautions For Use

Because of the increased heart rate produced by the administration of anticholinergics, glycopyrrolate should be administered with care in patients with coronary artery disease; congestive heart failure; cardiac dysrhythmias; hypertension; thyrotoxicosis. Extreme care must be observed if it is necessary to use glycopyrrolate in pyrexial patients due to the inhibition of sweating.

Quaternary ammonium compounds in large dose have been shown to block the nicotinic muscle end plate receptors. This must be evaluated prior to its administration in patients with myasthenia gravis.

Anticholinergic drugs can cause ventricular arrhythmias when administered during inhalation anaesthesia especially in association with the halogenated hydrocarbons.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The effects of glycopyrrolate may be enhanced by the concurrent administration of other drugs with antimuscarinic properties.

4.6 Pregnancy And Lactation

Although reproduction studies in rats and rabbits revealed no teratogenic effects from glycopyrrolate, safety in human pregnancy and lactation has not been established.

Diminished rates of conception and of survival at weaning were observed in rats, in a dose related manner. Studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. The significance of this for man is not clear.

4.7 Effects On Ability To Drive And Use Machines

Although disturbances in visual accommodation may occur which might affect a patient's ability to drive and use machines, the conditions under which glycopyrrolate is administered would generally preclude any opportunity to drive or operate machines.

4.8 Undesirable Effects

Glycopyrrolate may produce the following effects which are extensions of its fundamental pharmacological actions : dry mouth, difficulty in micturition, disturbances in visual accommodation, tachycardia, palpitation, inhibition of sweating.

4.9 Overdose

Because glycopyrrolate is a quaternary ammonium compound, symptoms of overdosage are peripheral rather than central in nature. To treat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methyl sulphate may be given in a dose of 1000 micrograms (1.0mg) for each 1000 micrograms (1.0mg) of glycopyrrolate known to have been administered by the parenteral route.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycopyrrolate has a specific effect on salivary and sweat gland activity with little effect on pupil size, visual accommodation or heart rate. At a dose of 0.2mg intramuscularly, sweat gland activity and salivation are markedly inhibited for over 6 hours.

Absorption from the intramuscular site of administration is almost complete and as rapid, as that following intravenous (I.V.) administration. As would be anticipated from a quaternary ammonium compound, oral absorption is poor and erratic.

Glycopyrrolate is a superior drug when compared with atropine. A dose of 0.4mg IM inhibits salivation by over 90% and produces only slight slowing of the heart rate. Atropine has been shown in doses of 2.0mg I.M. to inhibit salivation by approximately 80% but produces a rise in heart rate of greater than 80%.

5.2 Pharmacokinetic Properties

Studies involving radio-labelled glycopyrrolate (200ug intravenously) show that the initial distribution phase is extremely rapid, approximately 90% of the radio-activity disappeared from plasma within five minutes and being rapidly excreted in bile and urine.

Approximately 10 - 20% is absorbed from the gastro-intestinal tract and is excreted in bile and urine as unchanged drug and metabolites. Like all quaternary ammonium compounds, it penetrates the blood brain barrier only poorly.

5.3 Preclinical Safety Data

No further information other than which is included in the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Chloride BP

Dilute Hydrochloric Acid BP

Water for Injections BP

6.2 Incompatibilities

Glycopyrrolate has been shown to be physically compatible with the following agents commonly used in anaesthetic practice: butorphanol, lorazepam, droperidol and fentanyl citrate, levorphanol tartrate, pethidine hydrochloride, morphine sulphate, neostigmine, promethazine and pyridostigmine.

Glycopyrrolate is incompatible with alkalis, these include the following agents used in anaesthetic practice : diazepam, dimenhydrinate, methohexitone sodium, pentazocine, pentobarbitone sodium, propofol, thiopentone sodium.

6.3 Shelf Life

20 months.

If only part of an ampoule is used, discard the remaining solution.

6.4 Special Precautions For Storage

Protect from light.

Store in a cool dry place.

6.5 Nature And Contents Of Container

1ml and 3ml clear glass ampoules, glass type I, Ph. Eur. borosilicate glass packed in cardboard cartons to contain 10 x 1ml or 10 x 3ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

For I.M. and I.V. Injection.

Use as directed by the physician.

Keep out of reach of children.

If only part used, discard the remaining solution.

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 02848/0159.

9. Date Of First Authorisation/Renewal Of The Authorisation

05 November 1991.

10. Date Of Revision Of The Text

23 October 1996.

Monday, 17 September 2012

eprosartan

Generic Name: eprosartan (EP roe SAR tan)

Brand Names: Teveten

What is eprosartan?

Eprosartan is in a group of drugs called angiotensin II receptor antagonists. Eprosartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Eprosartan is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.

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

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

Stop using this medication and tell your doctor right away if you become pregnant. Eprosartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. You should not use this medication if you are allergic to eprosartan. Drinking alcohol can further lower your blood pressure and may increase certain side effects of eprosartan. Do not use potassium supplements or salt substitutes while you are taking eprosartan, unless your doctor has told you to.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

In rare cases, eprosartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

What should I discuss with my healthcare provider before taking eprosartan?

You should not use this medication if you are allergic to eprosartan.

To make sure you can safely take eprosartan, tell your doctor if you have any of these other conditions:

kidney disease;

liver disease;

congestive heart failure; or

if you are dehydrated.

FDA pregnancy category D. Do not use eprosartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Eprosartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking eprosartan. It is not known whether eprosartan 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 should I take eprosartan?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

You may take eprosartan with or without food.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking eprosartan. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Visit your doctor regularly.

It may take 2 to 3 weeks of using this medicine before your blood pressure is under control. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 3 weeks of treatment.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store eprosartan at room temperature away from moisture and heat.

See also: Eprosartan dosage (in more detail)

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dizziness or feeling like you might pass out.

What should I avoid while taking eprosartan?

Drinking alcohol can further lower your blood pressure and may increase certain side effects of eprosartan. Do not use potassium supplements or salt substitutes while you are taking eprosartan, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Eprosartan 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. In rare cases, eprosartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Call your doctor at once if you have a serious side effect such as:

feeling like you might pass out;

urinating less than usual or not at all;

chest pain, fast heart rate; or

swelling in your hands or feet.

Less serious side effects may include:

runny or stuffy nose, sore throat, cough;

joint pain;

nausea, stomach pain, diarrhea;

headache, dizziness; or

tired feeling.

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.

Eprosartan Dosing Information

Usual Adult Dose for Hypertension:

Initial dose: 600 mg once daily assuming adequate intravascular volume
Maintenance dose: total daily doses of 400 to 800 mg administered once or twice daily

What other drugs will affect eprosartan?

Tell your doctor about all other medicines you use, especially:

a diuretic (water pill); or

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

This list is not complete and other drugs may interact with eprosartan. 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 eprosartan resources

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

eprosartan Advanced Consumer (Micromedex) - Includes Dosage Information

Eprosartan MedFacts Consumer Leaflet (Wolters Kluwer)

Eprosartan Prescribing Information (FDA)

Eprosartan Mesylate Monograph (AHFS DI)

Teveten Prescribing Information (FDA)

Compare eprosartan with other medications

High Blood Pressure

Where can I get more information?

Your pharmacist can provide more information about eprosartan.

See also: eprosartan side effects (in more detail)

Saturday, 15 September 2012

Covonia Vapour Drops

1. Name Of The Medicinal Product

Covonia Vapour Drops

2. Qualitative And Quantitative Composition

Covonia Vapour Drops contains the following active ingredients:

Menthol BP natural or Menthol BP synthetic 17.5% w/v

Peppermint Oil BP 0.2% v/v

For excipients, see 6.1

3. Pharmaceutical Form

Inhalation vapour, solution.

A clear yellow liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of catarrh, hay fever and nasal congestion.

4.2 Posology And Method Of Administration

Adults, the elderly and children over 3 months:

Sprinkle a few drops on a handkerchief and inhale the vapour.

Children under 3 months:

Not recommended for children under 3 months.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Not recommended for children under 3 months.

4.4 Special Warnings And Precautions For Use

In young children, menthol can cause spasm of the glottis and cases of collapse have been reported in children following local application.

The label states:

1 If symptoms persist, consult your doctor.

2 Avoid contact with the eyes.

3 Not to be taken internally.

4 Keep all medicines out of the sight and reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

The safety of Covonia Vapour Drops in pregnancy and lactation has not been established, but is not thought to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No or negligible influence.

4.8 Undesirable Effects

Occasional hypersensitivity reactions are a possibility.

4.9 Overdose

Following oral ingestion, the following symptoms may be expected: insomnia, unsteady gait, tremor of hands, nausea and vomiting, delirium, epileptiform convulsions, depression and coma. Treatment should consist of gastric lavage and aspiration. A saline purgative such as 30g of sodium sulphate in 250ml of water may be given and any convulsions controlled by intravenous diazepam.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

R01A X – Other nasal preparations, combinations

Menthol, a frequent constituent of inhalation preparations, produces a sensation of decreased nasal congestion, possibly by virtue of its local anaesthetic action on the nasal mucosal surface. Peppermint Oil possesses the physiological actions and therapeutic uses of menthol.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Eucalyptus Oil Ph. Eur

Cajuput Oil BPC 1973

Spike Lavender Fragrance Oil HSE

Industrial Methylated Spirit BP

6.2 Incompatibilities

None stated.

6.3 Shelf Life

10ml: 36 months

15ml: 36 months

30ml: 36 months

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

10ml, 15ml & 30ml pack - amber glass bottle with polyethylene screw cap with integral polyethylene dropper.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

19 June 2002

10. Date Of Revision Of The Text

19/09/03

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable

Thursday, 13 September 2012

Triaminic Cough/Sore Throat Chewable Tablets

Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Dextromethorphan/Pseudoephedrine
Brand Name: Triaminic Cough/Sore Throat

Triaminic Cough/Sore Throat Chewable Tablets are used for:

Relieving pain, congestion, and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Triaminic Cough/Sore Throat Chewable Tablets are an analgesic, decongestant, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you breathe more easily. The analgesic and cough suppressant work in the brain to decrease pain and reduce the cough reflex.

Do NOT use Triaminic Cough/Sore Throat Chewable Tablets if:

you are allergic to any ingredient in Triaminic Cough/Sore Throat Chewable Tablets

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

you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (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 Triaminic Cough/Sore Throat Chewable Tablets:

Some medical conditions may interact with Triaminic Cough/Sore Throat Chewable Tablets. 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, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, or liver problems, or if you consume more than 3 alcohol-containing drinks per day

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

Some MEDICINES MAY INTERACT with Triaminic Cough/Sore Throat Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Triaminic Cough/Sore Throat Chewable Tablets may be increased

Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat, or heart attack may be increased

Bromocriptine because the risk of side effects may be increased by Triaminic Cough/Sore Throat Chewable Tablets

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Triaminic Cough/Sore Throat Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triaminic Cough/Sore Throat Chewable Tablets 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 Triaminic Cough/Sore Throat Chewable Tablets:

Use Triaminic Cough/Sore Throat Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Triaminic Cough/Sore Throat Chewable Tablets may be taken with or without food.

Chew thoroughly before swallowing.

If you miss a dose of Triaminic Cough/Sore Throat Chewable Tablets, 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 Triaminic Cough/Sore Throat Chewable Tablets.

Important safety information:

Triaminic Cough/Sore Throat Chewable Tablets may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Triaminic Cough/Sore Throat Chewable Tablets. Using Triaminic Cough/Sore Throat Chewable Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Do not take appetite suppressants while you are taking Triaminic Cough/Sore Throat Chewable Tablets without checking with your doctor.

Triaminic Cough/Sore Throat Chewable Tablets contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.

Do NOT exceed the recommended dose or take Triaminic Cough/Sore Throat Chewable Tablets for longer than prescribed without checking with your doctor.

If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

Triaminic Cough/Sore Throat Chewable Tablets may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Triaminic Cough/Sore Throat Chewable Tablets or other pain relievers/fever reducers. Alcohol use combined with Triaminic Cough/Sore Throat Chewable Tablets may increase your risk for liver damage.

Triaminic Cough/Sore Throat Chewable Tablets may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Triaminic Cough/Sore Throat Chewable Tablets.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Triaminic Cough/Sore Throat Chewable Tablets.

Use Triaminic Cough/Sore Throat Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects.

Caution is advised when using Triaminic Cough/Sore Throat Chewable Tablets in CHILDREN because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Triaminic Cough/Sore Throat Chewable Tablets, discuss with your doctor the benefits and risks of using Triaminic Cough/Sore Throat Chewable Tablets during pregnancy. It is unknown if Triaminic Cough/Sore Throat Chewable Tablets are excreted in breast milk. Do not breast-feed while taking Triaminic Cough/Sore Throat Chewable Tablets.

Possible side effects of Triaminic Cough/Sore Throat Chewable Tablets:

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:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.

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: Triaminic Cough/Sore Throat 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; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Triaminic Cough/Sore Throat Chewable Tablets:

Store Triaminic Cough/Sore Throat Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Triaminic Cough/Sore Throat Chewable Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Triaminic Cough/Sore Throat Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.

Triaminic Cough/Sore Throat Chewable Tablets are 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 Triaminic Cough/Sore Throat Chewable Tablets. 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

More Triaminic Cough/Sore Throat resources

Triaminic Cough/Sore Throat Side Effects (in more detail)
Triaminic Cough/Sore Throat Use in Pregnancy & Breastfeeding
Triaminic Cough/Sore Throat Drug Interactions
Triaminic Cough/Sore Throat Support Group
1 Review for Triaminic Cough/Sore Throat - Add your own review/rating

Compare Triaminic Cough/Sore Throat with other medications

Cold Symptoms

Wednesday, 12 September 2012

Psyllium Powder

Pronunciation: SILL-i-um
Generic Name: Psyllium
Brand Name: Examples include Konsyl and Metamucil Smooth Texture

Psyllium Powder is used for:

Treating occasional constipation and restoring regularity. It may also be used for other conditions as determined by your doctor.

Psyllium Powder is a fiber laxative. It works by absorbing water and swelling in the intestines. This helps the stool form the bulk necessary to be easily passed.

Do NOT use Psyllium Powder if:

you are allergic to any ingredient in Psyllium Powder

you have appendicitis, difficulty swallowing, severe constipation, intestinal blockage, or undiagnosed rectal bleeding

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

Before using Psyllium Powder:

Some medical conditions may interact with Psyllium Powder. 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 sudden change in bowel habits persisting for more than 2 weeks

if you have stomach or intestinal pain, nausea, or vomiting

Some MEDICINES MAY INTERACT with Psyllium Powder. However, no specific interactions with Psyllium Powder are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Psyllium Powder 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 Psyllium Powder:

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

Psyllium Powder may be taken with or without food.

Empty the contents of 1 packet (unless directed by your doctor to use a different dose) into an empty glass. Mix Psyllium Powder with a full glass (at least 8 oz or 240 mL) of water or other liquid. Stir briskly and drink immediately. If the mixture thickens, add more liquid and stir.

Do not take other oral medicines within 2 hours before or 2 hours after taking Psyllium Powder.

If you miss a dose of Psyllium Powder, 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 Psyllium Powder.

Important safety information:

If your symptoms do not improve within 7 days or if they become worse, check with your doctor.

Do not take additional laxatives or stool softeners with Psyllium Powder unless directed by your doctor.

Do not use Psyllium Powder if you experience stomach pain, nausea, vomiting, or rectal bleeding, except under the direction of your doctor.

If you notice a sudden change in bowel habits that lasts for 2 weeks or more, do not continue using Psyllium Powder. Instead, check with your doctor.

Taking this product without enough liquid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty swallowing. If you experience chest pain, vomiting, or difficulty swallowing or breathing after taking this product, seek immediate medical attention.

Do not use Psyllium Powder in CHILDREN younger than 12 years of age without first checking with your doctor.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Psyllium Powder, discuss with your doctor the benefits and risks of using Psyllium Powder during pregnancy. It is unknown if Psyllium Powder is excreted in breast milk. If you are or will be breast-feeding while you are using Psyllium Powder, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Psyllium Powder:

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:

Abdominal fullness; minor bloating.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty swallowing; trouble breathing; vomiting.

See also: Psyllium 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.

Proper storage of Psyllium Powder:

Store Psyllium Powder at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Psyllium Powder out of the reach of children and away from pets.

General information:

If you have any questions about Psyllium Powder, please talk with your doctor, pharmacist, or other health care provider.

Psyllium Powder 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 Psyllium Powder. 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

More Psyllium resources

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

Compare Psyllium with other medications

Constipation
Dietary Fiber Supplementation
Irritable Bowel Syndrome

Tuesday, 11 September 2012

Cetirizine Hydrochloride

Class: Second Generation Antihistamines
VA Class: AH105
Chemical Name: [2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl] ethoxy]-acetic acid dihydrochloride
Molecular Formula: C₂₁H₂₅C_lN₂O₃•2ClH
CAS Number: 83881-52-1
Brands: Zyrtec, Zyrtec-D

Introduction

Second generation antihistamine; piperazine-derivative, carboxylic acid metabolite of hydroxyzine.¹ ² ³ ¹¹ ¹² ²⁰

Uses for Cetirizine Hydrochloride

Allergic Rhinitis

Self-medication for symptomatic relief of rhinorrhea, sneezing, lacrimation, itching eyes, and/or oronasopharyngeal itching associated with seasonal (e.g., hay fever) allergic rhinitis or other upper respiratory allergies.¹ ² ³ ¹² ²⁰ ²⁵ ²⁶ ²⁷ ⁴² ⁴⁶ ⁴⁹ ⁶² ⁶³ ⁶⁸ ⁶⁹ ⁷⁰ ⁷¹

Symptomatic relief of perennial (nonseasonal) allergic rhinitis.¹

May be used alone or in fixed combination with pseudoephedrine hydrochloride;¹ ⁶³ ⁶⁹ use fixed-combination preparation only when both antihistamine and nasal decongestant activity are needed concurrently.⁶³

Chronic Idiopathic Urticaria

Self-medication for symptomatic relief of pruritus associated with chronic idiopathic urticaria (e.g., hives);¹ ² ³ ¹² ²⁰ ²⁸ ²⁹ ⁴⁶ ⁷² not for prevention of chronic idiopathic urticaria or allergic skin reactions.⁷²

Cetirizine Hydrochloride Dosage and Administration

Administration

Oral Administration

Administer orally without regard to food.¹ ² ³ ¹² ¹⁴ ²⁰ May adjust time of administration for individual patient requirements.¹ ³

Oral solution (syrup): Use only the measuring device (i.e., cup) provided by the manufacturer.⁷⁰ ⁷²

Chewable tablets: Administer with or without water.¹ ⁷¹

Fixed combination cetirizine/pseudoephedrine tablets (Zyrtec-D): Swallow whole; do not break or chew.⁶³ ⁶⁹

Dosage

Available as cetirizine hydrochloride; dosage expressed in terms of the salt.¹

Pediatric Patients

Allergic Rhinitis

Seasonal

Self-medication in children 2 to <6 years of age: 2.5 mg once daily (as oral solution); may increase dosage to a maximum of 5 mg daily, given either as a 5-mg dose once daily or, alternatively, as a 2.5-mg dose every 12 hours.¹ ⁷⁰ (See Pediatric Use under Cautions.)

Self-medication in children ≥6 years of age: 5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity.¹ ² ³ ¹⁵ ²⁰ ²² ²³ ²⁵ ⁶⁸ ⁷⁰ ⁷¹ In clinical trials, most children ≥12 years of age received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.¹

Self-medication in children ≥12 years of age: 5 mg every 12 hours (in fixed combination with 120 mg pseudoephedrine hydrochloride).⁶³ ⁶⁹

Perennial

Oral

Children 6 months to <2 years of age: 2.5 mg once daily (as oral solution).¹ In children 12–23 months of age, may increase dosage to a maximum of 5 mg daily, given as 2.5 mg every 12 hours.¹ (See Pediatric Use under Cautions.)

Children 2–5 years of age: 2.5 mg once daily (as oral solution);¹ may increase dosage to a maximum of 5 mg daily, given either as a 5-mg dose once daily (as chewable tablets or oral solution) or, alternatively, as a 2.5-mg dose every 12 hours (as oral solution).¹ (See Pediatric Use under Cautions.)

Children ≥6 years of age: 5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity.¹ ² ³ ¹⁵ ²⁰ ²² ²³ ²⁵ In clinical trials, most children ≥12 years of age received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.¹

Children ≥12 years of age: 5 mg twice daily (every 12 hours) (in fixed combination with 120 mg pseudoephedrine hydrochloride).⁶³

Chronic Idiopathic Urticaria

Oral

Self-medication in children ≥6 years of age: 5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity.¹ ² ³ ¹⁵ ²⁰ ²² ²³ ²⁵ ⁷² In clinical trials, most children ≥12 years of age received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.¹

Adults

Allergic Rhinitis

Seasonal

Oral

Self-medication: 5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity.¹ ² ³ ¹⁵ ²⁰ ²² ²³ ²⁵ ⁶⁸ ⁷⁰ ⁷¹ In clinical trials, most patients received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.¹

Self-medication: 5 mg twice daily (every 12 hours) (in fixed combination with 120 mg pseudoephedrine hydrochloride).⁶³ ⁶⁹

Perennial

Oral

5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity.¹ ² ³ ¹⁵ ²⁰ ²² ²³ ²⁵ In clinical trials, most patients received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.¹

5 mg twice daily (every 12 hours) (in fixed combination with 120 mg pseudoephedrine hydrochloride).⁶³

Chronic Idiopathic Urticaria

Oral

Self-medication: 5 or 10 mg once daily (as chewable or conventional tablets or oral solution), depending on symptom severity.¹ ² ³ ¹⁵ ²⁰ ²² ²³ ²⁵ ⁷² In clinical trials, most patients received an initial dosage of 10 mg daily; no additional benefit observed with 20-mg daily dosage.¹

Prescribing Limits

Pediatric Patients

Allergic Rhinitis

Oral

Children 12 months to <2 years of age: Maximum 5 mg daily.¹

Self-medication in children 2 to <6 years of age: Maximum 5 mg in 24 hours.⁷⁰ (See Pediatric Use under Cautions.)

Self-medication in children ≥6 years of age: Maximum 10 mg in 24 hours.⁶⁸ ⁷⁰ ⁷¹

Self-medication in children ≥12 years of age: Maximum 10 mg daily (in fixed combination with 120 mg pseudoephedrine hydrochloride).⁶⁹ Fixed-combination preparation not recommended for children <12 years of age; contains 120 mg pseudoephedrine hydrochloride, which exceeds recommended single dose in such patients.⁶³

Children ≥12 years of age: In clinical trials, a 20-mg daily dosage did not provide additional clinical benefit.¹

Chronic Idiopathic Urticaria

Oral

Children 12 months to 5 years of age: Maximum 5 mg daily.¹

Self-medication in children ≥6 years of age: Maximum 10 mg in 24 hours.⁷²

Children ≥12 years of age: In clinical trials, a 20-mg daily dosage did not provide additional clinical benefit.¹

Adults

Allergic Rhinitis

Oral

Self-medication: Maximum 10 mg in 24 hours (alone or in fixed combination with 120 mg pseudoephedrine hydrochloride).⁶⁸ ⁶⁹ In clinical trials, a 20-mg daily dosage did not provide additional clinical benefit.¹

Chronic Idiopathic Urticaria

Oral

Self-medication: Maximum 10 mg in 24 hours.⁷² In clinical trials, a 20-mg daily dosage did not provide additional clinical benefit.¹

Special Populations

Hepatic Impairment

Children <6 years of age: Use not recommended.¹

Adults and children ≥6 years of age: 5 mg once daily (as chewable or conventional tablets or oral solution).¹ ³

Adults and children ≥12 years of age: 5 mg once daily (in fixed combination with 120 mg pseudoephedrine hydrochloride).⁶³

Renal Impairment

Children <6 years of age: Use not recommended.¹

Adults and children ≥6 years of age: 5 mg once daily (as chewable or conventional tablets or oral solution) in patients with impaired renal function (e.g., Cl_cr of 11–31 mL/minute) or those on hemodialysis (e.g., Cl_cr <7 mL/minute).¹ ³

Adults and children ≥12 years of age: 5 mg once daily (in fixed combination with 120 mg pseudoephedrine hydrochloride) in patients with impaired renal function (e.g., Cl_cr of 11–31 mL/minute) or those on hemodialysis (e.g., Cl_cr <7 mL/minute).⁶³

Geriatric Patients

Self-medication in patients ≥65 years of age: 5 mg once daily (as chewable or conventional tablets or oral solution); do not exceed this amount in 24 hours.⁷⁰ ⁷¹ ⁷²

Cautions for Cetirizine Hydrochloride

Contraindications

Known hypersensitivity to cetirizine, hydroxyzine, or any ingredient in the formulation.¹ ³ ⁶³ ⁶⁸ ⁶⁹ ⁷⁰ ⁷¹ ⁷²

Warnings/Precautions

General Precautions

Prescribing and Dispensing Errors

Ensure accuracy of prescription; similarities in spelling, dosage intervals, and tablet strengths of Zyrtec and Zyprexa (olanzapine, an atypical antipsychotic agent) may result in errors.⁶⁵

CNS Effects

Risk of somnolence;¹ ² ³ ⁵ ⁶ ²⁷ ²⁸ ³⁹ ⁴¹ ⁴² ⁴³ ⁴⁹ caution required when performing hazardous activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle).¹ ³ (See Specific Drugs under Interactions.)

Use of Fixed Combinations

When used in fixed combination with pseudoephedrine hydrochloride (Zyrtec-D), consider the cautions, precautions, and contraindications associated with pseudoephedrine.⁶³ ⁶⁹

Specific Populations

Pregnancy

Chewable or conventional tablets or oral solution: Category B.¹

Fixed-combination cetirizine hydrochloride/pseudoephedrine hydrochloride: Category C.⁶³

Lactation

Distributed into milk.¹ ⁶³ Use not recommended.¹ ³ ⁵⁷ ⁶³ ⁶⁸ ⁶⁹ ⁷⁰ ⁷¹ ⁷²

Pediatric Use

Chewable or conventional tablets or oral solution: Safety and efficacy not established in children <6 months of age; oral solution is the recommended formulation in children <2 years of age.¹

Fixed-combination cetirizine hydrochloride/pseudoephedrine hydrochloride: Safety and efficacy not established in children <12 years of age; use not recommended in this age group.⁶³

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.⁶⁶ ⁶⁷ Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.⁶⁶ Therefore, FDA recommended not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of nonprescription cough and cold preparations to avoid overdosage.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹ No overall differences in safety relative to younger patients, but increased sensitivity cannot be ruled out.¹ Select dosage with caution because of age-related decreases in renal function; periodic monitoring of renal function recommended.¹ ³ ²⁰ ³⁹ ⁴⁶ Dosage adjustment recommended in patients ≥65 years of age.¹ (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Decreased clearance in patients with chronic hepatic impairment.¹ ³ ²⁰ ³⁹ Dosage adjustment necessary.¹ ³ (See Hepatic Impairment under Dosage and Administration.) Use not recommended in children <6 years of age with hepatic impairment.¹

Renal Impairment

Decreased clearance in patients with moderate renal impairment (Cl_cr of 11–31 mL/minute) or in those on hemodialysis.¹ ³ ²⁰ ⁴⁶ ⁶⁰ Dosage adjustment necessary.¹ (See Renal Impairment under Dosage and Administration.) Use not recommended in children <6 years of age with renal impairment.¹

Common Adverse Effects

Adults and children ≥12 years of age: somnolence, fatigue, dry mouth.¹ Insomnia reported with cetirizine hydrochloride-pseudoephedrine hydrochloride fixed combination.⁶³

Children 2–11 years of age: headache, pharyngitis, abdominal pain.¹

Children 6 months to 2 years of age: irritability, fussiness, insomnia, fatigue, malaise.¹

Interactions for Cetirizine Hydrochloride

Metabolized minimally in the liver;² not known whether metabolized by CYP microsomal enzyme system.⁴⁸ ⁵⁶ ⁵⁷ May have low potential for adverse drug interactions associated with metabolic enzyme systems.²

Drugs Affecting Hepatic Microsomal Enzymes

Concomitant administration with drugs known to inhibit CYP microsomal enzymes has not been associated with clinically important changes in ECG parameters (e.g., QT_c intervals).¹ ³ ³¹ ⁵⁶

Specific Drugs

Drug	Interaction	Comments
Azithromycin	No clinically important changes in ECG parameters observed with concomitant therapy; no clinically important interactions reported¹ ³ ³¹ ⁵⁶
CNS depressants (e.g., alcohol, sedatives, tranquilizers)	Possible additive CNS effects (e.g., increased drowsiness)¹ ³ ⁶⁸ ⁶⁹ ⁷⁰ ⁷¹ ⁷²	Avoid concomitant use¹ ³
Erythromycin	No clinically important changes in ECG parameters observed with concomitant therapy; no clinically important interactions reported¹ ³ ³¹ ⁵⁶
Ketoconazole	Prolongation of QT_c interval (with an increase of 17.4 msec) observed with concomitant administration; no clinically important interactions reported¹ ⁵⁶ ⁵⁷	Not considered clinically important¹ ⁵⁶ ⁵⁷
MAO	Potentiated pressor effects of sympathomimetic drugs (e.g., pseudoephedrine)⁶³	Avoid concomitant use of fixed-combination preparation containing cetirizine hydrochloride and pseudoephedrine hydrochloride (Zyrtec-D) with an MAO inhibitor, or for 2 weeks after discontinuance of an MAO inhibitor⁶³
Pseudoephedrine	No pharmacokinetic interactions observed¹ ³
Theophylline	Decreased clearance (16%) of cetirizine; disposition of theophylline not altered with concomitant administration¹ ³

Cetirizine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from the GI tract following oral administration,¹² ¹⁴ ⁴⁷ ⁴⁸ with peak plasma concentrations achieved in about 1 hour.¹ ² ³ ⁴ ¹⁴ ³⁹ ⁴⁶ ⁴⁷ ⁴⁸

Bioavailability of chewable tablets or oral solution is comparable to that of conventional tablets.¹

Onset

Antihistaminic effect noted in 95% of adults and children at 1 hour.¹ ² ³ ⁶ ¹⁴ ²⁰ ⁴³

Duration

Antihistaminic effect persists for about 24 hours.¹ ² ³ ⁶ ¹⁴ ²⁰ ⁴³

Food

Food may decrease peak plasma concentrations and rate of absorption, but does not affect extent of absorption.¹ ² ³ ¹² ²⁰ ⁶³

Distribution

Extent

Distribution into human body tissues not fully elucidated.¹ ³ Appears to be extensively distributed into many body tissues and fluids in animals; ³ brain cetirizine concentrations were <10% of those measured in plasma.²

Distributed into milk.¹

Plasma Protein Binding

Approximately 93%.¹ ³

Elimination

Metabolism

Undergoes a low degree of first-pass metabolism in the liver; metabolized to limited extent by oxidative O-dealkylation to a metabolite with negligible antihistaminic activity.¹ ² ³ ¹¹ ¹⁴ ³⁹ ⁴⁶ ⁴⁷ ⁵⁶ ⁵⁷

Elimination Route

80% of a dose is excreted in urine, mainly as unchanged drug.¹ ² ⁴ ¹² ¹⁴ ²⁰ ³⁹ ⁴⁶ ⁴⁷ ⁴⁸ ⁵⁷

Half-life

Initial distribution half-life is about 3 hours;⁴⁸ terminal elimination half-life is about 8.3 hours.¹ ² ⁴ ¹² ¹⁴ ²⁰ ³⁹ ⁴⁷ ⁴⁸ ⁵⁷

Special Populations

In patients with chronic hepatic impairment or moderate renal impairment (e.g., Cl_cr of 11–31 mL/minute) or in those on hemodialysis, half-life is increased and clearance is decreased.¹ ³ ²⁰ ³⁹

In geriatric patients (mean: 77 years of age), half-life is increased and clearance is decreased,¹ possibly due to age-related changes in renal function.¹ ³ ²⁰ ³⁹ ⁴⁶

In pediatric patients, half-life is decreased and clearance is increased.¹

Stability

Storage

Oral

Tablets and Chewable Tablets

20–25°C (may be exposed to 15–30°C).¹ ⁶³ ⁶⁸ ⁷¹ ⁷²

Solution

20–25°C (may be exposed to 15–30°C).¹ Also may be refrigerated at 2–8°C.¹

ActionsActions

Exhibits selective antagonism of peripheral histamine H₁-receptors.¹ ² ³ ⁶ ¹⁴ ²⁰ ⁴⁷ ⁴⁸

Antihistaminic effect is comparable to that of astemizole (no longer commercially available in the US), clemastine, chlorpheniramine, diphenhydramine, hydroxyzine, loratadine, pyrilamine, and terfenadine (no longer commercially available in the US).² ³ ²⁰ ⁴³ Tolerance to antihistaminic effect usually does not occur.²

No appreciable anticholinergic or antiserotonergic effects in animal models,⁵⁶ ⁵⁷ but dry mouth more common with cetirizine than placebo in clinical trials.¹ ³ ²⁰ ²⁸ ⁴¹ ⁴⁹

Advice to Patients

For self-medication, importance of taking only as directed and not exceeding recommended dosage.⁶⁹

Risk of somnolence;¹ ² ³ ⁵ ⁶ ²⁷ ²⁸ ³⁹ ⁴¹ ⁴² ⁴³ ⁴⁹ importance of exercising caution when performing activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle).¹ ⁶⁸ ⁶⁹ ⁷⁰ ⁷¹ ⁷²

For self-medication with cetirizine in fixed combination with pseudoephedrine, importance of discontinuing therapy and contacting a clinician if symptoms do not improve within 7 days or are accompanied by fever, or if nervousness, dizziness, or sleeplessness occurs.⁶⁹

For self-medication for management of chronic idiopathic urticaria (e.g., hives), importance of understanding that cetirizine does not prevent hives.⁷² Importance of consulting a clinician before initiating therapy if hives are unusual in color, look bruised or blistered, or do not itch.⁷² Importance of discontinuing therapy and contacting a clinician if symptoms do not improve within 3 days or if hives have persisted for >6 weeks.⁷²

Importance of understanding that chronic idiopathic urticaria may present with other severe allergic reactions, including anaphylactic shock (e.g., trouble swallowing, swelling of the tongue, trouble speaking, wheezing or trouble breathing, dizziness or loss of consciousness, swelling in or around the mouth, drooling).⁷² These manifestations may occur when hives first appear or up to several hours later and can be life-threatening if not treated immediately.⁷² Importance of immediately seeking emergency help if anaphylactic shock occurs.⁷² If an epinephrine auto-injector has been prescribed, importance of carrying this device at all times; never use cetirizine as a substitute for the epinephrine auto-injector.⁷²

Importance of discontinuing the drug immediately and informing a clinician if an allergic or hypersensitivity reaction occurs.⁶⁹ ⁷⁰ ⁷¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.¹ ⁶³

Importance of patients with renal or hepatic impairment, heart disease, hypertension, thyroid disease, diabetes mellitus, glaucoma, or difficulty in urination resulting from prostate enlargement not undertaking self-medication without first consulting a clinician.⁶⁹ ⁷⁰ ⁷¹ ⁷²

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹ ⁶³

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

Preparations

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

Cetirizine Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution	5 mg/5 mL	Children's Zyrtec Hives Relief Syrup	McNeil
			Children's Zyrtec Syrup	McNeil
	Tablets, chewable	5 mg	Children's Zyrtec Chewables	McNeil
		10 mg	Children's Zyrtec Chewables	McNeil
	Tablets, film-coated	10 mg	Zyrtec	McNeil

Cetirizine Hydrochloride Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, extended-release	5 mg with Pseudoephedrine Hydrochloride 120 mg	Zyrtec-D	McNeil

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cetirizine HCl 10MG Tablets (PERRIGO): 100/$18.99 or 300/$39.96

Cetirizine HCl 5MG Tablets (APOTEX): 100/$99.99 or 300/$253.98

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

1. Pfizer Labs. Zyrtec (cetirizine hydrochloride) tablets and syrup prescribing information. New York, NY; 2004 Jul.

2. Spencer CM, Faulds D, Peters DH. Cetirizine: a reappraisal of its pharmacological properties and therapeutic use in selected allergic disorders. Drugs. 1993; 46:1055-80. [IDIS 359174] [PubMed 7510611]

3. Pfizer Laboratories. Zyrtec (cetirizine hydrochloride) tablets product monograph. New York, NY: Undated.

4. Sale ME, Barbey JT, Woosley RL et al. The electrocardiographic effects of cetirizine in normal subjects. Clin Pharmacol Ther. 1994; 56:295-301. [IDIS 336633] [PubMed 7924125]

5. Schweitzer PK, Muehlbach MJ, Walsh JK. Sleepiness and performance during three- day administration of cetirizine or diphenhydramine. J Allergy Clin Immunol. 1994; 94:716-24. [IDIS 336957] [PubMed 7930305]

6. Gengo FM, Dabronzo J, Yurchak A et al. The relative antihistaminic and psychomotor effects of hydroxyzine and cetirizine. Clin Pharmacol Ther. 1987; 42:265-72. [IDIS 234435] [PubMed 2887328]

7. Borge PA. Problems in allergic rhinitis. Arzneimittelforschung. 1982; 32:11199-201.

8. Anon. Treatment of seasonal and perennial allergic rhinitis. BMJ. 1981; 283:808-10. [PubMed 6117350]

9. Food and Drug Administration. Over-the-counter drugs: establishment of a monograph for OTC cold, cough, allergy, bronchodilator and antihistaminic products. [21 CFR 341]. Fed Regist. 1976; 41:38312-424.

10. Douglas WW. Histamine and 5-hydroxytryptamine (serotonin) and their antagonists. In: Gilman AG, Goodman LS, Rall TW et al eds. Goodman and Gilman’s the pharmacologic basis of therapeutics. 7th ed. New York: Macmillan Publishing Company. 1985:605-638.

11. Campoli-Richards DM, Buckley MMT, Fitton A. Cetirizine: a review of its pharmacological properties and clinical potential in allergic rhinitis, pollen-induced asthma, and chronic urticaria. Drugs. 1990; 40:762-81. [IDIS 359171] [PubMed 1981354]

12. Barnes CL, McKenzie CA, Webster KD et al. Cetirizine: a new, nonsedating antihistamine. Ann Pharmacother. 1993; 27:464-70. [IDIS 313114] [PubMed 8477125]

13. Reviewers’ comments (personal observations).

14. Pfizer, New York, NY: Personal communication.

15. Grant JA, Nicodemus CF, Findlay SR et al. Cetirizine in patients with seasonal rhinitis and concomitant asthma: prospective, randomized, placebo-controlled trial. J Allergy Clin Immunol. 1995; 95:923-32. [IDIS 349096] [PubMed 7751511]

16. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for OTC antihistamine drug products. Final rule. [21 CFR Parts 201, 310, 341, 369] Fed Regist. 1992; 57:58356-8.

17. Meltzer EO. To use or not to use antihistamines in patients with asthma. Ann Allergy. 1990; 64:183-6. [IDIS 297019] [PubMed 1967918]

18. Pierson WE, Virant FS. Antihistamines in asthma. Ann Allergy. 1989; 63:601-3. [IDIS 301484] [PubMed 2574551]

19. Simons FER, Simons KJ. The pharmacology and use of H₁-receptor antagonist drugs. N Engl J Med. 1994; 330:1663-70. [IDIS 330632] [PubMed 7909915]

20. Anon. Cetirizine—a new antihistamine. Med Lett Drugs Ther. 1996; 38:21-3. [PubMed 8598822]

21. Simons FE, Sussman GL, Simons KJ. Effect of the H₂-antagonist cimetidine on the pharmacokinetics and pharmacodynamics of the H₁-antagonists hydroxyzine and cetirizine in patients with chronic urticaria. J Allergy Clin Immunol. 1995; 95:685-93. [IDIS 344281] [PubMed 7897151]

22. Jobst S, van den Wijngaart W, Schubert A et al. Assessment of the efficacy and safety of three dose levels of cetirizine given once daily in children with perennial allergic rhinitis. Allergy. 1994; 49:598-604. [IDIS 359190] [PubMed 7653736]

23. Masi M, Candiani R, van de Venne H. A placebo-controlled trial of cetirizine in seasonal allergic rhino-conjunctivitis in children aged 6–12 years. Pediatr Allergy Immunol. 1993; 4(Suppl):47-52. [IDIS 359271] [PubMed 8353660]

24. Watson WTA, Simons KJ, Chen XY et al. Cetirizine: a pharmacokinetic and pharmacodynamic evaluation in children with seasonal allergic rhinitis. J Allergy Clin Immunol. 1989; 84:457-64. [IDIS 309078] [PubMed 2571627]

25. Lockey RF, Widlitz MD, Mitchell DQ et al. Comparative study of cetirizine and terfenadine versus placebo in the symptomatic management of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1996; 76:448-54. [IDIS 366728] [PubMed 8630719]

26. Aaronson DW. Evaluation of cetirizine in patients with allergic rhinitis and perennial asthma. Ann Allergy Asthma Immunol. 1996; 76:440-6. [IDIS 366727] [PubMed 8630718]

27. Meltzer EO, Weiler JM, Widlitz MD. Comparative outdoor study of the efficacy, onset and duration of action, and safety of cetirizine, loratadine, and placebo for seasonal allergic rhinitis. J Allergy Clin Immunol. 1996; 97:617-26. [IDIS 360732] [PubMed 8621847]

28. Breneman D, Bronsky EA, Bruce S et al. Cetirizine and astemizole therapy for chronic idiopathic urticaria: a double-blind, placebo-controlled, comparative study. J Am Acad Dermatol. 1995; 33(2 Part 1):192-8. [IDIS 350767] [PubMed 7622644]

29. Andri L, Senna GE, Betteli C et al. A comparison of the efficacy of cetirizine and terfenadine: a double-blind, controlled study of chronic idiopathic urticaria. Allergy. 1993; 48:358-65. [IDIS 359189] [PubMed 8368464]

30. Woosley RL. Cardiac actions of antihistamines. Annu Rev Pharmacol Toxicol. 1996; 36:233-52. [PubMed 8725389]

31. Simons FER. H₁-Receptor antagonists: comparative tolerability and safety. Drug Saf. 1994; 10:350-80. [IDIS 359177] [PubMed 7913608]

32. Turner RB, Sperber SJ, Sorrentino JV et al. Effectiveness of clemastine fumarate for treatment of rhinorrhea and sneezing associated with the common cold. Clin Infect Dis. 1997; 25:824-30. [IDIS 395789] [PubMed 9356796]

33. Douglass JA, Dhami D, Gurr CE et al. Influence of interleukin-8 challenge in the nasal mucosa in atopic and nonatopic subjects. Am J Respir Crit Care Med. 1994; 150:1108-13. [IDIS 338161] [PubMed 7921444]

34. Proud D, Naclerio RM, Gwaltney JM et al. Kinins are generated in nasal secretions during natural rhinovirus colds. J Infect Dis. 1990; 161:120-3. [PubMed 2295843]

35. Proud D, Gwaltney JM Jr, Hendley JO et al. Increased levels of interleukin-1 are detected in nasal secretions of volunteers during experimental rhinovirus colds. J Infect Dis. 1994; 169:1007-13. [IDIS 329294] [PubMed 8169385]

36. Turner RB. Elaboration of interleukin 8 from fibroblast cells and human nasal epithelium in response to rhinovirus challenge. Program and abstracts of the thirty-fourth Interscience Conference on Antimicrobial Agents and Chemotherapy. Orlando, FL: 1994. Abstract No. B43.

37. Berkowitz RB, Tinkelman DG. Evaluation of oral terfenadine for treatment of the common cold. Ann Allergy. 1991; 67:593-7. [IDIS 294960] [PubMed 1750722]

38. Lambert D, Hantzperg M, Danglas P et al. Double-blind comparative study of terfenadine and cetirizine in chronic idiopathic urticaria. Allerg Immunol. 1993; 25:235- 40.

39. Simons FER, Watson WTA, Minuk GY et al. Cetirizine pharmacokinetics and pharmacodynamics in primary biliary cirrhosis. J Clin Pharmacol. 1993; 33:949-54. [IDIS 320880] [PubMed 7693767]

40. Wasserfallen JB, Leuenberger P, Pécoud A. Effect of cetirizine, a new H₁ antihistamine, on the early and late allergic reactions in a bronchial provocation test with allergen. J Allergy Clin Immunol. 1993; 91:1189-97. [IDIS 315943] [PubMed 8099593]

41. Berkowitz RB, Dockhorn R, Lockey R et al. Comparison of efficacy, safety, and skin test inhibition of cetirizine and astemizole. Ann Allergy Asthma Immunol. 1996; 76:363- 8. [IDIS 363440] [PubMed 8612120]

42. Harcup JW, Hawkes G, Saul PA. The efficacy and sedative profile of astemizole and cetirizine in the tre