Zotex-D Syrup

Generic Name: carbetapentane citrate, pseudoephedrine hydrochloride and pyrilamine maleate
Dosage Form: syrup

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ZOTEX™-D Syrup

Rx Only

Antitussive / Decongestant / Antihistamine

Zotex-D Syrup Description

Each teaspoonful (5 mL) for oral administration contains:

Carbetapentane Citrate 20 mg
Pseudophedrine HCl 8 mg
Pyrilamine Maleate 7.5 mg

Inactive ingredients: Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, Cherry Flavor, Purified Water

Carbetapentane Citrate 1-Phenylcyclopentanecarboxylic acid, 2-(2-diethylaminoethoxy) ethyl ester citrate is a white crystalline powder. It is freely soluble in water and chloroform. Its structure is as follows:

C20H31NO3 C6H8O7                                          MW 525.6

Pseudoephedrine Hydrochloride (Benzenemethanol, α-[1-(methylamino) ethyl]-, [S-(R*, R*)]-, hydrochloride) is the hydrochloride of pseudoephedrine, a naturally occurring dextrorotatory stereoisomer of ephedrine. Its structure is as follows:

C10H15NO • HCl                                          MW 201.69

Pyrilamine Maleate is an antihistamine having the chemical name 2-[[2-Dimethylamino)ethyl] (p-methoxybenzyl)amino] pyridine maleate (1:1). Its structural formula is as follows:

C17H23N3O•C4H4O4                                          MW 401.47

Zotex-D Syrup - Clinical Pharmacology

Antitussive, decongestant, and antihistaminic actions.

Carbetapentane Citrate is a centrally acting non-narcotic antitussive.

Pseudoephedrine hydrochloride is an oral sympathomimetic amine that acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine has less pressor effect in normotensive adults. Serum half-life or pseudoephedrine is 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. About one-half of the administered drug is excreted in the urine.

Pyrilamine maleate is a histamine antagonist, specifically an H1 receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Pyrilamine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilatation, increased vascular permeability, increased mucus secretion) of nasal tissue. Pyrilamine is well absorbed from the gastrointestinal tract, with peak plasma concentration after a single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.

Indications and Usage for Zotex-D Syrup

For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Contraindications

Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary heart disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and during an asthma attack. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

Warnings

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure, or prostatic hypertrophy, (see CONTRAINDICATIONS). Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions.

Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended doses, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage.

Precautions

GENERAL

Before prescribing medication to suppress or modify cough, identify and provide therapy for the underlying cause of the cough and take caution that modification of cough does not increase the risk of clinical or physiologic complications.

Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus, and prostatic hypertrophy.

Information for patients

Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience moderate severe drowsiness. Patients sensitive to sympathomimetics may note mild CNS stimulation.

Drug Interactions

Antihistamines may enhance the effect of tricyclic antidepressants, barbiturates, alcohol, and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa, and mecamylamine. Effects of sympathomimetics are increased with MAO inhibitors and beta-adrenergic blockers.

Pregnancy Category C

Animal reproduction studies have not been conducted with this product. It is not known whether this product can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Give to pregnant women only if clearly needed.

Nursing Mothers

It is not known if the drugs in this product are excreted in human milk. Since many drugs may be excreted into human milk and because of the potential for serious side effects in the nursing infant, this product should only be given to nursing mothers if clearly needed.

Pediatric use

Safety and effectiveness of this product in pediatric patients below the age of two years have not been established.

Adverse Reactions

Antihistamines

Sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria, and dysuria, and rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy.

Sympathomimetic Amines

Convulsions, CNS stimulation, cardiac arrhythmia, respiratory difficulties, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, pallor and dysuria.

Overdosage

The signs, symptoms and treatment described below are those of H1 antihistamine, pseudoephedrine and dextromethorphan overdose.

Symptoms

Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, predominate symptoms are excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma, and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.

Should sympathomimetic symptoms predominate central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability, and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmia, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea and abdominal cramps.

Treatment

a) Evacuate stomach as condition warrants. Activated charcoal may be useful. b) Maintain a non-stimulating environment. c) Monitor cardiovascular status. d) Do not give stimulants. e) Reduce fever with sponging. f) Treat respiratory depression with naloxone if dextromethorphan toxicity is suspected. g) Use sedatives or anticonvulsants to control CNS excitation, and convulsions. h) Physostigmine may reverse anti-cholinergic symptoms. i) Ammonium Chloride may acidify the urine to increase urinary excretion of pseudoephedrine. j) Further care is symptomatic and supportive.

Zotex-D Syrup Dosage and Administration

Adults and Children 12 years of age and older: 1-2 teaspoonfuls every 4-6 hours, not to exceed 12 teaspoonfuls in a 24 hour period. Children 6 to 12 years of age: 1/2 to 1 teaspoonful every 4-6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.

* In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.

How is Zotex-D Syrup Supplied

Zotex™-D Syrup is supplied as a clear, cherry-flavored liquid available in 16 fl oz bottles, NDC 68025-036-16 and 10 mL sample bottles, NDC 68025-036-10.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Store at controlled room temperature, 15° - 30°C (59° - 86°F). Avoid exposure to heat.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for:
Vertical Pharmaceuticals, Inc.
Sayreville, NJ 08872

Rev. 08/08

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 68025-036-16

ZOTEX-D
Syrup

Antitussive / Decongestant / Antihistamine

Cherry Flavor

Each teaspoonful (5 mL) for oral
administration contains:

Carbetapentane Citrate 20 mg
Pseudophedrine HCl 8 mg
Pyrilamine Maleate 7.5 mg

Alcohol Free • Dye Free
Sugar Free

Rx Only

VERTICAL
PHARMACEUTICALS, INC.

16 fl oz (473 mL)

ZOTEX-D 
carbetapentane citrate, pseudoephedrine hydrochloride and pyrilamine maleate syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68025-036
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBETAPENTANE CITRATE (CARBETAPENTANE) CARBETAPENTANE CITRATE 20 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 8 mg  in 5 mL
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 7.5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
PROPYLENE GLYCOL  
SORBITOL  
CITRIC ACID MONOHYDRATE  
SODIUM CITRATE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68025-036-16 473 mL in 1 BOTTLE
2 NDC:68025-036-10 10 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/01/2008
Labeler - Vertical Pharmaceuticals, Inc. (173169017)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories 056139553 MANUFACTURE, PACK, LABEL
Revised: 01/2010
 
Vertical Pharmaceuticals, Inc.

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