carbetapentane citrate, pseudoephedrine hydrochloride
Dosage Form: liquid
Corzall Liquid
Corzall Liquid
Rx Only
Antitussive / Decongestant
DESCRIPTION
Each teaspoonful (5 mL) for oral administration contains:
Carbetapentane Citrate.......................... 20 mg
Pseudoephedrine Hydrochloride.............. 30 mg
Inactive ingredients: Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate,
Sodium Saccharin, Sorbitol.
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:
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:
Corzall - Clinical Pharmacology
Antitussive and decongestant actions.
Carbetapentane citrate is a centrally acting non-narcotic antitussive. Carbetapentane citrate has atropine-like and local
anesthetic actions, as well as temporarily controls and suppresses the cough reflex by selective depression of the
medullary cough center. It has no significant analgesic or sedative properties, does not depress respiration or predispose
to addiction with usual doses.
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 for 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.
Indications and Usage for Corzall
CorzallTM is indicated for the symptomatic relief of the cough, coryza and nasal congestion associated with the common
cold, sinusitis, allergic rhinitis and other upper respiratory tract conditions. Appropriate therapy should be provided for the
primary disease.
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.
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.
A persistent cough may be a sign of a serious condition. If cough persists for more than one week or tends to recur, or is
accompanied by fever, rash, or persistent headache, patient re-evaluation should be considered.
Precautions
General: There are studies which demonstrate that carbetapentane has antitussive activity which may suppress or modify
cough. 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 sympathomimetics may note
mild CNS stimulation.
Drug Interactions:
Carbetapentane citrate should not be used in patients receiving MAO inhibitors, including 14 days after stopping the MAOI
drug. The use of Carbetapentane citrate may result in additive CNS depressant effects when coadministered with alcohol,
antihistamines, psychotropics or other drugs that produce CNS depression.
Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and
veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of pseudoephedrine. Use of
other vasopressor drugs during halothane anethesia may cause serious cardiac arrhythmias.
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 in pediatric patients below the age of six have not been established. Product not intended for
administration for children 6 years of age and under.
Geriatric use:
The elderly (60 years and older) are more likely to have adverse reactions to sympathomimetics. Overdosage of
sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death.
Adverse Reactions
Adverse effects associated with Carbetapentane citrate are rare, but nausea and/or other gastrointestinal disturbances
sometimes occur.
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 pseudoephedrine and carbetapentane.
Symptoms: Should sympathomimetic symptoms predominate, central effects includes 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) Use sedatives or anticonvulsants to control CNS excitation, and convulsions.
g) Physostigmine may reverse anti-cholinergic symptoms.
h) Ammonium Chloride may acidify the urine to increase urinary excretion of pseudoephedrine.
I) Further care is symptomatic and supportive.
DOSAGE AND ADMINISTRATION*
Adults and Children 12 years of age and older:
1-2 teaspoonfuls (5-10 mL) 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 (2.5-5 mL) every 4-6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.
Children under 6 years of age:
Consult a physician.
*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.
How is Corzall Supplied
CorzallTM Liquid is supplied in a clear, grape flavored liquid available in 16 fl oz bottles, NDC 63717-552-16 and 1/2 fl. oz.
(15 mL) sample bottles, NDC 63717-552-99.
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 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature]
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:
Hawthorn Pharmaceuticals, Inc.
Madison, MS 39110
HI 253 08/09
PRODUCT PACKAGING:
The packaging below represents the labeling currently used.
NDC 63717-552-16
CorzallTM LIQUID
Antitussive / Decongestant
Each teaspoonful (5 mL) for oral administration contains:
Carbetapentane Citrate......... 20 mg
Pseudoephedrine HCl........... 30 mg
Rx Only
Dye Free / Sugar Free / Alcohol Free
Hawthorn Pharmaceuticals, Inc.
16 fl oz (473 mL)
Side Panel:
USUAL DOSAGE: See Package Insert for Complete Dosage Recommendations.
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 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature]
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
This bottle is not to be dispensed to the consumer. Dispense in a tight, light-resistant container with a child-resistant closure.
Call your doctor for medical advice about side effects. You may reports side effects to FDA at 1-800-FDA-1088 (Toll Free).
Manufactured for: Hawthorn Pharmaceuticals, Inc., Madison, MS 39110
HL206 08/09
| Corzall LIQUID carbetapentane citrate, pseudoephedrine hydrochloride liquid | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved other | 08/27/2009 | ||
| Labeler - Hawthorn Pharmaceuticals, Inc. (118049704) |
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