Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

INDICATIONS AND USAGE TussiCaps® (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules are indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.

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Advisory information

contraindications
CONTRAINDICATIONS TussiCaps® extended-release capsules are contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine. The use of TussiCaps® extended-release capsules are contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.
Special warnings and precautions
PRECAUTIONS General Caution is advised when prescribing this drug to patients with narrow-angle glaucoma, asthma, or prostatic hypertrophy. Special Risk Patients – As with any narcotic agent, TussiCaps® extended-release capsules should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Information for Patients As with all narcotics, TussiCaps® extended-release capsules may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly. TussiCaps® extended-release capsules must not be diluted with fluids or mixed with other drugs as this may alter the resin-binding and change the absorption rate, possibly increasing the toxicity. Keep out of the reach of children. Cough Reflex – Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when TussiCaps® extended-release capsules are used postoperatively, and in patients with pulmonary disease. Drug Interactions Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with TussiCaps® extended-release capsules may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity and reproductive studies have not been conducted with TussiCaps® extended-release capsules. Pregnancy Teratogenic Effects Pregnancy Category C – Hydrocodone has been shown to be teratogenic in hamsters when given in doses 700 times the human dose. There are no adequate and well-controlled studies in pregnant women. TussiCaps® extended-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. Labor and Delivery As with all narcotics, administration of TussiCaps® extended-release capsules to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from TussiCaps® extended-release capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The use of TussiCaps® extended-release capsules are contraindicated in children less than 6 years of age (see CONTRAINDICATIONS and ADVERSE REACTIONS , Respiratory, Thoracic and Mediastinal Disorders). TussiCaps® extended-release capsules should be used with caution in pediatric patients 6 years of age and older (see WARNINGS , Pediatric Use). Geriatric Use Clinical studies of hydrocodone polistirex and chlorpheniramine polistirex extended-release did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Adverse reactions
ADVERSE REACTIONS Gastrointestinal Disorders Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of TussiCaps® extended-release capsules may produce constipation. General Disorders and Administration Site Conditions Death Nervous System Disorders Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes. Renal and Urinary Disorders Ureteral spasm, spasm of vesical sphincters, and urinary retention have been reported with opiates. Respiratory, Thoracic and Mediastinal Disorders Dryness of the pharynx, occasional tightness of the chest, and respiratory depression (see CONTRAINDICATIONS). TussiCaps® extended-release capsules may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE). Use of TussiCaps® in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with TussiCaps® extended-release capsules in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression. Skin and Subcutaneous Tissue Disorders Rash, pruritus. To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals, North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Adults and Children 12 Years and Older One (1) full-strength TussiCaps® extended-release capsule (hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate) every 12 hours; do not exceed 2 capsules in 24 hours. Children 6 to 11 Years of Age One (1) half-strength TussiCaps® extended-release capsule (hydrocodone polistirex equivalent to 5 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg of chlorpheniramine maleate) every 12 hours; do not exceed 2 capsules in 24 hours. This medicine is contraindicated in children under 6 years of age (see CONTRAINDICATIONS).
Pregnancy and lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from TussiCaps® extended-release capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Interactions

Drug Interactions Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with TussiCaps® extended-release capsules may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus.

More information

Category Value
Authorisation number ANDA077273
Agency product number 6YKS4Y3WQ7
Orphan designation No
Product NDC 0187-0054,0187-0108
Date Last Revised 06-03-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1087389
Storage and handling Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container. A Schedule CII Narcotic. Manufactured for: ECR Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Manufactured By: SpecGx LLC Hobart, NY 13788 USA TussiCaps is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. © Valeant Pharmaceuticals North America LLC 9417901 Rev. 03/2018 MG #35890
Marketing authorisation holder VALEANT PHARMACEUTICALS NORTH AMERICA LLC