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INDICATION
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.
IMPORTANT SAFETY INFORMATION
  • Do not use TussiCaps in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.
  • Do not use in children less than 6 years of age due to the risk of fatal respiratory depression.
  • Because of the risk of respiratory depression, exercise caution when using TussiCaps postoperatively and in patients with pulmonary disease, or whenever ventilatory function is depressed. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated.
  • The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.
  • The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
  • Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder.
  • Exercise caution when administering TussiCaps to pediatric patients 6 years of age and older. Overdose or concomitant administration of TussiCaps with other respiratory depressants may increase the risk of respiratory depression in pediatric patients.
  • Use with caution in elderly or debilitated patients and those with narrow-angle glaucoma, asthma, prostatic hypertrophy, severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, or urethral stricture.
  • Inform patients that TussiCaps 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.
  • Do not dilute with fluids or mix with other drugs as this may alter the resin-binding and change the absorption rate, possibly increasing the toxicity.
  • Use with caution when combined therapy includes narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with TussiCaps because patients may exhibit additive CNS depression.
  • The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus.
  • TussiCaps is a Schedule II narcotic and can be associated with drug abuse and dependence. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, TussiCaps extended-release capsules should be prescribed and administered with caution.
  • The following Adverse Events may occur:
    • Nausea and vomiting
    • Constipation
    • Death
    • Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes
    • Ureteral spasm, spasm of vesical sphincters, and urinary retention
    • Dryness of the pharynx, occasional tightness of the chest, and respiratory depression
    • Rash, pruritus
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