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.

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 ).

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.

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® extended-release capsules 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.

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.

Drug Abuse and Dependence

TussiCaps® extended-release capsules are Schedule III narcotics. 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. However, psychic dependence is unlikely to develop when TussiCaps® extended-release capsules are used for a short time for the treatment of cough. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy.

Overdosage

Signs and Symptoms – Serious overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. Although miosis is characteristic of narcotic overdose, mydriasis may occur in terminal narcosis or severe hypoxia. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. The manifestations of chlorpheniramine overdosage may vary from central nervous system depression to stimulation.

Treatment – Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to narcotics including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of hydrocodone in this formulation may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

Description

Each full-strength TussiCaps® (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsule contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate. Each half-strength TussiCaps® (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsule contains hydrocodone polistirex equivalent to 5 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg of chlorpheniramine maleate. TussiCaps® extended-release capsules provide up to 12-hour relief per dose. Hydrocodone is a centrally-acting narcotic antitussive. Chlorpheniramine is an antihistamine. TussiCaps® extended-release capsules are for oral use only.

Hydrocodone Polistirex: sulfonated styrene-divinylbenzene copolymer complex with 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one.

Chlorpheniramine Polistirex: sulfonated styrene-divinylbenzene copolymer complex with 2-[p-chloro-α-[2-(dimethylamino)ethyl]-benzyl]pyridine.

Inactive Ingredients: Butyl alcohol, dehydrated alcohol, gelatin, iron oxide black JPE, isopropyl alcohol, microcrystalline cellulose, propylene glycol, purified water, SDA 3A alcohol (27 CFR), shellac, shellac glaze-45% in SD-45 alcohol, strong ammonia solution, titanium dioxide, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2 aluminum lake, FD&C blue #2/indigo carmine aluminum lake, and FD&C red #40/allura red AC aluminum lake.

Chemical Structure of Polistirex and Hydrocodone Chemical Structure of Polistirex and Chlorpheniramine

Clinical Pharmacology

Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, and physical and psychological dependence.

Chlorpheniramine is an antihistamine drug (H₁ receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

Hydrocodone and chlorpheniramine release from TussiCaps® extended-release capsules is controlled by use of an ion-exchange polymer matrix.

Following multiple dosing with hydrocodone polistirex and chlorpheniramine polistirex extended-release suspension, hydrocodone mean (S.D.) peak plasma concentrations of 22.8 (5.9) ng/mL occurred at 3.4 hours. Chlorpheniramine mean (S.D.) peak plasma concentrations of 58.4 (14.7) ng/mL occurred at 6.3 hours following multiple dosing. Peak plasma levels obtained with an immediate-release syrup occurred at approximately 1.5 hours for hydrocodone and 2.8 hours for chlorpheniramine. The plasma half-lives of hydrocodone and chlorpheniramine have been reported to be approximately 4 and 16 hours, respectively.

How Supplied / Storage and Handling

Full-Strength: 10 mg/8 mg

TussiCaps® (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules

Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “

” on the cap and “HP/CP” over “10/8” on the body.

Bottles of 20.......................................NDC 54868-5957-0

Imprint Code

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a well-closed container.

A Schedule CIII Narcotic.

For Medical Information

Contact: Product Monitoring Department
Phone: 800-778-7898

Manufactured by:
Mallinckrodt Inc.
Hazelwood, Missouri
63042 U.S.A.

COVIDIEN, COVIDIEN with Logo, TussiCaps and

are trademarks of Covidien AG or an affiliate.

Rev 060308

COVIDIEN
Mallinckrodt

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

Patient Counseling Information

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.

Professional Information — Tussicaps