Hydrocodone Bitartrate and Homatropine Methylbromide Tablets

Tussigon contains hydrocodone (dihydrocodeinone) bitartrate, a semi-synthetic centrally-acting narcotic antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.

Each TUSSIGON tablet contains: Hydrocodone Bitartrate USP 5 mg Homatropine Methylbromide USP 1.5 mg.

The hydrocodone component is 4,5á- Epoxy-3-methoxy-17-methylmorphinan -6-one-tartrate (1:1) hydrate (2:5), a fine white crystal or crystalline powder which is derived from the opium alkaloid, thebaine, has a molecular weight of (494.50) and may be represented by the following structural formula:

C18H21N03•C4H606•2½H20
Hydrocodone Bitartrate

Homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane, 3-[(hydroxy phenylacetyl)oxy]-8, 8- dimethyl-,bromide, endo-, a white crystal or fine white crystalline powder, with a molecular weight of (370.29).

C17H24BrN03
Homatropine Methylbromide

TUSSIGON is indicated for the symptomatic relief of cough.

Each blue, scored tablet contains 5 mg hydrocodone bitartrate and 1.5 mg homatropine methylbromide and is available in:

Bottles of 100 NDC 61570-102-01

Store at controlled room temperature 15°–30°C (59°–86°F). Oral prescription where permitted by state law.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Distributed by: Pfizer Inc, New York,NY 10017.Revised: Aug 2016.

Central Nervous System

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.

Gastrointestinal System

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients.

Prolonged administration of TUSSIGON may produce constipation.

Genitourinary System

Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.

Respiratory Depression

TUSSIGON may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSE).

Dermatological

Skin rash, pruritus.

Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of TUSSIGON and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs (see Drug Abuse And Dependence).

Respiratory Depression

TUSSIGON produces dose-related respiratory depression by directly acting on brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated.

Head Injury And Increased Intracranial Pressure

The respiratory depression properties 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. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of TUSSIGON or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Pediatric Use

In young children, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Benefit to risk ratio should be carefully considered especially in children with respiratory embarrassment (e.g. croup).