FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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).
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.
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.
The administration of TUSSIGON or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
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).
Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
TUSSIGON is indicated for the symptomatic relief of cough.
History
There is currently no drug history available for this drug.
Other Information
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 4,5α- 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
Sources
Tussigon Manufacturers
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Pfizer Laboratories Div Pfizer Inc
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