HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE syrup

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), HOMATROPINE METHYLBROMIDE (UNII: 68JRS2HC1C) (HOMATROPINE - UNII:8QS6WCL55Z)

Fáanlegur frá:

Rebel Distributors Corp

INN (Alþjóðlegt nafn):

HYDROCODONE BITARTRATE

Samsetning:

HYDROCODONE BITARTRATE 5 mg in 5 mL

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for the symptomatic relief of cough. Hydrocodone bitartrate and homatropine methylbromide syrup should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide. Hydrocodone bitartrate and homatropine methylbromide syrup is a Schedule III narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, hydrocodone bitartrate and homatropine methylbromide should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and homatropine methylbromide is 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 p

Vörulýsing:

Hydrocodone Bitartrate and Homatropine Methylbromide Syrup NDC 21695-869-16 is available as a clear red colored, cherry flavored syrup in: Bottles of 16 fl. oz. (one pint) Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP. Oral prescription where permitted by state law. Manufactured By: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 043:00 3/09 MG #21271 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE- HYDROCODONE
BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP
REBEL DISTRIBUTORS CORP
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HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP
DESCRIPTION
This product contains hydrocodone (dihydrocodeinone) bitartrate, a
semisynthetic centrally-acting
narcotic antitussive. Homatropine methylbromide is included in a
subtherapeutic amount to discourage
deliberate overdosage.
Each teaspoonful (5 mL) for oral administration contains:
Hydrocodone Bitartrate, USP 5 mg
WARNING: MAY BE HABIT FORMING.
Homatropine Methylbromide, USP 1.5 mg
Hydrocodone Bitartrate and Homatropine Methylbromide Syrup also
contains: Caramel color, cherry
flavor, citric acid, FD&C Red #40, methylparaben, propylparaben,
purified water, sorbitol solution and
sucrose syrup. Citric acid and/or sodium citrate may be added to
adjust pH.
The hydrocodone component is a 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:
Homatropine methylbromide is 8- Azoniabicyclo
[3.2.1]octane,3-[(hydroxyphenylacetyl) oxy]-8,8-
dimethyl-,bromide, endo-; a white crystal or fine white crystalline
powder, with a molecular weight of
(370.29).
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, physical and physiological dependence.
Following a 10 mg oral dose of hydrocodone administered to five adult
male subjects, the mean p