ANTITUSSIVE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS
Hydrocodone bitartrate and homatropine methylbromide tablets contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting narcotic antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.
Each hydrocodone bitartrate and homatropine methylbromide tablet for oral administration contains:
Hydrocodone bitartrate, USP 5 mg
Homatropine methylbromide, USP 1.5 mg
Hydrocodone bitartrate and Homatropine methylbromide tablets also contain: citric acid, colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, starch pregelatinized, and stearic acid.
The hydrocodone component is 4,5 α-Epoxy-3-methoxy-17-methylmorphinone-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:
C18H21NO3·C4H6O6 · 2 1/2H2O
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) and the following structural formula: