Antitussive Hydrocodone and Homatropine

Hydrocodone Bitartrate and Homatropine Methylbromide Tablet, USP contains hydrocodone

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

Each Hydrocodone Bitartrate and Homatropine Methylbromide Tablet contains:

Hydrocodone Bitartrate, USP 5 mg

Homatropine Methylbromide, USP 1.5 mg

Hydrocodone Bitartrate and Homatropine Methylbromide Tablets also contain: anhydrous lactose, dicalcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.

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:

C18H21NO3• C4H6O6• 2½H2O

Hydrocodone Bitartrate

Homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane, 3-[(hydroxyphenyl-acetyl)oxy]-

8, 8-dimethyl-, bromide, endo-; a white crystal or fine white crystalline powder, with a molecular weight of (370.29).

C17H24BrNO3

Homatropine Methylbromide

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. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. The ingestion of very large amounts of hydrocodone bitartrate and homatropine methylbromide tablets may, in addition, result in acute homatropine intoxication.

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 opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. 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.