Prescription Drug Name:

Hydrocodone Bitartrate and Homatropine Methylbromide Syrup

ID:

06c6c6a9-b6d8-4107-b2b0-494705ef260d

Code:

34391-3

DESCRIPTION


id: 8181655a-76a8-4c86-ac5c-c213d6df3619
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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


id: 38467a0d-4b87-403d-a774-dc6dbe4d1c14
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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 peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α-and 6-β-hydroxymetabolites.

INDICATIONS AND USAGE


id: fcf0fab0-fd66-4b36-9146-502f4f9fb496
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for the symptomatic relief of cough.

CONTRAINDICATIONS


id: 90161c38-607e-460f-8591-c1d8a4effd21
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Hydrocodone bitartrate and homatropine methylbromide syrup should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

WARNINGS


id: e9daa7cf-4569-4a14-b882-6926aac9e89f
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

May be habit forming. 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 hydrocodone bitartrate and homatropine methylbromide 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 ).

ADVERSE REACTIONS


id: 81d0e596-d480-46c0-946d-ab775f93d444
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch.

DRUG ABUSE AND DEPENDENCE


id: 3ec73082-4ad8-448e-8015-be0981374295
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

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 physical dependence may develop after a few days of narcotic therapy.

HOW SUPPLIED


id: b424268f-04d0-4e13-b73a-e9b7978a7582
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrocodone Bitartrate and Homatropine Methylbromide Syrup is available as a clear red colored, cherry flavored syrup in: Bottles of 16 fl. oz. (one pint)  ……  NDC 54868-5168-0 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
Additional barcode label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma     74146

PRINCIPAL DISPLAY PANEL


id: a74f3cfb-20c8-4efb-bec3-4eb13fd9f00c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 54868-5168-0 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP 5 mg/1.5 mg per 5 mL Each 5 mL (teaspoonful) contains: Hydrocodone Bitartrate, USP………………………………5 mg Homatropine Methylbromide, USP……………………..1.5 mg Usual Dosage: Read accompanying product information. Dispense in a tight, light-resistant container as defined in the USP. KEEPT TIGHTLY CLOSED. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Oral prescription where permitted by state law. Rx only 16 fl oz (473 mL)