HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP

/HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP

ID:

fcf959cd-925b-4eb1-8a7a-b5e25e64cad0

Code:

34391-3


id: a6dd19a1-d4e2-46b8-8030-6463fbb4a016
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Rx only

DESCRIPTION


id: a7e2c0d6-102a-48cd-b48c-fa19db325d97
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains: Hydrocodone Bitartrate, USP ……………………. 10 mg Acetaminophen, USP ……………………………… 325 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Meets USP Dissolution Test 1.

CLINICAL PHARMACOLOGY


id: a46ca0be-38ed-464a-9e59-c28bd99d7b99
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

INDICATIONS AND USAGE


id: a7bd24ca-bac4-4cde-998c-891739c560eb
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.

CONTRAINDICATIONS


id: af68700c-6111-4594-842c-6da7711700fe
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone.

ADVERSE REACTIONS


id: a09fc1bb-ce2f-4ff1-a3a0-f80c43bcb14d
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include: Central Nervous System:  Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes. Gastrointestinal System:  Prolonged administration of hydrocodone bitartrate and acetaminophen tablets may produce constipation. Genitourinary System:  Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates. Respiratory Depression:  Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory centers (see OVERDOSAGE ). Special Senses:  Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Dermatological:  Skin rash, pruritus. The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis. Potential effects of high dosage are listed in the OVERDOSAGE section.

OVERDOSAGE


id: a53da4a5-103e-4767-8038-143c8922892e
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.

DOSAGE AND ADMINISTRATION


id: a0f0b5ab-6bcd-4389-8bf1-4e40f3fefa05
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose should not exceed 6 tablets.

HOW SUPPLIED


id: a25d587c-f24c-4311-b092-a1950bcc188c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 325 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 110” on obverse and bisected on the reverse. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are available as follows: Bottles of 100:   NDC 53746-110-01 Bottles of 500:   NDC 53746-110-05 Bottles of 1000: NDC 53746-110-10 Storage:   Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. A Schedule CIII Narcotic.


id: a0a3c79f-a70f-4769-9bd7-b2c6ae78a2b2
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 09-2010