Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII, Rx Only, Warning

/Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII, Rx Only, Warning
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII, Rx Only, Warning2018-09-06T09:12:40+00:00

Prescription Drug Name:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII, Rx Only, Warning

ID:

d589d665-b189-474f-bc77-7f1554a46745

Code:

34391-3

BOXED WARNING


id: 93994db8-b25d-4103-b474-3454a2d75875
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.

DESCRIPTION


id: c6686126-4e5a-4fd1-8383-ddb556539e64
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Hydrocodone bitartrate and acetaminophen is 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: Hydrocodone bitartrate and acetaminophen tablets, USP are available in the following strengths:

Strength Hydrocodone Bitartrate Acetaminophen
5 mg/300 mg  5 mg 300 mg
7.5 mg/300 mg 7.5 mg 300 mg
10 mg/300 mg  10 mg 300 mg

CLINICAL PHARMACOLOGY


id: c5015d43-f7c1-4e66-a9b5-39abb0e69562
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: cac29fc6-92ae-48b2-9e1c-6bb50eb705b4
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: ae85c9ef-a9ce-4bbb-b4fa-67eba83811b7
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. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

ADVERSE REACTIONS


id: 3f62322c-a639-48be-844e-54578458a2ef
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The most frequently reported adverse reactions include: lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory 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 center. (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: e3ea680d-ab69-4013-b798-04f508454b72
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE AND ADMINISTRATION


id: 588f8396-8da5-4d74-ace6-7c61ef20bf8d
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. Hydrocodone bitartrate and acetaminophen tablets, 5 mg/300 mg: The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets. Hydrocodone bitartrate and acetaminophen tablets, 7.5 mg/300 mg: The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets. Hydrocodone bitartrate and acetaminophen tablets, 10 mg/300 mg: The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

HOW SUPPLIED


id: d9852f8f-9d04-4cd2-b87b-09ac45ea534b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrocodone bitartrate and acetaminophen tablets, USP are supplied as follows: Hydrocodone bitartrate and acetaminophen tablets, USP 5 mg/300 mg CII White, capsule-shaped, bisected tablets, debossed “n” score “351”on one side and plain on the other side in bottles of 30, 100 and 500 tablets: Bottles of 30        NDC 40032-351-03 Bottles of 100      NDC 40032-351-01 Bottles of 500      NDC 40032-351-05 Hydrocodone bitartrate and acetaminophen tablets, USP 7.5 mg/300 mg CII White, capsule-shaped, bisected tablets, debossed “n” score “352”on one side and plain on the other side in bottles of 30, 100 and 500 tablets: Bottles of 30        NDC 40032-352-03 Bottles of 100      NDC 40032-352-01 Bottles of 500      NDC 40032-352-05 Hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/300 mg CII White, capsule-shaped, bisected tablets, debossed “n” score “353”on one side and plain on the other side in bottles of 30, 100 and 500 tablets: Bottles of 30        NDC 40032-353-03 Bottles of 100      NDC 40032-353-01 Bottles of 500      NDC 40032-353-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


id: da096f21-a0d5-4e7b-9100-4fced1fe03ba
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg CII 30 count Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/300 mg CII 100 count Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/300 mg CII 100 count