displayName: Boxed Warning section
FDA Article Code: 34066-1
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.
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:
C18H21NO3•C4H6O6•2½ H2O M.W.494.49
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 for oral administration are available in the following strengths.
In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
The 7.5 mg/325 mg and 10 mg/650 mg tablets also include D&C Yellow #10 aluminum lake.
The 10 mg/500 mg and 10 mg/650 mg tablets also include FD&C Blue #2 aluminum lake.
5 mg/325 mg, 7.5 mg/325 mg, 7.5 mg/500 mg, 7.5 mg/650 mg, 10 mg/325 mg, 10 mg/500 mg, 10 mg/650 mg, and 10 mg/660 mg; Meets USP Dissolution Test 1.
5 mg/500 mg and 7.5 mg/750 mg; Meets USP Dissolution Test 2.
||Hydrocodone Bitartrate USP
|5 mg/325 mg
|5 mg/500 mg
|7.5 mg/325 mg
|7.5 mg/500 mg
|7.5 mg/650 mg
|7.5 mg/750 mg
|10 mg/325 mg
|10 mg/500 mg
|10 mg/650 mg
|10 mg/660 mg
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
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Hydrocodone bitartrate and acetaminophen tablets 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.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The most frequently reported adverse reactions include: 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, psychological 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
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
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Dosage should be adjusted according to the severity of the pain and 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 for Hydrocodone Bitartrate and Acetaminophen Tablets USP is:
||Usual Adult Dosage AS NEEDED FOR PAIN
||The total daily dosage should not exceed
|10 mg/325 mg
One tablet every four to six hours
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
10 mg/325 mg: White to off-white, oval-shaped, biconvex, uncoated tablets debossed with ‘176’ on one side and scored on the other side. Each tablet contains 10 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows:
NDC 42254-214-20 Bottles of 20
NDC 42254-214-30 Bottles of 30
NDC 42254-214-60 Bottles of 60
NDC 42254-214-90 Bottles of 90
NDC 42254-214-00 Bottles of 100
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
Store at 20 – 25°C (68 – 77°F). (See USP for Controlled Room Temperature).
A Schedule Controlled Drug Substance.
Distributed by: Caraco Pharmaceutical Laboratories, Ltd.
Detroit, MI 48202
Manufactured by: Sun Pharmaceutical Industries, Inc.
Cranbury, New Jersey 08512
Repackaged by: Rebel Distributors Corp.
Thousand Oaks, CA 91320
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4