displayName: Description section
FDA Article Code: 34089-3
Hydrocodone bitartrate and acetaminophen 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: 4,5 α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:C18H21NO3• C4H6O6• 2½H2O M.W. 494.490Acetaminophen, 4´-hydroxy-acetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:C8H9NO2 M.W. 151.16Each tablet contains:Hydrocodone Bitartrate………………10 mgWARNING: May be habit- forming.Acetaminophen…………………………650 mgIn addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and FD&C Blue #1 Lake.This product complies with Dissolution Test 1.
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 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
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.
displayName: Adverse Reactions section
FDA Article Code: 34084-4
The most frequently reported adverse reactions are 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 aIleviated 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.
displayName: Overdosage section
FDA Article Code: 34088-5
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
DOSAGE AND ADMINISTRATION
displayName: Dosage and 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 dosage should not exceed 6 tablets.
displayName: How Supplied section
FDA Article Code: 34069-5
Hydrocodone Bitartrate and Acetaminophen Tablets, each of which contains hydrocodone bitartrate 10 mg (WARNING: May be habit-forming) and acetaminophen 650 mg, are light-blue, capsule-shaped, scored tablets, debossed “IL/3658”, and are supplied in containers of 100 and 500 tablets.