DailyMed Label: Hydrocodone Acetaminophen

DailyMed Label: Hydrocodone Acetaminophen

2011

DailyMed Prescription

Hydrocodone Acetaminophen

HYDROCODONE, ACETAMINOPHEN

RedPharm Drug Inc.

NDC: 67296-0016

NDC: 67296-0016

DESCRIPTION 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: 4,5a- 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 for oral administration are available in the following strengths Strength Hydrocodone Bitartrate Acetaminophen 2.5 mg/500 mg 2.5 mg 500 mg 5 mg / 500 mg 5 mg 500 mg 7.5 mg / 325 mg 7.5 mg 325 mg 7.5 mg / 500 mg 7.5 mg 500 mg 7.5 mg / 650 mg 7.5 mg 650 mg 7.5 mg / 750 mg 7.5 mg 750 mg 10 mg / 325 mg 10 mg 325 mg 10 mg / 500 mg 10 mg 500 mg 10 mg / 650 mg 10 mg 650 mg 10 mg / 660 mg 10 mg 660 mg 10 mg / 750 mg 10 mg 750 mg In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate,microcrystalline cellulose, povidone, starch, and stearic acid; except the 7.5mg/325mg, 10 mg/325 mg and 10 mg/500 mg tablets do not contain anhydrous lactose.  The 7.5 mg/325 mg tablets include FD and C Yellow # 6 Aluminum Lake; the 7.5 mg/650 mg tablets include FD and C Red #40 Aluminum Lake; the 10 mg/325 mg and 10 mg/750 mg tablets include D and C Yellow # 10 Aluminum Lake; the 10 mg/500 mg tablets include FD and C Blue #2 Aluminum Lake; and the 10 mg/650mg tablets include FD and C Blue #1 Aluminum Lake and D and C Yellow #10 Aluminum Lake.  Meets USP Dissolution Test 1. structural formula structural formula

INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION 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. 2.5 mg/500 mg 5 mg/500 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. 7.5 mg/325 mg 7.5 mg/500 mg 7.5 mg/650 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. 10 mg/325 mg 10 mg/500 mg 10 mg/650 mg 10 mg/660 mg The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 5 tablets. 10 mg/750 mg The usual adult dosage is one table every four to six hours as needed for pain.  The total daily dosage should not exceed 5 tablets.

CONTRAINDICATIONS 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

PRECAUTIONS General Special Risk Patients: As with any narcotic analgesic agent, hydrocodone bitartrate and acetaminophen tablets should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Cough Reflex: Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone bitartrate and acetaminophen tablets are used postoperatively and in patients with pulmonary disease.

ADVERSE REACTIONS

Drug Interactions Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

HOW SUPPLIED Hydrocodone bitartrate and acetaminophen tablets, USP are available in the following strengths: 2.5 mg/500 mg 2.5 mg hydrocodone bitartrate and 500 mg acetaminophen, oblong, white tablets bisected on one side and debossed with WATSON 388 on the other side, supplied in bottles of 100. 5 mg/500 mg 5 mg hydrocodone bitartrate and 500 mg acetaminophen, capsule-shaped, white tablets bisected on one side and debossed with WATSON 349 on the other side, supplied in bottles of 100 and 500. 7.5 mg/325 mg 7.5 mg hydrocodone bitartrate and 325mg acetaminophen, capsule-shaped, light orange tablets bisected on one side and debossed with WATSON 3203 on the other side, supplied in bottles of 100. 7.5 mg/500 mg 7.5 mg hydrocodone bitartrate and 500 mg acetaminophen, capsule-shaped, white tablets bisected on one side and debossed with WATSON 385 on the other side, supplied in bottles of 100 and 500. 7.5 mg/650 mg 7.5 mg hydrocodone bitartrate and 650 mg acetaminophen, capsule-shaped, pink tablets bisected on one side and debossed with WATSON 502 on the other side, supplied in bottles of 100 and 500. 7.5 mg/750 mg 7.5 mg hydrocodone bitartrate and 750 mg acetaminophen, oblong, white tablets bisected on one side and debossed with WATSON 387 on the other side, supplied in bottles of 100 and 500. 10 mg/325 mg 10 mg hydrocodone bitartrate and 325 mg acetaminophen, capsule-shaped, yellow tablets bisected on one side and debossed with WATSON 853 on the other side, supplied in bottles of 100 and 500. 10 mg/500 mg 10 mg hydrocodone bitartrate and 500 mg acetaminophen, capsule-shaped, blue tablets bisected on one side and debossed with WATSON 540 on the other side, supplied in bottles of 100 and 500. 10 mg/650 mg 10 mg hydrocodone bitartrate and 650 mg acetaminophen, capsule-shaped, light green tablets bisected on one side and debossed with WATSON 503 on the other side, supplied in bottles of 100 and 500. 10 mg/660 mg 10 mg hydrocodone bitartrate and 660 mg acetaminophen, oval shaped, white tablets bisected on one side and debossed with WATSON 517 on the other side, supplied in bottles of 100 and 500. 10 mg/750 mg 10 mg hydrocodone bitartrate and 750 mg acetaminophen, capsule-shaped, yellow tablets bisected on one side and debossed with WATSON 3228n the other side, supplied in bottles of 100. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: June 2008 0608B 173191

CLINICAL PHARMACOLOGY 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.

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