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Hydrocodone Bitartrate [Developed, April 1994; Revised, February 1998; February 1999; March 2000; March 2001; April 2002; March 2003] TEXAS MEDICAID DRUG USE REVIEW CRITERIA FOR OUTPATIENT USE Prepared by the Drug Information Service, The University of Texas Health Science Center at San Antonio, and the College of Pharmacy, The University of Texas at Austin with review by the Texas Medicaid Drug Use Review Board. Information on indications for use or diagnosis is assumed to be unavailable. All criteria may be applied retrospectively; prospective application is indicated with [*]. 1.* Dosage Hydrocodone bitartrate is an opioid antitussive and analgesic used for the relief of cough and moderate to moderately severe pain. This drug should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence. Hydrocodone bitartrate is available in the United States only in fixed combinations with non-opiate drugs (e.g., acetaminophen, acetylsalicylic acid, ibuprofen, chlorpheniramine, pseudoephedrine, guaifenesin). The usual adult dose of hydrocodone is 5 to 10 mg every 4 to 6 hours as needed, not to exceed 40 mg per day with the 5 mg dose and 60 mg per day with the 10 mg dose. The maximum recommended dose for hydrocodone when used in combination with ibuprofen is 37.5 mg per day while the maximum recommended dosage for hydrocodone when used in combination with acetaminophen is 60 mg per day. The dosage should be adjusted according to the severity of the pain and the response and tolerance of the patient. In individuals with severe pain or those who have become tolerant to the analgesic effects of hydrocodone, it may be necessary to exceed the usual dosage. The use of hydrocodone when prescribed by multiple physicians will be reviewed. 2. Duration of Therapy There is no basis for limiting the duration of hydrocodone therapy as hydrocodone may be utilized to manage chronic painful conditions as well as acute pain events and coughing that requires medical therapy. However, the smallest effective dose should be administered as infrequently as possible to minimize the development of tolerance and physical dependence. 3.* Drug-Drug Interactions Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. The following drug-drug interactions are considered clinically relevant for hydrocodone. Only those drug-drug interactions classified as clinical significance level 1/contraindicated or those considered life-threatening which have not yet been classified will be reviewed: a. CNS Depressants (clinical significance level - undetermined) Concurrent therapy with other narcotic analgesics, antipsychotics, antianxiety agents, sedatives, hypnotics and other CNS drugs such as tricyclic antidepressants may result in potentiation of CNS depression. b. Naltrexone [clinical significance level - contraindicated (First DataBank)] Concurrent administration of naltrexone and narcotic analgesics or administration of naltrexone within 7 to 10 days of narcotic analgesic therapy may induce an acute abstinence syndrome. Combined administration of naltrexone and narcotic analgesics or administration of naltrexone to patients dependent on narcotic analgesics is contraindicated by the manufacturer as patients dependent on narcotics may experience withdrawal symptoms within five minutes of ingesting naltrexone. The adjunctive use of naltrexone and hydrocodone is not recommended and will be reviewed. c. Monoamine Oxidase Inhibitors (MAOIs), Furazolidone [clinical significance level - contraindicated (First DataBank)] The combined use of MAOIs and certain narcotic analgesics may result in hypotension, hyperpyrexia, sedation, somnolence, and death. Although documentation with hydrocodone is lacking, concurrent therapy with MAOIs should be avoided if possible or monitored closely as the consequences are potentially severe if an interaction does occur. Concomitant therapy with MAOIs and hydrocodone is not recommended and will be reviewed. d. Cimetidine [clinical significance level - severe (First DataBank); 4 (DIF); 3 (Hansten & Horn)] Concurrent use of some narcotic analgesics and cimetidine may result in enhanced pharmacologic effects of narcotic analgesics. It is speculated that hepatic metabolism of certain narcotic analgesics may be inhibited by cimetidine, resulting in significant respiratory and/or central nervous system depression. Morphine undergoes glucuronidation rather than metabolism by the cytochrome P450 enzyme system and is minimally effected by adjunctive cimetidine administration. Other available H2-receptor antagonists are less likely to interact than cimetidine and should be considered in patients prescribed narcotic analgesics. Patients receiving cimetidine concurrently with narcotic analgesics should be observed for signs and symptoms of enhanced respiratory and/or central nervous system depression. References 1. Wang RIH, Drugdex® Editorial Staff. Hydrocodone (Drug Evaluation). In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex® System. Englewood, CO: Micromedex, Inc., edition expires 2003. 2. Hydrocodone Bitartrate Monograph. In: McEvoy GK, editor. AHFS Drug Information 2003. Bethesda: American Society of Health-System Pharmacists, Inc., 2002:2033-4, 2577-80. 3. Physicians' Desk Reference. 56th edition. Montvale, NJ: Medical Economics Company, Inc., 2002. 4. Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons, 2003. 5. Medscape Drug Info with First DataBank and ASHP. (2003) New York, NY: Medscape, Inc. Retrieved March 12th, 2003 from the World Wide Web at http://medscape.com/druginfo. 6. Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons, Inc., 2003. This page is maintained by the HHSC Medicaid/CHIP: Vendor Drug. Comments
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