Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), HOMATROPINE METHYLBROMIDE (UNII: 68JRS2HC1C) (METHYLHOMATROPINE - UNII:P97OGJ7L1L)
Genus Lifesciences Inc.
ORAL
PRESCRIPTION DRUG
Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: - Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]. - Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)]. - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Hydrocodone bitartrate and homatropine methylbromide is contraindicated for: - All pediatric patients younger than 6 years of age [see Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.4)]. - Significant respiratory depression [see Warnings and Precautions (5.2)]
Hydrocodone bitartrate and homatropine methylbromide is supplied as a white-colored, biconvex tablet, one face bisected and debossed with "205", and the other face plain, available in: Store tablets at controlled room temperature 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Hydrocodone bitartrate and homatropine methylbromide is available as a clear red-colored, cherry-flavored oral solution in: Store oral solution at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed.
New Drug Application Authorized Generic
AND HOMATROPINE METHYLBROMIDE TABLET HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION Genus Lifesciences Inc. ---------- MEDICATION GUIDE Hydrocodone bitartrate and homatropine methylbromide tablets and oral solution, for oral use (HIGH-droe-KOE-dohn by-TAR-trate and hoe-MAT-troe-peen METH-ill-BROE-mide) CII What is the most important information I should know about Hydrocodone Bitartrate and Homatropine Methylbromide? Hydrocodone bitartrate and homatropine methylbromide is not for children under 18 years of age. Hydrocodone bitartrate and homatropine methylbromide can cause serious side effects, including: • Addiction, abuse and misuse. Taking hydrocodone bitartrate and homatropine methylbromide or other medicines that contain an opioid can cause addiction abuse, and misuse, which can lead to overdose and death. This can happen even if you take hydrocodone bitartrate and homatropine methylbromide exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems. • Do not share your hydrocodone bitartrate and homatropine methylbromide with other people. • Keep hydrocodone bitartrate and homatropine methylbromide in a safe place away from children. • Life-threatening breathing problems (respiratory depression). Hydrocodone bitartrate and homatropine methylbromide can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking hydrocodone bitartrate and homatropine methylbromide, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly, or have certain other health problems. Children are at higher risk for respiratory depression. Breathing problems can happen even if you take hydrocodone bitartrate and homatropine methylbromide Olvassa el a teljes dokumentumot
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION GENUS LIFESCIENCES INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE. HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS, FOR ORAL USE, CII HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION, CII INITIAL U.S. APPROVAL: 1943 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING AND MONITOR CLOSELY FOR THESE BEHAVIORS AND CONDITIONS. (5.1) SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR WHEN USED IN PATIENTS AT HIGHER RISK. (5.2) ACCIDENTAL INGESTION OF HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROCODONE. (5.2) ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE. DOSING ERRORS CAN RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (2.1, 5.5) CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4 INDUCERS) CAN RESULT IN A FATAL OVERDOSE OF HYDROCODONE. AVOID THE USE OF HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE IN PATIENTS TAKING CYP3A4 INHIBITORS OR Olvassa el a teljes dokumentumot