देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
HYDROCODONE (UNII: 6YKS4Y3WQ7) (HYDROCODONE - UNII:6YKS4Y3WQ7), CHLORPHENIRAMINE (UNII: 3U6IO1965U) (CHLORPHENIRAMINE - UNII:3U6IO1965U)
Neos Therapeutics LP
HYDROCODONE
HYDROCODONE 10 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension extended-release suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important 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 Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension 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
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension, equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL, is a gold- colored suspension, available as: Each bottle is supplied with a plastic dosing spoon calibrated for measuring 2.5 mL and 5 mL doses. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°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 the oral dosing dispenser and correctly measure the oral suspension as prescribed.
Abbreviated New Drug Application
CHLORPHENIRAMINE POLISTIREX SUSPENSION, EXTENDED RELEASE Neos Therapeutics LP ---------- MEDICATION GUIDE HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION, CII This Medication Guide has been approved by the U.S. Food and Drug Administration. U.S. Patent 8,470,375; 8,512,759; 8,318, 210; 7,871,645; 8,329,224; 8,343,546 PIN030117 07/20 Revised: July 2020 What is the most important information I should know about Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended- Release Oral Suspension? Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended- Release Oral Suspension is not for children under 18 years of age. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended- Release Oral Suspension can cause serious side effects, including: • Addiction, abuse and misuse. Taking Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension 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 Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension exactly as prescribed by your healthcare provider. Your risk MEDICATION GUIDE HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION, CII 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 Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension with other people. • Keep Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension in a safe place away from children. • Life-threatening breathing problems (respiratory depression). Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of पूरा दस्तावेज़ पढ़ें
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX- HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX SUSPENSION, EXTENDED RELEASE NEOS THERAPEUTICS LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION. HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE SUSPENSION, FOR ORAL ADMINISTRATION, CII INITIAL U.S. APPROVAL: 1987 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 POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION 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 POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROCODONE. ( 5.2) ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION. 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 POLISTIREX AND CHLORPHENIRAMINE P पूरा दस्तावेज़ पढ़ें