Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
CODEINE PHOSPHATE ANHYDROUS (UNII: 2X585M1M3T) (CODEINE - UNII:Q830PW7520), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)
Aytu BioPharma, Inc.
ORAL
PRESCRIPTION DRUG
TUZISTRA XR 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.TUZISTRA XR 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 [ ]. Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations (8.4) ]. Not indicated for pediatric patients under 18 years of age [ ]. Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations (8.4) ]. - Contraindicated in pediatric patients under 12 years of age [ see Contraindications (4),Use in Specific Populations (8.4) ]. Contraindicated in pedi
TUZISTRA XR is supplied as a pink to reddish pink, cherry-flavored liquid oral suspension containing codeine polistirex, providing 14.7 mg of codeine (equivalent to 20 mg codeine phosphate), and chlorpheniramine polistirex, providing 2.8 mg chlorpheniramine (equivalent to 4 mg chlorpheniramine maleate) per 5 mL. It is available in bottles of 16 fluid oz. (473 mL) NDC 69654-480-01. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Shake well. 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
Aytu BioPharma, Inc. ---------- MEDICATION GUIDE TUZISTRA® XR (Two-zis-tra) (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, C-III What is the most important information I should know about TUZISTRA XR? TUZISTRA XR is not for children under 18 years of age. TUZISTRA XR can cause serious side effects, including: • Addiction, abuse and misuse. Taking TUZISTRA XR 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 TUZISTRA XR 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 TUZISTRA XR with other people. • Keep TUZISTRA XR in a safe place away from children. • Life-threatening breathing problems (respiratory depression). TUZISTRA XR 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 TUZISTRA XR, 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 TUZISTRA XR exactly as prescribed by your healthcare provider. Call your healthcare provider or get emergency medical help right away if anyone taking TUZISTRA XR has any of the symptoms below: • increased sleepiness • confusion • difficulty breathing • shallow breathing • limpness Keep TUZISTRA XR in a safe place away from children. Accidental use of even 1 dose of TUZISTRA XR, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. If a child accidentally takes TUZISTRA XR, get emergency help right away. • Overdose and death due to med Lire le document complet
TUZISTRA XR- CODEINE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX SUSPENSION, EXTENDED RELEASE AYTU BIOPHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TUZISTRA XR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TUZISTRA XR. TUZISTRA XR (CODEINE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) EXTENDED-RELEASE ORAL SUSPENSION, CIII INITIAL U.S. APPROVAL: 1985 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLIS OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ TUZISTRA XR 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 TUZISTRA XR, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF CODEINE. ( 5.2) LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO RECEIVED CODEINE; MOST CASES FOLLOWED TONSILLECTOMY AND/OR ADENOIDECTOMY, AND MANY OF THE CHILDREN HAD EVIDENCE OF BEING AN ULTRA-RAPID METABOLIZER OF CODEINE DUE TO A CYP2D6 POLYMORPHISM. ( 5.3) TUZISTRA XR IS CONTRAINDICATED IN CHILDREN YOUNGER THAN 12 YEARS OF AGE AND IN CHILDREN YOUNGER THAN 18 YEARS OF AGE FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY. ( 4) AVOID THE USE OF TUZISTRA XR IN ADOLESCENTS 12 TO 18 YEARS OF AGE WHO HAVE OTHER RISK FACTORS THAT MAY INCREASE THEIR SENSITIVITY TO THE RESPIRATORY DEPRESSANT EFFECTS OF CODEINE. ENSURE ACCURACY WHEN PRESCRIBING, Lire le document complet