TUZISTRA XR- codeine phosphate anhydrous and chlorpheniramine maleate suspension, extended release
Aytu BioPharma, Inc.
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
Addiction, Abuse, and Misuse
TUZISTRA XR exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve TUZISTRA XR 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. Assess each patient’s risk prior to prescribing TUZISTRA XR, prescribe TUZISTRA XR for the shortest duration that is consistent with individual patient treatment goals , monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment. [ see Warnings and Precautions (5.1) ]
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of TUZISTRA XR. Monitor for respiratory depression, especially during initiation of TUZISTRA XR therapy or when used in patients at higher risk [ see Warnings and Precautions (5.2) ] .
Accidental ingestion of even one dose of TUZISTRA XR, especially by children, can result in a fatal overdose of codeine [ see Warnings and Precautions (5.2) ].
Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children
Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism [ see Warnings and Precautions (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 [ see Contraindications (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.
Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering TUZISTRA XR. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering TUZISTRA XR [ see Dosage and Administration (2.1), Warnings and Precautions (5.6)].
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of TUZISTRA XR in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor [ see Warnings and Precautions (5.8), Drug Interactions ( 7.1, 7.2, 7.4)].
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death . Avoid the use of TUZISTRA XR in patients taking benzodiazepines, other CNS depressants, or alcohol. [ see Warning and Precautions (5.9), Drug Interactions (7.5) ]
Neonatal Opioid Withdrawal Syndrome
TUZISTRA XR is not recommended for use in pregnant women [ see Use in Specific Populations (8.1)]. Prolonged use of TUZISTRA XR during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If TUZISTRA XR is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [ see Warnings and Precautions (5.15)].
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) ].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1)], reserve TUZISTRA XR 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.
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