Tuxarin

TUXARIN- codeine phosphate and chlorpheniramine maleate tablet, extended release
Mainpointe Pharmaceuticals

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTIAL INGESTION; ULTRA-RAPID METABOLISM 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 OPOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse

TUXARIN ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve TUXARIN ER 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 TUXARIN ER, prescribe TUXARIN ER 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 TUXARIN ER. Monitor for respiratory depression, especially during initiation of TUXARIN ER therapy or when used in patients at higher risk [see Warnings and Precautions (5.2) ].

Accidental Ingestion

Accidental ingestion of even one dose of TUXARIN ER, 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) ]. TUXARIN ER 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 TUXARIN ER 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. [See Warnings and Precautions (5.1) ].

Risk of Medication Errors

Ensure accuracy when prescribing, dispensing, and administering TUXARIN ER. Dosing errors can result in accidental overdose and death. [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 TUXARIN ER 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, 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 use of TUXARIN ER in patients taking benzodiazepines, other CNS depressants, or alcohol. [see Warning and Precautions (5.9) Drug Interactions (7.5)].

Neonatal Opioid Withdrawal Syndrome

TUXARIN ER is not recommended for use in pregnant women [see Use in Specific Populations (8.1) ]. Prolonged use of TUXARIN ER 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 TUXARIN ER 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) ].

1 INDICATIONS AND USAGE

TUXARIN ER 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

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Administer TUXARIN ER by the oral route only.

Advise patients not to increase the dose or dosing frequency of TUXARIN ER because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.2), Overdosage (10)]. The dosage of TUXARIN ER should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [see Dosage and Administration (2.3), Warnings and Precautions (5.5)].

2.2 Recommended Dosage

Adults 18 years of age and older: one tablet every 12 hours as needed, not to exceed 2 tablets in 24 hours.

2.3 Monitoring, Maintenance, and Discontinuation of Therapy

Prescribe TUXARIN ER for the shortest duration that is consistent with individual patient treatment goals [see Warnings and Precautions (5.1) ]

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [see Warnings and Precautions (5.2) ].

Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Warnings and Precautions (5.5) ]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with TUXARIN ER, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1) ].

Do not abruptly discontinue TUXARIN ER in a physically-dependent patient [see Drug Abuse and Dependence (9.3) ]. When a patient who has been taking TUXARIN ER regularly and may be physically dependent no longer requires therapy with TUXARIN ER, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.

3 DOSAGE FORMS AND STRENGTHS

Extended-release tablets: Each tablet contains 54.3 mg of codeine phosphate (equivalent to 40 mg of codeine); and 8 mg of chlorpheniramine maleate (equivalent to 5.6 mg of chlorpheniramine). Each tablet is white to off-white, uncoated, round, debossed with MP on one side and CC on the other side [see Description (11) ].

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