Butalbital, Aspirin, Caffeine and Codeine Phosphate

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE- codeine phosphate, butalbital, caffeine and aspirin capsule
Actavis Pharma, Inc.

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES

Addiction, Abuse, and Misuse

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions ( 5.2 )]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

  • complete a REMS-compliant education program,
  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
  • consider other tools to imp r ove patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP. Monitor for respiratory depression, especially during initiation of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP or following a dose increase [see Warnings and Precautions ( 5.3 )] .

Accidental Ingestion

Accidental ingestion of even one dose of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, especially by children, can result in a fatal overdose of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP [see Warnings and Precautions ( 5.3 )].

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 [see Warnings and Precautions ( 5.4 , 5.8 ), Drug Interactions ( 7 )].

  • Reserve concomitant prescribing of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

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 ( 5.5 )]. Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 opioid use is required 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 ( 5.6 )].

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. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP requires careful consideration of the effects on codeine, and the active metabolite, morphine [see Warnings and Precautions ( 5.7 , 5.8 ), Drug Interactions ( 7 )].

1 INDICATIONS AND USAGE

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP are indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate.

Limitations of Use :

Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions ( 5.1)] , reserve Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics):

• Have not been tolerated, or are not expected to be tolerated,

• Have not provided adequate analgesia, or are not expected to provide adequate analgesia

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5)] .

Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions ( 5.1)].

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