Ascomp with Codeine

ASCOMP WITH CODEINE- butalbital, aspirin, caffeine and codeine phosphate capsule
LGM Pharma Solutions, LLC

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 WITHDRAWL SYNDROME; and INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES

Addiction, Abuse, and Misuse ASCOMP with CODEINE 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 ASCOMP with CODEINE, 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 educations programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following:
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 improve patient, household, and community safety.
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of ASCOMP with CODEINE. Monitor for respiratory depression, especially during initiation of ASCOMP with CODEINE or following a dose increase [see Warnings and Precautions (5.3)].
Accidental Ingestion Accidental ingestion of even one dose of ASCOMP with CODEINE, especially by children, can result in a fatal overdose of ASCOMP with CODEINE [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 ASCOMP with CODEINE 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)]. ASCOMP with CODEINE 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 ASCOMP with CODEINE 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 ASCOMP with CODEINE 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 ASCOMP with CODEINE 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

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)].

2.2 Dosing Information

One or two capsules every 4 hours. Total daily dosage should not exceed 6 capsules.

2.3 Safe Reduction or Discontinuation of ASCOMP with CODEINE

3 DOSAGE FORMS AND STRENGTHS

Capsules: Butalbital, 50 mg, Aspirin, 325 mg, Caffeine, 40 mg, Codeine Phosphate, 30 mg

Blue cap with a yellow body. Body is imprinted with “B 074” in black ink.

4 CONTRAINDICATIONS

ASCOMP with CODEINE is contraindicated for:

All children younger than 12 years of age [see Warnings and Precautions (5.4)]
Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.5)].

ASCOMP with CODEINE is also contraindicated in patients with:

Significant respiratory depression [see Warnings and Precautions (5.8)]
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)]
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.9)/Drug Interactions (7)].
Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13)]
Hypersensitivity or intolerance to aspirin, caffeine, butalbital, or codeine.
Hemophilia [see Warnings and Precautions (5.17)]
Reye’s Syndrome [see Warnings and Precautions (5.18)]
Known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) [see Warnings and Precautions (5.19)]
Syndrome of asthma, rhinitis, and nasal polyps [see Warnings and Precautions (5.19)]

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