Acetaminophen, Caffeine and Dihydrocodeine Bitartrate

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE- acetaminophen, caffeine and dihydrocodeine bitartrate tablet
Atland Pharmaceuticals, LLC

BOXED WARNING

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

Addiction, Abuse and Misuse

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets expose 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 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].

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.] 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 improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets. Monitor for respiratory depression, especially during initiation of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets or following a dose increase [see WARNINGS].

Accidental Ingestion

Accidental Ingestion of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets, especially by children, can result in a fatal overdose of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets [see WARNINGS].

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 and ultra-rapid metabolizer of codeine due to CYP2D6 polymorphism [see WARNINGS and PRECAUTIONS]. Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets are 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]. Avoid the use Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets 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 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which maybe life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolong period in a pregnant woman, advise the patient the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS].

Interactions with Drug 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 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine [see WARNIGNS and PRECAUTIONS].

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceeds 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see WARNINGS].

Risks From Concomitant Use of 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, PRECATIOUNS; Drug Interactions].

  • Reserve concomitant prescribing of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum reported.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

DESCRIPTION

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are supplied in tablets form for oral administration.

Each tablet contains:

Acetaminophen……………….. 325 mg

Caffeine ………………………….. 30 mg

Dihydrocodeine bitartrate…….. 16 mg

Acetaminophen (4′-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

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In addition, each tablet also contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.

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