Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE- acetaminophen, caffeine and dihydrocodeine bitartrate capsule
Xspire Pharma, Llc
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYME; HEPATOTOXICITY and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse and Misuse
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate 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 and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Monitor for respiratory depression, especially during initiation of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate or following a dose increase [see WARNINGS].
Accidental Ingestion
Accidental ingestion of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate, especially by children, can result in a fatal overdose of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate [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 an ultra-rapid metabolizer of codeine due to CYP2D6 polymorphism [see WARNINGS and PRECAUTIONS]. Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate 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]. Avoid the use of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate 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 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].
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 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.
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 exceed 4,000 milligrams per day, and often involve more than one Acetaminophen-containing product [see WARNINGS].
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, PRECAUTIONS; Drug Interactions].
• Reserve concomitant prescribing of Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate 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.
DESCRIPTION:
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules are supplied in capsule form for oral administration.
Each red capsule contains:
Acetaminophen ……………………………….. 320.5 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:
Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder or white glistening needles, is a central nervous system stimulant. It has the following structural formula:
Dihydrocodeine Bitartrate (4,5 α-epoxy-3-methoxy-17-methylmorphinan-6 α-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:
In addition, each capsule contains the following inactive ingredients: crospovidone, magnesium stearate, povidone, pregelatinized corn starch, stearic acid. The capsule is composed of FD&C Red #40, and gelatin. Imprinting ink is composed of ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, pharmaceutical glaze (modified) in SD-45, propylene glycol, simethicone, and titanium dioxide.
CLINICAL PHARMACOLOGY:
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE capsules contain dihydrocodeine which is a semi-synthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components. The principal action of therapeutic value is analgesia. This combination product also contains Acetaminophen, a non-opiate, non-salicylate analgesic and antipyretic. This combination product contains caffeine as an analgesic adjuvant. Caffeine is also a CNS and cardiovascular stimulant.
Effects on the Endocrine System
Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to hormonal changes that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see ADVERSE REACTIONS].
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