Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
Generic Name: acetaminophen, caffeine, dihydrocodeine bitartrate
Brand Names:
Trezix
DESCRIPTION: TREZIX™ 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.
Overview
DESCRIPTION: TREZIX™ 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.
Uses
INDICATIONS AND USAGE: TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsulesare indicated for the relief of moderate to moderately severe pain.
Dosage
DOSAGE AND ADMINISTRATION: The usual adult dosage is two (2) TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than two (2) capsules should be taken in a 4-hour period. No more than five (5) doses, or ten (10) capsules should be taken in a 24-hour period.
Side Effects
ADVERSE REACTIONS: Dihydrocodeine: The most frequently observed adverse reactions include light-headedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, and skin reactions. With the exception of constipation, tolerance develops to most of these effects. Other reactions that have been observed with dihydrocodeine or other opioids include respiratory depression, orthostatic hypotension, cough suppression, confusion, diarrhea, miosis, abdominal pain, dry mouth, indigestion, anorexia, spasm of biliary tract, and urinary retention. Physical and psychological dependence are possibilities.
Interactions
Drug Interactions: Dihydrocodeine with Other Central Nervous System Depressants: Patients receiving other opioid analgesics, sedatives or hypnotics, muscle relaxants, general anesthetics, centrally acting anti-emetics, phenothiazines or other tranquilizers, or alcohol concomitantly with this combination product may exhibit additive depressant effects on the central nervous system. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Dihydrocodeine with Monoamine Oxidase Inhibitors: Dihydrocodeine, like all opioid analgesics, interacts with monoamine oxidase inhibitors causing central nervous system excitation and hypertension.
Warnings
WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. WARNINGS: 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 4000 milligrams per day, and often involve more than one acetaminophen containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. CONTRAINDICATIONS: Dihydrocodeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
Pregnancy
Pregnancy: Teratogenic Effects – Pregnancy Category C . Animal reproduction studies have not been conducted with TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules. It is also not known whether this combination product can cause fetal harm when administered to pregnant women or can affect reproduction capacity in males and females. This combination product should be given to pregnant women only if clearly needed, especially during the first trimester.
Storage
HOW SUPPLIED: TREZIX™ capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg, are supplied in bottles of 30(NDC #63187-705-30), 60(NDC #63187-705-60), 90(NDC #63187-705-90), 100 (NDC #63187-705-00) and 120 capsules (NDC #63187-705-72) Capsules are imprinted “TREZIX” on the red cap in white ink. Store at 20°C to 25°C (68°F to 77°F).
Frequently Asked Questions
What is Acetaminophen, Caffeine, Dihydrocodeine Bitartrate used for?▼
INDICATIONS AND USAGE: TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsulesare indicated for the relief of moderate to moderately severe pain.
What are the side effects of Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?▼
ADVERSE REACTIONS: Dihydrocodeine: The most frequently observed adverse reactions include light-headedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, and skin reactions. With the exception of constipation, tolerance develops to most of these effects. Other reactions that have been observed with dihydrocodeine or other opioids include respiratory depression, orthostatic hypotension, cough suppression, confusion, diarrhea, miosis, abdominal pain, dry mouth, indigestion, anorexia, spasm of biliary tract, and urinary retention. Physical and psychological dependence are possibilities.
Can I take Acetaminophen, Caffeine, Dihydrocodeine Bitartrate during pregnancy?▼
Pregnancy: Teratogenic Effects – Pregnancy Category C . Animal reproduction studies have not been conducted with TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules. It is also not known whether this combination product can cause fetal harm when administered to pregnant women or can affect reproduction capacity in males and females. This combination product should be given to pregnant women only if clearly needed, especially during the first trimester.
What are the important warnings for Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?▼
WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. WARNINGS: 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 4000 milligrams per day, and often involve more than one acetaminophen containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. CONTRAINDICATIONS: Dihydrocodeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.