Kenyan Health Patient Information Leaflet
Central Nervous System Stimulant [EPC], Methylxanthine [EPC]
INDICATIONS AND USAGE: TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsulesare indicated for the relief of moderate to moderately severe pain. Clinical selection for Dihydrocodeine should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC. Class context: Central Nervous System Stimulant [EPC], Methylxanthine [EPC]. Confirm site-specific dose, duration and monitoring before prescribing.
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.
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. Hypersensitivity reactions (including anaphylactoid reactions), hallucinations, vivid dreams, granulomatous interstitial nephritis, severe narcosis and acute renal failure have been reported rarely during dihydrocodeine administration. Acetaminophen: Acetaminophen in therapeutic doses rarely causes adverse reactions. The most serious adverse reaction is hepatoxicity from overdosage (see OVERDOSAGE ). Thrombocytopenia, leukopenia, pancytopenia, neutropenia, thrombocytopenic purpura, and agranulocytosis have been reported in patients receiving acetaminophen or p-aminophenol derivatives. Hypersensitivity reactions including urticarial or erythematous skin reactions, laryngeal edema, angioedema, or anaphylactoid reactions are rare. Caffeine: Adverse reactions associated with caffeine use include anxiety, anxiety neurosis, excitement, headaches, insomnia, irritability, lightheadedness, restlessness, tenseness, tremor, extrasystoles, palpitations, tachycardia, diarrhea, nausea, stomach pain, vomiting, diuresis, urticaria, scintillating scotoma, and tinnitus.
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). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture. Rx Only Manufactured for: WraSer Pharmaceuticals LLC Ridgeland, MS 39157 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 13001 Rev. May 2014 Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc.