Dihydrocodeine

TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsulesare indicated for the relief of moderate to moderately severe pain.

• The usual adult dosage is two TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules orally every four hours, as needed
• Dosage should be adjusted according to the severity of the pain and the response of the patient
• No more than two capsules should be taken in a 4-hour period
• No more than five doses, or ten capsules should be taken in a 24-hour period

• Safety and effectiveness of TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules
• In pediatric patients have not been established
• Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). …

TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules should be given with caution to the elderly.

• Patients receiving TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules should be given the following information: 1
• Do not take TREZIX™ if you are allergic to any of its ingredients. 2
• If you develop signs of allergy such as a rash or difficulty breathing stop taking TREZIX™ and contact your healthcare provider immediately. 3
• Do not take more than 4000 milligrams of acetaminophen per day
• Call your doctor if you took more than the recommended dose. 4
• Patients should be advised that TREZIX™ capsules may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. 5. …

• Dihydrocodeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy
• This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment …

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. …

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. …

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. …

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. …

Following an acute overdosage with TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules, toxicity may result from the dihydrocodeine or the acetaminophen. Toxicity due to the caffeine component is less likely, due to the relatively small amounts in this formulation. An overdose is a potentially lethal polydrug overdose situation, and consultation with a regional Poison Control Center is recommended. A listing of the poison control centers can be found in standard references such as the Physician's Desk Reference®. …

This combination product is subject to the provisions of the Controlled Substance Act and has been placed in Schedule III. Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Like other opioid analgesics, dihydrocodeine may produce subjected effects other than analgesia (e.g., euphoria, relaxation), which may contribute to abuse by some patients. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.