TRAMOPHEN

Acetaminophen
Absorption: Gastrointestinal tract
Peak plasma concentration: About 10 to 60 minutes
Plasma Protein Binding: Negligible
Distribution: Most body tissues; crosses placenta and present in breast milk
Metabolism: Mainly in the liver
Elimination Half-life: About 1 to 3 hours
Excretion: Urine mainly as the glucuronide and sulfate conjugates

Indications and Dose
Symptomatic treatment of moderate to severe pain: Initially 2 tablets or as directed by a physician. Max. dose: 8 tablets per day. The dosing interval should not be less than six hours.
Pediatric use: Effective and safe use has not been established in children below the age of 12 years.
Elderly patients: A dose adjustment is not necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency.

Side Effects
Acetaminophen
REPORTED: thrombocytopenia, leucopenia, pancytopenia, neutropenia, agranulocytosis
OCCASIONALLY: skin rashes, hypersensitivity reactions

Tramadol
COMMON: nausea, vomiting, constipation, drowsiness, confusion
MAY OCCUR: tolerance on long use, micturition difficulty, uretic or biliary spasm, alterations in liver enzyme values, dry mouth, dizziness, sweating, facial flushing, headache, vertigo, bradycardia, hypothermia, restlessness, changes of mood, decreased libido or potency, hallucinations, miosis, raised intracranial pressure, muscle rigidity
OCCASIONALLY: hypotension, respiratory depression

Contraindications
Children below 12 years of age, post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy, significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; patients with known or suspected gastrointestinal obstruction, including paralytic ileus; hypersensitivity to tramadol, acetaminophen any other component of this product; concurrent use of monoamine oxidase inhibitors or use within the last 14 days

Warnings/ Precautions
• Risk of opioid addiction, abuse and misuse, which can lead to overdose and death.
• Serious, life-threatening, or fatal respiratory depression may occur.
• Accidental ingestion of even one dose, especially by children can result in a fatal overdose of tramadol.
• Prolonged use 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.
• Use with cytochrome P450 3A4 inducers, 3A4 inhibitors or 2D6 inhibitors requires careful consideration of the effects on the parent drug.
• Concomitant use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death.

Drug Interactions
• Carbamazepine is reported to diminish the analgesic activity of tramadol by reducing serum concentrations.
• The risk of seizures is increased if tramadol is used with other drugs that have the potential to lower the seizure threshold.
• Tramadol inhibits reuptake of noradrenaline and serotonin and enhances serotonin release. Therefore, there is the possibility that it may interact with other drugs that enhance monoaminergic neurotransmission including lithium, tricyclic antidepressants, and SSRIs.
• The depressant effects of opioid analgesics are enhanced by other CNS depressants such as alcohol, anaesthetics, anxiolytics, hypnotics, tricyclic antidepressants, and antipsychotics.
• Cyclizine may counteract the haemodynamic benefits of opioids.
• The actions of opioids may in turn affect the activities of other drugs. For instance, their gastrointestinal effects may delay absorption as with mexiletine or may be counteractive as with cisapride, metoclopramide, or domperidone.
• The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes.
• The absorption of paracetamol may be accelerated by drugs such as metoclopramide.
• Excretion may be affected and plasma concentrations altered when given with probenecid.
• Colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.

Pregnancy Category: C

Presentation
TRAMOPHEN: 10 X 10’s

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