TRAMADOL Hcl +Acetaminophen

Indications & Dose:

Tratment (i.e. three days or less) of mild to moderate acute pain Chronic Pain.

DOSAGE AND DIRECTIONS FOR USE

To be used in adults and children over 16 years of age. Do not exceed the recommended dose.

Acute pain: 2 tablets every 4 to 6 hours as needed for pain relief. Do not exceed 8 tablets per day.

Renal impairment: For patients with creatinine clearance <30 mL/min, the dosing interval. Should be increased not exceed 2 tablets every to 12 hours.

Contraindications:

Known hypersensitivity to tramadol, paracetamol or other oploids such as codeine. It is also contraindicated in cases of severe liver function impairment and in acute intoxication with alcohol, hypnotics, centrally acting analgesics, oploids or psychotopic medicines. It should not be adminstered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal.Must not be used for narcotic withdrawal treatment.

Should not be given to patients with respiratory depression especially in the presence of cyanosis and excessive bronchial secretions. Should not be given to patients with increased intracranial pressure or central nervous system depression due to head injury or cerebral disease. Safety during pregnancy and lactation has not been established. Tramadol has been shown to cross the placenta. 

Side Effects:

SIDE-EFFECTS AND SPECIAL PRECUATIONS 

Gastrointestinal system: Nausea; abdominal pain, constipation, flatulence, vomiting: dry mouth; dyspepsia and diarrhoea. Central Nervous System and Psychiatric: Dizziness, headache, nervousness, anxiety, agitation, euphoria, emotional lability, hallucinations, hypertonia and tremor. Somnolence, insomnia, anorexia, anxiety, confusion, euphoria and nervousness. Other reported side-effects include pruritus, fatigue, upper respiratory tract infection, increased sweating, hot flushes, rashes and asthenia. Other side-effects reported with the use of tramadol include: anaphylaxis, increased liver enzyme values, postural hypotension or cardiovascular collapse and the potential for Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome. Paracetamol may cause allergic reactions and skin rash. The rash usually appears as red areas or allergic wheals, and may be accompanied by fever and involvement of the mucous membranes. The use of paracetamol has been associated with the occurrence of neutropenia, pencytopenia and leucopenia

Cautions:

Precautions:

Interaction:

Carbamazepine may cause significantly decreased tramadol and M1 concentrations. Patients receiving carbamazepine may have significantly reduced analgesic effect from the tramadol

Inhibitors of CYP2D6 such as fluoxetine, paroxetine, quindine and amitriptyline could result in some inhibition of the metabolism of tramadol. Simultaneous administration with cimetine is associated with clinically insignificant changes in serum concentrations of tramadol.

Must not be combined with a MAO-inhibitor, or within 14 days of discontinuation of it, as potentiation of serotonergic and noradrenergic effects may result. Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity and rare alterations of warfarin effect including elevation of prothrombin times. 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

 Do not co-administer  with other tramadol or paracetamol containing products. Should not be taken with alcohol containing beverages. Concurrently with central nervous system (CNS) depressents such as alcohol, opioids, anaesthetic agents, phenothiazines, tranquilizers or sedative hypnotics is likely to intensity and prolong CNS effects. Patients with impaired renal function and in patients prone to convulsive disorders or in shock.

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: