Actidol-DP Tab

Side Effects of Actidol-DP Tab

Nausea, vomiting, constipation, diarrhoea, abdominal pain, dry mouth, dyspepsia, flatulence, dizziness, somnolence, headache, confusion, mood changes, nightmares, amnesia, sweating, pruritus. Potentially Fatal: Severe anaphylactic reactions.

Drug Interactions

Increased risk serotonin syndrome with SSRI and triptans. Increased risk of seizures of SSRI, TCA, antipsychotics, centrally acting analgesics or local anaesthesia. Decreased tramadol levels with carbamazepine. Decreased analgesic efficacy of tramadol with ondansetron. Increased INR with warfarin. Potentially Fatal: Increased risk of serotonin syndrome with MAOIs, avoid concurrent use or within 2 wk of discontinuation from MAOIs. Increased risk of CNS and respiratory depression with CNS depressants (e.g. alcohol, opioids, anaesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics).

Contraindications

Hypersensitivity to tramadol, paracetamol or opioids. Situations where opioid use may be contra-indicated (e.g. acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs). Severe hepatic impairment, uncontrolled epilepsy. Concurrent use or within 2 wk of discontinuation from MAOIs.

Mechanism of Action

Tramadol is a centrally acting opioid analgesic which binds to mu-opioid receptors and weakly inhibits the reuptake of norepinephrine and serotonin. Paracetamol, a para-aminophenol derivative, has analgesic, antipyretic and weak anti-inflammatory activity. Used together, tramadol and paracetamol combination has a faster onset of action compared to tramadol alone and longer duration of action compared to paracetamol alone. Onset: 17 minutes Duration: 5 hr Absorption: Tramadol: Readily absorbed from GI tract; mean absolute bioavailability 75-90%. Paracetamol: Readily absorbed from GI tract, peak plasma concentrations reached in 10-60 minutes. Distribution: Tramadol: Widely distributed, crosses the placenta and distributes into the breast milk; protein binding: 20%. Paracetamol: Widely distributed; crosses placenta and distributes into breast milk; negligible protein binding. Metabolism: Tramadol: Undergoes metabolism by the cytochrome P450 isoenzymes CYP3A4 and CYP2D6; one of the metabolites, O-desmethyltramadol is pharmacologically active. Paracetamol: Metabolised in liver. Excretion: Tramadol: Excreted via urine as metabolites (60%) and unchanged drug (30%); elimination half-life of O-desmethyltramadol: 7 hr. Paracetamol: Excreted mainly in urine as metabolites and unchanged drugs (<5%); elimination half life: 1-3 hr.

Special Precautions

Not recommended in severe renal impairment (CrCl <10 ml/min), severe respiratory insufficiency, liver disease or opioid dependent patients. Increased intracranial pressure or head injury, patients at risk of seizures or on drugs that may lower the seizure threshold (e.g. SSRI, TCA, antipsychotics, centrally acting analgesics or local anaesthesia), biliary tract disorders, in a state of shock or unconsciousness. May impair ability to drive or operate machinery. Avoid abrupt withdrawal. May cause withdrawal symptoms, dependence and abuse. Elderly. Pregnancy, lactation.

How to Use

Take orally with food and water, as directed by your physician.

How to Store

Keep in a cool, dry place away from sunlight and moisture.

Safety Concerns

• Alcohol: Avoid during treatment.
• Breastfeeding: Not recommended.
• Pregnancy: Contraindicated.
• Liver/Kidney: Use with caution.

Content Disclaimer

This content is for educational purposes only. Please consult your doctor before use.