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Paracetamol + Tramadol information from DrugsUpdate  

See Available Brands of Paracetamol + Tramadol in India

P - Caution when used during pregnancy
L - Caution when used during lactation

Information Not Available

Pharmacodynamics

Pharmacokinetics

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 Hours.

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 hours. Paracetamol: Excreted mainly in urine as metabolites and unchanged drugs (<5%); elimination half life: 1-3 hours.

Paracetamol + Tramadol Indications / Paracetamol + Tramadol Uses

Information Not Available

Paracetamol + Tramadol Adverse Reactions / Paracetamol + Tramadol Side Effects

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.

Precautions

Information Not Available

Special Precautions

Not recommended in severe renal impairment (CrCl <10 ml/minutes), 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.

Other 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 weeks 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).

Other Interactions

Information Not Available

Dosage

Oral
Moderate to severe pain
Adult: ≥12 years: As combination tablet containing tramadol hydrochloride 37.5 mg and paracetamol 325 mg: 2 tablets every 6 hours. Max: 8 tablets daily.
Child: ≥12 years: As combination tablet containing tramadol hydrochloride 37.5 mg and paracetamol 325 mg: 2 tablets at least every 6 hourly. Max: 8 tablets daily.
CrCl (ml/min)    Dosage Recommendation
10-30               Max: 2 tablets 12 hourly.

Food(before/after)

Information Not Available

List of Contraindications

Paracetamol + Tramadol and Pregnancy

Caution when used during pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Paracetamol + Tramadol and Lactation

Caution when used during lactation

Paracetamol + Tramadol and Children

Information Not Available

Paracetamol + Tramadol and Geriatic

Information Not Available

Paracetamol + Tramadol and Other Contraindications

Overdosage
Symptoms: Tramadol: CNS depression, respiratory depression, lethargy, seizure, cardiac arrest, coma. Paracetamol: hepatic necrosis, hepatic failure, renal tubular necrosis, hypoglycemia and coagulation defects. Management: Treatment is supportive and symptomatic with maintenance of respiratory and circulatory functions. Oral methionine or IV N-acetylcysteine may be admin up to at least 48 hr after the paracetamol overdose. Naloxone may be used to reverse respiratory depression caused by tramadol but may increase seizure risk. Haemodialysis and haemofiltration unlikely to be helpful.

Storage

Oral
Store between 15 - 30°C (59 - 86°F).

Lab interference

Oral
Store between 15 - 30°C (59 - 86°F).

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