P Â - Caution when used during pregnancy
L Â - Caution when used during lactation
|Indication & Dosage||Oral
Moderate to severeÂ pain
Adult:Â â‰¥12 yr: As combination tablet containing tramadol hydrochloride 37.5 mg and paracetamol 325 mg: 2 tablets every 6 hr. Max: 8 tablets daily.Â
Child:Â â‰¥12 yr: As combination tablet containing tramadol hydrochloride 37.5 mg and paracetamol 325 mg: 2 tablets at least every 6 hrly. Max: 8 tablets daily.
|Administration||May be taken with or without food.
|Overdose||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.|
|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.|
|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.|
|Adverse Drug Reactions||Nausea, vomiting,
constipation, diarrhoea, abdominal pain, dry mouth, dyspepsia, flatulence, dizziness, somnolence, headache, confusion, mood changes, nightmares, amnesia,
Potentially Fatal:Â 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
Potentially Fatal:Â 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).
|Pregnancy Category (US FDA)||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.|
|Storage||Oral:Â Store between 15 - 30Â°C (59 - 86Â°F).|
|Pharmacology||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:Â 17 minutes
Duration:Â 5 hr
Absorption:Â 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:Â 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:Â 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:Â 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.
|ATC Classification||N02AX02 - tramadol; Belongs to the
class of other opioids. Used to relieve pain.Â
N02BE01 - paracetamol; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Total Products : 3
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|ACETRAM||Square Pharmaceuticals Ltd.||Paracetamol 325mg + Tramadol 37.5mg||Tablet||3x10's: 240.90 MRP|
|NAPADOL||Beximco Pharmaceuticals Ltd||Paracetamol 325mg+ Tramadol 37.5mg||Tablet||30's: 240.00 MRP|
|Resadol||Incepta Pharmaceuticals Limited||Paracetamol 325mg + Tramadol Hydrochloride 37.5mg||Film Coated Tablet||10x3's:MRP 240 Tk|