Dotramol

Dotramol

tramadol + paracetamol

Manufacturer:

Yarindo Farmatama
Concise Prescribing Info
Contents
Paracetamol 325 mg, tramadol HCl 37.5 mg
Indications/Uses
Short-term treatment of acute pain.
Dosage/Direction for Use
Adult & adolescent ≥16 yr Initially 2 caplet. Max: 8 caplet/day. Min dosing interval should not be <6 hr.
Administration
May be taken with or without food: Swallow whole, do not break/chew.
Contraindications
Hypersensitivity. Acute intoxication w/ alcohol, hypnotics, centrally-acting analgesics, opioids or psychotropic drugs. Patients receiving MAOIs or w/in 2 wk of w/drawal. Severe hepatic impairment. Epilepsy not controlled by treatment. Pregnancy & lactation.
Special Precautions
Renal & hepatic insufficiency, non-cirrhotic alcoholic liver disease; severe resp insufficiency. Not suitable in opioid dependent patient. Patients susceptible to seizure or taking other drugs that lower seizure threshold. Cranial trauma, biliary tract disorders, state of shock, altered state of consciousness for unknown reasons, increased intracranial pressure. May impair ability to drive or operate machinery. Childn <16 yr.
Adverse Reactions
Nausea, dizziness & somnolence.
Drug Interactions
Selective & non-selective MAOIs. Increased sedative effect w/ alcohol. Reduced efficacy w/ carbamazepine & other enzyme inducers. Decreased analgesic effect w/ opioid agonists-antagonists. SSRIs, triptans; CNS depressants eg, other opioid derivatives, barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative, antidepressant & antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide, baclofen; warfarin; ketoconazole, erythromycin.
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Presentation/Packing
Form
Dotramol FC caplet
Packing/Price
10's
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