RiteMED Tramadol HCl + Paracetamol

RiteMED Tramadol HCl + Paracetamol

tramadol + paracetamol

Manufacturer:

XL Lab

Distributor:

RiteMED
Concise Prescribing Info
Contents
Tramadol HCl 37.5 mg, paracetamol 325 mg.
Indications/Uses
Symptomatic treatment of moderate to severe pain; fever.
Dosage/Direction for Use
Adult Initially 2 tab. May take additional doses as needed. Max: 8 tab/day. Dosing interval: Should not be <6 hr.
Administration
Should be taken with food.
Special Precautions
Not recommended in severe renal impairment (CrCl <10 mL/min); severe resp impairment. Not to be used in severe hepatic impairment. Not to be used during pregnancy & lactation. Childn <12 yr. Tramadol: Not suitable as a substitute in opioid-dependent patients; cannot suppress morphine w/drawal symptoms. Convulsions in patients susceptible to seizures or taking other medications that lower seizure threshold, especially SSRIs, TCAs, antidepressants, antipsychotics, centrally acting analgesics or local anaesth; increased risk when exceeded the recommended upper dose limit. History of epilepsy. Paracetamol: Patients w/ non-cirrhotic alcoholic liver disease. Alcohol dependence.
Adverse Reactions
Tramadol: Resp depression & constipation; hypotension, HTN. Paracetamol: Haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, & agranulocytosis; skin rashes & hypersensitivity reactions.
Drug Interactions
Tramadol: Diminished analgesic activity w/ carbamazepine. Increased risk of seizures w/ other drugs w/ potential to lower seizure threshold. Inhibits reuptake of noradrenaline & serotonin; enhances release of serotonin. May interact w/ other drugs that enhance monoaminergic neurotransmission including lithium, TCA, & SSRIs; MAOIs or w/in 14 days of their discontinuation. Increased conc w/ quinidine. Paracetamol: Increased risk of toxicity w/ other hepatotoxic drugs or drugs that induce liver microsomal enzymes. May accelerate absorption w/ metoclopramide. May affect excretion & alter plasma conc w/ probenecid. Reduced absorption w/ colestyramine (if given w/in 1 hr).
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
Ritemed Tramadol HCl + Paracetamol FC tab
Packing/Price
100's
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