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Lotram Plus

Lotram Plus

tramadol + paracetamol

Manufacturer:

Rhydburg Pharma

Distributor:

Trumed
Concise Prescribing Info
Contents
Paracetamol 325 mg, tramadol HCl 37.5 mg
Indications/Uses
Symptomatic treatment of moderate to severe pain.
Dosage/Direction for Use
Adult & childn >16 yr Initially 2 tab. Max single dose: 1-2 tab every 4-6 hr up to max of 8 tab daily. Renal impairment (CrCl <30 mL/min) Not to exceed 2 tab every 12 hr.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Cases of acute intoxication w/ alcohol, hypnotics, narcotics, centrally-acting analgesics, opioids or psychotic drugs.
Special Precautions
Not to be given in patients w/ history of anaphylactoid reactions to codeine & other opioids. Not to be used in opioid-dependent patients. Increased risk of seizure w/ doses above the recommended range. Risk of convulsions may be increased in patients w/ epilepsy, those w/ history of seizures, or those w/ a recognized risk for seizure. Patients at risk for resp depression; w/ increased ICP or head injury. Chronic heavy alcohol abusers may be at increased risk of liver toxicity. W/drawal symptoms may occur in abrupt discontinuation. Use w/ caution & in reduced doses in patients receiving CNS depressants eg, alcohol, opioids, anaesth agents, phenothiazines, tranquilizers or sedative hypnotics. Not to be coadministered w/ other tramadol- or paracetamol-containing products. Concomitant use w/ SSRI, TCA, other tricyclic compd (eg, cyclobenzaprine, promethazine), or opioids; MAOIs, neuroleptics, or other drugs that reduce seizure threshold. May impair mental & physical abilities required for the performance of potentially hazardous tasks eg, driving a car or operating machinery. Not recommended in severe hepatic impairment. Safe use in pregnancy has not been established. Not recommended during lactation. Not recommended in childn <12 yr.
Adverse Reactions
Drug Interactions
Increased risk of seizure w/ SSRIs, TCAs, & other tricyclic compd (eg, cyclobenzaprine, promethazine), or opioids. May enhance risk of seizure w/ MAOIs, neuroleptics or other drugs that reduce seizure threshold. Increased risk of adverse events including seizure & serotonin syndrome w/ MAOIs & SSRIs.
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
Lotram Plus FC tab
Packing/Price
100's
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