Tramadol Stada/Tramadol Stada 50

Tramadol HCl

Moderately severe to severe pain.

Tramadol Stada oral drops Adult & childn >16 yr Moderately severe pain 0.5-1 mL (50-100 mg) as a single dose. If pain relief is inadequate w/in 30-60 min give a 2nd single dose of 0.5 mL (50 mg). Severe pain Initially 1 mL (100 mg). Elderly >75 yr Administer <300 mg/day in divided doses. Hepatic or renal (CrCl <30 mL/min) insufficiency May require longer dosing interval of about 12 hr. Max daily dose: 200 mg. Tramadol Stada inj Adult & childn >16 yr Moderately severe pain 100 mg IM, IV (inj slowly or infuse diluted in an infusion soln), or SC as a single dose. If analgesic effect is inadequate, administer 100 mg as a single dose after 30-60 min. Severe post-op pain Doses up to 500 mg/4 hr may be used in an on-demand analgesia system. Elderly >75 yr Administer <300 mg/day in divided doses. Hepatic or renal (CrCl <30 mL/min) insufficiency May require longer dosing interval of about 12 hr. Max daily dose: 200 mg. Tramadol Stada 50 cap Adult & childn >16 yr Moderately severe pain 1-2 cap (50-100 mg) as a single dose. If analgesic effect is inadequate after 1 dose of 1 cap (50 mg), administer 2nd single dose of 1 cap (50 mg) after 30-60 min. Severe pain Initially, 2 cap (100 mg). Elderly >75 yr Administer <300 mg/day in divided doses. Hepatic or renal (CrCl <30 mL/min) insufficiency May require longer dosing interval of about 12 hr. Max daily dose: 200 mg.

May be taken with or without food.

Hypersensitivity. Acute intoxication w/ alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drug; concomitantly receiving MAOI. Use w/ great caution in opiate dependence; disturbance of consciousness of unknown cause; disorders of the resp center or resp function; conditions w/ raised intracranial pressure, unless artificial ventilation is being given. Severe renal (CrCl <10 mL/min) &/or hepatic impairment.

Possible misuse, dependence & tolerance w/ long-term use. Cross-tolerance w/ other opioids. Not suitable for drug substitution. Resp depression if recommended dosage is exceeded &/or concomitant use w/ other central nervous depressants. Hypersensitivity to morphine-like analgesic, patients w/ head injury & history of seizures; patients w/ myxedema, hypothyroidism or hypoadrenalism. Capacity to drive or operate machinery may be abolished. Patients w/ renal or hepatic disorders. Avoid chronic treatment throughout pregnancy. Lactation.

Resp depression, sedation; nausea, sweating, dry mouth, dizziness, giddiness; skin diaphoresis.

Potentiated CNS effects particularly resp depression w/ other CNS depressants or alcohol. Convulsions w/ neuroleptic drugs. Possible life-threatening interactions affecting the CNS, resp & circulatory function w/ MAOIs administered w/in the last 14 days before opioid administration. Increased incidence of seizures w/ TCAs eg, cyclobenzaprine, MAOI, SSRIs, neuroleptic agents & other drugs that lower the seizure threshold.

Analgesics (Opioid) / Supportive Care Therapy

N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.

P₁S₁S₃