Simtram Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info

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 daily. Interval dose should be not <6 hr.

Contraindications

Hypersensitivity to tramadol, paracetamol, opioid or other component of this drug. Acute intoxication w/o acute alcohol intoxication, hypnotic, narcotics, central acting analgesics, opioid psychotropic drug. Patient receiving MAOIs. Uncontrolled seizure. Severe liver dysfunction.

Special Precautions

Severe resp disorders. Patients w/ head trauma, seizure, biliary tract disorders, shock, undiagnosed changes of consciousness, increased ICP. May cause w/drawal syndrome. Severe kidney dysfunction w/ CrCl <10 mL/min. Severe liver dysfunction.

Adverse Reactions

Nausea, dizziness, drowsiness, weakness, fatigue, hot flushes, headache, tremor, abdominal pain, constipation, diarrhea, dyspepsia, bloating, dry mouth, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, pruritus, skin redness, sweating.

View ADR Monitoring Form

Drug Interactions

MAOIs, alcohol or other CNS depressants, carbamazepine, other enzyme inducers, buprenorphine, nalbuphine, pentazocine, SSRIs, tryptan, other opioid derivatives, benzodiazepine, barbiturate, barbitrate, benzodiazepine, other anxiolytic, hypnotics, sedative antidepressants, sedative antihistamine, neuroleptic, centrally acting antihypertensive, thalidomide, baclofen, warfarin, ketoconazole, erythromycin, bupropion, TCAs, neuroleptics, metoclopramide, domperidone, cholestyramine.

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.

Regulatory Classification

Presentation/Packing

Form

Simtram FC caplet

Packing/Price

3 × 10's (Rp255,000/boks)

Simtram

tramadol + paracetamol

Manufacturer:

Simex