Tramset Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info

Concise Prescribing Info

Contents

Tramadol HCl 37.5 mg, paracetamol 325 mg

Indications/Uses

Short-term treatment of acute pain.

Dosage/Direction for Use

Adult & adolescents ≥16 yr Initially, 2 tab 6 hrly. Max dose: Tramadol 300 mg & paracetamol 2,600 mg daily.

Contraindications

Hypersensitivity. Patients receiving MAOIs; severe hepatic impairment; epilepsy.

Special Precautions

Opioid-dependent patients; patients w/ cranial trauma, prone to convulsive & biliary tract disorders; shock, altered state of consciousness; increased intracranial pressure. Hepatic toxicity. W/drawal symptoms eg, agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor & GI symptoms. Severe resp, renal & hepatic insufficiency. May affect ability to drive or operate machinery. Childn <16 yr. Elderly >75 yr.

Adverse Reactions

Nausea, dizziness & somnolence. HTN, palpitations, tachycardia, arrhythmia; dizziness, somnolence, headache, trembling, involuntary muscle contractions, paraesthesia, tinnitus, ataxia, convulsions; psychiatric disorders; blurred vision; dyspnea; GI disorders; increased hepatic transaminases; sweating, pruritus, rash, urticaria; albuminuria, dysuria, urinary retention; shivers, hot flushes, thoracic pain.

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Drug Interactions

Nonselective MAOIs; selective A & B MAOIs. Alcohol, opioid agonists-antagonist eg, buprenorphine, nalbuphine, pentazocine. SSRIs, triptans, other opioid derivatives, benzodiazepines, barbiturates, other anxiolytics, hypnotics, sedative antidepressants & antihistamines, neuroleptics, centrally-acting antihypertensives, thalidomide & baclofen; 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.

Regulatory Classification

Presentation/Packing

Form

Tramset FC caplet

Packing/Price

3 × 10's

Tramset

tramadol + paracetamol

Manufacturer:

Fahrenheit