Tramadol Hydrochloride 50 mg

Drug Classification : Alnalgesic ( Opioid )

Composition :

Each capsule contains 50 mg tramadol hydrochloride

Each ml injection contains 50 mg tramadol hydrochloride

Actions :

Tramadol hydrochloride is a synthetic, centrally active analgesic. The pharmacologic effects tramadol of tramadol result in part from agonist activity at oplate receptors. Tramadol binds stereospecifically at central nervous system receptors, then block of pain sensation and response. Tramadol inhibits neurotransmitter relieving from aferen nervous which is sensitive of stimulation, then inhibits pain impuls.

Indications :

Effective for the treatment of moderately severe acute and chronic pain, including postoperative.

Dosage and Administration :

-  Oral therapy

Adult and children 14 years of age and older.

Usual dosage : Single dose 50 mg, for continued relief 50 mg can be administered after 30 – 60 minutes as needed.

Maximum dosage 400 mg daily.

In patients with renal or hepatic impairment with creatinine clearance less than 30 ml/minute : 50 – 100 mg every 12 hours, not to exeed 200 mg daily.

-  Parenteral therapy

Adults and children 14 years of age and older

i.v. administration  : 100 mg ( 1 ampoule ), injected slowly or dilute in infuse solution.

i.m. administration : 100 mg ( 1 ampoule )

subcutataneous       : 100 mg ( 1 ampoule )

For continued relief 50 mg tramadol injection ( 1 ml ) can be administered after 30 – 60 minutes as needed. Adjustment dosage is needed to patients with renal or hepatic impairment. Maximun dosage 400 mg daily.

Precaution :

For long term therapy, tramadol may produce dependence the physician must be decide the therapeutic period. This drug should be used with caution in patient with head trauma, increased intracranical pressure, serious hepatic and renal function impairment, bronchus hypersecretion becaue may increase risk of spasm or shock.

Concomitant administration with CNS suppressing agents or a large doses may caused lung function decreases. Tramadol should be used during pregnancy only if the potential benefit justifies the potential rist to the mother an to the fetus. Because the drug is excreted when the tramadol is administered to a nursing woman. Tramadol may cause neurologic adverse effects, patient should be advised to be careful before operating an automobile or machinery. Respiration depression caused by tramadol overdosage can be neutralized by naloxone withdrawal symptom caused by morphine therapy.

Side Effects :

General side effects e.g. dizziness, sedation, fatigue, headache, pruritus, sweating, erythema, drymouth, nausea, vomiting, dyspepsia and obstipation.

Contraindications :

Patients hypersensitive to tramadol or oplate and patients treated by MAO inhibitor, intoxication acute with alcohol, hypnotic, analgesic or CNS agents.

Drug interactions :

Concomitant administration with central nervous system drug e.g. tranquilizer, hypnotic, may increase sedation and analgesic effect of tramadol.

Storage :

Keep in a cool and dry please

Presentation :

Tramadol 50 mg capsule, box of 5 strips @ 10 capsules

Tramadol 50 mg/ml injection, box of 25 ampoules @ 2 ml