COMPOSITIONS :
Tramadol HCl Capsule 50 mg, each capsule contains : Tramadol HCl 50 mg.
DESCRIPTIONS :
Tramadol HCl with Tramadol HCl as active ingredient available in capsule 50 mg.
INDICATIONS :
For the treatment of severe acute and chronic pain, postoperative pain.
DOSAGE AND ADMINISTRATIONS :
Adults and Children > 16 years :
Generally dose : Single dose 50 mg. Dose usually achieve adequate pain, if pain relief is unsatisfactory, a second single dose of 50 mg may given after 30 – 60 minutes.
Maximum dose : 400 mg as daily dose.
Dose depend on pain intensity. Patients with hepatic impairment and renal impairment with Creatinine Clearance < 30 ml/minute : 50 – 100 mg, every 12 hours, maximum 200 mg daily.
The recommended dose for Patients with cirrhosis : 50 mg, every 12 hours.
CONTRAINDICATONS :
Patient with dependence drugs and Opiate.
Patient with known hypersensitivity to Tramadol HCl or Opiate and patients receiving MAO inhibitor, acute alcohol intoxication, hypnotic, analgesic or other agents which central nervous system.
WARNINGS AND PRECAUTIONS :
In long term treatment, it has dependance potential. Doctor should give duration of treatment.
Caution should be used in patients head injury, increased intracranial pressure, severe liver and kidney dysfunctions or bronchus hypersecretions because it can increase the risk of convulsion or shock.
Concurrently use with act on other CNS or use high dose can cause reduced bronchus function.
Use in pregnancy must consider useful and the risk.
Caution should be used in women lactation because Tramadol HCl is excreted in breast milk.
Tramadol HCl has such a significant effect on mental alertness that patients must not driver a car or operate dangerous machinery.
Respiratory depression in overdosage can be neutralized by Naloxone and seizure can be supressed by Benzodiazepine.
Although Tramadol HCl is an Opioid agonist, it cannot suppress Morphine withdrawl symptoms.
Not recommended for children < 16 years because safety and eficacy are not established.
Tramadol HCl has potent physical and psychological dependence similiar with Morphine (µ-opioid).
Not recommended for use in patients who have a tendency to do drug abuse or use in chronic Opium.
DRUG INTERACTIONS :
Analgesic effect and sedative effect of Tramadol HCl can be elevated in concomitant use with compunds that act on central nervous system e.g., transquilizer, hipnotics.
ADVERSE REACTIONS :
Dizzines, sedation, fatigue, headache, pruritus, sweating, flushing, dry mouth, nausea, vomiting, dyspepsia, and constipation.
PRESENTATIONS :
Tramadol HCl Capsule 50 mg Box, 3 blisters @ 10 capsules Reg. No. GKL0502337501A1
Tramadol HCl Capsule 50 mg Box, 10 blisters @ 10 capsules Reg. No. GKL0502337501A1
STORAGE :
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
