COMPOSITIONS :
Forgesic® Capsule 50 mg, each capsule contains : Tramadol HCl 50 mg.
DESCRIPTIONS :
Forgesic® which active ingredient is Tramadol HCl available as 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. The dose is usually enough to relieve the pain, if it still feels the pain can be added to 50 mg after an interval of 30 – 60 minutes.
- Maximum dose : 400 mg daily.
- Dose depend on pain intensity. Patients with hepatic impairment and renal impairment with creatinine clearance < 30 ml/min : 50 – 100 mg every 12 hours, maximum 200 mg daily.
- The recommended dose for patients with cirrhosis is 50 mg every 12 hours.
CONTRAINDICATIONS :
- Patient with dependence drugs and opiate.
- Patient with known hypersensitivity to Tramadol 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 depressant or use high dose can cause reduce pulmonary
- Use in pregnancy must consider useful and the risk, either to the fetus or the mother.
- Caution should be used in women lactation because Tramadol is excreted in breast milk.
- Tramadol HCl has such a significant effect on mental alertness that patients must not drive 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 use in patients who have a tendency to misuse the drug, have a history of drug dependence or chronic Opium users.
PRESENTATION :
Forgesic® Capsule 50 mg Box, 3 strips @ 10 capsules
Reg. No. : DKL9602323401A1
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
