FORGESIC Injection

Tramadol HCl 50 mg / ml

COMPOSITION :

Forgesic® Injection 50 mg/ml, each ml contains : Tramadol HCl 50 mg.

 

DESCRIPTIONS :

Forgesic® contains Tramadol HCl as active ingredient is available in injection 50 mg/ml.

 

INDICATIONS :

  • Severe, acute and chronic pain.
  • Postsurgical pain.
  • Pain caused by diagnostic measures.

 

DOSAGE AND ADMINISTRATIONS :

Adult and children > 14 years :

  • IV route : 1 – 2 ampoules, slowly injected or dissolved in solution and then infused intravenously.
  • IM or SC route : 1 – 2 ampoules.

If the pain sensation still exists, 1 more ampoule of Forgesic® Injection can be given after 30 – 60 minutes. Dose adjustment is required for the patients with kidney or liver impairments.

The maximum daily dose should not exceed 400 mg per day.

 

CONTRAINDICATIONS :

  • Acute intoxication with alcohol, hypnotics, analgesics, opiates or psychotropic drugs.
  • Patients treated with MAO inhibitor.
  • Patients with hypersensitivity to Tramadol HCl or opiates.

 

WARNINGS AND PRECAUTIONS :

  • In long term treatment, it has dependance potential. Doctor should give duration of
  • Caution should be used in patients head injury, increased intracranial pressure, severe liver and dysfunctions or bronchus hypersecretions because it can increase the risk of convulsion or shock.
  • Concurently use with act on other CNS or use high dose can cause reduce  bronchus
  • Use in pregnancy must consider useful and the risk through fetus or mother.
  • 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.
  • Alhtough Tramadol HCl is an opioid antagonist, it cannot suppress Morphine withdrawl symptoms.
  • Tramadol HCl has potent physical and psychological dependence similar with Morphine (µ-opioid).
  • Not recommended for use in patients who have a tendency to drug abuse or use in chronic Opium.

 

PRESENTATION :

Forgesic® Injection 50 mg/ml         Box, 5 ampoules @ 1 ml       Reg. No. DKL9702323943A1

 

STORAGE :

STORE BELOW 30ºC, PROTECT FROM LIGHT. STORE THE PRODUCT ON THE BOX BEFORE USED.

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

PT. BERNOFARM

Sidoarjo – Indonesia