COMPOSITIONS :
Tramadol HCl Injection 50 mg/ml, each ml contains : Tramadol HCl 50 mg.
DESCRIPTIONS :
Tramadol HCl contains Tramadol HCl as active ingredient is available in 50 mg/ml injection.
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 Tramadol HCl 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, hypnotic drugs, 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 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 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.
- Although Tramadol HCl is an Opioid agonist, it cannot suppress Morphine withdrawl symptoms.
- 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 :
- Concurrent administration of Tramadol HCl with CNS tranquilizers or hypnotics will increase the sedative effect.
- Concurrent administration with tranquilizers may also be increased the analgesics effect.
ADVERSE REACTIONS :
- In normal doses, such as in the class of Opioid analgesics may occur nausea, vomiting, constipation, drowsiness, confusion may occur ureteric or biliary spasm also antidiuretic effect.
- Dry mouth, sweating, skin redness, vertigo, bradycardia, palpitation, orthostatic-hypotension, hypothermia, lethargy, miosis.
- Larger doses can lead to respiratory depression and hypotension with circulatory failure and coma.
- Convulsions may occur in infants and children.
- Effect of mild dependence.
PRESENTATIONS :
Tramadol HCl Injection 50 mg/ml Box, 10 ampoules @ 2 ml Reg. No. GKL0402336943A1
Tramadol HCl Injection 50 mg/ml Box, 100 ampoules @ 2 ml Reg. No. …
STORAGE :
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
