Urgendol® (Tramadol Hydrochloride Injection/Capsule)

Urgendol® (Tramadol Hydrochloride Injection/Capsule)

Urgendol® (Tramadol Hydrochloride Injection/Capsule)

Each ml of Urgendol injection contains, Tramadol Hydrochloride BP 50mg.

Each Urgendol capsule contains, Tramadol Hydrochloride BP 50mg.

Tramadol, a centrally acting synthetic analgesic, acts as an agonist at mu-opioid receptors and also inhibits the reuptake of serotonin and noradrenaline. Tramadol has a bioavailability of 75-100%, and a half life of 6-7 hours. The efficacy of Tramadol is comparable to other opioids with low incidence of side-effects, minimal respiratory depression and negligible abuse or addiction potential.

Indications

Moderate to severe acute or chronic pain, and in painful diagnostic or surgical procedures.

Side effects, Precautions & warnings

Dizziness, nausea, constipation, headache, vomiting, pruritus, sweating and dry mouth may occur after tramadol administration. Palpitation and postural hypotension has been observed in rare cases. Convulsions have been reported with the use of tramadol especially in those taking higher doses of the product and/or tricyclic antidepressants, SSRI antidepressants, or MAO inhibitors, with a higher risk of epileptics.

Tramadol should be used with caution in pregnancy, during labour, epilepsy, renal failure, cirrhosis, elderly, increased intracranial pressure and acute abdominal conditions.

Tramadol may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

The safety of tramadol in pregnancy has not been established (Pregnancy category C).

Dosage and Administration

Adults: The dose depends on the intensity of the pain and the sensitivity of the individual. (Usual doses by mouth are 50 to 100mg every 4 to 6 hours. The total oral daily dosage should not exceed 400mg. a dose of 50 to 100mg may be given every 4 to 6 hours by intravenous injection over 2 to 3 minutes, or by intravenous infusion.

For the treatment of post-operative pain, the initial dose is 100mg followed by 50mg every 10 to 20 minutes if necessary to a total maximum (including the initial dose) of 250mg in the first hour. Thereafter, doses are 50 to 100mg every 4 to 6 hours up to a total daily dose of 600mg.

Children: not indicated

Elderly: Maximum dose 300mg/day.

Renal failure (creatinine clearance <30ml/min): maximum 100mg 12 hourly. (7% removed in 4 hr. dialysis).

Cirrhotics: 50mg 12 hrly.

Epileptics on carbamazepine: may require up to twice the normal daily dose.

Administration of tramadol is not related to food intake.

Route of administration

Urgendol injection is recommended for IM and slow IV use only. Urgendol capsules is for oral use only.

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Contraindications

  • Hypersensitivity to tramadol
  • Acute central nervous system intoxications due to alcohol, opioids or psychotropics
  • Opioid-dependent patients
  • Children
  • Nursing mothers
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