TRAGESIC® 50
TRAGESIC® 50
Pain killer

Indication

  • TRAGESIC® is indicated in management of moderate to severe pain. 

Composition

Each capsule of TRAGESIC® 50 contains: 

  • Tramadol Hydrochloride         50 mg 

Dosage

¤ The dosage should be adjusted to the intensity of the pain. Unless otherwise prescribed, TRAGESIC® should be administered as follow:

-Single dose for adults and adolescents over 12 years of age:

  • 1–2 capsules (to be taken with a little liquid) and total daily dosage should not exceed 400 mg (8 capsules).

-In elderly patients (over 75 years) and renal insufficiency or hepatic insufficiency: 

  • It may be necessary to prolong the dosage intervals to reach 12 hours. 

-Children:

  • TRAGESIC® capsules are not intended for use in children weighing less than 25 kg. 
  • Tramadol is a centrally acting synthetic analgesic compound. Its analgesic effects are mediated via both the stimulation of μ-opioid receptors and indirect modulation of central monoaminergic inhibitory pain pathways.
  • Tramadol is rapidly and almost completely absorbed after oral administration and extensively metabolized.
  • Analgesic effect begins approximately within one hour after administration and reaches the peak in approximately two to three hours.
  • Tramadol is widely distributed, crosses the placenta, and appears in small amount in breast milk.
  • Approximately 30% of the dose is excreted in the urine as unchanged drug whereas 60% of the dose is excreted as metabolites.
  • The elemination half life of Tramadol is about 6 hours after oral administration.

Each capsule of TRAGESIC® 50 contains: 

  • Tramadol Hydrochloride         50 mg 
  • TRAGESIC® is indicated in management of moderate to severe pain. 

TRAGESIC® is not used in the following cases :  

  • Known hypersensitivity to Tramadol;
  • Acute intoxication with alcohol, hypnotics, analgesics, opioids, or other psychotropic drugs;
  • Patients who are receiving MAO inhibitors or who have taken them within the last 14 days. 
  • Carbamazepine diminishes the analgesic activity of TRAGESIC® by reducing serum concentrations.
  • TRAGESIC® inhibits reuptake of noradrenaline and serotonin and enhances serotonin release. It may interact with other drugs that enhance monoaminergic neurotransmission including Lithium, tricyclic antidepressants and selective serotonin reuptake inhibitors.
  • Quinidine may increase concentrations of TRAGESIC® and lower concentrations of its active metabolite
  • TRAGESIC® should not be used in pregnant women prior to or during labor.
  • TRAGESIC® is not recommended for post delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.  

¤ Very common:

  • nausea and dizziness.

¤ common:

  • vomiting, constipation, sweating, dry mouth, headache, drowsiness.

¤ Rarely:

  • effect on circulatory regulation (palpitations, tachycardia, feeling of weakness), gastrointestinal irritation, skin reactions (pruritus, rash, urticaria.), blurred vision, and psychological disorders  may appear according to the patients personality and length of therapy such as ; hallucination, confusion, sleep disorders, nighmares, and change in mood may appear.

¤ Very rarely:

  • epileptic seizures (occured  mainly after taking high doses of TRAGESIC® or when medicines that may cause seizures themselves), hypertension, bradycardia, and respiratory depression.

Overdosage:

  • Pin point or wide pupils, vomiting, fall in blood pressure, fast heart–beat, feeling faint, reduced level of consciousness up to coma, epileptic fits, and difficulty in breathing up to stoppage of breathing may occur. In such cases call the nearest doctor immediately.

¤ The dosage should be adjusted to the intensity of the pain. Unless otherwise prescribed, TRAGESIC® should be administered as follow:

-Single dose for adults and adolescents over 12 years of age:

  • 1–2 capsules (to be taken with a little liquid) and total daily dosage should not exceed 400 mg (8 capsules).

-In elderly patients (over 75 years) and renal insufficiency or hepatic insufficiency: 

  • It may be necessary to prolong the dosage intervals to reach 12 hours. 

-Children:

  • TRAGESIC® capsules are not intended for use in children weighing less than 25 kg. 

¤ Driving and operating machinery:

  • If you feel that your reactions are affected, don’t drive, don’t use electric tools or operate machinery, and don’t work without a firm hold.
  • Blisters of 10 capsules, Packs of one blister.
  • Hospital packs of different sizes. 
  • Store in a dry place below 25°C.