Ultradol

Ultradol

 Pain killer

Composition

 Each of the following forms contain:

 

Tablet

150 mg  tramadol HCl 

Suppository 

100 mg  tramadol HCl

Ampoule 

100 mg  tramadol HCl

Properties

No properties

Indications

  • Ultradol is indicated for the management of moderate to moderately severe pain.

Contra-indication

  •  Hypersensitivity to any of the product's components.
  • Pregnancy & lactation.
  • Hypersensitivity to opioids.
  • In acute intoxication with alcohol, hypnotics, centrally acting
  • analgesic or psychotropic drugs.

Side effects

Nausea, vomiting, sweating, dizziness, dry mouth, constipation, headache, CNS stimulation, dyspepsia, asthenia, pruritis, GIT bleeding, hepatitis, stomatitis, diarrhea, migraine, deafness, tinnitus, and fatigue may occur. Nausea, vomiting, sweating, dizziness, dry mouth, constipation, headache, CNS stimulation, dyspepsia, asthenia, pruritis, GIT bleeding, hepatitis, stomatitis, diarrhea, migraine, deafness, tinnitus, and fatigue may occur.

Dosage

  •  The dosage should be adjusted according to the intensity of the pain unless otherwise prescribed by the physician.
  • Adults & adolescents over 16 years:
  • Tablets: 50 to 100 mg to be taken with a little liquid is usually sufficient to relieve the pain,150 mg may be taken in severe pain.
  • Suppositories: one suppository is sufficient to relieve pain, if however, pain still persists, a further suppository may be taken after one hour.
  • Ampoules: one ampoule to be slowly injected intravenously, intramuscularly or subcutaneously.
  • In general the daily dose should not exceed 400 mg.
  • In patients over 75 years old, daily dose should not exeed 300 mg.
  • Dosage should be reduced in patients with renal impairment or cirrhotic liver.

Drug interactions

  • The sedative effect (fatigue) may be intensified with concomitant administration of substances which also act on the central nervous system (e.g. tranquilizers, hypnotics). However, combining Ultradol with a tranquilizermay probably have a favorable effect on pain sensation.
  • Ultradol should not be used in patients receiving MAO inhibitors.
  • Carbamazepine significantly increases Ultradol metabolism.
  • Co-administration of quinine causes an increase in Ultradol concentration and reduces concentration of its metabolites.

Precaution

  •  It may affect the reaction ability of the patient to such an extent that capacity to drive or operate machines may be impaired; this applies particularly in conjunction with alcohol.
  • Anaphylactic reaction may occur.
  • Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite.
  • Metabolism of tramadol and its metabolite is reduced in patients with advanced cirrhosis of the liver.
  • Seizure risk which is especially enhanced in patientsreceiving tricyclic anti-depressants, SSRI & MAO inhibitors. Risk of seizure may also be enhanced in patients with epilepsy or having a history of seizures.
  • CNS infections, head trauma, metabolism disorders.
  • Ultradol should be administered cautiously in patients with respiratory depression.
  • Withdrawal symptoms may occur if Ultradol is discontinued abruptly, these symptoms may include: anxiety, sweating, insomnia, nausea, tremors & diarrhea, upper respiratory syndrome and piloerection.

Storage

  • Store in refrigerator
  • Keep out of reach of children

Package

Tablets: Box of 1 strip of 6 tablets.
Suppositories: Box of 3 suppositories
Ampoules: Box of 3 (2ml) ampoules