Ultradol

COMPOSITION

Ultradol 50 Capsule: Each capsule contains Tramadol Hydrochloride BP 50 mg.

INDICATIONS

Ultradol (Tramadol) is used for the treatment of moderate to severe painful conditions. These include: Post-operative pain Colic and spastic pain Cancer pain Joint pain Neck and back pain Pain associated with osteoporosis Chest pain (including pain associated with myocardial infarction and angina) etc.

DOSAGE AND ADMINISTRATION

Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions as initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain. The total daily dosage by mouth should not exceed 400 mg.

CONTRAINDICATIONS

Ultradol (Tramadol) is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

PRECAUTIONS

Respiratory depression: Ultradol (Tramadol) should be administered cautiously in patients at risk for respiratory depression. Opioid dependence: Ultradol (Tramadol) is not recommended for patients who are dependent on opioids. Concomitant CNS depressants: Ultradol (Tramadol) should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.

SIDE EFFECTS

Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhea.

DRUG INTERACTIONS

The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Ultradol (Tramadol). Concomitant administration of carbamazepine with Ultradol (Tramadol) causes a significant increase in Ultradol (Tramadol) metabolism and it requires to increase the dose of Ultradol (Tramadol).

USE IN PREGNANCY AND LACTATION

Safe use of Ultradol (Tramadol) in pregnancy has not been established. Ultradol (Tramadol) has been shown to cross the placenta. There are no adequate and well controlled studies in pregnant women. Therefore, Ultradol (Tramadol) should be used during pregnancy only if the potential benefit justifies the risk to the foetus.

STORAGE PRECAUTIONS

Protect from light and store below 30°C temperature in a dry place. Keep out of the reach of children.

COMMERCIAL PACK

Ultradol 50 Capsules: Box containing 3 X 10 Capsules in blister pack.