Doloran PRT 100 mg (Tablet (Prolonged Release))
Medicine Details
| Category | Details |
|---|---|
| Generic | Tramadol hydrochloride |
| Company | Sandoz a novartis division |
| Also available as |
Indications
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis
Pharmacology
Centrally acting synthetic analgesic compound. It inhibits the reuptake of neurotransmitters- serotonin and noradrenaline. Modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
Dosage & Administration
- Capsule or Tablet:
- 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 an initial dose of 50 mg is recommended.
- Subsequent doses should be 50 to 100 mg administered 4-6 hourly.
- The total daily dosage by mouth should not exceed 400 mg.
- Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours.
- Injection:
- A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion.
- The initial dose for postoperative pain is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour.
- Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg every 6 hours.
Interaction
Monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination. Concomitant administration of carbamazepine with Doloran PRT causes a significant increase in Doloran PRT metabolism.
Contraindications
- Hypersensitivity to tramadol
- Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs
Side Effects
- Dizziness/vertigo
- Nausea
- Constipation
- Headache
- Somnolence
- Vomiting
- Pruritus
- CNS stimulation
- Asthenia
- Sweating
- Dyspepsia
- Dry mouth
- Diarrhoea
- Malaise
- Allergic reaction
- Weight loss
- Vasodilatation
- Palpitations
- Abdominal pain
- Anorexia
- Flatulence
- GI bleeding
- Hepatitis
- Stomatitis
Pregnancy & Lactation
Safe use in pregnancy has not been established. Should not be administered during breastfeeding.
Precautions & Warnings
- Respiratory depression with large doses
- Not recommended for patients dependent on opioids
- Use with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers, or sedative hypnotics
- Use with great caution in patients taking MAO inhibitors
- Use with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions
Use in Special Populations
- Pediatric:
- In children from the age of 1 year Doloran PRT can be given in a dose of 1-2 mg/kg body weight.
- Suppository should not be administered in children and adolescents below the age of 14 years.
- Doloran PRT 100 mg SR Capsules have not been studied in children.
Therapeutic Class
Opioid analgesics
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.