Opalgic 50 mg (Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Tramadol hydrochloride |
| Company | Euro pharma ltd |
Indications
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis
Pharmacology
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
Dosage & Administration
- Usual doses are 50 to 100 mg every four to six hours for Capsule or Tablet
- One SR capsule or tablet every 12 hours for Sustained Release Capsule or Tablet
- A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion for Injection
- Tramadol suppository should be administered rectally with usual dose of 100 mg Tramadol Hydrochloride 6 hourly for Suppository
Interaction
In general, physician need not be concerned about drugs interacting with Opalgic. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Opalgic. Concomitant administration of carbamazepine with Opalgic causes a significant increase in Opalgic metabolism and it requires to increase the dose of Opalgic.
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 of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Precautions & Warnings
- Respiratory depression
- Opioid dependence
- Concomitant CNS depressants
- Concomitant MAO inhibitors
- Increased intracranial pressure
- Acute abdominal conditions
Use in Special Populations
In children from the age of 1 year Opalgic can be given in a dose of 1-2 mg/kg body weight. However, suppository (100 mg Opalgic) should not be administered in children and adolescents below the age of 14 years. Opalgic 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
Therapeutic Class
Opioid analgesics
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.