Product Details
Tramadol 100 mg,200 mg,300 mg Tab
Product Description :
TRAMADOL TABLETS
100 mg, 200 mg & 300 mg
1. COMPOSITION
Each tablet contains:
Tramadol Hydrochloride 100 mg / 200 mg / 300 mg
Excipients: q.s.
Colour: As approved.
2. PHARMACEUTICAL FORM
Tablets
3. THERAPEUTIC CLASS
Opioid Analgesic / Centrally Acting Analgesic
4. INDICATIONS
Tramadol is indicated for the management of moderate to moderately severe pain when an opioid analgesic is considered appropriate.
5. CONTRAINDICATIONS
Hypersensitivity to tramadol or any component of the formulation.
Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic medicines.
Concomitant treatment with MAO inhibitors or use within the appropriate period after discontinuation.
Uncontrolled epilepsy or seizure disorders.
Severe respiratory depression.
Severe hepatic or renal impairment unless specifically prescribed with appropriate adjustment.
6. DRUG INTERACTIONS
Tramadol may interact with:
MAO inhibitors
SSRIs, SNRIs, and tricyclic antidepressants
Other opioids and CNS depressants
Sedatives and hypnotics
Alcohol
Medicines affecting CYP2D6 or CYP3A4
Concomitant use with serotonergic medicines may increase the risk of serotonin syndrome. Combination with CNS depressants may increase sedation and respiratory depression.
7. ADMINISTRATION
For oral use only.
The dose should be individualized according to the severity of pain, patient response, age, and clinical condition.
Swallow the tablet whole with water. Do not exceed the prescribed dose.
If the 200 mg or 300 mg strength is formulated as a modified-release tablet, it should be swallowed whole and should not be crushed, chewed, or divided.
Tramadol may cause dizziness, drowsiness, impaired coordination, dependence, and respiratory depression. Avoid alcohol and driving or operating machinery if affected.
Prolonged treatment should not be discontinued abruptly without medical supervision.
8. STORAGE
Store below 25°C, protected from moisture and excessive heat.
Keep the container tightly closed and out of reach of children.
Store and dispense in accordance with applicable controlled-medicine requirements.
Do not use after the expiry date stated on the package.
