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Tramatol (Tramadol 37.5 mg and Paracetamol 325 mg)

COMPOSITION:

Tramatol Tablet: Each flim-coated tablet contains Tramadol Hydrochloride BP equivalent to Tramadol 37.5 mg and Paracetamol BP 325 mg.

PHARMACOLOGY:

Tramadol Hydrochloride is an opioid analgesic that acts on the central nervous system. Tramadol Hydrochloride is a pure non selective agonist of the µ, delta , k, opioid receptors with a higher affinity for the µ receptors. Unlike morphine, a broad range of analgesic dose of Tramadol has no respiratory depressant effect. Paracetamol is a non-opiate, non-salicylate analgesic. The precise mechanism of the analgesic properties of paracetamol is unknown but may involve central and peripheral effects.

INDICATIONS:

Tramatol tablet is indicated for the management of moderate to moderately severe pain in adults. It is also indicated for the short-term (five days or less) management of acute pain.

DOSAGE AND ADMINISTRATION:

Tramatol tablet can be administered without regard to food.

Management of moderate to moderately severe pain: The recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets daily.

Short-term (five days or less ) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets daily.

SIDE EFFECTS:

The most commonly reported side effects are nausea, dizziness and somnolence.

CONTRAINDICATIONS :

Hypersensitivity to Tramadol HCl, paracetamol or to any of the excipients of the medicinal procuct.Acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioid or psychotropic drugs. Should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal. Severe hepatic impairment.

PRECAUTIONS:

This tablet may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. This tablet should not be taken with alcohol containing beverages & with other tramadol or paracetamol-containing products, including over-the-counter preparations. This tablet should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.

USE IN PREGNANCY AND LACTATION:

US FDA Pregnancy Category C:

There are no adequate and well-controlled studies in pregnant women. This tablet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.This tablet is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because it’s safety in infants and newborns has not been studied.

DRUG INTERACTIONS:

Concomitant administration of CYP2D6 and/or CYP3A4 inhibitors such as quinidine, fluoxetine, paroxetine, and amitriptyline (CYP3A4 inhibitors), and ketoconazole and erythromycin (CYP3A4 inhibitors) may reduce metabolic clearance of tramadol, increasing the risk for serious adverse events including seizures and serotonin syndrome.

STORAGE:

  • Store in cool & dry place, protect from light.  
  • Keep out of reach of children.

PACKAGING:

Tramatol Tablet: Each box contains 3x10 tablets in blister pack.

 

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