Indication

Jakloc is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to Methotrexate or other disease-modifying antirheumatic drugs (DMARDs). It can be used as monotherapy or in combination with Methotrexate or other nonbiologic disease modifying antirheumatic drugs (DMARDs). It is also indicated in psoriatic arthritis, and ulcerative colitis.


Dosage & Administration

The recommended dose of Tofacitinib is 5 mg twice daily or as directed by the registered physician. Dose adjustment for Hepatic and renal impaired patients: The dose is 5 mg once daily in patients with moderate or severe renal insufficiency and moderate hepatic impairment. Jakloc 5 tablet should not be used in patients with severe hepatic impairment. Usage in Pediatric patient: The safety and effectiveness of Tofacitinib in pediatric patients have not been established. Geriatric use: As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly patient.


Precautions

Use of Tofacitinib should be avoided in patients with an active infection including localized infections. Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before administering Tofacitinib. Pregnancy and lactation: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Tofacitinib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Tofacitinib is excreted in human milk. Caution should be exercised when this product is administered to a nursing woman.


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