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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