Jakloc XR Tablet (Extended Release) XR Tablet 11 mg is a Product of the Generic Tofacitinib

What Is Jakloc XR Tablet (Extended Release) XR Tablet 11 mg Indications and Uses?

Rheumatoid Arthritis : Jakloc XR 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. It may be used as monotherapy or in combination with methotrexate or other nonbiologic ... Read more Rheumatoid Arthritis : Jakloc XR 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. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). Psoriatic Arthritis : Jakloc XR is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). Ulcerative Colitis : Jakloc XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

Pharmacology (Source, Chemical and Physical Composition) Of Jakloc XR Tablet (Extended Release) XR Tablet 11 mg

Rheumatoid arthritis is an autoimmune disease characterized by a dysregulation of pro-inflammatory cytokines including IL7, IL15, IL21, IL6, IFN-alpha, and IFN-beta. (3) Cytokines signalling results in tissue inflammation and joint damage by stimulating the recruitment and activation of immune cells via the janus kinase signalling pathway. Jakloc XR Tablet (Extended Release) XR Tablet 11 mg (Tofacitinib) is a partial and reversible janus kinase (JAK) inihibitor that will prevent the body from responding to cytokine signals. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs. The JAK-STAT signalling pathway is involved in the transcription of cells involved in hematopoiesis, and immune cell function. Tofacitinib works therapeutically by inhibiting the JAK-STAT pathway to decrease the inflammatory response. However, there is evidence to suggest that it may also achieve efficacy via other pathways as well.

Dosage And Administration of Jakloc XR Tablet (Extended Release) XR Tablet 11 mg

Rheumatoid Arthritis : Jakloc XR Tablet (Extended Release) XR Tablet 11 mg (Tofacitinib) 5 mg twice daily or Tofacitinib 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily. Psoriatic Arthritis (in combination with nonbiologic DMARDs): Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily. Ulcerative Colitis : Tofacitinib 10 mg twice daily for at least 8 weeks; then 5 or 10 mg twice daily. Discontinue after 16 weeks of 10 mg twice daily, if adequate therapeutic benefit is not achieved. Use the lowest effective dose to maintain response.

Drug Interactions of Jakloc XR Tablet (Extended Release) XR Tablet 11 mg

Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., Ketoconazole) Recommended dose is Jakloc XR 5 mg once daily: One or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole) Recommended dose is Jakloc XR 5 mg once daily Potent CYP inducers (e.g.Rifampin): May result in loss of or reduced clinical response.

Side Effects of Jakloc XR Tablet (Extended Release) XR Tablet 11 mg

The most commonly reported adverse reactions during the first 3 months in controlled clinical trials (occurring in greater than or equal to 2% of patients treated with Jakloc XR monotherapy or in combination with DMARDs) were upper respiratory tract infections, headache, diarrhea and nasopharyngitis.

Precautions And Warnings for Jakloc XR Tablet (Extended Release) XR Tablet 11 mg

Serious Infections: Avoid use of Jakloc XR during an active serious infection, including localized infections. Gastrointestinal Perforations: Use with caution in patients that may be at increased risk. Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. Immunizations: Live vaccines: Avoid use with Jakloc XR. Do not initiate Jakloc XR if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 gm/dL.

Use During Pregnancy and Lactation

Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Jakloc XR Tablet (Extended Release) XR Tablet 11 mg (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. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Tofacitinib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug for the mother

Therapeutic Class

Immunosuppressant

Storage Conditions of It

Store below 30°C. Protect from light & moisture. Keep all medicines out of the reach of children. Pack Image: Jakloc XR 11 mg XR Tablet Thanks for using MedEx! How would you rate your experience so far?