Tofashine 5 Mg Tablet (10 Tab)

TOFASHINE 5 MG TABLET

Tofashine 5 mg Tablet is a medication manufactured by Sun Pharmaceutical Industries Ltd., primarily used in the management of various inflammatory conditions.

• Name:

  • Brand Name: Tofashine 5 mg Tablet
  • Common Name: Tofacitinib (active ingredient)

• Composition:

  • Each tablet contains 5 mg of Tofacitinib. Tofacitinib is a Janus kinase (JAK) inhibitor, which works by interfering with enzymes that trigger inflammation.

• Uses: Tofashine 5 mg Tablet is prescribed for the treatment of:

  • Moderate to severe rheumatoid arthritis in adults, especially those who have not responded well to methotrexate.
  • Active psoriatic arthritis in adults.
  • Moderately to severely active ulcerative colitis in adults.
  • Active ankylosing spondylitis.
  • Polyarticular course juvenile idiopathic arthritis (pcJIA) and juvenile psoriatic arthritis in patients aged 2 and above.

• Dosage and Administration:

  • The typical adult dosage is 5 mg, taken once or twice a day, as prescribed by a doctor.
  • The tablet can be taken with or without food and should be swallowed whole with water; it should not be crushed, chewed, or broken.
  • Dosage may be adjusted based on the patient's condition and response to treatment. It is crucial not to exceed the prescribed dose or discontinue the medicine abruptly without consulting a doctor.

• Side Effects:

  • Common Side Effects: Upper respiratory tract infections (such as inflammation of the nose and throat), headache, diarrhea, nausea, vomiting, cough, elevated liver enzymes, and high blood pressure.
  • Serious Side Effects (rare): Blood clots (e.g., deep vein thrombosis, pulmonary embolism), and gastrointestinal tears. Patients should seek immediate medical attention if they experience severe or persistent side effects.

• Precautions:

  • Contraindications: Allergy to tofacitinib, active serious infections (like tuberculosis or sepsis), severe liver disease, pregnancy, and breastfeeding.
  • Warnings: Tofashine can increase the risk of infections, and patients should be screened for tuberculosis before starting treatment. Caution is advised for individuals with a history of lung disease, kidney disease, liver impairment (dosage adjustment may be needed for moderate impairment), hepatitis B or C, or those at risk of thrombosis. Not recommended for children under 18 unless specified for juvenile arthritis.
  • Drug Interactions: Levels of Tofashine can be increased by medicines like fluconazole, ketoconazole, itraconazole, ritonavir, nefazodone, and telithromycin. Rifampicin can decrease its levels.
  • Women of childbearing potential should use effective contraception during treatment.

• Storage:

  • Store in a cool and dry place, away from direct sunlight.
  • Maintain storage temperature below 30°C (or between 10°C to 25°C).
  • Keep out of reach and sight of children.

Tofashine 5 MG Tablet contains Tofacitinib, a Janus kinase (JAK) inhibitor, and is used to treat various inflammatory conditions. It works by interfering with the JAK-STAT signaling pathway, which helps modulate the immune system and reduce inflammation in the body.

Here are some frequently asked questions about Tofashine 5 MG Tablet:

1. What is Tofashine 5 MG Tablet used for?

Tofashine 5 MG Tablet is primarily used to manage moderate to severe rheumatoid arthritis in adults who have not responded well to methotrexate. It is also indicated for active psoriatic arthritis, moderately to severely active ulcerative colitis, and active ankylosing spondylitis. Additionally, it can be used for certain juvenile arthritis conditions, such as polyarticular course juvenile idiopathic arthritis and juvenile psoriatic arthritis, in patients aged 2 and above.

2. How does Tofashine 5 MG Tablet work?

Tofashine 5 MG Tablet contains Tofacitinib, which functions as a Janus kinase (JAK) inhibitor. It works by blocking the action of Janus kinase enzymes, specifically JAK1, JAK2, JAK3, and to a lesser extent TyK2. This interference with the JAK-STAT signaling pathway reduces the production of pro-inflammatory chemicals (cytokines), thereby decreasing inflammation throughout the body and alleviating symptoms of inflammatory conditions.

3. What is the usual dosage of Tofashine 5 MG Tablet?

For adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, the usual dosage is 5 milligrams (mg) twice a day, often taken with another medicine. For ulcerative colitis, the initial dosage is typically 10 mg twice daily for 8 to 16 weeks, which may then be reduced to 5 mg twice daily for maintenance. Pediatric dosages for juvenile idiopathic arthritis are based on body weight and determined by a doctor. It can be taken with or without food. Your doctor may adjust the dose based on your condition and response to the medicine.

4. What are the possible side effects of Tofashine 5 MG Tablet?

Common side effects include headache, diarrhea, inflammation of the nose and throat (nasopharyngitis), and upper respiratory tract infections. Other reported side effects can include elevated liver enzymes, high blood pressure, and rash. More serious side effects can occur, such as an increased risk of serious infections (including tuberculosis), blood clots (deep vein thrombosis, pulmonary embolism), and heart problems (heart attack, stroke). There is also an increased risk of certain cancers, including lymphoma.

5. Is Tofashine 5 MG Tablet safe during pregnancy or breastfeeding?

Tofashine 5 MG Tablet is generally not recommended during pregnancy, and its use is contraindicated as a precautionary measure due to limited information on safety. Women of childbearing potential should use effective contraception during treatment and for at least 4 weeks after discontinuing the medicine. Breastfeeding is also not recommended during treatment with Tofashine 5 MG Tablet and for at least 18 to 36 hours after the last dose, as there is limited information on its excretion in human breast milk. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

6. Can Tofashine 5 MG Tablet be taken with other medications?

Tofashine 5 MG Tablet can interact with other medicines. It should not be taken with strong immunosuppressants (like cyclosporine or azathioprine) or biologic disease-modifying antirheumatic drugs (DMARDs) (such as infliximab or adalimumab) due to an increased risk of infection. Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) and strong CYP2C19 inhibitors (e.g., fluconazole) can increase Tofacitinib levels in the body, while strong CYP3A4 inducers (e.g., rifampicin) can decrease its effectiveness. Always inform your doctor about all medications, supplements, and herbal products you are currently taking to avoid potential interactions.

7. What precautions should be taken while using Tofashine 5 MG Tablet?

Before starting Tofashine 5 MG Tablet, you should be screened for tuberculosis (TB) and hepatitis B/C. It is crucial not to start treatment if you have an active infection, and to report any signs of infection (fever, chills, cough) to your doctor immediately. This medicine can increase your risk of infections, heart problems, blood clots, and certain cancers. Regular blood tests are necessary to monitor blood counts, liver function, kidney function, and cholesterol levels. Use with caution if you have a history of liver or kidney disease, heart disease, or conditions that increase your risk of infection. Avoid live vaccines during treatment.

8. What happens if a dose of Tofashine 5 MG Tablet is missed?

If you miss a dose of Tofashine 5 MG Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

9. How should Tofashine 5 MG Tablet be stored?

Store Tofashine 5 MG Tablet in a closed container at room temperature, away from heat, moisture, and direct light. Keep it out of reach of children.