Tofe Er 11

TOFE ER 11mg Tablet

TOFE ER 11mg Tablet, manufactured by Alkem Laboratories Ltd., is an extended-release medication used to manage various inflammatory and autoimmune conditions.

Composition The active ingredient in TOFE ER 11mg Tablet is Tofacitinib at a strength of 11mg. Tofacitinib is a Janus kinase (JAK) inhibitor, which works by decreasing the activity of the immune system to reduce inflammation.

Uses TOFE ER 11mg Tablet is prescribed for the treatment of:

• Rheumatoid arthritis: A chronic inflammatory disease causing pain, swelling, and loss of function in the joints. It is used in adults who have not responded to or cannot tolerate other medications.
• Psoriatic arthritis: A condition causing joint pain, swelling, and scales on the skin.
• Ankylosing spondylitis: An inflammatory disease affecting the spine.
• Ulcerative colitis: A chronic inflammatory bowel disease affecting the colon.
• Polyarticular juvenile idiopathic arthritis and Juvenile psoriatic arthritis: Long-term diseases primarily causing pain and swelling of joints in patients 2 years of age and older.

Dosage and Administration TOFE ER 11mg Tablet is an extended-release formulation typically taken once daily. It can be taken with or without food. The tablets should be swallowed whole and not broken, crushed, or chewed. The specific dose and duration of treatment are determined by a healthcare professional based on the patient's condition and other factors. It is important to take the medicine at the same time each day for maximum benefit and not to stop taking it without consulting a doctor.

Side Effects Common side effects of TOFE ER 11mg Tablet include:

• Headache
• Diarrhea
• Nausea and vomiting
• Upper respiratory tract infections, including nasopharyngitis (inflammation of the nose and throat)
• Cough
• Painful urination
• Increased cholesterol levels
• Skin rashes

Serious side effects can include an increased risk of severe infections (such as tuberculosis and fungal, bacterial, or viral infections), reactivation of hepatitis B infection, and an increased risk of certain cancers, including lymphoma and skin cancers.

Precautions

• Contraindications: TOFE ER 11mg Tablet should not be used if you are allergic to Tofacitinib or any other ingredients. It is also contraindicated in patients with severe blood infections, active tuberculosis, severe liver problems (including cirrhosis), pregnancy, or breastfeeding.
• General Warnings: Inform your doctor about any existing infections, liver, kidney, heart, or lung problems, a history of tuberculosis or hepatitis B, high blood pressure, high cholesterol, or if you are a current or past smoker. Caution is advised in elderly patients and children under 2 years of age.
• Drug Interactions: Inform your doctor about all medicines, supplements, or herbal products you are taking. Interactions can occur with certain antibiotics (e.g., rifampicin, fluconazole, ketoconazole), immunosuppressants (e.g., azathioprine, mercaptopurine, ciclosporin, tacrolimus), and corticosteroids (e.g., prednisone). Do not take TOFE ER 11mg Tablet with tocilizumab as it can increase the risk of infections.
• Alcohol: Avoid or limit alcohol consumption as it may increase the risk of liver damage.
• Pregnancy and Breastfeeding: Use is generally not recommended during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment and for at least 4 weeks after the last dose.

Storage Store TOFE ER 11mg Tablet at room temperature (20°C to 25°C) or below 30°C. Keep it in a cool, dry place, away from direct sunlight and moisture. Keep the tablets out of the reach and sight of children and pets.

TOFE ER 11 by ALKEM LABORATORIES LTD is a medication containing Tofacitinib, an active ingredient used to manage various inflammatory conditions. It is a disease-modifying anti-rheumatic drug (DMARD) and belongs to the class of Janus Kinase (JAK) inhibitors.

What is TOFE ER 11 used for?

TOFE ER 11 is primarily used to treat several autoimmune and inflammatory disorders in adults. These include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and moderately to severely active ulcerative colitis. It is also indicated for polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients 2 years of age and older. This medication helps in reducing joint pain, swelling, and stiffness, thereby improving the ability to perform daily tasks.

How does TOFE ER 11 work?

TOFE ER 11 works by inhibiting the action of a specific enzyme in the body called Janus kinase (JAK). Janus kinase plays a crucial role in the inflammatory process associated with conditions like rheumatoid arthritis. By blocking this enzyme, Tofacitinib, the active substance in TOFE ER 11, helps to decrease the activity of the immune system and reduce inflammation, pain, and discomfort in the joints.

What is the usual dosage of TOFE ER 11?

The dosage of TOFE ER 11 is determined by your doctor based on your specific medical condition and its severity. It is typically taken once daily, with or without food. The tablet should be swallowed whole with a glass of water and should not be broken, crushed, or chewed, as this can lead to an increased risk of side effects by releasing the entire drug at once. It is crucial to take the medicine exactly as prescribed by your doctor and not to discontinue it without consultation.

What are the possible side effects of TOFE ER 11?

Common side effects of TOFE ER 11 can include headache, diarrhea, cough, upper respiratory tract infection, nasopharyngitis (inflammation of the throat and nasal passages), increased blood pressure, and increased cholesterol levels. Some individuals may also experience nausea, vomiting, or skin rashes. More serious, but less common, side effects can include severe infections, blood clots, stomach or intestinal perforations, and heart attack symptoms. It's important to contact your doctor immediately if you experience any severe side effects or if common side effects persist or worsen.

Is TOFE ER 11 safe during pregnancy or breastfeeding?

TOFE ER 11 is generally considered unsafe during pregnancy and is contraindicated. Limited information is available regarding its safety in pregnant women, and animal studies have shown harmful effects on the developing baby. Women of childbearing potential should use effective contraceptive measures while undergoing treatment with TOFE ER 11 and for at least 4 weeks after stopping the medication. Similarly, it is advised to avoid taking TOFE ER 11 while breastfeeding due to limited information on its excretion in human breastmilk and potential risks to the breastfed child.

Can TOFE ER 11 be taken with other medications?

TOFE ER 11 can interact with other medications, potentially affecting its efficacy or increasing the risk of side effects. It is important to inform your doctor about all medicines, supplements, and herbal products you are currently taking or plan to take. For example, taking TOFE ER 11 with certain immunosuppressants (like cyclosporine or tacrolimus) can increase the risk of infections. Medications like ketoconazole, itraconazole, ritonavir, nefazodone, and telithromycin can increase the levels of Tofacitinib in the body, while rifampicin can decrease its levels.

What precautions should be taken while taking TOFE ER 11?

Before starting treatment with TOFE ER 11, inform your doctor if you have any existing infections, a history of tuberculosis (TB), liver or kidney disease, heart disease, high blood pressure, or high cholesterol. TOFE ER 11 can increase your susceptibility to infections or worsen existing ones, so avoid contact with people who have easily transmissible infections like chickenpox, measles, or flu. Your doctor may conduct regular blood tests to monitor your liver function, kidney function, blood counts, and cholesterol levels. It's also advised to inform your doctor before any immunizations/vaccinations, as this medicine may interfere with vaccines.

What happens if a dose of TOFE ER 11 is missed?

If you miss a dose of TOFE ER 11, 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 compensate for the missed one.

How should TOFE ER 11 be stored?

TOFE ER 11 should be stored at room temperature, typically between 20°C to 25°C, away from light and moisture. Keep all medications out of the reach of children and pets. Do not store it in the bathroom. Ensure proper disposal of any expired or no longer needed medication by consulting your pharmacist or doctor.