BDTOFA XR 11 mg Tofacitinib Extended-Release Tablets
BDTOFA XR 11 mg Tofacitinib Extended-Release Tablets
Available in stock (20)
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Estimated delivery: Oct 30 - Nov 03
Reviewed By :Vinita Kaushik D.Pharma MBA
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Product Introduction
BDTOFA XR 11 mg is an oral, extended-release prescription medicine containing tofacitinib, presented on the packaging as tofacitinib citrate equivalent to tofacitinib 11 mg. It is marketed by BDR Pharmaceuticals Int’l Pvt. Ltd. and manufactured by Akums Drugs & Pharmaceuticals Ltd.
Tofacitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. It modifies specific immune-system signalling pathways and may be prescribed by a specialist for certain inflammatory and autoimmune conditions, depending on the patient's diagnosis and the approved product indication.
Important: This is a specialist-supervised prescription medicine, not a general painkiller or an over-the-counter anti-inflammatory product. Tofacitinib can increase the risk of serious infections and other potentially severe adverse effects. Use it only when prescribed by an appropriately qualified doctor.
Uses
Tofacitinib extended-release formulations may be prescribed for certain immune-mediated inflammatory conditions, depending on the applicable product approval and the specialist's assessment. These may include:
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Rheumatoid arthritis in eligible patients.
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Psoriatic arthritis in eligible patients.
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Ulcerative colitis in eligible patients.
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Other approved inflammatory conditions where the specific formulation is indicated.
Product-listing note: The supplied packaging does not state the approved indications. Confirm the Indian prescribing information for this exact brand and formulation before publishing a definitive list of approved uses. Do not imply that this medicine is suitable for every type of arthritis or inflammatory disease.
Key Ingredients & Full Ingredients
Active ingredient
- Tofacitinib citrate IP, equivalent to tofacitinib 11 mg per extended-release tablet.
Other ingredients
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Excipients: quantity sufficient (q.s.).
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Colouring agents listed on the packaging: Ferric Oxide USP-NF Red and Titanium Dioxide IP.
The pack does not provide a complete quantitative list of excipients. Refer to the package insert for the complete formulation and any ingredient-specific precautions.
Benefits
When prescribed for an appropriate condition, tofacitinib may:
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Help control inflammation associated with certain autoimmune diseases.
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Reduce disease activity and associated symptoms in eligible patients.
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Help improve physical function and daily activities when the underlying condition responds to treatment.
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Provide extended-release delivery of the active medicine.
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Support long-term disease management under specialist monitoring.
These are potential treatment outcomes, not guaranteed results. The benefits depend on the diagnosis, individual response, treatment duration and medical supervision.
Side Effects
Possible side effects include:
Common or reported effects
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Headache.
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Diarrhoea.
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Nausea.
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Upper respiratory tract infections.
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Increased cholesterol levels.
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Changes in liver enzymes or blood-cell counts.
Serious risks requiring prompt medical attention
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Serious infections, including tuberculosis and opportunistic infections.
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Blood clots, including deep-vein thrombosis and pulmonary embolism.
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Major cardiovascular events, such as heart attack or stroke.
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Certain cancers, including lymphoma and skin cancers.
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Gastrointestinal perforation in susceptible patients.
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Severe allergic reactions.
Seek urgent medical attention for chest pain, sudden breathlessness, one-sided leg swelling, sudden weakness or difficulty speaking, severe abdominal pain, or signs of a serious infection. This list is not exhaustive; consult the package insert and prescribing specialist for the full safety profile.
Product Form
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Dosage form: Film-coated extended-release tablet.
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Strength: 11 mg tofacitinib equivalent per tablet.
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Route of administration: Oral.
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Brand name: BDTOFA XR.
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Pack size: Not visible in the supplied images; verify from the complete carton or blister pack.
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Prescription status: Prescription-only medicine; the pack specifically restricts retail sale to prescriptions from a rheumatologist, gastroenterologist, hepatologist or specialist in internal medicine.
How to Use
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Take BDTOFA XR only in the dose and at the time prescribed by your specialist.
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Swallow the tablet whole with water.
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Do not crush, chew, split or break the tablet, because it is an extended-release formulation.
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If you miss a dose, follow your doctor's instructions. Do not double the next dose to compensate.
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Attend all recommended blood tests and follow-up appointments.
The packaging states: “Dosage: As directed by the Physician.” Do not use a general online dosing schedule as a substitute for your prescription.
How it Works
Tofacitinib is a Janus kinase (JAK) inhibitor. JAK enzymes participate in signalling pathways used by various cytokines, which help regulate immune responses and inflammation.
By inhibiting specific JAK pathways, tofacitinib reduces certain inflammatory and immune-system signals. This can help control disease activity in patients with conditions for which the medicine is prescribed.
The extended-release formulation is designed to release the active ingredient over time. It must remain intact when swallowed to preserve the intended drug-release characteristics.
3. Medical & Safety Information
Safety Advice
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Pregnancy: Tell your doctor if you are pregnant, planning pregnancy or could become pregnant. The risks and benefits must be assessed before treatment.
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Breastfeeding: Consult your specialist before use. Current prescribing information advises against breastfeeding during treatment.
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Alcohol: No specific alcohol instruction is visible on the packaging. Ask your doctor whether alcohol is appropriate, particularly if you have liver problems or take other medicines.
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Driving: Avoid driving or operating machinery if you experience dizziness or another symptom that affects alertness.
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Kidney or liver conditions: Inform your doctor before starting treatment. Kidney or liver impairment may require a different dose or make certain formulations unsuitable.
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Infections: Report current or recurrent infections, fever, persistent cough or possible tuberculosis exposure. Treatment may need to be delayed or interrupted during a serious infection.
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Heart and clotting risks: Inform your doctor about a history of heart disease, stroke, blood clots, smoking or cancer.
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Vaccination: Discuss vaccination before treatment. Live vaccines should generally be avoided during tofacitinib treatment.
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Monitoring: Your doctor may check blood counts, liver enzymes, cholesterol and infection status before and during treatment.
Quick Tips
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Take the medicine consistently according to your prescription.
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Keep a record of your doses and follow-up appointments.
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Do not share your prescription medicine with anyone else.
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Tell your doctor about all medicines, supplements and herbal products you take.
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Seek medical advice promptly if you develop signs of infection.
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Store the medicine in its original packaging, away from moisture and direct light.
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Keep it out of children's reach.
Fact Box
|
Attribute |
Details |
|---|---|
|
Brand |
BDTOFA XR |
|
Active ingredient |
Tofacitinib |
|
Strength |
11 mg |
|
Form |
Extended-release tablet |
|
Therapeutic class |
Janus kinase (JAK) inhibitor |
|
Administration |
Oral |
|
Prescription required |
Yes |
|
Habit forming |
Not generally considered habit-forming |
|
Intended use |
Specialist-directed treatment of eligible inflammatory conditions |
|
Storage |
Below 30°C; protect from light and moisture |
|
Colouring agents |
Ferric Oxide USP-NF Red and Titanium Dioxide IP |
|
Diet restrictions |
No specific dietary restriction stated on the supplied pack; follow your doctor's advice |
|
Pack size |
Not visible in the supplied images |
Interaction with Drugs
Tofacitinib has clinically important drug interactions. Always provide your doctor and pharmacist with a complete medication list.
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Strong CYP3A4 inhibitors, such as ketoconazole, may increase tofacitinib exposure and require specialist-directed dose adjustment.
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Fluconazole may increase exposure through CYP3A4 and CYP2C19 inhibition; the combination may require a dose adjustment.
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Strong CYP3A4 inducers, such as rifampicin (rifampin), may reduce tofacitinib exposure and treatment effectiveness.
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Other immunosuppressants, including azathioprine, ciclosporin (cyclosporine) and tacrolimus, may increase immunosuppression and the risk of infection.
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Biologic immunomodulators, including certain biologic DMARDs, generally should not be combined with tofacitinib unless the relevant prescribing information and specialist explicitly support the combination.
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Live vaccines may pose additional risks during treatment.
These examples are not exhaustive. Do not start, stop or adjust a medicine to manage an interaction without medical advice.
4. Business Details
The following details are transcribed from the supplied packaging.
Marketed by:
BDR Pharmaceuticals Int’l Pvt. Ltd.
407/408, Sharda Chambers, 15,
New Marine Lines, Mumbai-400 020.
India
Manufactured by:
Akums Drugs & Pharmaceuticals Ltd.
At: Plot No. 26A, 27-30, Sector-8A,
I.I.E., SIDCUL, Ranipur,
Haridwar-249 403, Uttarakhand.
Manufacturing licence number: 4/UA/LL/2014
Importer: Not shown on the supplied packaging.
Brand: BDTOFA XR
Product description on the pack: Tofacitinib Extended Release Tablets 11 mg
Additional packaging instructions:
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Dosage: As directed by the physician.
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Store at a temperature not exceeding 30°C; protect from light and moisture.
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Keep out of reach of children.
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Refer to the enclosed pack insert for further information.
5. FAQs
1. What is BDTOFA XR 11 mg used for?
It contains tofacitinib, a JAK inhibitor used for certain inflammatory and autoimmune conditions in eligible patients. The exact approved uses for BDTOFA XR should be confirmed from its Indian prescribing information and your specialist's advice.
2. Can I take BDTOFA XR without a prescription?
No. The supplied packaging specifically restricts retail sale to a prescription from a rheumatologist, gastroenterologist, hepatologist or specialist in internal medicine.
3. Can BDTOFA XR tablets be crushed or chewed?
No. The packaging instructs users to swallow the tablet whole. Crushing or chewing can interfere with the intended extended-release delivery.
4. What precautions should I take while using BDTOFA XR?
Inform your doctor about infections, tuberculosis exposure, kidney or liver disease, heart disease, previous blood clots, cancer, pregnancy and all medicines you take. Attend recommended blood tests and seek prompt medical attention for serious symptoms.
5. How long does BDTOFA XR take to work?
The response varies according to the condition being treated and the individual patient. Improvement may take time, so follow your specialist's treatment plan and do not change the dose or discontinue treatment on your own.
Ingredients
Ingredients
Tofacitinib 11 mg (as Tofacitinib Citrate IP), an active Janus kinase (JAK) inhibitor.
Benefits
Benefits
Shipping & Return
Shipping & Return
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FAQ
FAQ
1. What is BDTOFA XR 11 mg used for? It contains tofacitinib, a JAK inhibitor used for certain inflammatory and autoimmune conditions in eligible patients. The exact approved uses for BDTOFA XR should be confirmed from its Indian prescribing information and your specialist's advice. 2. Can I take BDTOFA XR without a prescription? No. The supplied packaging specifically restricts retail sale to a prescription from a rheumatologist, gastroenterologist, hepatologist or specialist in internal medicine. 3. Can BDTOFA XR tablets be crushed or chewed? No. The packaging instructs users to swallow the tablet whole. Crushing or chewing can interfere with the intended extended-release delivery. 4. What precautions should I take while using BDTOFA XR? Inform your doctor about infections, tuberculosis exposure, kidney or liver disease, heart disease, previous blood clots, cancer, pregnancy and all medicines you take. Attend recommended blood tests and seek prompt medical attention for serious symptoms. 5. How long does BDTOFA XR take to work? The response varies according to the condition being treated and the individual patient. Improvement may take time, so follow your specialist's treatment plan and do not change the dose or discontinue treatment on your own.
Manufacturing, Packaging and Import Info
Manufacturing, Packaging and Import Info
Akums Drugs & Pharmaceuticals Ltd.
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