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Introduction About TOFATAS OINTMENT
TOFATAS OINTMENT is used to manage mild to moderate atopic dermatitis (AD), such as dry, itchy, swollen, and red skin. It contains Tofacitinib, which belongs to the group of medicines called Janus Kinase Inhibitors. It suppresses an overactive immune system by inhibiting certain enzymes called Janus kinases (JAKs). Thus, TOFATAS OINTMENT blocks the production of pro-inflammatory substances (including cytokines) that contribute to the development of inflammation and other symptoms of atopic dermatitis.
Apply TOFATAS OINTMENT to the affected area as directed by your doctor to get the most benefit. Prior to the initiation of this medicine, your doctor may order blood tests to understand and monitor your existing condition.
TOFATAS OINTMENT is not recommended for use in pregnant women and breastfeeding women. Consult your doctor before using it.
TOFATAS OINTMENT is not recommended for use if you have active tuberculosis (TB) or severe liver disease. Consult your doctor before using it.
TOFATAS OINTMENT should be used with caution in patients with a history of chronic lung disease or in those who develop interstitial lung disease due to the increased risk of infections. Consult your doctor before using it.
The safety and efficacy of TOFATAS OINTMENT in children are not established. Consult your child’s doctor for advice.
The most common side effects of using TOFATAS OINTMENT are application site eczema, application site itching, and fever. Consult your doctor if any of the side effects worsen.
Uses Of TOFATAS OINTMENT
It is used to:
- manage mild to moderate atopic dermatitis
How TOFATAS OINTMENT Works
TOFATAS OINTMENT suppresses an overactive immune system by inhibiting certain enzymes called Janus kinases (JAKs). Thus, TOFATAS OINTMENT blocks the production of pro-inflammatory substances (including cytokines) that contribute to the development of inflammation and other symptoms of atopic dermatitis.
How to use TOFATAS OINTMENT
Apply TOFATAS OINTMENT as advised by your doctor. It is for external use only. Apply TOFATAS OINTMENT as a thin layer to the affected area as directed by your doctor to get the most benefit. Your doctor will decide the correct dose and duration of TOFATAS OINTMENT for you depending upon your age, body weight, and disease condition.
Side Effects Of TOFATAS OINTMENT
Common
- Application site eczema
- Application site itching
- Fever
Rare
Stop taking TOFATAS OINTMENT and contact your physician immediately if you experience any of the following side effects:
- Serious infection, an opportunistic infection, or sepsis
- Serious allergic reactions such as urticaria and angioedema
- Signs of myocardial infarction or stroke
How To Manage Side Effects
Skin rash Or Itching
Keep the affected area clean and dry and avoid scratching to prevent further irritation or infection. Apply calamine lotion to help reduce itching and inflammation. Applying cool compresses and wearing loose, breathable clothing can also provide relief. If the itching persists, consult your doctor.
Warning & Precautions
Pregnancy
ContraindicatedTOFATAS OINTMENT is not recommended for use by pregnant women. Women of childbearing potential should be advised to use effective contraception during management with TOFATAS OINTMENT and for at least 4 weeks after the last dose. Consult your doctor before using it.
Breastfeeding
ContraindicatedTOFATAS OINTMENT is not recommended for use by breastfeeding women. Consult your doctor before using it.
Driving and Using Machines
SafeTOFATAS OINTMENT has no influence on the ability to drive or operate machinery.
Liver
ContraindicatedTOFATAS OINTMENT is not recommended for use if you have severe liver disease. Consult your doctor before using it.
Allergy
ContraindicatedDo not use TOFATAS OINTMENT if you are allergic to tofacitinib or any of the other ingredients in this medicine.
Lungs
Consult your doctorTOFATAS OINTMENT is not recommended for use if you have active tuberculosis (TB). It should be used with caution in patients with a history of chronic lung disease or in those who develop interstitial lung disease due to the increased risk of infections. Consult your doctor before using it.
Use In Pediatrics
Consult your doctorThe safety and efficacy of TOFATAS OINTMENT in children are not established. Consult your child’s doctor for advice.
Others
TOFATAS OINTMENT is not recommended for use if you:
- Have serious infections, such as sepsis, or opportunistic infections
- Have a low white blood cell count
- Have low levels of haemoglobin
Before using TOFATAS OINTMENT, inform your doctor if you:
- Have a chronic or recurrent infection
- Have been exposed to tuberculosis
- History of a serious or an opportunistic infection
- Have resided or travelled in areas of endemic tuberculosis or endemic mycoses
- Have underlying conditions that may predispose to infections
- Have a decrease in white blood cell count
- Have herpes zoster (due to virus reactivation)
- Have an increased risk of thrombosis (blood clots)
Interactions
A. Drug-Drug interactions:
- Antifungals (Ex. ketoconazole, fluconazole)
- Anti-tubercular agent (Ex. rifampicin)
- Immunosuppressants (Ex. tacrolimus, ciclosporin)
- Live vaccines
Overdosage:
If you or anyone else accidentally swallows too much of TOFATAS OINTMENT, consult your doctor immediately or visit the nearby hospital.
Synopsis
| Drug | : | Tofacitinib |
| Pharmacological Category | : | Janus Kinase Inhibitors |
| Therapeutic Indication | : | Atopic dermatitis |
| Dosage Forms | : | Tablet, Capsule, Gel, and Ointment |
More Information
Storage
- Keep TOFATAS OINTMENT out of reach of children
- Store at room temperature not exceeding 30ºC. Do not freeze
FAQs About TOFATAS OINTMENT
Q: What is TOFATAS OINTMENT used for?
A: TOFATAS OINTMENT is used to manage mild to moderate atopic dermatitis (AD) such as dry, itchy, swollen, and red skin. Consult your doctor before using it.
Q: How does TOFATAS OINTMENT work?
A: TOFATAS OINTMENT suppresses an overactive immune system by inhibiting certain enzymes called Janus kinases (JAKs). Thus, TOFATAS OINTMENT blocks the production of pro-inflammatory substances (including cytokines) that contribute to the development of inflammation and other symptoms of atopic dermatitis.
Q: How should I apply TOFATAS OINTMENT?
A: Apply TOFATAS OINTMENT as advised by your doctor. It is for external use only. Apply TOFATAS OINTMENT to the affected area as directed by your doctor to get the most benefit. Your doctor will decide the correct dose and duration of TOFATAS OINTMENT for you depending upon your age, body weight, and disease condition.
Q: Is TOFATAS OINTMENT safe during pregnancy?
A: TOFATAS OINTMENT is not recommended for use by pregnant women. Women of childbearing potential should be advised to use effective contraception during management with TOFATAS OINTMENT and for at least 4 weeks after the last dose. Consult your doctor before using it.
Q: Can TOFATAS OINTMENT be used with children?
A: The safety and efficacy of TOFATAS OINTMENT in children are not established. Consult your child’s doctor for advice.
Q: Can I use TOFATAS OINTMENT daily?
A: Apply a thin layer of TOFATAS OINTMENT twice daily to affected areas for 4 consecutive weeks or as directed by the physician. It is for topical use only. Tofacitinib ointment 2% w/w is not for ophthalmic, oral, or intravaginal use.
Q: What are the side effects of using TOFATAS OINTMENT?
A: The most common side effects of using TOFATAS OINTMENT are application site eczema, application site itching, and fever. Consult your doctor if any of the side effects worsen.
Q: Who should not use TOFATAS OINTMENT?
A: TOFATAS OINTMENT is not recommended for use if you have active tuberculosis (TB), severe liver disease, are allergic to Tofacitinib, have serious infections such as sepsis or opportunistic infections, have a low white blood cell count, or have low levels of haemoglobin. Consult your doctor before using it.
Q: What precautions must be taken while using TOFATAS OINTMENT?
A: Before using TOFATAS OINTMENT, inform your doctor if you have a history of chronic lung disease, interstitial lung disease, chronic or recurrent infection, have been exposed to tuberculosis, have a history of a serious or an opportunistic infection, or if you have resided or travelled in areas of endemic tuberculosis or endemic mycoses, have underlying conditions that may predispose to infections, a decrease in white blood cell count, herpes zoster (due to virus reactivation), or have an increased risk of thrombosis (blood clots).
Q: Can I use other medicines along with TOFATAS OINTMENT?
A: Before using TOFATAS OINTMENT, inform your doctor if you are taking prescription, non-prescription, or herbal medicines.
References
1. Purohit VS, Ports WC, Wang C, Riley S. Systemic Tofacitinib Concentrations in Adult Patients With Atopic Dermatitis Treated With 2% Tofacitinib Ointment and Application to Pediatric Study Planning. NIH, National Library of Medicine. National Centre for Biotechnology Information. PubMed Central. [Revised in December 2018] [Accessed on 15th June 2024] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6590358/
2. MSN Laboratories Private Limited. Tofacitinib. [Revised in September 2023] [Accessed on 15th June 2024] https://www.msnlabs.com/img/RxList/MFLL0034-00.pdf
Useful Diagnostic Tests
- Complete Blood Count (CBC)/ Hemogram
- Liver Function Test (LFT)
- Tuberculosis - Gamma Interferon - Quantiferon (T.B Gold)
- Infection Checkup Profile
- Tb - Whole Genome Sequencing
- Afb-Detection By Smear Examination Zn Stain, Sputum
- Lipid Profile Test/Cholesterol-Total, Serum
- Men Health Checkup - Advanced
- Complete Women Checkup
- Senior Citizen Checkup - Female
- Senior Citizen Checkup – Male
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