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Introduction About AZTOFA 2% OINTMENT
AZTOFA 2% Ointment is used to manage mild to moderate atopic dermatitis, 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, AZTOFA blocks the production of pro-inflammatory substances (including cytokines) that contribute to the development of inflammation and other symptoms of atopic dermatitis.
Apply AZTOFA 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.
AZTOFA Ointment is not recommended for use in pregnant women and breastfeeding women or if you are suffering from active tuberculosis (TB) or severe liver disease. It should be used with caution in patients with a history of chronic lung disease or interstitial lung disease due to the increased risk of infections. The safety and efficacy of AZTOFA Ointment in children are not established. Therefore, consult your child’s doctor for advice before using this medicine.
The most common side effects of using AZTOFA Ointment are application site eczema, application site itching, and fever. Consult your doctor if any of the side effects worsen.
Uses Of AZTOFA 2% OINTMENT
- It is used to manage signs of mild to moderate atopic dermatitis such as (skin rashes, redness, peeling, dryness, flakiness, bumps or fissures)
How AZTOFA 2% OINTMENT Works
AZTOFA Ointment suppresses an overactive immune system by inhibiting certain enzymes called Janus kinases (JAKs) in the body. This action blocks the production of pro-inflammatory substances (including cytokines) within the body that contributes to the development of inflammation and other symptoms of atopic dermatitis.
How to use AZTOFA 2% OINTMENT
Apply AZTOFA 2% OINTMENT as advised by your doctor. It is for external use only. Apply AZTOFA 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 AZTOFA 2% OINTMENT for you depending upon your age, body weight, and disease condition.
Side Effects Of AZTOFA 2% OINTMENT
Common
- Application site eczema
- Application site itching
- Fever
Stop using AZTOFA 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
ContraindicatedAZTOFA 2% OINTMENT is not recommended for use by pregnant women. Women of childbearing potential should be advised to use effective contraception during therapy with AZTOFA and for at least 4 weeks after the last dose. Therefore, consult your doctor before using it.
Breastfeeding
ContraindicatedAZTOFA 2% OINTMENT is not recommended for use by breastfeeding women. Therefore, consult your doctor before using it.
Driving and Using Machines
Use with CautionAZTOFA Ointment has no influence on the ability to drive or operate machinery.
Liver
ContraindicatedAZTOFA 2% OINTMENT is not recommended for use if you have severe liver disease. Therefore, consult your doctor before using AZTOFA.
Allergy
ContraindicatedDo not use AZTOFA 2% OINTMENT if you are allergic to tofacitinib or any of the other ingredients in this medicine.
Lungs
Consult your doctorAZTOFA 2% 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 developed interstitial lung disease due to the increased risk of infections. Therefore, consult your doctor before using it.
Use In Pediatrics
Consult your doctorThe safety and efficacy of AZTOFA 2% OINTMENT in children are not established. Therefore, consult your child’s doctor for advice.
Others
AZTOFA 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 AZTOFA 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 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 applied too much of AZTOFA Ointment, rinse with plenty of water. If irritation persists, consult your doctor for advice.
Synopsis
| Drug | : | Tofacitinib |
| Pharmacological Category | : | Janus Kinase Inhibitors |
| Therapeutic Indication | : | Atopic dermatitis |
| Dosage Forms | : | Tablet, Capsule, Gel, and Ointment |
More Information
Storage
- Keep AZTOFA Ointment out of reach of children
- Store AZTOFA at room temperature not exceeding 30ºC. Do not freeze
FAQs About AZTOFA 2% OINTMENT
Q: What is AZTOFA 2% OINTMENT used for?
A: AZTOFA 2% 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 AZTOFA Ointment work?
A: AZTOFA Ointment suppresses an overactive immune system by inhibiting certain enzymes called Janus kinases (JAKs). Thus, AZTOFA 2% 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 AZTOFA 2% OINTMENT?
A: Apply AZTOFA 2% OINTMENT as advised by your doctor. It is for external use only. Apply AZTOFA 2% 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 AZTOFA 2% OINTMENT for you depending upon your age, body weight, and disease condition.
Q: Is AZTOFA Ointment safe during pregnancy?
A: AZTOFA Ointment is not recommended for use by pregnant women. Women of childbearing potential should be advised to use effective contraception during management with AZTOFA 2% OINTMENT and for at least 4 weeks after the last dose. Consult your doctor before using it.
Q: Can AZTOFA Ointment be used with children?
A: The safety and efficacy of AZTOFA in children are not established. Consult your child’s doctor for advice.
Q: Can I use AZTOFA Ointment daily?
A: Apply a thin layer of AZTOFA 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 AZTOFA Ointment?
A: The most common side effects of using AZTOFA 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 AZTOFA Ointment?
A: AZTOFA 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 AZTOFA Ointment?
A: Before using AZTOFA 2% 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 AZTOFA Ointment?
A: Before using AZTOFA 2% 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
- Tuberculosis-Gamma Interferon-Quantiferon (T.B Gold)
- Skin Care Package
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