Tacroz Ointment 0.03% 10gm

TACROZ OINTMENT 0.03% 10GM by GLENMARK-GRAC SPECAILITY CARE

Name

• Brand Name: Tacroz Ointment 0.03%
• Common Name: Tacrolimus Ointment 0.03%

Composition

• Active Ingredient: Tacrolimus 0.03% w/w
• Other Ingredients: Ointment base q.s.

Uses

Tacroz Ointment 0.03% is prescribed for the treatment of moderate to severe atopic dermatitis (eczema) in adults, adolescents, and children from 2 years of age who have not responded adequately to, or are intolerant of, conventional therapies such as topical corticosteroids. It works by suppressing the immune system's response in the skin, thereby reducing inflammation, itching, redness, and improving rashes associated with the condition.

Dosage and Administration

• Tacroz Ointment 0.03% is for external use only.
• Apply a thin layer of the ointment to the affected skin areas twice daily and rub in gently and completely.
• Treatment should continue for one week after signs and symptoms of atopic dermatitis have cleared.
• It is crucial to follow the doctor's directions and not use it too frequently or cover the treated area with bandages or other occlusive dressings unless advised by a doctor.
• Wash hands before and after application, unless the hands are the area being treated.
• If no improvement is observed after two weeks of treatment, or if the condition worsens, consult a doctor.
• This strength (0.03%) is recommended for pediatric patients 2 years of age and older. It is not recommended for children below 2 years of age.

Side Effects

Common side effects may include:

• Burning or tingling sensation, pain, itching, irritation, redness, dryness, or peeling at the application site. These are usually mild to moderate and often improve within a week of starting treatment.
• Headache.
• Hair follicle inflammation (folliculitis).
• Increased skin sensitivity (e.g., to hot/cold, pain, touch).
• Flu-like symptoms (e.g., fever, chills, runny nose, sore throat, muscle aches).
• Acne.

Serious side effects, though rare, have been reported, including an increased risk of lymphomas and skin malignancies with long-term use. Report any unusual skin changes, changes in moles, unusual growths, or swollen lymph nodes to your doctor immediately.

Precautions

• Allergies: Do not use if allergic to Tacrolimus or other macrolide medications.
• Sunlight Exposure: Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using this medicine, and use sunscreen with a high SPF and wear protective clothing.
• Skin Conditions: Not recommended for patients with Netherton's syndrome, lamellar ichthyosis, or generalized erythroderma due to increased risk of systemic absorption and severe side effects.
• Immunocompromised Patients: Should not be used in immunocompromised patients.
• Other Medications: Inform your doctor about any other topical preparations (ointments, lotions, gels) you are using, as concomitant use may lead to undesired side effects. Use with caution with erythromycin, itraconazole, ketoconazole, and diltiazem. Avoid applying moisturizing creams and lotions within 2 hours of applying Tacroz Ointment.
• Alcohol: Avoid alcohol consumption as it may cause facial flushing or skin irritation.
• Pregnancy and Breastfeeding: Tacroz Ointment should be used during pregnancy only if clearly needed and the potential benefit to the mother justifies the potential risk to the fetus. Tacrolimus is excreted in human milk, so a decision should be made to discontinue nursing or discontinue the drug, considering its importance to the mother.
• Other: Avoid applying to open wounds, infected areas, pre-malignant skin conditions, or mucous membranes (eyes, nose, mouth, vagina).

Storage

Store Tacroz Ointment in its original container in a clean and dry place, protected from moisture, sunlight, and heat, typically below 30°C. Keep the medicine out of reach of children and pets. Do not use expired or damaged medicines.

What is Tacroz Ointment 0.03% used for?

Tacroz Ointment 0.03% is primarily used to treat moderate to severe atopic dermatitis, also known as eczema, a skin condition characterized by dry, red, and itchy skin. It is often prescribed for patients who have not responded well to or are intolerant of conventional therapies, such as topical corticosteroids.

How does Tacroz Ointment 0.03% work?

The active ingredient in Tacroz Ointment 0.03% is tacrolimus, which belongs to a class of medications called topical calcineurin inhibitors (TCIs) and immunosuppressants. It works by suppressing the over-reaction of immune cells in the skin by inhibiting T-lymphocyte activation. This action reduces allergic reactions, inflammation (redness and swelling), and helps to relieve itching and improve rashes associated with atopic dermatitis.

What is the usual dosage and how should it be applied?

Tacroz Ointment 0.03% is for external use only and should be applied as directed by a doctor. Generally, a thin layer of the ointment is applied to the affected areas of clean, dry skin twice daily. It should be gently rubbed into the skin until fully absorbed. Treatment may be continued for one week after the signs and symptoms of atopic dermatitis have cleared. For children aged 2 to 15 years, only the 0.03% strength is recommended. The treated area should not be covered with bandages or occlusive dressings unless advised by a doctor.

What are the possible side effects of Tacroz Ointment 0.03%?

Common side effects at the application site include burning, itching, redness, irritation, tingling sensation, pain, dryness, and peeling. These are usually mild to moderate and often improve within the first week of treatment. Other possible side effects include headache, hair follicle inflammation (folliculitis), acne, and increased skin sensitivity to hot/cold. In rare cases, more serious side effects such as skin infections (herpes simplex, chickenpox, shingles) have been reported. Consult your doctor if any side effects persist or worsen.

Is Tacroz Ointment 0.03% safe during pregnancy or breastfeeding?

Tacroz Ointment 0.03% is generally not recommended during pregnancy unless clearly necessary and the potential benefits outweigh the risks, as there is limited information on its safety in human pregnancy. For breastfeeding mothers, it is also not recommended as tacrolimus can pass into breast milk. A doctor should be consulted to discuss the risks and benefits before using this medication during pregnancy or breastfeeding. If used while breastfeeding, application to breast areas (nipple) that may come into contact with the infant should be avoided.

Can Tacroz Ointment 0.03% be taken with other medications?

Formal topical drug interaction studies have not been conducted with tacrolimus ointment. However, interactions with systemically administered drugs are unlikely due to minimal absorption but cannot be entirely ruled out. Tacroz Ointment 0.03% may interact with other topical medications, so avoid applying other creams, lotions, or gels on the same area of skin simultaneously. It should be used with caution alongside known CYP3A4 inhibitors such as erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers, and cimetidine. It's advisable to avoid using moisturizing creams and lotions within 2 hours of applying Tacroz Ointment. Always inform your doctor about all medications, supplements, and herbal products you are using.

What precautions should be taken?

Minimize or avoid exposure to natural and artificial sunlight (tanning beds, UVA/B treatment) while using Tacroz Ointment 0.03% as it may increase skin sensitivity. Wear protective clothing and use sunscreen with a high sun protection factor. Avoid applying the ointment to open wounds, cuts, scrapes, or infected areas. Do not use in children younger than 2 years of age. Avoid continuous long-term use; treatment should be for short periods only, with breaks if needed. If your condition does not improve after two weeks or worsens, consult your doctor. Avoid alcohol consumption, as it may cause facial flushing or skin irritation. This medication is not recommended if you have Netherton's syndrome, lamellar ichthyosis, or generalized erythroderma due to an increased risk of severe side effects. Wash your hands before and after application, unless your hands are the treated area. Avoid getting the ointment in your eyes, nose, or mouth; rinse thoroughly with water if contact occurs.

What happens if a dose is missed?

If you miss a dose of Tacroz Ointment 0.03%, apply it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not overapply or double the dose to compensate for a missed one.

How should it be stored?

Tacroz Ointment 0.03% should be stored in its original container in a cool and dry place, protected from moisture, sunlight, and heat, typically below 25°C or 30°C. Keep the medicine out of reach of children and pets. Do not use expired or damaged medicine.