Tacroz Ointment 0.03% (20 Gm)

TACROZ OINTMENT 0.03% (20 GM) by GLENMARK LABORATORIES

Tacroz Ointment 0.03% is a topical medication manufactured by Glenmark Laboratories, primarily used in the management of certain skin conditions.

• Name:

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

• Composition:

  • Active Ingredient: Each gram contains Tacrolimus 300 mcg (0.03% w/w).

• Uses: Tacroz Ointment 0.03% is prescribed for the treatment of moderate to severe atopic dermatitis (eczema) in adults and children aged 2 years and above who do not respond adequately or are intolerant to conventional therapies like topical corticosteroids. It works by suppressing the over-reaction of immune cells in the skin, thereby reducing inflammation, itching, redness, and swelling associated with eczema.

• Dosage and Administration:

  • For external use only.
  • Clean and dry the affected skin areas before application.
  • Apply a thin layer of the ointment to the affected areas, usually twice daily, or as directed by your doctor.
  • Rub it in gently and completely.
  • Avoid covering the treated area with bandages or occlusive dressings unless advised by your doctor, as this method has not been studied and may increase systemic absorption.
  • Treatment should continue for one week after signs and symptoms of atopic dermatitis have cleared, or as prescribed by your doctor. If there is no improvement after two weeks or if the condition worsens, inform your doctor.

• Side Effects: Common side effects at the application site include:

  • Burning or tingling sensation
  • Itching (pruritus)
  • Irritation, pain, dryness, peeling, and redness (erythema)
  • Increased skin sensitivity
  • Headache
  • Hair follicle inflammation (folliculitis)
  • Increased risk of localized infections such as herpes simplex (cold sores)

  Serious side effects, though rare, include an increased risk of lymph node tumors (lymphoma) and skin cancers, especially with long-term use.

• Precautions:

  • Avoid excessive exposure to natural or artificial sunlight (e.g., tanning beds) while using this medication. Use protective clothing and apply sunscreen.
  • Inform your doctor if you are pregnant, planning a pregnancy, or breastfeeding, as Tacrolimus may pass into breast milk and its safety during human pregnancy is limited.
  • Not recommended for use in children younger than 2 years of age.
  • Do not use if you are allergic to tacrolimus or any other components of the ointment, or to macrolides in general.
  • Avoid use in patients with Netherton's syndrome, lamellar ichthyosis, generalized erythroderma, skin areas with cancers or pre-cancers, or a weakened immune system.
  • Avoid alcohol consumption as it may cause facial flushing or skin irritations.
  • Discuss with your doctor if you are using other topical creams, lotions, or gels, or certain oral medications like erythromycin, itraconazole, ketoconazole, and diltiazem, as interactions may occur. Do not apply moisturizing creams and lotions within 2 hours of applying Tacroz Ointment.
  • Not for ophthalmic, oral, or intravaginal use.

• Storage:

  • Store in its original container in a cool and dry place, protected from light and moisture, at temperatures below 30°C (some sources specify below 25°C or 35°C).
  • Do not freeze.
  • Keep out of reach of children and pets.
  • Always check the expiry date and discard if expired or damaged.

Tacroz Ointment 0.03% (20 GM) by Glenmark Laboratories is a topical medication primarily used to treat atopic dermatitis. Its active ingredient, tacrolimus, helps manage the symptoms of eczema by modulating the skin's immune response.

What is Tacroz Ointment 0.03% used for?

Tacroz Ointment 0.03% is used to treat moderate to severe atopic dermatitis (eczema) in adults and children aged 2 years and older who have not responded well to other conventional therapies, such as topical corticosteroids. It helps relieve symptoms like itching, redness, and inflammation associated with eczema.

How does Tacroz Ointment 0.03% work?

This medicine contains tacrolimus, which is a topical calcineurin inhibitor. It works by suppressing the overactive immune response in the skin that causes inflammation and allergic reactions in eczema. By inhibiting specific immune cells, it reduces the release of inflammatory substances, thereby alleviating dryness, peeling, redness, and itching.

What is the usual dosage of Tacroz Ointment 0.03%?

For children aged 2 to 15 years, a thin layer of Tacroz Ointment 0.03% is typically applied to the affected areas of the skin twice daily. Adults and adolescents (16 years and older) can also use the 0.03% strength or a 0.1% strength. Treatment should continue until symptoms clear, and if no improvement is seen within 6 weeks, a doctor should reassess the condition. For maintenance, it may be applied once a day twice weekly to areas commonly affected by atopic dermatitis to prevent flare-ups. It is not recommended for continuous long-term use.

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

Common side effects at the application site include burning, stinging, itching, redness, or tingling sensation. These effects are usually mild to moderate and often improve within the first week of treatment. Other possible side effects include headache, acne, inflammation of hair follicles, and increased skin sensitivity, especially to sunlight.

Are there any serious warnings associated with Tacroz Ointment?

While rare, there is a warning regarding a possible increased risk of skin cancer and lymphoma with long-term use of topical tacrolimus. It is advised to use the smallest amount needed to control symptoms and not to use it continuously for prolonged periods. Your doctor will discuss this risk with you and monitor your condition.

Is Tacroz Ointment 0.03% safe during pregnancy or breastfeeding?

Pregnancy: The experience with topical tacrolimus in pregnant women is limited. It should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Always consult your doctor if you are pregnant, planning a pregnancy, or think you might be pregnant.

Breastfeeding: Topical tacrolimus is considered to pose a low risk to a breastfed infant because it is poorly absorbed into the bloodstream after skin application. However, care should be taken to ensure the infant's skin does not come into direct contact with treated areas, and if applied to the breast, it should be thoroughly cleaned off before nursing.

Can Tacroz Ointment 0.03% be taken with other medications?

Topical tacrolimus is less likely to interact with orally taken medicines as it's applied externally. However, certain oral medications like erythromycin, itraconazole, ketoconazole, diltiazem, and cimetidine should be used with caution as they might interact. It's best to avoid applying moisturizing creams or lotions within 2 hours of applying Tacroz Ointment. Consuming alcohol while using this medicine may cause facial flushing or redness and a feeling of warmth. Always inform your doctor about all prescription and non-prescription medications, vitamins, and herbal products you are using.

What precautions should be taken while using Tacroz Ointment 0.03%?

• Avoid excessive exposure to natural or artificial sunlight (e.g., tanning beds). Wear protective clothing and use sunscreen with a high SPF when outdoors, as this medicine can increase sun sensitivity.
• Do not use the ointment on skin areas that have active bacterial, viral (like herpes or chickenpox), or fungal infections.
• Avoid contact with your eyes, inside your nose or mouth, or on open wounds or cuts. If accidental contact occurs, rinse the area thoroughly with water.
• Do not cover the treated skin area with bandages, dressings, or wraps, as this has not been studied and may increase systemic absorption.
• Inform your doctor if you have a weakened immune system, Netherton's syndrome, other widespread skin conditions, or kidney problems.
• Tacroz Ointment 0.03% is not recommended for children younger than 2 years of age.

What happens if a dose of Tacroz Ointment 0.03% is missed?

If you miss a dose, apply 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 apply extra ointment to make up for a missed dose.

How should Tacroz Ointment 0.03% be stored?

Store Tacroz Ointment 0.03% in a closed container at room temperature, away from excessive heat, moisture, and direct light. Do not freeze the ointment. Ensure the tube is tightly closed after each use.