Tacroz Forte Ointment 20 Gm

TACROZ FORTE OINTMENT 20 GM by GLENMARK PHARMACEUTICALS LTD.

• Name:

  • Brand Name: Tacroz Forte Ointment
  • Common Name: Tacrolimus Ointment

• Composition: Each gram of ointment contains Tacrolimus USP 1 mg (0.1% w/w).

• Uses: Tacroz Forte Ointment is prescribed for the treatment of moderate to severe atopic dermatitis (eczema) in adults and adolescents aged 16 years and above who have not responded adequately to, or are intolerant of, conventional therapies such as topical corticosteroids. It works by suppressing the activity of specific immune cells in the skin, thereby reducing inflammation, itching, redness, and swelling.

• Dosage and Administration: Apply a thin layer of Tacroz Forte Ointment to the affected skin areas twice daily, or as directed by a physician. Rub the ointment gently and completely into the skin. Treatment should be continued until the lesion clears. This medicine is for external application only and should not be used with occlusive dressings.

• Side Effects: Common side effects include application site reactions such as skin burning, itching (pruritus), redness (erythema), tingling, pain, irritation, and dryness. Other reported side effects may include folliculitis, acne, and herpes simplex infections. Facial flushing or skin irritation may occur after alcohol consumption.

• Precautions: Minimize or avoid exposure to natural and artificial sunlight, and use sunscreen on treated areas. Skin infections should be treated prior to starting therapy. Tacroz Forte Ointment should not be used on broken or infected skin, or on large areas of the body. It is not recommended for children under 16 years of age. Consult a doctor if you are pregnant, breastfeeding, or have conditions like Netherton's syndrome. Avoid concomitant use with CYP3A4 inhibitors without caution.

• Storage: Store at temperatures not exceeding 30°C or below 25°C. Do not freeze. Keep in a cool, dry place, away from sunlight and out of the reach of children.

Tacroz Forte Ointment is a topical medication containing Tacrolimus (0.1% w/w) as its active ingredient, manufactured by Glenmark Pharmaceuticals Ltd. It is primarily used for the treatment of moderate to severe atopic dermatitis, also known as eczema.

Here are some frequently asked questions about Tacroz Forte Ointment:

What is Tacroz Forte Ointment used for?

Tacroz Forte Ointment is used to treat moderate to severe atopic dermatitis (eczema), a chronic skin condition characterized by red, itchy, and inflamed patches on the skin. It is often prescribed when conventional therapies are ineffective or unsuitable, and helps to reduce inflammation, itching, and irritation.

How does it work?

Tacroz Forte Ointment contains Tacrolimus, which is a topical immunosuppressant. It works by suppressing the over-reaction of immune cells in the skin, specifically by inhibiting T-lymphocyte activation and reducing the production of certain chemical substances that cause inflammation, redness, and swelling.

What is the usual dosage?

Tacroz Forte Ointment is for external use only. For adults and adolescents (16 years and above), treatment typically starts with applying a thin layer of the 0.1% w/w ointment to the affected skin areas twice a day. The treatment should continue until the lesions clear. After initial clearance, an attempt may be made to reduce the frequency of application. It should be applied slowly and evenly to the skin until it is rubbed in. It is generally advised not to use it continuously for more than 6 weeks, with an application-free period of up to 2 weeks, or as directed by your doctor.

What are the possible side effects?

Common side effects of Tacroz Forte Ointment include burning, stinging, itching, redness, pain, or tingling sensation at the application site. These are usually mild to moderate and tend to improve within the first few days of treatment as the skin lesions heal. Other possible side effects include folliculitis (inflammation of hair follicles), acne, and an increased incidence of herpes simplex infections (cold sores, eczema herpeticum). Alcohol consumption can also cause facial flushing or skin irritation.

Is it safe during pregnancy or breastfeeding?

Pregnancy: Tacroz Forte Ointment is generally not recommended during pregnancy due to limited information on its effects and potential risks to the developing fetus. It should only be used if the potential benefit to the mother justifies the potential risk to the fetus, and only if recommended by a doctor.

Breastfeeding: Tacrolimus may be excreted in human milk. Therefore, it is generally not recommended during breastfeeding unless considered necessary by a doctor, who will weigh the importance of the drug to the mother against potential risks to the infant. If used, avoid applying it to areas like the breast or nipple that may come into contact with the infant.

Can it be taken with other medications?

Formal topical drug interaction studies with Tacroz Forte Ointment have not been conducted. However, interactions with systemically administered drugs are unlikely due to minimal absorption. Caution is advised with concomitant administration of known CYP3A4 inhibitors (e.g., erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers, cimetidine) in patients with widespread or erythrodermic disease. It may interact with other topical medicines, so avoid applying other creams, lotions, or gels on the same area. It is also advised not to use moisturizing creams and lotions within 2 hours of applying Tacroz Forte Ointment.

What precautions should be taken?

• Sunlight Exposure: Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using the ointment, as it may increase skin sensitivity to the sun. Use a sunscreen with a high SPF.
• Skin Infections: Existing skin infections should be treated before starting therapy with Tacroz Forte Ointment.
• Occlusive Dressings: Do not use occlusive dressings (bandages or other coverings) over the treated area, as this has not been studied and may increase systemic exposure.
• Children: Tacroz Forte Ointment 0.1% (Forte) is generally not for use in children under 16 years of age. For children aged 2 years and above, a lower strength (0.03%) may be prescribed. It is not recommended for children under 2 years of age.
• Other Conditions: Avoid use in immunocompromised patients, those with Netherton's Syndrome, lamellar ichthyosis, or generalized erythroderma, due to potential for increased systemic absorption or risk of side effects.
• Allergies: Do not use if you are allergic to tacrolimus or any other ingredients in the ointment.

What happens if a dose is missed?

If you miss a dose of Tacroz Forte Ointment, apply it as soon as you remember. If it is almost time for your next scheduled application, skip the missed dose and continue with your regular schedule. Do not apply a double dose to make up for the missed one.

How should it be stored?

Tacroz Forte Ointment should be stored at temperatures not exceeding 30°C. Keep the ointment tube tightly closed when not in use to protect it from air and moisture. Do not freeze. Store in a cool and dry place, away from sunlight, and out of the sight and reach of children.