Tacroz Forte Ointment 10 Gm

TACROZ FORTE OINTMENT 10 GM

Tacroz Forte Ointment is a topical medication manufactured by Glenmark Pharmaceuticals Ltd., primarily used for the management of atopic dermatitis.

• 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 (16 years and above) who have not responded adequately to conventional therapies or for whom conventional therapies are unsuitable. It works as an immunosuppressant by suppressing the activity of certain immune cells in the skin that cause inflammation, thereby relieving itching, redness, and rashes associated with eczema.

• Dosage and Administration:

  • This medicine is for external use only.
  • Apply a thin layer of the ointment to the affected skin areas twice daily, rubbing it in gently and completely. Some sources suggest 2-4 times a day or once or twice daily, as advised by a physician.
  • Ensure the affected area is clean and dry before application.
  • Treatment may continue for one week after the signs and symptoms of atopic dermatitis have cleared.
  • Wash hands thoroughly after application, unless the hands are the area being treated.
  • Do not cover the treated area with occlusive dressings, bandages, or wraps unless specifically directed by a doctor, as this may increase the risk of side effects. Tacroz Forte Ointment is not for oral, ophthalmic, or intravaginal use.

• Side Effects:

  • Common Side Effects: Application site reactions such as burning, itching, irritation, redness (erythema), stinging, tingling, warmth, pain, altered sensation, and rash. These are usually mild to moderate and often resolve within the first week of treatment.
  • Serious/Less Common Side Effects: Folliculitis, acne, herpes simplex infections (e.g., cold sores, eczema herpeticum), headache, hyperaesthesia (increased skin sensitivity), and alcohol intolerance (facial flushing or skin irritation after consuming alcohol). Long-term continuous use of tacrolimus ointment has been associated with an increased risk of lymph node tumors (lymphoma) and skin malignancies.

• Precautions:

  • Tacroz Forte Ointment (0.1% strength) is not recommended for children below 16 years of age.
  • It is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other macrolides.
  • Any skin infections should be treated before initiating therapy with this ointment.
  • Avoid use in immunocompromised patients or those with conditions that may increase systemic absorption, such as Netherton's syndrome, lamellar ichthyosis, or generalized erythroderma.
  • Minimize or avoid exposure to natural or artificial sunlight (tanning beds) while using this medication. It is important to use a sunscreen with an SPF of at least 30.
  • Do not use continuously for more than 6 weeks unless advised by a doctor.
  • Pregnant or breastfeeding women should consult their doctor before using this medication.
  • Alcohol consumption may cause facial flushing or skin irritation.
  • Report to your doctor if there is no improvement after two weeks of treatment or if the skin condition worsens.
  • Avoid applying moisturising creams and lotions within 2 hours of applying Tacroz Forte Ointment. Caution is advised when used concurrently with certain oral medications like erythromycin, itraconazole, ketoconazole, and diltiazem.

• Storage:

  • Store at temperatures not exceeding 30°C (some sources indicate below 25°C).
  • Keep in the original container, protected from moisture, sunlight, and heat.
  • Do not freeze.
  • Keep out of reach of children.

TACROZ FORTE OINTMENT 10 GM, manufactured by Glenmark Pharmaceuticals Ltd., contains Tacrolimus as its active ingredient (0.1% w/w). It is a topical immunosuppressant primarily used to treat moderate to severe atopic dermatitis (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, also known as eczema, in adults and adolescents aged 16 years and above. Atopic dermatitis is a chronic skin condition characterized by red, dry, itchy, and inflamed patches of skin. This ointment is often prescribed when conventional therapies are ineffective or unsuitable, or when patients have not responded adequately to topical corticosteroids.

How does Tacroz Forte Ointment work?

The active ingredient, Tacrolimus, is a topical immunosuppressant. It works by suppressing the activity of certain immune cells (T-lymphocytes) in the skin that cause inflammation, redness, swelling, and itching associated with atopic dermatitis. By modulating the immune response, it helps to alleviate these symptoms and promote skin healing.

What is the usual dosage of Tacroz Forte Ointment?

For adults and adolescents (16 years of age and above), treatment typically starts with Tacrolimus Ointment 0.1% twice a day, and treatment should continue until the lesion clears. A thin layer of the ointment should be applied to the affected skin areas and rubbed in gently and completely. It is important to use this medicine as prescribed by your doctor and not for a duration longer than recommended, often not continuously for more than 6 weeks without a break.

What are the possible side effects of Tacroz Forte Ointment?

Common side effects include a burning sensation, itching (pruritus), redness (erythema), and tingling at the application site. These are usually mild to moderate and often improve within the first week of treatment. Other possible side effects can include folliculitis, acne, and herpes simplex infections. In some cases, consuming alcohol while using the ointment may cause facial flushing or skin irritation.

Is Tacroz Forte Ointment safe during pregnancy or breastfeeding?

Pregnancy: Tacroz Forte Ointment is generally not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus, as animal studies have shown harmful effects. Tacrolimus can cross the placenta. It is advised to consult your doctor if you are pregnant or planning a pregnancy.

Breastfeeding: Tacrolimus is excreted in human milk when taken systemically, but levels are shown to be low with topical use. However, it is generally recommended to consult a doctor before using Tacroz Forte Ointment while breastfeeding. If prescribed, avoid applying the ointment to breast areas that may come into contact with the infant.

Can Tacroz Forte Ointment be taken with other medications?

Formal topical drug interaction studies with Tacrolimus Ointment have not been extensively 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, and cimetidine) in patients with widespread disease. Avoid using other topical medications on the same area of skin simultaneously without consulting your doctor.

What precautions should be taken while using Tacroz Forte Ointment?

• Sunlight Exposure: Minimize or avoid exposure to natural or artificial sunlight (e.g., tanning beds) while using this ointment, as it may increase skin sensitivity. Use protective clothing and sunscreen.
• Skin Infections: Existing skin infections should be treated before starting therapy with topical Tacrolimus.
• Not for Children: The 0.1% strength is generally not recommended for children below 16 years of age.
• Certain Skin Conditions: It should not be used in immunocompromised patients or those with conditions like Netherton's syndrome, lamellar ichthyosis, or generalized erythroderma due to the potential for increased systemic absorption.
• External Use Only: This ointment is for external use on the skin only. Avoid contact with eyes, nose, mouth, or vagina. If accidental contact occurs, rinse thoroughly with water.
• Do not cover the treated area with occlusive dressings (e.g., bandages) unless specifically directed by a doctor.

What happens if a dose 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 schedule. Do not apply a double dose to make up for the missed one.

How should Tacroz Forte Ointment be stored?

Tacroz Forte Ointment should be stored at room temperature, typically below 25°C or not exceeding 30°C. Keep the ointment tube tightly closed when not in use, protected from moisture, sunlight, and heat. Do not freeze the ointment. Always keep this medicine out of reach of children and pets.