TBIS 0.1% Ointment

Name

Common Name: Tbis 0.1% Ointment Brand Name: TBIS 0.1% Ointment (by ERIS OAKNET HEALTHCARE PVT LTD)

Composition

TBIS 0.1% Ointment contains Tacrolimus 0.1% w/w as its active ingredient. Tacrolimus is a topical immunosuppressant belonging to the calcineurin inhibitor class.

Uses

This medicine is primarily used to treat moderate to severe atopic dermatitis (eczema) in adults and children who do not respond adequately to or are intolerant to conventional therapies like topical corticosteroids. Atopic dermatitis is a common skin condition characterized by inflamed, itchy, dry, flaky, swollen, rough, and irritated skin patches. Tacrolimus works by suppressing the over-reaction of immune cells in the skin, thereby reducing inflammation, redness, and itching. Some sources also indicate its use in treating psoriasis and vitiligo.

Dosage and Administration

TBIS 0.1% Ointment is for external use only.

• Clean and dry the affected skin area thoroughly before application.
• Apply a thin layer of the ointment to the affected area, usually twice daily or as directed by your doctor.
• Gently rub the ointment until it is fully absorbed.
• Wash hands before and after using the ointment, unless the hands are the area being treated.
• Avoid covering the treated area with airtight dressings or bandages unless specifically instructed by a doctor.
• Do not use it too often. Consult your doctor if there is no improvement after two weeks or if the condition worsens.

Side Effects

Common side effects may include:

• Itching, burning sensation, pain, or tingling at the application site.
• Redness, irritation, dryness, or peeling of the skin.
• Increased skin sensitivity.
• Headache, and inflammation of hair follicles.

Serious, though rare, side effects can include an increased risk of infections due to immune suppression, severe allergic reactions, and a potential increased risk of skin cancer or lymphoma with long-term use.

Precautions

• Allergies: Do not use if allergic to Tacrolimus, any other ingredients in the ointment, or macrolide antibiotics.
• Age Restriction: The 0.1% strength is generally not recommended for children below 16 years of age. For children above 2 years, usage and dosage should be as advised by a healthcare provider, typically with a lower strength (0.03%).
• Pregnancy and Breastfeeding: Use with caution during pregnancy and breastfeeding; consult a doctor as effects on the fetus or infant are not fully known.
• Sun Exposure: Avoid excessive exposure to sunlight and artificial UV light (e.g., tanning beds) during treatment, as it may increase skin sensitivity. Use protective clothing and a high-factor sunscreen.
• Medical Conditions: Inform your doctor if you have liver diseases, skin tumors, skin cancer, a weakened immune system, severe skin infections, or rare genetic skin diseases like Netherton's syndrome. Do not apply to areas with active cutaneous viral infections or infected lesions.
• Interactions: Avoid consuming alcohol, as it may cause skin flushing. Consult your doctor before using other topical medications, antifungal medications, antibiotics, antivirals, blood pressure drugs, or vitamin E supplements, as interactions may occur.

Storage

Store TBIS 0.1% Ointment in its original container in a clean and dry place, protected from moisture, sunlight, and heat. It should be stored at temperatures between 10ºC to 25ºC or below 30ºC. Keep the medicine out of the sight and reach of children and pets.

Frequently Asked Questions About TBIS 0.1% OINTMENT

TBIS 0.1% Ointment, manufactured by ERIS OAKNET HEALTHCARE PVT LTD, is a topical medication containing Tacrolimus. It is primarily used to manage moderate to severe atopic dermatitis (eczema).

What is TBIS 0.1% Ointment used for?

TBIS 0.1% Ointment is used for the short-term relief and intermittent long-term management of moderate to severe atopic dermatitis (eczema) in adults and children over 2 years of age. It is often prescribed when other treatments, such as topical corticosteroids, are not effective or cannot be tolerated. The ointment helps to reduce symptoms like itching, redness, swelling, and rashes associated with eczema.

How does TBIS 0.1% Ointment work?

The active ingredient in TBIS 0.1% Ointment is Tacrolimus, which is an immunosuppressant. It works by targeting and suppressing the overactive immune cells (T-cells) in the skin that cause inflammation in atopic dermatitis. By inhibiting an enzyme called calcineurin, Tacrolimus reduces the release of inflammatory substances, thereby alleviating allergic reactions and inflammation.

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

TBIS 0.1% Ointment is for external use only. It should be applied as a thin layer to the affected skin areas, typically twice daily or as directed by your doctor. Before application, ensure the affected skin is clean and dry. Gently massage the ointment until it is fully absorbed. Remember to wash your hands thoroughly before and after applying the ointment, unless your hands are the area being treated. Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor.

What are the possible side effects of TBIS 0.1% Ointment?

Common side effects include burning, itching, redness, pain, tingling, and irritation at the application site. These reactions are usually mild to moderate and often resolve within about a week of starting treatment. Other possible side effects include increased skin sensitivity to hot or cold temperatures, dry skin, peeling, headache, and inflamed hair follicles. Long-term use carries a theoretical concern about an increased risk of skin cancer or lymphoma. If you experience persistent or worsening side effects, consult your doctor.

Is TBIS 0.1% Ointment safe during pregnancy or breastfeeding?

Pregnancy: TBIS 0.1% Ointment should be used with caution during pregnancy. There is limited information on its safety in human pregnancy, and animal studies have shown potential harmful effects on the developing baby. It is generally not recommended unless clearly necessary and the potential benefits outweigh the risks. Always consult your doctor if you are pregnant or planning to become pregnant.

Breastfeeding: It is generally considered probably safe to use during breastfeeding if prescribed, as limited human data suggests no significant risk to the baby. However, Tacrolimus can pass into breast milk. If advised for use, avoid applying the ointment to breast areas that may come into contact with the infant. Consult your doctor before using this medicine while breastfeeding.

Can TBIS 0.1% Ointment be taken with other medications?

Since it is an external application, TBIS 0.1% Ointment is less likely to interact with orally taken medicines. However, it can interact with other topical treatments. Inform your doctor if you are using other topical creams, lotions, or gels, and avoid applying moisturizing creams within two hours of using TBIS 0.1% Ointment. Caution is advised if you are taking antifungal medications, antibiotics, antivirals, blood pressure drugs, vitamin E supplements, or other immunosuppressants, as interactions can occur.

What precautions should be taken while using TBIS 0.1% Ointment?

Do not apply TBIS 0.1% Ointment to broken, infected skin, open wounds, or mucous membranes (eyes, nose, mouth, vagina). Rinse with water immediately if accidental contact occurs. This medication can increase your skin's sensitivity to sunlight, so limit sun exposure, wear protective clothing, and use sunscreen with a high SPF. Avoid consuming alcohol while using this ointment as it may cause facial flushing or redness. Inform your doctor if your condition does not improve after two weeks or if your skin worsens.

What should I do if I miss a dose?

If you miss a dose of TBIS 0.1% Ointment, 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 application schedule. Do not apply a double dose to make up for a missed one.

How should TBIS 0.1% Ointment be stored?

Store TBIS 0.1% Ointment in its original container in a cool, dry place, away from direct sunlight, moisture, and heat. Keep it out of the sight and reach of children and pets. The ointment should be stored below 25°C or 30°C. Do not use the medicine if it is expired or damaged.