INTRODUCTION

TBIS 0.1% OINTMENT contains Tacrolimus which belongs to the group of medicines called Immunosuppressants. It is used to treat and prevent moderate to severe atopic dermatitis (eczema) when other conventional therapies fail to provide adequate results.

Atopic dermatitis is an allergic skin condition that makes your skin itchy, red, dry and irritated. It is characterized by small, raised bumps on the skin with pus accompanied by severe skin itching, redness and inflammation.

TBIS 0.1% OINTMENT is suitable for use both in adults and children (aged 16 years or older). Apply a thin layer of TBIS 0.1% OINTMENT on the affected skin areas. You may use your regular skin moisturizer and/or other skin lotions along with TBIS 0.1% OINTMENT, but make sure to apply them after 2 hours of applying TBIS 0.1% OINTMENT.

Do not use TBIS 0.1% OINTMENT for more than the stipulated duration recommended by your doctor. Regularly visit your doctor (once a year or as instructed) for reviewing your condition even if your condition remains under control.

Before using TBIS 0.1% OINTMENT inform your doctor if you have any other skin disease apart from eczema such as skin cancer, skin infections or lesions at the application site, any inherited skin barrier disease or generalised erythroderma (severe skin redness and scaling).

You must also inform your doctor if you have a weak immune system, liver problems or any autoimmune disease conditions. Consult your doctor before using TBIS 0.1% OINTMENT if you are pregnant or breastfeeding.

While undergoing therapy with TBIS 0.1% OINTMENT, avoid exposing your skin towards direct sunlight or towards any artificial light sources. Wear loose-fitting protective clothes and apply sunscreen while going outdoors. Also, avoid the consumption of alcohol as it may make your skin look more flushed. Do not smoke or go near naked flames as it may increase the risk of burns.

The most common side effects of applying TBIS 0.1% OINTMENT are skin irritation, burning sensation, redness or warmth at the site of application. Consult your doctor if this side effect troubles you.

USES OF TBIS 0.1% OINTMENT

It is used in adults and in children (aged 16 years or older) to treat and prevent:

• Moderate to severe atopic dermatitis (eczema)

HOW TBIS 0.1% OINTMENT WORKS

TBIS 0.1% OINTMENT is an immunosuppressive agent. It works by blocking the release of certain chemicals in the body (such as T-cells) that cause allergic and inflammatory reactions. When applied topically, it suppresses the immune system and prevents the abnormal immune response towards allergens. This reduces skin dryness, redness, itching and inflammation associated with auto-immune skin conditions.

DIRECTIONS FOR USE

Apply a small amount of TBIS 0.1% OINTMENT into the affected skin areas or directed by the physician. It is for topical use only. Wash your hands before and after application unless your hands are also treated.

Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight and health condition. Do not stop using or overuse TBIS 0.1% OINTMENT without consulting your doctor.

Avoid contact of TBIS 0.1% OINTMENT with your eyes, mouth, ears, nose or with open wounds. Do not cover the application site with bandages, dressings or clothes.

SIDE EFFECTS OF TBIS 0.1% OINTMENT

HOW TO MANAGE SIDE EFFECTS

Application Site Reactions:

Place an icepack on the affected skin areas to ease the irritation. Avoid using harsh chemicals or soaps on the affected areas. Wear protective loose-fitting clothes while going outdoors. Regularly moisturize your skin. Avoid exposing your skin towards direct sunlight. If the condition did not improve, contact your doctor.

WARNING & PRECAUTIONS

PREGNANCY

TBIS 0.1% OINTMENT should be used in pregnant women only if considered necessary by the physician. Therefore, consult your doctor before using it.

BREASTFEEDING

TBIS 0.1% OINTMENT should be used in breastfeeding women only if considered necessary by the physician. Therefore, consult your doctor before using it.TBIS 0.1% OINTMENT is unlikely to affect your ability for driving and using machinery. However, do not drive or handle any heavy tools or machines if your ability is affected by TBIS 0.1% OINTMENT.

ALCOHOL

Avoid consumption of alcohol while using TBIS 0.1% OINTMENT as it may make your skin look more flushed.

LIVER

TBIS 0.1% OINTMENT should be used with caution in patients with liver problems (such as liver failure). Therefore, consult your doctor before using it.

ALLERGY

Talk to your doctor before using TBIS 0.1% OINTMENT if you are allergic to Tacrolimus or to any macrolide antibiotics (such as erythromycin, azithromycin).

INTERACTIONS

A. Drug – Drug interaction:

Before using TBIS 0.1% OINTMENT inform your doctor if you are taking the following medicines such as:

• erythromycin (a medicine used to treat bacterial infections)
• medicines used to treat fungal infection (Ex. ketoconazole, itraconazole)
• diltiazem (a medicine used to treat heart problems)
• cimetidine (a medicine used to treat stomach ulcers)

Overdosage:

If you or anyone else accidentally swallowed TBIS 0.1% OINTMENT, consult your doctor for advice or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep TBIS 0.1% OINTMENT out of reach of children
• Store TBIS 0.1% OINTMENT at room temperature

FAQs ABOUT TBIS 0.1% OINTMENT

What is the use of TBIS 0.1% OINTMENT?

TBIS 0.1% OINTMENT is used to treat and prevent moderate to severe atopic dermatitis (eczema) when other conventional therapies fail to provide adequate results.

How TBIS 0.1% OINTMENT works?

TBIS 0.1% OINTMENT is an immunosuppressive agent. It works by blocking the release of certain chemicals in the body (such as T-cells) that cause allergic and inflammatory reactions. When applied topically, it suppresses the immune system and prevents the abnormal immune response towards allergens. This reduces skin dryness, redness, itching and inflammation associated with auto-immune skin conditions.

How to use TBIS 0.1% OINTMENT?

Apply a small amount of TBIS 0.1% OINTMENT into the affected skin areas or directed by the physician. It is for topical use only. Wash your hands before and after application unless your hands are also treated.

What precautions must be followed while using TBIS 0.1% OINTMENT?

TBIS 0.1% OINTMENT is for topical use only. Avoid contact of TBIS 0.1% OINTMENT with your eyes, mouth, ears, nose or with open wounds. Do not cover the application site with bandages, dressings or clothes. Wash your hands before and after application. Before using TBIS 0.1% OINTMENT inform your doctor if you have any other skin disease apart from eczema such as skin cancer, skin infections or any inherited skin barrier disease. Consult your doctor before using TBIS 0.1% OINTMENT if you are pregnant or breastfeeding. Avoid exposing your skin towards direct sunlight and wear protective loose-fitting clothes and sunscreen while going outdoors.

Is TBIS 0.1% OINTMENT safe?

TBIS 0.1% OINTMENT may cause skin irritation, burning sensation, redness and warmth at the site of application. Consult your doctor if this bothers you.

What are the common side effects of using TBIS 0.1% OINTMENT?

The most common side effects of applying TBIS 0.1% OINTMENT are skin irritation, burning sensation, redness or warmth at the site of application. Consult your doctor if this side effect troubles you.

What to do if I forget to apply TBIS 0.1% OINTMENT?

If you forgot to apply a dose of TBIS 0.1% OINTMENT, apply it as soon as you remember. However, if it is time for the next dose of TBIS 0.1% OINTMENT, skip the missed dose and apply the next one regularly. Do not apply a double dose of TBIS 0.1% OINTMENT to compensate for the missed ones.

How long will it take for TBIS 0.1% OINTMENT to heal my condition?

You need to apply TBIS 0.1% OINTMENT as long as your doctor prescribes you the medicine. Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight and disease condition.

Can I use other topical medicines while using TBIS 0.1% OINTMENT?

Avoid using any other topical medicines along with TBIS 0.1% OINTMENT without consulting your doctor.

Can TBIS 0.1% OINTMENT be used in pregnant women?

TBIS 0.1% OINTMENT should be used in pregnant women only if considered necessary by the physician. Therefore, consult your doctor before using it.

Can TBIS 0.1% OINTMENT be used in children?

TBIS 0.1% OINTMENT should be used in children and adolescents (aged 16 years or above) only if prescribed by the physician. It is not recommended for use in children aged below 16 years. However, consult your doctor for advice.

Can I use TBIS 0.1% OINTMENT for psoriasis?

TBIS 0.1% OINTMENT is usually prescribed for the treatment of eczema. Consult your doctor for advice if you are wishing to use this medicine to treat psoriasis.

Can I use TBIS 0.1% OINTMENT for my 4-year-old son?

TBIS 0.1% OINTMENT is not recommended for use in children aged below 16 years. Therefore, consult your doctor for advice. Your doctor may prescribe a suitable lower dose of tacrolimus for your child depending upon their age, body weight and severity of the disease.

REFERENCES

1. KD. Tripathi. Autocoids and related drugs. Essentials of Medical Pharmacology. 8th edition. 2019. Page – 940-941.

2. Mamitaro Ohtsuki, Hiroshi Morimoto and Hidemi Nakagawa. Tacrolimus ointment for the treatment of adult and pediatric atopic dermatitis: Review on safety and benefits. 1. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. August 2018. [Accessed on 25th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6099320/

3. Accord Healthcare Limited. United Kingdom. Electronic Medicines compendium (EMC) [Revised in February 2021] [Accessed on 26th October 2022] https://www.medicines.org.uk/emc/files/pil.9757.pdf

4. Astellas Toyama Co., Ltd. U.S. Food and Drug Administration. [Revised in November 2011]. [Accessed on 26th October 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050777s018lbl.pdf

5. Glenmark Pharmaceuticals Inc., USA. Tacrolimus Ointment 0.03% Ointment 0.1%.  [Revised in March 2021]. [Accessed on 26th October 2022] https://glenmarkpharma-us.com/wp-content/uploads/Tacrolimus-Ointment-Medication-Guide.pdf

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 27 Oct 2022 | 10:28 AM(IST)