INTRODUCTION

CLONATE OINTMENT contains Clobetasol, which belongs to the group of medicines called Topical corticosteroids. It is used in adults and adolescents (aged 12 years or above) to treat inflammatory skin conditions such as psoriasis, eczema and dermatitis that have not responded to milder steroid creams or ointments.

Psoriasis is an immune-mediated skin disease that speeds up the growth cycle of skin cells, causing patches of thick red skin and silvery scales, typically on the elbows, knees, scalp, lower back, face, palms, and soles, but can affect other places also. Eczema (also called dermatitis) includes several different types of skin swelling, causing dry, itchy skin and rashes on the face, inside the elbows, behind the knees, and on the hands and feet. Scratching the skin can make it turn red, swell and itch even more.

CLONATE OINTMENT is not recommended for use in patients with other bacterial, fungal, or viral infections (such as herpes simplex, chicken pox and tuberculosis). Before using CLONATE OINTMENT, inform your doctor if you have a skin infection, diabetes, adrenal gland problem, scheduled surgery, acne, plaques around your mouth, underarms, anus, or genitals and liver diseases.

CLONATE OINTMENT should be used during pregnancy only if recommended by your doctor. CLONATE OINTMENT should be used with caution by breastfeeding women. CLONATE OINTMENT is not recommended for use by children under 12 years of age. The most common side effects of using CLONATE OINTMENT are thinning of the skin, widening of small veins in the skin, skin discomfort and dryness. Contact your doctor if any of your symptoms get worse or persist.

USES OF CLONATE OINTMENT

• Treats inflammatory condition of the skin such as psoriasis, eczema, dermatitis, etc

HOW CLONATE OINTMENT WORKS

CLONATE OINTMENT is a topical corticosteroid with anti-itching, anti-inflammatory and vasoconstrictive properties. It acts by blocking the release of certain chemical mediators (prostaglandins, leukotrienes) in the body that causes pain, inflammation and swelling. As a result, it effectively reduces the skin redness, itchiness, inflammation, swelling, and irritation associated with certain skin problems.

DIRECTIONS FOR USE

Always apply CLONATE OINTMENT as directed by your physician. It is for external use only. Wash your hands before and after application. Apply a thin layer of CLONATE OINTMENT on the affected area. Do not cover the affected site after applying CLONATE OINTMENT.

Avoid contact of CLONATE OINTMENT with your eyes (including eyelids), ears, nose, armpits or with other mucous membranes (such as the vagina). Do not apply CLONATE OINTMENT to the damaged skin.

SIDE EFFECTS OF CLONATE OINTMENT

HOW TO MANAGE SIDE EFFECTS

Irritation and burning:

Avoid sharing vessels, personal items, or cosmetics with others. Use disinfects on objects you use in public spaces, such as gym equipment. Drink enough water and consume a nutritious diet. Do not use irritants or harsh chemicals. Sleep seven to eight hours every night. Use sunscreens to prevent sunburn and other sun damage. Wash hands regularly with soap and water.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before using CLONATE OINTMENT, inform your doctor if you are taking, have taken, or might take any other medicine, including prescription, non-prescription or any herbal medicine.

Overdosage:

If you or anyone else accidentally used more of CLONATE OINTMENT, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include features of hypercortisolism (easy bruising, wide purple stretch marks, mainly on the stomach, breasts, hips, and under the arms, weak muscles).

SYNOPSIS

MORE INFORMATION

• Keep CLONATE OINTMENT out of reach from children
• Store at room temperature

FAQs ABOUT CLONATE OINTMENT

What is CLONATE OINTMENT used for?

CLONATE OINTMENT is used in adults and adolescents (aged 12 years or above) to treat inflammatory skin conditions such as psoriasis, eczema and dermatitis that have not responded to milder steroid creams or ointments.

Can I use CLONATE OINTMENT for wounds?

CLONATE OINTMENT is not intended for use on wounds. Do not use it for any indication other than prescribed. Consult your doctor for advice.

Can we use CLONATE OINTMENT for kids?

CLONATE OINTMENT is not recommended for use in children (younger than 12 years of age). Consult your child’s doctor for advice. The doctor will decide on an appropriate dose or select a suitable alternative treatment for your child.

Can CLONATE OINTMENT be used for vitiligo?

CLONATE OINTMENT can be used for the treatment of limited areas of vitiligo. Do not use it for any indication other than prescribed. Consult your doctor for advice.

Can I use CLONATE OINTMENT on my face for face brightening?

CLONATE OINTMENT is not intended for beauty purposes. Do not use it for any indication other than prescribed. Consult your doctor for advice.

Will over-usage of CLONATE OINTMENT cause any harmful side effects?

Long term usage of CLONATE OINTMENT can cause some systemic effects such as suppression of pituitary-adrenal function, resulting in secondary adrenal insufficiency. Consult your doctor for advice.

Can I use CLONATE OINTMENT along with my regular medications if I already have a skin infection?

No. Do not use CLONATE OINTMENT without consulting your doctor if you already have a skin infection. Avoid using CLONATE OINTMENT for other infections as it may cause other serious effects.

How should I use CLONATE OINTMENT?

Always apply CLONATE OINTMENT as directed by your physician. It is for external use only. Wash your hands before and after application. Apply a thin layer of CLONATE OINTMENT on the affected area. Do not cover the affected site after applying CLONATE OINTMENT. Avoid contact of CLONATE OINTMENT with your eyes (including eyelids), ears, nose, armpits or with other mucous membranes (such as the vagina). Do not apply CLONATE OINTMENT on the damaged skin. Contact your doctor immediately if you cannot see any improvement in your condition even after using CLONATE OINTMENT for the stipulated duration.

Can CLONATE OINTMENT be used on the face?

No. CLONATE OINTMENT should not be used on the face, groin, or armpits. Consult your doctor for advice.

REFERENCES

1. Tilo Grosser, Emer Smyth and Garret A. FitzGerald. Dermatological Pharmacology. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1682.

2. KD Tripathi. Drugs Acting on Skin and Mucous Membranes. Essentials of Pharmacology. Seventh edition. 2013. Page no: 895.

3. J Clin Aesthet Dermatol. Topical Corticosteroid Therapy for Psoriasis—A Review of Clobetasol Propionate 0.025% Cream and the Clinical Relevance of Penetration Modification. NCBI. PMC US National Library of Medicine. National Institute of Health February 2020. [Accessed on 14th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7158910/

4. Stiefel, a GSK Company. Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis. NIH U.S. National Library of Medicine. ClinicalTrials.gov. [Revised in October 2012] [Accessed on 27th August 2022] https://clinicaltrials.gov/ct2/show/NCT00828464?term=clobetasol&cond=Skin+Diseases&draw=2&rank=1

5. Lupin limited. U.S. Food and Drug Administration. [Revised in May 2020] [Accessed on 14th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213691s000lbl.pdf

6. Sandoz Canada Inc health Canada. Sandoz Clobetasol (Clobetasol Propionate Solution). [Revised in December 2017] [Accessed on 14th June 2022] https://pdf.hres.ca/dpd_pm/00054412.PDF

7. Torrent Pharmaceuticals Ltd. Cortaz Foam (Clobetasol propionate Topical Foam 0.05% w/w). [Revised in July 2021] [Accessed on 27th August 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2893.pdf

8. Dailymed. Clobetasol propionate. [Revised in September 2020] [Accessed on 27th August 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2d4fa3a3-dc1c-4d3c-9959-4751e09d25be&type=display