INTRODUCTION

PRAISVATE CREAM 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.

PRAISVATE CREAM is not recommended for use in patients with other bacterial, fungal, or viral infections (such as herpes simplex, chicken pox and tuberculosis). Before using PRAISVATE CREAM, 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.

PRAISVATE CREAM should be used during pregnancy only if recommended by your doctor. PRAISVATE CREAM should be used with caution by breastfeeding women. PRAISVATE CREAM is not recommended for use by children under 12 years of age. The most common side effects of using PRAISVATE CREAM 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 PRAISVATE CREAM

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

HOW PRAISVATE CREAM WORKS

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

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

SIDE EFFECTS OF PRAISVATE CREAM

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 PRAISVATE CREAM, 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 PRAISVATE CREAM, 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 PRAISVATE CREAM out of reach from children
• Store at room temperature

FAQs ABOUT PRAISVATE CREAM

What is PRAISVATE CREAM used for?

PRAISVATE CREAM 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 PRAISVATE CREAM for wounds?

PRAISVATE CREAM 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 PRAISVATE CREAM for kids?

PRAISVATE CREAM 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 PRAISVATE CREAM be used for vitiligo?

PRAISVATE CREAM 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 PRAISVATE CREAM on my face for face brightening?

PRAISVATE CREAM 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 PRAISVATE CREAM cause any harmful side effects?

Long term usage of PRAISVATE CREAM 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 PRAISVATE CREAM along with my regular medications if I already have a skin infection?

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

How should I use PRAISVATE CREAM?

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

Can PRAISVATE CREAM be used on the face?

No. PRAISVATE CREAM 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