INTRODUCTION
TOPSOR SOLUTION 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.
TOPSOR SOLUTION is not recommended for use in patients with other bacterial, fungal, or viral infections (such as herpes simplex, chicken pox and tuberculosis). Before using TOPSOR SOLUTION, 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.
TOPSOR SOLUTION should be used during pregnancy only if recommended by your doctor. TOPSOR SOLUTION should be used with caution by breastfeeding women. TOPSOR SOLUTION is not recommended for use by children under 12 years of age. The most common side effects of using TOPSOR SOLUTION 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 TOPSOR SOLUTION
Treats inflammatory condition of the skin such as psoriasis, eczema, dermatitis, etc
HOW TOPSOR SOLUTION WORKS
TOPSOR SOLUTION 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 TOPSOR SOLUTION as directed by your physician. It is for external use only. Wash your hands before and after application. Apply a thin layer of TOPSOR SOLUTION on the affected area. Do not cover the affected site after applying TOPSOR SOLUTION.
Avoid contact of TOPSOR SOLUTION with your eyes (including eyelids), ears, nose, armpits or with other mucous membranes (such as the vagina). Do not apply TOPSOR SOLUTION to the damaged skin.
SIDE EFFECTS OF TOPSOR SOLUTION
COMMON
Irritation and burning at the infected site
Thinning of the skin
Widened small veins in the skin
Skin discomfort, dryness
UNCOMMON
Wounds that take time to heal
RARE
Stop using TOPSOR SOLUTION and contact your doctor immediately if you experience any of the following:
Reduced adrenal function (tiredness, nausea, vomiting, lack of energy, low blood pressure, weakness, heart attack)
Cushing’s syndrome (weight gain, thin arms, legs, belly fat)
Hyperglycaemia (high blood sugar)
Vision problems like cataract (cloudy lens) and glaucoma (high pressure in the eye)
Skin reactions at the infected area
Growth impairment in children
Dizziness
Worsening of psoriasis (red, scaly, thick patches on the skin)
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
PREGNANCY
TOPSOR SOLUTION should be used during pregnancy only if recommended by your doctor. Consult your doctor before using TOPSOR SOLUTION.
BREASTFEEDING
TOPSOR SOLUTION should be used with caution by breastfeeding women. Consult your doctor before using TOPSOR SOLUTION.
DRIVING AND USING MACHINES
TOPSOR SOLUTION is not expected to have any effects on your ability to drive and use machines.
LIVER
TOPSOR SOLUTION should be used with caution in patients with liver disease. Consult your doctor before using TOPSOR SOLUTION.
ALLERGY
Do not use TOPSOR SOLUTION if you are allergic to Clobetasol or any of the other ingredients in this medicine.
LUNGS
TOPSOR SOLUTION should not be used in patients with untreated tuberculosis. Consult your doctor before using TOPSOR SOLUTION.
OTHERS
TOPSOR SOLUTION is not recommended for use if you:
Have other bacterial, or viral infections (Ex. herpes simplex, chicken pox, cold sores)
Have fungal infections (Ex. ringworm, athletes’ foot or thrush)
Have a weak immune response
Have acne rosacea or acne vulgaris
Are about to have any surgery
Have plaques around your mouth, underarms, back passage, or genitals
Before using TOPSOR SOLUTION inform your doctor if you:
Have a skin infection
Have diabetes
Have adrenal gland problems
Have acne
Have a history of irritation or other skin reactions to a steroid medicine
Use in pediatrics:
TOPSOR SOLUTION is not recommended for use in children (under 12 years of age). Consult your child’s doctor for advice.
Use in geriatrics:
TOPSOR SOLUTION should be used with caution in elderly patients (aged above 65 years). Consult your doctor before using TOPSOR SOLUTION.
INTERACTIONS
A. Drug-Drug interactions:
Before using TOPSOR SOLUTION, 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 TOPSOR SOLUTION, 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
Drug :
Clobetasol
Pharmacological Category :
Topical corticosteroid
Therapeutic Indication :
Inflammatory condition of the skin like psoriasis, eczema, dermatitis, etc
Dosage Forms :
Ointment, Lotion, Cream, Gel, Foam, Topical solution, Shampoo
MORE INFORMATION
Keep TOPSOR SOLUTION out of reach from children
Store at room temperature
FAQs ABOUT TOPSOR SOLUTION
What is TOPSOR SOLUTION used for?
TOPSOR SOLUTION 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 TOPSOR SOLUTION for wounds?
TOPSOR SOLUTION 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 TOPSOR SOLUTION for kids?
TOPSOR SOLUTION 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 TOPSOR SOLUTION be used for vitiligo?
TOPSOR SOLUTION 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 TOPSOR SOLUTION on my face for face brightening?
TOPSOR SOLUTION 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 TOPSOR SOLUTION cause any harmful side effects?
Long term usage of TOPSOR SOLUTION 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 TOPSOR SOLUTION along with my regular medications if I already have a skin infection?
No. Do not use TOPSOR SOLUTION without consulting your doctor if you already have a skin infection. Avoid using TOPSOR SOLUTION for other infections as it may cause other serious effects.
How should I use TOPSOR SOLUTION?
Always apply TOPSOR SOLUTION as directed by your physician. It is for external use only. Wash your hands before and after application. Apply a thin layer of TOPSOR SOLUTION on the affected area. Do not cover the affected site after applying TOPSOR SOLUTION. Avoid contact of TOPSOR SOLUTION with your eyes (including eyelids), ears, nose, armpits or with other mucous membranes (such as the vagina). Do not apply TOPSOR SOLUTION on the damaged skin. Contact your doctor immediately if you cannot see any improvement in your condition even after using TOPSOR SOLUTION for the stipulated duration.
Can TOPSOR SOLUTION be used on the face?
No. TOPSOR SOLUTION 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
Net Qty
1 N
Item Weight
40 g
Ingredient
CLOBETASOL PROPIONATE 0.05%W/W
Hsn Code
30043200
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