INTRODUCTION

FM DERMA OINTMENT is a combination of Fluticasone and Mupirocin which belongs to the group of medicines called Corticosteroids and Antibiotics respectively. It is used to treat and manage steroid-responsive inflammatory disorders of the skin where secondary bacterial infections are present, suspected, or likely to occur.

These include atopic dermatitis, nummular dermatitis (discoid eczemas), irritant or allergic contact dermatitis, seborrhoeic dermatitis, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis), lichen simplex chronicus (neurodermatitis) and lichen planus, discoid lupus erythematosus, insect bite reactions, and miliaria (prickly heat).

Dermatitis is a common skin irritation which has many causes and forms and usually involves itchy, dry skin or a rash, blistering, oozing, crust or flake off. Psoriasis is a long-term skin disease that causes a rash with itchy, scaly patches, most commonly on the knees, elbows, trunk, and scalp which can be painful, interfere with sleep and make it hard for you to focus.

During course of the treatment your doctor might regularly examine your skin to avoid any untoward side effects.

FM DERMA OINTMENT is not recommended for long-term continuous use in infants, children and adolescents under 12 years of age.

Before using FM DERMA OINTMENT inform your doctor if you have skin conditions such as rosacea, acne vulgaris, perioral dermatitis, pruritus without inflammation, perianal and genital pruritus, primary or secondary viral, yeast, fungal and bacterial infections, or dermatoses in infants under 3 months of age.

FM DERMA OINTMENT should be used in pregnant and breastfeeding women only if specifically directed by your doctor.

The most common side effects of using FM DERMA OINTMENT are burning, or itching. Contact your doctor if any of the side effects worsen.

USES OF FM DERMA OINTMENT

It is used to treat and manage:

• atopic, nummular, irritant or allergic contact, and seborrhoeic dermatitis
• prurigo nodularis
• psoriasis
• lichen simplex chronicus and lichen planus
• discoid lupus erythematosus
• insect bite reactions
• miliaria

HOW FM DERMA OINTMENT WORKS

FM DERMA OINTMENT relieves skin infection and inflammation where fluticasone exerts a direct local effect of blood vessel constriction and anti-inflammatory action by decreasing inflammatory cells like eosinophils, monocytes, mast cells, macrophages, and dendritic cells, along with the number of cytokines they produce, and decreasing mucus gland secretions. Mupirocin mediates its antibacterial activity by blocking the bacterial protein synthesis and formation of bacterial proteins essential for survival.

DIRECTIONS FOR USE

Apply FM DERMA OINTMENT as advised by your physician. It is for external use only. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF FM DERMA OINTMENT

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before using FM DERMA OINTMENT inform your doctor if you are taking any of the following medicines:

• ritonavir (used to treat HIV infection)
• itraconazole (used to treat fungal infection)

Overdosage:

If you or anyone else accidentally uses too much of FM DERMA OINTMENT, contact your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep FM DERMA OINTMENT out of reach of children
• Do not store above 25°C

FAQs ABOUT FM DERMA OINTMENT

Can I stop using FM DERMA OINTMENT?

Do not stop using FM DERMA OINTMENT unless your doctor advises you to stop. Treatment with topical corticosteroids should be gradually withdrawn once control is achieved as rebound of pre-existing skin disease can occur with abrupt discontinuation.

Can I use FM DERMA OINTMENT for acne?

Do not use FM DERMA OINTMENT for conditions other than that prescribed for, and it is not recommended for use in acne vulgaris. Consult your doctor before using it.

Can I apply FM DERMA OINTMENT on the face?

Long-term application of FM DERMA OINTMENT on the face is not recommended, as this area is more susceptible to atrophic changes. Consult your doctor before using it.

Can FM DERMA OINTMENT be used for psoriasis?

FM DERMA OINTMENT should be used with caution in psoriasis as rebound, tolerance, risk of generalized pustular psoriasis and local or systemic toxicity due to impaired barrier function of the skin can occur. Careful patient supervision is important when used in psoriasis. Consult your doctor before using it.

What if FM DERMA OINTMENT accidentally gets into my eye?

Avoid contact of FM DERMA OINTMENT with the eyes to ensure it does not enter the eye as cataract and glaucoma might result from repeated exposure. If contaminated, wash your eyes thoroughly with water until the medicine residues have been removed. Consult your doctor if you feel any eye discomfort.

REFERENCES

1. Kailey Remien, Andy Bowman. Fluticasone. StatPearls. StatPearls Publishing. November 2021. [Accessed on 31st May 2022] https://www.ncbi.nlm.nih.gov/books/NBK542161/#article-37573.s3

2. M A Parenti, S M Hatfield, J J Leyden. Mupirocin: a topical antibiotic with a unique structure and mechanism of action. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. October 1987. [Accessed on 31st May 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Mupirocin#section=Pharmacology

3. GlaxoSmithKline Pharmaceuticals Limited. Fluticasone Propionate and Mupirocin Ointment. [Revised in October 2021] [Accessed on 31st May 2022] https://india-pharma.gsk.com/media/6377/flutibact-skin-ointment.pdf

4. Fluticasone Propionate and Mupirocin. Canbro Healthcare. [Accessed on 31st May 2022] https://www.canbro.in/product/fluticasone-propionate0-005-mupirocin-2-in-a-cream-base

5. Mayo Clinic. Dermatitis. [Accessed on 31st May 2022] https://www.mayoclinic.org/diseases-conditions/dermatitis-eczema/symptoms-causes/syc-20352380

6. Mayoclinic. Psoriasis. [Accessed on 31st May 2022] https://www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840#:~:text=Psoriasis%20is%20a%20skin%20disease,make%20it%20hard%20to%20concentrate