Cream Presentation

Each Tube Contains:

Ofloxacin IP	0.5%W/W
Fluocinolone Acetonide IP	0.01%W/W
Clotrimazole IP	1.0%W/W
Chlorocresol IP (As Preservative)	0.1%W/W

Clotrimazole is an antifungal with broad-spectrum and is structurally derived from imidazole and triazole. Fluocinolone acetonide is a corticosteroid that presents a high lipophilicity. It has been used extensively in dermatological preparations to provide relief of inflammatory dermatosis, dermatitis, psoriasis, hypertrophic tissues, keloid tissues and atopic dermatitis.. Ofloxacin is an antibiotic of fluoroquinolone family of medications useful for the treatment of a number of bacterial infections. Ofloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria.

Indications:

• Atopic Dermatitis
• Psoriasis of the scalp
• Dermatosis
• Fungal and bacterial infection of the dermal
• Candidiasis

Mechanism of Action:

Ofloxacin: DNA replication requires DNA gyrase and topoisomerase IV. DNA gyrase allows the untwisting required to replicate one DNA double helix into two. Topoisomerase IV provides stability to the unwind DNA during replication. Ofloxacin inhibits these two and inhibit DNA replication thereby inhibits normal cell division.
Fluocinolone acetonide is a synthetic anti-inflammatory corticosteroid. It can be inferred that it acts by inhibiting the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition, and scar formation. Fluocinolone acetonide presents a high binding affinity for the glucocorticoid receptor. After binding the receptor, the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements in the promoter region of the target genes.
Clotrimazole inhibits fungus growth by inhibiting the division. It alters the permeability of the fungal cell wall by inhibiting the biosynthesis of ergosterol and other sterols required for cell membrane production that eventually leads to cell death. It also inhibits the activity of enzymes within the cell.

Side Effects:

The product is possible safe for most adults. There is no disadvantage associated with the product if taken under the recommended usage however irritation, sensitivity, burning, acne and excessive drying can occur in some patients.

Interactions:

• Fluocinolone may interact with corticosteroids taken by mouth (e.g., prednisone), other corticosteroids applied to the skin (e.g., hydrocortisone), drugs that lower the immune system (e.g., cyclosporine)
• Some products that may interact with ofloxacin which include: "blood thinners" (such as acenocoumarol, warfarin), strontium. Many drugs besides ofloxacin may affect the heart rhythm (QT prolongation), including dofetilide, procainamide, amiodarone, quinidine, sotalol, among others

Contraindications:

You should not use this medicine if you are allergic to mupirocin Renal impairment Do not use mupirocin topical on a child without medical advice. The cream should not be used on a child younger than 3 months old Not be used in pregnancy and breast feeding.

Precautions & Warnings:

• Avoid contact with your eyes, nose, mouth or any areas of broken skin
• Do not exceed the prescribed amount by your physician

How to use:

• Apply this cream on the infected portion after cleaning thoroughly
• Do not exceed the prescribed amount by your physician

Storage:

Store below 25°C and do not freeze.Keep out of reach of children.