Ofiderm

Description

OFIDERM contains Ofloxacin 0.75%, Ornidazole 2.00%, Itraconazole 1.00% and Clobetasol Propionate 0.05%, with Methylparaben 0.20% and Phenoxyethanol 0.02% as preservatives, in topical cream form. This combination brings together antibacterial, antiprotozoal/anaerobic antimicrobial, antifungal and corticosteroid components. It may be prescribed for selected mixed or complicated skin conditions involving infection and inflammation when all components are clinically appropriate.

For related dermatology and pharmaceutical formulations, explore the Medhexa Pharma Products range.

Therapeutic Segment

Dermatology | Antifungal Therapy | Topical Antibacterial Therapy | Anti-inflammatory Therapy | Mixed Skin Infections

Uses of OFIDERM

OFIDERM may be prescribed for selected skin conditions where a healthcare professional determines that combined antimicrobial and anti-inflammatory treatment is appropriate.

Depending on the diagnosis, it may be considered for:

• Selected superficial bacterial skin infections
• Certain fungal skin conditions accompanied by significant inflammation
• Mixed or complicated superficial skin infections where susceptible microorganisms are involved
• Inflammatory skin conditions with a clinically identified infectious component
• Selected infected dermatoses requiring combination topical therapy

The exact indication depends on the diagnosis and the microorganisms involved. A combination containing a potent topical corticosteroid should not be used routinely for every rash, itching or suspected fungal infection.

Because Clobetasol Propionate 0.05% is a super-high-potency topical corticosteroid, OFIDERM should be used only for an appropriate diagnosis and for the duration prescribed by a healthcare professional.

Key Benefits of OFIDERM

• Antibacterial Support: Ofloxacin helps target susceptible bacteria responsible for certain skin infections.
• Antimicrobial Activity: Ornidazole provides activity against susceptible anaerobic microorganisms and certain protozoal organisms.
• Antifungal Support: Itraconazole is an azole antifungal that interferes with fungal cell membrane formation.
• Inflammation Control: Clobetasol Propionate helps reduce inflammation, redness and itching associated with corticosteroid-responsive skin conditions.
• Combination Formulation: Brings together antimicrobial and anti-inflammatory components in one topical preparation.
• Convenient Topical Cream: Allows localized application to affected skin as directed.
• 15 GM Pack: Convenient topical formulation for prescribed dermatological use.

How OFIDERM Works

Each active ingredient contributes through a different mechanism.

Ofloxacin is a fluoroquinolone antibacterial agent. It interferes with bacterial DNA replication by inhibiting bacterial enzymes involved in DNA synthesis. This action helps control susceptible bacterial growth.

Ornidazole belongs to the nitroimidazole class. In susceptible anaerobic microorganisms, it undergoes reduction and produces reactive intermediates that damage microbial DNA.

Itraconazole is a triazole antifungal agent. It inhibits fungal enzymes involved in ergosterol synthesis. Ergosterol is an important component of fungal cell membranes, so reducing its production interferes with fungal growth.

Clobetasol Propionate is a highly potent topical corticosteroid. It reduces inflammatory activity in the skin and helps relieve redness, swelling and itching associated with corticosteroid-responsive dermatoses.

Methylparaben and Phenoxyethanol are included as preservatives to help maintain the stability and microbiological quality of the topical formulation.

Common Side Effects of OFIDERM

Some people may experience local skin reactions after applying the cream. Possible effects include:

• Burning or stinging
• Itching
• Redness
• Skin irritation
• Dryness
• Peeling
• Folliculitis
• Changes in skin colour
• Increased sensitivity at the application site

Because OFIDERM contains Clobetasol Propionate 0.05%, prolonged, excessive or inappropriate use can increase the risk of corticosteroid-related effects such as skin thinning, stretch marks, visible small blood vessels, secondary infection and, with significant absorption, systemic corticosteroid effects.

Stop using the product and seek medical advice if you develop severe irritation, swelling, blistering, worsening infection or other significant skin reactions.

Important Safety Information

Use OFIDERM only according to the instructions of a qualified healthcare professional.

• OFIDERM is intended for external topical use only.
• Avoid contact with the eyes, mouth and other mucosal surfaces.
• Do not swallow the cream.
• Do not apply to the face, groin, underarms or other sensitive areas unless specifically prescribed.
• Do not use the cream on large areas of the body unless directed by a healthcare professional.
• Avoid covering treated areas with airtight or occlusive dressings unless specifically advised.
• Clobetasol Propionate 0.05% is a super-high-potency corticosteroid. Prolonged or inappropriate use can cause skin atrophy and systemic corticosteroid effects.
• Do not use OFIDERM simply for unexplained itching or an undiagnosed rash.
• The corticosteroid component can reduce visible inflammation while potentially masking or worsening an underlying infection.
• Do not continue treatment longer than prescribed.
• Do not use together with another topical corticosteroid unless specifically advised.
• Tell your healthcare professional about any existing skin infection, recurrent fungal infection or other dermatological condition.
• Avoid unnecessary use of topical antibiotics and antifungals because inappropriate antimicrobial exposure can contribute to resistance.
• Children may be more susceptible to systemic effects from potent topical corticosteroids. Pediatric use should follow specific medical advice.
• Tell your healthcare professional if you are pregnant, planning pregnancy or breastfeeding before using the product.
• Stop treatment and seek medical attention if you develop severe irritation, facial swelling, difficulty breathing or other signs of an allergic reaction.
• If the condition becomes worse or fails to improve, seek medical reassessment rather than continuing the cream indefinitely.

For detailed safety information regarding the corticosteroid component, refer to the DailyMed information on Clobetasol Propionate Cream.

Dosage & Administration

Apply OFIDERM exactly as prescribed by your healthcare professional.

Because this product contains several active ingredients, the application frequency and duration should follow the approved product directions or individual prescription rather than being inferred from any one ingredient.

General application guidance:

1. Clean and gently dry the affected skin.
2. Apply a thin layer of OFIDERM to the affected area.
3. Rub in gently unless otherwise instructed.
4. Wash your hands before and after application unless the hands are being treated.
5. Avoid contact with the eyes, lips and mucosal surfaces.
6. Do not cover the treated area with an occlusive dressing unless directed.
7. Use the cream only for the prescribed duration.

Because clobetasol is highly potent, treatment should generally remain short and limited to the affected area. Reference labeling for clobetasol 0.05% limits treatment to short courses and emphasizes reassessment when improvement does not occur.

Do not apply more frequently or in larger quantities than prescribed.

Storage

• Store OFIDERM in a cool, dry place.
• Protect the cream from excessive heat and direct sunlight.
• Keep the tube tightly closed when not in use.
• Store in the original packaging.
• Do not freeze the product.
• Keep out of reach of children.
• Do not use after the expiry date printed on the pack.