Garamycin 0.1% Cream 15 g

Garamycin 0.1% Cream 15 g

Composition:

Each 1 gram of cream contains:
Active ingredient:
Gentamicin (as sulfate) 1 mg (0.1%).
Excipients:
Chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white petrolatum, liquid paraffin, sodium dihydrogen phosphate.

Description:

A broad-spectrum antibacterial cream for topical use.
Contains the aminoglycoside antibiotic gentamicin.
Effective against many gram-positive and gram-negative bacteria causing primary and secondary skin infections.
Helps clear infected areas, including cases resistant to other topical antibiotics.

Indications for Use:

• Primary bacterial skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, pyoderma.
• Secondary bacterial infections complicating dermatoses: Infected eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, bacterial superinfections of fungal or viral infections.
• Other conditions: Infected wounds, abrasions, lacerations, minor burns, insect bites/stings; infected stasis and other skin ulcers, paronychia; adjunct after incision and drainage of infected skin cysts and abscesses.

Dosage and Administration:

• Topical use only. Apply a small amount of cream to the affected area 3 to 4 times daily.
• The treated area may be covered with a gauze dressing if desired.
• For impetigo, crusts should be removed before application to ensure maximum contact between the antibiotic and the infection.
• Can be used in adults and children over 1 year of age.

Contraindications:

Hypersensitivity to gentamicin, other aminoglycosides, or any component of the cream.

Precautions:

• For cutaneous use only. Avoid contact with eyes, mucous membranes, and the ear canal.
• Development of resistance. Prolonged use may result in overgrowth of nonsusceptible organisms (bacteria, fungi). If superinfection occurs, discontinue treatment.
• Irritation and sensitization. Rarely, local irritation, pruritus, erythema, or photosensitization may occur. Discontinue if significant local reactions or signs of allergy develop.
• Special groups. Use with caution in patients with extensive skin lesions, renal impairment (risk of systemic absorption), and in patients with a history of sensitivity to other topical antibiotics (e.g., neomycin), although cross-sensitivity is uncommon.

Side Effects:

• Local reactions: Uncommon: skin irritation, erythema, pruritus, burning, dryness, peeling at the application site.
• Allergic reactions: Rare: contact dermatitis, rash, urticaria, photosensitivity.
• Other: When applied to large damaged skin areas (burns, ulcers), systemic absorption with a risk of ototoxicity and nephrotoxicity is possible (extremely rare with topical use).

Pregnancy and Lactation:

Pregnancy:
Use only if the potential benefit justifies the potential risk to the fetus.
Avoid application over extensive areas.
Lactation:
Data on the passage of gentamicin into breast milk after topical application are insufficient.
Use with caution, avoiding application to the breast area.

Storage Conditions:

Store at a temperature not exceeding 30°C. 
Keep out of reach of children.

Packaging:

Carton box containing a tube 15 g of cream, and a package leaflet.