Rosamet, 1%, 25 g

Jadran-Galenski Laboratories a.s., Croatia

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Product Overview

Composition

Active substance:

metronidazole - 10 mg.

Excipients:

glycerin - 12.9 mg,

liquid paraffin - 90 mg,

emulsifying wax - 100 mg,

propylene glycol - 20 mg,

methyl parahydroxybenzoate - 0.7 mg,

propyl parahydroxybenzoate - 0.3 mg,

purified water - 766.1 mg.

pharmachologic effect

Pharmacodynamics

When applied topically, it has an anti-acne effect, the mechanism of which is not exactly known (it is not associated with the effect on the Demodex folliculorum mite, found in hair follicles and the secretion of the sebaceous glands, and any effect on the production of this secret).

Metronidazole for external use may have antioxidant activity.

It has been found that it significantly reduces the production of active oxygen, hydroxyl radicals and hydrogen peroxide by neutrophils, which are potential oxidants that can cause tissue damage at the site of inflammation.

Metronidazole for external use is ineffective against telangiectasias seen with rosacea.

Pharmacokinetics

When applied topically, the drug is practically not absorbed.

Indications

  • Treatment of inflamed papules and pustules;
  • erythema with rosacea and acne vulgaris (acne rozacea, acne vulgaris);
  • balanoposthitis;
  • vulvovaginitis.

Application during pregnancy and lactation

Use with caution during pregnancy (I trimester) and during lactation.

Contraindications

  • Hypersensitivity.

With care: pregnancy (I trimester); lactation period.

Side effects

Side effects after external use of metronidazole are extremely rare.

Allergic reactions: possible - urticaria, skin rash, hyperemia, peeling and burning of the skin, lacrimation.

Interaction

After external use, the concentration of metronidazole is very low and the possibility of interaction is minimal.

When administered simultaneously, it enhances the effect of warfarin and other indirect anticoagulants.

How to take, course of administration and dosage

Treatment of inflamed papules, pustules, erythema with rosacea and acne vulgaris (acne rozacea, acne vulgaris)

Apply a thin layer to the skin previously cleaned with warm water or a light detergent and rub in 1-2 times a day, morning and evening. The course of treatment is 1-2 months. It is recommended to take a break of 15-20 minutes between cleansing the skin and applying the cream. The therapeutic effect occurs in about 3 weeks. The average duration of treatment is 3-4 months.

Balanoposthitis, vulvovaginitis (for convenience, it is recommended to use the applicator for intravaginal use)

After squeezing out a small amount of cream from the tube, apply to the surface of the lesions of the glans penis, foreskin, labia minora, the vestibule of the vagina, using a cotton swab or fingers, gently rubbing, or using an applicator (intravaginally), using 1-2 once a day. The duration of treatment is 8-10 days.

Special instructions

The drug is intended for external use only.

Avoid contact with eyes as this can cause eye inflammation and watery eyes. In case of contact with eyes, rinse with plenty of water.

In case of skin inflammation, the frequency of use of the drug should be reduced or temporarily discontinued.

Avoid direct sunlight while using the drug.

Release form

Cream for external use

Storage conditions

At a temperature not exceeding 25 ° C

Shelf life

2 years

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