Rosamet, cream 1% 25 g

Pharmacodynamics:

Metronidazole is a nitroimidazole derivative. It has antimicrobial and antiprotozoal activity against Gram-negative aerobic and anaerobic microorganisms and protozoa. Metronidazole is especially effective against papulopustular inflammatory elements of rosacea when applied topically. The mechanism of action seems to include an anti-inflammatory effect as well.

Pharmacokinetics:

The maximum plasma concentration of metronidazole when 1 g of Rosamet cream is applied externally to the face averages 32.9 ng/ml (range 14.8 – 54.4 ng/ml) and is reached after 6-24 hours. Maximum plasma concentration of metronidazole when administered externally does not exceed 0.5% of the average maximum plasma concentration of metronidazole after oral administration of 250 mg of metronidazole in tablet form.

In external use, the concentration of metronidazole at the site of application of the cream is significantly higher than in plasma. Binding to plasma proteins is insignificant. The lowest concentration of metronidazole is determined in adipose tissue. Excreted by the kidneys unchanged and as metabolites.

Indications

Active ingredient

Composition

1 g of the cream contains:

active ingredient: metronidazole 10.00 mg;

excipients: Glycerol, liquid paraffin, emulsifier Lanette SX [cetostearyl alcohol, sodium lauryl sulfate, purified water], propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

How to take, the dosage

Externally.

The treatment of inflamed papules, pustules, erythema in pink and vulgar acne (acne rozacea, acne vulgaris): Apply a thin layer on the skin previously cleansed with warm water or 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 15-20 minute break between cleaning the skin and applying the cream. The therapeutic effect occurs after about 3 weeks. The average duration of treatment is 3 to 4 months.

Balanopostitis, vulvovaginitis: squeeze a small amount of cream from the tube and apply to the surface of the lesions of the penis head, foreskin, labia minor, the vaginal fornix, using a cotton swab or fingers of the hand, gently rubbing, 1-2 times a day. The duration of treatment is 8-10 days.

Interaction

In the use of Rosamet cream no cases of interaction with other drugs have been reported. Interaction with systemic drugs is unlikely due to the low absorption of metronidazole when used externally.

Special Instructions

In case of signs of skin irritation due to the use of Rosamet cream, you should reduce the frequency of application, temporarily suspend or stop using the drug and consult a doctor.
Avoid getting the cream in the eyes and on the mucous membranes. If accidental contact occurs, rinse thoroughly with warm water.

At all times during treatment, avoid exposure to ultraviolet (UV) radiation (direct sunlight, tanning beds, sunlamps). Metronidazole is converted to an inactive metabolite when exposed to UV light, so its activity is significantly reduced.

Avoid excessive and prolonged use of the drug.

Metronidazole is a nitroimidazole derivative and should be used with caution in patients with a history of blood disorders.

The drug contains propylene glycol, which may cause skin irritation.

With methyl parahydroxybenzoate and propyl parahydroxybenzoate in the product, there is a risk of allergic reactions.

Impact on the ability to operate vehicles and machinery:
The drug has no effect on the ability to operate vehicles and machinery (based on the pharmacodynamic profile and clinical experience of use).

Synopsis

Contraindications

Hypersensitivity to metronidazole and other components of the drug.

Children under 18 years of age.

Side effects

Classification of adverse reactions by organ and system by frequency of occurrence:

Very common (≥1/10)

Frequent (≥1/100 to <1/10)

Infrequent (≥1/1,000 to <1/100)

Rarely (≥1/10,000 to <1/1,000)

p> Very rare (<1/10,000), including individual reports

Frequency unknown (frequency cannot be estimated from available data).

Skin and subcutaneous tissue disorders

Often: dry skin, erythema, itching, skin discomfort (burning sensation of skin, sore skin/tingling), skin irritation, increased manifestations of rosacea.

Frequency unknown: contact dermatitis, skin flaking, facial swelling.

Nervous system disorders

Infrequent: hypoesthesia, paresthesia, dysgeusia (“metallic” taste in the mouth).

Gastrointestinal tract disorders

Infrequent: nausea.

If any of the side effects listed in the instructions worsen, or if any other side effects not listed in the instructions are noted, you should tell your doctor immediately.

Overdose

Pregnancy use

Pregnancy
There are no data on clinical experience with external use of metronidazole in pregnant women. When administered orally, metronidazole penetrates the placental barrier and rapidly enters the fetal bloodstream. After oral administration of metronidazole to rats or mice, no evidence of fetal toxicity was observed. However, because reproductive toxicity studies in animals do not always predict response in humans, and because carcinogenic properties have been demonstrated with oral administration of metronidazole to rodents, the drug should only be used in pregnancy if the anticipated benefit to the mother exceeds the potential risk to the fetus after consultation with a physician. If you are pregnant, or think you may have been pregnant, or are planning to become pregnant, you should consult your doctor.

Breastfeeding period

After oral administration, metronidazole penetrates into breast milk in concentrations similar to those found in plasma. Although plasma concentrations of metronidazole are significantly lower in breastfeeding women after external administration compared to oral administration, the decision to stop breastfeeding or to discontinue use of the drug should be based on an assessment of the benefit to the mother and the risk to the baby after consultation with a physician.

Similarities