Metronidazole gel for external use 1% tube, 30g

Composition

Active ingredient: metronidazole – 1,0 g.

Excipients: propylene glycol-5.0 g, carbomer-1.0 g, sodium hydroxide-0.127 g, disodium edetate-0.05 g, propyl parahydroxybenzoate-0.04 g, methyl parahydroxybenzoate-0.032 g, purified water-up to 100.0 g

Pharmacological action

Metronidazole is a derivative of nitroimidazole. It has antimicrobial and antiprotozoal activity against gram-negative aerobic and anaerobic microorganisms and protozoa. Metronidazole when applied externally is particularly effective against papulo-pustular inflammatory elements of rosacea. The mechanism of action also seems to include an anti-inflammatory effect.

Pharmacokinetics

The maximum concentration of metronidazole in blood plasma with external application of 1 g of gel on the face is on average 32.9 ng / ml (range 14.8-54.4 ng / ml) and is reached in 6-24 hours. The maximum concentration of metronidazole in blood plasma with external use does not exceed 0.5% of the average maximum concentration of metronidazole in blood plasma after oral use of 250 mg of metronidazole in tablet form. When applied externally, the concentration of metronidazole at the site of gel application is significantly higher than in the blood plasma. The association with plasma proteins is insignificant. The lowest concentration of metronidazole is found in adipose tissue. It is excreted by the kidneys unchanged and in the form of metabolites.

Indications

Treatment of rosacea.

Use during pregnancy and lactation

Pregnancy. There are no data on clinical experience with external use of metronidazole in pregnant women. When taken orally, metronidazole penetrates the placental barrier and quickly enters the fetal bloodstream. After oral use of metronidazole to rats and mice, no signs of fetal toxicity were observed. However, since studies of reproductive toxicity in animals do not always predict a response in humans, and since oral use of metronidazole to rodents has demonstrated its carcinogenic properties, Metronidazole gel during pregnancy is used only if the intended benefit to the mother exceeds the potential risk to the fetus after consulting a doctor. If you are pregnant, or think that you might be pregnant, or are planning to become pregnant, you should consult your doctor.

Breast-feeding period. After oral use, metronidazole passes into breast milk at concentrations similar to those found in blood plasma. Despite the fact that after external use of metronidazole in breast-feeding women, its plasma concentration is significantly lower than after oral use, the decision to stop breastfeeding or discontinue the drug should be made taking into account the assessment of the importance of the drug for the mother and the risk to the child after consulting a doctor.

Contraindications

Hypersensitivity to metronidazole and other components of the drug. Children under 18 years of age.

Side effects

Classification of adverse reactions to the body and systems, indicating the frequency of their occurrence: very common (≥ 1/10), common (≥ 1/100, < 1/10), infrequent (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (

Skin and subcutaneous tissue disorders

Often: dry skin, erythema, pruritus, skin discomfort (burning sensation of the skin, skin soreness/tingling), skin irritation, increased manifestation of rosacea.

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

Nervous system disorders

Infrequently: hypesthesia, paresthesia, dysgeusia (“metallic” taste in the mouth).

Disorders of the gastrointestinal tract

Infrequently: nausea.

If you experience any of the side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

When using the gel, no cases of interaction with other drugs were reported. Interaction with systemic drugs is unlikely due to the low absorption of metronidazole with external use.

However, a disulfiram-like reaction is observed in a small number of patients with simultaneous oral use of metronidazole and ethanol.

Caution should be exercised when concomitant use of metronidazole with warfarin or other indirect anticoagulants due to the possible increase in prothrombin time applies only to metronidazole when taken orally.

If you are using the above or other medications (including over-the-counter medications), please consult your doctor before using Metronidazole gel.

How to take, course of use and dosage

For external use only.

For adults. The gel is applied in a thin layer on pre-cleansed affected areas of the skin 2 times a day, morning and evening, avoiding contact with the eyes, lips and nasal mucosa. Before applying the gel, the affected area of the skin should be washed with warm water or a mild detergent that does not cause skin irritation. After applying the gel, it is possible to use cosmetics that do not have comedogenic and astringent properties.

The average duration of treatment is 3-4 months. However, if there are clear signs of the effectiveness of therapy, the attending physician may consider continuing treatment for an additional 3-4 months, depending on the severity of the patient’s condition. If there is no clear clinical improvement, treatment should be discontinued.

Elderly patients do not need to adjust the dose.

Metronidazole gel is not recommended for use in children under 18 years of age due to the lack of data on the safety and efficacy of metronidazole in patients of this age category.

If there is no improvement after treatment or new symptoms appear, you should consult your doctor. Use the drug only according to the method of application and in the doses indicated in the instructions for use.

Overdose

To date, there have been no reports of overdose with external use of the drug. When using the drug in accordance with the instructions for use, overdose is unlikely.

Description

Transparent or almost transparent, colorless or slightly yellowish tint gel.

Special instructions

Avoid contact with the gel in the eyes and on the mucous membranes. In case of accidental contact, wash them thoroughly with warm water.

If there are signs of skin irritation due to the use of the drug, you should reduce the frequency of its application, temporarily suspend or stop using the drug, and consult a doctor.

During treatment, you should avoid exposure to ultraviolet (UV) radiation (direct sunlight, tanning beds, sun lamps). Under the influence of UV radiation, metronidazole becomes an inactive metabolite, so its activity is significantly reduced.

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

Avoid excessive and prolonged use of the drug.

The product contains propylene glycol, which can cause skin irritation.

Given that the drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, there is a risk of allergic reactions.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and mechanisms (based on the pharmacodynamic profile and clinical experience of use).

Form of production

Gel for external use 1% of 10.0 g; 15.0 g; 25.0 g; 30.0 g or 40.0 g in aluminum tubes with bouchons with internal lacquer coating. Each tube together with the instructions for medical use is placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Metronidazole

Dosage form

gel for external use