Makmiragil COMPLEX (Cream) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

G01AA51 (Nystatin in combination with other drugs)

Active Substances

Nystatin (Rec.INN registered by WHO)

Nifuratel (Rec.INN registered by WHO)

Dosage Form

Makmiragil COMPLEX

Vaginal cream 40000 IU+0.1 g/1 g: tubes 10 g, 15 g, 20 g, 25 g, 30 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g or 100 g

Dosage Form, Packaging, and Composition

Vaginal cream liquid, homogeneous, yellow in color.

Excipients: xalyphin 15 – 10 g, methylparahydroxybenzoate – 0.11 g, propylparahydroxybenzoate – 0.04 g, glycerol (glycerin) – 5 g, sorbitol solution 70% – 10 g, propylene glycol – 5 g, carbomer – 0.4 g, triethanolamine 30% – 1.5 g, purified water – up to 100 g.

10 g – tubes (1) – cardboard packs.
15 g – tubes (1) – cardboard packs.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
90 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial and antifungal action for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, excluding combinations with corticosteroids; antibiotics

Pharmacological Action

Antimicrobial agent for topical use. It has antiprotozoal, antifungal and antibacterial action.

Nifuratel – a derivative of nitrofuran – is highly active against a number of bacteria, fungi and protozoa (including Trichomonas vaginalis).

Nystatin – an antifungal antibiotic of the polyene group. By binding to sterols in the fungal cell membrane, it disrupts its permeability, which leads to cell death. It is highly active against Candida albicans.

The combination of nifuratel and nystatin allows for a more pronounced antifungal effect and significantly expands the spectrum of antimicrobial action.

The high efficacy and low toxicity of the drug components determine the wide spectrum of its clinical application in the treatment of vaginitis of mixed etiology, in particular, use for the prevention of mycoses caused by specific treatment of trichomoniasis.

It does not disrupt the physiological flora, which allows to avoid the development of dysbiosis and quickly restore vaginal normocenosis.

Pharmacokinetics

The concentration of nifuratel in blood plasma is below the limit of quantitative determination. C_max 4.54 ng/ml; T_max 8.0 h; AUC 10.27 ng×ml^-1 h.

Nystatin is not absorbed through the skin and mucous membranes when applied topically.

Indications

Vulvovaginal infections caused by pathogens sensitive to the drug: including bacterial vaginitis, vaginal trichomoniasis; vaginitis caused by fungi of the genus Candida, mixed vaginitis.

ICD codes

Dosage Regimen

Administer intravaginally once daily, preferably at bedtime.

Apply a single dose of approximately 5 grams of cream, using the supplied applicator.

Continue treatment for 8 consecutive days, even if symptoms improve earlier.

If symptoms persist, repeat the course after the next menstrual period, following medical consultation.

Thoroughly wash hands before and after each application to prevent contamination and spread of infection.

Ensure the sexual partner receives concurrent treatment to avoid risk of re-infection.

Abstain from sexual intercourse for the duration of the therapy.

Do not use tampons or douches during the treatment period.

If a dose is missed, apply as soon as remembered, unless it is almost time for the next dose; in that case, continue with the regular schedule.

Do not double the dose to make up for a forgotten application.

Complete the full prescribed course to ensure eradication of the infection and prevent recurrence.

Adverse Reactions

Possibleallergic reactions in the form of skin rash or itching. If allergic reactions occur, use should be discontinued.

Contraindications

Childhood (for use in the form of suppositories); hypersensitivity to the components of the combined drug.

Use in Pregnancy and Lactation

Use of the drug during pregnancy is possible if the potential benefit to the mother outweighs the risk to the fetus or child.

It can be used during breastfeeding, as the drug is practically not absorbed through the mucous membranes, therefore it does not penetrate into breast milk.

Pediatric Use

Not used in the form of suppositories.

Special Precautions

Simultaneous treatment of the sexual partner is necessary due to the risk of re-infection. Sexual intercourse should be avoided during treatment with the drug.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.