Mastodon

Natafucin® (Tablets, Suppositories) Instructions for Use

ATC Code

G01AA02 (Natamycin)

Active Substance

Natamycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with 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

Antifungal polyene antibiotic of the macrolide group, has a broad spectrum of antifungal action. It has a fungicidal effect. Natamycin binds sterols of cell membranes, disrupting their integrity and functions, which leads to the death of microorganisms. Most pathogenic yeast fungi, especially Candida albicans, are sensitive to natamycin.

Dermatophytes are less sensitive to natamycin.

Resistance to natamycin has not been observed in clinical practice.

Pharmacokinetics

When applied to intact skin and mucous membranes, it is practically not subject to systemic absorption.

Indications

Vaginitis, vulvitis, vulvovaginitis caused mainly by fungi of the genus Candida.

ICD codes

ICD-10 code Indication
B37.3 Candidiasis of vulva and vagina
N77.1 Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
ICD-11 code Indication
1F23.10 Candidiasis of vulva and vagina
1F65 Enterobiasis
1H0Z Unspecified infection
1A94.0 Genital or urogenital tract infection caused by Herpes simplex virus
GA41 Ulcerative or erosive diseases of vulva

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

When taken orally, a single dose is 100 mg. The frequency of administration for adults is 4 times/day, for children – 2 times/day.

The duration of the course of treatment is set individually. After the symptoms of the disease disappear, it is recommended to continue treatment for a few more days.

Suppositories

Intravaginally – 1 time/day at night for 3-6 days.

The duration of the course of treatment is set individually. After the symptoms of the disease disappear, it is recommended to continue treatment for a few more days.

Adverse Reactions

Local reactions mild irritation of the vaginal mucosa, burning sensation are possible.

Contraindications

Hypersensitivity to natamycin.

Use in Pregnancy and Lactation

It can be used during pregnancy and breastfeeding according to indications in recommended doses.

Pediatric Use

Natamycin can be prescribed to newborns.

Special Precautions

In case of chronic or recurrent infection, local treatment can be supplemented with the use of natamycin in oral dosage forms to sanitize the focus of candidal infection in the intestine. If clinical signs of infection persist after completion of treatment, a repeated microbiological examination should be performed to confirm the diagnosis.

During menstruation, Natamycin is not used intravaginally; it is advisable to start treatment after menstruation.

With intravaginal use, there is no need to exclude sexual intercourse. However, it is recommended to examine sexual partners and, if candidal infection is detected, conduct a course of treatment with natamycin. Also, during treatment, barrier contraceptives should be used.

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

Over-the-Counter

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Salvus, LLC (Russia)

Manufactured By

Advanced Pharma, LLC (Russia)

Dosage Form

Bottle OTC Icon Natafucin® Enteric-coated film-coated tablets, 100 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets white or almost white, round, biconvex; on the cross-section, the core is from white to light yellow.

1 tab.
Natamycin 100 mg

Excipients : potato starch – 76.5 mg, povidone K30 – 7 mg, magnesium stearate – 2.5 mg, lactose monohydrate – 64 mg.

Shell composition ready-made enteric coating Acryl-Eze 93F18509 (methacrylic acid and ethyl acrylate copolymer [1:1] – 40%, talc – 37.25%, titanium dioxide – 15%, triethyl citrate – 4.8%, colloidal silicon dioxide – 1.25%, sodium bicarbonate – 1.2%, sodium lauryl sulfate – 0.5%) – 25 mg.

10 pcs. – blisters (2) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Salvus, LLC (Russia)

Manufactured By

Rubicon, LLC (Republic of Belarus)

Dosage Form

Bottle OTC Icon Natafucin® Vaginal suppositories 100 mg: 3, 6, or 9 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories from light yellow to light brown, torpedo-shaped; on the longitudinal section, there should be no foreign inclusions; the presence of an air rod or a funnel-shaped depression is allowed.

1 supp.
Natamycin 100 mg

Excipients : cetyl alcohol – 690 mg, sorbitan trioleate – 460 mg, polysorbate 80 – 460 mg, sodium bicarbonate – 69 mg, adipic acid – 64 mg, hard fat – up to 2540 mg.

3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
3 pcs. – contour cell packs (3) – cardboard packs.

Table of Contents

→ TABLE OF CONTENTS