Ecofucin® (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. |
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.
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.
Adverse Reactions
Local reactions mild irritation of the vaginal mucosa, burning sensation are possible.
Contraindications
Hypersensitivity to natamycin.
Use in Pregnancy and Lactation
It is possible to use during pregnancy and during 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 by the use of natamycin in dosage forms for oral administration to sanitize the focus of candidal infection in the intestine. If clinical signs of infection persist after completion of treatment, a repeated microbiological study should be conducted to confirm the diagnosis.
Natamycin is not used intravaginally during menstruation; it is advisable to start treatment after menstruation.
With intravaginal use, there is no need to exclude sexual contacts. However, it is recommended to examine sexual partners and, if candidal lesions are detected, to 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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Vaginal suppositories 100 mg: 3 or 6 pcs.
Marketing Authorization Holder
Avva Kazakhstan, LLP (Kazakhstan)
Manufactured By
Avva Rus, JSC (Russia)
Dosage Form
 |
Ecofucin® | Vaginal suppositories 100 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Vaginal suppositories from light yellow to light brown in color, torpedo-shaped; there should be no foreign inclusions on the longitudinal section; the presence of an air rod or a funnel-shaped depression is allowed.
| 1 supp. | |
| Natamycin | 100 mg |
Excipients: lactulose – 300 mg, macrogol glyceryl hydroxystearate – 200 mg, colloidal silicon dioxide – 20 mg, hard fat (Suppocire AM) – up to 2300 mg.
3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
Enteric-soluble film-coated tablets, 100 mg: 20, 28, 30, or 40 pcs.
Marketing Authorization Holder
Avva Rus, JSC (Russia)
Dosage Form
|
Ecofucin® | Enteric-soluble film-coated tablets, 100 mg: 20, 28, 30, or 40 pcs. |
Dosage Form, Packaging, and Composition
Enteric-soluble film-coated tablets white or almost white, round, biconvex; on the cross section, the core is from almost white to yellow with a brownish tint.
| 1 tab. | |
| Natamycin (calculated as 100% substance) | 100 mg |
Excipients: potato starch – 76.5 mg, povidone K-17 – 13 mg, magnesium stearate – 2.5 mg, lactose monohydrate – to obtain an uncoated tablet weighing 250 mg.
Shell excipients methacrylic acid and ethyl acrylate copolymer (1:1) – 9.29 mg, talc – 5.52 mg, povidone K-25 – 2.51 mg, macrogol-4000 – 1.42 mg, titanium dioxide – 1.26 mg.
7 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
![Ecofucin® [Tablets, Suppositories] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Ecofucin® [Tablets, Suppositories] 2")