Ekofucin® vaginal suppositories 100 mg

Ekofucin® vaginal suppositories 100 mg

Natamycin

Ecofucin® is an antifungal drug for the treatment of thrush, containing a prebiotic. It provides targeted local action at the site of infection: it acts on the causative agent of thrush and stimulates the growth of the body's own lactobacilli, promoting the restoration of the vaginal microflora.

Approved for use from the first day of pregnancy
Approved for use from the first day of pregnancy
Restores the vaginal microflora
Restores the vaginal microflora
Use once a day
Use once a day

Description

Ecofucin® is an antifungal drug for thrush with a prebiotic. Natamycin is a broad-spectrum polyene antifungal antibiotic from the macrolide group. It has a fungicidal effect. It binds to sterols in cell membranes, disrupting their integrity and function, which leads to the death of microorganisms. Microbial resistance to natamycin is not encountered in clinical practice. Ecofucin® does not have systemic effects, as it is not absorbed through intact skin and mucous membranes.  

Active Substance

Natamycin

Dosage Form and Composition

Vaginal suppositories 100 mg, 3 or 6 suppositories per pack.

Active substance: natamycin (calculated as 100% substance) – 100 mg;

Excipients: lactulose – 300 mg, macrogolglycerol hydroxystearate – 200 mg, colloidal silicon dioxide – 20 mg, hard fat up to 2300 mg.

Indications for Use

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

All indications for use (package insert)


Contraindications

Hypersensitivity to the components of the drug.

Dosage and Administration

One suppository daily for 3–6 days.

The suppository is inserted deep into the vagina while lying down, once daily at bedtime.

The duration of the treatment course (3-6 days) is determined individually. It is recommended to continue treatment for a few more days after the symptoms disappear. The use of suppositories should be interrupted during menstruation. During treatment, it is not necessary to abstain from sexual intercourse, but it is recommended to examine sexual partners and, if candidal infection is detected, to conduct a course of treatment. Barrier methods of contraception should be used during treatment.

Use during Pregnancy and Breastfeeding

Ekofucin® can be used from the first trimester of pregnancy and during breastfeeding 

Pharmacy Supply Terms

Over-the-counter



Instructions for Use of Ekofucin® vaginal suppositories 100 mg

International Nonproprietary Name:  natamycin

Trade Name of the Drug:  Ekofucin®

Dosage Form:  vaginal suppositories

Composition per one suppository:

Active substance: natamycin (calculated as 100% substance) – 100 mg;

Excipients: lactulose – 300 mg, macrogol glyceryl hydroxystearate – 200 mg,  colloidal silicon dioxide – 20 mg, hard fat (Suppocire AM) up to 2300 mg.

Description

Torpedo-shaped suppositories from almost white to light brown in color. The presence of white specks is allowed. The presence of an air core or a funnel-shaped depression is allowed.

Pharmacotherapeutic Group

Antifungal agent

ATC Code:  G01AA02

Pharmacological Properties

Pharmacodynamics

Natamycin is a polyene antifungal antibiotic from the macrolide group with a broad spectrum of action. It has a fungicidal effect. It binds to sterols in cell membranes, disrupting their integrity and functions, which leads to the death of microorganisms.

It is active against most pathogenic yeast-like fungi (especially Candida albicans),  yeasts (Torulopsis and Rhodotorula), as well as other pathogenic fungi (Aspergillus, Penicillium.).  It is less active against  dermatophytes (Trichophyton, Microsporum, Epidermophyton). It does not affect gram-positive and gram-negative bacteria in vitro.

Resistance to natamycin is not encountered in clinical practice.

Pharmacokinetics

Ekofucin® does not have a systemic effect, as it is practically not absorbed through intact skin and mucous membranes.

Indications for Use

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

Contraindications

Hypersensitivity to the components of the drug.

Use during Pregnancy and Breastfeeding

The use of Ekofucin® is possible during pregnancy and lactation.

Dosage and Administration

For candidal vaginitis, vulvitis, vulvovaginitis: intravaginally, one suppository daily for 3–6 days.

After freeing from the contour packaging, the suppository should be inserted deep into the vagina while lying down, once daily at bedtime.

The duration of the course of treatment is determined individually. It is recommended to continue treatment for a few more days after the symptoms of the disease disappear. The use of suppositories should be interrupted during menstruation.

In cases of persistent vaginitis caused by Candida albicans, natamycin tablets for oral administration are additionally  prescribed: 1 tablet 4 times a day for 10-20 days to eliminate the focus of candidal infection in the intestine.

Side Effects

Local application may cause slight irritation and a burning sensation at the site of application.

Overdose

There have been no reports of overdose with Ekofucin® to date.

Drug Interactions

No drug interactions of Ekofucin® with other medicinal products have been described.

Special Instructions

During vaginal application, the suppositories melt under body temperature, turning into a foamy mass, which promotes even distribution of natamycin over the vaginal mucosa.

During treatment, it is not necessary to abstain from sexual intercourse, but it is recommended to examine sexual partners and, if candidal infection is detected, to conduct a course of treatment with natamycin. Barrier methods of  contraception should be used during treatment.

Effect on Ability to Drive and Operate Machinery

The use of Ekofucin® does not affect the ability to drive vehicles and operate machinery.

Packaging

Vaginal suppositories 100 mg.

3 or 6 suppositories in a PVC/PE blister strip.

1 or 2 blister packs of 3 suppositories each, or 1 blister pack of 6 suppositories, together with the instructions for use in a cardboard carton.

Storage Conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C.

Keep out of reach of children.

Legal Status

Over-the-counter.

Shelf Life

2 years. Do not use after the expiration date printed on the package.

Name and Address of the Marketing Authorization Holder / Organization for Claims:

JSC "AVVA RUS", Russia, 121614,

Moscow, ul. Krylatskie Kholmy, 30, building 9.

tel: (495) 956-75-54.

avva.com.ru

ecoantibiotic.ru

Manufacturer:

JSC "AVVA RUS", Russia,

610044, Kirov region, Kirov, ul. Luganskaya, 53a.

tel: +7 (8332) 25-12-29.

avva.com.ru

ecoantibiotic.ru