Natamycin 100 mg
Description
Dosage Form and Composition
Vaginal suppositories, 100 mg.
3 suppositories are placed in a PVC/PE film blister strip.
1 or 2 blister strips, together with the package insert, are placed in a cardboard carton
Active substance: Natamycin (calculated as 100% substance) – 100.0 mg
Indications for Use
Vaginitis, vulvitis, vulvovaginitis caused by fungi of the genus Candida.
Dosage and Administration
Route of administration - for vaginal use
After removing from the blister strip, insert the suppository deep into the vagina while lying down, once daily at bedtime.
Dosing
For candidal vaginitis, vulvitis, vulvovaginitis: intravaginally, one suppository daily for 3–6 days.
The duration of the treatment course is determined individually.
After the symptoms of the disease disappear, it is recommended to continue treatment for a few more days. 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.
Prescription Status
Available without a prescription
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Package Insert for the Medicinal Product Natamycin
Brand Name: Natamycin
International Nonproprietary Name: Natamycin
Dosage Form: Vaginal suppositories
Composition per one suppository:
Active substance: Natamycin (calculated as 100% substance) – 100.0 mg;
Excipients: Macrogolglycerol hydroxystearate – 75.0 mg, Colloidal silicon dioxide – 20.0 mg, Hard fat (Suppocire AM) to obtain a suppository weighing 1500.0 mg.
Description:
Torpedo-shaped suppositories from light yellow to light brown in color. The longitudinal section should be free of foreign inclusions. The presence of an air core or a funnel-shaped depression is allowed.
Pharmacotherapeutic Group: Antifungal agent
ATC Code: G01AA02
Pharmacological Properties
Mechanism of Action
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 functions, which leads to the death of microorganisms[citation:1][citation:2].
It is active against most pathogenic yeast-like fungi (especially Candida albicans), yeasts (Torulopsis and Rhodotorula), as well as other pathogenic fungi (Aspergillus, Penicillium). Less active against dermatophytes (Trichophyton, Microsporum, Epidermophyton)[citation:1][citation:2][citation:4].
In vitro susceptibility
Does not affect gram-positive and gram-negative bacteria in vitro[citation:1][citation:2].
Resistance
Resistance to natamycin is not encountered in clinical practice[citation:1][citation:2][citation:7].
Pharmacokinetics
Natamycin is not absorbed systemically as it is not absorbed through intact skin and mucous membranes[citation:1][citation:2][citation:7].
Indications for Use
Vaginitis, vulvitis, vulvovaginitis caused by fungi of the genus Candida.
Contraindications
Hypersensitivity to the components of the drug[citation:1][citation:2][citation:7].
Dosage and Administration
Route of administration - for vaginal use
After removing from the blister strip, insert the suppository deep into the vagina while lying down, once daily at bedtime[citation:1][citation:2][citation:7].
Dosing
For candidal vaginitis, vulvitis, vulvovaginitis: intravaginally, one suppository daily for 3–6 days.
The duration of the treatment course is determined individually[citation:1][citation:2].
After the symptoms of the disease disappear, it is recommended to continue treatment for a few more days. The use of suppositories should be interrupted during menstruation[citation:1][citation:2][citation:5].
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[citation:1][citation:2][citation:3].
Side Effects
Mild irritation and a burning sensation at the site of application may occur[citation:1][citation:2][citation:7].
Drug Interactions
Drug interactions of Natamycin with other medicinal products have not been described[citation:1][citation:2][citation:8].
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[citation:1][citation:2][citation:7].
During treatment, there is no need to abstain from sexual intercourse; however, it is recommended to examine sexual partners and, if candidal infection is detected, conduct a course of treatment with natamycin. Barrier methods of contraception should be used during treatment[citation:1][citation:2][citation:7].
Packaging
Vaginal suppositories, 100 mg.
3 suppositories are placed in a PVC/PE film blister strip.
1 or 2 blister strips, together with the package insert, are placed in a cardboard carton[citation:1][citation:2].
Shelf Life
2 years. Do not use after the expiration date printed on the packaging[citation:1][citation:2][citation:7].
Storage Conditions
Store in the original packaging (carton) at a temperature not exceeding 25 °C.
Keep out of reach of children[citation:1][citation:2][citation:7].
Prescription Status
Available without a prescription[citation:1][citation:2][citation:7].
Marketing Authorization Holder:
AVVA Pharmaceuticals Ltd., Cyprus, 23A Spyrou Kyprianou, 4001 Mesa Geitonia, Limassol, Cyprus[citation:2][citation:8].
Organization Accepting Consumer Claims:
JSC "AVVA RUS", Russia, 121614, Moscow, ul. Krylatskie Kholmy, 30, building 9[citation:2][citation:7][citation:8].
Tel.: +7 (495) 956-75-54[citation:2][citation:7].
avva-rus.ru[citation:2][citation:7]
Manufacturer:
JSC "AVVA RUS", Russia, Kirov region, Kirov, ul. Luganskaya, 53A.
Tel.: +7 (8332) 25-12-29[citation:1][citation:2][citation:7].
