Ketoconazole-pharmex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KETOCONAZOLE-PHARMEX (KETOCONAZOLE-PHARMEX)

Composition:

Active substance: ketoconazole;

1 suppository contains 400 mg of ketoconazole;

Excipients: butylhydroxyanisole (E 320), macrogol 1500, macrogol 400.

Dosage form. Suppositories.

Main physicochemical properties: white, white with yellowish or greyish hue suppositories of torpedo shape. A cup-shaped depression and an air channel may be present.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology.

ATC code G01AF11.

Pharmacological Properties

Pharmacodynamics.

Active substance – ketoconazole, an imidazolodioxolane derivative. Exerts fungicidal and fungistatic activity against dermatophytes (Trichophyton spp., Epidermophyton floccosum, Microsporum spp.) and yeasts (Candida spp., Pityrosporum spp.). The mechanism of action is directed at inhibition of ergosterol biosynthesis and alteration of the lipid composition of fungal cell membranes.

The drug is active against staphylococci and streptococci.

Pharmacokinetics.

After vaginal administration, the drug is poorly absorbed; a small amount enters the systemic circulation. Maximum plasma concentration of ketoconazole after administration of 400 mg of the drug ranges from 0 to 20.7 ng/mL.

Clinical characteristics.

Indications.

• Treatment of acute and chronic recurrent fungal infections of the vagina.
• Prevention of vaginal fungal infections in conditions of reduced body resistance and during treatment with agents that disturb the normal vaginal microflora.

Contraindications.

Individual hypersensitivity to any component of the medicinal product, pregnancy (first trimester).

Interaction with other medicinal products and other forms of interaction.

When the medicinal product Ketoconazole-Pharmex is used concomitantly with rifampicin and isoniazid, the plasma concentration of ketoconazole is reduced. When used concomitantly with cyclosporine, indirect anticoagulants, and methylprednisolone, ketoconazole may increase plasma concentrations of these agents. The clinical significance of these interactions in treatment with ketoconazole in the form of vaginal suppositories is unknown.

Special precautions.

In isolated cases, local allergic reactions in the sexual partner are possible. To reduce the risk of disease recurrence, simultaneous treatment of the sexual partner is recommended. Contact with latex products (contraceptive diaphragms, condoms) should be avoided.

Sexual intercourse should be avoided during treatment.

Ketoconazole-Farmeks is recommended to be administered at night, since the preparation exerts an osmotic and drainage effect, which is accompanied by increased vaginal discharge. It is recommended to use sanitary pads during the treatment with Ketoconazole-Farmeks at night.

If hypersensitivity reactions develop, the drug should be discontinued and medical advice should be sought.

Use during pregnancy or breastfeeding.

Not used during the first trimester of pregnancy. During the second and third trimesters of pregnancy and during breastfeeding, the drug should be used only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence reaction rate when driving vehicles or operating machinery.

No effect.

Dosage and Administration.

The drug is administered intravaginally. Before use, remove the suppository from its blister packaging and insert deeply into the vagina while lying on the back. Apply 1 suppository once daily for 3–5 days, depending on the course of the disease. If necessary, repeat the treatment course until clinical recovery, confirmed by laboratory tests. For chronic candidiasis, use 1 suppository daily for 10 days.

During pregnancy (II–III trimesters) and breastfeeding, the route of administration and dosage are as usual.

Children.

There is no experience with the use of the drug in children; therefore, it should not be prescribed to this age group of patients.

Overdose .

Overdose and toxic effects have not been observed with the use of the drug.

Side effects.

Possible hyperemia and irritation of the vaginal mucosa, vaginal itching at the site of suppository insertion, allergic reactions (skin rash, urticaria).

In isolated cases, nausea and dizziness may occur.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging.

5 suppositories in a blister made of polyvinyl chloride film. 1 or 2 blisters per cardboard box.

Availability. Over-the-counter.

Manufacturer.

LLC "FARMEKS GROUP".

Manufacturer's address and place of business.

100, Shevchenka Street, Boryspil, Kyiv region, Ukraine, 08301.