Dermazole (Ketoconazole) 400mg 10 suppositories — Made in India— Free Delivery

Pharmacological properties

Pharmacodynamics. Ketoconazole is a synthetic derivative of imidazole dioxolane. has a pronounced fungicidal and fungistatic effect on dermatophytes (trichophyton spp., epidermophyton floccosum, microsporum spp.), yeast fungi (candida spp., pityrosporum spp., torulopsis spp, cryptococcus spp, rhodotorula spp., and higher dimorphic fungi) ... less sensitive to ketoconazole aspergillus spp., sporothrix schenkii, some dermatiaceae, mucor spp. and other phycomycetes, excluding entomophthales. ketoconazole is also active against gram-positive cocci (staphylococcus spp., streptococcus spp.).

The mechanism of action is aimed at suppressing the biosynthesis of ergosterol and changing the lipid composition of the membrane of fungi, which leads to their lysis. The preparation is also active against pathogens resistant to antifungal antibiotics (nystatin, levorin), as well as to clotrimazole. The development of secondary resistance during treatment with ketoconazole has not yet been noted.

Pharmacokinetics. With intravaginal use, the preparation is poorly absorbed, only a small amount (less than 1%) enters the systemic circulation. Cmax in blood plasma after application of 400 mg of ketoconazole ranges from 0-10.7 ng / ml, which is considered trace and does not have a systemic effect.

Indications

Treatment of acute and chronic recurrent vulvovaginal candidiasis. prevention of fungal infections of the vagina with reduced resistance of the body and against the background of treatment with preparations that disrupt the normal microflora of the vagina.

Application

Release the suppository from the strip and insert deep into the vagina in a supine position with knees bent and legs pulled up to the chest or squatting. suppositories should not be cut into pieces, since such a change in the storage conditions of the preparation can lead to a violation of the distribution of the active substance. apply 1 suppository a day before bedtime for 3-5 days. if necessary, repeat the course of treatment until clinical and laboratory-confirmed recovery. for chronic candidiasis, use 1 suppository for 10 days.

It is recommended to wash your hands after using the preparation in order to prevent accidental contact of its residues with eyes, mucous membranes or skin.

Contraindications

Hypersensitivity to the components of the preparation.

Side effects

Usually occur rarely and quickly disappear after discontinuation of the preparation.

Local reactions: irritation of the vaginal mucosa, accompanied by itching, burning sensation, hyperemia.

On the part of the skin and subcutaneous tissue: itching, rash, hyperemia.

From the immune system: hypersensitivity reactions, including anaphylactic and anaphylactoid reactions, angioedema, urticaria.

From the digestive tract: nausea, abdominal pain.

From the nervous system: dizziness.

Special instructions

In rare cases, local allergic reactions in the sexual partner are possible. to reduce the risk of recurrence of the disease, simultaneous treatment of the sexual partner is recommended. contact with latex contraceptives (contraceptive diaphragms, condoms) should be avoided due to a decrease in the reliability of mechanical contraception, therefore, the possibility of pregnancy or infection with sexually transmitted diseases is not excluded. during treatment, you should refrain from sexual intercourse. the preparation is recommended to be used at night, since it has an osmotic and drainage effect, accompanied by an increase in vaginal discharge. it is recommended to use sanitary napkins for the period of treatment with dermazole at night.

With the development of adverse reactions, including hypersensitivity reactions, the preparation should be discontinued and a doctor should be consulted.

The preparation contains butylhydroxyanisole (E320), therefore it can cause local skin reactions (eg contact dermatitis) or irritation of the mucous membranes.

Use during pregnancy and lactation. Although systemic absorption with intravaginal use of ketoconazole is very low or absent, there are no adequate controlled clinical studies of the safety of ketoconazole in pregnant women. The preparation should not be used in the first trimester of pregnancy.

In the II-III trimester of pregnancy and during lactation, the preparation should be used only when the expected benefit to the mother outweighs the potential risk to the fetus or child.

Children. There is no experience of using the preparation in children, so it should not be prescribed to this age category of patients.

The ability to influence the reaction rate when driving vehicles or other mechanisms. Usually does not affect, but the possibility of dizziness in persons with hypersensitivity should be considered.

Interactions

With the simultaneous use of ketoconazole with rifampicin and isoniazid, the concentration of ketoconazole in the blood plasma decreases. when used simultaneously with cyclosporine, indirect anticoagulants and methylprednisolone, ketoconazole can increase the concentration of the latter in blood plasma. the practical significance of these interactions in the treatment of ketoconazole in the form of vaginal suppositories is unknown.

Overdose

In case of an overdose, local reactions are possible: hyperemia, burning, itching, irritation of the vaginal mucosa. in such cases, douching with water is recommended.

Storage conditions

At a temperature not higher than 25 ° C.