clotrimazole cream vaginas. 2% 20g tuba

Description

Composition
Active substance:
clotrimazole – 2.0 g;
Excipients:
sorbitan stearate – 2.0 g, cetyl palmitate – 3.0 g of cetostearyl alcohol [60% cetyl alcohol and stearyl alcohol, 40%] – 10.0 g Polysorbate 60 – 1.5 g, octyl dodecanol – 13.5 g benzyl alcohol – 1.0 g purified water – 67.0 g
Description:
uniform cream white, odorless.
Product form:
2% vaginal cream.
20 g aluminum tubes. Tube together with disposable applicators (3 pcs.) For intravaginal administration, and instructions for use placed into cardboard pack.
Contraindications
– increased sensitivity to clotrimazole or other ingredients, especially cetostearyl alcohol;
– menstrual period;
– I trimester of pregnancy.
Carefully
During breastfeeding.
Dosage
20 mg / g
Indications
Genital infections caused by yeast fungi of the genus Candida (vulvovaginal candidiasis).
If necessary, please consult your physician before using the drug.
Interaction with other drugs
Vaginal administration of clotrimazole reduces Amphotericin B activity and other polyene antibiotics.
While the use of natamycin and nystatin may decrease the activity of clotrimazole.
Concomitant use of clotrimazole vaginally and tacrolimus, sirolimus may orally lead to increased concentration of the latter in the blood plasma, so you should watch for female patients for the development of symptoms of an overdose, if necessary, with the measurement of plasma concentrations.
Overdose
In case of overdose, the following symptoms: dizziness, nausea, vomiting.
Treatment. No specific antidote. In case of accidental intake of the following inside the symptomatic treatment.
pharmachologic effect
Pharmacodynamics:
Clotrimazole is an antifungal broad-spectrum topical. Antifungal effect of clotrimazole active principle (imidazole derivative) is connected with the violation of the synthesis of ergosterol, a component of fungal cell membranes that modifies membrane permeability and cause subsequent lysis of the cells. In low concentrations acts fungistatic and fungicidal in large, not only in proliferating cells. The fungicidal concentrations interacts with mitochondrial and peroxidase enzymes, resulting in increased concentrations of hydrogen peroxide up to a toxic level, which also contributes to the destruction of fungal cells.
It is effective against dermatophytes, yeast, fungi and protozoa. Has antimicrobial activity against Gram positive (Streptococcus spp., Staphylococcus spp.) And anaerobes (Bacteroides spp., Gardnerella vaginalis). Clotrimazole no effect on lactobacilli. In vitro at a concentration of 0.5-10 ug / ml of clotrimazole inhibits bacterial growth Corinebacteria and Gram-positive cocci family (with the exception of enterococci); trihomonatsidnoe action has a concentration of 100 .mu.g / ml.
Pharmacokinetics:
In the application of clotrimazole intravaginally absorption is 3 – 10% of the administered dose. High concentrations in the vaginal secretions and the low concentration in the blood are retained within 48 -. 72 hours in the liver is metabolized to inactive metabolites output from the kidneys and in the intestine.
Pregnancy and breast-feeding
Application in I trimester of pregnancy is contraindicated. The feasibility of using the drug in II-III trimesters of pregnancy should be decided individually after consulting a doctor.
Use of the drug during breast-feeding is allowed only in the case if, in the opinion of the physician, the potential benefits of applying the cream to the mother outweighs the potential risk to the child.
Conditions of supply of pharmacies
Without a prescription.
side effects
According to the World Health Organization (WHO), undesirable effects are classified according to their rate of development as follows: very common (> 1/10), common (> 1/100,
special instructions
Please read the instructions for use before the first use of the drug. Keep these instructions, it may be needed again. If you have any questions, consult your doctor.
Medicines that you are being treated meant to you personally, and should not be transferred to other persons as it may harm them even if you have the same symptoms that you have.
When allergic reactions or irritations at the site of drug treatment is stopped.
The drug should not be used during menstruation time, it is advisable to start treatment after menstruation.
When simultaneous infection of labia and adjacent portions (candida vulvitis) should carry out further local treatment with clotrimazole.
During pregnancy, treatment of vaginal cream is carried out without an applicator.
simultaneous treatment of sexual partners need to prevent infection.
During treatment advised to refrain from sexual intercourse.
During treatment, it is recommended to use contraception. The risk of rupture of the condom or diaphragm increases during their simultaneous use with the drug. You must use reliable methods of contraception.
should practice good hygiene to prevent re-infection.
If clinical signs of infection persist after treatment is completed, there should be repeated microbiological examination to confirm the diagnosis.
Effect on the ability to drive mechanisms and
The drug has no effect on ability to drive and engage in other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Locally. Only for intravaginal use.
For 6 consecutive days, once per day at night before bedtime administered content filled applicator (about 5 g) as deeply as possible into the vagina in the supine position, with slightly bent legs.
Use of vaginal creams using a disposable applicator:
1. Open the tube and fasten a disposable applicator.
2. Gently squeezing the tube, fill the single-use applicator, until the piston is fully pressed out.
3. Remove the applicator from the tube. Insert applicator as deeply as possible into the vagina (preferably in a supine position) and to squeeze out the contents of the applicator, pushing the plunger.
4. Remove the disposable applicator after use and throw away.
Use drug only according to the application and in the doses indicated in the instructions for use.
Repeated treatment is possible after consultation with the attending physician.
If after treatment there is no improvement or there are new symptoms, you should consult with your doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist