Crinon vaginal gel 90mg/dose 1.125g applicators, 15pcs

Composition

1 The applicator contains:  

Active ingredient:

progesterone – 90 mg.

Auxiliary substances:

glycerol,

light liquid paraffin,

hydrogenated palm oil glyceride,

carbomer 974 R,

sorbic acid,

polycarbophil,

sodium hydroxide,

purified water.

Pharmacological action

Progesterone is a hormone of the corpus luteum. Causes the transition of the uterine mucosa from the proliferation phase caused by FSH to the secretory phase. Reduces excitability and contractility of the uterine and fallopian tube muscles. Progesterone inhibits the secretion of hypothalamic FSH and LH release factors, inhibits the formation of gonadotropin hormones in the pituitary gland, and inhibits ovulation. In Krainon®, progesterone in the form of a vaginal gel is included in a polymer delivery system that binds to the vaginal mucosa and guarantees a constant release of the drug for at least 3 days.

Pharmacokinetics

Suction. When using a vaginal gel in a dose containing 90 mg of progesterone, the T_maxof the drug in the blood (11 ng / ml) is about 6 hours. T_1/2 — 34-48 hours.

Metabolism. Progesterone is primarily metabolized in the liver. Vaginal application significantly reduces the effect of the first passage through the liver.

The main metabolite,3α,5β-pregnanediol, is excreted in the urine.

Indications

• Maintenance of the luteal phase in the process of using assisted reproduction methods
• Secondary amenorrhea, dysfunctional uterine bleeding due to progesterone deficiency
• Hormone replacement therapy

Use during pregnancy and lactation

Krainon should not be used during pregnancy, except for use in the early period of pregnancy in the process of conducting assisted reproduction methods.

Krainon should not be used during breastfeeding.

Contraindications

• hypersensitivity to progesterone or other components of the drug;
• vaginal bleeding of unknown etiology;
• acute porphyria;
• malignant tumors of the genital organs or mammary glands or suspected of their presence;
• acute thrombosis or thrombophlebitis, thrombroembolic diseases, acute cerebrovascular accident (including in the anamnesis);
• incomplete abortion;
• breastfeeding period.

With caution:  arterial hypertension, chronic renal failure, cardiovascular insufficiency, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia.

Side effects

Headache, drowsiness, abdominal pain, breast tenderness.

Rarely-intermenstrual bleeding, irritation of the vaginal mucosa at the application site.

Interaction

The use of Krainon together with other intravaginal agents is not recommended.

How to take, course of use and dosage

Intravaginally.

Maintenance of the luteal phase in the process of using assisted reproduction methods. Starting from the day of embryo transfer, gel in the amount of 1,125 g (90 mg of progesterone — 1 applicator) is administered daily intravaginally. If pregnancy occurs, therapy is continued for up to 12 weeks or for 10-12 weeks from the date of confirmed pregnancy.

Secondary amenorrhea, dysfunctional uterine bleeding caused by progesterone deficiency. 1.125 g (90 mg of progesterone) of the gel is administered intravaginally every other day from the 15th to the 25th day of the cycle. If necessary, the dose can be reduced or increased.

Postmenopausal hormone replacement therapy (in combination with estrogenic drugs). 90 mg of progesterone (1 applicator) 2 times a week.

Patient information for self-use

It is necessary to strictly follow the doctor’s recommendations when using the drug Krainon®. Krainon®contains a yellow body hormone identical to the natural hormone progesterone. Krainon® is inserted into the vagina. For hygienic reasons and for ease of use, Kraynon®is packaged in a single-use applicator, which is discarded after use.

The applicator consists of an air container, a flat end, an upper end, a lower end, and a breakable cap.

The application should be carried out in accordance with these instructions:

Take the applicator, holding its upper end tightly between your thumb and forefinger. Shake the applicator like a medical thermometer so that the gel moves to the lower end of the applicator.

Hold the applicator by the upper flat end of the air container, remove the cap that breaks off from the opposite end by turning. Do not apply pressure to the air container.

The applicator can be inserted either in a sitting position or in a lying position with slightly bent knees. Carefully insert the lower end of the applicator into the vagina.

Squeeze the air container tightly so that the gel from the applicator gets into the vagina. Despite the fact that a certain amount of gel remains in the applicator, the patient receives the required dose in full. Then you can throw away the applicator with the rest of the gel in it. Krainon ® covers the vaginal mucosa, providing a long-lasting release of progesterone.

Special instructions

The composition of the drug Kraynon includes sorbic acid, which can cause a local skin reaction (contact dermatitis). During long-term treatment, regular gynecological examinations are necessary in order to exclude the possibility of developing endometrial hyperplasia.

In order to prevent the possibility of a “threatening” miscarriage when using Kraynon, the level of chorionic gonadotropin should be determined or an ultrasound examination should be performed. Use with caution in case of impaired liver function. In the case of sudden bleeding, as well as in the case of irregular vaginal bleeding, a non-functional cause should be excluded. In case of vaginal bleeding of unclear etiology, an appropriate examination should be performed.

Since progestins have the ability to retain fluid in the body, patients with diseases such as epilepsy, migraines, asthma, cardiovascular insufficiency, and impaired renal function should be carefully monitored.

Patients with a history of depression should be closely monitored and treatment should be discontinued if the depression worsens.

A small number of patients receiving estrogen-progestogen therapy may experience a decrease in glucose tolerance. The mechanism of this disorder is not known. In this regard, patients suffering from diabetes mellitus should be carefully monitored during progesterone treatment.

Form of production

Vaginal gel

Storage conditions

At a temperature not exceeding 25° C.

Shelf

life is 3 years.

Active ingredient

Progesterone

Conditions of release from pharmacies

By prescription

Dosage form

vaginal gel

Description

For postmenopausal women, Adults as prescribed by a doctor, For women of childbearing age, For women planning pregnancy

Indications

Infertility Treatment, Bleeding, Menopause, Menstrual Disorders