Extreme

Active material: Progesterone
When ATH: G03DA04
CCF: Progestogen
ICD-10 codes (testimony): N91, N92, N93, Z31.1
When CSF: 15.11.03
Manufacturer: SERONO LIMITED (Great Britain)

DOSAGE FORM, COMPOSITION AND PACKAGING

Vaginal gel homogeneous, white or nearly white, soft consistency, and odor.

Excipients: glycerol, paraffin light liquid, hydrogenated palm oil glyceride, carbomer 974R, sorbic acid, polycarbophil, Sodium hydroxide, Purified water.

1 dose (1.125 g) – disposable vaginal polyethylene applicators (1) – packages (6) – packs cardboard.
1 dose (1.125 g) – disposable vaginal polyethylene applicators (1) – packages (15) – packs cardboard.

Pharmacological action

Progesterone – hormone of the corpus luteum. Causes the transition of the uterine mucosa from the proliferation phase, caused by the action of FSH, the secretory phase. Reduces excitability and contractility of the muscles of the uterus and fallopian tubes.

Progesterone inhibits the secretion of hypothalamic release factors FSH and LH, inhibits the formation of gonadotropic hormones in the pituitary gland and inhibits ovulation.

In the vaginal gel, progesterone is included in the polymer delivery system, which binds to the vaginal mucosa and provides continuous release of progesterone, at least, during 3 days.

Pharmacokinetics

Distribution

When using vaginal gel in doses, relevant 90 mg progesterone, C_max achieved through 6 h and is 11 ng / ml.

Metabolism and excretion

T_1/2 – 34-48 no. Progesterone is metabolized primarily in the liver. Intravaginal use significantly reduces the effect “first pass” through the liver. The major metabolite, 3-a, 5-β-pregnanediol, excreted in the urine.

Testimony

- maintaining the luteal phase, incl. after using assisted reproductive technologies;

- secondary amenorrhea or dysfunctional uterine bleeding, caused by progesterone deficiency;

- Hormone replacement therapy.

Dosage regimen

To maintaining the luteal phase during the use of assisted reproductive techniques, starting from the day of embryo transfer, the gel is used in a dose 1.125 g (90 mg progesterone – 1 applikator) and is administered intravaginally daily for 30 days from clinically confirmed pregnancy.

At secondary amenorrhea, dysfunctional uterine bleeding, caused by progesterone deficiency, 1.125 g gel (90 mg progesterone) administered intravaginally every other day with 15 by 25 Day cycle. If necessary, the dose can be reduced or increased.

During the hormone replacement therapy the drug dose 90-180 mg (1-2 applicator) introduced 1-2 times / day.

Terms of use of the drug

The patient should be informed about the need to strictly follow the recommendations for the use of the drug..

To maintain hygienic conditions and ease of use, Krynon is packaged in a disposable applicator, which should be thrown away after use.

1. Hold the applicator at the top between your thumb and forefinger. Shake the applicator like a medical thermometer like this, so that the gel moves to the lower end of the applicator.

2. Hold the applicator by the top flat end. Remove the break-off cap from the opposite end by turning. Do not press on the air container.

3. The patient should be in a supine position with knees slightly bent. Carefully insert the lower end of the applicator into the vagina.

4.Squeeze the air container tightly, so that the gel from the applicator enters the vagina. Despite, that some gel remains in the applicator, the dose is fully administered. Now the applicator with the remaining gel can be thrown away. Progesterone will be absorbed slowly and over a long period of time.

Side effect

CNS: headache, drowsiness.

From the digestive system: stomach ache.

On the part of the reproductive system: breast tenderness; rarely – intermenstrual bleeding, irritation of the vaginal mucosa at the site of application.

Contraindications

- Vaginal bleeding of unknown etiology;

- Porphyria;

- malignant tumors of the genital organs or mammary glands;

- acute thrombosis or thrombophlebitis, thromboembolic disease;

- Acute ischemic stroke (incl. history);

- undeveloped pregnancy;

- Lactation;

- Hypersensitivity to the drug.

Pregnancy and lactation

Crinone should not be used during pregnancy, except for use in early pregnancy during assisted reproduction methods..

Contraindicated for use during lactation (breast-feeding).

Cautions

The composition of the drug Crinone includes sorbic acid, which may cause a local skin reaction (contact dermatitis).

With long-term therapy, it is necessary to conduct regular gynecological examinations in order to, to exclude the possibility of developing endometrial hyperplasia.

When using Crinon, the level of human chorionic gonadotropin should be determined or an ultrasound should be performed to prevent the occurrence of threatened abortion..

Prescribe the drug with caution in case of liver dysfunction.

In case of sudden bleeding, as well as in the case of irregular vaginal bleeding, non-functional cause should be excluded. If vaginal bleeding of unknown etiology occurs, appropriate examination should be performed..

The drug is prescribed to patients with epilepsy with caution and under constant monitoring., migraine, asthma, chronic heart failure, impaired renal function (due to possible fluid retention in the body).

Patients should be monitored closely, with a history of depression and discontinue the drug if depression worsens.

During the use of estrogens and progestogens, some patients may experience a decrease in glucose tolerance (the mechanism of this disorder is unknown). While using the drug, patients with diabetes mellitus should be closely monitored.

The effect of the drug on the ability to drive a car and control other mechanisms

Patients, using Crinon, must be careful when engaging in activities, require attention (tk. You may feel tired). Drinking alcohol may increase this effect.

Overdose

Currently, no cases of overdose of the drug Crinon have been reported..

Drug Interactions

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

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C; Do not freeze. Shelf life - 3 year.