Expiration date: 04/2025

Release form and composition:

The vaginal gel is homogeneous, white or almost white, soft consistency, and odor.

1 applicator (1.125 g)

progesterone 90 mg

Excipients: glycerol, light liquid paraffin, glyceride-hydrogenated palm oil, carbomer 974?, sorbic acid, polycarbophil, sodium hydroxide, purified water.

1 dose (1.125 g) - polyethylene vaginal applicators disposable (1) packs (6) - packs cardboard.

1 dose (1.125 g) - polyethylene vaginal applicators disposable (1) - packs (15) - packs of cardboard.

Pharmacological action:

Progesterone - the hormone yellow body. Causes the mucous membrane of the uterus phase proliferation due to the action of FSH in the secretory phase. Reduces anxiety and airway muscles uterus and fallopian tubes.

Progesterone inhibits the secretion of hypothalamic factors LH and FSH release, inhibits the formation of the pituitary gonadotropin-releasing hormone and inhibits ovulation.

In a vaginal gel progesterone included in the polymer delivery system that binds with mucosa of the vagina and provides a continuous release of progesterone, at least for 3 days.

Pharmacokinetics:

Distribution

When applying the vaginal gel at doses corresponding to 90 mg of progesterone, the Cmax achieved through 6 h and is 11 ng/ml.

Metabolism and excretion

T1/2 - 34-48 h. Progesterone is metabolized primarily in the liver. Intravaginal use significantly reduces the first pass effect through the liver. The main metabolite, 3-apha, 5-beta-pregnandiol, excreted in the urine.

Indications:

— maintaining the luteal phase, i.e. after the application of assisted reproductive technologies

— secondary amenorrhea or dysfunctional uterine bleeding due to progesterone deficiency

— hormone replacement therapy.

Dosing regimen:

For the luteal phase in the process of applying assisted reproductive techniques, starting from the day of embryo transfer, the gel is used at a dose of 1.125 g (90 mg of progesterone - 1 applicator) and administered daily intravaginally within 30 days from the date of clinically confirmed pregnancies.

In secondary amenorrhea, dysfunctional uterine bleeding due to progesterone deficiency, 1.125 g of gel (90 mg of progesterone) is administered intravaginally in a day from 15 to 25 day cycle. If necessary, the dose may be reduced or increased.

When conducting hormone replacement therapy drug in the dose of 90-180 mg (1-2 applicator) is administered 1-2 times/day.

How to use the drug

Should inform the patient of the need to precisely follow the recommendations for use of the drug.

To comply with hygiene and ease of use of Crayon packaged in a disposable applicator, which after use should be discarded.

1. Hold the applicator in the upper part between thumb and forefinger. Shake the applicator is like a medical thermometer so that the gel has moved to the lower end of the applicator.

2. Hold the applicator over the upper flat end. Remove from the opposite end snap off the cap by turning. Not to put pressure on the air container.

3. The patient should be in supine position with slightly bent knees. Gently push the bottom end of the applicator into the vagina.

4.Greatly compress air container, so that the gel from the applicator was in the vagina. Despite the fact that some gel remains in the applicator, the dose injected. Now the applicator with the remaining gel can be discarded. The progesterone will be absorbed slowly and for a long time.

Side effects:

CNS: headache, drowsiness.

From the digestive system: abdominal pain.

From the reproductive system: breast tenderness rarely intermenstrual bleeding, irritation of the vaginal mucosa at the site of application.

Contraindications:

• is vaginal bleeding unclear etiology
  
• porphyria
  
• malignant tumors of the genitals or mammary glands
  
• acute thrombosis or thrombophlebitis, thromboembolic disease
  
• acute violation of cerebral circulation (including in history)
  
• developing pregnancy
  
• lactation
  
• hypersensitivity to the drug.
  

Pregnancy and lactation:

Crayon should not be used during pregnancy except for use in early pregnancy, the process of auxiliary methods of reproduction.

Contraindicated in lactation (breastfeeding).

Special instructions:

The preparation of Crinan part of sorbic acid which may cause local skin reaction (contact dermatitis).

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

When using Crinone should determine the level of human chorionic gonadotropin or conduct an ultrasound to prevent a threatening abortion.

With caution assign product in the liver.

In case of sudden bleeding, as in the case of irregular vaginal bleeding, should be deleted non-functional reason. If you experience vaginal bleeding of unknown etiology should undertake an appropriate survey.

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

Should closely monitor patients with a history of depression and stop the drug when increasing depression.

On the background of the use of estrogen and progestogen, some patients may experience a decrease in glucose tolerance (the mechanism of this violation is unknown). On the background of the drug, patients with diabetes should be monitored carefully.

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

Patients using Crayon should be careful when doing activities that require increased attention (because it may cause feelings of fatigue). Drinking alcohol may intensify this effect.

Overdose:

Currently, the cases of drug overdose of Crinan was not reported.

Drug interactions:

The drug of Crayon together with other intravaginal drugs are not recommended.

Terms and conditions of storage:

The drug should be stored out of reach of children at temperature not exceeding 25°C. do not freeze. Shelf life – 3 years.