Expiration date: 05/2025

Release form and composition:

Vaginal Gel, homogeneous, white or almost white, with a soft consistency, and odor.

1 applicator (1.125 g) contains 90mg progesterone

Other ingredients: glycerol, light liquid paraffin, hydrogenated palm oil glyceride, carbomer 974P, sorbic acid, polycarbophil, sodium hydroxide, purified water.

1 dose (1.125 g) - vaginal applicators, disposable plastic (1) - packs (15) - packs cardboard.

Pharmachologic effect:

Progesterone - a hormone of the corpus luteum. It is the transition from the lining of the uterus phase proliferation caused by the action of FSH in the secretory phase. Reduces muscle excitability and contractility of the uterus and fallopian tubes.

Progesterone inhibits the secretion of hypothalamic releasing factor FSH and LH, inhibits the formation of the pituitary gonadotropins and inhibits ovulation.

The progesterone vaginal gel incorporated into the polymer delivery system that communicates with the vaginal mucosa and provides sustained release of progesterone, at least 3 days.

Pharmacokinetics:

Distribution

In the application of a vaginal gel in dosages corresponding to 90 mg of progesterone, Cmax is achieved within 6 h at 11 ng / ml.

Metabolism and excretion

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

Testimony:

• Maintenance of the luteal phase, including after the application of assisted reproductive technologies
  
• Secondary amenorrhea or dysfunctional uterine bleeding caused by progesterone deficiency
  
• Hormone replacement therapy.
  

Dosage and administration:

To maintain the luteal phase in the use of assisted reproductive techniques, starting from the day of embryo transfer, the gel is applied at a dose of 1.125 g (90 mg of progesterone - 1 applicator) and vaginally administered daily for 30 days from the date of clinically confirmed pregnancy.

In secondary amenorrhea, dysfunctional uterine bleeding caused by deficiency of progesterone, 1.125 g of gel (90 mg of progesterone) are administered vaginally every other day with 15 to 25 day cycle. the dose may be decreased or increased if necessary.

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

Terms of use of the drug

It should inform the patient of the need to accurately implement the recommendations on the use of the drug.

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

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

2. Hold the applicator over the upper flat end. Remove from the opposite end of the twist off the cap by turning. Do not press down on the air container.

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

4.Silno squeeze the air container to the applicator of gel to keep the vagina. Despite the fact that some gel remains in the applicator, the dose administered completely. Now, with the remaining gel applicator can be discarded. Progesterone is slowly absorbed 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:

• Vaginal bleeding of unknown etiology
  
• porphyria
  
• Malignant genital tumors, or breast
  
• Acute thrombosis or thrombophlebitis, thromboembolic disease
  
• Acute cerebrovascular accident (including history)
  
• Developing pregnancy
  
• lactation
  
• Hypersensitivity to the drug.
  

Pregnancy and lactation:

Crinone not be used during pregnancy except for use in early pregnancy in the course of assisted reproduction techniques.

Do not use this during lactation (breastfeeding).

Special instructions:

The composition of the drug Crinone include sorbic acid, which may cause local skin reactions (contact dermatitis).

During prolonged therapy should have regular gynecological check-ups in order to exclude the possibility of the development of endometrial hyperplasia.

When using Crinone should determine the level of human chorionic gonadotropin, or to carry out ultrasound to prevent threatened abortion.

Be wary prescribers with abnormal liver function.

If breakthrough bleeding, as in the case of irregular vaginal bleeding, should be deleted nonfunctional cause. If you have vaginal bleeding of unknown etiology should conduct an appropriate examination.

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

You should carefully monitor patients with a history of depression and stop the drug with increased depression.

Against the background of the use of estrogens and progestogens, some patients may experience impaired glucose tolerance (the mechanism of this disorder is unknown). Against the background of the drug, patients with diabetes should be monitored carefully.

Effect on the ability to drive a car and other management mechanisms

Patients applying Crinone should use caution when doing activities that require attention (as may cause feelings of fatigue). Alcohol may enhance the effect.

Overdose:

Currently, the cases of drug overdose Crinone were reported.

Drug Interactions:

Application Crinone drug along with other intravaginal agents is not recommended.

Conditions and terms:

The drug should be stored out of reach of children at or above 25 ° C, do not freeze. Shelf life - 3 years.