Prajisan - instructions for use, doses, side effects, contraindications

Excipients: paraffin light liquid 42.00 mg, sorbic acid 0.80 mg, glycerol 129.00 mg, guar gum 7.00 mg, palm oil of hydrogenated glyceride 10.00 mg, hypromellose K100M 7.0 mg, purified water q.s. up to 1.0 g.

Description:

Homogeneous gel of white color, soft consistency.

Pharmacotherapeutic group:gestagen

ATX: & nbsp

G.03.D.A Derivative derivatives

G.03.D.A.04 Progesterone

Pharmacodynamics:

Progesterone is a hormone of the yellow body. By binding to receptors on the surface of the cells of target organs, it penetrates into the nucleus, where, by activating DNA, it stimulates the synthesis of RNA.Causes the transition of the uterine mucosa from the proliferation phase, caused by follicle-stimulating hormone (FSH), into the secretory phase. Reduces excitability and contractility of the musculature of the uterus and fallopian tubes. In small doses increases, and in large - suppresses the production of gonadotropic hormones of the pituitary gland and inhibits ovulation. Activates the growth of the secretory department of the mammary glands and induces lactation. Promotes the development of normal endometrium.

Stimulating proteinolipase, increases fat stores; increases the utilization of glucose, increasing the concentration of basal and stimulated insulin; promotes the accumulation of glycogen in the liver; increases the production of aldosterone.

In the vaginal gel progesterone is incorporated into a polymeric delivery system that binds to the vaginal mucosa and provides continuous release of progesterone for at least 3 days.

Pharmacokinetics:

Suction

After vaginal injection, the rate of absorption of progesterone is less than that of oral administration. The maximum concentration of progesterone is reached on average after 6 hours.

Distribution

Progesterone intensively binds to plasma proteins, especially albumin (about 80%) and corticosteroid-binding globulin (about 17%).

Metabolism and excretion

Progesterone undergoes intensive biotransformation in the liver. Vaginal route of administration allows to avoid pronounced presystemic elimination. In general, the drug is excreted by the kidneys in the form of 3-α, 5-β-pregnanediol.

Indications:

- Infertility due to luteal insufficiency;

- maintenance of the luteal phase in the process of using auxiliary methods of reproduction;

- Secondary amenorrhea, dysfunctional uterine bleeding due to progesterone deficiency;

- replacement hormone therapy in postmenopause (in combination with estrogenic drugs).

Contraindications:

- Hypersensitivity to progesterone or other components of the drug;

- vaginal bleeding of unclear etiology;

- porphyria;

- malignant tumors of genital organs or mammary glands or suspected of their presence;

- Acute thrombosis or thrombophlebitis, thromboembolic disease, acute impairment of cerebral circulation (including in the anamnesis);

- incomplete abortion;

- the period of breastfeeding.

Carefully:

With arterial hypertension, cardiovascular failure, chronic renal failure, impaired liver function, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia.

Pregnancy and lactation:

Prajisan gel is contraindicated in pregnancy, except for use in early pregnancy during assistive reproduction methods. The use of the drug in a later period of pregnancy is not recommended.

Prajisan is contraindicated in the period of breastfeeding.

Dosing and Administration:

In the treatment infertility due to luteal insufficiency 90 mg of progesterone (1 applicator) is administered daily intravaginally, from the day of confirmed ovulation or from 18 to 21 day of the cycle for 10 days.

For maintenance of luteal phase in the process of using assisted reproductive technologies (ART): starting from the day of embryo transfer, the gel is used in a dose of 90 mg of progesterone (1 applicator) and administered daily intravaginally. When pregnancy occurs, the drug is continued for 12 weeks or for 10-12 weeks from the date of pregnancy confirmation.

Secondary amenorrhea, dysfunctional uterine bleeding due to progesterone deficiency: 90 mg of progesterone (1 applicator) is administered intravaginally every other day from the 15th to the 25th day of the cycle. If necessary, the dose may be decreased or increased.

Replacement hormone therapy in postmenopause (in combination with estrogenic preparations): 90 mg of progesterone (1 applicator) is administered 2 times a week.

Information for the patient when self-administered

Precisely follow the doctor's recommendations when applying Prajisan.

Prajisan contains the hormone of the yellow body, identical to the natural hormone progesterone. Prajisan is introduced into the vagina. For hygienic reasons and for ease of use, Prajisan is packaged in a disposable applicator that is discarded after use.

a) Cylinder of the applicator

b) The piston

c) Cap

1) Open the bag with the applicator and pull the applicator out of it.

2) Unscrew the cap.

3) Hold the applicator firmly between the thumb and middle finger and the index finger over the piston.

4) Take the position lying on the back with slightly bent knees. Carefully insert the applicator into the vagina.

5) Strongly press the index finger on the applicator's plunger so that the gel from the applicator enters the vagina.

Note: Despite the fact that some amount of gel remains in the applicator, you get all the necessary dose. Progesterone will be absorbed slowly and for a long time. Now you can discard the applicator with the remaining gel.

Side effects:

From the central nervous system: headache, drowsiness.

From the side of the digestive tract: stomach ache.

On the part of the reproductive system: tenderness of the mammary glands; intermenstrual bleeding, irritation of the mucous membrane of the vagina at the place of application.

Other: allergic reactions, usually manifested in the form of skin rashes.

Overdose:

No cases of an overdose of Prajisan were reported.

Interaction:

There is no data on the interaction of the preparation of Prajisan with other drugs. It is not recommended to be used together with other intravaginal drugs.

Special instructions:

The composition of the preparation Prajisan includes sorbic acid, which can cause a local skin reaction (contact dermatitis).

With prolonged therapy, regular gynecological examinations are necessary in order to exclude the possibility of developing endometrial hyperplasia. When applying Prajisan, it is necessary to determine the concentration of chorionic gonadotropin or to conduct ultrasound (to prevent the occurrence of a "threatening" abortion).

With sudden bleeding, as in the case of irregular vaginal bleeding, organic pathology should be ruled out. If there is a vaginal bleeding of an unclear etiology, an appropriate examination should be carried out.

Effect on the ability to drive transp. cf. and fur:

Patients using Prajisan should exercise caution when engaging in activities that require increased attention (as drowsiness may occur).

Form release / dosage:Vaginal gel, 8%.

Packaging:

According to 1.125 g of gel containing 90 mg of progesterone, in a disposable plastic vaginal applicator with a blue cap, which is screwed in a polypropylene cap, packed in a bag of aluminum foil and polyethylene.

One package with an applicator, along with instructions for use, is placed in a cardboard box.

Storage conditions:

Store in a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001371

Date of registration:19.12.2011

The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India

Manufacturer: & nbsp

Sun Pharmaceutical Industries, Ltd. India

Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India

Information update date: & nbsp01.09.2015

Illustrated instructions

Instructions

Prajisan (Pragisan)