Kraynon gel vaginal packs. with applik. 90mg N15
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Active ingredients
Progesterone
Release form
Gel
Composition
Progesterone, glycerol, liquid paraffin light, hydrogenated palm oil glyceride, carbomer 974P, sorbic acid, polycarbophil, sodium hydroxide, purified water.
Pharmacological effect
Progestin Progesterone is a yellow body hormone. Causes the transition of the mucous membrane of the uterus from the proliferation phase, due to the action of FSH, in the secretory phase. Reduces the excitability and contractility of the muscles of the uterus and fallopian tubes. Progesterone inhibits the secretion of hypothalamic factors releasing FSH and LH, inhibits the formation of gonadotropic hormones in the pituitary and inhibits ovulation. In Kraynon; Progesterone vaginal gel is incorporated into the polymer delivery system, which binds to the mucous membrane of the vagina and provides a constant release of progesterone for at least 3 days.
Pharmacokinetics
Absorption When using a vaginal gel in a dose containing 90 mg of progesterone, the Cmax of the active substance in the blood is reached in 6 hours and is 11 mg / ml. Metabolism and elimination of T1 / 2 are 34-48 hours. Progesterone is metabolized mainly in the liver. Intravaginal application significantly reduces the effect of the first passage through the liver. The main metabolite, 3-α, 5-β-pregnandiol, is excreted in the urine.
Indications
- maintenance of the luteal phase in the process of using auxiliary methods of reproduction; - secondary amenorrhea, dysfunctional uterine bleeding due to progesterone deficiency; - postmenopausal hormone replacement therapy (in combination with estrogen preparations).
Contraindications
- vaginal bleeding of unclear etiology; - acute porphyria; - malignant tumors of the genital organs or mammary glands or suspicion of their presence; - acute thrombosis or thrombophlebitis, thromboembolic diseases; - acute cerebral circulation (including in history); - incomplete abortion; - breastfeeding period; - hypersensitivity to the components of the drug. The drug should be used with caution in case of arterial hypertension, chronic renal failure, cardiovascular failure, diabetes, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia.
Precautionary measures
Keep out of the reach of children.
Use during pregnancy and lactation
Kraynon can be used in the first trimester of pregnancy in the absence of function of the corpus luteum. The use of the drug Kraynon in the later stages of pregnancy is not recommended. Use during breastfeeding is contraindicated.
Dosage and administration
Maintaining the luteal phase in the process of applying auxiliary methods of reproduction. 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 is administered daily intravaginally. When pregnancy occurs, therapy is continued for up to 12 weeks or within 10-12 weeks from the moment of confirmed pregnancy. Secondary amenorrhea, dysfunctional uterine bleeding due to progesterone deficiency: 1.25 g of gel (90 mg progesterone) is administered intravaginally every other day from day 15-25. If necessary, the dose can be reduced or increased. Postmenopausal replacement hormone therapy (in combination with estrogen preparations) 90 mg (1 applicator) is administered 2 times a week. Rules for using the drug Should inform the patient about the need to accurately follow the recommendations on the use of the drug. To comply with hygienic conditions and ease of use Kraynon; Packed in a disposable applicator that should be discarded after use. Take the applicator, tightly holding it in the upper part between the 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 top flat end of the air container. Remove the breakaway cap from the opposite end by turning it. Do not press on the air container. The applicator can be inserted both in a sitting position and in a lying position with slightly bent knees. Carefully insert the lower end of the applicator into the vagina. Strongly squeeze the air container to the gel from the applicator into the vagina. Although a certain amount of gel remains in the applicator, the dose is fully injected. Now the applicator with the remaining gel can be discarded. Kraynon; it covers the vaginal mucosa, providing a prolonged release of progesterone.
Side effects
On the part of the central nervous system: headache, drowsiness. On the part of the digestive system: abdominal pain. On the part of the reproductive system: breast tenderness, intermenstrual bleeding, irritation of the vaginal mucosa and other local reactions of moderate severity in the area of application. Allergic reactions: hypersensitivity reactions are possible usually manifested as a skin rash.
Overdose
Currently, cases of overdose of the drug Kraynon were reported.
Interaction with other drugs
The use of the drug Kraynon together with other intravaginal means is not recommended.
special instructions
Special attention should be paid to the possible appearance of early symptoms of thrombotic disorders (thrombophlebitis, cerebral circulation disorders, pulmonary embolism and retinal thrombosis). If a symptom is revealed that indicates these disorders or even suggests their presence, the drug should be promptly discontinued. Patients with any risk factors for thrombotic disorders should be carefully monitored. Regular gynecological examinations are necessary in the course of long-term treatment in order to rule out the possibility of endometrial hyperplasia. Physical examination before the start of therapy should include an assessment of the condition and development of the mammary glands, etc. of the organs, as well as a cervical smear (Pap test). In order to prevent the possibility of incomplete abortion when using the drug Kraynon, it is necessary to determine the level of human chorionic gonadotropin or conduct an ultrasound examination. Use with caution in case of liver dysfunction. In cases of breakthrough bleeding, as in in all cases of irregular vaginal bleeding, organic pathology should be excluded. In case of vaginal bleeding of unknown etiology, an appropriate pathology should be carried out. sledovanie.T.k. progestogens have the ability to trap body fluids, patients with diseases such as epilepsy, migraine, bronchial asthma, cardiovascular insufficiency, impaired kidney function, should be closely monitored. Patients with a history of depression and treatment interruption should be carefully monitored. if depression increases. A small number of patients receiving estrogen-progestogen therapy may experience a decrease in glucose tolerance.The mechanism of this violation is not known. In this regard, patients suffering from diabetes in the process of treatment with progesterone should be under close observation. The drug Kraynon includes sorbic acid, which can cause a local skin reaction (contact dermatitis). The effect of the drug on the ability to drive a car and control others mechanisms Krajon has a weak or moderate degree of impact on the ability to drive and work with mechanisms. Since when using the drug Kraynon; fatigue or drowsiness may appear, caution is required when driving a car and other mechanisms. The use of alcohol can enhance this effect.