Cyclo-Proginova
Cyclo-Proginova: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. For violations of liver function
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Cyclo-Proginova
ATX code: G03AA06
Active ingredient: estradiol valerate (Estradiol Valerate) + norgestrel (Norgestrel)
Manufacturer: Bayer Weimar GmbH & Co. KG (Germany)
Description and photo updated: 2018-26-11
Prices in pharmacies: from 738 rubles.
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Cyclo-Proginova is an anti-climacteric drug.
Release form and composition
Cyclo-Proginova is produced in the form of pellets: round, of two types - white and light brown [21 pcs. (11 pcs. White and 10 pcs. Light brown) in blisters; in a carton box 1 blister].
1 white dragee contains:
- active substance: estradiol valerate - 2 mg;
- auxiliary components: lactose monohydrate, corn starch, povidone 25,000, magnesium stearate, talc;
- shell: wax, calcium carbonate, macrogol 6000, povidone 700 000, crystalline sucrose, talc.
1 dragee of light brown color contains:
- active ingredients: estradiol valerate - 2 mg, norgestrel - 500 mcg;
- auxiliary components: lactose monohydrate, corn starch, povidone 25,000, magnesium stearate, talc;
- shell: glycerol 85%, microcrystalline sucrose, povidone 700,000, calcium carbonate, macrogol 6000, titanium dioxide (E171), montaglycol wax, iron dye yellow oxide (E172), iron dye red oxide (E172), talc.
Pharmacological properties
Pharmacodynamics
Cyclo-Proginova is an anti-climacteric drug, the mechanism of action of which is due to the combination of estrogen and norgestrel.
Estrogen in the form of estradiol valerate, turning into the natural 17beta-estradiol, compensates for the estrogen deficiency in the female body that occurs after menopause. Its presence effectively eliminates the symptoms of climacteric psychoemotional and vegetative disorders. Promotes the restoration of heartbeat, normal sleep, libido. Eliminates increased sweating, frequent "hot flashes", irritability, increased nervous irritability, headache, cardialgia, dizziness, joint and muscle pain. It inhibits the processes of involution of the skin and mucous membranes, especially the mucous membranes of the genitourinary system, associated with urinary incontinence, dryness and irritation of the vagina. Relieves soreness during intercourse. Estrogen deficiency causes bone loss and osteoporosis. The use of Cyclo-Proginova prevents these processes. Estradiol suppresses osteoclast function and promotes a shift in the process of bone remodeling towards bone formation. Long-term hormone replacement therapy (HRT) reduces the risk of bone fractures in women after menopause.
Norgestrel is a progesterone derivative. Its cyclic use for 10 days prevents the development of endometrial hyperplasia and cancer.
The combined composition and cyclic regimen of regular intake, which includes taking only estrogen for 11 days, then estrogen and gestagen for 10 days and a break of 7 days, helps to establish the menstrual cycle in women with a preserved uterus.
The use of Cyclo-Proginov does not suppress ovulation, does not significantly affect the production of hormones by the body itself. Its use is indicated for the regulation of the menstrual cycle in women of reproductive age and for the treatment of irregular uterine bleeding in perimenopause.
The drug has a beneficial effect on the skin of the body, ensuring the maintenance of the normal content of collagen and density of the epidermis, slowing down the formation of wrinkles.
HRT lowers the level of total cholesterol, low density lipoprotein cholesterol (LDL), causes an increase in high density lipoprotein (HDL) cholesterol and triglyceride levels. The presence of a gestagen in Cyclo-Progin's composition prevents the effect of estradiol on lipid metabolism.
According to the results of observational studies against the background of the use of HRT in postmenopausal women, the incidence of colon cancer decreases.
Pharmacokinetics
After taking Cyclo-Proginova inside, there is a rapid absorption from the gastrointestinal tract of each of the active substances: estradiol valerate is absorbed completely, norgestrel - almost completely. The maximum concentration (Cmax) of estradiol in serum is reached after 4-9 hours, norgestrel - 1-1.5 hours after taking the pill, and is approximately 30 pg / ml and 7-8 pg / ml, respectively. The bioavailability of estradiol is about 3%; simultaneous food intake does not affect it.
Norgestrel binds to sex hormone binding globulin (SHBG) and albumin.
Estradiol is metabolized rapidly with the formation of 17beta-estradiol and estrone, which then undergo further biotransformation.
Estradiol is excreted through the kidneys in the form of metabolites (sulfates and glucuronides), norgestrel - through the kidneys and intestines. The half-life of norgestrel is 24 hours.
Indications for use
- treatment of primary or secondary amenorrhea;
- restoration of irregular menstrual cycles;
- HRT for symptoms of estrogen deficiency caused by natural menopause or hypogonadism, sterilization or primary ovarian dysfunction in women with an unremoved uterus;
- HRT of climacteric disorders, depressive conditions, involutional changes in the skin and genitourinary tract in the climacteric period;
- prevention of postmenopausal osteoporosis.
Contraindications
- breast cancer or suspicion of it;
- vaginal bleeding of unknown origin;
- hormone-dependent precancerous disease or hormone-dependent malignant tumor, including if they are suspected;
- severe stage of liver disease;
- benign or malignant liver tumors, including history;
- stage of exacerbation of deep vein thrombosis;
- acute arterial thrombosis or thromboembolism, including myocardial infarction, stroke;
- thromboembolism, including history;
- severe hypertriglyceridemia;
- period of pregnancy;
- breast-feeding;
- hypersensitivity to the components of the drug.
If these conditions occur during HRT, the drug is discontinued.
According to the instructions, Cyclo-Proginova is prescribed with caution for diabetes mellitus, arterial hypertension, congenital hyperbilirubinemia (Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome), an indication of a history of cholestatic jaundice or cholestatic itching during pregnancy, uterine myoma, endometriosis.
Instructions for use of Cyclo-Proginova: method and dosage
Dragee Cyclo-Proginova is taken orally, swallowed whole and washed down with a sufficient amount of liquid.
The drug can be taken at any time of the day convenient for the woman, but it should be strictly adhered to during the entire period of HRT.
With regular menstrual bleeding, pills are taken on the fifth day of the menstrual cycle (or bleeding).
With amenorrhea or very rare menstruation, postmenopausal women can begin treatment at any time, only after excluding pregnancy.
One pack is designed for 21 days of therapy. They begin the course with taking white pills, and after 11 days they switch to taking light brown pills for 10 days. After taking 21 tablets from the blister, there is a 7-day break, during which, usually 2-3 days after taking the last tablet, menstrual bleeding occurs, due to the withdrawal of the drug.
The new packaging of Cyclo-Proginovs begins after a 7-day break on the day of the week on which the first dragee from the previous blister was taken.
In case of accidental delay in admission at the prescribed time, the pills should be taken as soon as they remember. If treatment is interrupted for more than 24 hours, the risk of vaginal bleeding increases.
Side effects
- on the part of the reproductive system and mammary glands: breakthrough bleeding, dysmenorrhea, an increase in the frequency and intensity of uterine bleeding, intermenstrual spotting (usually weakened during treatment), changes in vaginal discharge, symptoms of premenstrual syndrome in the form of pain, tension and / or enlargement of the mammary glands, changes in libido;
- from the central nervous system: increased fatigue, migraine, headache, dizziness, anxiety, symptoms of depression;
- from the gastrointestinal tract: abdominal pain, dyspepsia, nausea, vomiting, bloating, cholestatic jaundice;
- dermatological reactions: pruritus, rash, erythema nodosum, chloasma;
- others: allergic reactions, palpitations, increased blood pressure (BP), thromboembolism, venous thrombosis, edema, muscle cramps, contact lens intolerance, visual impairment, changes in body weight.
Overdose
Symptoms: nausea, vomiting, vaginal bleeding.
Treatment: there is no specific antidote. Symptomatic therapy is recommended.
special instructions
Cyclo-Proginova should not be used for contraception. During HRT, it is required to use non-hormonal contraceptive methods.
The appointment of Cyclo-Proginova should be carried out taking into account the results of preliminary general medical and gynecological examinations, including a thorough cytological examination of cervical mucus, examination of the mammary glands, exclusion of pregnancy and disorders of the blood coagulation system. Treatment must be accompanied by periodic follow-up examinations.
Reception of Cyclo-Proginova is started only if the expected effect of therapy exceeds the existing risks of developing adverse events.
The use of HRT increases the relative likelihood of developing deep vein thrombosis or pulmonary embolism (venous thromboembolism). Risk factors for venous thromboembolism include severe obesity, an individual or family history of the disease, prolonged immobilization, major surgical interventions, and massive trauma. Therefore, when carrying out operations involving subsequent prolonged immobilization, it is advisable to temporarily stop HRT. If symptoms of thrombotic disorders are suspected, treatment should be discontinued immediately.
Long-term estrogen monotherapy increases the risk of developing endometrial hyperplasia or carcinoma. The presence of gestagens in the dragee reduces the likelihood of developing endometrial cancer.
The increased risk of breast cancer tends to gradually decrease to normal levels a few years after discontinuation of HRT.
In rare cases, while taking Cyclo-Proginov, benign or malignant neoplasms of the liver may appear. It is recommended to take this into account in the differential diagnosis of pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding in women taking the drug.
In some cases, treatment predisposes to the development of gallstone disease, this is due to the ability of estrogens to increase the lithogenicity of bile.
Immediate cancellation of Cyclo-Proginova may be required when migraine-like or very severe and frequent headaches appear for the first time, the development of persistent clinically significant arterial hypertension, deterioration of liver function indicators, recurrence of cholestatic jaundice or cholestatic pruritus (in women with cholestatic jaundice or cholestatic pruritus, during gestation or with previous therapy with sex steroid hormones).
It should be borne in mind that in women with moderately elevated triglyceride levels, taking Cyclo-Proginova can significantly raise their level and cause the development of acute pancreatitis.
The appearance of frequent or persistent pathological uterine bleeding is the basis for the study of the endometrium.
In the absence of a therapeutic effect from the use of Cyclo-Proginov for the treatment of irregular menstrual cycles, it is necessary to conduct an appropriate examination to exclude pathology of organic genesis.
In case of recurrence of endometriosis, an increase in the size of uterine fibroids while taking the drug, treatment is stopped.
Before starting HRT, women with suspected prolactinoma should be screened to rule out the disease.
If you are prone to chloasma, prolonged exposure to direct sunlight and ultraviolet radiation should be avoided.
The use of sex steroids can cause a violation of the biochemical functional parameters of the liver, thyroid gland, kidneys, adrenal glands; to influence the parameters of coagulation and fibrinolysis, carbohydrate metabolism, the content of such transport proteins in the plasma as corticosteroid-binding globulin, lipid or lipoprotein fractions.
Influence on the ability to drive vehicles and complex mechanisms
Cyclo-Proginova does not affect the concentration of attention and the speed of psychomotor reactions required to control complex mechanisms and vehicles.
Application during pregnancy and lactation
The use of Cyclo-Proginova is contraindicated during gestation and during breastfeeding.
During conception after the use of steroid hormones, including for the purpose of HRT, the risk of developing birth defects in children does not increase. In addition, the teratogenic effects of hormones have not been established when Cyclo-Proginova is accidentally taken in the early stages of pregnancy.
For violations of liver function
The appointment of Cyclo-Proginova is contraindicated in patients with severe liver disease, benign or malignant liver tumors, including a history.
Drug interactions
- hormonal contraceptives: the combination of HRT with hormonal contraceptives is contraindicated, so they should be canceled before starting treatment with the drug and, if necessary, use other methods of contraception;
- some anticonvulsants, antimicrobial drugs, hydantoins, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin and other drugs that induce liver enzymes: long-term therapy in combination with these drugs can increase the clearance of sex hormones and reduce clinical efficacy. It should be borne in mind that the maximum induction of liver enzymes appears 2 weeks after the start of the use of these funds and lasts for 4 weeks after their cancellation;
- penicillins, tetracyclines and antibiotics of other groups: in rare cases, they can cause a decrease in the concentration of estradiol;
- paracetamol and other substances that undergo conjugation to a significant extent: can increase the bioavailability of estradiol;
- oral antidiabetic agents, insulin: it should be borne in mind that in some cases, Cyclo-Proginova may impair glucose tolerance, and promptly adjust the dose of concomitant therapy;
- Ethanol: May increase circulating estradiol levels.
Analogs
The analogues of Cyclo-Proginova are Proginova, Janine, Lindinet, Ginepriston, Regulon, Logest, Ladybon, Femoden, Ovidon, Rigevidon.
Terms and conditions of storage
Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Cyclo-Proginov
Reviews about Cyclo-Proginov are mostly positive. Patients report high efficacy of the drug when used as HRT and in order to normalize the menstrual cycle. Several months of treatment allows you to streamline the cycle, restore ovulation. They often indicate good tolerance, and only in some cases did the drug cause an increase in body weight, bloating, swelling, and breast tenderness.
The price of Cyclo-Proginova in pharmacies
The price of Cyclo-Proginov for 21 tablets in a package can range from 799 to 916 rubles.
Tsiklo-Proginova: prices in online pharmacies
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Drug name Price Pharmacy |
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Cyclo-Proginova dragee 21 pcs. 738 RUB Buy |
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Cyclo-Proginova dragee 21 pcs. 856 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
