Buy Cyclo-Progynova® dragee 21 pcs
  • Buy Cyclo-Progynova® dragee 21 pcs

Cyclo-Progynova® [Norgestrel, Estradiol]

Bayer Pharma AG
1482 Items
2019-09-19
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$42.15
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Clinical Pharmacology

Cyclo-progynova - anti-menopausal.

Fills the lack of endogenous estrogen, reduces the level of LDL cholesterol in the blood. Suppresses somatic, mental and other climacteric symptoms during periods of pre- and postmenopause; prevents bone loss and osteoporosis. Hormone replacement therapy reduces the risk of developing cardiovascular diseases; in combination with gestagen - prevents the development of proliferative processes in the endometrium.

Indications

Estrogen deficiency (pre- and postmenopausal period, oophorectomy for non-malignant tumors, radiation castration); postmenopausal osteoporosis prevention, amenorrhea (primary and secondary), ovarian dysfunction.

Composition

1 tablet contains:

Active substance: norgestrel;

Auxiliary means: lactose monohydrate; corn starch; Povidone 25,000; talc; magnesium stearate; crystalline sucrose; povidone 700000, macrogol 6000; calcium carbonate; montanglycol wax;

Additionally for light brown dragees: glycerol 85%; precipitated calcium carbonate; titanium dioxide; iron oxide yellow pigment.

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Cyclo-Progynova® [Norgestrel, Estradiol]

Dosage and Administration

Insideswallowing whole with a little liquid. If the patient continues to have menstruation, treatment should begin on the 5th day of the menstrual cycle (the 1st day of menstrual bleeding corresponds to the 1st day of the menstrual cycle).

Patients with amenorrhea or very rare menstrual periods, as well as postmenopausal women, can begin taking the drug at any time, provided that pregnancy is ruled out.

Each package is designed for a 21-day reception.

Every day, for the first 11 days, take one white dragee, and then, for 10 days, take one light brown dragee each day. After a 21-day drug intake, there is a 7-day break, during which menstrual-like bleeding occurs, caused by drug withdrawal (usually 2-3 days after taking the last bean). After a 7-day break, begin a new packaging Cyclo-progynova®, taking the first dragee on the same day of the week as the first dragee from the previous package.

The time of day when a woman takes the drug does not matter, however, if the dragee is started at any particular time, you should continue to follow it. If the dragee is not taken on time, it should be taken within the next 12-24 hours. If treatment is interrupted for a longer time, vaginal bleeding may occur.

Adverse reactions

In rare cases - headaches, nausea, dysfunction of the stomach, engorgement of the mammary glands, changes in body weight, uterine bleeding, chloasma.

Pregnancy, severe abnormal liver functions, Dubin-Johnson and Rotor syndromes, liver tumors and thromboembolic processes (including history), severe diabetes with vascular complications, sickle cell anemia, breast or endometrial cancer, disorders of fat metabolism, herpes (in history), idiopathic jaundice, itching or worsening of otosclerosis during a former pregnancy.

Drug interactions

At the beginning of HRT it is necessary to stop the use of hormonal contraceptives. If necessary, the patient should be recommended non-hormonal contraceptives.

Long-term treatment with drugs that induce liver enzymes (for example, some anticonvulsant and antimicrobial drugs) can increase the clearance of sex hormones and reduce their clinical efficacy. A similar property to induce liver enzymes was found in hydantoins, barbiturates, primidone, carbamazepine and rifampicin, the presence of this feature is also expected in oxcarbazepine, topiramate, felbamate and griseofulvin. The maximum induction of enzymes is usually observed not earlier than in 2-3 weeks, but then it can persist for at least 4 weeks after stopping the drug.

In rare cases, a decrease in the level of estradiol was observed against the background of concomitant administration of certain antibiotics (for example, the penicillin and tetracycline groups).

Substances that are highly conjugated (for example, paracetamol) can increase the bioavailability of estradiol due to competitive inhibition of the conjugation system during the absorption process.

Due to the effect of HRT on glucose tolerance, in some cases, the need for oral antidiabetic agents or insulin may change.

Interaction with alcohol:

Excessive alcohol intake during HRT may lead to an increase in circulating estradiol levels.

Pregnancy and Lactation

Contraindicated in pregnancy.

Special instructions

Cyclo-progynova is not used for contraception.

If contraception is necessary, non-hormonal methods should be used (except for the calendar and temperature methods). If pregnancy is suspected, pills should be stopped until pregnancy is excluded (seesection "Pregnancy and lactation").

If any of the following conditions or risk factors are present or worsening, before starting or continuing HRT, the ratio of the individual risk to the benefit of treatment should be evaluated.

Venous thromboembolism

In a number of controlled randomized, as well as epidemiological studies, an increased relative risk of developing venous thromboembolism (VTE) was revealed in the presence of HRT, i.e. deep vein thrombosis or pulmonary embolism. Therefore, when prescribing HRT to women with VTE risk factors, the ratio of the risk and benefit of treatment should be carefully weighed and discussed with the patient.

Risk factors for VTE include an individual and family history (the presence of VTE in immediate relatives at a relatively young age may indicate a genetic predisposition) and severe obesity. The risk of VTE also increases with age. The question of the possible role of varicose veins in the development of VTE remains controversial.

The risk of VTE may temporarily increase with prolonged immobilization, “large” planned and traumatic operations or massive injury. Depending on the cause or duration of immobilization, the question of whether to temporarily stop HRT should be decided.

Treatment should be discontinued immediately if symptoms of thrombotic disorders appear or if they are suspected.

Arterial thromboembolism

In the course of randomized controlled trials with long-term use of combined conjugated estrogens and medroxyprogesterone acetate, no evidence of a positive effect on the cardiovascular system was obtained. In large-scale clinical trials of this compound, a possible increase in the risk of coronary disease in the first year of use was identified. An increased risk of stroke was also detected. So far, no other long-term randomized controlled trials have been conducted with other drugs for HRT in order to detect a positive effect on morbidity and mortality related to the cardiovascular system. Therefore, it is not known whether this increased risk extends to drugs for HRT containing other types of estrogen and progestogen.

Endometrial cancer

Long-term estrogen monotherapy increases the risk of endometrial hyperplasia or carcinoma. Studies have confirmed that adding progestogens reduces the risk of endometrial hyperplasia and cancer.

Mammary cancer

According to clinical trials and observational studies, an increase in the relative risk of developing breast cancer in women using HRT for several years has been found. This may be due to an earlier diagnosis, the biological effect of HRT, or a combination of both factors. The relative risk increases with increasing duration of treatment and possibly further increases with the combination of estrogens and progestogens. This increase is comparable to the increase in the risk of breast cancer in women with every year delay in the onset of natural menopause, as well as in obesity and alcohol abuse. The increased risk gradually decreases to the usual level during the first few years after the termination of HRT.

According to research data, breast cancer detected in women taking HRT is usually more differentiated than women not taking it.

HRT increases the mammographic density of the mammary glands, which in some cases may have a negative effect on the x-ray detection of breast cancer.

Liver tumor

Against the background of the use of sex steroids, which include drugs for hormone replacement therapy, benign and, even more rarely, malignant tumors of the liver have been observed in rare cases. In some cases, these tumors led to life threatening intra-abdominal bleeding. For pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding, a differential diagnosis should take into account the likelihood of a liver tumor.

Cholelithiasis

It is known that estrogen increases the lithogenicity of bile. Some women are predisposed to the development of cholelithiasis with estrogen therapy.

Other states

Treatment should be stopped immediately, with the first appearance of migraine-like or frequent and unusually severe headaches, as well as with the appearance of other symptoms - possible harbingers of a cerebral thrombotic stroke.

The relationship between HRT and the development of clinically severe arterial hypertension has not been established. In women taking HRT, a slight increase in blood pressure has been described, a clinically significant increase is rare. However, in some cases, with the development of HRT with persistent, clinically significant arterial hypertension, the withdrawal of HRT may be considered.

In cases of mild abnormalities in liver function, including various forms of hyperbilirubinemia, such as Dubin-Johnson syndrome or Rotor syndrome, physician observation is required, as well as periodic liver function tests. With a deterioration in liver function, HRT should be abolished.

When recurrent cholestatic jaundice or cholestatic pruritus, observed for the first time during pregnancy or prior treatment with sex steroid hormones, it is necessary to immediately stop HRT.

Special attention should be paid to women with moderately elevated triglyceride levels. In such cases, the use of HRT may cause a further increase in the level of triglycerides in the blood, which increases the risk of acute pancreatitis.

Although HRT may affect peripheral insulin resistance and glucose tolerance, it is usually not necessary to change the treatment regimen for diabetics when performing HRT. However, women with diabetes mellitus should be monitored during HRT.

In some patients, unwanted manifestations of estrogen stimulation, such as abnormal uterine bleeding, may develop under the influence of HRT. Frequent or persistent abnormal uterine bleeding during treatment is an indication for endometrial examination.

If the treatment of irregular menstrual cycles does not give results, an examination should be conducted to exclude diseases of an organic nature.

Under the influence of estrogen, uterine fibroids may increase in size. In this case, treatment should be discontinued.

It is recommended to stop treatment in case of endometriosis recurrence with HRT.

If you suspect the presence of prolactinomas before the start of treatment, this disease should be excluded.

In some cases, chloasma may be observed, especially in women with a history of chloasma in pregnant women. During HRT, women with a tendency to chloasma should avoid prolonged exposure to the sun or ultraviolet radiation.

The following conditions may occur or be aggravated against the background of HRT. Although their relationship with HRT has not been proven, women with these conditions should be monitored by a physician during an HRT: epilepsy; benign breast tumor; bronchial asthma; migraine; porphyria; otosclerosis; systemic lupus erythematosus, small chorea.

Medical examination and counseling

Before starting or resuming HRT, a woman is recommended to undergo a thorough general medical and gynecological examination (including breast examination and cytological examination of cervical mucus), to exclude pregnancy. In addition, violations of the blood coagulation system should be excluded. Periodic control tests should be carried out.

Impact on laboratory results

Acceptance of sex steroids can affect the biochemical indicators of liver, thyroid, adrenal and kidney function, the content of transport proteins, such as corticosteroid-binding globulin and lipid / lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis indices.

Influence on ability to drive motor transport and control mechanisms

Does not affect.

  • Brand name: Cyclo-Progynova®
  • Active ingredient: Norgestrel, Estradiol
  • Dosage form: Dragee
  • Manufacturer: Bayer Pharma AG
  • Country of Origin: Germany

Studies and clinical trials of Norgestrel, Estradiol (Click to expand)

  1. Automated Stability-Indicating High-Performance Liquid Chromatographic Assay for Ethinyl Estradiol and (Levo)norgestrel Tablets
  2. Post-coital contraception using d1-norgestrel/ethinyl estradiol combination
  3. Bleeding and serum d-norgestrel, estradiol and progesterone patterns in women using d-norgestrel subdermal polysiloxane capsules for contraception
  4. Clinical performance and endocrine profiles with contraceptive vaginal rings containing a combination of estradiol and D-Norgestrel
  5. Serum bile acids during biphasic contraceptive treatment with ethinyl estradiol and norgestrel
  6. Metabolic effects of two triphasic formulations containing ethinyl estradiol and dl-norgestrel
  7. Postcoital contraception with dl-norgestrel/ethinyl estradiol combination: Six years experience in a student medical clinic
  8. Modulation of hepatic cholesterol metabolsim by ethinyl estradiol and norgestrel
  9. Results of a controlled study employing d-norgestrel and ethinyl estradiol: A new oral contraceptive combination
  10. Plasma levels of d-norgestrel, estradiol and progesterone during treatment with silastic implants containing d-norgestrel
  11. Pituitary and gonadal function during the use of norgestrel-estradiol vaginal rings
  12. The effects of twelve month use of an estradiol/norgestrel preparation by postmenopausal women on lipid metabolism and hemostatic parameters
  13. Effects of norethindrone (17-ethyny1-17β-hydroxy-4-estren-3-one) and norgestrel (dl-13β-ethyl-17-ethyny1-17β-hydroxy-4-gonen-3-one) on the tissue distribution of 3H-estradiol-17β in ovariectomized rats
  14. Development of a Validated Liquid Chromatography Method for the Simultaneous Determination of Ethinyl Estradiol, Cyproterone Acetate, and Norgestrel in Breast Milk Following Solid‐Phase Extraction
  15. Effect of two different progestins (cyproterone acetate and norgestrel), administered in a cyclical estradiol valerate regimen, on markers of bone turnover
  16. Estradiol valerate/norgestrel
  17. Disappearance of a uterine arteriovenous malformation following long-term administration of oral norgestrel/ethinyl estradiol
  18. Effects of Prolonged Administration of the 19-NOR-Testosterone Derivatives Norethindrone and Norgestrel to Female NZB/W Mice: Comparison with Medroxyprogesterone and Ethinyl Estradiol
  19. Attenuation of Mild Hyperandrogenic Activity in Postpubertal Acne by a Triphasic Oral Contraceptive Containing Low Doses of Ethynyl Estradiol and d,l-Norgestrel
  20. A 1-year comparison of the efficacy and clinical tolerance in postmenopausal women of two hormone replacement therapies containing estradiol in combination with either norgestrel or trimegestone
  21. Assessment of the metabolic tolerance in postmenopausal women over a 1-year period of two hormone replacement therapies containing estradiol in combination with either norgestrel or trimegestone
  22. Serum levels of d-norgestrel, luteinizing hormone, follicle-stimulating hormone, estradiol, and progesterone in women during and following ingestion of combination oral contraceptives containing dl-norgestrel
  23. Clinical Experience with Ethinyl Estradiol and D-Norgestrel as an Oral Contraceptive

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