Junel Fe 1 / 20 is a birth control drug containing ethinyl estradiol, norethindrone and 7 inert pills with ferrum ferate.
Indications for use
Mechanism of action
Junel Fe 1/20 is a combined oral contraceptive, which composition includes ethinyl estradiol and norethisterone. In therapeutic doses, norethisterone has an antiandrogenic and weak anti-aldosterone effect. Norethisterone does not possess estrogenic, glucocorticoid and antiglucocorticoid activity. Thus, it has a pharmacological profile close to natural progesterone.
The contraceptive effect is based on the combination of various factors, the most important of which are the ovulation inhibition and the corresponding changes in the endometrium.
In clinical studies, an insignificant anti-aldosterone effect due to properties was specified.
Mode of application and dosage
Junel Fe 1/20 should be taken in the order defined on the package daily at about the same time. Take 1 pill daily for 28 forthcoming days. The application of each next package begins the day after the latest pill from the previous package is taken according to the regimen given by a doctor. Menstruation usually starts on the 2-3 day of application of inert pills. Though they may not end you should start taking a new package containing other 28 pills of Junel Fe 1/20.
Combined oral contraceptives including the described birth control drug should not be prescribed for patients suffering from one of the diseases listed below. If any of these conditions are observed appeared on the background of hormonal contraception, Junel Fe 1/20 should be immediately discontinued.
There are the following contraindications:
- hypersensibility to active components or any of the constituent parts;
- predisposition to thromboembolism or vein thrombosis;
- venous thrombosis: diagnosed or suspected;
- surgical interventions with long-lasting postoperative patient’s immobilization;
- a high risk of venous thromboembolism associated with the presence of multiple risk factors;
- predisposition to arterial thromboembolism;
- atherosclerosis: currently diagnosed or suspected;
- cerebrovascular accident (stroke) at the present or in the medical history;
- diagnosed hereditary or acquired predisposition to arterial thromboembolism;
- migraine with focal neurological symptoms in the medical history;
- diabetes mellitus with vascular complications;
- a severe form of increased blood pressure;
- severe dyslipidaemia;
- severe hepatic dysfunctions including its failure and tumors;
- severe form of kidney failure including acute kidney failure;
- diagnosed or suggested hormone-dependent malignant disorders (including genitals or mammary glands);
- vaginal bleeding of unclear genesis.
Often (≥1 / 100,
Not infrequently (≥1 / 100,
Rarely (≥1 / 10000,
An increased risk of arteries and veins thrombosis and tromboembolic episodes, including myocardial infarction, stroke, transient ischemic attack (TIA), venous thrombosis and pulmonary embolism were recorded in women using combined oral contraceptives.
During this drug application, the following serious negative reactions were specified:
- increased blood pressure;
- hepatic tumors;
- Crohn’s disease, ulcerative colitis, epilepsy, uterine body myoma, porphyria, systemic lupus erythematosus, herpes of pregnant women, Sydenham’s chorea, haemolytic uremic syndrome, cholestatic jaundice;
- in the case of acute or chronic hepatic dysfunctions, it may be necessary to temporarily withdraw combined hormoal contraceptives prior to the normalization of hepatic samples;
- with congenital angioneurotic edema, the use of estrogen preparations may provoke the development of the disease or its symptoms’ worsening.
Women who take Junel Fe 1/20 have a slightly increased incidence of breast cancer (breast cancer). Since breast cancer is rare in women younger than 40, the increase in the number of breast cancer diagnoses in women taking/recently discontinuing COCs does not affect the overall risk factor for breast cancer.
Drug interactions, which result in an increase in sex hormones clearance, can cause breakthrough bleeding and inefficiency of contraceptive protection. This effect was found in hydantoins (eg, phenytoin), barbiturates, primidon, carbamazepine and rifampicin. There are also an increased risk of contraceptive effect reduction with the simalteneous application of oxcarbazepine, topiramate, felbamate, griseofulvin, ritonavir, nevirapine and preparations containing St. John’s Wort.
The mechanism of their action is probably based on the ability of these substances to increase the performance of “hepatic” enzymes. The maximum induction of enzymes is usually manifested not earlier than 2-3 weeks after the beginning of taking these birth control drugs, but can last for at least 4 weeks after their discontinuation. Cases of the ineffectiveness of contraceptives have also been defined with the simultaneous antibiotics’ use.
In the case of short-term use of any of these drugs that cause an increase in the activity of “hepatic” enzymes, it is recommended that additional barrier methods of contraception be used from the time of taking these medications, during the entire treatment period and for 4 weeks after their discontinuation. Women prescribed these antibiotics with a short course treatment should temporarily use barrier methods of contraception simultaneously with contraceptive pills. If the next package is completed sooner than the period of time that requires the use of additional contraceptive methods, the active tablets should be taken from the next package without the use of placebo tablets.
In the case of long-term use of these drugs, patients are recommended to use other contraceptives (condoms, spermacides).
Many HIV / HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors taken with hormonal contraceptives including Junel Fe 1/20 can increase or decrease the estrogens or progestins level in the blood plasma. These changes in some cases may be clinically significant.
Strong and moderate CYP3A4 inhibitors, such as antifungals (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg clarithromycin, erythromycin), diltiazem and grapefruit juice can increase the concentration of estrogen or progestin or both substances in the blood plasma.
Based on the results of in vivo interactions among volunteers using omeprazole, simvastatin or midazolam as marker substrates, there is no clinically confirmed effect of norethindrone on the metabolism of other medications mediated by the cytochrome P450 system.
Genital steroid hormones can increase the concentration in the blood plasma of cyclosporine, which can lead to the development of toxic effects. Simultaneous application of lamotrigine and hormonal contraceptives can lead to a decrease in the lamotrigine concentration in plasma and impaired control of seizures in women who started using COCs.
Conducted clinical trials show that the administration of hormonal contraceptives containing ethinylestradiol did not result in any increase or even a slight increase in the isoenzyme concentrations of the CYP3A4 substrates (eg, midazolam) in blood plasma.
There is a theoretical possibility of increasing the serum potassium level in women receiving Junel Fe 1/20 tablets concomitantly with other drugs that can increase the serum potassium level. These drugs include angiotensin II receptor antagonists, potassium-sparing diuretics and aldosterone antagonists.
What if I miss a dose?
If the delay in taking the pill is less than 12 hours, the contraceptive protection does not decrease, it is necessary to take the pill as soon as possible, the next one is taken at the usual time.
If the delay in taking the tablets is more than 12 hours, the contraceptive protection can be decreased. In this case, you can meet the following 2 basic rules regarding the intake of skipped pills:
- the drug should never be discontinued for more than 7 days;
- 7 days of continuous tablets intake is required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.
Junel Fe 1 / 20 and pregnancy
Junel Fe 1 / 20 is not prescribed during pregnancy.
If the pregnancy diagnosed on the background of this drug application, an immediate discontinuation is mandatory. In the course of large-scale epidemiological studies, there was no increased risk of developmental defects in children born by women who took COCs before pregnancy, as well as teratogenic effects when unintentionally taking COC during pregnancy. The existing data during pregnancy are limited. They do not allow to value the drug effect on the course of pregnancy, fetal development and the newborn health. Nowadays, no significant epidemiological data have been obtained. The increased risk of thromboembolic complication in the puerperium should be considered if the drug is administered repeatedly.
Junel Fe 1 / 20 can have an influence on breasfeeding: they can help reduce the amount of breast milk, as well as change its composition. For this reason, it is recommended to start COCs only after stopping breastfeeding. Small amounts of hormonal contraceptives and/or their metabolites can penetrate the breast milk and affect the baby’s body.