Genora 1/50 is a combined birth control containing norethindrone and ethinyl estradiol. It is prescribed for the prevention of unwnated pregnancy. It suppresses ovulation within a 28-days course.
Contents:
Indications for use
Genora 1/50 is prescribed as a contraceptive means.
Mechanism of action
Genora 1/50 is an oral combination drug with antiandrogenic effect, contains norethindrone and ethinyl estradiol. Contraceptive effect of the drug is achieved due to various factors. The most important factors are inhibition of ovulation, increased viscosity of cervical mucus, changes in the motility of the fallopian tubes and the structure of the endometrium. The antiandrogenic effect of the combined oral contraceptive is based on a decrease in the concentration of androgens in plasma. Numerous studies have shown that taking this birth control drug led to the alleviation of symptoms of mild and moderate acne and had a positive outcome in patients with seborrhea.
Mode of application and dose
This drug is taken daily as a course at one and the same time. The pill should be washed down with water. The treatment course is 28 days. No breaks are prescribed.
Contraindications
Get acquainted with possible contraindications in the list below:
- arterial and venous thromboembolic diseases at present or in the anamnesis (for example, deep vein thrombosis, pulmonary embolism);
- thrombosis (arterial and venous) and current or history of thromboembolism (including thrombosis, deep vein thrombophlebitis; pulmonary thromboembolism, myocardial infarction, ischemic or hemorrhagic cerebrovascular disorders);
- conditions preceding thrombosis;
- pancreatitis with severe hypertriglyceridemia currently or in history;
- porphyria;
- jaundice, congenital hyperbilirubinemia syndrome;
- sickle cell an hemia;
- multiple or pronounced risk factors for venous or arterial thrombosis, including history of risk factors for arterial thrombosis: diabetes mellitus with vascular complications (angiopathy, retinopathy);
- uncontrolled arterial hypertension;
- severe dyslipoproteinemia;
- congenital or acquired predisposition to arterial thrombosis, for example, resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus erythematosus);
- over the age of 35 years old;
- severe forms of liver disease;
- liver tumors (benign or malignant), including history;
- hormone-dependent malignant diseases of the genitals or mammary glands, including history;
- vaginal bleeding of unknown origin;
- migraine with local neurological symptoms, including history;
- epilepsy;
- pregnancy;
- lactation;
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- hypersensitivity to the drug components.
Side effects
- The blood and lymphatic system: rarely – anemia.
- Cardiovascular system: rarely – tachycardia; very rarely – myocardial infarction.
- Nervous system: often – headache; infrequently – migraine, irritability, dizziness; rarely – cerebrovascular accident.
- The side of the organ of vision: rarely – visual impairment, conjunctivitis, dry mucous membrane, intolerance to contact lenses.
- The organ of hearing: rarely – hypoacusia, tinnitus, sudden hearing loss, hearing impairment.
- Respiratory system, chest and mediastinum: rarely – sinusitis, bronchial asthma, bronchitis.
- Digestive tract: often – nausea, vomiting; infrequently – abdominal pain; rarely – diarrhea, dyspepsia, gastritis, enteritis; very rarely – cholecystitis, cholelithiasis.
- Kidneys and urinary tract: infrequently – an infection of the urinary system.
- Skin and subcutaneous tissues: infrequently – acne, acneform dermatitis, exanthema, skin allergic reactions, chloasma, alopecia, erythema multiforme, skin itching, including generalized itching, erythema nodosum, vascular purpura; rarely – hypertrichosis, virilism, hyperhidrosis, seborrhea, hyperpigmentation, eczema, dandruff, angioedema, telangiectasia (spider veins).
- Metabolism and nutrition: often – increase in body weight; infrequently – increased appetite, weight loss; rarely – loss of appetite.
- Infectious and parasitic diseases: infrequently – vaginitis, vaginal candidiasis; rarely – fungal infections, herpetic lesions of the oral cavity.
- Vascular system: infrequently – arterial hypotension, varicose veins, thrombophlebitis of superficial veins; rarely – deep vein thrombophlebitis, thrombosis, pulmonary thromboembolism, hematoma, cerebrovascular accident, flushing, pain along the veins.
- General disorders and disorders at the injection site: infrequently – a feeling of fatigue/malaise, swelling; rarely, flu-like symptoms.
- Immune system: rarely – allergic reactions.
- Genitals: often – pain and soreness of the mammary glands, enlargement of the mammary glands; infrequently – acyclic spotting or bleeding, painful menstrual bleeding, ovarian cysts, dyspareunia, increased vaginal discharge, endometrial hyperplasia, vaginitis/vulvovaginitis, salpingitis, endometritis; rarely, scarce menstrual bleeding, mastitis, fibrocystic dysplasia of the mammary glands, the appearance of mammary gland secretion, leiomyoma, endometritis, salpingitis, cervicitis, vulvovaginal itching, breast lipoma; very rarely – endometrial cancer.
- Mental health: often – decreased mood; rarely – insomnia, sleep disturbances, depression, anorexia, changes in libido, aggressiveness, apathy.
- Musculoskeletal and connective tissue: often – back pain, cramps in the calf muscles; rarely – arthralgia, myalgia.
Interactions
Interactions associated with the activation of microsomal enzymes between oral contraceptives and other drugs can result in breakthrough bleeding and/or reduce the contraception effectiveness. These effects have been shown for hydantoin, phenobarbital, primidone, carbamazepine, and rifampicin. Such effects are also possible for rifabutin, efavirenz, nevirapine, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and herbal drugs – drugs of St. John’s wort (Hypericum perforatum). The mechanism of these interactions is based on the ability of these drugs to activate microsomal liver enzymes.
According to clinical observations, the simultaneous administration of certain antibiotics (such as ampicillin and tetracycline) can lead to a decrease in the effectiveness of contraception.
Women taking rifampicin should use barrier methods during the time they take rifampicin and 28 days after withdrawal. If the concomitant drug is taken at the end of the package, the next package should be started immediately, without the usual break.
Drug interactions that enhance the clearance of sex hormones can lead to breakthrough uterine bleeding and a decrease in the contraceptive effectiveness of the drug.
What if I miss a dose?
If the delay in taking the drug was less than 12 hours, contraceptive effect does not decrease. A woman should take the drug as soon as possible, taking the next pill at the habitual time. If the delay in taking the pill was over 12 hours, contraceptive protection may be reduced. In this case, use other non-hormonal contraceptive effect.
Genora 1/50 and pregnancy
Genora 1/50 is contraindicated during pregnancy. If pregnancy occurs during drug use, then a woman should immediately withdraw the drug. Available information regarding the use of the drug during pregnancy is too limited to draw conclusions about the negative effects of the drug for pregnancy, fetal and newborn health. Extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who took sex hormones for contraception before pregnancy or by negligence in the early stages of pregnancy. It is contraindicated for use in breastfeeding women.