Amethia is a biphasic birth control preparation which application lasts for 91 days without breaks. The main components are ethinyl estradiol and levonorgestrel.
Indications for use
Mechanism of action
Amethia is a combined oral contraceptive in the composition of which estrogen and progestin are contained for a continuous use for 91 days.
The drug contraceptive effect lies in the complementary mechanisms of the active substances. The most significant mechanisms are suppression of ovulation, an increase in the viscosity of the cervical secretion. As a result of these mechanisms, it becomes difficult for the spermatozoa to enter the uterine cavity, and change the endometrium that prevents a fertilized egg attachment.
When using Amethia, the number of menstrual bleeding decreases to 4 per year. In the last 7 days of long-lasting drug use (in the period of 85-91 days), when 10 mcg of ethinyl estradiol is used instead of placebo, the follicular ovarian system is suppressed and the risk of inhibiting ovulation is magnified. Menstruation-like bleeding associated with withdrawal of the drug takes place due to the fact that there is no progestin effect on the endometrium, but in women, residual suppression of the hypothalamic-pituitary system persists due to taking a small dose of ethinyl estradiol for monitoring the ovaries’ functional activity.
Mode of application and dosage
Amethia is prescribed for continuous application within 91 days, 1 tablet a day at the same time in the order indicated on the package (blister).
To achieve the greatest contraceptive effect, the drug should be taken in accordance with the recommendations and at intervals not exceeding 24 hours. It implies one and the same time of reception day after day.
Tablets should be taken every day with a small amount of water. One orange tablet containing levonorgestrel and ethinylestradiol is taken daily for 84 days, then one white pill containing ethinylestradiol is taken for 7 days, during which there is a menstruation.
- The conditions causing hereditary or acquired predisposition to venous or arterial thrombosis: activated protein C resistance, hyperhomocisteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);
- The conditions preceding thrombosis inclusively of transient ischemic attacks, angina pectoris diagnosed or in the medical history;
- Venous and arterial thrombosis and thromboembolism diagnosed or in the medical history adding deep vein thromboembolism of the pulmonary artery, myocardial infarction, cerebrovascular disorders;
- Multiple or pronounced risk factors for venous or arterial thrombosis;
- Presently or prior diagnosed migraine with focal neurologic symptoms;
- Uncontrolled blood pressure increase;
- Diabetes mellitus with diabetic angiopathy;
- Pancreatitis with severe hypertriglyceridemia at present or in the medical history;
- Hepatic insufficiency and severe hepatic dysfunction (before the normalization of hepatic function tests);
- Hepatic tumors (benign or malignant) presently diagnosed or in the medical history;
- Dyslipoproteinemia of severe form;
- Identified hormone-dependent malignant diseases;
- Vaginal bleeding of unclear etiology;
- Pregnancy or suspicion of it;
- Age under 18 years;
- Hypersensitivity to any of Amethia components;
- Intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption. since the composition of the drug includes lactose;
- Postmenopausal period.
The frequency of side effects that were determined during the use of is distinguished in the following way:
- often (≥1 / 100, <1/10);
- infrequently (≥1 / 1000, <1/100);
- rarely (≥1 / 10,000, <1/1000).
- Immune system: rarely – bronchial asthma, hypersensitivity reactions.
- Nervous system: often – a headache.
- Mental disorders: often – a depressive condition; infrequently – a change in libido.
- Organs of senses: rarely – hearing loss.
- Cardiovascular system: often – migraine; infrequently – increased blood pressure, lowering blood pressure; rarely – thromboembolism.
- Digestive system: often – nausea; infrequently – vomiting, diarrhea.
- Skin and subcutaneous tissues: infrequently – acne, eczema, itching; rarely erythema nodosum, erythema multiforme.
- Reproductive system and breast: often – menstrual irregularities, acyclic bleeding, mammary glands tenderness, leucorrhoea, candidiasis vulvovaginitis; infrequently – an increase in the mammary glands, vaginitis; rarely – allocations from the mammary glands.
- Other: infrequent – fluid retention, change in a body weight.
The following serious adverse events were reported in women taking this birth control drug:
- venous thromboembolism;
- arterial thromboembolism;
- increased blood pressure;
- hepatic tumors;
- Crohn’s disease;
- ulcerative colitis;
- uterine fibroids;
- herpes in the previous pregnancy;
- Sydenham’s chorea;
- hemolytic-uremic syndrome;
- cholestatic jaundice;
The interaction of Amethia with other drugs can lead to breakthrough bleeding and/or a decrease in contraceptive reliability. Women taking these drugs should temporarily use barrier methods of contraception in addition to the drug or choose another method of contraception.
Amethia Effect Decrease
Influence on hepatic metabolism. The use of drugs that induce microsomal hepatic enzymes can lead to an increase in sex hormones’ clearance, which, in turn, can lead to breakthrough bleeding or a decrease in the contraception reliability. Such drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John’s Wort.
During the administration of drugs that affect microsomal liver enzymes, and within 28 days after their withdrawal, the barrier method of contraception should be applied additionally.
HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine) and their combinations also have a potential effect on hepatic metabolism.
Effect on intestinal hepatic recirculation. Some antibiotics (for example, penicillin and tetracycline) can reduce the intestinal hepatic circulation of estrogens, thereby lowering the concentration of ethinylestradiol. During the application of antibiotics (such as penicillins and tetracyclines) and within 7 days after their withdrawal, the barrier method of contraception should also be used.
What if I miss a dose?
The effectiveness of Amethia may decrease if the patient has forgotten to take an orange tablet (containing levonorgestrel + ethinyl estradiol), and especially if the patient forgot to take the 1 pill from the blister. If the delay in taking the drug was less than 12 hours, the contraceptive effect is not decreased. A woman should take the pill as soon as possible, the next pill is taken at the common time.
If the delay in the administration of one or more orange tablets is more than 12 hours, a contraceptive effect may be reduced. It is recommended to use additional contraceptive methods.
The application of white tablets containing ethinylestradiol
Tablets that the patient forgot to take should be thrown away. Forthcoming pills should be taken at the usual time, until the end of the package. Additional methods of contraception are not required.
If a woman did not have a menstruation bleeding during the 13th week (during the application of white tablets containing ethinyl estradiol), the possibility of pregnancy should be excluded before starting a new 91-day course.
Amethia and pregnancy
Amethia is contraindicated during pregnancy and breastfeeding.
If pregnancy is diagnosed the drug should be immediately discontinued. The conducted epidemiological trials have not discovered an increased risk of congenital malformations in children whose mothers take combined contraceptives in the early stages of pregnancy.
As a result of hormonal contraceptives, the volume of breastmilk may be reduced. The composition of breastmilk may be also changed. On the period of breastfeeding, it is better to stop taking contraceptives.