Amethia Lo is a 91-pills course containing 2 hormones to prevent an unwanted pregnancy. This birth control drug block the ovulation that the main aim of this medication.
Indications for use
Mechanism of action
This birth control drug belongs to combined oral estrogen-progestin medication for continuous long-term use for 91 days. The contraceptive the drug effect is achieved due to the complementary mechanisms of the active substances. The most important mechanisms are inhibition of ovulation, a gain in the viscosity of the cervical secretion. The viscosity gain makes it difficult for spermatozoa to penetrate into the uterine cavity, and changes in the endometrium that prevent the attachment of a fertilized egg.
When using this birth control, the amount of menstrual bleeding decreases to 4 per year. In the last 7 days of a long-lasting use of the drug (on days 85-91), when 10 mcg of ethinylestradiol is applied instead of placebo, the follicular ovarian system is inhibited and the risk of missing ovulation is magnified. Menstruation-like bleeding associated with the cancellation of the drug is achieved due to the fact that there is no progestin effect on the endometrium, but in women, there is residual suppression of the hypotolamo-pituitary system achieved due to the intake of a small dose of ethinylestradiol for monitoring the functional activity of the ovaries.
Mode of application and dosage
Amethia Lo is taken orally continuously for 91 days 1 tablet per day at the same time in the order specified 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.
- Thromboses (venous and arterial) and thromboembolism presently diagnosed or in the medical history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- Multiple or pronounced risk factors for venous or arterial thrombosis;
- Hereditary or acquired predisposition to venous or arterial thrombosis;
- Migraine with focal neurologic symptoms presently diagnosed or in the medical history;
- Arterial hypertension with no control;
- Diabetes mellitus with angiopathy;
- Pancreatitis with severe hypertriglyceridemia at present or in the anamnesis;
- Hepatic insufficiency and severe liver disease (before the normalization of liver function tests);
- Hepatic tumors (benign or malignant) presently diagnosed or in the medical history;
- Severe dyslipoproteinemia;
- identified hormone-dependent malignant diseases (including genitals or mammary glands): diagnosed or suspected;
- Vaginal bleeding of unknown etiology;
- Pregnancy: diagnosed or suspected;
- Age under 18 years (due to the lack of data on the effectiveness and safety of the drug in adolescent under the age of 18);
- Simultaneous application with preparations of St. John’s wort;
- Hypersensitivity to any of the drug components;
- Intolerance to galactose, insufficiency of lactase or glucose-galactose malabsorption; the composition of the drug includes lactose;
- Postmenopausal period.
- Mental state: often – depression.
- Nervous system: very often – headache; often – migraine.
- Digestive tract: often – nausea, abdominal pain.
- Skin condition, subcutaneous and soft tissues: often – acne
- Musculoskeletal and connective tissues: often- back pain.
- Reproductive system and breast condition: very often – painful menstrual-like bleeding; often – metrorrhagia, a sensitivity of mammary glands.
- Research: often – weight gain.
Amethia Lo may cause the following side effects in women:
- venous thrombosis;
- arterial thrombosis;
- cerebrovascular disorders;
- increased blood pressure;
- liver tumor;
- impaired liver function;
- impaired glucose tolerance or influence on peripheral insulin resistance;
- the emergence or deterioration of conditions, whose dependence on oral contraceptive use is not confirmed: Crohn’s disease, ulcerative colitis, epilepsy, migraine, uterine myoma, cervical cancer, gallbladder stones, porphyria, herpes during pregnancy, Sydenham’s chorea, hemolytic-uremic syndrome, cholestatic jaundice, hearing loss associated with otosclerosis, jaundice and / or itching associated with cholestasis;
- acute pancreatitis;
- impaired vision;
Acute or chronic hepatic dysfunction can cause the withdrawal of combined oral contraceptives prior to the normalization of functional liver tests. In women with hereditary angioedema, estrogens can provoke or intensify the symptoms of the disease.
Influence on hepatic metabolism
The use of Amethia Lo that induce liver microsomal enzymes can result in an increase in the sex hormones clearance, which in turn can become a cause of breakthrough bleeding or a decrease in the contraception reliability. These drugs include phenytoin, bosentan, vemurafenib, barbiturates, primidone, carbamazepine, rifampicin, rifabutin. There may also be oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John’s Wort. The maximum induction of enzymes is achieved after 10 days and lasts for 4 weeks after the end of the use of such preparations. During the administration of drugs that influence liver microsomal enzymes, and within 28 days after their withdrawal, the barrier method of contraception should be used.
HIV protease inhibitors (eg, ritonavir) and Non-Nucleoside Reverse Transcriptase Inhibitors (eg, nevirapine) and their combinations also have to affect hepatic metabolism.
Women who undergo a short-term treatment with any of the above drugs, except for rifampicin, should temporarily use the barrier method of contraception in addition to the oral contraceptive, i.e. during the application of concomitant therapy and within 7 days after its withdrawal.
Women taking rifampicin and griseofulvin should use the barrier method of contraception in addition to the oral contraceptive during the reception of rifampicin and within 28 days after its withdrawal.
Women who undergo a long-term treatment with drugs containing active substances inducing microsomal liver enzymes are recommended to use a barrier method of contraception.
Effect on intestinal hepatic recycling
Some antibiotics (for example, penicillin and tetracycline) can decrease the intestinal hepatic circulation of estrogens, thereby lowering the concentration of ethinylestradiol.
COCs can affect the metabolism of other drugs, leading to an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in their concentrations in plasma and tissues.
Women who undergo thyroid hormone replacement therapy may need to increase the dose of the thyroid hormone drug, as the concentration of globulin binding the thyroid hormone in the blood plasma increases when taking an oral contraceptive.
What if I miss a dose?
The reliability of Amethia Lo may decrease if the patient forgot to take a tablet (containing ethinylestradiol + levonorgestrel), and especially if the patient forgot to take the first pill from the blister.
If the delay in taking the drug was less than 12 hours, the contraceptive protection is not decreased. A woman should take the pill as soon as possible, the next pill is taken at the usual time.
If the missing in the intake of one or more tablets are more than 12 hours, contraceptive protection may be decreased.
The following 2 basic rules should be followed:
- the drug should never be interrupted for more than 7 days;
- the drug requires 7 days of continuous intake of tablets to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.
Amethia Lo and pregnancy
The drug is contraindicated in pregnancy and during breastfeeding.
If pregnancy is detected during Amethia Lo application, the drug should be immediately discontinued. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born by mothers who received COC prior to pregnancy or teratogenicity, with the occasional use of COCs in early pregnancy.
Admission of combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is contraindicated until the termination of breastfeeding.