VyLibra is a contraceptive which contains a combination of 2 hormones, norgestimate and ethinyl estradiol.
- Oral contraception.
VyLibra is a hormonal contraceptive for systemic use. The action of the preparation is determined by the inhibition of gonadotropic and pituitary gland function. By suppressing the secretion of follicle-stimulating and luteal hormone hormones, the drug inhibits egg cell maturation in the follicle and ovulation. It also affects the cervical secretion, increasing the viscosity of the cervical calf.
Due to the combination of estrogen and progestogen, the drug can both regulate menstruation and help to stop the acyclic uterine bleeding.
Each pack of the drug contains 21 active and 7 inert tablets. VyLibra active tablets are dark blue (1-21 days). Green tablets are inactive (22-28 days).
Take the first tablet on the 1st day of menstruation, even if another hormonal drug was used to prevent pregnancy. Continue taking tablets until all the pack is empty. Vaginal bleeding occurs 2-4 days after taking the last active tablet. Once you’ve finished the pack, start a new one without interruption, regardless of whether the bleeding has stopped or continues.
After childbirth or abortion, VyLibra should be started on the 1st day of the first spontaneous menstruation. If necessary, pills can be started earlier (7 days after birth or immediately after an abortion). In these cases, the patient should be advised to additionally use backup contraception during the first 2 weeks.
An overdose is possible. An excessive dose of norgestimate and ethinyl estradiol can cause nausea and vomiting that can last up to several days. This does not lead to serious consequences.
The use of hormonal contraceptives is associated with an increased risk of thromboembolic diseases of the veins and arteries, such as venous thrombosis, pulmonary embolism, stroke, myocardial infarction. This risk can be further increased through additional factors, such as smoking, high blood pressure, disorders of hemostasis or lipid metabolism, a significant overweight, varicose veins, phlebitis and thrombosis in the past.
Possible side effects: a feeling of engorgement of the mammary glands, fluctuations in body weight, depressive mood disorders, changes in sexual desire, indigestion, nausea, vomiting, headache (including migraine-like), reduced contact lenses portability, chloasma, candidiasis, skin rash, change in voice tone.
Sometimes, during the first cycles of the contraceptive, women experience menstrual disorders, such as intermenstrual bleeding or the absence of menstrual bleeding.
Long-term use of VyLibra pills can cause a slightly increased incidence of the biliary tract. The data about the possibility of the formation of gallstones in women taking drugs containing estrogen are contradictory. In rare cases, taking hormones can cause benign and malignant changes in the liver, which led to life-threatening bleeding into the abdominal cavity in some cases.
Hormonal drugs can change some clinical and chemical indicators, for example, the rate of blood sedimentation may increase.
Norgestimate and ethinyl estradiol can increase susceptibility to other factors that influence the development of breast cancer.
In unique cases, the drug caused breast discharge and breast enlargement.
VyLibra is contraindicated for use in the following cases:
- Acute and chronic liver diseases, liver diseases in the past;
- Increased content of yellow-brown gall pigment (bilirubin) in the blood due to disorders of its excretion (Dubin-Johnson and Rotor syndromes);
- Disorders of biliary secretion, violation of bile secretion (cholestasis now or in the past, if its occurrence was associated with pregnancy or taking sex hormones). In addition, jaundice or itching during a previous pregnancy or undergoing treatment with sex hormones;
- Liver tumors now or in the past;
- Presence of past or present tendency to blood clots (thrombosis, thromboembolism) in the veins or arteries (especially stroke, myocardial infarction, deep vein thrombosis, pulmonary embolism), as well as any conditions that increase the tendency to the above listed diseases (disorders of the blood coagulation system with a tendency to the occurrence of blood clots and certain heart diseases), high blood pressure that is difficult to control;
- Severe disorders of lipid metabolism, especially when accompanied by other risk factors for cardiovascular disorders;
- Severe diabetes mellitus with a change of vessels (microangiopathy), a migraine that superconnects paralysis, disorders of the senses and/or motor function;
- Malignant tumors, for example, tumors of the mammary glands or the uterus (endometrium), including those that are currently being treated or suspected;
- Herpes in the period of a previous pregnancy;
- Deafness associated with middle ear diseases (otosclerosis), signs of which were exacerbated during a previous pregnancy;
- Severe obesity;
- Sickle cell anemia; vaginal hemorrhage;
- Increased sensitivity to norgestimate/ethinyl estradiol or other components of the drug.
VyLibra in combination with:
- sulfonamides, phenytoin, barbiturates, carbamazepine, rifampicin, pyrazolone derivatives, St. John’s wort – contraceptive efficacy decreases;
- protease inhibitors, antiretroviral drugs – the concentration of combined hormonal contraceptives in the blood changes;
- tetracycline, ampicillin – insufficiently estrogen conjugates are split;
- hypoglycemic drugs – correction of their dose is required.
Oral contraceptives can affect the quantity and quality of milk in the mammary glands. A small amount of hormones can penetrate the milk. It is unlikely that inhibitors of ovulation, such as VyLibra, in low doses can affect infant feeding. However, women who breastfeed should not use oral contraceptives until they stop breastfeeding. Since breastfeeding women are not fully protected against the possibility of becoming pregnant, they are recommended additional backup contraception. The use of oral contraceptives in the early stages of pregnancy can
lead to developmental defects in newborns.
- If one pill was missed, it must be taken as soon as possible (but the delay between doses should not exceed 24 hours). The following pill should be taken at the usual time. This means that you can take 2 tablets in one day;
- If 2 tablets were missed in the 1st or 2nd week of the cycle, you should take 2 tablets on the day you remember and 2 tablets the next day. Then you should take 1 tablet per day according to the usual schedule until the package is empty. At the same time, you should use additional methods of non-hormonal contraception for the next 7 days;
- If 2 tablets were missed during the 3rd week of the cycle, the rest of the tablets should be discarded. Start a new pack on the same day. At the same time, you should use additional methods of non-hormonal contraception for the next 7 days;
- If 3 pills were missed during the first 3 weeks of the cycle, discard the remaining pills and begin a new pack on the same day. At the same time, you should use additional methods of non-hormonal contraception for the next 7 days;
- If any pills were missed in the 4th week of the cycle, discard them since they do not have any contraceptive effect and are used as “reminders’. You do not need additional methods of non-hormonal contraception.
VyLibra has a contraceptive effect but does not protect against HIV and infections that are sexually transmitted.
Before taking birth control pills, a woman should be examined by a gynecologist and other specialists to determine the general state of health.
If a woman had hepatitis, then the contraceptive pills should be taken no earlier than 3 months after receiving normal liver test results.
Patients with heart and liver dysfunction, arterial hypertension, fluid retention, diabetes, glucose intolerance, bronchial asthma, gallbladder disease, noticeable varicosity, bladder fibromyoma, depression, epilepsy require constant monitoring.
The use of oral contraceptives is associated with an increased risk of thromboembolism, myocardial infarction, stroke, and the like. The significant risk is manifested with age, especially in patients who smoke a lot (more than 15-20 cigarettes per day). Therefore, women over the age of 30 are strongly recommended to quit smoking. Sometimes an increased risk persists for several years after cessation of oral contraception.
Use of VyLibra pills should be discontinued if the following conditions/diseases occur:
- onset or suspicion of pregnancy;
- a migraine-type headache or severe unusual headache attacks;
- acute visual or hearing impairment;
- first signs of thrombophlebitis or thromboembolic complications;
- epileptic seizures and/or increased convulsions;
- jaundice and/or persistent itching of the whole body;
- a marked increase in blood pressure;
- a marked increase in fibroids;
- an increase in the size of the liver with a suspected liver tumor;
- prolonged immobility, for example after injury, before surgical
- operations (at least 6 weeks) and the like.
The drug does not affect the ability to drive vehicles and work with complex mechanisms.
If you have breakthrough bleeding, therapy should be continued. Bleeding usually disappears after the third cycle of the contraceptive but may vary depending on the individual characteristics. If the bleeding continues further, you should consult your doctor.
If vomiting occurs within 3 hours after taking an active tablet of the drug, or acute diarrhea lasts for 24 hours, the effectiveness of the contraceptive may be insufficient. Additional methods of non-hormonal contraception should be used for the next 7 days. If vomiting or diarrhea does not stop, you need to review the feasibility of contraception with VyLibra.