Introvale is a combination birth control pill which contains ethinyl estradiol and levonorgestrel, that are used to prevent pregnancy.
Indications for use
- Prevention of pregnancy.
Mechanism of action
Introvale is a combined oral contraceptive estrogen-progestational drug, which oppresses a pituitary secretion of gonadotropic hormones. The use of tablets containing progestin (levonorgestrel) and estrogen (ethinylestradiol) provides a concentration of these hormones in the blood that are close to their concentrations during the normal menstrual cycle and promotes the secretory transformation of the endometrium.
The contraceptive effect is associated with several mechanisms. Levonorgestrel blocks the releasing factors (luteinizing and follicle-stimulating hormones) of the hypothalamus, suppressing the secretion of the gonadotrophic hormones by the pituitary gland, which leads to inhibition of maturation and release of the ovum ready for fertilization. Ethinyl estradiol retains a high viscosity of the cervical mucus (making it difficult for sperm to enter the uterine cavity). In addition, the drug normalizes the menstrual cycle by replenishing the level of endogenous hormones with the hormonal components of Introvale tablets. In 7-day periods, when you take inert tablets, a uterine bleeding occurs.
Dosage and mode of application
This contraceptive is taken in cycles. To achieve a contraceptive effect, take 91 tablets (1 tablets per day), according to the directions on the blister, at the same time of a day.
Take the first tablet on the 1st day of the menstrual cycle, starting with active tablets containing levonorgestrel and ethinylestradiol, for 84 consecutive days. Then take 1 inert pill for 7 days. During this period, menstrual bleeding occurs. Start a new Introvale pack without breaks. Follow the same regimen.
Each next 91-day cycle begins on the same day of the week in which the patient took her first dose of the drug.
In some cases, Introvale pills can cause the following side effects:
- Reproductive system: engorgement of the mammary glands, decreased libido, intermenstrual bleeding, increased vaginal discharge, candidiasis of the vagina;
- Digestive system: nausea, vomiting, jaundice, hepatitis, liver adenoma, gallbladder disease (cholelithiasis, cholecystitis), diarrhea;
- Nervous system: headache, depressed mood, an increase in the frequency of epileptic seizures;
- Senses: eyelid edema, conjunctivitis, visual impairment, discomfort when wearing contact lenses (these phenomena are temporary), hearing loss;
- Metabolism: an increase in body weight, an increase in the concentration of triglycerides, glucose in the blood, a decrease in glucose tolerance;
- Skin and subcutaneous tissues: chloasma, skin rash, hair loss, generalized itching;
- Other: increased fatigue, increased blood pressure, thrombosis and venous thromboembolism, cramps calf muscles, coarsening of the voice.
Before using Introvale, it’s necessary to exclude the following contraindications:
- thrombosis (venous and arterial);
- thromboembolism (current conditions or history);
- conditions preceding thrombosis (current conditions or history);
- multiple or expressed risk factors for venous or arterial thrombosis;
- hereditary or acquired predisposition to venous or arterial thrombosis;
- migraine with focal neurologic symptoms (current conditions or history);
- uncontrolled arterial hypertension;
- diabetes mellitus with diabetic angiopathy;
- pancreatitis with severe hypertriglyceridemia (current conditions or history);
- hepatic insufficiency and severe liver disease;
- liver tumors (benign or malignant) (current conditions or history);
- severe dyslipoproteinemia;
- hormone-dependent malignant diseases (current conditions or history);
- bleeding from the vagina of unknown origin;
- lactation period (breastfeeding);
- postmenopausal period;
- age under 18 years;
- simultaneous use with preparations of St. John’s wort perfumed;
- hypersensitivity to ethinyl estradiol and levonorgestrel or other components of the drug.
- mild or moderate liver disease;
- diseases that first occurred or worsened during the previous pregnancy or against the background of the previous use of hormonal contraceptives (jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham’s chorea);
- women with hereditary angioedema, chloasma, depression, epilepsyrisk factors for thrombosis and thromboembolism: smoking, hereditary predisposition to thrombosis (thrombosis, a history of myocardial infarction or impaired cerebral circulation), overweight, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve disease;
- diabetes mellitus without diabetic angiopathy, hemolytic uremic syndrome, Crohn’s disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
Introvale tablets can interact with the following drugs:
- barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives;
- some antimicrobial agents (ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines);
- anticoagulants, coumarin or indanedione derivatives;
- tricyclic antidepressants, maprotiline, beta-blockers;
- oral hypoglycemic drugs and insulin;
- drugs with a potential hepatotoxic effect, for example, dantrolene.
Pregnancy and breastfeeding
Introvale is contraindicated for use during pregnancy or lactation period (breastfeeding).
What if I miss a pill?
If you miss an active pill (1-84 days), you should take it within the next 12 hours. If the delay exceeds 12 hours, you should continue taking birth control pills at your usual time without taking the missed pill. If you missed active tablets, the likelihood of sudden bleeding increases. If you miss an inert pill (85-91 days), discard it and continue taking birth control pills at your usual time.
Before using the medication, you should exclude pregnancy an undergo general medical and gynecological examination.
A regular gynecological examination is required at least every 6 months.
The drug can be used no earlier than 6 months after the previous viral hepatitis.
If a patient has a sharp pain in the upper abdominal areas, hepatomegaly or signs of intra-abdominal hemorrhage, she should exclude a liver tumor. In this case, birth control pills should be discontinued.
If a patient has acyclic bleeding, she can continue taking Introvale after excluding organic pathology.
If a patient has violations of the liver, you should consult a doctor.
If a patient has vomiting or diarrhea, she should continue taking the drug. It’s recommended to use an additional non-hormonal contraceptive method.
Birth control pills should be discontinued at least 3 months before the planned pregnancy.
Oral contraceptives containing ethinyl estradiol can change certain laboratory parameters (functional parameters of the liver, kidneys, adrenals, thyroid gland, blood coagulation factors and fibrinolytic factors, levels of lipoproteins and transport proteins).
The drug should be discontinued immediately if a patient has a migraine-like or unusually severe headache, acute worsening of visual acuity, a sharp increase in blood pressure, jaundice or hepatitis, generalized itching or the increase of epileptic seizures.
The drug should be discontinued 6 weeks before the planned surgery, with prolonged immobilization.
Introvale does not affect the ability to drive a car and work with mechanisms.