Jasmiel is a hormonal birth control drug containing two female hormones: estrogen and progestin. This drug is intended to suppress ovulation and preven unwanted pregnancy.
Indications for use
Mechanism of action
Jasmiel is a microdose monophasic oral contraceptive with anti-corticosteroid and anti-androgenic effect. The contraceptive effect is achieved due to a number of factors, the most important of which are inhibition of ovulation and a change in the viscosity of cervical mucus. The endometrium remains unprepared for egg implantation. As a result of the change in the viscosity of cervical mucus, the penetration of sperm into the uterine cavity is difficult. Drospirenone has anti-corticosteroid activity, which can prevent weight gain and other symptoms associated with fluid retention.
In combination with ethinyl estradiol, this drug improves the lipid profile and increases the concentration of HDL. It has antiandrogenic activity, which contributes to a decrease in acne formation and a decrease in the production of sebaceous glands, does not affect the increase in the formation of sex hormone-binding globulin caused by ethinyl estradiol. Drospirenone is devoid of any androgenic, estrogenic, GCS and antiGCS activity.
Mode of application and dose
Oral administration. A woman should take 1 tablet, in the order indicated on the package, every day at about the same time with a small amount of water, continuously for 28 days. There is no 7-days break. During the latest 7 pills, menstruation will start.
This drug, like other combined oral contraceptives, is contraindicated in any of the following conditions:
- hypersensitivity to the drug or any of the components of the drug;
- thrombosis (arterial and venous) and thromboembolism currently or in history;
- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris), currently or in history;
- multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the vessels of the brain or coronary arteries;
- uncontrolled arterial hypertension, volumetric surgery with prolonged immobilization, smoking over the age of 35 years, obesity with a body mass index> 30;
- a hereditary or acquired predisposition to venous or arterial thrombosis;
- lactation period;
- pancreatitis with severe hypertriglyceridemia at present or in history;
- an existing (or history) severe liver disease, provided that the liver function is not currently normalized;
- severe chronic or acute renal failure;
- a liver tumor (benign or malignant) at present or in history;- hormone-dependent malignant neoplasms of the genitals or mammary gland at present or in the anamnesis;
- vaginal bleeding of unknown origin;
- a migraine with focal neurological symptoms in the anamnesis;
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency.
- Infectious and parasitic diseases: rarely – candidiasis.
- The blood and lymphatic system: rarely – anemia, thrombocytopenia.
- The immune system: rarely – allergic reactions; frequency unknown – hypersensitivity.
- Metabolism and nutrition: rarely – increased appetite, anorexia, hyperkalemia, hyponatremia.
- Mental health: often – emotional lability, depression, decreased libido; infrequently – nervousness, drowsiness; rarely – anorgasmia, insomnia.
- The nervous system: often – headache; infrequently – dizziness, paresthesia; rarely – vertigo, tremor.
- The organ of vision: rarely – conjunctivitis, dry mucous membranes of the eyes.
- The cardiovascular system: often – migraine; infrequently – varicose veins, increased blood pressure; rarely tachycardia, phlebitis, nosebleeds, fainting, venous thromboembolism, arterial thromboembolism.
- The digestive tract: often – nausea; infrequently – abdominal pain, vomiting, dyspepsia, flatulence, gastritis, diarrhea; rarely – bloating, a feeling of heaviness in the abdomen, a hiatal hernia, candidiasis of the oral cavity, constipation, dry mouth.
- The liver and biliary tract: rarely – biliary dyskinesia, cholecystitis.
- The skin and subcutaneous tissues: infrequently – acne, itching, rash; rarely – chloasma, eczema, alopecia, acne dermatitis, dry skin, erythema nodosum, hypertrichosis, striae, contact dermatitis, photodermatitis, skin nodules; frequency unknown – erythema multiforme.
- The musculoskeletal system: infrequently – back pain, pain in the limbs, muscle cramps.
- The genitals and mammary gland: often – pain in the mammary glands, metrorrhagia, lack of menstrual bleeding; infrequently – vaginal candidiasis, pelvic pain, enlargement of the mammary glands, fibrocystic masses in the mammary gland, spotting/bleeding from the genital tract, secretions from the genital tract, hot flashes with sensation of heat, vaginitis, painful menstrual bleeding scanty menstrual bleeding, profuse menstrual bleeding, dryness of the vaginal mucosa, pathological results of the Papanicolaou test; rarely – dyspareunia, vulvovaginitis, postcoital bleeding, withdrawal bleeding, breast hyperplasia, neoplasm in the mammary gland, cervical polyp, endometrial atrophy, ovarian cyst, uterine enlargement.
- Laboratory and instrumental data: infrequently – weight gain; rarely – weight loss.
- Other: infrequently – asthenia, increased sweating, edema (generalized edema, peripheral edema, facial edema); rarely – malaise.
Jasmiel is possible to interact with drugs that induce microsomal enzymes, as a result of which the clearance of sex hormones can increase, which, in turn, can lead to breakthrough uterine bleeding and/or a decrease in the contraceptive effect.
Women who undergo therapy with such drugs in addition to Jasmiel are advised to use the barrier method of contraception or choose another non-hormonal method of contraception. The barrier method of contraception should be used during the entire period of taking concomitant drugs, as well as within 28 days after their withdrawal.
Drugs that increase the clearance of this birth control drug (weakening effectiveness by inducing enzymes): phenytoin, barbiturates, primidone, carbamazepine, rifampicin and, possibly, oxcarbazepine, topiramate, felbamate, griseofulvin, as well as drugs containing St. John’s wort.
Drugs with different effects on the clearance of this drug: when used together with this birth control drug, many HIV protease inhibitors or hepatitis C virus and non-nucleoside reverse transcriptase inhibitors can both increase and decrease the concentration of estrogens or progestins in the blood plasma. In some cases, this effect may be clinically significant.
Means of reducing clearance of combined oral contraceptives (enzyme inhibitors) are: strong and moderate inhibitors of CYP3A4, such as antifungals azole groups (e.g., itraconazole, voriconazole, fluconazole), verapamil, antibiotic macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of estrogen or progestin, or both.
What is I miss a dose?
If the delay in taking the pills was over 12 hours (the interval from the last pill should not be over 36 hours), contraceptive protection can be reduced. If you miss the drug on the 1-2 weeks, you must take the last missed tablet as soon as possible (even if it means taking 2 tablets at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception should be used over the next 7 days.
Jasmiel and pregnancy
The drug is contraindicated during pregnancy. If pregnancy has occurred during the drug use, its administration should be discontinued immediately. Extensive epidemiological studies did not reveal an increase in the risk of birth defects in children born to women who took combined oral contraceptives before pregnancy, nor the teratogenic effect of combined oral contraceptives when they were inadvertently taken during pregnancy. According to preclinical studies, it is impossible to exclude undesirable effects that affect the course of pregnancy and fetal development, due to the hormonal action of the active components.
Jasmiel can affect lactation. It can reduce the amount of milk and change its composition. Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk while taking combined oral contraceptives. These amounts may affect the baby health. The drug use during breastfeeding is contraindicated.