Delsia, 3 mg+0.03 mg 63 pcs

A combined monophasic hormonal contraceptive. The contraceptive effect is based on the interaction of various factors, the most important of which are inhibition of ovulation, increasing the viscosity of the cervical secretion, as a result of which it becomes impermeable to sperm.

When used correctly, the Perl index (a measure of the number of pregnancies per 100 women using the contraceptive over the course of a year) is less than 1. The Perl Index may increase if you miss a dose or use it incorrectly.

In a therapeutic dose, drospirenone also has antiandrogenic and weak anti-mineralocorticoid properties. Deprived of estrogenic, glucocorticoid and antiglucocorticoid activity, drospirenone has a pharmacological profile similar to that of natural progesterone.

With its anti-androgenic activity, it helps to reduce sebum production and improve the clinical course in women with acne (acne vulgaris).

This should be considered when choosing a contraceptive drug, especially for women with hormone-dependent fluid retention and for women with acne and seborrhea. In combination with ethinylestradiol, it improves the lipid profile and increases HDL concentrations.

The use of this combination regulates menstrual bleeding, helping to reduce the severity of pain and volume of menstrual bleeding, reducing one of the risk factors for iron deficiency anemia.

Pharmacokinetics

Indications

Active ingredient

Composition

Excipients: lactose monohydrate – 60 mg, corn starch – 12.77 mg, colloidal silica – 0.8 mg, hypromellose 2910 – 1.6 mg, talc – 1.2 mg, magnesium stearate – 0.6 mg.

Film coating composition: opadray II yellow 31F82689 – 2.4 mg (hypromellose 2910 – 33%, lactose monohydrate – 28%, titanium dioxide (E171) – 22.5%, macrogol 6000 – 10%, talc – 5%, iron oxide yellow dye (E172) – 1.5%).

How to take, the dosage

Interaction

Long-term treatment with drugs that induce microsomal liver enzymes and increase clearance of sex hormones may lead to decreased contraceptive efficacy. These drugs include phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, rifampicin, rifabutin, topiramate, felbamate, griseofulvin, and drugs containing St. John’s wort.

HIV protease inhibitors (ritonavir), non-nucleoside reverse transcriptase inhibitors (nevirapine) and their combinations, can also potentially affect hepatic metabolism.

The maximum induction of enzymes is usually achieved about 10 days after initiation of these drugs, but may persist for at least 4 weeks after their withdrawal.

The concomitant use of drugs that affect the induction of microsomal liver enzymes and for 28 days after their withdrawal, a barrier method of contraception should be used temporarily.

The contraceptive protection is reduced while taking antibiotics of the penicillin and tetracycline series because of the decrease of intrahepatic circulation of estrogen and the consequent reduction of ethinyl estradiol concentrations. While taking these antibiotics and for 7 days after their withdrawal, an additional barrier method of contraception should be used.

As the main metabolites of drospirenone in human plasma are formed without the participation of the cytochrome P450 system, inhibitors of this enzyme system do not affect the metabolism of drospirenone.

The oral combined estrogen-gestogen contraceptives may affect the metabolism of other drugs, resulting in increased (cyclosporine) or decreased (lamotrigine) plasma and tissue concentrations.

Special Instructions

Pregnancy should be ruled out and a thorough general and gynecologic exam, including breast exams and cervical cytology, should be performed before starting medications containing this combination.

In addition, a clotting disorder should be ruled out. Prophylactic controls should be done at least once every 6 months if prolonged use is indicated.

A number of epidemiological studies have found an increased incidence of venous and arterial thrombosis and thromboembolism when taking OCs.

The greatest risk of these complications is in the first year of use (especially in the first 3 months) or resuming use after a 4-week break. The use of any OC can be complicated by the development of venous thromboembolism (VTE), manifesting as deep vein thrombosis and pulmonary embolism.

The estimated incidence of VTE in women taking low-dose oral contraceptives with estrogen (less than 50 mcg ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 0.5-3 per 10,000 women not using oral contraceptives.

The risk of thrombosis (venous and/or arterial) and thromboembolism increases: with age, in smokers (as the number of cigarettes smoked or age increases, the risk further increases, especially in women over 35), with a family history (i.e. venous or arterial thromboembolism ever in a close relative or parent at a relatively young age); obesity (BMI greater than 30 kg/m2); dyslipoproteinemia, arterial hypertension, heart valve disease, atrial fibrillation; prolonged immobilization; temporary immobilization, including air travel for more than 4 h serious surgical intervention; any lower extremity surgery or extensive trauma – in these situations, the drug should be discontinued; if surgery is planned, 4 weeks prior to surgery and do not resume for 2 weeks after the end of immobilization.

Peripheral circulatory disorders may also be seen in diabetes, SLE, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraines during the use of OCs (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these medications.

In rare cases, the development of liver tumors has been observed during the use of OCs. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be considered in the differential diagnosis.

Recurrent cholestatic jaundice that develops for the first time during pregnancy or during previous use of sex hormones requires discontinuation of OCs.

Women with hypertriglyceridemia or a family history have an increased risk of pancreatitis while taking OC.

While small increases in BP have been described in many women taking OCs, clinically significant increases have rarely been reported. The relationship between taking OCs and clinically significant increases in BP has not been established. However, if a persistent, clinically significant increase in BP develops during OC use, discontinuation and treatment of hypertension is necessary. OCs may be continued after physician consultation if BP has returned to normal with the help of hypotensive therapy.

While OCs may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using OCs. However, women with diabetes should be closely monitored while taking OCs.

Women with a tendency to chloasma should avoid prolonged sun exposure and exposure to UV radiation while taking OCs.

Drospirenone increases plasma renin and aldosterone concentrations due to its anti-mineralocorticoid activity.

Drospirenone may worsen the course of endogenous depression and epilepsy while taking OCs.

An irregular bleeding (spotting or breakthrough bleeding) may occur with OC, especially during the first months of use. Therefore, evaluation of any irregular bleeding is meaningful only after 3-4 months of contraception.

If irregular bleeding recurs or develops after previous regular cycles, a thorough evaluation should be performed to rule out malignancy or pregnancy.

Some women may not develop “withdrawal” bleeding during a break in the pill. If the OCs were taken as directed, pregnancy is unlikely. However, if the OCs have been taken irregularly before, or if there are no two consecutive “withdrawal” bleeds, pregnancy should be ruled out before continuing to take the medication.

Contraindications

Thrombosis (venous and arterial), current or history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders); conditions preceding thrombosis (including transient ischemic attacks, atrial fibrillation, angina pectoris).Current or past history of thrombosis (including transient ischemic attacks, atrial fibrillation, angina pectoris); presence of multiple or pronounced risk factors for venous or arterial thrombosis, including complicated valvular heart disease, atrial fibrillation, cerebrovascular or coronary artery disease; uncontrolled arterial hypertension, prolonged immobilization, major surgery, lower extremity surgery, major trauma, smoking over 35 years, obesity with BMI over 30 kg/msup>2; hereditary or acquired predisposition to venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and presence of antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant) migraine with focal neurological symptoms at present or in anamnesis; diabetes with diabetic angiopathy; liver failure and severe liver disease (before normalization of liver function tests and within 3 months after returning to normal values); liver tumors (benign or malignant) at present or in anamnesis; severe or acute renal failure; revealed hormone dependent malignant diseases (including genital or mammary organs and breast cancer).including genital or mammary glands) or suspected; vaginal bleeding of unclear genesis; pregnancy or suspected pregnancy; lactation (breast-feeding); pancreatitis with significant hypertriglyceridemia at present or in the past; hypersensitivity to the components of the combination.

If any of the above diseases or conditions develop for the first time while using a drug containing this combination, it should be stopped immediately.

With caution

Risk factors for thrombosis and thromboembolism: Smoking, obesity with a BMI less than 30 kg/m2, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart defects, a family history of thrombosis and thromboembolism (thrombosis, myocardial infarction or stroke at a young age in an immediate family member); age over 35 years in non-smoking women.

Diseases in which peripheral circulatory disorders may be noted: diabetes without vascular disorders, SLE, hemolytic-uremic syndrome, Crohn’s disease, ulcerative colitis, sickle cell anemia, superficial vein phlebitis.

Hereditary angioedema.

Hypertriglyceridemia;

Mild to moderate liver disease.

Diseases that first occurred or worsened during pregnancy or on previous use of sex hormones (including jaundice and/or pruritus associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, a history of herpes during pregnancy, Sindenham’s chorea, chloasma, postpartum).

Side effects

Immune system disorders: rare – bronchial asthma, hypersensitivity reactions.

Nervous system disorders: often – headache.

Psychiatric disorders: often – depression; infrequent – changes in libido.

Hearing organ: rarely – decreased hearing.

The cardiovascular system: frequent – migraine; infrequent – increased BP, decreased BP; rare – thromboembolism.

The digestive system: frequently – nausea; infrequently – vomiting, diarrhea.

Skin and subcutaneous tissue disorders: infrequent – acne, eczema, pruritus; rarely – erythema multiforme.

Reproductive system and breast: often – menstrual irregularities, acyclic bleeding, breast pain, breast hypersensitivity, colocolitis, candidiasis vulvovaginitis; infrequent – enlargement of the breast, vaginitis; rarely – mammary gland discharge.

Others: infrequent – fluid retention, weight changes.

Pregnancy use

Similarities