Drospifem 30 (ethinylestradiol, drospirenone) coated tablets 0.03 mg/3 mg. №21

Description

Drospifem Storage
active substances: ethinyl estradiol, drospirenone;

1 tablet contains: 0.03 mg of ethinyl estradiol and 3 mg of drospirenone;

Drospifem Excipients: lactose monohydrate, corn starch, maltodextrin, magnesium stearate, Opadry 10A32290 yellow (hypromellose, talc, titanium dioxide (E 171), polysorbate 80, iron oxide yellow (E 172).

Drospifem Dosage form
Film-coated tablets

Main physical and chemical properties: round tablets are covered with a yellow film coating without coating defects.

Pharmacotherapeutic group
Gonadal hormones and drugs used in pathology of the genital area. Hormonal contraceptives for systemic use.

Progestogens and estrogens, fixed combinations. Drospirenone and ethinyl estradiol.

ATX code G03A A12.

Pharmacological properties

Pharmacodynamics.

Pearl of contraceptive failures for the drug: 0.09 (upper bilateral 95% confidence interval (CI): 0.32).

General Pearl index (contraceptive failures + errors on the part of patients) for the drug: 0.57 (upper bilateral 95% confidence interval (CI): 0.90).

Drospifem® 30 is a combined oral contraceptive containing ethinyl estradiol and drospirenone. In therapeutic doses, drospirenone exhibits antiandrogenic and moderate antimineralocorticoid properties. It has no estrogenic, glucocorticoid or antiglucocorticoid activity. Therefore, drospirenone has a similar pharmacological profile to natural progesterone.

The contraceptive effect of the drug is based on the interaction of various factors, the most important of which are the suppression of ovulation and changes in cervical secretion.

According to clinical studies, moderate antimineralocorticoid properties of the drug Drospifem® 30 lead to moderate antimineralocorticoid effects.

Indication
Oral contraception.

The decision to prescribe Drospifem® 30 should be made taking into account the individual available risk factors of the patient, in particular the risk factors for venous thromboembolism (VTE). The risk of VTE during treatment with Drospifem® 30 should also be compared with that with other combined hormonal contraceptives (COCs) (see Contraindications and Special Precautions for details).

Contraindication
CGC should not be used in the presence of at least one of the following conditions. If any of these conditions occur for the first time during the use of KGK, the drug should be discontinued immediately.

Presence or risk of venous thromboembolism (VTE):
o venous thromboembolism at present, in particular due to anticoagulant therapy, or in the anamnesis (eg deep vein thrombosis (DVT) or pulmonary embolism (pulmonary embolism));

o hereditary or acquired predisposition to venous thromboembolism, in particular resistance to activated protein C (including Leiden factor V mutation), antithrombin-III deficiency, protein C deficiency, protein S deficiency;

o major surgical interventions with prolonged immobilization (see section “Features”);

o high risk of venous thromboembolism due to the presence of numerous risk factors (see section “Peculiarities”).

Presence or risk of arterial thromboembolism (ATE):
o the presence of arterial thromboembolism at present or in the anamnesis (eg myocardial infarction) or the presence of prodromal symptoms (eg angina);

o cerebral circulatory disorders at present or in the anamnesis, the presence of prodromal symptoms (eg, transient ischemic attack (TIA));

o hereditary or acquired predisposition to arterial thromboembolism, in particular hyperhomocysteinemia and antibodies to phospholipids (antibodies to cardiolipins, lupus anticoagulant);

o migraine with focal neurological symptoms in the anamnesis;

o high risk of arterial thromboembolism due to the presence of numerous risk factors (see section “Peculiarities”) or due to the presence of one serious risk factor, such as: