Jazz Plus (ethinyl estradiol, drospirenone) coated tablets №28

Description

Jazz Plus Composition
active ingredients: ethinylestradiol, drospirenone, calcium levomefolate;

1 package contains 28 tablets (24 pink and 4 light orange tablets);

1 pink tablet contains ethinylestradiol 0.02 mg (in the form of a clathrate with betadex) and drospirenone 3 mg, calcium levomefolate 0.451 mg;

Jazz Plus excipients: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hydroxypropyl methylcellulose, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E 171), iron oxide red (E 172);

1 tablet of light orange color contains 0.451 mg of calcium levomefolate;

excipients: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hydroxypropyl methylcellulose, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172).

Jazz Plus Dosage form
Film-coated tablets.

Basic physical and chemical properties:

film-coated tablets containing hormones, round, biconvex, pink, on one side of which “Z +” is displaced in a regular hexagon;
film-coated tablets containing only levomefolate, round, biconvex, light orange in color, on one side of which “M +” is displaced in a regular hexagon.
Pharmacological group
Hormonal contraceptives for systemic use.

ATX code G03A A12.

Pharmacological properties

Pharmacodynamics.

Mechanism of action

Combined oral contraceptives (COCs) reduce the risk of pregnancy mainly by inhibiting ovulation. Other possible mechanisms include changes in the nature of cervical mucus, which make it difficult for sperm to enter, and changes in the endometrium, which reduce the likelihood of implantation.

Pharmacodynamic properties

Drospirenone is an analogue of spironolactone, which has antimineralocorticoid and antiandrogenic properties. The estrogenic component of Jazz Plus is ethinyl estradiol.

Contraceptive action

Special studies of the pharmacodynamic properties of the drug Jazz Plus were not carried out.

Two studies evaluated the effect of the 3 mg drospirenone / 0.02 mg ethinylestradiol combination on the suppression of ovarian activity, determined by follicular size using transvaginal ultrasound and analysis of serum hormones (progesterone and estradiol) during two treatment cycles (21-day period of taking active pills plus a 7-day interval for taking pills). Suppression of ovulation was observed in more than 90% of the subjects participating in the study. One study compared the suppression of ovarian activity with a combination of 3 mg drospirenone / 0.02 mg ethinylestradiol in two different regimens (24-day active tablet intake plus 4-day interval and 21-day active tablet intake plus 7-day dose). interval in admission) for two cycles of treatment. During the first treatment cycle, ovulation was not observed in any of the women (0 / 49.0%) who received the drug in the 24-day regimen, and was observed in one woman (1 / 50.2%), who took the drug in 21 – daytime mode. After deliberate non-compliance with the dosage (three missed active tablets during the first three days of the cycle) during the second cycle of treatment, ovulation was observed in 1 patient (1 / 49.2%) from the group where the 24-day regimen was used, and in 4 patients (4 / 50.8%) from the group of drug use in the 21-day regimen.

Indications
Oral contraception

Jazz Plus is indicated for use by women in order to prevent pregnancy.

Premenstrual Dysphoric Disorder (PMDD)

Jazz Plus is prescribed to treat symptoms of premenstrual dysphoric disorder in women who have opted for oral contraception as a method of preventing pregnancy. The effectiveness of Jazz Plus in PMDD when used for more than three menstrual cycles has not been studied.

Acne

Jazz Plus is prescribed for the treatment of moderate forms of acne in women over the age of 14 (subject to the onset of persistent menstruation), which have no contraindications to oral contraceptive therapy. Jazz Plus should be used to treat acne only if the patient wishes to use oral contraception as a contraceptive.

Ensuring folate status

Jazz Plus is prescribed for women who have opted for oral contraception as a method of preventing pregnancy to increase folate levels in order to reduce the risk of a neural tube defect.

Contraindications
The drug Jazz Plus should not be used by women in the presence of one of the following diseases.

Impaired renal function.
Insufficiency of the adrenal cortex.
High risk of developing arterial or venous thrombosis. This category includes, for example, women who:
smoke and are over 35 years old (see the section “Peculiarities of use”);
have deep vein thrombosis or pulmonary embolism (PE), including a history (see section “Peculiarities of use”);
have cerebrovascular diseases (see section “Peculiarities of use”);
patients with ischemic heart disease (see section “Peculiarities of use”);
have thrombogenic defects of the heart valve or thrombogenic heart rhythm disturbances (for example, subacute bacterial endocarditis with valve lesions or atrial fibrillation (see section “Peculiarities of use”));
patients with hereditary or acquired hypercoagulopathy (see section “Peculiarities of use”);
patients with uncontrolled arterial hypertension (see section “Peculiarities of use”);
patients with diabetes mellitus with vascular complications (see section “Peculiarities of use”);
suffer from headaches with focal neurological symptoms or migraines with or without aura and are over 35 years old (see section “Peculiarities of use”).
Abnormal uterine bleeding of unknown etiology (see section “Peculiarities of use”.
Breast cancer or other types of cancer sensitive to estrogens or progestins, including a history (see the section “Peculiarities of use”).
Tumors of the liver, benign or malignant, or liver disease (see section “Peculiarities of use”, “Method of administration and dosage”).
Pregnancy (due to the absence of the need to use COCs during pregnancy) (see section “Peculiarities of use”, “Use during pregnancy or lactation”).
The use of a combination of drugs for the treatment of hepatitis C, containing ombitasvir / paritaprevir / ritonavir with or without the addition of dasabuvir, due to a potential increase in ALT levels (see sections “Peculiarities of use” and “Interaction with other drugs and other forms of interaction”).