Delsia tabs 3mg + 0.03mg #21

Delsia instruction for use

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Release form and composition

The drug is produced in the form of film-coated tablets: round, biconvex, yellow, engraved on one side "647", the core is from white to almost white (21 pcs. In blisters, in a cardboard box 1 or 3 blisters and instructions for the use of Delsia).
1 tablet contains:
    active ingredients: ethinylestradiol - 0.03 mg, drospirenone - 3 mg;
    auxiliary components: corn starch, lactose monohydrate, hypromellose 2910, colloidal silicon dioxide, magnesium stearate, talc;
    film casing: Opadray II yellow 31F82689.

Pharmacodynamics

Delsia is a combined monophasic hormonal contraceptive drug, the contraceptive effect of which is associated with the interaction of the following most important factors: inhibition of ovulation and an increase in the viscosity of the cervical secretion. With increased viscosity, the cervical secretion becomes impermeable to sperm.
If the recommended dosage regimen is observed, the Pearl index (an indicator of the number of pregnancies in 100 women taking a contraceptive for 12 months) is less than 1. The Pearl index increases with improper use or missed admission.
Drospirenone (gestagen) in a therapeutic dose also has antiandrogenic and weak antimineralocorticoid properties. Without estrogenic, antiglucocorticoid and glucocorticoid activity, the pharmacological profile of drospirenone is similar to that of natural progesterone. The presence of antiandrogenic activity provides a decrease in the production of the secretion of the sebaceous glands. This effect is especially important for women with acne, hormone-dependent fluid retention and seborrhea and should be considered when choosing a contraceptive.
The combination of progestogen with ethinyl estradiol (estrogen) in Delsia improves the lipid profile, increases the concentration of HDL (high density lipoproteins).
The use of the drug regulates the menstrual cycle, reduces the severity of pain and the volume of menstrual bleeding, which helps to reduce the risk of developing iron deficiency anemia.

Pharmacokinetics

After taking Delsia inside, drospirenone and ethinyl estradiol are rapidly and almost completely absorbed, their bioavailability is 76–85% and 60%, respectively. On the background of receiving a single dose, the maximum concentration (Cmax) of active substances in the blood plasma is reached within 1-2 hours and is: drospirenone ~ 35 ng / ml, ethinylestradiol - 88-100 ng / ml. With the simultaneous intake of food, the bioavailability of drospirenone does not change, and ethinyl estradiol decreases in 25% of women.
The binding of ethinyl estradiol to plasma proteins is ~ 98.5%. Drospirenone binds to blood plasma albumin, does not bind to SHBG (sex hormone binding globulin) or CSG (corticosteroid binding globulin). The content of free drospirenone does not exceed 3-5% of the dose taken. An increase in SHBG (induced by estradiol) does not affect the binding of drospirenone to plasma proteins. Ethinylestradiol induces the synthesis of SHBG in the liver.
Average apparent volume of distribution (Vd): drospirenone - 3.7 l / kg, ethinylestradiol - ~ 5 l / kg. The equilibrium plasma concentration (Css) of drospirenone is reached between 7 and 14 days of therapy and is about 60 ng / ml, ethinylestradiol - in the second half of the cycle.
0.02% of the dose of ethinyl estradiol penetrates into breast milk.
Drospirenone is metabolized in the liver almost completely and without the involvement of the cytochrome P450 system, mainly with the formation of acid forms of drospirenone and 4,5-dihydro-drospirenone-3-sulfate.
Ethinylestradiol is completely metabolized as a result of presystemic conjugation in the mucous membrane of the small intestine (50-60% of the dose) during the period of absorption and the first passage through the liver. The main metabolic pathway is aromatic hydroxylation with the formation of hydroxylated and methylated free metabolites, and in the form of conjugates with sulfuric and / or glucuronic acid. Ethinyl estradiol conjugated with glucuronic acid is reabsorbed in the intestine after excretion in the bile.
The rate of metabolic clearance from blood plasma is: drospirenone (on average) - 1.5 ml / min / kg, ethinylestradiol - 5 ml / min / kg.
Active substances are excreted in the form of metabolites through the kidneys and intestines, their half-life (T1 / 2): drospirenone - 40 hours, ethinylestradiol - 24 hours.

Indications for use

Delsia tablets are recommended to be taken in order to prevent unwanted pregnancies.

Contraindications

Absolute:
    venous and arterial thrombosis, including deep vein thrombosis, pulmonary embolism, cerebrovascular disorders, myocardial infarction (including history);
    transient ischemic attacks, atrial fibrillation, angina pectoris and other conditions preceding thrombosis (including history);
    diseases of the vessels of the brain or coronary arteries, complicated lesions of the valvular apparatus of the heart, atrial fibrillation and other severe or multiple risk factors for venous or arterial thrombosis;
    predisposition (hereditary or acquired) to venous or arterial thrombosis - resistance to activated protein C (APC), protein C deficiency, antithrombin III deficiency, protein S deficiency, the presence of antiphospholipid antibodies (lupus anticoagulant, antibodies to cardiolipin), hyperhomocysteinemia;
    uncontrolled arterial hypertension;
    migraine with focal neurological symptoms (including history);
    major trauma or surgery, lower limb surgery;
    prolonged immobilization;
    obesity with a BMI (body mass index) of more than 30 kg / m2;
    diabetes mellitus with diabetic angiopathy;
    severe liver disease (including within 3 months after normalization of liver function tests), liver failure;
    lactase deficiency, lactose intolerance, glucose-galactose malabsorption (Delsia tablets contain lactose);
    benign or malignant liver tumors (including history);
    pancreatitis with severe hypertriglyceridemia (including history);
    acute or severe renal failure;
    identified hormone-dependent malignant pathologies (including mammary glands, genitals) or suspicion of them;
    vaginal bleeding of unknown origin;
    smoking over the age of 35;
    pregnancy or suspicion of it;
    breast-feeding;
    hypersensitivity to the components in Delsia.
With caution, Delsia should be prescribed to patients with risk factors for thrombosis and thromboembolism, such as controlled arterial hypertension, migraine without focal neurological symptoms, obesity with a BMI less than 30 kg / m2, dyslipoproteinemia, the presence of thrombosis and thromboembolism in the family history or violation of cerebral circulation in close relatives at a young age), uncomplicated valvular heart disease, smoking, age over 35 years in non-smoking women; for diseases that may be accompanied by peripheral circulatory disorders (systemic lupus erythematosus, diabetes mellitus without vascular disorders, ulcerative colitis, Crohn's disease, hemolytic uremic syndrome, phlebitis of superficial veins, sickle cell anemia); with mild to moderate liver disease, hereditary angioedema, hypertriglyceridemia, new or aggravated pathologies during pregnancy / against the background of previous use of sex hormones (including itching and / or jaundice associated with cholestasis, cholelithiasis, porphyria, otosclerosis with hearing impairment, chloasma , history of herpes during pregnancy, Sydenham's chorea, postpartum period).

Delsia, instructions for use: method and dosage

Delsia tablets are taken orally 1 pc. a day at a set time, washed down with water.
It is required to observe the order indicated on the blister, taking the tablets within 21 days. This is followed by a 7-day break, after which the pills from the next package begin to be taken. During the break, menstrual bleeding takes place, usually it begins 2-3 days after the last tablet is taken from the blister.
If hormonal contraception is used for the first time, then it is necessary to start the course of Delsia on the first day of menstrual bleeding. In the case when tablets from the first package are received from the second to the fifth day of the menstrual cycle, it is recommended to additionally use barrier methods of contraception for the first 7 days.
When switching from another combined hormonal contraceptive, Delsia should be taken the day after using the last hormone-containing pill, on the day the vaginal ring or patch is removed.
When switching from drugs containing only gestagens, the first 7 days additionally use a barrier method of contraception. You can switch from a mini-pill without interruption on any day, from an injectable contraceptive - on the day of the next injection, from an implant or intrauterine system - on the day of their removal.
You can start taking Delsia immediately after an abortion in the first trimester of pregnancy without using additional methods of contraception.
It is recommended to start using the drug after childbirth or termination of pregnancy in the II trimester from 21 to 28 days without using additional methods of contraception. At a later start, the first week requires additional use of barrier contraceptives. If the woman had sexual intercourse before the start of the Delsia course, conception must be excluded.
When the pill is taken with a delay of less than 12 hours, the contraceptive protection does not decrease, further administration is continued at the set time.
The likelihood of pregnancy is the higher, the more tablets are missed, and the longer the interval between receiving them.
The activity of Delsia depends on adequate suppression of the hypothalamic-pituitary-ovarian system, which is achieved against the background of 7 days of a continuous course, therefore, the drug intake should not be interrupted for more than a 7-day period. If you are more than 12 hours late (that is, more than 36 hours have passed since the last pill was taken), there is a risk of a decrease in the contraceptive effect. The woman should take the missed pill immediately, even if it is necessary to take two pills at the same time, and continue using Delsia at the usual time.
If the delay occurred during the first 7 days of therapy, then the next 7 days additionally use a barrier method of contraception.
If the delay occurred in the period from 8 to 14 days, then there is no need to use additional contraceptive measures, provided that the therapy regimen has not been violated in the week preceding the first missed pill. If there are delays or missing two or more Delsia tablets, barrier contraceptives are additionally used for 7 days.
If the delay in admission occurred in the period from 15 to 21 days, then the risk of conception increases due to the upcoming break in the course. If the pills are used correctly within the previous 7 days before the first missed pill, there is no need for additional contraception. Otherwise, they adhere to one of two schemes:
    the first option: interrupt taking pills from the current blister and start the planned 7 days off (including the day of missing the pill), then continue therapy using pills from the new blister;
    second option: after taking the missed pill, continue using Delsia from the current package to the end and immediately start the next package without interruption. Withdrawal menstrual bleeding is unlikely to occur until the second pack is consumed. It is important to consider the risk of spotting bleeding or breakthrough bleeding during this period.
Recommendations when skipping taking Delsia tablets must be taken into account if vomiting occurs in the first 4 hours after receiving the next dose.
In the absence of menstrual bleeding against the background of missing pills, a woman should exclude conception.
If you want to delay menstrual bleeding, it is recommended to start using a new package without interruption, and continue using them for the required period. The appearance of spotting bleeding or breakthrough uterine bleeding is possible. After the usual 7 days of interruption, the regular intake of Delsia is resumed from the next package according to the scheme.
To postpone the onset of withdrawal bleeding to another day of the week, shorten the usual break in the course by the required number of days.

Side effects

    nervous system: headache;
    immune system: hypersensitivity reactions, bronchial asthma;
    mental disorders: depression, changes in libido;
    cardiovascular system: increase or decrease in blood pressure, migraine, thromboembolism;
    organ of hearing: decreased auditory perception;
    digestive system: nausea, vomiting, diarrhea;
    reproductive system and mammary gland: acyclic bleeding, menstrual irregularities, leucorrhoea, soreness and / or hypersensitivity of the mammary gland, breast enlargement, discharge from the mammary glands, vulvovaginal candidiasis, vaginitis;
    dermatological reactions: itching, acne, eczema, erythema nodosum and / or multiforme;
    others: change in body weight, fluid retention.

Overdose

Symptoms of a Delsia overdose: nausea, vomiting, bleeding from the vagina, metrorrhagia.
Treatment: there is no specific antidote, symptomatic therapy is indicated.

Special instructions

Before prescribing Delsia, the doctor must make sure that there is no pregnancy and disorders of the blood coagulation system, conduct a general medical and thorough gynecological examination, including a cytological examination of the cervix and mammary gland. With prolonged use of the drug, women are recommended to undergo control examinations at least once every 6 months.
The first months of contraception, the presence of irregular bleeding is allowed, but if they are repeated 3-4 months of therapy or occur after previous regular cycles, their clinical evaluation is required to exclude pregnancy or malignant neoplasms.
Patients should be informed that against the background of combined oral contraceptives, the incidence of venous and arterial thrombosis and thromboembolism increases, especially during the first 3 months. The likelihood of such complications increases with age, with a family history of venous or arterial thromboembolism, women who smoke (especially over the age of 35), obesity, arterial hypertension, heart valve disease, dyslipoproteinemia, atrial fibrillation, prolonged immobilization and forced restriction movement.
With major surgery, lower limb surgery or significant trauma, the course must be interrupted. Delsia is canceled 1 month before the planned operation and its reception is resumed 1/2 month after the end of immobilization.
In addition, peripheral circulatory disorders can also be observed in women with diabetes mellitus, with systemic lupus erythematosus, hemolytic uremic syndrome, ulcerative colitis, Crohn's disease, sickle cell anemia.
With an increase in the frequency and severity of migraine, the appearance of recurrent cholestatic jaundice (which first appeared during pregnancy or during the previous intake of sex hormones), the use of the drug should be discontinued immediately.
In women taking Delsia, when making a differential diagnosis of severe pain in the abdomen, signs of intra-abdominal bleeding and enlargement of the liver, the possible development of liver tumors should be taken into account.
It is recommended to avoid prolonged exposure to ultraviolet radiation if you are prone to chloasma.
The use of Delsia can worsen the course of epilepsy and endogenous depression.

Influence on the ability to drive vehicles and complex mechanisms

The drug does not affect the ability to drive vehicles and complex mechanisms.

Application during pregnancy and lactation

It is contraindicated to use Delsia tablets during pregnancy and lactation.

Childhood use

The use of Delsia in girls is permissible after the onset of the first menstruation.

With impaired renal function

The use of Delsia is contraindicated in acute or severe renal failure.

For violations of liver function

The use of Delsia is contraindicated in severe liver failure, severe liver disease (including within 3 months after the return of liver function tests to normal), benign or malignant liver tumors (including history).
Precautions should be taken when prescribing a contraceptive for mild to moderate liver disease.

Use in the elderly

The use of Delsia after menopause is contraindicated.

Drug interactions

    phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, barbiturates, primidone, rifampicin, rifabutin, griseofulvin, St.
    ritonavir, nevirapine: during treatment with HIV protease inhibitors (human immunodeficiency virus), non-nucleoside reverse transcriptase inhibitors or their combination and within 28 days after discontinuation, you must additionally use a barrier method of contraception;
    antibiotics of the penicillin and tetracycline series: during therapy with these agents and for a week after their cancellation, it is recommended to additionally use a barrier method of contraception;
    inhibitors of the cytochrome P450 system: drugs of this group do not affect the metabolism of drospirenone;
    cyclosporine: Delsia increases its concentration in plasma and tissues;
    lamotrigine: its level in plasma and tissues decreases.

Terms and conditions of storage

Keep out of the reach of children.
Store at temperatures up to 25 ° C.
Shelf life is 3 years.

Reviews about Delsia

Reviews about Delsia are controversial. Some women indicate high contraceptive effectiveness, cycle stability, and good drug tolerance. At the same time, some patients complain about prolonged bleeding, weight gain and other undesirable effects.

Terms of sell

You don't need a prescription to buy Delsia.