Lindynette 30 tabs #21

Lindynette 30 instruction for use

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Lindynette 30 is a drug with an estrogen-progestin contraceptive effect.

Release form and composition

Dosage form of release of Lindynette 30 - coated tablets: yellow, round biconvex shape; core color - white (in a carton box 1 or 2 blister packs, 21 tablets in each pack).
Active substances in 1 tablet:
    ethinylestradiol - 30 mcg;
    gestodene - 75 mcg.
Additional components:
    core: lactose monohydrate - 37,155 mcg; corn starch - 15,500 mcg; sodium calcium edetate - 65 mcg; povidone - 1700 mcg; magnesium stearate - 200 mcg; colloidal silicon dioxide - 275 mcg;
    shell: talc - 4242 mcg; quinoline yellow dye (E104) - 18 mcg; macrogol 6000 - 2230 mcg; povidone - 171 mcg; titanium dioxide - 448 mcg; calcium carbonate - 8231 mcg; sucrose - 19,660 mcg.

Pharmacodynamics

Lindynette 30 is one of the monophasic oral contraceptives.
The contraceptive action is associated with the properties of the active substances:
    ethinylestradiol is an estrogenic component, is a synthetic analogue of the follicular hormone estradiol; along with the hormone of the corpus luteum takes part in the regulation of the menstrual cycle;
    gestodene - a progestogen component, is a derivative of 19-nortestosterone; the natural hormone of the corpus luteum progesterone and other synthetic progestogens (in particular, levonorgestrel) are superior in strength and selectivity of exposure. Due to its high activity, it is used in low dosages, in which androgenic properties are not manifested and there is practically no effect on lipid / carbohydrate metabolic processes.
In addition to these central and peripheral mechanisms, the contraceptive effect is associated with a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus that is in the cervix, which makes it relatively impassable for spermatozoa.
With regular intake, in addition to the main action, Lindynette 30 helps to normalize the menstrual cycle and prevent the occurrence of a number of gynecological diseases, including pathologies of tumor etiology.

Pharmacokinetics

Pharmacokinetic characteristics of Ethinylestradiol:
    absorption: after oral administration, it is absorbed almost completely and quickly. The achievement of the average Cmax in the blood serum occurs after 60-120 minutes and is 30-80 pg / ml. Absolute bioavailability - approximately 60% (due to primary metabolism and presystemic conjugation);
    distribution: there is a complete (approximately 98.5%), but non-specific binding to albumins. The substance induces an increase in the level of SHBG in the blood serum. The average Vd ranges from 5 to 18 l/kg. Css (stationary concentration of the substance) is set on the 3rd-4th day of taking Lindynette 30. It is 20% higher than the concentration of the drug after a single application;
    metabolism: ethinyl estradiol undergoes hydroxylation with subsequent formation of methylated / hydroxylated metabolites present as free metabolites or conjugates (sulfates and glucuronides). Metabolic clearance from blood plasma - approximately 5-13 ml;
    excretion: serum concentration decreases biphasically. T1 / 2 in the β-phase - approximately 16-24 hours. Ethinylestradiol is excreted only in the form of metabolites, with urine and bile (ratio 2: 3). T1 / 2 metabolites - approximately 24 hours.
Pharmacokinetic characteristics of gestodene:
    absorption: from the gastrointestinal tract is absorbed quickly and in full. After taking a single dose, Cmax (the maximum concentration of the substance) is noted after 60 minutes and ranges from 2 to 4 ng / ml. Has high bioavailability (about 99%);
    distribution: the substance binds to albumin and to SHBG (globulin that binds sex hormones). From 1 to 2% is in free form in plasma, from 50 to 75% specifically binds to SHBG. The increase in the level of SHBG in the blood caused by ethinylestradiol affects the level of gestodene: the fraction associated with SHBG increases and the fraction associated with albumin decreases. The average Vd (volume of distribution) is from 0.7 to 1.4 l / kg. Pharmacokinetic processes of gestodene are determined by the level of SHBG. The plasma concentration of SHBG in the blood under the influence of estradiol increases 3 times. The concentration of gestodene when taking Lindynette 30 daily in the blood plasma increases by 3-4 times and reaches a state of saturation in the second half of the cycle;
    Metabolism and excretion: Gestodene is biotransformed in the liver. The average plasma clearance is from 0.8 to 1 ml / min / kg. The serum level of gestodene in the blood decreases biphasically. T1 / 2 (half-life) in the β-phase is in the range of 12-20 hours. Gestodene is excreted only in the form of metabolites: with urine - 60%; with feces - 40%. T1 / 2 metabolites - approximately 24 hours.

Indications for use

According to the instructions, Lindynette 30 is prescribed for contraception.

Contraindications

Absolute:
    migraine, accompanied by focal neurological symptoms, including instructions in the anamnesis;
    burdened family history of venous thromboembolism;
    diabetes mellitus with angiopathy;
    a period of prolonged immobilization after surgery;
    pancreatitis, accompanied by severe hypertriglyceridemia, including indications in history;
    dyslipidemia;
    jaundice while taking glucocorticosteroids;
    cholelithiasis, including instructions in history;
    severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis (including indications in the anamnesis) - you can prescribe Lindynette 30 3 months after the normalization of indicators;
    venous or arterial thrombosis / thromboembolism (including pulmonary embolism, stroke, myocardial infarction, deep vein thrombosis of the leg), including indications in the anamnesis;
    Gilbert, Rotor and Dubin-Johnson syndromes;
    liver tumors, including indications in history;
    hormone-dependent malignant neoplasms of the genital organs / mammary glands, including suspicion of them;
    vaginal bleeding of unknown origin;
    smoking more than 15 cigarettes per day over the age of 35;
    severe itching, otosclerosis or its progression while taking glucocorticosteroids or during a previous pregnancy;
    precursors of thrombosis (including angina pectoris, transient ischemic attack), including indications in the anamnesis;
    severe / multiple risk factors for venous or arterial thrombosis, including atrial fibrillation, complicated valvular heart disease, cerebrovascular or coronary artery disease, severe or moderate arterial hypertension with BP (blood pressure) ≥ 160/100 mm Hg. Art.;
    pregnancy (confirmed or suspected) and lactation;
    individual intolerance to any component of Lindynette 30.
Relative (the drug is prescribed under medical supervision):
    diabetes mellitus without vascular complications;
    SLE (systemic lupus erythematosus);
    granulomatous enteritis;
    hypertriglyceridemia, including indications of a family history;
    liver disease in acute and chronic course;
    hereditary angioedema;
    Gasser's disease (hemolytic-uremic syndrome);
    obesity (with a body mass index of more than 30 kg/m2);
    arterial hypertension;
    dyslipoproteinemia;
    ulcerative colitis;
    epilepsy;
    migraine;
    sickle cell anemia;
    atrial fibrillation;
    valvular heart disease;
    prolonged immobilization;
    extensive surgical interventions, surgical interventions on the lower extremities;
    severe injuries;
    severe depression, including a history of indications;
    superficial thrombophlebitis and varicose veins;
    conditions in which the likelihood of venous or arterial thrombosis / thromboembolism increases, including smoking, age over 35 years, hereditary predisposition to thrombosis (thrombosis, cerebrovascular accident or myocardial infarction at a young age in immediate relatives);
    changes in biochemical parameters (antithrombin III deficiency, activated protein C resistance, hyperhomocysteinemia, protein C or S deficiency, antiphospholipid antibodies);
    diseases that arose for the first time / worsened during pregnancy or against the background of previous use of sex hormones, including hematoporphyria (porphyrin disease), herpes of pregnancy, Sydenham's chorea, chorea minor, chloasma;
    postpartum period, including lactating women after the end of the lactation period, non-lactating women (21 days after birth).

Instructions for use Lindynette 30: method and dosage

Lindynette 30 tablets are taken orally once a day, preferably at the same time of day.
After finishing taking the pills from the package (21 pcs.), You need to take a break for seven days. Withdrawal bleeding usually occurs at this time. Then the cycle (21 days of admission + 7 days off) is repeated.
The first tablet should be taken between days 1-5 of the menstrual cycle.
Features of the beginning of the drug:
    switching from another combined oral contraceptive: therapy with Lindynette 30 is started after taking the last tablet from the package of such an oral contraceptive;
    transition from "mini-pill" (containing only progestogen): therapy can be started on any day of the cycle (the first seven days additional methods of contraception must be used);
    transition from the implant: therapy can be started the next day after its removal (the first seven days additional methods of contraception should be used);
    switching from contraceptive injections: therapy can be started on the eve of the last injection (the first seven days additional methods of contraception should be used);
    period after abortion in the first trimester of pregnancy: therapy can be started after surgery;
    the period after childbirth or after an abortion in the second trimester of pregnancy: therapy can be started on days 21–28 (the first seven days additional methods of contraception should be used, with a later start of taking the drug, additional, barrier methods of contraception are required); if sexual contact has taken place during this period, either pregnancy should be excluded or therapy with Lindynette 30 should be started after menstruation.
If you miss taking Lindynette 30, you should be guided by the following recommendations (depending on the interval between doses of the drug):
    before 36 hours: the missed tablet should be taken as soon as possible. The contraceptive effect during this period does not decrease. Next, you should resume the usual dosing regimen;
    over 36 hours: the contraceptive effect may decrease. It is necessary to continue taking Lindynette 30 as usual, without making up for the missed dose, while additional methods of contraception should be used in the next seven days. If more than 14 tablets from the package were taken, the seven-day break should not be taken. Withdrawal bleeding in such cases does not occur until the end of taking the drug from the second package, and spotting / breakthrough bleeding may occur. If withdrawal bleeding does not occur after completion of taking Lindynette 30 from the second package, pregnancy should be excluded before continuing therapy.
If vomiting / diarrhea develops within 3-4 hours after taking the drug, this may lead to a decrease in the contraceptive effect. In such cases, it is necessary to follow the instructions related to skipping pills. If you do not want to deviate from the usual scheme of taking the drug, the missed tablets can be taken from another package.
To speed up the onset of menstruation, the break in taking the drug should be reduced. The shorter this period, the greater the likelihood of breakthrough or spotting bleeding while taking the pills from the next pack.
If it is necessary to delay the onset of menstruation, Lindynette 30 should be continued without interruption. This method can be used until the end of the last pill from the second package. With a delay in menstruation, breakthrough or spotting bleeding may occur. After the usual seven-day break, you can return to the standard dosing regimen.

Side effects

The frequency of occurrence of violations: (> 10%) - very often; (> 1% and < 10%) - often; (> 0.1% and < 1%) - infrequently; (> 0.01% and < 0.1%) - rarely; (< 0.01% and including individual reports) - very rare.
Adverse reactions, during the development of which Lindynette 30 is canceled:
    cardiovascular system: arterial hypertension; rarely - arterial / venous thromboembolism (including pulmonary embolism, myocardial infarction, stroke, deep vein thrombosis of the lower extremities); very rarely - arterial / venous thromboembolism of the renal, mesenteric, retinal, hepatic arteries and veins;
    sensory organs: hearing loss due to otosclerosis;
    other reactions: Gasser's disease, hematoporphyria; rarely - reactive SLE (exacerbation); very rarely - Sydenham's chorea (passes after the abolition of Lindynette 30).
The development of other disorders are more common, but they are less severe. The doctor determines the expediency of continuing to take Lindynette 30 individually after assessing the ratio of the benefits of therapy and the existing risk.
Possible violations:
    reproductive system: pain, tension, candidiasis, galactorrhea, enlargement of the mammary glands, amenorrhea after discontinuation of the drug, acyclic bleeding / bloody discharge from the vagina, changes in the state of vaginal mucus, the development of inflammatory processes in the vagina;
    central nervous system: headache, depression, mood lability, migraine;
    digestive system: occurrence / exacerbation of jaundice and / or itching associated with cholestasis, hepatitis, cholelithiasis, granulomatous enteritis, epigastric pain, vomiting, nausea, ulcerative colitis, liver adenoma;
    metabolism: weight gain, fluid retention in the body, decreased carbohydrate tolerance, hyperglycemia, increased thyroglobulin levels;
    dermatological reactions: increased alopecia, exudative erythema, erythema nodosum, chloasma, rash;
    sensory organs: increased sensitivity of the cornea (when wearing contact lenses), hearing loss;
    other: allergic reactions.

Overdose

The main symptoms of overdose: vomiting, nausea, vaginal bleeding (in young patients). The development of severe symptoms after taking large doses of Lindynette 30 was not reported.
There is no specific antidote. Symptomatic treatment is prescribed.

Special instructions

Prior to the appointment of Lindynette 30, a general medical (includes a detailed personal / family history, blood pressure measurement, laboratory tests) and gynecological examinations are required. In the future, such examinations should be carried out regularly 2 times a year.
Lindynette 30 is one of the reliable contraceptives with a Pearl index of 0.05 (subject to the correct dosing regimen). The effect of the drug is fully manifested by the 14th day from the start of administration, therefore, during this period, the use of non-hormonal contraceptive methods is recommended.
The question of the advisability of taking Lindynette 30 should be decided individually, taking into account the benefits and possible negative effects.
The woman's condition must be carefully monitored. If during the period of taking Lindynette 30 any of the following conditions / diseases appears / worsens, the therapy is canceled (with the transition to a non-hormonal method of contraception):
    diseases of the hemostasis system;
    migraine;
    conditions / diseases that predispose to the occurrence of cardiovascular, renal failure;
    epilepsy;
    factors that increase the likelihood of an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
    diabetes mellitus without vascular disorders;
    sickle cell anemia;
    severe depression (in cases where depression is associated with impaired tryptophan metabolism, vitamin B6 may be used for correction);
    abnormalities in laboratory tests evaluating liver function.
There is a connection between taking Lindynette 30 and an increased risk of developing arterial and venous thromboembolic diseases. Factors that increase the likelihood of their development include:
    indications of a family history of thromboembolic diseases (if a genetic predisposition is suspected, a medical consultation is required beforehand);
    age;
    smoking;
    obesity with a body mass index of 30 kg/m2;
    arterial hypertension;
    dyslipoproteinemia;
    atrial fibrillation;
    heart valve diseases complicated by hemodynamic disorders;
    prolonged immobilization after major surgery, surgery on the lower extremities, severe injuries (recommended period of temporary cessation of the use of Lindynette 30 - 28 days before surgery / 14 days after remobilization);
    diabetes mellitus with vascular lesions.
After childbirth, the risk of venous thromboembolic disease increases. Also, risk factors include granulomatous enteritis, SLE, diabetes mellitus, Gasser's disease, ulcerative colitis, sickle cell anemia.
When evaluating the benefit of taking Lindynette 30 and the risk, it should be taken into account that with targeted treatment of this condition, the likelihood of thromboembolism is reduced.
Symptoms of thromboembolism:
    shortness of breath that appeared suddenly;
    chest pain, which appeared suddenly, which radiates to the left arm;
    headache, unusually severe of any etiology, which lasts for a long time or appears for the first time. Patients who have a combination with the following disorders need special attention: sudden complete / partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of one half of the body, movement disorders, severe unilateral pain in the gastrocnemius muscle, symptom complex "sharp belly"
Taking Lindynette 30 can be regarded as one of the risk factors for developing cervical cancer.
There are few reports on the occurrence of a benign / malignant liver tumor against the background of long-term use of the drug, which must be taken into account when conducting a differential diagnosis of abdominal pain.
If there is a risk of chloasma while taking Lindynette 30, contact with sunlight or ultraviolet radiation should be avoided.
Due to the estrogen component, it is possible to change the level of some laboratory parameters - hemostasis indicators, functional indicators of the liver, adrenal glands, kidneys, thyroid gland, levels of transport proteins and lipoproteins.
For patients who have had acute viral hepatitis, Lindynette 30 can be taken after normalization of liver function (not earlier than six months later).
Lindynette 30 does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Use during pregnancy and lactation

Lindynette 30 tablets are not prescribed to women during pregnancy / breastfeeding.

For impaired liver function

    diseases / severe violations of the liver function, liver tumors (including indications in the anamnesis): therapy is contraindicated;
    liver failure, cholestatic jaundice (including in a history of pregnancy): Lindynette 30 should be administered with caution.

Drug interaction

Possible interactions:
    other drugs (including cyclosporine, theophylline): increase / decrease in their concentration in blood plasma, which is associated with ethinyl estradiol, which affects metabolism;
    ampicillin, tetracycline, rifampicin, barbiturates, primidone, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine: decreased contraceptive action of Lindynette 30, increased breakthrough bleeding and menstrual disorders; during the period of combined use and for another seven days after the end of the course, additional non-hormonal methods of contraception must be used; after using rifampicin, these precautions must be observed for 4 weeks;
    topiramate, hydantoin, felbamate, rifabutin, griseofulvin, rifampicin, phenylbutazone, barbiturates, phenytoin, oxcarbazepine and other inducers of microsomal liver enzymes: a decrease in the plasma level of ethinylestradiol in the blood;
    any drugs that increase the motility of the gastrointestinal tract: a decrease in the absorption of the active components of Lindynette 30 and their plasma level in the blood;
    itraconazole, fluconazole and other liver enzyme inhibitors: increased plasma levels of ethinyl estradiol in the blood;
    drugs whose sulfation occurs in the intestinal wall (including ascorbic acid): competitive inhibition of ethinylestradiol sulfation, which leads to an increase in the bioavailability of ethinylestradiol;
    ampicillin, tetracycline and some other antibiotics: obstruction of the intrahepatic circulation of estrogen, which leads to a decrease in the level of ethinyl estradiol in plasma;
    hypoglycemic agents: decreased carbohydrate tolerance, increased need for insulin / oral antidiabetic agents, which may cause a correction in the dosing regimen of these drugs;
    St. John's wort preparations (including infusion): a decrease in the concentration of the active components of Lindynette 30 in the blood, which can cause breakthrough bleeding / pregnancy; the appointment of this combination is not recommended, the interaction is observed for another 14 days after the end of the course of taking St. John's wort;
    ritonavir: decrease in AUC (area under the concentration-time curve) of ethinyl estradiol by 41%; if necessary, the combined use of drugs shows the use of a hormonal contraceptive with a higher content of ethinyl estradiol or the use of additional non-hormonal methods of contraception.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 °C. Keep away from children.
Shelf life - 3 years.

Reviews about Lindynette 30

According to reviews, Lindynette 30 is an inexpensive contraceptive. In some cases, the development of adverse reactions is reported, which can lead to the abolition of therapy.

Terms of sell

You can buy Lindynette 30 without a prescription from a doctor.