Lindinet 30

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Lindinet 30: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. For violations of liver function
11. Drug interactions
12. Analogs
13. Terms and conditions of storage
14. Terms of dispensing from pharmacies
15. Reviews
16. Price in pharmacies

Latin name: Lindynette 30

ATX code: G03AA10

Active ingredient: Ethinylestradiol + Gestodene (Ethinylestradiol + Gestodene)

Manufacturer: Gedeon Richter (Hungary)

Description and photo update: 2018-26-10

Prices in pharmacies: from 467 rubles.

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Lindinet 30 is a drug with estrogen-gestagenic contraceptive action.

Release form and composition

Dosage form of Lindinet 30 - coated tablets: yellow, round biconvex; core color - white (in a cardboard box 1 or 2 blisters of 21 tablets in each package).

Active ingredients 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 μg; macrogol 6000 - 2230 mcg; povidone - 171 mcg; titanium dioxide - 448 mcg; calcium carbonate - 8231 mcg; sucrose - 19 660 mcg.

Pharmacological properties

Pharmacodynamics

Lindinet 30 is one of the monophasic oral contraceptives.

The contraceptive effect is associated with the properties of the active substances:

ethinyl estradiol - an estrogenic component, is a synthetic analogue of the follicular hormone estradiol; along with the corpus luteum hormone, it takes part in the regulation of the menstrual cycle;
gestodene - a gestagenic component, is a derivative of 19-nortestosterone; the strength and selectivity of the effect is superior to the natural corpus luteum hormone progesterone and other synthetic progestogens (in particular, levonorgestrel). 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 mucus that is located in the cervix, which makes it relatively impassable for spermatozoa.

When taken regularly, in addition to the main action, Lindinet 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. Achievement of the average Cmax in the blood serum occurs after 60–120 minutes and is 30–80 pg / ml. Absolute bioavailability - about 60% (due to primary metabolism and presystemic conjugation);
distribution: complete (approximately 98.5%), but nonspecific binding to albumin occurs. The substance induces an increase in the serum SHBG level. The average Vd is in the range from 5 to 18 l / kg. Css (stationary concentration of the substance) is established on the 3-4th day of taking Lindinet 30. It is 20% higher than the concentration of the drug after a single use;
metabolism: ethinylestradiol undergoes hydroxylation with the subsequent formation of methylated / hydroxylated metabolites, which are present as free metabolites or conjugates (sulfates and glucuronides). Metabolic clearance from blood plasma - approximately 5-13 ml;
excretion: concentration in blood serum decreases in two phases. T _1/2 in β-phase - approximately 16-24 hours. Ethinylestradiol is excreted only in the form of metabolites, with urine and bile (ratio 2: 3). T _{1/2 of} metabolites is approximately 24 hours.

Pharmacokinetic characteristics of gestodene:

absorption: absorbed from the gastrointestinal tract quickly and in full. After taking one dose, Cmax (maximum concentration of the substance) is noted after 60 minutes and ranges from 2 to 4 ng / ml. Has a high bioavailability (approximately 99%);
distribution: the substance binds to albumin and SHBG (globulin that binds sex hormones). From 1 to 2% is in free form in plasma, from 50 to 75% specifically binds to SHBG. An increase in the level of SHBG in the blood caused by ethinyl estradiol affects the level of gestodene: the fraction associated with SHBG increases and the fraction that is associated with albumin decreases. Average Vd (volume of distribution) - 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 action of estradiol increases 3 times. The concentration of gestodene when taking Lindinet 30 daily in the blood plasma increases 3-4 times and reaches saturation in the second half of the cycle;
metabolism and excretion: Gestodene is biotransformed in the liver. Average plasma clearance is from 0.8 to 1 ml / min / kg. The serum level of gestodene in the blood decreases in two phases. 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, Lindinet 30 is prescribed for contraception.

Contraindications

Absolute:

migraine, accompanied by focal neurological symptoms, including indications 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 the anamnesis;
dyslipidemia;
jaundice while taking glucocorticosteroids;
gallstone disease, including indications in the anamnesis;
severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis (including instructions in the anamnesis) - you can prescribe Lindinet 30 in 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 a history of indications;
hormone-dependent malignant neoplasms of the genitals / 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 when 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 lesions of the valvular apparatus of the heart, diseases of the cerebral or coronary arteries, severe or moderate arterial hypertension with blood pressure (blood pressure) ≥ 160/100 mm Hg. Art.;
pregnancy (confirmed or if suspected) and lactation;
individual intolerance to any component of Lindinet 30.

Relative (the drug is prescribed under medical supervision):

diabetes mellitus without vascular complications;
SLE (systemic lupus erythematosus);
granulomatous enteritis;
hypertriglyceridemia, including family history indications;
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 / m ²);
arterial hypertension;
dyslipoproteinemia;
ulcerative colitis;
epilepsy;
migraine;
sickle cell anemia;
atrial fibrillation;
valvular heart disease;
prolonged immobilization;
extensive surgery, surgery on the lower limbs;
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 close relatives);
changes in biochemical parameters (deficiency of antithrombin III, resistance of activated protein C, hyperhomocysteinemia, deficiency of protein C or S, 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 pregnant women, Sydenham's chorea, chorea minor, chloasma;
postpartum period, including lactating women after the end of the lactation period, non-lactating women (21 days after childbirth).

Instructions for use of Lindinet 30: method and dosage

Lindinet 30 tablets are taken orally once a day, preferably at the same time of the day.

After the end of taking the tablets from the package (21 pcs.), You need to take a break for seven days. Withdrawal bleeding usually occurs during this time. Then the cycle (21 days of intake + 7 days off) is repeated.

The first tablet should be taken between 1-5 days of the menstrual cycle.

Features of starting the drug:

switching from another combined oral contraceptive: Lindinet 30 therapy is started after taking the last tablet from the package of such an oral contraceptive;
transition from "mini-pili" (containing only progestogen): therapy can be started on any day of the cycle (additional methods of contraception must be used for the first seven days);
transition from the implant: therapy can be started the next day after its removal (additional methods of contraception must be used for the first seven days);
switching from contraceptive injections: therapy can be started on the eve of the last injection (additional methods of contraception must be used for the first seven days);
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 II trimester of pregnancy: therapy can be started on 21-28 days (the first seven days, additional methods of contraception should be used, at a later start of taking the drug, additional, barrier methods of contraception are required); if during this period sexual intercourse took place, it is necessary either to exclude pregnancy, or to begin therapy with Lindinet 30 after menstruation.

When you skip taking Lindinet 30, you must be guided by the following recommendations (depending on the interval between taking the drug):

up to 36 hours: the missed tablet should be taken as soon as possible. The contraceptive effect does not decrease during this period. Next, you should resume the usual dosing regimen;
over 36 hours: contraceptive effect may be reduced. It is necessary to continue taking Lindinet 30 as usual, without replenishing the missed dose, while additional methods of contraception should be used in the next seven days. If more than 14 tablets have been taken from the package, the seven-day break should not be taken. Withdrawal bleeding in such cases does not occur until the end of the drug intake from the second package, while spotting / breakthrough bleeding may occur. If withdrawal bleeding does not occur after the end of Lindinet 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, you must follow the instructions for skipping the pill. If you do not want to deviate from the usual dosage regimen, missed tablets can be taken from a different 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 tablets from the next package.

If it is necessary to delay the onset of menstruation, Lindinet 30 should be continued without interruption. This method can be used until the end of the last pill from the second pack. 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

Frequency of occurrence of violations: (> 10%) - very often; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; (<0.01% and including isolated messages) - very rare.

Adverse reactions, with the development of which Lindinet 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;
sense organs: hearing loss due to otosclerosis;
other reactions: Gasser's disease, hematoporphyria; rarely - reactive SLE (exacerbation); very rarely - Sydenham's chorea (disappears after the cancellation of Lindinet 30).

The development of other disorders is more common, but they are less severe. The doctor determines the advisability of continuing to take Lindinet 30 individually after assessing the ratio of the benefits of therapy and the existing risk.

Possible violations:

reproductive system: pain, tension, candidiasis, galactorrhea, breast enlargement, amenorrhea after drug withdrawal, acyclic bleeding / spotting from the vagina, changes in the state of vaginal mucus, 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 an overdose: vomiting, nausea, vaginal bleeding (in young patients). The development of severe symptoms after taking large doses of Lindinet 30 was not reported.

There is no specific antidote. Symptomatic treatment is prescribed.

special instructions

Prior to the appointment of Lindinet 30, a general medical (includes a detailed personal / family history, blood pressure measurement, laboratory tests) and gynecological examination is required. In the future, such surveys should be carried out regularly 2 times a year.

Lindinet 30 is one of the most 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 admission, therefore, the use of non-hormonal contraceptive methods is recommended during this period.

The question of the advisability of taking Lindinet 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 Lindinet 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 hemostatic system;
migraine;
conditions / diseases that predispose to the onset 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 disturbances in tryptophan metabolism, vitamin B ₆ may be used for correction);
abnormalities in laboratory tests that evaluate liver function.

There is a link between taking Lindinet 30 and an increased risk of developing arterial and venous thromboembolic diseases. Factors that increase the likelihood of their development include:

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 / m ²;
arterial hypertension;
dyslipoproteinemia;
atrial fibrillation;
heart valve diseases complicated by hemodynamic disorders;
long-term immobilization after major surgery, surgery on the lower extremities, severe injuries (the recommended period of temporary discontinuation of Lindinet 30 is 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 assessing the balance between the benefits of taking Lindinet 30 and the risk, it should be borne in mind that with targeted treatment of this condition, the likelihood of thromboembolism decreases.

Thromboembolism symptoms:

shortness of breath that appears suddenly;
chest pain that comes on suddenly, which radiates to the left arm;
an unusually severe headache of any etiology that lasts 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 half of the body, movement disorders, severe unilateral pain in the gastrocnemius muscle, symptom complex "Sharp abdomen".

Taking Lindinet 30 can be regarded as one of the risk factors for developing cervical cancer.

There is little information about the occurrence of benign / malignant liver tumors against the background of prolonged use of the drug, which must be taken into account when conducting differential diagnosis of abdominal pain.

If there is a risk of chloasma while taking Lindinet 30, contact with the sun or ultraviolet radiation should be avoided.

Due to the estrogenic component, a change in the level of some laboratory parameters is possible - indicators of hemostasis, functional indicators of the liver, adrenal glands, kidneys, thyroid gland, levels of transport proteins and lipoproteins.

For patients who have undergone acute viral hepatitis, Lindinet 30 can be taken after normalization of hepatic function (not earlier than six months later).

Lindinet 30 does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Application during pregnancy and lactation

Lindinet 30 tablets are not prescribed for women during pregnancy / breastfeeding.

For violations of liver function

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

Drug interactions

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: decrease in the contraceptive effect of Lindinet 30, increased frequency of breakthrough bleeding and menstrual irregularities; during the period of combined use and for another seven days after the end of the course, it is additionally necessary to use non-hormonal methods of contraception, 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 ethinyl estradiol in the blood;
any drugs that increase the motility of the gastrointestinal tract: a decrease in the absorption of the active components of Lindinet 30 and their plasma level in the blood;
itraconazole, fluconazole and other inhibitors of liver enzymes: increased plasma levels of ethinyl estradiol in the blood;
drugs, sulfation of which occurs in the intestinal wall (including ascorbic acid): competitive inhibition of ethinyl estradiol sulfation, which leads to an increase in the bioavailability of ethinyl estradiol;
ampicillin, tetracycline and some other antibiotics: obstruction of intrahepatic circulation of estrogens, 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 correction of the dosage regimen of these drugs;
St. John's wort preparations (including infusion): a decrease in the concentration of the active components of Lindinet 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 the 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.

Analogs

The analogues of Lindinet 30 are: Logest, Femoden, Gestarella, Femiss Ginesta, Lindinet 20.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Lindinet 30

According to reviews, Lindinet 30 is an inexpensive contraceptive. In some cases, adverse reactions have been reported that can lead to discontinuation of therapy.

Price for Lindinet 30 in pharmacies

The approximate price for Lindinet 30 (21 pcs. In a package) is 450-567 rubles.

Lindinet 30: prices in online pharmacies

Drug name

Price

Pharmacy

Lindinet 30 30 mcg + 75 mcg film-coated tablets 21 pcs.

467 r

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Lindinet 30 tablets p.o. 21 pcs.

623 RUB

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!