LACTINET-RICHTER
Latin name: LACTINETTE-RICHTER
ATX code: G03AC09
Active ingredient: desogestrel (Desogestrel)
Producer: Gedeon Richter, JSC (Gedeon Richter, Plc.) (Hungary)
Description and photo update: 2020-10-08
LACTINET-RICHTER is a drug for oral contraception belonging to the pharmacotherapeutic group of synthetic progestogens.
Release form and composition
The drug is produced in the form of film-coated tablets: round, biconvex, almost white or white, engraved with “75” on one side and “D” on the other (28 pcs in a blister, 1 blister in a laminated package aluminum foil; in a cardboard box 1 or 3 packs with blisters, a flat cardboard case for storing the blister and instructions for use LACTINETA-RICHTER).
1 tablet contains:
- active substance: desogestrel - 0.075 mg;
- additional components: potato starch, colloidal silicon dioxide, lactose monohydrate, povidone K30, racemic α-tocopherol acetate (all-rac-α-tocopherol), stearic acid 50;
- film casing: Opadray II white - titanium dioxide (E171), macrogol 3000, polyvinyl alcohol, talc.
Pharmacological properties
Pharmacodynamics
LACTINET-RICHTER is an oral contraceptive containing progestogen - desogestrel, a new generation progestogen as an active ingredient. Like other oral contraceptives (PCs) containing only one progestogen (mini-pili), the drug is most suitable for use during breastfeeding and for patients who do not want to take estrogens or who are contraindicated in their use.
Unlike mini-pills, the contraceptive effect of LACTINET-RICHTER is mainly based on suppressing ovulation. Other effects are achieved by increasing the viscosity of cervical mucus. During the first 56 days of the course, the ovulation rate does not exceed 1%, if the drug is discontinued after the end of this period, ovulation occurs after 7-30 days (after about 17 days).
In a comparative efficacy study in which the missed pills could only be used for 3 hours, the Pearl total index (an indicator showing the number of unplanned conceptions in 100 women who had contraception using any method of contraception for 12 months) for LACTINETA-RICHTER was equal to 0.4 in the group of all patients included in the study. The Pearl index of the drug is comparable to that of combined oral contraceptives (COCs) in the general population of patients using PC.
Desogestrel causes a decrease in the plasma concentration of estradiol in the blood to a level corresponding to the early follicular phase. However, there is no clinically significant effect on carbohydrate / lipid metabolism and hemostasis parameters.
Pharmacokinetics
When taken orally, desogestrel is intensively absorbed. In the blood serum, the maximum concentration (C max) of the active substance after taking the pill is noted after 1.8 hours. The bioavailability of the active metabolite of the drug, etonogestrel, is approximately 70%.
Equilibrium concentrations (C ss) in blood plasma are recorded after 4–5 days. The connection of etonogestrel with plasma proteins, mainly with albumin and to a lesser extent with globulin (a protein that binds sex hormones - gonadosteroids), averages 95.5–99%.
Desogestrel is biotransformed by hydroxylation and dehydrogenation to etonogestrel. As a result of the metabolism of the latter, glucuronide and sulfate conjugates are formed. The average elimination half-life (T 1/2) of etonogestrel is approximately 30 hours, both with a single dose and with a course. Etonogestrel and its metabolites are eliminated in urine and feces (in a ratio of 1.5 ÷ 1) in the form of free steroids and conjugates.
Indications for use
LACTINET-RICHTER is recommended for use to prevent unwanted pregnancy.
Since the drug contains only a progestogen, it is primarily prescribed for contraception during breastfeeding or for women for whom the use of drugs containing estrogens is contraindicated or undesirable.
Contraindications
Absolute:
- the presence at present or in the anamnesis of hepatic dysfunction, severe liver disease (until the normalization of liver function tests);
- venous thromboembolism, including deep vein thrombosis of the lower extremities and pulmonary thromboembolism (including a history);
- suspected / diagnosed malignant hormone-dependent tumors (including breast cancer);
- vaginal bleeding of unknown origin;
- glucose-galactose malabsorption, lactase deficiency, lactose intolerance (1 tablet contains 55.095 mg of lactose monohydrate);
- suspected / confirmed pregnancy;
- age up to 18 years;
- hypersensitivity to any of the constituents of the drug.
Relative (before taking LACTINET-RICHTER tablets, it is required to carefully assess the benefits and possible threat from the use of a gestagen individually for each patient in the presence of any of the following conditions / diseases):
- long-term immobilization caused by trauma, disease or surgery;
- resistant arterial hypertension; in case of ineffectiveness of antihypertensive therapy or a pronounced increase in blood pressure (BP), the use of the drug should be discontinued;
- liver cancer, since it is impossible to exclude the biological effect of gestagens on the course of the disease;
- diabetes mellitus, due to the increased risk of the effect of progestogens on glucose tolerance and peripheral insulin resistance; patients with diabetes mellitus in the first months of using the drug need careful monitoring;
- chloasma, especially if there is a history of its development during pregnancy (if there is a predisposition to chloasma, it is required to avoid prolonged exposure to ultraviolet radiation, including sunlight);
- systemic lupus erythematosus (SLE);
- porphyria;
- herpes (with a history of pregnancy).
LACTINET-RICHTER, instructions for use: method and dosage
LACTINET-RICHTER film-coated tablets are taken orally. You should start taking birth control pills on the first day of your menstrual bleeding (menstrual cycle).
Tablets are taken 1 pc / day with a small volume of water, preferably at the same time of the day, in the order indicated on the package. The interval between taking 2 tablets should be 24 hours. Each next blister pack should be started immediately after the last tablet from the previous one has been taken. When using LACTINET-RICHTER, there is no need to take any interruptions.
If PCs were not used in the previous month, the drug should be taken from the first day of the menstrual cycle. It is also permissible to start taking contraceptive pills on days 2–5 of the natural cycle, but in this case, it is recommended to resort to a barrier method of contraception during the first 7 days of the course.
When switching from a combined hormonal contraceptive (transdermal patch, vaginal ring, COC) to the use of LACTINET-RICHTER, it is recommended to start taking the latter on the day of removing the vaginal ring, removing the patch, or the day after taking the last active COC tablet.
It is also allowed to start taking a gestagen-containing contraceptive the next day after the end of the usual break in the use of a COC, ring or patch, or the next day after using a placebo of the previous combined hormonal contraceptive - on the day when a new patch should be glued, a new ring inserted, or started taking new COC packaging. Moreover, during the first 7 days of taking LACTINET-RICHTER tablets, additional contraceptives are required.
Switching to the drug from the "mini-pili" can be done any day. You can switch from the use of other means that include only a gestagen, such as an implant or a gestagen-releasing intrauterine system, on the day of their removal, and from using injectable forms of contraceptives - on the day when the next injection is scheduled. In all these cases, additional methods of protection are not necessary.
After an abortion performed in the first trimester of pregnancy, it is recommended to immediately start taking LACTINET-RICHTER, without using additional methods of contraception.
After childbirth or abortion in the second trimester, the drug should be used no earlier than 21-28 days later. In the case of a later start of admission, a barrier method of contraception is required during the first 7 days. If, after childbirth or abortion, before the use of LACTINET-RICHTER, unprotected sexual contacts have taken place, it is necessary to exclude the possibility of pregnancy or wait for the next menstruation.
If the next dose of the pill was missed, and the period between two subsequent doses is more than 36 hours, the contraceptive effect of the drug may decrease. If the tablet is taken less than 12 hours late, the missed dose should be taken as early as possible, and the next dose at the usual time. In this case, the effect of the agent does not decrease; an additional barrier method is not required. If the delay in admission exceeds 12 hours, the contraceptive protection of LACTINETA-RICHTER may weaken. As a result, it is required to be guided by the above recommendations and use additional contraceptives for the next 7 days.
If you skip taking the drug in the first week of the course, when unprotected intercourse took place within 7 days preceding the skipping, you should take into account the possibility of pregnancy.
If vomiting or severe diarrhea occurs after taking LACTINET-RICHTER for 3-4 hours, desogestrel absorption may be incomplete and the reliability of contraception may decrease. In this case, it is required to follow the recommendations regarding the missed tablets.
Side effects
In the course of clinical studies, with the use of desogestrel in a daily dose of 0.075 mg, adverse reactions most often (> 2.5%) were noted: mood lability, acne, nausea, increased body weight, breast tenderness, irregular spotting.
The following side effects, according to the research results, were assessed as having a probable, possible or established relationship with the use of LACTINET-RICHTER:
- nervous system: often - headache;
- digestive system: often - nausea; infrequently - vomiting;
- psyche: often - decreased libido, mood changes, depressive disorder;
- organ of vision: infrequently - intolerance to contact lenses;
- genitals and mammary gland: often - amenorrhea, irregular menstrual bleeding, breast tenderness; infrequently - dysmenorrhea, vaginitis, ovarian cyst; rarely - ectopic pregnancy, discharge from the mammary glands;
- general reactions: often - an increase in body weight; infrequently - fatigue;
- skin and subcutaneous tissue: often - acne; infrequently - alopecia; rarely - erythema nodosum, skin rash, urticaria.
When using COCs, in rare cases, such serious disorders as chloasma, arterial and venous thromboembolism and thrombosis, hormone-dependent tumors were observed.
Against the background of taking gestagens, the following adverse reactions may also appear (a reliable connection with drug treatment has not been identified): the formation of calculi in the gallbladder, caused by cholestasis, itching of the skin and / or jaundice, porphyria, herpes of pregnant women, hereditary angioedema, SLE, Sydenham's chorea, hemolytic -uremic syndrome (HUS), hearing loss caused by otosclerosis.
Overdose
Symptoms of a desogestrel overdose may include vomiting, nausea, and bleeding from the vagina (mostly in young girls). There have been no reports of serious side effects resulting from intoxication.
In this condition, symptomatic therapy is recommended. The antidote for the progestogen desogestrel is currently unknown.
special instructions
Before prescribing the drug, it is necessary to carry out a thorough history taking and conduct a gynecological examination in order to exclude the possible presence of pregnancy.
Before taking LACTINET-RICHTER, it is required to establish the causes of menstrual irregularities - oligomenorrhea, amenorrhea. The frequency of control medical examinations is determined by the doctor individually for each patient (at least 1 time per year).
If the drug is capable of affecting latent or active disease, follow-up medical examinations should be carried out regularly.
In some cases, despite the continuous use of LACTINET-RICHTER, irregular bleeding may occur. If these violations are very frequent, you should consider the possibility of replacing the contraceptive. With a stable nature of these symptoms, organic pathology must be excluded.
Treatment of amenorrhea during the period of use of the drug depends on the careful implementation of the recommendations for taking the pills and may also include a pregnancy test. When you install the last LACTINET-RICHTER, you must cancel.
Patients should be aware that PCs do not protect against human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), as well as other sexually transmitted diseases.
During the period of oral administration of gestagen-containing contraceptives, vaginal bleeding in some women may become more prolonged / frequent, while in others it may be more scarce and rare, or even stop altogether. Having decided to start taking LACTINET-RICHTER, the patient should take into account the possible occurrence of such changes in the nature of menstruation, and not refuse because of this from strict adherence to the doctor's recommendations or from this method of contraception. Assessment of vaginal bleeding is required on the basis of the clinical picture, using possible methods of appropriate examinations, in order to exclude pregnancy or malignant neoplasms.
Against the background of the use of low-dose hormonal contraceptives, the formation of follicles is observed, sometimes reaching sizes that exceed those in the normal cycle. In most cases, these enlarged follicles are asymptomatic and spontaneous, but sometimes mild pain in the lower abdomen may occur. Surgery is extremely rare.
According to available data, the use of COCs can have a certain effect on the results of certain laboratory tests, including the parameters of fibrinolysis and coagulation, carbohydrate metabolism, biochemical parameters of the kidneys, adrenal glands, liver and thyroid gland, as well as on the plasma content of blood transport proteins, including corticosteroid-binding globulin. As a rule, these changes are within the normal range. Whether this applies to progestin-only contraceptives has not been established.
LACTINET-RICHTER effectively inhibits ovulation, however, in the case of amenorrhea or the appearance of abdominal pain, it is necessary to carry out differential diagnosis to exclude an ectopic pregnancy.
The risk of developing breast cancer increases with age. In the case of COC use, this threat slightly increases, then gradually weakens over 10 years after the completion of the PC intake, it is not related to the duration of use and depends on the patient's age. In women taking gestagen-containing contraceptives, the risk of breast cancer is presumably similar to that of COCs.
Influence on the ability to drive vehicles and complex mechanisms
Given the pharmacodynamic profile of the contraceptive drug, it is believed that it does not adversely affect the ability to drive vehicles and perform particularly difficult and potentially hazardous work.
Application during pregnancy and lactation
The use of LACTINET-RICHTER during pregnancy is contraindicated.
In the course of preclinical studies on animals, it was found that taking excessively high doses of gestagens led to masculinization of the female fetus. However, according to the data of epidemiological studies, there was no exacerbation of the threat of teratogenic action and congenital defects in children born to mothers who used PC before pregnancy or unintentionally at the beginning of pregnancy.
LACTINET-RICHTER does not affect the production of breast milk and its composition - the level of lactose, protein and fat. At the same time, in humans, the desogestrel metabolite (etonogestrel) is excreted in breast milk in a milk / serum ratio of 0.37–0.55. From which we can conclude that with the consumption of breast milk in an amount of about 150 ml / kg / day, the newborn can receive etonogestrel at a dose of 0.01–0.05 μg / kg / day.
There are limited data from long-term follow-up of children whose mothers started taking the drug in a daily dose of 75 mcg 4-8 weeks after delivery. Children were breastfed up to 7 months, and under supervision - up to 1.5 or 2.5 years. When assessing growth, psychomotor and physical development, they did not reveal any increased risk when compared with children whose mothers used a non-hormonal intrauterine contraceptive. Based on the available data, during lactation, LACTINET-RICHTER can be used at a dose of 75 mcg / day, but only under the condition of careful monitoring of the development and growth of the infant.
Pediatric use
In girls and girls under 18 years of age, LACTINET-RICHTER is contraindicated, since its safety profile in this category of patients has not been studied.
With impaired renal function
There are no data on the use of LACTINET-RICHTER in patients with functional impairment of the kidneys.
For violations of liver function
Reception of LACTINET-RICHTER is contraindicated in the presence or in the history of liver dysfunction or severe liver damage until normalization of liver function parameters is established, since serious liver diseases can lead to metabolic disorders of steroid hormones.
If during the use of the drug acute / chronic disorders of hepatic function develop, it is necessary to conduct an examination after consulting a specialist.
Drug interactions
Established pharmaceutical interaction of LACTINETA-RICHTER with simultaneously used medicinal substances / preparations:
- medicines that induce microsomal enzymes (which causes an increase in the clearance of sex hormones), including barbiturates (phenobarbital), hydantoins (phenytoin), rifampicin, primidone, carbamazepine, oxcarbazepine, grisetonofulvin, felbamatabine, and topical rhytomyramate, drugs perforated: the contraceptive effect of desogestrel may decrease and breakthrough bleeding may develop; during treatment with any of these drugs and for 28 days after the end of their intake, in addition to LACTINET-RICHTER, it is necessary to resort to barrier or other non-hormonal methods of contraception; if long-term therapy with hepatic enzyme inducers is necessary, it is necessary to consider the possibility of using non-hormonal methods of protection against unwanted pregnancy;
- activated carbon: reduces the absorption of desogestrel, and, as a result, weakens its contraceptive effect; with this combination, it is necessary to adhere to the recommendations regarding the missed pill intake;
- ampicillin, tetracycline and other antibiotics: weaken the effect of the drug;
- cyclosporine: its metabolism changes and plasma concentration increases.
Since hormonal contraceptives can affect the metabolic transformation of other drugs, to identify possible interactions, you should read the instructions for simultaneously used drugs.
Analogs
Analogues of LACTINETA-RICHTER are Feanola, Model Mam, Microlut, Charosetta, Exluton, etc.
Terms and conditions of storage
Store in a place protected from light and moisture, out of reach of children, at a temperature not exceeding 30 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about LACTINET-RICHTER
Numerous reviews of LACTINET-RICHTER are ambiguous. Most patients believe that the drug effectively protects against unwanted pregnancy, does not affect lactation, and eliminates, first of all, such a symptom of premenstrual syndrome (PMS) as lower abdominal pain.
However, some women note that the drug, due to the low content of hormones, is not suitable for everyone, leads to mood swings, decreased libido, weight gain, problems with menstruation, and increases the feeling of heaviness in the legs.
Price for LACTINET-RICHTER in pharmacies
Price for LACTINET-RICHTER in the form of film-coated tablets for a pack containing 28 pcs. 0.075 mg each, can be 850 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, 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!
