Lactinet-Richter, 0.075 mg 28 pcs

Lactinet® is an oral gestagen-containing contraceptive with the active ingredient deogestrel. Like other hormonal contraceptives with only progestogen as an active ingredient, Lactinet® can be taken by women during breastfeeding and if there are contraindications to estrogens or if the use of estrogen-containing contraceptives is not desired.

In contrast to other gestagenic contraceptives, the contraceptive effect of Lactinet® is explained by ovulation inhibition, which is confirmed by absence of ovulatory follicle at ultrasound and absence of increase in serum LTH and progesterone values in the middle of menstrual cycle. At the same time, desogestrel, like other progestagens, has the property of increasing the viscosity of cervical mucus, preventing the advancement of sperm.

The Perl index (an indicator reflecting the occurrence of pregnancy in 100 women during a year of contraception) is 0.4, which is comparable to the use of combined hormonal contraceptives for oral use. The use of Lactinet® leads to a decrease in plasma estradiol to values corresponding to the early follicular phase. Progestagens affect carbohydrate and lipid metabolism.

Pharmacokinetics

Absorption

Desogestrel is rapidly absorbed when taken orally. Tmax is reached 1.8 h after taking the tablet. The bioavailability of etonogestrel is about 70%.

Distribution

The etonogestrel is 95.5-99% bound to plasma proteins, mainly to albumin and to a lesser extent to sex hormone-binding globulin (hGBS).

Metabolism

Desogestrel is metabolized by hydroxylation and dehydrogenation to the active metabolite etonogestrel. Etonogestrel is metabolized by formation of sulfate and glucuronide conjugates.

The average T1/2 of etonogestrel is about 30 h, both with single and multiple doses. Css in plasma are established after 4-5 days. Etonogestrel and its metabolites are excreted by the kidneys and through the intestine (at a ratio of 1.5:1) as free steroids and conjugates. In breastfeeding mothers etonogestrel is excreted with breast milk at a milk/serum ratio of 0.37-0.55.

Hence, with an approximate maternal milk intake of 150 mg/kg/day, a newborn can receive etonogestrel at 0.01-0.05 µg/kg/day.

Indications

Contraception

Active ingredient

Composition

Active ingredient:

desogestrel 0.075 mg;

Auxiliary substances:

Core: D,L-α-tocopherol – 0.08 mg;

silicon dioxide colloid – 0.8 mg;

stearic acid – 0.8 mg;

magnesium stearate – 0.4 mg;

potato starch – 8 mg;

povidone K30 – 2.4 mg;

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Lactose monohydrate – 67.445 mg;

Filmed wrapper:

Opadry II white (titanium dioxide (E171) Cl 77891 – 0.25 mg, talc – 0.148 mg, macrogol 3000 – 0.202 mg, polyvinyl alcohol – 0.4 mg) – 1 mg;

How to take, the dosage

To the oral route.

If there is no previous use of hormonal contraceptives (within the last month), the pills are started from the first day of the menstrual cycle, 1 tablet a day, at the same time of day if possible, following the direction indicated on the package, so that a break of 24 hours between taking 2 pills, if necessary with a little liquid. This drug does not require a break in intake. Each subsequent package should be started immediately after the end of the previous package.

The order of taking the drug

Women who have not taken oral contraceptives in the previous month. The 1st tablet should be started on the first day of the menstrual cycle (menstruation). In this case the use of additional contraceptive methods is not required.

The pills may be started on the 2nd-5th day of the menstrual cycle, but in this case additional contraceptive methods should be used during the first 7 days of taking the pills.

Women switching from another combined oral contraceptive (CAP) to Lactinet®. If possible, the day after taking the last pill of the previous CCP. No additional contraceptive methods are required in this case.

Women who are switching from mono-pills containing only progestagen (mini-pills, injectables, implants, or intrauterine contraceptives releasing progestagen). When switching from the mini-pill, you can start taking the medication on any day; in the case of injections, on the day the next injection should have been given; in the case of an implant, on the day after it was removed.

In all of these cases, the use of barrier methods of contraception for the first 7 days is recommended.

Taking the drug after a first trimester abortion. It is recommended that after a first trimester abortion the drug be taken immediately after the abortion, in which case no additional contraceptive methods are needed.

The drug is taken after childbirth or after a termination of pregnancy in the second trimester. The drug should be started at the earliest on days 21-28 after a second trimester abortion or after childbirth. If the drug intake is supposed to be started later, it is necessary to use a barrier method of contraception during the first 7 days. Besides, if unprotected sexual intercourse took place before the beginning of using the drug, it is necessary to exclude pregnancy or to postpone the beginning of taking the drug to the first day of the next menstrual period (when the menstrual cycle is restored).

Missed (forgotten) pills. The effectiveness of the contraceptive decreases if more than 36 hours elapse between doses of 2 pills. If the interval does not exceed 12 hours, the contraceptive effect is not reduced, and the use of an additional contraceptive method is not required. The remaining pills are continued on the usual schedule.

If there is a break of more than 12 hours, the contraceptive effect may decrease. To achieve effective hypothalamic-pituitary-ovarian blockage, the drug must be taken daily for 7 days.

Thus, if the break is more than 12 hours, taking the drug continues as usual, but in the next 7 days it is necessary to use additional (barrier) contraceptive methods. If the reception of the pill was missed in the 1st week of its use and unprotected intercourse took place in the preceding 7 days, it is impossible to exclude the possibility of pregnancy.

The measures taken in case of vomiting. If vomiting develops within 3-4 hours after taking the pill, then the pill has not been fully absorbed. This should be handled in the same way as in the case of missed pills. The necessary tablet(s) should be replenished from another package.

Watch. Menstrual irregularities may occur despite taking the pills regularly. If menstruation occurs very often and irregularly, another method of contraception should be considered. If the disorders persist, an organic cause should be ruled out.

The management of amenorrhea during use depends on whether the pills were taken as directed or not; a pregnancy test may be necessary.

If pregnancy occurs, the drug must be stopped.

It should be remembered that taking Lactinet® does not protect against infection with HIV (AIDS) and other sexually transmitted diseases.

Interaction

Simultaneous use of inducers of microsomal liver enzymes may cause breakthrough bleeding and decrease the contraceptive effect of the drug. These drugs are derivatives of guidantoin (including phenytoin), rifabutin, barbiturates, primidone, carbamazepine and rifampicin, and oxcarbazepine, topiramate, felbamate and griseofulvin.

Specialized studies on the interaction of desogestrel with other drugs have not been conducted. Maximum induction of microsomal liver enzymes is achieved not earlier than 2-3 weeks after initiation of the respective inducer and lasts up to 4 weeks after its withdrawal. Antibiotics (e.g., ampicillin and tetracycline) reduce the effectiveness of oral contraceptives.

Women taking drugs that induce microsomal liver enzymes should be advised to temporarily use additional barrier or other non-hormonal methods of contraception.

If the above drugs are used concomitantly with desogestrel, barrier contraception is recommended for the entire course of treatment and for 7 days (for rifampicin, 28 days) after the end of therapy.

The treatment with activated charcoal may reduce steroid absorption and hence contraceptive efficacy. In this case, you should follow the recommendations given in the “Dosage and administration” section for missed intake of the drug.

Special Instructions

In the presence of any condition or risk factor, the physician should balance the risks and benefits of Lactinet® individually for each woman before starting hormonal contraception. If any undesirable effect or risk factor appears, it is necessary to inform immediately the attending physician in order to decide whether further use of the drug is advisable. Women with diabetes should be under close supervision during first months of using Lactinet®.

Lactinet® reduces serum estradiol to values corresponding to early follicular phase. The protective effect of traditional progestogenonly contraceptives in terms of preventing ectopic pregnancy is not as pronounced as that of combined oral contraceptives, which is associated with relatively frequent ovulation during progestogenonly contraceptives.

While Lactinet® generally inhibits ovulation, the possibility of ectopic pregnancy should be kept in mind in the differential diagnosis if a woman develops amenorrhea or abdominal pain. Chloasma can sometimes occur, especially in women with a history of pregnancy chloasma.

Women with a tendency to chloasma should avoid sunlight and ultraviolet irradiation while taking Lactinet®. Patients with lactose intolerance should be aware that one film-coated tablet of Lactinet® contains 67.445 mg of lactose monohydrate. Patients with rare hereditary diseases such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take the drug.

Impact on the ability to drive a vehicle or other working mechanisms. Does not affect the ability to drive or operate machinery.

Contraindications

With caution: resistant arterial hypertension developing with the drug, including in case of ineffective antihypertensive therapy; chloasma, especially if there is a history of chloasma during pregnancy; diabetes (because of the possible effect of progestagens on peripheral insulin resistance and glucose tolerance); porphyria; systemic lupus erythematosus; herpes (during pregnancy in the history).

Side effects

Often – acne, nausea, mood changes, decreased libido, breast soreness, menstrual cycle disorders, headache, weight gain.

Infrequent – alopecia, fatigue, vomiting, discomfort when wearing contact lenses, vaginitis, dysmenorrhea, ovarian cysts.

Rarely – redness of the skin, rash, urticaria, erythema nodosum.

Overdose

Symptoms: nausea, vomiting, bloody discharge/vaginal bleeding.

Treatment: symptomatic, no specific antidote.

Pregnancy use

The use of the drug is contraindicated during pregnancy. In preclinical studies, masculinization of the female fetus was observed with very high doses of progestogen.

Epidemiologic studies have not shown an increased risk of teratogenic effects and birth defects among children whose mothers took oral hormonal contraceptives before pregnancy or inadvertently in early pregnancy.

Lactinet®, like other progestogen-only drugs, does not affect the quality and quantity of maternal milk, but a small amount of the metabolite deogestrel (etonogestrel) is excreted with maternal milk and is approximately 0.01-0.05 µg/kg/day (at 150 ml/kg/day of breast milk intake).

The results of 7-month follow-up showed no increased risks for breastfed children when assessing their growth, psychomotor and physical development. However, careful dynamic monitoring of child development and growth during breastfeeding is necessary if a woman uses Lactinet® for contraceptive purposes.

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