LAKTINET PILLS 0,075MG

(LACTINETTE®)

Trade name of the drug: LACTINET®

International Nonproprietary Name (INN): desogestrel

Dosage Form: film pills

CompositionA: Each pill contains:
Active substance: desogestrel 0.075 mg;
Excipients: 
composition of the pill core: DL-α-tocopherol, colloidal silicon dioxide, stearic acid, Magnesium stearate, potato starch, povidone K30. lactose monohydrate;
shell composition: opadry II white (titanium dioxide (EI71). C1 77891, talc, macrogol 3000, polyvinyl alcohol).

Pharmacotherapeutic group: progestin

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics 
Laknet® - This is a gestagen-containing oral contraceptive, the active ingredient of which is desogestrel. Like other hormonal contraceptives, which include as an active component exclusively progestogen, Lactinet® You can take women during lactation, as well as in the presence of contraindications to estrogen or unwillingness to use estrogen-containing contraceptives.
Unlike other progestin contraceptives, the contraceptive effect of the drug Lactinet® due to the inhibition of the ovulation process, as evidenced by the absence of the ovulatory follicle during ultrasound and the absence of an increase in the values ​​of luteotropic hormone (LH) and Progesterone in the serum in the middle of the menstrual cycle.At the same time, desogestrel, as well. like other progestogens, has the ability to increase the viscosity of cervical mucus, preventing the progress of sperm.
The Pearl Index (an indicator reflecting the onset of pregnancy in 100 women during a year of contraception) is 0.4, which is comparable with the use of combined hormonal contraceptives for oral use. Use of the drug Lactinet® leads to a decrease in the content of estradiol in the blood plasma to the values ​​corresponding to the early follicular phase. Progestogens affect carbohydrate and lipid metabolism.

Pharmacokinetics 
Suction 
When ingestion, desogestrel is absorbed quickly. The average maximum concentration in serum is reached after 1.8 hours (Tmax) after taking the pill. Bioavailability of etonogestrel is about 70%.
Distribution in the body 
Etonogestrel in 95.5-99% binds to plasma proteins, mainly albumin and to a lesser extent with sex hormone-binding globulin (SHBG).
Metabolism 
Desogestrel by hydroxylation and dehydrogenation is metabolized to the active metabolite etonogestrel. Etonogestrel is metabolized by the formation of sulfate and glucuronide conjugates.
Excretion from the body 
The average elimination half-life of etonogestrel is about 30 hours, both in single and multiple doses. Equilibrium plasma concentrations are set after 4-5 days.Etonogestrel and its metabolites are excreted by the kidneys and through the intestine (in the ratio 1.5: 1) in the form of free steroids and conjugates.
In nursing mothers, etonogestrel is excreted in breast milk in a milk / serum ratio of 0.37-0.55. Thus, with an approximate consumption of mother's milk in the amount of 150 mg / kg / day, the newborn can receive 0.01-0.05 mcg etonogestrel per kg of body weight per day.

Indications for use 
Contraception.

Contraindications

• the presence or history of venous thromboembolism (including deep venous thrombosis of the lower extremities, pulmonary embolism;
• severe liver disease now or anamnesis (until normalization is indicative of liver function);
• liver failure now or a history of;
• established or suspected malignant hormone-dependent tumors (including breast cancer);
• liver cancer;
• bleeding from the vagina of unknown etiology;
• established or suspected pregnancy;
• Hypersensitivity to desogestrel or any other component of the drug.
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• prolonged immobilization, incl. associated with surgery or disease (risk of venous thromboembolism).

Carefully

• resistant arterial hypertension. developing on the background of taking the drug, including the ineffectiveness of antihypertensive therapy;
• chloasma, especially in the presence of chloasma during pregnancy in history;
• diabetes mellitus (due to the possible effect of progestogens on peripheral nsulin resistance and glucose tolerance);
• porphyria;
• systemic lupus erythematosus (SLE);
• herpes (during pregnancy in history).

Pregnancy and lactation period 
Pregnancy 
During pregnancy, the use of the drug is contraindicated.
In preclinical studies. with the introduction of very high doses of progestogen, masculinization of the female fetus was observed.
Epidemiological studies have not revealed an increased risk of a teratogenic effect and congenital developmental defects among children whose mothers took oral hormonal contraceptives before pregnancy or unintentionally in the early stages of pregnancy.
Lactation period 
Like other progestogen containing drugs, Lactinet® does not affect the quality and quantity of breast milk, but a small amount of the metabolite desogestrel (etonogestrel) is excreted in breast milk and is approximately 0.01-0.05 mcg / kg / day (when the amount of breast milk consumed is 150 ml / kg / day). The results of a 7-month observation did not reveal increased risks for breastfed infants when assessing their growth, psychomotor and physical development.
However, careful dynamic monitoring of the development and growth of the baby during breastfeeding is necessary if the woman uses Laktinet for contraception® .

Dosage and administration 
In the absence of previous use of hormonal contraceptives (during the last month), taking pills starts from the first day of the menstrual cycle, one pill per day, if possible at the same time of day, following the direction indicated on the package so that the interval between taking two pills should be 24 hours, if necessary with a small amount of liquid. This drug does not require a break in the reception. Each next package should be started immediately after the end of the previous one.
First dose 
Women who in the previous month did not take oral contraceptives: 
Reception of the first pill should begin from the first day of the menstrual cycle (menstruation). In this case, the use of additional methods of contraception is not required.
You can start taking the pills from 2-5 days of menstruation, but in this case, in the first cycle, you need to use additional methods of contraception in the first 7 days of taking the pills.
Women who are switching from another oral oral contraceptive pill (CPC) to Lactinet® 
If possible, the next day after taking the last pill of the previous PDA. In this case, the use of additional methods of contraception is not required.
Women who are switching from monocomponent preparations containing progestogen only (mini-pili, injections, implants or intrauterine contraceptives that release progestogen) 
When switching from a mini-pill, you can start taking the drug on any given day; in the case of injections, on the day when another injection should be given; in the case of an implant, the day after its removal.
In all these cases, the use of barrier methods of contraception is recommended for the first 7 days.
Taking the drug after an abortion in the first trimester of pregnancy 
After an abortion in the first trimester of pregnancy, it is recommended to start taking the drug immediately after the abortion, and in this case there is no need to use additional methods of contraception.
Taking the drug after childbirth, or after abortion in the second trimester of pregnancy 
Taking the drug start no earlier than 21-28 days after termination of pregnancy in the second trimester or after childbirth. If taking the drug suggest starting later, then you need to use a barrier method of contraception during the first 7 days. In addition, if unprotected sexual intercourse took place before the start of the drug use, it is necessary to exclude pregnancy or postpone the start of the drug on the first day of the next menstruation (when the menstrual cycle is restored).
Missed (forgotten) tablets 
The effectiveness of a contraceptive is reduced if more than 36 hours have passed between taking two tablets. If a breakdoes not exceed 12 hours, the contraceptive effect is not reduced, and the use of an additional contraceptive method is not required.
Acceptance of the remaining pills continue on the usual schedule.
In the case of more,than a 12-hour break, the contraceptive effect may be reduced.
To achieve effective blockage of the hypothalamic-pituitary-ovarian system, it is necessary to take the drug daily for 7 days. In this way,with a break longer than 12 hours, the drug is continued as usual, however, in the next 7 days it is necessary to use additional (barrier) methods of contraception. If the pill was missed during the first week of the drug use and unprotected sexual intercourse took place in the previous 7 days, then the probability of pregnancy may not be excluded.
Measures taken in case of vomiting 
If vomiting develops within 3-4 hours after taking the pill, the pill is not completely absorbed. In this case, you should do the same as in the case of missed pills. The required pill (required tablets) should be replenished from another package.
Observation 
Despite the regular intake of pills, there may be irregular menstruation. If menstruation occurs very often and irregularly, you should consider using another method of contraception. If the disorder persists, it is necessary to eliminate the organic cause.
Tactics in case of amenorrhea during the use of the drug depends on whether the pills were taken in accordance with the instructions or not; may require a pregnancy test.
If pregnancy occurs, the drug should be stopped.
It must be remembered that taking Lakinet® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Side effects 
The most frequent adverse effect reported in clinical studies was irregular menstruation. Up to 50% of women using desogestrel noted acyclic bleeding: in 20-30% of women, menstruation becomes more frequent, while in the other 20% it is less common or even completely stopped. Menstruation may also be longer.
After several months of taking the drug, menstruation tends to become less frequent. Informing the physician, observation by the physician, and the use of a menstrual diary can increase the compliance of drug treatment.
The following are undesirable effects that have an established, probable or possible association with the use of the drug.
If any of the following conditions / risk factors are observed, the expected benefits and the risk of using a contraceptive should be carefully weighed when consulting with your doctor throughout the entire period of contraception. When any of the following conditions / risk factors appear, increase, or change, the patient should immediately consult a doctor to decide on the possibility of further use of the drug.
Often: acne, nausea, mood changes, decreased libido, breast tenderness, menstrual disorders, headache, weight gain.
Infrequently: alopecia, fatigue, vomiting, discomfort when wearing contact lenses, vaginitis, dysmenorrhea, ovarian cysts.
Rarely: skin redness, rash, urticaria, erythema nodosum.
Although a reliable connection with the intake of gestagens has not been established, cholestatic jaundice, pruritus, cholelithiasis, chorea, pregnant herpes, otosclerosis, deafness, and the development of hemolytic-uremic syndrome are possible.

Overdose 
Signs of overdose: nausea, vomiting, bloody discharge / bleeding from the vagina. There is no specific antidote, the treatment is symptomatic.

Interaction with other drugs 
The simultaneous use of drugs, inducers of liver microsomal enzymes, can cause breakthrough bleeding and reduce the contraceptive effect of the drug. These drugs are derivatives of hydantoin (including phenytoin), rifabutin, barbiturates, primidone, Carbamazepine and rifampicin, as well as oxcarbazepine, topiramate . felbamate and Griseofulvin . Specialized research on the interaction of desogestrel with other drugs has not been conducted. The maximum induction of liver microsomal enzymes is reached no earlier than in 2-3 weeks. after the start of the application of the corresponding inductor up to 4 weeks. after its cancellation.
Antibiotics (eg, ampicillin and tetracycline) reduce the effectiveness of oral contraceptives.
Women taking medications that induce liver microsomal enzymes should be recommended to temporarily supplement the use of barrier or other non-hormonal methods of contraception.
With simultaneous use. of the above drugs with desogestrel, it is recommended to use a barrier method of contraception throughout the course of treatment and for 7 days (for rifampicin - 28 days) after the end of therapy.
With Activated carbon treatment, the absorption of steroids, and, consequently, contraceptive efficacy, may decrease. In this case, you should follow the recommendations given in the section "Dosing regimen" for the missed dose of the drug.

special instructions 
If there is any condition or risk factor, the physician must relate the risks and benefits of using Lactinet.® individually for each woman before the start of hormonal contraception. In case of occurrence of any undesirable effect or risk factor, it is necessary to immediately notify the attending physician to decide on the advisability of further administration of the drug.
Women with diabetes should be closely monitored during the first months of using Lactinet.®. 
Reception Lakinet® reduces serum estradiol to the value corresponding to the early follicular phase.
The protective effect of traditional progestagens containing contraceptives in terms of prevention of ectopic pregnancy is not as pronounced as that of combined oral contraceptives, which is associated with ovulation that occurs relatively frequently while receiving progestogens containing drugs.
Although Lactinet®As a rule, inhibits ovulation, the possibility of ectopic pregnancy should be borne in mind when a differential diagnosis develops in a woman amenorrhea or abdominal pain.
Chloasma can sometimes occur, especially in women with a history of chloasma in pregnant women. Women with a tendency to chloasma should avoid sun and ultraviolet radiation while taking Lactinet®. 
Patients with lactose intolerance need to keep in mind that one film-coated pill is 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.

Influence on ability to drive a car or other working mechanisms 
Does not affect the ability to drive a car and working mechanisms.

Storage conditions 
Store in original packaging at a temperature not higher than 25 ° C.
Keep out of reach of children.