Laktionet - instructions for use, dose, side effects, contraindications

tablet core composition: DL-α-tocopherol, silicon dioxide colloid, stearic acid, magnesium stearate, potato starch, povidone K30, lactose monohydrate;

composition of the shell: Opapray II white (titanium dioxide (E171), C1 77891, talc, macrogol 3000, polyvinyl alcohol).

Description:

Round, biconcave tablets, covered with a film shell of white or almost white color, marked "D"on one side and" 75 "on the other side.

Pharmacotherapeutic group:gestagen

ATX: & nbsp

G.03.A.C Progestogens

G.03.A.C.09 Desogestrel

Pharmacodynamics:

Lactineth® is a gestagen-containing contraceptive for oral use, the active ingredient of which is desogestrel. Like other hormonal contraceptives, which include an exclusively progestagen as an active ingredient, Lactineth® can be taken to women during lactation,and also in the presence of contraindications to estrogens or unwillingness to use estrogen-containing contraceptives.

Unlike other gestagen contraceptives, the contraceptive effect of Lactanet® is due to inhibition of the ovulation process, as evidenced by the absence of an ovulatory follicle in 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. In the same time desogestrel as well as other progestogens, has the property of increasing the viscosity of the cervical mucus, preventing the advancement of spermatozoa.

Perl index (the indicator reflecting the onset of pregnancy in 100 women during the year of contraception) is 0.4, which is comparable with the use of combined hormonal contraceptives for oral use.

The use of the drug Lactanet® leads to a decrease in the content of estradiol in the blood plasma to values corresponding to the early follicular phase.

Progestogens affect carbohydrate and lipid metabolism.

Pharmacokinetics:

Suction

Ingestion desogestrel absorbed quickly.The average maximum concentration in the blood serum is achieved after 1.8 hours (T_max) after taking the pill. Bioavailability of etonogestrel is about 70%.

Distribution in the body

Ethonogestrel in 95.5-99% binds to blood plasma proteins, mainly with 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 metabolized by the formation of sulfate and glucuronide conjugates.

Excretion from the body

The average half-life of etonogestrel is about 30 hours, both with single and multiple administration. Equilibrium concentrations in the blood plasma are established after 4-5 days. Etonogestrel and its metabolites are excreted by the kidneys and through the intestine (in a ratio of 1.5: 1) in the form of free steroids and conjugates.

Nursing mothers etonogestrel is excreted in breast milk in the ratio of milk / serum 0.37-0.55. Thus, with an approximate milk consumption of the mother at 150 mg / day / day, the newborn can receive 0.01-0.05 μg of etonogestrel per kg of body weight per day.

Indications:

Contraception.

Contraindications:

- Presence at present or anamnesis of venous thromboembolism (including deep vein thrombosis of lower extremities, pulmonary thromboembolism);

- severe liver disease at present or anamnesis (before the normalization of liver function);

- hepatic insufficiency at present or anamnesis;

- established or suspected malignant hormone-dependent tumors (including breast cancer);

- liver cancer;

- bleeding from the vagina of an unclear etiology;

- established or suspected pregnancy;

- hypersensitivity to desogestrel or any other component of the drug;

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

- Long-term immobilization, incl. associated with surgery or disease (risk of venous thromboembolism).

Carefully:

- Resistance arterial hypertension, which develops against the background of the drug, including with ineffectiveness of antihypertensive therapy;

- Chlamydia, especially in the presence of chloasma during pregnancy in history;

- diabetes mellitus (due to the possible effect of progestogens on peripheral insulin resistance andtolerance to glucose);

- porphyria;

- systemic lupus erythematosus (SLE);

- herpes (during pregnancy in the anamnesis).

Pregnancy and lactation:

Pregnancy

During pregnancy, the use of the drug is contraindicated.

In preclinical studies, with the administration of very high doses of the progestogen, masculinization of the female fetus was observed.

In epidemiological studies, there was no increased risk of teratogenic effects and birth defects in children whose mothers took oral hormonal contraceptives prior to pregnancy or unintentionally in the early stages of pregnancy.

Lactation period

Like other preparations containing only progestogen, Lactineth® does not affect the quality and quantity of mother's milk, but a small amount of the metabolite of desogestrel (etonogestrel) is excreted in the mother's milk and is approximately 0.01-0.05 μg / kg / day (with the amount of breast milk consumed, 150 ml / kg / day). The results of a 7-month follow-up showed no increased risks for breastfed infants when assessing their growth, psychomotor and physical development.

However, careful observation of the dynamic development and growth of the baby during breastfeeding, if a woman with the purpose of contraception use Laktinet® drug.

Dosing and Administration:

In the absence of previous use of hormonal contraceptives (within the last month) pills begin with the first day of the menstrual cycle, one tablet a day, possibly at the same time of the day following the specified on the packaging direction so that the interval between the reception of two tablets was 24 hours, if necessary with a small amount of liquid. This drug does not require a break in admission. Each next package should be started immediately after the end of the previous one.

The first drug intake

Women who did not take oral contraceptives in the previous month: the first tablet should be taken from the first day of the menstrual cycle (menstruation). In this case, no additional methods of contraception are required.

Taking the pill you can start with 2-5 days of menstruation, but in this case in the first cycle it is necessary to use additional methods of contraception during the first 7 days of receivingtablets.

Women who switch from another combination oral contraceptive (CPC) on Lactineth®

If possible, the day after the last tablet of the previous PDA. In this case, no additional methods of contraception are required.

Women who switch from mono-component preparations containing only progestogen (mini-pili, injections, implants or intrauterine contraceptives that release progestogen)

When switching from minipilli, the drug can be taken any day; in the case of injections - the day that the next injection should be given; In the case of an implant, the day after its removal.

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

Admission after abortion in the first trimester of pregnancy

After 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 for additional methods of contraception.

Taking the drug after childbirth or after the termination of pregnancy in the second trimester

Reception of the drug begins not earlier than 21-28 days after the termination of pregnancy in the second trimester or after childbirth. If the drug is supposed to start later, then it is necessary to use the barrier method of contraception during the first 7 days. In addition, if unprotected sex has occurred before starting the use of the drug, pregnancy should be excluded or the beginning of the drug on the first day of the next menstruation (during the restoration of the menstrual cycle) be postponed.

Missed (forgotten) tablets

The effectiveness of the contraceptive is reduced if more than 36 hours have passed between the two tablets. If the break does not exceed 12 hours, the contraceptive effect does not decrease, and the use of an additional contraceptive method is not required. The intake of the remaining tablets is continued according to the usual schedule.

In the case of a more than 12-hour break, the contraceptive effect may decrease. To achieve effective blocking of the hypothalamic-pituitary-ovarian system, it is necessary to take the drug daily for 7 days. Thus, with a break of more than 12 hours, the drug is continued in normal mode, however, additional (barrier) methods of contraception must be used in the next 7 days.If the intake of the tablet was missed during the first week of the drug and in the previous 7 days there was an unprotected sexual intercourse, it is impossible to exclude the possibility of pregnancy.

Measures taken in case of vomiting

If vomiting develops within 3-4 hours after taking the pill, then the tablet is not fully absorbed. In this case, you should do the same as in the case of missed tablets. The necessary tablet (the necessary pills) should be replenished from another package.

Observation

Despite the regular intake of tablets, there may be irregular menstruation. If menstruation occurs very often and irregularly, consider using another method of contraception. If the disorder persists, it is necessary to eliminate the organic cause.

Tactics with amenorrhea that occurs during the use of the drug depends on whether the tablets were taken according to the instructions or not; a pregnancy test may be required.

If pregnancy occurs, the drug should be discontinued.

It must be remembered that taking Laktionet® does not protect against the infection of HIV (AIDS) and other sexually transmitted diseases.

Side effects:

The most frequent undesirable effect reported in clinical studies was irregular menstruation. Up to 50% of women who used desogestrel, noted acyclic spotting: in 20-30% of women, menstruation becomes more frequent, while in the other 20% - more rare or even completely can stop. Menstruation can also become more prolonged.

After several months of taking the drug, menstruation tends to become less frequent. Informing a doctor, seeing a doctor, and using a diary of menstruation may increase the compliance of the drug with the drug.

Below are the undesirable effects that have an established, probable or possible relationship with the use of the drug.

In the event that any of the following conditions / risk factors are observed, the expected benefits and risk of contraceptive use should be carefully weighed in consultation with the attending physician throughout the contraceptive period. If any of the following conditions / risk factors appear, increase, change, the patient should immediately consult a doctor to decide whether to continue using the drug.

Often: acne, nausea, mood changes, decreased libido, breast tenderness, menstrual irregularity, headache, weight gain.

Infrequently: alopecia, fatigue, vomiting, discomfort when wearing contact lenses, vaginitis, dysmenorrhea, ovarian cysts.

Rarely: redness of the skin, rash, hives, erythema nodosum.

Although there is no reliable connection with the use of gestagens, cholestatic jaundice, pruritus, cholelithiasis, chorea, pregnant herpes, otosclerosis, deafness, development of hemolytic-uremic syndrome are possible with their reception.

Overdose:

Signs of an overdose: nausea, vomiting, spotting / bleeding from the vagina.

There is no specific antidote, treatment is symptomatic.

Interaction:

Simultaneous use of inducers of microsomal liver enzymes can cause breakthrough bleeding and a decrease in the contraceptive effect of the drug. Such drugs are derivatives of hydantoin (incl. phenytoin), rifabutin, barbiturates, primidon, carbamazepine and rifampicin, and oxcarbazepine, topiramate, felbamate and griseofulvin. Specialized studies for the interaction of desogestrel with other drugs have not been conducted. The maximum induction of microsomal liver enzymes is achieved not earlier than 2-3 weeks after the start of the application of the corresponding inductor up to 4 weeks after its cancellation.

Women taking medications that induce microsomal enzymes of the liver should be recommended temporary additional use of barrier or other nonhormonal methods of contraception.

Antibiotics (eg, ampicillin and tetracycline) reduce the effectiveness of oral contraceptives.

With the simultaneous use of the above drugs with desogestrel, the use of the barrier method of contraception throughout the course of treatment and for 7 days (for rifampicin - 28 days) after the end of therapy is recommended.

When treating with activated charcoal, the absorption of steroids, and, consequently, the contraceptive efficacy, may decrease. In this case, follow the recommendations given in the section "Dosage regimen" for the missed intake of the drug.

Special instructions:

If there is any condition or risk factor, the physician should correlate the risk and benefit of using Lactaneth ® individually for each woman prior to the onset of hormonal contraception. In case of occurrence of any undesirable effect or risk factor it is necessary immediately to put the attending physician in a notification for the decision of a question on expediency of the further reception of a preparation.

Women with diabetes should be monitored carefully during the first months of use of Lactineth®.

Reception Lactitet® reduces serum estradiol to a value corresponding to the early follicular phase.

The protective effect of traditional only progestogen-containing contraceptives in terms of preventing ectopic pregnancy is not as pronounced as in combined oral contraceptives, which is associated with a relatively common occurrence when taking progestogen-only preparations by ovulation. In spite of the fact that Lactineth®, as a rule, inhibits ovulation, the possibility of ectopic pregnancy should be borne in mind when a differential diagnosis occurs when a woman develops amenorrhea or abdominal pain.

Sometimes there may be a chloasma, especially in women with a history of pregnant women with chloasma. Women with a tendency to chloasma should avoid sunlight and ultraviolet irradiation while taking Lactineth®.

Patients with lactose intolerance should bear in mind that one film-coated Lactitet® tablet 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.

Effect on the ability to drive transp. cf. and fur:

Does not affect the ability to control the car and working mechanisms.

Form release / dosage:Tablets coated with a film coat, 0.075 mg.

Packaging:

28 tablets, film-coated, in a blister of PVC / PVDH-film and aluminum foil.

For 1 or 3 blisters together with instructions for use in a cardboard box.

Storage conditions:

Store in the original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002481/10

Date of registration:26.03.2010

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER, Ltd. Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp03.01.2016

Illustrated instructions

Instructions

Lactinet® (Lactinette®)