Expiration date: 02/2025

Structure and Composition: 

Tablets, film-coated. 1 tablet contains active substance: 0.075 mg desogestrel

Excipients: DL- & alpha-tocopherol colloidal silicon dioxide magnesium stearate, stearic acid, potato starch, lactose monohydrate povidone K30

shell film: Opadry II White (titanium dioxide - E171, the CI 77891, talc, macrogol 3000, polyvinyl alcohol)

in blisters made of PVC / PVDC / aluminum foil 28 pcs. In the paper cartons 1 or 3 blisters.

Description pharmaceutical form:

Biconvex tablets round shape, film-coated white or almost white, marked «D» on one side and "75" on the other.

Pharmacokinetics:

Suction

When administered desogestrel is rapidly absorbed. The average value Tmax of 1.8 hours after ingestion of the tablet. The bioavailability of etonogestrel is approximately 70%.

Distribution in the body

Etonogestrel in 95,5-99% bound to plasma proteins, mainly to albumin and to a lesser extent with binding globulin sex hormones.

Metabolism

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

Withdrawal from the body

The average T1 / 2 of about 30 parts of etonogestrel, both single and multiple dose. Css in plasma installed in 4-5 days. Etonogestrel and its metabolites are excreted via the kidneys and intestines (in a ratio of 1.5 / 1) in the form of free steroids and conjugates.

In nursing mothers etonogestrel is excreted in breast milk at a ratio of milk / serum 0,37-0,55 - with exemplary consumption of mother's milk in an amount of 150 mg / kg / day, a newborn can receive 0.01-0.05 mcg etonogestrel per kg body weight per day.

Description of the pharmacological actions:

Lactinette - gestagensoderzhaschy contraceptive for oral use, the active ingredient of which it is desogestrel. Like other hormonal contraceptives, whose composition as an active component includes only progestogen, Lactinette can be taken for women during lactation, as well as contraindications to estrogen use or unwillingness estrogensoderzhaschie kontratsetivy.

Unlike other progestin contraceptive, a contraceptive drug action explained Lactinette inhibition of ovulation, as evidenced by the absence of ovulatory follicles by ultrasound and absence LTG increase and progesterone serum values ??in the middle of the menstrual cycle. At the same time, desogestrel, as well as other progestogens has the property to increase the viscosity of cervical mucus, sperm preventing advancement.

Pearl Index (an indicator of 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 leads to lower Lactinette  of estradiol in blood plasma values ??corresponding to the early follicular phase. Progestogens affect the carbohydrate and lipid metabolism.

Testimony: 

• Contraception.
  

Contraindications:

• the presence of current or a history of venous thromboembolism (including deep vein thrombosis of the lower extremities, pulmonary embolism)
  
• severe liver disease at present or in history (up to normalization of liver function)
  
• liver failure in the present or in history
  
• established or suspected hormone-dependent malignant tumors (including breast cancer)
  
• liver cancer
  
• vaginal bleeding 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, including associated with surgery or disease (risk of venous thromboembolism).
  

Precautions: resistant hypertension that develops in patients receiving the drug, including the ineffectiveness chloasma antihypertensive therapy, especially when during pregnancy chloasma history of diabetes mellitus (due to the possible influence of progestogens on peripheral insulin resistance and glucose tolerance), porphyria systemic lupus erythematosus herpes (during pregnancy history).

Application of pregnancy and breastfeeding:

During pregnancy, the use of the drug is contraindicated.

In preclinical studies, the introduction of very high doses of progestogen observed masculinization of female fetuses.

Epidemiological studies have revealed no increased risk of teratogenic effects and birth defects in children whose mothers took oral hormonal contraceptives prior to pregnancy or inadvertently in early pregnancy.

As with other drugs that contain only progestogen, Lactinette  does not affect the quality and quantity of breast milk, but a small amount of a metabolite of desogestrel (etonogestrel) is excreted in breast milk and is approximately 0.01-0.05 mg / kg / day (with the amount consumed breast-milk 150 ml / kg / day). The results of 7-month follow-up revealed no elevated risks for children who are breastfed, the assessment of their growth, psychomotor and physical development.

Nevertheless, the need for careful monitoring of the dynamic development and growth of the baby during breastfeeding, if a woman uses contraception with a view Lactinette  drug.

Side effect:

The most common adverse effect reported in clinical studies were irregular menstruation. Up to 50% of women using desogestrel, noted acyclic spotting: 20-30% of menstruating women are becoming more frequent, while in the other 20% - a rare or even may stop. Menstruation can also become longer.

After several months of ingestion, menses tend to become less frequent. Inform the doctor, medical supervision, as well as the use of menstrual diary can improve the compliance of drug treatment.

Below are the unwanted effects that have established a probable or possible relationship to the use of the drug.

In that case, if there is any of the following conditions / risk factors, you should carefully weigh the expected benefits and risks of the contraceptive in consultation with the doctor during the whole period of contraception. When prompted, strengthen, change any of the following conditions / risk factors, the patient should immediately consult your 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.

It is not often - alopecia, fatigue, vomiting, discomfort while wearing contact lenses, vaginitis, dysmenorrhea, ovarian cyst.

Rarely - skin redness, rash, urticaria, erythema nodosum.

Although a significant association with the intake of progestogens has not been established, at their reception possible cholestatic jaundice, pruritus, cholelithiasis, chorea, herpes gestationis, otosclerosis, hearing loss, development of hemolytic-uremic syndrome.

Drug Interactions:

Concomitant use of drugs that act both as inducers of microsomal liver enzymes, can cause breakthrough bleeding and reducing the contraceptive effect. Such drugs are hydantoin derivatives (including phenytoin), rifabutin, barbiturates, primidone, carbamazepine and rifampicin and oxcarbazepine, topiramate, felbamate and griseofulvin. Specialized studies for desogestrel interactions with other drugs have not been conducted. Maximum induction of microsomal liver enzymes is achieved no earlier than 2-3 weeks after the start of the corresponding inducer up to 4 weeks after its cancellation.

Antibiotics (such as ampicillin and tetracycline) reduce the effectiveness of oral contraceptives.

Women taking drugs that induce microsomal liver enzymes should be advised to use an additional temporary 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 during treatment and for 7 days (for rifampicin - 28 days) after the end of therapy.

In the treatment with activated carbon absorption of steroids and hence contraceptive efficacy may decrease. In this case, you should follow the advice given in section "Dosage and administration" on missed receiving the drug.

Dosage and administration:

In the absence of prior use of hormonal contraceptives (within the last month), tablet-taking start from the first day on 1 tab of the menstrual cycle. a day, possibly at the same time of the day, following a direction indicated on the package to break between reception Table 2. It was 24 hours, if necessary with a small amount of liquid. This formulation does not require a break in reception. Every next pack should be started immediately after the previous one.

Women, who in the previous month did not take oral contraceptives. Receiving the first tablet should be started from the first day of the menstrual cycle (menstruation). In this case, you do not need to use additional contraceptive methods.

tablets and reception can begin with 2-5 th day of menstruation, but in this case in the first cycle it is necessary to apply additional methods of contraception during the first 7 days of taking the pills.

Women who switch from another combined oral contraceptive (CPC) at Lactinette. If possible, the next day after taking the last tablet of the previous handheld. In this case, you do not need to use additional contraceptive methods.

Women who switch from monocomponent preparations containing only progestogen (mini-pill, injection, implant or IUD, releasing progestogen). In the transition from the mini-pill receiving the drug can begin in any day in case of injection - a day, should be done when the next injection in the case of the implant - a day after its removal.

In all these cases, we recommend the use of barrier methods of contraception during the first 7 days.

Acceptance of the drug after the abortion I trimester of pregnancy. After the abortion I trimester of pregnancy is recommended to start taking the drug immediately after an abortion, and in this case there is no need to use additional contraceptive methods.

Taking the drug after delivery or abortion in the II trimester. Acceptance of the drug begin no earlier than 21-28 days after termination of pregnancy in the II trimester or after delivery. If the drug suggest to start later, you should use a barrier method of contraception for the first 7 days. In addition, if there have been unprotected sex, pregnancy must be excluded or postpone the beginning of the drug on the first day of the next menstruation (the reduction of the menstrual cycle) before use of the drug.

Missed (neglected) tablets. The effectiveness of the contraceptive is reduced if between taking 2 tablets. more than 36 hours have passed. If the interruption does not exceed 12 hours, the contraceptive effect is not reduced, and the use of additional contraceptive method is required.

Receiving the remaining tablets continue on the normal schedule.

In the case of a break of more than 12 hours contraceptive effect may be reduced. To achieve an effective blocking of the hypothalamic-pituitary-ovarian system is necessary to take the drug every day for 7 days. Therefore, a break of more than 12 hours, the drug continues as usual, but in the next 7 days is necessary to use an additional (barrier) method of contraception. If a pill is missed the first week of the drug in the previous 7 days had unprotected sexual intercourse, it is impossible to exclude the possibility of pregnancy.

Measures to be taken in case of vomiting. If within 3-4 hours after tablet develops vomiting, the tablet incompletely absorbed. In this case, you should do the same as in the case of missed pills. The desired tablet (tablet necessary) that fill out another package.

Observation. Despite the regular intake of tablets, there can be a violation of menstruation. If menstruation occur very often and regularly, you should consider using another method of contraception. If the disorder is stored, it is necessary to exclude an organic cause.

Management of the arisen during the application of the drug amenorrhea depends on whether the pills are taken in accordance with the instructions or not may require a pregnancy test.

If there is a pregnancy, the drug should be discontinued.

It must be remembered that taking Lactinette  drug does not protect against HIV infection and other diseases, sexually transmitted diseases.

Overdose:

Symptoms include nausea, vomiting, spotting / bleeding from the vagina.

Treatment: No specific antidote treatment is symptomatic.

Precautionary measures:

If you have any condition or risk factor, the doctor must correlate the risks and benefits of the drug Lactinette individually for each woman prior to the start of hormonal contraception. In case of any undesirable effect or risk factors should immediately put notify your doctor to decide on whether to continue taking the drug.

Women with diabetes should be under careful surveillance during the first months of use Lactinette drug.

Lactinette reception means reduces the content of estradiol in the serum to a value corresponding to the early follicular phase.

The protective effect of traditional, progestin-only contraceptives, in terms of prevention of ectopic pregnancy is not as pronounced as that of combined oral contraceptives, which is associated with a relatively common occurring in patients receiving drugs progestin-only ovulation. Although Lactinette  tend to inhibit ovulation, the possibility of an ectopic pregnancy should be borne in mind in the differential diagnosis when a woman developing amenorrhea or abdominal pain.

Sometimes chloasma may occur, especially in women with a history of chloasma pregnant. Women with a tendency to chloasma should avoid sunlight and ultraviolet radiation while taking Lactinette.

Patients with lactose intolerance should be borne in mind that one film-coated tablet contains Lactinette  67.445 mg lactose monohydrate. Patients with rare hereditary conditions such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take the drug.

Effects on ability to drive or to perform work requiring higher rate of physical and mental reactions. It does not affect the ability to drive a car and operating machinery.