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One tablet of drug of Laktinet contains 0,075 mkg of a dezogestrel and a number of auxiliary components:
- silicon dioxide colloid (Silicii dioxydum colloidale);
- D, L-α-токоферол (dl-alfa-Tocopherol);
- stearic acid (Acidum stearicum);
- magnesium stearate (Magnesium stearate);
- K30 povidone (Povidonum K30);
- potato starch (Amylum solani);
- lactoses monohydrate.
As a part of a film cover which covered tablets are present:
- talc (Talcum);
- macrogoal of 3000 (Macrogolum 3000);
- titanium dioxide CI 77891 (Titanium Dioxide);
- opadray II white (Opadry II White);
- polyvinyl alcohol (Spiritus polyvinylicus).
Laktinet's drug is issued in the form of biconvex, film coated tablets of a round form, color which can vary from almost white to white. At one party of a tablet there is an engraving in the form of the letter "D", with another number "75" is engraved.
Tablets are packed into blisters on 28 pieces. In one cardboard box there can be one or at the same time three blisters.
Laktinet belongs to pharmacological group of the monophase gestagensoderzhashchy contraceptives intended for oral administration for the purpose of the prevention of approach of pregnancy.
Pharmacodynamics and pharmacokinetics
Film coated contraceptive tablets of Laktinet represent contraceptive means which basis is made by progestogen of the third generation dezogestret.
High degree of affinity of substance to receptors of progesterone provides reliable contraception even when using it in low doses. Its main advantage is that it practically does not exert impact on a lipidic range of blood. Also it does not influence an exchange of carbohydrates and indicators of a hemostasis.
These useful qualities of a dezogestrel are guarantee of safety (taking into account contraindications to their use) the modern low-dosed oral contraceptives which also Laktinet treats.
As as active agent other hormonal components except for progestogen are not used, Laktinet's tablets are safe for the women nursing and also for the women having contraindications or not persons interested to accept estrogensoderzhashchy drugs.
The mechanism of action of a dezogestrel is caused by braking of an ovulation that is confirmed by lack of a follicle when carrying out procedure of ultrasonic diagnosis, and also indicators of low contents in an organism of luteotropic (lactogenic) hormone.
Efficiency of action of a dezogestrel is confirmed also by low concentration of progesterone in the middle of a menstrual cycle.
One more not less important property of substance — ability to increase density and viscosity of cervical slime which is developed by glands of a neck of uterus. It in turn creates a barrier to passing of spermatozoa and interferes with fertilization of an ovum.
Perl's index for drug makes 0,4. This indicator reflects the number of pregnancies in group of one thousand women within a year without use of contraceptive means, and also the level of reliability of a method of contraception. Than it is lower, especially the contraceptive is considered effective.
Concerning Laktinet Perl's index is similar to the indicator established for contraceptives of the combined type.
Data of comparative research showed that at reception of the passed tablets at most three hours later after appropriate time, in group of the women accepting drug, value of an index of Perl remained invariable — 0,4. Perl's index for levonorgestrel increased up to an indicator 1,6.
After reception of per os of a tablet of Laktinet dezogestret quickly it is absorbed in a stomach and intestines. The average value of the maximum concentration of substance in the circulating blood at the same time is noted from 1,8 to 2 hours later. The indicator of bioavailability is in limits of 70%.
Under the influence of enzymes dezogestret is exposed to processes of a hydroxylation and dehydrogenation therefore it biotransformirutsya to an etonogestrel which is its main metabolite. The further metabolization of an etonogestrel comes to the end with formation of glyukuronidny and sulphatic conjugates.
Etonogestrel who is the most active metabolite of a dezogestrel possesses ability to contact proteins of a blood plasma for 95,5-99%. More it concerns albumine, in a little smaller — globular proteins (globulins) which are responsible for binding of sex hormones.
The elimination half-life of metabolites of a dezogestrel averages about 30 hours. And its duration does not change depending on whether there was an administration of drug single or course (repeated).
Equilibrium concentration is noted 4-5 days later after the beginning of reception of tablets.
Removal of metabolites in the form of conjugates and free steroid hormones is carried out mainly by kidneys with urine. In much smaller degree they are brought with intestines contents.
At the nursing women etonogestret gets to milk. A ratio the milk/blood plasma at the same time makes 0,37/0,55. It, and also that the child on average receives within a day about 150 ml of breast milk on each kilogram of the weight he can receive with it and from 0,01 to 0,05 mkg of an etonogestrel.
Indications to use
By Laktinet it is shown as contraceptive means to the women wishing to prevent unplanned pregnancy.
Contraindications to purpose of drug are:
- the thromboembolism (noted in the anamnesis or which is available now);
- heavy pathologies of a liver (the contraindication remains until indicators of function of a liver are not normalized);
- dysfunction, and also hepatic unsufficiency;
- existence or the assumption on existence at the patient of a hormonedependent malignant new growth;
- allocations from a vagina of not clear nature of an origin;
- pregnancy or suspicion on it;
- intolerantnost to lactose;
- lactose intolerance;
- glucose galactose malabsorption;
- forced immobilization throughout a long span;
- hypersensitivity to active ingredient or some of auxiliary components.
Researches of drug of Laktinet and its active ingredient showed that the most frequent side reaction disturbance of a regularity of a menstrual cycle attends administration of drug.
Approximately at a half of the women accepting drug not cycling bloody vulval allocations are noted. At every third or fifth woman against reception of tablets of periods become more rare (up to that over time completely disappear) or — on the contrary — become frequent.
In some cases also increase in duration of menstrual bleeding can be observed. However, as a rule, after two months of reception of periods become less frequent phenomenon.
For increase of degree of safety and decrease in risk of development of side effects, the woman accepting Laktinet is regularly recommended to visit the gynecologist, to report to him about all changes of the state, and also to keep the diary of menstrual allocations.
Belong to the category of the gestagensoderzhashchy oral contraceptives of effects which are most often arising against reception:
- nausea attacks;
- emergence of an acne;
- lability of mood;
- decrease in sexual desire;
- morbidity in mammary glands;
- weight set;
Are slightly less often noted:
- the increased fatigue;
- hair loss (alopecia);
- increase of level of intracranial pressure;
- inflammatory processes mucous vaginas;
- cystous educations in ovaries;
- infectious diseases of a vagina;
- increase of expressiveness of pains in the lower part of a stomach during menstrual bleeding.
Rather seldom there can be such phenomena as an enanthesis, a nodose erythema, reddening of integuments, the small tortoiseshell. Some women can have allocations from mammary glands. In rare instances ectopic pregnancy is registered.
Laktinet's reception can become a provocative factor for development or increase in degree of manifestation of a Quincke's disease, and also for its aggravation if the last is inborn.
Cases when at the women accepting oral contraceptives also more serious effects were noted are known. Formation of hormonedependent cancer tumors and development of a thromboembolism concern to them (venous or arterial).
Application instruction of Laktinet: way of reception and drug dosing
If before Laktinet's use the woman did not drink any oral contraceptives, reception of tablets is begun from the first day of a cycle. A daily dose of drug — 1 tablet.
At the same time it is recommended to be accepted accurately at the same time, maintaining an interval lasting 24 hours and following the instruction specified on packaging. At Laktinet's reception it is not required to do intervals between each two courses.
If earlier the woman did not use hormonal contraception (at least in the previous month), reception of tablets begin in the first after the termination of menstrual bleeding put. Auxiliary barrier contraceptives at the same time are not necessary.
If administration of drug is begun in an interval between the 2 and 5 in the days after the termination of menstrual bleeding, in this case contraceptive tablets supplement with barrier contraceptives.
In need of replacement of other combined contraceptive on Laktinet it is recommended to do it the next day after refusal of the means used earlier. Need for use of additional resources of protection is absent.
In need of replacement of other monocomponent drug containing progestogen on Laktinet reception of tablets is also begun at once after cancellation of the means used earlier, whether it be mini-saw, progestagensoderzhashchy injections, intrauterine contraceptives or implants.
In each of cases within the first week for bigger reliability of contraception it is necessary to resort to use along with tablets of barrier contraceptives.
After carrying out procedure of abortion, and also after a misbirth in the first three months of pregnancy, administration of drug is recommended to be begun at once after abortion. Need for additional methods of contraception is absent.
After abortion during the period between 13 and 24 weeks, and also after the delivery, Laktinet's reception is appointed not earlier than in 21-28 days. If is going to begin a course later, then in the first seven days of a tablet combine with use of barrier contraceptives.
In situations when before a course of administration of drug the unprotected sexual relations took place, the woman is recommended to exclude a possibility of pregnancy or it is offered to displace the first day of the beginning of use of tablets for the first day of the following menstrual cycle.
If the previous reception of a tablet was missed, but there passed less than twelve hours, the contraceptive effect of drug remains invariable, further reception is continued according to the usual scheme, without using additional methods of protection against undesirable pregnancy.
If passed from twelve hours to three days, then reliability of contraception decreases significantly. Drug continues to be accepted according to the usual scheme, however, supplement it with use of other ways of contraception.
If in several hours after reception of a tablet vomiting begins, it is the certificate that full absorption of active agent of drug did not happen. In this case the instruction on Laktinet recommends to resort to the counter-measures similar to what resort if the next reception was missed. For completion of a missing tablet it is taken from the following packaging of drug.
If against reception of tablets menstrual disturbances are noted (for example, too frequent, long, painful or irregular bleedings), it is necessary to consider drug replacement option. If the symptomatology does not disappear and after that, passing of careful inspection is necessary for establishment of the exact reason of its emergence.
In some cases the arising amenorrhea and other disturbances of a cycle can be a consequence of the wrong administration of drug.
In case of pregnancy approach, Laktinet's reception is immediately stopped.
At excess by the recommended instruction of a dose of drug can be noted:
- bloody allocations or plentiful bleedings from a vagina.
At emergence of any of these signs the symptomatic treatment is appointed. Drug has no specific antidote.
The concomitant use with the drugs inducing microsomal liver enzymes can become the reason of breakthrough bleeding and reduce contraceptive effect of Laktinet.
Hydantoin derivatives belong to such medicines:
- Primidonum okskarbazepin.
To receive medical treatment in case of need for these drugs the woman is recommended to supplement reception of contraceptive tablets with use of additional resources of contraception throughout all course of treatment and within seven days after its termination. After the termination of rifampicin it is recommended to use barrier contraceptives within 28 days.
After reception of absorbent carbon or its analog it is necessary to be guided by recommendations concerning a drug dosing at the admission of reception of a tablet.
Terms of sale
Laktinet belongs to category of the drugs which are released according to the recipe.
Drug is recommended to be stored in original packaging at a temperature which is not exceeding 25 °C.
Period of validity
It is suitable for the use within 3 years.
Coincidence on the ATH code of the 4th level:
Laktinet's analogs are drugs Charozetta and Dezogestrel.
Laktinet's use during the breastfeeding and pregnancy
Laktinet's use by pregnant women is forbidden. It is caused by results of the preclinical trials which showed that high doses of progestogens (one of which is active agent of drug) promote an excessive masculinization of female fruits.
As for epidemiological researches, they did not reveal the increased risk of emergence of inborn uglinesses in the child and any frustration of an embryogenesis at newborn babies whose mothers accepted contraceptives before pregnancy or — inadvertently — in the first weeks after its approach.
Accepted when breastfeeding Laktinet does not exert impact on quantity at the woman of breast milk and its quality indicators. However dezogestret possesses ability in small amounts to get to milk.
Supervision over the feeding women using when breastfeeding Laktinet for protection from pregnancy confirmed that dezogestret does not provoke any growth disorder and development (both physical, and intellectual).
Nevertheless, for the purpose of safety careful supervision over the child from the qualified pediatrician is recommended.
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