Can be administered to women during lactation, as well as contraindications to estrogen or unwillingness to use estrogensoderzhaschie kontraptsetivy. Unlike other progestin contraceptives, the contraceptive effect of the drug methenolone enanthate is due to inhibition of ovulation process, as evidenced by the absence of ovulatory follicle on ultrasound and the absence of increasing values luteotrophic hormone , and progesterone in the blood serum in the middle of the menstrual cycle. At the same time, desogestrel, also. Like other progestogens, has the property to increase the viscosity of the cervical mucus, preventing sperm promotion. 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 methenolone enanthate leads to a decrease of estradiol in the blood plasma to a value corresponding to the early follicular phase. Progestogens affect the carbohydrate and lipid metabolism. Absorption When administered desogestrel is rapidly absorbed. The average maximum serum concentration achieved after 1.8 hours after administration of the tablet. Etonogestrel bioavailability is about. The distribution in the body of etonogestrel in bound to plasma proteins, mainly to albumin and to a lesser extent with binding globulin sex hormones (SHBG). Metabolism Desogestrel by dehydrogenation and hydroxylation metabolized to the active metabolite etonogestrel. Etonogestrel is metabolized through the formation of sulfate and glucuronide conjugates.
- Currently presence or history of venous thromboembolic events (including deep vein thrombosis of the lower extremities, pulmonary embolism;
- severe liver disease, current or history (up to normalization of liver function);
- liver failure current or history;
- established or suspected methenolone enanthate 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 formulation.
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- prolonged immobilization, including associated with surgery or disease (risk of venous thromboembolism).
- resistant hypertension. developing on the background of 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 influence on the peripheral nnsulinrezistentnost progestogens and glucose tolerance);
- Systemic lupus erythematosus (SLE);
- herpes (during pregnancy in history).
Pregnancy and lactation Pregnancy During methenolone enanthate 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 unintentionally – in the early stages of pregnancy. Lactation As with other drugs containing progestogen only, Laktinet ® 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 (when the amount of intake of breast milk 150 ml / kg / day). The results of 7-month follow-up revealed no elevated risks for children who are breastfed in the assessment of their growth, psychomotor and physical development. However, the need to carefully monitor the dynamic development and growth of the baby during breastfeeding if a woman for the purpose of contraception using a drug methenolone enanthate .
Dosing and Administration
In the absence of prior use of hormonal contraceptives (within the last month) reception of tablets start from the first day of the menstrual cycle, one tablet per day, if possible at one and the same time of day, following in the indicated on the packaging direction to the break between intake of two tablets was 24 hours, if necessary with a small amount of liquid. This drug does not require a break in the reception. Every next pack should be started immediately after the previous one. The first appointment of the drug women, who in the previous month did not take oral kontratseptivov : Receiving the first tablet should be started from the first day of the menstrual cycle (menstruation). In this case, do not need to use additional contraceptive methods. Tablets Admission 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 receiving pills. Women who switch from another combined oral contraceptive (CPC) at Laktinet ® If possible, the next day after taking the last tablet of the previous handheld. In this case, it does not require the use of additional methods of contraception. Women who switch from monocomponent preparations containing only progestogen (mini-pill, injection, implant or IUD, releasing progestogen) During the transition from mini-pill the drug, you can start on any day ; in the case of injection – on a day when should be methenolone enanthate done next injection; in the case of the implant -. a day after his removal In all these cases, we recommend the use of barrier methods of contraception during the first 7 days. Acceptance of the drug after an abortion in the first trimester of pregnancy, after abortion in the first trimester of taking the drug pregnancy is recommended to start immediately after abortion, and this case, there is no need to use additional contraceptive methods. Receiving the drug after delivery or after abortion in the second trimester of the drug is not an early start 21-28 days after the termination of pregnancy in the second trimester or after delivery. If you start taking the drug suggest later, you should use a barrier method of contraception for the first 7 days. In addition, if prior to the start of the drug have been unprotected sex, it is necessary to exclude pregnancy or postpone the beginning of the drug is on the first day of the next menstruation (the reduction of the menstrual cycle). Missed (neglected) pill contraceptive effectiveness is reduced if between taking two tablets have passed over 36 hours. If a break not exceeding 12 hours , the contraceptive effect is not reduced, and the use of an additional contraceptive method is not required. Admission remaining tablets continue on the regular schedule. In the case of more than 12-hour break , the contraceptive effect may be reduced. In order to achieve an effective blocking of the hypothalamic-pituitary -yaichnikovoy system needs to take the drug every day for 7 days. Thus, when a break of greater than 12 hours , taking the drug continues as usual, but in the next 7 days is necessary to use an additional (barrier) methods of contraception. If the reception of the tablet was missed in 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 taken in case of vomiting If within 3-4 hours after taking the pill develop vomiting, the pill is absorbed incompletely. In this case, you should do the same as in the case of missed pills. The desired tablet (tablets needed) should fill from a new package. Observation Although 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 pill according to the instructions or not accepted; may require a pregnancy test. If there is a pregnancy, the drug should be stopped. It must be remembered that taking methenolone enanthate drug does not protect against HIV infection (AIDS) and other diseases, sexually transmitted diseases.
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. Menses may also be longer.
After several months of ingestion, menses tend to become less frequent. Informing clinicians, medical supervision, as well as the use of menstrual diary can improve the compliance of drug treatment.
The following are the unwanted effects that have established, probable or possible link to the use of the drug.
In that case, if there is any of the following conditions / risk factors need to be carefully weighed the expected benefits and risks of the contraceptive in consultation with the doctor methenolone enanthate 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 pain, weight gain.
Uncommon: alopecia, fatigue, vomiting, discomfort while wearing contact lenses, vaginitis, dysmenorrhea, ovarian cyst.
rare: skin redness, rash, urticaria, erythema nodosum.
Although a significant association with the intake of progestogens has not been established, with their reception possible cholestatic jaundice, pruritus, cholelithiasis, chorea, herpes gestationis, otosclerosis, hearing loss, development of hemolytic-uremic syndrome.
Overdose Symptoms: nausea, vomiting, spotting / bleeding from the vagina. No specific antidote, treatment is symptomatic.
Interaction with other medicinal products
Concomitant use of drugs, 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 (eg., ampicillin and tetracycline) reduce the effectiveness perorapnyh contraception.
Women taking drugs that induce microsomal liver enzymes should be advised to use an additional temporary barrier or other non-hormonal contraceptive methods.
In an application. 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 of activated carbon absorption of steroids and hence, and contraceptive efficacy may be reduced. In this case, you should follow the advice given in section “Dosage and administration” on missed receiving the drug.
If you have any condition or risk factor, the doctor must correlate the risks and benefits of the drug Laktinet ® individually for each woman prior to the start of hormonal contraception. In case of any undesirable effect or risk factor you must immediately put the doctor in popularity for a decision on whether to continue taking the drug.
Women with diabetes should be under careful surveillance during the first months of use Laktinet ® .
Reception Laktinet ® reduces the estradiol serum to a value corresponding to the early follicular phase.
the protective effect of traditional only progestagensoderzhaschih contraceptives in terms of ectopic pregnancy prevention is not as pronounced as that of combined oral contraceptives, which is associated with relatively often occurring in patients receiving only progestagensoderzhaschih preparations ovulation.
Despite the fact that Laktinet ® , usually inhibits ovulation, the possibility of an ectopic pregnancy should be borne in mind in the differential diagnosis in the development of women in amenorrhea or abdominal pain.
chloasma may occur sometimes, especially in women with a history of chloasma pregnant. Women with a tendency to chloasma should avoid sunlight and ultraviolet radiation while taking Laktinet ® .
Patients with lactose intolerance should be borne in mind that one film-coated tablet Laktinet ® contains 67.445 mg of lactose monohydrate. Patients with rare hereditary conditions such as lactose intolerance, lactase deficiency or glucose-galactose malabsorbtsiey should not take the drug.