Expiration date: 01/2025

Structure and Composition:

Dragee. 1 dragee contains:

gestodene 0.075 mg

0.02 mg ethinylestradiol

Excipients: lactose monohydrate, corn starch, talc, magnesium stearate, polyvidone sucrose 25,000 calcium carbonate Macrogol 6000 Carnauba wax

in a blister pack with a calendar scale of 21 pcs. in box 1 or 3 blisters.

Description pharmaceutical form:

Round white dragee.

Characteristic:

Low-dose monophasic oral combined estrogen-progestin contraceptive drug.

Pharmachologic effect:

The contraceptive effect Logest carried out through various complementary mechanisms, the most important of which are inhibition of ovulation and changes in the properties of the cervical secretion.

In women taking combined oral contraceptives, menstrual cycle becomes more regular, less often observed painful menstruation, it decreases the amount of bleeding, thereby reducing the risk of iron deficiency anemia.

There is information about reducing the risk of endometrial cancer and ovarian cancer.

Pharmacokinetics:

Gestodene. Once inside quickly and completely absorbed (bioavailability about 99%). Serum Cmax (3.5 ng / mL) was reached after about 1 h. Gestodene binds to serum albumin and globulin, sex hormone binding (SHBG, 69%). Only about 1.3% of the total serum gestodene is in free form. The relative distribution of fractions (free gestodene associated with albumin and an associated GSM) depends on the serum concentration of SHBG. Following induction SHBG fraction associated with SHBG increases to 80%, and the free fraction bound to albumin is reduced. Gestodene is almost completely metabolized. The metabolic clearance rate - 0.8 ml / min / kg. There is a biphasic decrease in the serum concentration, T1 / 2 in the terminal phase of about 12 h unmodified form gestodene not displayed, but only as metabolites. (T1 / 2 - about 24 hours), which are excreted in the urine and bile in a ratio of about 6 :4.

Ethinyl estradiol. Once inside quickly and completely absorbed from the gastrointestinal tract. Average absolute bioavailability of 45% due to the effect of "first pass" through the liver. Cmax is reached after 1.7 hours. Nonspecifically binds to serum albumin (approximately 98%), about 2% is in the free form in plasma, serum (65 pg / ml). The apparent volume of distribution - 2,8-8,6 l / kg. Treated presistemna conjugation in the small intestine mucosa and in the liver. The main pathway - aromatic hydroxylation. The metabolic clearance rate from plasma - 2,3-7 ml / min / kg. There is a biphasic decrease in serum: T1 / 2 - about 1 h and 10-20 h, respectively. In an unmodified form of the organism is not displayed. As metabolites excreted in the urine and bile in a ratio of 4: 6 with a T1 / 2 of about 24 h.

Based on the T1 / 2 and the final phase of the daily dose, the equilibrium concentration reached after 5-6 days of treatment.

Indications: Contraception.

Contraindications:

Logest should not be applied if any of the conditions listed below. If any of these conditions develop for the first time in patients receiving the drug should be immediately repealed.

Thrombosis (venous and arterial) and thromboembolism present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident).

Conditions prior thrombosis (including transient ischemic attack, angina pectoris), at present or in history.

Migraine with focal neurological symptoms history.

Diabetes mellitus with vascular complications.

Multiple or severe venous or arterial thrombosis risk factors, including valvular lesions, cardiac arrhythmias, cerebral vascular disease or coronary artery uncontrolled hypertension.

Pancreatitis with severe hypertriglyceridemia now or in history.

Liver failure and severe liver disease (as long as liver function tests have not come back to normal).

Liver tumors (benign or malignant) now or in history.

Identified malignant hormone-dependent diseases (including genital or mammary glands) or are suspected.

Vaginal bleeding of unknown origin.

Pregnancy or suspected it.

The period of lactation.

Hypersensitivity to any component Logest drug.

Prolonged immobilisation, major surgery, surgery on the legs, extensive trauma.

CAREFULLY

Marked disorders of fat metabolism (obesity, hyperlipidemia), superficial vein thrombophlebitis otosclerosis with deterioration of hearing, idiopathic jaundice or pruritus during a previous pregnancy migraine congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor), diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, sickle cell anemia hypertension.

Application of pregnancy and breastfeeding:

Logest not appointed during pregnancy and lactation. If pregnancy is detected during the reception Logest the drug, the drug is immediately canceled. However, extensive epidemiological studies have revealed no increased risk of defects in children born to women treated with hormones before pregnancy, or teratogenic effects when sex hormones were taken inadvertently in early pregnancy.

Admission combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is contraindicated during lactation. Small amounts of sex steroids and / or their metabolites may be excreted in milk, but there is no confirmation of their negative impact on the health of the newborn.

Side effect:

In rare cases, it may be soreness and tension of the mammary glands, breast enlargement, discharge from the breasts, spotting and breakthrough uterine bleeding, headache, migraine, changes in libido, decrease / mood changes, poor tolerance of contact lenses, visual disturbances, nausea , vomiting, abdominal pain, change in vaginal secretions, skin rash, erythema nodosum, erythema multiforme, generalized pruritus, cholestatic jaundice, fluid retention, weight change, allergic reactions, rarely - fatigue, diarrhea sometimes - chloasma, especially in women with a history of chloasma during pregnancy.

As when taking other combined oral contraceptives in rare cases may develop thrombosis and thromboembolism.

Drug Interactions:

Sulfonamide derivatives, pyrazolone can enhance metabolism included in the preparation of steroid hormones.

Long-term treatment with drugs that induce liver enzymes, resulting in increased clearance of sex hormones can lead to breakthrough bleeding and / or reduce the contraceptive efficacy of the drug Logest. Such drugs include phenytoin, barbiturates, primidone, carbamazepine and rifampicin have also assumptions regarding oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin and preparations containing St. John's wort.

The contraceptive protection is reduced when taking antibiotics such as ampicillin and tetracyclines, because, according to some sources, they may reduce intrahepatic circulating estrogen, thereby reducing the concentration of ethinyl estradiol.

Combination oral contraceptives may affect the metabolism of other drugs (including Cyclosporine), which leads to a change in their concentration in the plasma and tissues.

When receiving estrogen-progestin drugs may require correction dosing regimen hypoglycemic agents and anticoagulants.

Dosage and administration:

Inside, a small amount of water every day about the same time of day, in the order indicated on the package. Take 1 tablet a day, continuously for 21 days. Receiving the next pack is started after a 7-day break in taking pills, during which usually occurs withdrawal bleeding. Bleeding usually begins 2-3 days after the last pellet and can not end before receiving a new package.

Admission Logest begin:

• Without taking any hormonal contraceptive use in the preceding month. Admission Logest begins on the first day of the menstrual cycle (ie the first day of menstrual bleeding). Shall start receiving 2-5 days of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of tablet-taking from the first package
  
• The transition to the other combined oral contraceptives. Preferably begin receiving Logest the next day after the last active pellets from the previous package, but in any case no later than the next day after the usual 7 day interval (for formulations comprising 21 pills) or after the last inactive pills (for preparations containing 28 pills in the package)
  
• The transition from contraceptives containing only progestin (mini-pill, injectable form, implant) or from a progestogen-releasing intrauterine device (Mirena). A woman can go to the mini-pill Logest on any day (without a break), with the implant or intrauterine device with progestin - the date of its removal from the injection mold - the day when the next injection should have to be made. In all cases, you must use an additional barrier method of contraception during the first 7 days of tablet
  
• After the abortion I trimester of pregnancy. The woman may start taking the drug immediately. Subject to this condition the woman does not need extra contraceptive protection
  
• After delivery or abortion in the II trimester of pregnancy. It is recommended to start taking the drug on day 21-28 after delivery or abortion in the II trimester of pregnancy. If the reception is started later, you must use an additional barrier method of contraception during the first 7 days of tablet-taking. If a woman has been sexually active, before you start taking Logest pregnancy should be excluded or must wait for the first menstrual period.
  

Admission missed pills. If the delay in receiving the drug was less than 12 hours, contraceptive protection is not reduced. The woman should take pills as soon as possible, should be taken at the usual time.

If the delay in taking pills made more than 12 hours, contraceptive protection may be reduced. It is possible to be guided by the following two basic rules:

• Receiving the drug should never be interrupted for more than 7 days
  
• Required 7 days of continuous tablet-taking in order to achieve adequate suppression of the hypothalamic-pituitary-ovarian regulation.
  

If the delay in taking pills made more than 12 hours (interval from the receipt of the last pills for more than 36 h), the following advice can be given.

The first week of taking the drug

The woman should take the last missed pills as soon as possible (even if this means taking two pills at once). Next take the pills at the usual time. In addition to be used a barrier method of contraception (eg a condom) for the next 7 days. If intercourse took place during the week before skipping pills, you need to take into account the chance of pregnancy. The more pills missed and the closer they are to a break in the reception of active substances, the greater the likelihood of pregnancy.

The second week of taking the drug

The woman should take the last missed pills as soon as possible (even if this means taking two pills at once). Next take the pills at the usual time. Provided that the woman has taken pills correctly in the 7 days preceding the first missed pills, there is no need to use additional contraceptive measures. Otherwise, as well as skipping the reception of two or more must be added dragees barrier methods of contraception (e.g. condom) for 7 days.

The third week of taking the drug

The risk of reduced reliability is imminent because of the forthcoming break in taking pills. A woman should strictly stick to one of the following options (if the 7 days preceding the first missed pills, all the pills are taken correctly, there is no need to use additional contraceptive methods):

1. The woman should take the last missed pills as soon as possible (even if this means taking two pills at once). Next pills taken at the usual time, there are no more pellets in the current package. The next pack should be started immediately. Withdrawal bleeding is unlikely until the end of the second pack, but may experience spotting and breakthrough bleeding during the tablet-taking.

2. The woman may also interrupt the reception of pills from the current package. Then she should take a break for 7 days, including the day of skipping pills, and then start receiving new packaging.

If a woman misses pills, and then during a break in taking pills she had no withdrawal bleeding, pregnancy must be excluded.

Recommendations in case of vomiting and diarrhea

If a woman has had vomiting or diarrhea within up to 4 hours after taking the active pills, absorption may not be complete and should be additional contraceptive measures are taken. In these cases, you should be guided by the recommendations by skipping pills.

Changing the date of the beginning of the menstrual cycle

In order to delay the onset of menstruation, the woman should continue taking pills from a new package Logest immediately after taking all the pills from the previous one, without a break in the reception. Drops of this new packaging may be taken for as long as the woman wants (as long as the packaging is not finished). Against the background of the drug from the second package, women may experience spotting or breakthrough uterine bleeding. Resume Logest reception from a new package follows the usual 7-day break.

In order to move the first day of menstruation to another day of the week, the woman should be advised to shorten the next break in taking pills for as many days, as much as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding will continue to spotting and breakthrough bleeding while taking second pack (just as when she wanted to delay the onset of menses).

Overdose:

Symptoms include nausea, vomiting, spotting or metrorrhagia.

Treatment: symptomatic. No specific antidote.

Precautionary measures:

In the case of the planned operation should stop taking the drug for at least 4 weeks before it and not to renew the appointment within 2 weeks after the immobilization.

During reception drugs affecting microsomal enzymes and for 28 days after their removal should additionally use a barrier method of contraception.

During reception of antibiotics such as ampicillin and tetracycline and for 7 days after their removal should additionally use a barrier method of contraception.

If the period of use of barrier methods of protection ends later than Bean in a package, you need to go to the next package Logest without the usual break in receiving pills.

If any of the conditions / risk factors mentioned below are currently available, you should carefully weigh the potential risks and expected benefits of treatment Logest in each individual case and discussed with the woman before she decides to start taking the drug. In the case of aggravation, or amplification of the first manifestations of any of these conditions or risk factors, the woman should consult with your doctor, who can decide whether to cancel the drug.

Diseases of the cardiovascular system

There is evidence of increasing incidence of venous and arterial thrombosis and thromboembolism while taking combined oral contraceptives.

However, the incidence of venous thromboembolism, developing while taking combined oral contraceptives, is less than the rate associated with pregnancy (6 per 10 000 pregnant women per year).

In women taking combined oral contraceptives are described in very rare cases of thrombosis, other blood vessels, eg hepatic, mesenteric, renal arteries and veins, central retinal vein and its branches. Communication with the reception of combined oral contraceptives has not been proved.

Women need to stop taking the drug and consult a doctor if you develop symptoms of venous or arterial thrombosis or cerebrovascular disorders, which can include: unilateral leg pain and / or swelling sudden severe pain in the chest with irradiation or without the left arm sudden breathlessness sudden attack of coughing any unusual, severe, prolonged headache sudden partial or complete loss of vision diplopia slurred speech or aphasia dizziness, loss of consciousness and / or without convulsive seizure weakness or very marked numbness suddenly appeared on one side or in one part of the body movement disorders symptoms of "acute abdomen ".

The risk of thrombosis (venous and / or arterial) and thromboembolism is increased:

• with age
  
• Smokers (with the number of cigarettes or increasing age the risk further increases, especially in women over 35 years old)
  

in the presence of:

• Family history (ie venous or arterial thromboembolism ever in close relatives or parents at a relatively young age) in the case of hereditary predisposition, the woman should be assessed and the appropriate specialist to resolve the question of the possibility of using combined oral contraceptives
  
• Obesity (body mass index over 30 kg / m2)
  
• dislipoproteinemia
  
• Hypertension
  
• migraine
  
• Diseases of the heart valves
  
• Atrial fibrillation
  
• Prolonged immobilization, major surgery, any surgery to the legs, or major trauma.
  

In these situations, it is desirable to discontinue the use of combined oral contraceptive (in case the intended operation of at least 4 weeks before it), resuming the reception and for 2 weeks after the immobilization.

It is necessary to take into account the increased risk of thromboembolism during the postpartum period.

Circulatory disorders also may occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

Increased frequency and severity of migraine during use of combined oral contraceptives (which may be preceded by a cerebrovascular accident) may be a reason for immediate discontinuation of these drugs.

Biochemical parameters which can be indicative of hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, deficiency of antithrombin-III, protein C deficiency, protein deficit S, the presence of antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant) .

Tumors

There have been reports of an increased risk of developing cervical cancer with persistent HPV infection. His connection with the intake of combined oral contraceptives has not been proved. Contradictions persist as to the extent to which these findings relate to the characteristics of sexual behavior and the use of barrier contraception.

It was also found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives. His connection with the intake of combined oral contraceptives has not been proved. The observed increase in risk may be due to an earlier diagnosis of breast cancer in women using combined oral contraceptives.

In rare cases during treatment with combined oral contraceptives was observed the development of liver tumors. The emergence of severe pain in the abdomen or signs of intra-abdominal bleeding, liver enlargement should be considered in the differential diagnosis.

other conditions

Women with hypertriglyceridemia (or the presence of the state in family history) may increase the risk of developing pancreatitis while taking combined oral contraceptives.

Although a slight increase in blood pressure have been reported in many women taking COCs, clinically relevant increases were rare. However, if while taking combined oral contraceptives develops persistent, clinically significant increase in blood pressure, should be discontinued these drugs and begin treatment of hypertension. Admission combined oral contraceptives may be continued if using antihypertensive treatment achieved normal blood pressure values.

The following conditions have been reported to develop or worsen both during pregnancy and while taking combined oral contraceptives, but their relationship with the intake of combined oral contraceptives has not been proven: jaundice and / or pruritus associated with cholestasis formation of stones in the gallbladder porphyria systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea herpes pregnant hearing loss associated with otosclerosis. cases of Crohn's disease are also described and ulcerative colitis background on the use of combined oral contraceptives.

Acute or chronic disturbances of liver function may require the elimination of the use of combined oral contraceptives as long as liver function tests have not returned to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of COCs.

Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetics using low-dose COCs (<0.05 mg ethinylestradiol). However, women with diabetes should be carefully monitored during the reception of combined oral contraceptives.

Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to sunlight and ultraviolet radiation.

Laboratory tests

Admission combined oral contraceptives can affect the results of certain lab tests, including liver function tests, kidney, thyroid, adrenal, levels of transport proteins in the plasma, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes do not usually go beyond the normal range.

The effect on the menstrual cycle

While taking combined oral contraceptives may experience irregular bleeding (spotting or breakthrough bleeding), especially during the first months of use. Therefore, the evaluation of any irregular bleeding should be done only after a period of adaptation of approximately 3 cycles.

If irregular bleeding recur or develop after previous regular cycles, you should conduct a thorough examination to exclude malignancy or pregnancy.

In some women, during a break in taking pills may not develop withdrawal bleeding. If combined oral contraceptives are taken according to directions, it is unlikely that the woman is pregnant. Nevertheless, if before that combined oral contraceptives are taken irregularly, or if there is no withdrawal bleeding row 2, to continue receiving the drug should be excluded pregnancy.

Medical examinations

Before the start of the drug Logest she will need to undergo a thorough general medical and gynecological examination (including breast examination and cytological examination of cervical mucus), exclude pregnancy. In addition, to exclude blood coagulation disorders.

In the case of long-term use is necessary to conduct control tests, the frequency of which depends on the individual woman.

It should warn the woman that type Logest medications do not protect against HIV infection (AIDS) and other sexually transmitted diseases through!

Effects on ability to drive and use machinery have been identified.