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LOGEST® (Ethinylestradiol / Gestodene) 21 pills

$33.00

5e8363b0a58b

Description

One dragee contains

  • Active ingredients: Ethinylestradiol 0.02 mg, Gestodene 0.075 mg
  • Excipients: lactose monohydrate, corn starch, povidone 25, magnesium stearate,
  • Coating composition: sucrose, povidone 90, macrogol 6000, calcium carbonate, talc, montan glycol wax.

 

Indications for use

  • Oral contraception

The decision to prescribe Logest® should be made taking into account the patient’s risk factors, including risk factors for venous thromboembolism (VTE), as well as the risk of VTE associated with Logest® in comparison with other combined hormonal contraceptives (see sections “Contraindications” and “Special Instructions”).

 

Dosage and administration

For oral administration.

The dragee should be taken orally every day at the same time (with a little water if necessary). Take one tablet per day, continuously for 21 days. Reception of each subsequent package begins after a 7-day break, during which, usually on the 2-3rd day from the last pill, withdrawal bleeding is observed, which may not end before the start of a new package.

How to start taking Logest®

If you have not taken any hormonal contraceptives in the previous month:

Reception Logest® begins on the first day of the menstrual cycle.

When switching from other estrogen-progestin contraceptives (combined oral contraceptive (COC), vaginal ring, transdermal patch):

It is preferable to start taking Logest® the next day after taking the last hormone-containing tablet of the previous contraceptive or, at the latest, the day after the break. When switching from a vaginal ring or transdermal patch, it is preferable to start taking Logest® on the day the ring or patch is removed or, at the latest, on the day of the next scheduled installation.

When switching from pure progestin contraceptives (mini-pills, injectable forms, implant) or a progestogen-releasing intrauterine system (IUD):

A woman can switch from a microdose contraceptive to Logest® on any day of the cycle, while taking Logest® should be started the next day after stopping the microdose contraceptive. When switching from a pure progestin implant or IUD, Logest® should be started on the day after removal or on the day when the next injection of an injectable contraceptive should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking Logest®.

After an abortion in the first trimester of pregnancy

A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.

After childbirth or abortion in the second trimester of pregnancy

The early postpartum period is associated with an increased risk of thromboembolism; estrogen-progestin contraceptives should not be started less than 21 to 28 days after childbirth or abortion in the second trimester of pregnancy. If the reception is started later than 28 days after childbirth or abortion in the second trimester of pregnancy, it is necessary to use an additional barrier method of contraception during the first 7 days of taking Logest®. However, if there was sexual intercourse before taking Logest®, before taking an estrogen-progestin oral contraceptive, pregnancy should be excluded or the first menstruation should be waited.

Taking missed pills

Missing the pills is associated with the risk of pregnancy.

If you skip taking pills, contraceptive protection may be reduced, especially if the time interval between the last pill of the current pack and the first pill of the next pack increases.

If the delay in taking the dragee was less than 12 hours, it is necessary to take the dragee as soon as possible; the next dragee is taken at the usual time.

If the delay in taking the dragee was more than 12 hours, contraceptive protection is not guaranteed. In doing so, the following two basic rules must be followed:

• the interval between two packages should not exceed 7 days

• to achieve proper suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous intake of dragees.

Therefore, in the context of daily practice, the following recommendations can be made:

During the first week of taking the drug

The last missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next dragee is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If within 7 days before skipping the dragee there was sexual contact, then there is a possibility of pregnancy.

The more pills missed, and the closer the pass to the beginning of a new package, the higher the likelihood of pregnancy.

During the second week of taking the drug

The last missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next dragee is taken at the usual time.

If during the 7 days preceding the first pass of the dragee, the drug was taken correctly, then there is no need to use additional contraceptive measures. If you miss two or more pills, you must additionally use barrier methods of contraception for 7 days.

During the third week of taking the drug

The risk of reducing the contraceptive effect is the highest due to the proximity of the 7-day break in taking the dragee. However, a decrease in the contraceptive effect can be prevented by adjusting the tablet intake regimen as follows:

– if during the 7 days preceding the missed tablet, the tablets were taken correctly, then there is no need to use additional methods of contraception. One of the two options below should be followed.

– otherwise, the woman is advised to adhere to the first pill regimen and additionally use barrier methods of contraception for 7 days.

1 mode

A woman should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. The next dragee is taken at the usual time until the dragees from the current package run out. The next pack should be started immediately, i.e. without a break between two packs. Until the end of the second package, withdrawal bleeding is unlikely, but while taking the dragee, spotting or breakthrough bleeding may occur.

2 mode

A woman can also stop taking pills from the current package. The maximum interval without pills is 7 days, including the number of days you missed taking pills, then you should start taking pills from a new package.

If a woman missed taking 1 or more pills, and during the break in taking withdrawal bleeding did not occur, pregnancy should be excluded.

Recommendations in case of gastrointestinal disorders

In case of digestive disorders, such as vomiting or diarrhea within 3-4 hours after taking Logest® dragees, there may be a temporary decrease in the effect of the drug due to reduced absorption of the hormone, therefore, it is necessary to focus on recommendations when taking the dragee less than 12 hours late . You should take the dragee from the next package. In case of repetition of such episodes within a few days, it is recommended to focus on the recommendations regarding the delay in taking the pills by more than 12 hours. For longer episodes, another reliable method of contraception should be considered.

Additional information for special categories of patients

Patients with liver failure

Logest® is contraindicated in women with severe hepatic impairment (see section “Contraindications”).

Patients with renal insufficiency

Logest® has not been specifically studied in patients with renal insufficiency.

 

Side effects

Description of some adverse reactions

An increased risk of developing arterial and venous thrombotic and thromboembolic disorders, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis, and pulmonary embolism, has been reported in women using combined hormonal contraceptives, which are described in more detail in the Special Instructions section.

The most frequently reported adverse reactions (>10%) were headaches, including migraine, and bleeding/spotting.

The following undesirable effects have been described in women taking estrogen-progestin oral contraceptives:

Often (≥1/100, < 1/10)

– vaginitis, including vaginal candidiasis

– mood changes, including depression, changes in libido

– nervousness, dizziness

– nausea, vomiting, abdominal pain

– acne

– Pain and tension in the mammary glands

– dysmenorrhea, changes in vaginal and menstrual flow

– fluid retention/edema

– changes in body weight (increase or decrease)

Uncommon (≥1/1000, <1/100)

– increased or decreased appetite

– arterial hypertension

– abdominal cramps, bloating

– rash, chloasma (melasma), possibly persistent, hirsutism, alopecia

– changes in serum lipid levels, including hypertriglyceridemia

Rare (³ 1/10000, < 1/1000)

– anaphylactic reactions with very rare cases of urticaria, angioedema, severe disorders of the vascular and respiratory systems

– Impaired glucose tolerance

– Irritation associated with wearing contact lenses

– venous thromboembolism and arterial thromboembolism

– cholestatic jaundice

– nodular erythema

Very rare (< 1/10000)

– hepatocellular carcinoma, benign liver tumors (eg, focal nodular hyperplasia, liver adenoma)

– exacerbation of systemic lupus erythematosus

– exacerbation of porphyria

– exacerbation of chorea

– optic neuritis

– pancreatitis

– gallstones, cholestasis

– erythema multiforme

– hemolytic-uremic syndrome

With an unknown frequency

– ischemic colitis

The following serious adverse events have been observed in women using combined oral contraceptives, which are also described in the “Special Instructions” section:

Tumors

The frequency of diagnosis of breast cancer is very slightly increased among women taking COCs. Since breast cancer is rare in women younger than 40 years of age, the increase in the number of diagnoses is small in relation to the overall risk of developing this disease. Its connection with the use of combined oral contraceptives has not been proven.

Other violations

– The appearance or worsening of conditions for which the relationship with the use of combined oral contraceptives has not been proven: gestational herpes, otosclerosis-induced hypacusis, epilepsy, Crohn’s disease, ulcerative colitis

– Emergence or worsening of estrogen-induced angioedema symptoms in women with hereditary angioedema

– Impaired liver function

 

Interactions

Breakthrough bleeding and / or a decrease in the contraceptive effectiveness of the drug due to interactions of combined oral contraceptives with other drugs (enzyme inducers) (see section “Drug Interactions”).

Reporting suspected adverse reactions after drug registration is important. This facilitates continuous monitoring of the benefit/risk balance of the medicinal product.

 

Contraindications

Combined hormonal contraceptives should not be used in the presence of the following situations.

If one of these conditions develops for the first time while taking combined hormonal contraceptives, the drug should be immediately canceled:

presence or risk of venous thromboembolism

current (on anticoagulant therapy) or history of venous thromboembolism (eg, deep vein thrombosis, or pulmonary embolism)

hereditary or acquired predisposition to venous thromboembolism, for example, resistance to activated protein C (including factor V Leiden), deficiency of antithrombin III, protein C, protein S

major surgical interventions with prolonged immobilization

high risk of venous thromboembolism due to the presence of multiple risk factors

– presence or risk of arterial thromboembolism

current or past arterial thromboembolism (eg, myocardial infarction) or conditions preceding arterial thromboembolism (eg, angina pectoris)

cerebrovascular disease – current or history of stroke, or conditions prior to cerebrovascular disease (eg, transient ischemic attacks)

hereditary or acquired predisposition to arterial thromboembolism, for example, hyperhomocysteinemia or antiphospholipid antibodies (anti-cardiolipin antibodies and lupus anticoagulant)

migraine with a history of focal neurological symptoms

high risk of developing arterial thromboembolism due to the presence of multiple risk factors, such as:

– diabetes mellitus with vascular complications

– severe arterial hypertension

– severe dyslipoproteinemia

– severe liver disease at present or in history, before the normalization of liver function tests

– liver tumors (benign or malignant) at present or in history

– diagnosed hormone-dependent malignant diseases (for example, genital or mammary glands) or suspicion of them

– vaginal bleeding of unknown origin

– hypersensitivity to any of the components of the drug

– combined use with St. John’s wort (see section “Drug Interactions”).

– combined use with drugs containing ombitasvir / paritaprevir / ritonavir and dasabuvir (see sections “Special Instructions” and “Drug Interactions”).

 

Drug Interactions

When prescribing concomitant therapy, the drug interactions section of each prescribed drug should be reviewed to identify potential interactions.

The interaction of estrogen-progestin containing contraceptives with drugs can lead to an increase or decrease in the concentration of estrogens / progestins in plasma. Decreased plasma estrogen/progestin concentrations may cause an increase in the frequency of intermenstrual bleeding and menstrual irregularities and a possible decrease in the effectiveness of the estrogen-progestin contraceptive.

Enzyme induction can be observed after a few days of treatment. Maximum enzymatic induction usually occurs within a few weeks. After stopping treatment, enzyme induction may persist for up to 4 weeks.

Simultaneous use, which is contraindicated:

+ St. John’s wort

A decrease in the concentration of the components of a hormonal contraceptive in plasma due to the enzyme-inducing effect of St. John’s wort is accompanied by the risk of a decrease in effectiveness or lack of effect with potentially serious consequences (pregnancy development).

+ Protease inhibitors (ombitavir, paritaprevir and dasabuvir)

Increased hepatotoxicity.

Combined use with medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin may increase the risk of ALT elevation (see sections “Contraindications” and “Special Instructions”).

In this regard, women taking the drug Logest® should switch to an alternative method of contraception (for example, contraception with a progestogen or a non-hormonal method) before starting therapy with the above combination of drugs. Logest® can be resumed 2 weeks after completion of treatment with this combination regimen.

Simultaneous use, which is not recommended:

+ Enzyme inducers

Anticonvulsants (phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine); rifabutin, rifampicin, efavirenz, nevirapine, dabrafenib, enzalutamide. Loss of contraceptive efficacy due to increased metabolism of the components of the hormonal contraceptive in the liver due to the action of the inductor. It is recommended to use an additional method of contraception, in particular a barrier method, throughout the entire duration of the simultaneous intake and additionally for one cycle after its completion.

+ Lamotrigine (see also Concomitant Use Requiring Precautions section below)

Risk of reduced concentration and loss of efficacy of lamotrigine due to its increased metabolism in the liver. Starting oral contraceptives during the lamotrigine dose adjustment period should be avoided.

+ Modafinil

Risk of loss of contraceptive efficacy during treatment with modafinil and one cycle after its completion due to its enzyme-inducing potential. The use of normal dose oral contraceptives or another method of contraception is recommended.

+ Nelfinavir

Risk of loss of contraceptive efficacy due to lower hormonal contraceptive levels. It is recommended to use an additional method of contraception, in particular a barrier method (condom or intrauterine system) throughout the concurrent use and additionally for one cycle after its completion.

+ Elvitegravir

Decrease in the concentration of ethinylestradiol with the risk of reducing contraceptive effectiveness. In addition, an increase in the concentration of progestin.

Another estrogen-progestin contraceptive containing at least 30 micrograms of ethinyl estradiol should be used, or an additional method of contraception, such as a barrier method, should be used throughout the concurrent use and for an additional one cycle after its completion.

+ Ritonavir-boosted protease inhibitors

Risk of loss of contraceptive protection due to reduced hormonal contraceptive levels due to increased hepatic metabolism by ritonavir.

It is recommended to use an additional method of contraception, in particular a barrier method (condom or intrauterine system) throughout the concurrent use and additionally for one cycle after its completion.

+ Topiramate

At doses of topiramate from 200 mg per day and above: the risk of loss of contraceptive protection due to a decrease in estrogen concentration. The use of another method of contraception, in particular a barrier method, is recommended.

+ Vemurafenib

Risk of decreased estrogen/progestin levels with associated risk of insufficient efficacy.

+ Perampanel

When using doses of perampanel> 12 mg per day: the risk of reducing contraceptive protection. The use of another method of contraception, in particular a barrier method, is recommended.

+ When used together with estrogen-progestin contraceptives, many drugs used to treat HIV infection (AIDS) or HCV infection (hepatitis C) (protease inhibitors and non-nucleoside reverse transcriptase inhibitors) can increase or decrease plasma concentrations of estrogen or progestin. In some cases, these changes may be clinically significant. Please see the prescribing information for each drug used to treat HIV or HCV (protease inhibitors or non-nucleoside reverse transcriptase inhibitors) for recommendations.

Concomitant use requiring precautions:

+ Bosentan

Risk of loss of contraceptive protection due to increased metabolism of the hormonal contraceptive in the liver. The use of a reliable method of contraception is recommended, additionally or alternatively, throughout the duration of simultaneous use and additionally for one cycle after its completion.

+ Griseofulvin

Risk of loss of contraceptive protection due to increased metabolism of the hormonal contraceptive in the liver. It is recommended to use another method of contraception, in particular barrier, throughout the simultaneous use and additionally within one cycle after its completion.

+ Lamotrigine

Risk of reduced concentration and loss of efficacy of lamotrigine due to its increased metabolism in the liver. Clinical monitoring and dose adjustment of lamotrigine is necessary during the period of initiation of oral contraceptive use and after its termination.

+ Rufinamide

Moderate decrease in the concentration of ethinylestradiol. It is recommended to use another method of contraception, in particular barrier.

Simultaneous use to be taken into account:

+ Etoricoxib

Etoricoxib at a dose of 60 to 120 mg / day increases the concentration of ethinylestradiol in plasma by 1.4-1.6 times when taken simultaneously with combined hormonal contraceptives containing 0.035 mg of ethinylestradiol.

+ Substances that reduce the clearance of COCs (enzyme inhibitors)

Strong or moderate CYP3A4 inhibitors such as azole antifungals (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem, and grapefruit juice may increase plasma concentrations of estrogen, progestin, or both.

However, the clinical significance of this exposure is unknown.

Effects of COCs on other drugs

Combined oral contraceptives may interfere with the metabolism of other drugs, leading to an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.

Data from clinical studies suggest that ethinylestradiol inhibits the clearance of CYP1A2 substrates, resulting in a slight (eg, theophylline) or moderate (eg, tizanidine) increase in their plasma concentration.

Laboratory research

The use of combined estrogen-progestin contraceptives may affect the results of some laboratory tests, including liver, thyroid, adrenal and kidney function, plasma (transport) proteins such as corticosteroid-binding globulin and lipid/lipoprotein fractions, carbohydrate metabolism, parameters of coagulation and fibrinolysis. These changes usually do not go beyond normal values.

 

Special Instructions

In the case of a planned operation, it is recommended to stop taking the drug at least 4 weeks before it and not resume taking it within 2 weeks after the end of immobilization.

While taking drugs that affect microsomal enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception.

While taking antibiotics such as ampicillins and tetracyclines and within 7 days after their withdrawal, you should additionally use a barrier method of contraception.

If the period of using the barrier method of protection ends later than the pills in the package, you need to move on to the next package of Logest® without the usual break in taking the pills.

If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of Logest® treatment should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, worsen, or first appear, the woman should consult her physician, who may decide whether to discontinue the drug.

Diseases of the cardiovascular system

There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism when taking combined oral contraceptives.

However, the frequency of venous thromboembolism that develops when taking combined oral contraceptives is less than the frequency associated with pregnancy (6 per 10,000 pregnant women per year).

In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described. The relationship with the use of combined oral contraceptives has not been proven.

A woman should stop taking the drug and consult a doctor if symptoms of venous or arterial thrombosis or cerebrovascular disorders develop, which may include: unilateral leg pain and / or swelling; sudden severe chest pain with or without radiating to the left arm; sudden shortness of breath; a 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 with / or without a seizure; weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body; movement disorders; symptoms of an acute abdomen.

The risk of thrombosis (venous and / or arterial) and thromboembolism increases:
– with age;
– in smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years old);
in the presence of:
– family history (i.e. venous or arterial thromboembolism ever in close relatives or parents at a relatively young age); in the case of a hereditary predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
– obesity (body mass index more than 30 kg/m2);
– dyslipoproteinemia;
– arterial hypertension;
– migraine;
– diseases of the heart valves;
– atrial fibrillation;
– prolonged immobilization, major surgery, any operation on the legs or major trauma.

In these situations, it is advisable to stop the use of combined oral contraceptives (in the case of a planned operation, at least 4 weeks before it) and not resume taking within 2 weeks after the end of immobilization.

An increased risk of thromboembolism in the postpartum period should be taken into account.

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

An increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these drugs.

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

Tumors

There are reports of an increased risk of developing cervical cancer with persistent human papillomavirus infection. Its relationship with the use of combined oral contraceptives has not been proven. Controversy remains as to the extent to which these findings relate to sexual behavior and barrier use.

contraception.

It has also been found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives. Its relationship with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives.

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

Other states

Women with hypertriglyceridemia (or a family history of this condition) may be at an increased risk of developing pancreatitis while taking combined oral contraceptives.

Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of arterial hypertension should be initiated. Taking combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn’s disease and ulcerative colitis have also been described with the use of combined oral contraceptives.

Acute or chronic liver dysfunction may require discontinuation of the use of combined oral contraceptives until liver function tests return to normal. Recurrent cholestatic jaundice that develops for the first time during pregnancy or previous use of sex hormones requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (

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

Laboratory tests

Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein levels, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values.

Effect on the menstrual cycle

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

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.

Some women may not develop withdrawal bleeding during the pill break. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if combined oral contraceptives have been taken irregularly before, or if there are no 2 withdrawal bleedings in a row, pregnancy should be excluded before continuing to take the drug.

Medical examinations

Before starting the use of the drug Logest®, a woman is recommended to undergo a thorough general medical and gynecological examination (including examination of the mammary glands and a cytological examination of cervical mucus), to exclude pregnancy. In addition, violations of the blood coagulation system should be excluded.

In the case of prolonged use, it is necessary to conduct control examinations, the frequency of which depends on the individual characteristics of the woman.

A woman should be warned that preparations such as Logest® do not protect against HIV infection (AIDS) and other sexually transmitted diseases!

Influence on the ability to drive a car and machinery has not been identified.

 

Storage conditions

Shelf life – 3 years.
In a place protected from light, at a temperature not exceeding 25 ° C.

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