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Qlaira® (Estradiol Valerate/Dienogest) 28 film-coated tablets

$40.00

7f64a501c541

Description

The instruction for medical use

of Klayraâ medicine

the Trade name
of Klayraâ

the International non-proprietary name
Is not present

Medicinal a formatabletka, film coated

Structure
One dark yellow tablet, film coated soderzhitaktivny substance – oestradiol valerate, micro 20, in terms of 100% substance of 3.000 mg,
excipients:
kernel: lactoses monohydrate, starch corn, starch corn prezhelatinizirovanny, povidone 25, magnesium stearate,
cover: gipromelloza type 2910, macrogoal 6000, talc, titan dioxide (E171), ferrous oxide yellow (E 172).

One average-red tablet, film coated soderzhitaktivny substances:
oestradiol valerate, micro 20, in terms of 100% substance of 2.000 mg, diyenogest, micro, in terms of 100% substance of 2.000 mg,
excipients:
kernel: lactoses monohydrate, starch corn, starch corn prezhelatinizirovanny, povidone 25, magnesium stearate,
cover: gipromelloza type 2910, macrogoal 6000, talc, titan dioxide (E171), ferrous oxide yellow (E 172).
One light yellow tablet, film coated soderzhitaktivny substances:
oestradiol valerate, micro 20, in terms of 100% substance of 2.000 mg, diyenogest, micro, in terms of 100% substance of 3.000 mg,
excipients:
kernel: lactoses monohydrate, starch corn, starch corn prezhelatinizirovanny, povidone 25, magnesium stearate,
cover: gipromelloza type 2910, macrogoal 6000, talc, titan dioxide (E171), ferrous oxide yellow (E 172).
One dark red tablet, film coated soderzhitaktivny substance:
oestradiol valerate, micro 20, in terms of 100% substance of 1.000 mg,
excipients:
kernel: lactoses monohydrate, starch corn, starch corn prezhelatinizirovanny, povidone 25, magnesium stearate,
cover: gipromelloza type 2910, macrogoal 6000, talc, titan dioxide (E171), ferrous oxide yellow (E 172).
One white tablet film coated (placebo) soderzhitvspomogatelny substances:
kernel: lactoses monohydrate, starch corn, povidone 25, magnesium stearate
cover: gipromelloza type 2910, talc, titan dioxide (E171).

OpisanieTemno-zheltye tablets Oestradiol valerate of 3 mg
Tablets, film coated dark yellow color, round shape, biconvex, with an engraving of DD in the correct hexagon on one party.
Average-red tablets Oestradiol valerate of 2 mg + Diyenogest of 2 mg
Tablets, film coated average-red color, round shape, biconvex, with an engraving of DJ in the correct hexagon on one party.
Light yellow tablets Oestradiol valerate of 2 mg + Diyenogest of 3 mg
Tablets, film coated light yellow color, round shape, biconvex, with an engraving of DH in the correct hexagon on one party.
Dark red tablets Oestradiol valerate of 1 mg
Tablets, film coated dark red color, round shape, biconvex, with an engraving of DN in the correct hexagon on one party.
The white tablets Placebo
of the Tablet, film coated white color, round shape, biconvex, with an engraving of DT in the correct hexagon on one party.

Pharmacotherapeutic gruppapolovy hormones and modulators of a reproductive system. Hormonal contraceptives for system use. Progestogens and estrogen (for calendar reception)
the ATX G03AB Code
the Pharmacological

Pharmacokinetics of Diyenogest Absorption Later properties of oral administration diyenogest is quickly and almost completely soaked up. The maximum concentration in blood serum making 90.5 ng/ml is reached approximately in 1 hour after oral administration of a tablet of Klayra containing 2 mg of oestradiol of valerate + 3 mg of the diyenogest. The bioavailability is about 91%. The diyenogest pharmacokinetics in the dose range from 1 to 8 mg is characterized by dependence on a dose.
The concomitant use of food has no clinically significant impact on speed and extent of absorption of the diyenogest.
Distribution
Rather big (10%) a part of the circulating diyenogest is in an untied look whereas about 90% are nonspecific connected with albumine. Diyenogest does not contact GSPG and about the corticosteroid-the connecting globulin (CCG). For this reason there is no possibility of replacement of testosterone from its communication with GSPG or cortisol from its communication with KSG. Any influence on physiological processes of transport of endogenous steroids, therefore, is improbable. The volume of distribution of the diyenogest at equilibrium concentration is 46 l after intravenous administration of 85 mkg marked diyenogest hyzone.
Metabolism
of Diyenogest is almost completely metabolized, taking place the known ways of metabolism of steroid hormones (hydroxylation, a konjyugirovaniye), with formation mainly endocrinological of inactive metabolites. Metabolites are removed very quickly so the prevailing fraction in blood plasma is not changed diyenogest.
The general clearance after intravenous administration marked diyenogest hyzone – 5.1 l/h.
Elimination
Elimination half-life of the diyenogest is about 11 h of blood plasma. After intake in a dose of 0.1 mg/kg diyenogest it is removed in the form of metabolites which are removed by kidneys and through intestines in the ratio about 3:1. After oral administration of 42% of a dose 63% are removed within the first 24 hours, and – within 6 days by renal excretion. In 6 days the kidneys and through intestines remove in total 86% of a dose.
Equilibrium concentration
Pharmacokinetics of the diyenogest does not depend on concentration of GSPG. Equilibrium concentration is reached in 3 days of reception of the same dose making 3 mg of the diyenogest in combination with 2 mg of oestradiol of valerate. The minimum, maximum and average concentration of the diyenogest in blood serum at an equilibrium state make, respectively, 11.8 ng/ml, 82.9 ng/ml and 33.7 ng/m. Average coefficient of cumulation on the area under a curve concentration time (AUC0-24 of the h) – 1.24.
Oestradiol valerate
Absorption
After oestradiol intake valerate is quickly and completely absorbed. Splitting on oestradiol and valerianic acid happens during absorption in a mucous membrane of the digestive tract (DT) or during the first passage through a liver therefore oestradiol and its metabolites – estrone and estriol are formed. The maximum concentration of oestradiol in blood serum, equal 70.6 pg/ml, is reached between 1.5 and 12 hours after single intake of the tablet containing 3 mg of oestradiol of valerate in the 1st day of a cycle.
The concomitant use of food has no clinically significant impact on speed and extent of absorption of oestradiol of valerate.
Metabolism
Valerianic acid is very quickly metabolized. After intake about 3% of a dose become directly bioavailable in the form of oestradiol. Oestradiol is exposed to intensive effect of primary passing through a liver, and a considerable part of the entered dose is metabolized already in mucous by a GIT. In total with presistemny metabolism in a liver about 95% of the dose accepted inside are metabolized before receipt in system circulation. The main metabolites are estrone, estrone sulfate and estrone a glucuronide.
Distribution
In blood serum of 38% of oestradiol is connected with GSPG, 60% with albumine, and 2-3% circulate in an untied look. Oestradiol can slightly increase concentration of GSPG in blood serum, this effect depends on a dose. For the 21st day of a cycle of reception the concentration of GSPG made about 148% of initial, and by 28th day (end of a phase of reception of inactive tablets) decreased approximately to 141% of initial. The seeming distribution volume after intravenous administration – 1.2 l/kg.
Elimination
Elimination half-life of oestradiol is about 90 h of blood plasma. However the situation differs at intake. Owing to the big circulating pool of sulfates and glucuronides of estrogen and also enterohepatic recirculation, elimination half-life of oestradiol in a terminal phase after oral administration represents the complex parameter which depends on all these processes and is in range about 13-20 h.
Oestradiol and its metabolites are removed, mainly, by kidneys, at the same time about 10% are removed through intestines.
Equilibrium concentration
influences pharmacokinetics of oestradiol concentration of GSPG. At women the measured concentration of oestradiol in blood plasma represents set of the endogenous oestradiol and oestradiol which arrived at administration of drug of Klayraâ. During a phase of reception of the tablets containing 2 mg of oestradiol of valerate + 3 mg of the diyenogest the maximum and average concentration of oestradiol in blood serum at an equilibrium state make, respectively, 66.0 pg/ml and 51.6 pg/ml. During all 28-day cycle, stable minimum concentration of oestradiol in the range from 28.7 pg/ml to 64.7 pg/ml were maintained.
The pharmacodynamics
Contraceptive effect of Klayraâ is based on interaction of various factors, the most important of which are: braking of an ovulation, change of viscosity of cervical slime and change in endometrium. Besides contraceptive action, the combined oral contraceptives (COC) make positive impact which should be considered when choosing a control method of birth rate. The cycle becomes more regular, painful periods are less often observed, the intensity of bleeding decreases therefore the risk of an iron deficiency anemia decreases.
There is development of endometrial cancer and ovaries which are also given about risk reduction. High-dosage oral contraceptives (0.05 mg of ethinylestradiol) reduce the frequency of development of cysts of ovaries, inflammatory diseases of a small pelvis, benign diseases of a mammary gland and an extrauterine pregnancy. As far as these data belong to the low-dosed contraceptives, demands further study.
Advantage of the drug Klayraâ is that it contains in the structure the oestradiol having limited proliferative influence on endometrium and progestogen with the significant effect on endometrium and also presents the dosing mode in the form of a dose decline of estrogen and increase in a dose of progestogen that can be used for the purpose of treatment of heavy and/or long menstrual bleedings at the women without presence of organic pathology needing use of oral contraception.
Estrogen in the drug Klayraâ is oestradiol valerate, the predecessor of natural 17b-oestradiol of the person (1 mg of oestradiol of valerate corresponds to 0.76 mg of 17b-oestradiol). The estrogenic component used in this COC, thus, differs from the estrogen which is usually used in COC which is synthetic estrogen – ethinylestradiol or its predecessor mestranol, both containing etinilny group in provision 17a. This group causes higher metabolic stability, however, as well more significant action on a liver.
Administration of drug of Klayraâ leads to less significant action on a liver in comparison with three-phase COC, containing ethinylestradiol and levonorgestrel. It was shown that influence on concentration of the globulin, connecting sex hormones (G,CSH) and parameters of a hemostasis is less significant. In a combination with diyenogesty oestradiol valerate shows increase in lipoproteids of the high density (LPVP) whereas concentration of cholesterol of lipoproteids of the low density (LDL) decreases a little.
Diyenogest represents the progestogen operating at oral use which is characterized by additional partial anti-androgenic effects. Thanks to special chemical structure the range of pharmacological action combining the most important advantages of 19-holes-progestagenov and derivatives of progesterone is provided.

Indications
– oral contraception
– treatment of plentiful menstrual bleedings at the women without presence of organic pathology needing use of oral contraception.
The decision on purpose of Klayraâ should be made taking into account the risk factors which are available for the woman, in particular development of a venous thrombembolia, and assessment of risk of developing a venous thrombembolia against the background of reception of Klayraâ in comparison with other oral contraceptives individually.

The route of administration and doses
At the correct reception of the combined oral contraceptives an indicator of failure of a method makes no more than 1% a year. Contraceptive reliability can decrease at the admission of tablets or their wrong reception.
The route of administration
For intake
of the Tablet should be accepted inside on the order specified on packing, every day approximately at the same time with a small amount of water.
It is necessary to accept on one tablet a day consistently within 28 days. Each new packing is begun after reception of the last tablet from the previous calendar packing. Menstrualnopodobny bleeding usually begins during reception of the last tablets of calendar packing and can not come to the end prior to the following calendar packing yet. At some women the menstrualnopodobny bleeding begins after reception of the first tablets from new calendar packing.
How to begin reception of Klayraâ
– in the absence of reception of any hormonal contraceptives last month
the Reception of Klayraâ begins in the first day of a menstrual cycle (i.e. in the first day of menstrual bleeding).
– Upon transition from the combined hormonal contraceptives (the combined oral contraceptive, a vaginal ring, a transdermalny plaster)
the Woman should begin administration of drug of Klayraâ next day after reception of the last gormonsoderzhashchy tablet from the previous packing of the combined oral contraceptive.
Upon transition from a vaginal ring or a transdermalny plaster it is preferable to begin reception of Klayraâ in day of removal of a ring or plaster.
If earlier only the progestagenny method of contraception (mini-drank, an injection, an implant) was used or the intrauterine system with release of progestogen (Naval Forces)
the Woman can pass to administration of drug of Klayraâ from mini-saw in any day (from an implant or Naval Forces – in day of their removal, from an injection method – in day to which the next injection is appointed), but in all cases during the first 9 days of reception of tablets it is recommended to use a barrier method of contraception in addition.
After abortion in the first trimester of pregnancy
the Woman can begin reception of tablets immediately. In this case in additional measures of contraception there is no need.
After the delivery or abortion in the second trimester of pregnancy
It is necessary to recommend to the woman to start reception of tablets for 21-28 day after the delivery or abortion in the second trimester of pregnancy. If the woman began to take a pill later, then she is recommended to use in addition a barrier method of contraception during the first 9 days of reception of tablets. However if the sexual contact already took place, before the actual beginning of administration of drug of Klayraâ it is necessary to exclude pregnancy, or the woman should wait for approach of the first periods.
About the feeding women see the section Pregnancy and a lactation.
Reception of the passed tablets
the Passed (white) inactive tablets can be neglected. However they should be thrown out in order to avoid inadvertent extension of an interval between reception of active tablets.
The following councils treat only the admission of active tablets.
If the delay in reception of any of active tablets makes less than 12 hours, contraceptive protection does not decrease. The woman has to take the passed medicine at once as soon as she remembers it, and to take other pill in usual time.
If the delay in reception of any of active tablets makes more than 12 hours, contraceptive protection can decrease. The woman has to take the last passed pill at once as soon as she remembers it even if it will mean that she should take 2 medicines at the same time. Then she will continue to take a pill in usual time.
Depending on day of a cycle in which the tablet was passed (for more details see Table 1), it is required to take additional measures of contraception (for example, a barrier method of protection, in particular condoms) according to the following principles:
Table 1. The principles of the address with the passed

tablets DAYS

the Content of the Valerate Oestradiol (VO) and Diyegnogest (DNG) Colour

the Principles which are required to be followed if one tablet was passed and there passed more than 12 hours:

1 – 2

Dark yellow tablets (3.0 mg of EV)

– to Take the passed pill immediately, and the following tablet – in usual time (even if it means that it is necessary to take 2 pill in one day)

– to Continue to take a pill regularly

– Additional measures of contraception during the next 9 days

3-7

So-so – red tablets (2.0 mg of EV + 2.0 mg of DNG)

8-17

Light yellow tablets (2.0 mg of EV + 3.0 mg of DNG)

18-24

Light yellow tablets (2.0 mg of EV + 3.0 mg of DNG)

to Throw out the current calendar packing and to immediately begin reception with the first tablet from new calendar packing
to Continue to take a pill regularly
Additional measures of contraception during the next 9 days

25-26

Dark red tablets (1.0 mg of EV)

Immediately to take the passed pill, and the following tablet – in usual time (even if it means that it is necessary to take 2 pill in one day)
In additional measures of contraception is not present need

27-28

White tablets (Placebo)

to Throw out passed a tablet and to continue reception of tablets regularly
In additional measures of contraception is not present need
It is allowed to take no more than 2 pill in one day.
If the woman forgot to begin new calendar packing or passed one or more tablets from the 3rd to the 9th day of calendar packing, she can be already pregnant (in case it had a sexual contact within 7 days before the admission of a tablet). Than more tablets (especially with a combination of two active components in days from the 3rd on the 24th) are passed, and the closer they to a phase of reception of inactive tablets, the are higher pregnancy probability.
If the woman missed reception of tablets, and then at the end of calendar packing / at the beginning of new calendar packing the menstrualnopodobny bleeding at it was absent, it is necessary to consider pregnancy probability.
Recommendations in gastrointestinal disorders
In heavy gastrointestinal disorders the absorption can be incomplete therefore it is necessary to take additional contraceptive measures.
If vomiting occurs within 3-4 hours after reception of a gormonsoderzhashchy tablet, then at once it is necessary to take the following pill, it is desirable no later than 12 hours from the moment of the last reception. If the period after vomiting is more than 12 hours, then in this case the recommendations concerning the passed tablets which are given in the section Reception of the Passed Tablets work. If the woman does not want to change the usual scheme of reception of tablets, she needs to take an additional medicine (or tablets) from new packing.
Additional information for separate categories of patients
Patients of advanced age
it is not applicable. The drug Klayraâ is not shown after approach of a menopause.
Patients with abnormal liver functions
the Drug Klayraâ is contraindicated to women with a serious illness of a liver until indicators of function of a liver do not return to normal. See also section Contraindications.
Patients with renal failures
the Drug Klayraâ specially was not studied at patients with renal failures. The available data do not assume correction of the mode of dosing at such patients.
Use in pediatrics
Available data on use the drug Klayraâ at patients is younger than 18 years are absent.

Side effects
Data on the side reactions given below are classified according to the medical dictionary for regulatory activity of MedDRA, SOSc. Frequency is based on data of clinical trials. The most suitable term MedDRA was used for the description of a certain reaction, its synonyms and the connected diseases.
Often (³1/100, & lt, 1/10)
– a headache (including a sinus headache and a headache of tension)
– abdominal pain, nausea
– an acne (including pustular)
– an amenorrhea, discomfort in mammary glands (including pain, tension in mammary glands, disturbances and nipple pain), a dysmenorrhea, intercyclic bleedings, a metrorrhagia (including irregular periods)
– a body weight increase
Infrequently (³1/1,000, & lt, 1/100)
– fungal infections, vulvovaginal fungal infections (including vulvovaginal candidiasis and detection of a specific cervical fungal infection), vaginal infections
– the increased appetite
– a depression, decrease in mood, emotional lability (including tearfulness and affective lability), insomnia, decrease in a libido (including loss of a libido), disturbances of mentality, change in mood
– dizziness, migraine (including migraine with aura and without aura)
– inflows of heat, arterial hypertension
– diarrhea, vomiting
– increase in activity of enzymes of a liver (including ALT, nuclear heating plant and gamma glyutamiltransferrazu)
– an alopecia, the increased sweating, an itching (including generalized), rash (including macular)
– muscular spasms
– increase in mammary glands (including swelling), consolidation in a mammary gland, a dysplasia of a neck of the uterus, dysfunctional uterine bleedings, a dispareuniya, a fibrous cystic disease of mammary glands, a menorrhagia, disturbance of a menstrual cycle, an oothecoma, a premenstrual syndrome, a uterus leiomyoma, pain in pelvic area
– the spastic reductions of a uterus, uterine/vaginal bleeding including smearing discharges, vaginal discharges, dryness of a vagina
– fatigue, irritability, hypostases (including generalized hypostases)
– decrease in body weight, change of arterial blood pressure (including increase and decrease)
is rare (³1/10,000, & lt, 1/1000)
– candidiasis, herpes of an oral cavity, inflammatory diseases of bodies of a basin, a syndrome of expected histoplasmosis of eyes, shingles, infections of an urinary system, a bacterial vaginitis
– a liquid delay, a gipertriglitseridemiya
– aggression, concern, a dysphoria, increase in a libido, nervousness, nightmares in a dream, concern, sleep disorders, a stress
– disturbance of attention, paresthesia, vertigo
– intolerance of contact lenses, xerophthalmus, an eye
– a myocardial infarction, heartbeat
– a varicosity, a venous thrombembolia, an arterial thrombembolia, arterial hypotension, superficial phlebitis
– vein pain
– dryness in a mouth, constipations, dyspepsia, a gastroesophageal reflux
– a focal nodulyarny hyperplasia of a liver, chronic cholecystitis
– allergic skin reactions (including allergic dermatitis and a small tortoiseshell), a hloazma, dermatitis, a hirsutism, a hypertrichosis, neurodermatitis, pigmentation disturbances, seborrhea, skin disturbances, including consolidation
– dorsodynias, gnathalgias, heavy feeling
– pains in an urinary system
– pathological bleeding of cancellation, a benign neoplasia of a mammary gland, a new growth of a mammary gland in situ, a lactocele, discharges from a mammary gland, a polyp of a neck of the uterus, an erythema of a neck of the uterus, post-coital bleeding, a galactorrhoea, vaginal discharges, a hypomenorrhea, a periods delay, a rupture of an oothecoma, a smell from vaginal area
– sensation of burning and discomfort in vulvovaginal area
– a limfoadenopatiya
– asthma, short wind, nasal bleeding
– stethalgias, an indisposition, a hyperthermia swelled
– disturbances in a smear from the cervical channel
the Description of separate side reactions
Was reported about the increased risk of development of arterial and venous trombotichesky and thromboembolic disturbances, including a myocardial infarction, a stroke, the tranzitorny ischemic attacks, venous thrombosis and a pulmonary embolism at the women using the combined hormonal contraceptives about which it is in more detail written in the section Special Instructions.
The following side reactions were noted at the women using the oral combined contraceptives which are also described in the section Special Instructions:
– venous thromboembolic disturbances
– arterial thromboembolic disturbances
– arterial hypertension
– liver tumors
– emergence or deterioration in states for which the interrelation with reception of the combined oral contraceptives is not proved: Crohn’s disease, ulcer colitis, epilepsy, uterus fibroida, a porphyria, a system lupus erythematosus, gestational herpes, Sydenham’s chorea, a gemolitiko-uraemic syndrome, cholestatic jaundice
– a hloazma
– an acute or chronic abnormal liver function can demand the termination of reception of the combined oral contraceptive until functional hepatic trials return to norm
– at women with a hereditary Quincke’s disease exogenous estrogen can provoke or aggravate symptoms of this disease
– the frequency of the diagnosis of a breast cancer is slightly increased among the women accepting oral contraceptives. As the breast cancer is noted seldom at women 40 years are younger, increase in number of diagnoses is insignificant in relation to the general risk of developing this disease. Its communication with reception of the combined oral contraceptives is not proved. Additional information see in the sections Contraindications and Special Instructions
With an unknown frequency (in spite of the fact that these side reactions did not come to light in the course of clinical trials of Klayra®, it is impossible to exclude a possibility of their emergence):
– the multiformny erythema, a knotty erythema, discharges from mammary glands and reaction of a giprechuvstvitelnost

of the Contraindication
the Combined oral contraceptives should not be applied in the presence of any of the states which are listed below. If any of these states develop for the first time against the background of reception, drug has to be immediately cancelled.
– existence or risk of a venous thrombembolia
· a venous thrombembolia now (on anticoagulating therapy) or in the anamnesis (for example, a deep vein thrombosis, or a pulmonary embolism)
· hereditarily the caused or acquired predisposition to a venous thrombembolia (for example, resistance to the activated protein With (including the V Leiden factor), deficiency of antithrombin III, a protein With or S protein
· big surgical interventions with a long immobilization
· high risk of a venous thrombembolia owing to existence of multiple factors of risk
– existence or risk of an arterial thrombembolia
· an arterial thrombembolia now or in the anamnesis (for example, a myocardial infarction) or the states preceding an arterial thrombembolia (for example, stenocardia)
· cerebrovascular disturbances – a stroke now or in the anamnesis or the states preceding cerebrovascular disturbances (for example, the tranzitorny ischemic attacks)
· hereditarily the caused or acquired predisposition to an arterial thrombembolia (for example, a gipergomotsisteinemiya and anti-phospholipidic antibodies (antibodies to cardiolipin and lupoid anticoagulant)
· migraine with focal neurologic symptoms in the anamnesis

high risk of developing an arterial thrombembolia owing to existence of multiple factors of risk, such, as:
– diabetes with vascular complications
– the profound arterial hypertension
– the expressed dislipoproteinemiya
– pancreatitis with the expressed gipertriglitseridemiya now or in the anamnesis
– a serious illness of a liver now or in the anamnesis (before normalization of hepatic tests)
– liver tumors (benign or malignant) now or in the anamnesis
– the revealed hormonedependent malignant diseases (for example,
genitals or mammary glands) or suspicion on them
– vaginal bleeding of not clear genesis
– hypersensitivity to any of drug components

Medicinal interactions
Effects of other drugs on Klayr â
Vozmozhno interaction with the medicines inducing microsomal enzymes of a liver that can promote to increase of clearance of sex hormones and a message to breakthrough bleedings and/or decrease in contraceptive efficiency of drug.
During intake of such drugs, the woman should use in addition barrier or other method of contraception in addition to Klayraâ. At the same time the barrier method of contraception should be used during the period of the accompanying administration of drugs and within 28 days after their cancellation.
The substances increasing clearance of sex hormones (reducing efficiency of the combined hormonal contraceptives owing to induction of enzymes of a liver), for example:
Phenytoinum, barbiturates, Primidonum, carbamazepine and rifampicin, are also the assumptions concerning an okskarbazepin, the topiramat, the felbamat, griseofulvin and the drugs containing a St. John’s wort.
Substances with various effects on clearance of the combined oral contraceptives
At the combined use with the combined oral contraceptives many VICh/HCV protease inhibitors and nenukleozidny inhibitors of reverse transcriptase can increase or reduce concentration of estrogen or progestins in blood plasma. The specified changes in certain cases can have relevant value.
The substances reducing clearance of the combined oral contraceptives (inhibitors of enzymes)
of Diyenogest is substrate of a system of P450 cytochrome (CYP) 3A4.
The known CYP3A4 inhibitors, such as antifungal drugs (for example, itrakonazol, vorikonazol, flukonazol), verapamil, macroleads (for example, klaritromitsin, erythromycin), diltiazem and grapefruit juice can increase diyenogest level in blood plasma.
Effects of the drug Klayraâ concerning other
COOK medicines can influence metabolism of some other medicines (for example, a lamotridzhina) that can lead or to increase (for example, cyclosporine), or to decrease in concentration (for example,
to Develop

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