Trikvilar

Триквилар Drug photo

The description is actual on 08.04.2015

  • Latin name: Triquilar
  • ATH code: G03AB03
  • Active ingredient: Levonorgestrel + Ethinylestradiol (Levonorgestrel + Ethinylestradiol)
  • Producer: Bayer Weimar, GmbH & Co. KG (Germany)

Structure

1 tablet includes active ingredients levonorgestrel/ethinylestradiol in the following proportions: 40/75 mkg; 30/50 mkg and 30/125 mkg respectively.

Minor ingredients: lactoses monohydrate, calcium carbonate, red and yellow pigment of iron oxide, glitserol 85%, corn starch, montanglikolevy wax, magnesium stearate, povidone 25 000 and 700 000, macrogoal 6000, sucrose, titanium dioxide, talc.

Release form

Drug Trikvilar is let out in the form of tablets in three different proportions of active ingredients: 5 pieces — 40/75 mkg; 6 pieces — 30/50 mkg; 10 pieces — 30/125 mkg. In the sum one blister (numbered by shooters) includes 21 tablets. One packaging may contain 1 or 3 blisters.

Pharmacological action

Trikvilar is combined three-phase low-dosed oral is oestrogenic-gestagennym a contraceptive (contraceptive).

Contraceptive efficiency of Trikvilar depends on three mechanisms of his action supplementing each other:

  • oppression of an ovulation at the level of regulation of gipotalamo-pituitary system;
  • modification of characteristics of a cervical secret, for the purpose of forming of impermeability for spermatozoa;
  • transformation of an endometria, for creation of the conditions interfering implantation of an oospore.

When using by women of the combined oral (peroral) contraceptives (COOK) more regular menstrual cycle, reduction of quantity of painful periods, easing of intensity of bleedings and as a result lowering of risk of forming of an iron deficiency anemia is observed.

Levonorgestrel

At reception orally, levonorgestrel is soaked up during quite short time and almost completely. Serumal Cmax is observed approximately in 60 minutes and 2,3 ng/ml equal. One-time internal reception of 0,125 mg of levonorgestrel (the greatest concentration of substance in tablets) together with 0,33 mg of ethinylestradiol, leads to definition, approximately in an hour, its highest serumal contents at the level of 4,3 ng/ml. Bioavailability of levonorgestrel, at reception orally, nearly 100%.

Levonorgestrel forms communication with plasma albumine and globulin which connects sex hormones (GSPG). Only 1,4% of the general plasma contents are in a free look, 55% are connected with GSPG and about 44% with albumine. Thanks to induction ethinylestradiol of replication of the connecting protein, the part of substance connected with GSPG increases, and other part connected with albumine decreases. After one-time oral administration of the highest dosage of levonorgestrel for Trikvilar, its Vd it is approximately equal to 128 liters.

The levonorgestrel metabolism full also passes all typical ways of a metabolization for steroids. After one-time oral administration of the highest levonorgestrel dosage for Trikvilar the serumal clearance equals about 1,0 ml/min.

The plasma saturation levonorgestrel undergoes process of two-phase reduction. T1/2 in a terminal phase lasts about 22 hours. Levonorgestrel is removed with bile and urine (1:1) only in metabolizirovanny forms, with T1/2 about 24 hours.

The pharmacokinetics of levonorgestrel depends on the GSPG serumal level which for a course of administration of drug (21 days) increases approximately twice. At daily reception of Trikvilar the plasma level of substances increases approximately twice, and equilibrium concentration is observed in the second phase of a course. Speed of clearance and volume of distribution, at equilibrium concentration, respectively go down on 0,5 ml/min. and to 52 liters.

Ethinylestradiol

Internal reception of ethinylestradiol leads to fast and its full absorption. Serumal Cmax is observed in 80 minutes and 116 ng/ml equal. In the course of absorption and initial passing through a liver there is a metabolism of ethinylestradiol which defines its bioavailability at the level of about 45%, with individual discrepancies within 20-65%.

In mucous a small bowel and ethinylestradiol passes process of presistemny conjugation in a liver. The main way of a metabolism is the aromatic hydroxylation. The plasma clearance equals 2,3-7 ml/min.

Ethinylestradiol connects to albumine (is not specific) for 98%. Enters the inductor replications of GSPS. Vd equals 2,8-8,6 l/kg.

Lowering of serumal concentration of ethinylestradiol undergoes two phases, the first of them proceeds with T1/2 about 60 minutes, and the second from 10 to 20 hours. Are brought out of an organism, by means of a liver and kidneys (in the ratio 6:4), only metabolism products, with T1/2 about 24 hours.

In 7 days equilibrium concentration is observed.

Indications to use

Drug Trikvilar is appointed for the purpose of contraception (contraceptive).

Contraindications

  • the painful states with risk of forming of thromboses (including stenocardia, ischemic tranzitorny attacks) observed today or in the past;
  • vascular fibrinferments, and also the thromboembolisms observed in this hour or in the anamnesis (including, cerebrovascular disturbances, a thromboembolism of a pulmonary artery, a myocardial infarction, a deep vein thrombosis);
  • diabetes mellitus with complications of a vascular etiology;
  • the migraine proceeding with neurologic symptomatology of focal character (in the anamnesis);
  • the numerous or expressed risk factors of vascular thrombosis, including pathology of heart valves, frustration of a heart rhythm, painful conditions of coronary arteries and vessels of a brain, an arterial hypertension (uncontrollable);
  • the pancreatitis proceeding with a gipertriglitseridemiya of the expressed character observable today or in the past;
  • heavy pathologies of a liver and liver failure (until stabilization of liver enzymes);
  • the liver new growths (any nature) observed today or in the past;
  • vaginal bleedings of not clear origin;
  • hypersensitivity;
  • the diagnosed malignant hormonedependent pathologies (including mammary glands and bodies of the sexual sphere), and also suspicion on their existence;
  • the proved pregnancy or opportunity that;
  • long-term immobilization, extensive injuries, serious surgeries.

With care

  • frustration of a metabolism of the expressed character (a lipidemia, obesity);
  • idiopathic jaundice, otosclerosis with damage of hearing or an itch during the past pregnancy;
  • migraine;
  • inborn hyperbilirubinemias (Gilbert's illness, Rotor, Cudgel Johnson);
  • diabetes mellitus;
  • illness Krone;
  • uraemic hemolitic syndrome;
  • sickemia;
  • system lupus erythematosus;
  • arterial hypertension.

Side effects

  • various changes connected with mammary glands (allocations, increase, intensity, morbidity);
  • uterine bleedings (breakthrough);
  • nausea;
  • the bloody smearing allocations from a vagina;
  • headaches;
  • change of a libido;
  • migraine;
  • frustration of mood;
  • vision disorder;
  • deterioration in portability of use of contact lenses;
  • changes of secretion of a vagina;
  • vomiting;
  • rash on integuments;
  • abdominal pains;
  • knotty erythema;
  • generalized itch;
  • multiformny erythema;
  • change of weight;
  • liquid delay;
  • allergic manifestations;
  • cholestatic jaundice;
  • diarrhea;
  • increased fatigue.
  • occasionally the hloazma, in particular at women in whose anamnesis there is mentioning on hloazma of pregnant women can form.
  • in isolated cases observed development of a thromboembolism and thromboses.

Trikvilar, application instruction

Packaging of drug includes the application instruction of Trikvilar and the round blister (with strelochka) with 21 tablets which are located on the circle course. Reception of tablets should be begun with sector with the index "Beginning" then, following in the direction of arrows, to continue daily reception of the next tablet. A pill is taken orally (inside), it is desirable at the same time, washing down with water. Duration of reception corresponds to quantity of tablets — 21 days then the 7-day break with cancellation bleeding follows. As a rule, bleeding comes for 2-3 days after reception of the tablet completing the blister and can not stop before reception of the first tablet from the following packaging which begins to be drunk just after a 7-day interval.

Beginning of reception of tablets of Trikvilar

Fir-tree last month the woman did not accept any hormonal contraceptives, Trikvilar's reception should be begun in the first days of menstrual bleeding (cycle). Allow reception of an initial tablet for 2-5 days of a cycle, with parallel use, during the first 7 days, an additional barrier method of contraception (BQ).

In case of transition of the patient from others the COOK, it is desirable to begin to use Trikvilar the next days after reception of a final active tablet from the previous packaging, but not later than the following of 24 hours after a 7-day interval (for the COOK including 21 tablets) or after a final inactive tablet (for the COOK of the including 28 tablets).

In case of transition on Trikvilar from gestagenny contraceptive drugs ("mini-drank", implants, injection forms) or intrauterine means (for example, Mirren) it is necessary to observe the following recommendations:

  • transition from mini-was drunk it can be carried out without interruption in any day;
  • transition from intrauterine gestagenny means or implant is shown in day of its removal;
  • transition from injection forms is possible at the time of the following recommended injection.

In all above-mentioned cases, for 7 days, it is necessary to use BQ.

After carrying out abortion in the I trimester it is possible to begin to accept Trikvilar urgently, in this case there is no need for additional contraception.

After abortion or childbirth in the II trimester it is necessary to begin reception of tablets for 21-28 days. In case of later beginning of reception of tablets, 7 days use BQ.

Recommendations at the admission of reception of tablets

At the admission of the next tablet less than for 12 hours, its reception is carried out according to the usual scheme as soon as possible and further.

At the admission of the next tablet (or several tablets) more than for 12 hours, lowering of contraceptive protection is possible. The risk of undesirable pregnancy increases with quantity of the passed tablets and approach of time of a 7-day break in this connection, it is necessary to be guided by two basic below-stated principles:

  • not to interrupt Trikvilar's reception more than for 7 days at all;
  • continuous 7-day reception of tablets is necessary for pituitary and ovarian function for achievement of right oppression gipotalamo-.

In this regard it is possible to give the following instructions at the admission.

The admission of reception on the first week

It is necessary to take the final passed pill as it is possible earlier (even in case of a concomitant use of two tablets). The next pill is taken in due time. For 7 days BQ use. It is necessary to remember possible pregnancy when carrying out sexual intercourse for 7 days before the admission of tablets.

The admission of reception on the second week

It is necessary to take the final passed pill as it is possible earlier (even in case of a concomitant use of two tablets). The next pill is taken in due time. On condition of the correct previous week reception of Trikvilar, need for use of BQ is not present. In case of disturbances of reception on the first week or at the admission more than one tablet, it is necessary to use, for 7 days, BQ.

The admission of reception on the third week

Because of the forthcoming 7-day interval of reception of tablets the risk of lowering of reliability of effect of contraception increases. In case of the admission of tablets at this stage it is necessary to follow strictly one of two below-stated options. Along with it if in the last 7 days to the admission of the first tablet the others were accepted according to the instruction, it is possible not to use BQ.

  • At reception of a final tablet from the current blister, it is necessary to take the first pill from the following at once, passing a 7-day interval. In it couples cancellation bleeding, most likely, will come after reception of a final tablet from the second blister. Though in the course of reception of tablets there can be breakthrough bleedings or the smearing allocations.
  • It is possible to suspend reception of tablets from the current blister and to take a 7-day break, from the date of the admission of tablets. Then to begin reception of an initial tablet from the new blister. In this case, in the absence of cancellation bleeding, it is necessary to exclude possible pregnancy.

Recommendations at diarrhea and/or vomiting

In case of developing of diarrhea and/or vomiting, for 4 hours after reception of a tablet, lowering of contraceptive efficiency, because of drug absorption disturbance is possible. It is necessary to use BQ and to be guided by the recommendations made in case of the admission of one tablet.

Reorganization of a menstrual cycle

For a delay of the beginning of a cycle of periods it is necessary to take, after the end of use of the current blister, 10 last pill (for 10 days) from the following blister. It is investigative, the cycle can be extended for a period of up to 10 days, up to the termination of the second blister (breakthrough bleedings or the smearing allocations can take place). Resuming of regular reception of Trikvilar it is carried out after an obligatory 7-day interval.

For transfer of day of the beginning of a cycle of periods on the necessary day of the week, it is necessary to reduce the next interval in reception of tablets by the required number of days. At the same time, the risk not of approach of bleeding of cancellation increases according to shortening of an interval. In this case, when using the second blister, breakthrough bleedings or the smearing allocations are possible.

Overdose

The symptomatology of overdose is shown by nausea, the smearing bloody allocations, vomiting, a metrorrhagia.

The symptomatic treatment is shown.

Interaction

Pyrazyl ketone derivatives, streptocides can strengthen metabolic transformations of steroid hormones which are Trikvilar's part.

Long-term therapy by the medicines (barbiturates, Phenytoinum, Primidonum, Rifampicin, Carbamazepine, Griseofulvin, Okskarbazepin, Felbamat, Topiramat, Ritonavir, St. John's Wort drugs) inducing liver enzymes therefore the clearance of hormones increases (sexual) can become the reason of lowering of contraceptive efficiency of Trikvilar or breakthrough bleedings.

Parallel use of antibiotics from a number of tetracyclines and ampitsillin can lower contraceptive protection of Trikvilar, because of reduction of the intra hepatic address of estrogen that leads to reduction of content of ethinylestradiol.

Trikvilar can influence a metabolism of other drugs (for example, Cyclosporine) that can lead to change of their plasma and fabric concentration.

Terms of sale

Contraceptive tablets Trikvilar can be got according to the recipe.

Storage conditions

Tablets store in original packaging, at room (up to 25 °C) temperature.

Period of validity

Drug keeps the efficiency for 5 years.

Special instructions

At use of antibiotics of a number of tetracyclines and ampitsillin, and also in the next 7 days it is necessary to use BQ.

Some risk factors and painful states which existence, at Trikvilar's appointment, demands an individual approach in each separate case, taking into account possible risk / advantage for the woman are provided below. These issues should be resolved prior to reception the COOK and to inform the woman on probability of manifestation or weighting of these states, and also possible need, at emergence of complications, Trikvilar's cancellations in the future.

Cardiovascular system

At Trikvilar's reception some increase in frequency of forming of a thromboembolism and vascular thromboses was noted.

Also, at reception the COOK is rare references of cases of thrombosis of other vessels of circulatory system, such as: renal, mezenterialny, hepatic, retina and its branches. In this case communication using the COOK was not proved.

At detection of symptomatology of cerebrovascular disturbances or thromboses: unilateral hypostases or scelalgias; the expressed sudden stethalgia; dizziness; unexpected asthma; severe groundless cough; any headache (strong, unusual, long) not clear origin; diplopia; spontaneous total or partial loss of sight; aphasia or unintelligible speech; loss of consciousness; weakness; convulsive attack; sudden unilateral anesthesia; lack of coordination; symptoms of "acute abdomen", it is necessary to stop Trikvilar's reception and to consult with the doctor.

The risk of forming of a thromboembolism and thromboses amplifies at:

  • dislipoproteinemiya;
  • fibrillations of auricles;
  • obesity;
  • migraines;
  • arterial hypertension;
  • pathologies of valves of heart;
  • smoking (with age and increase in number of cigarettes raises further, in particular at women after 35 flyings);
  • existence of a thromboembolism in the family anamnesis, in particular at young age (in this case, after carrying out comprehensive survey, it is necessary to resolve an issue of expediency of use the COOK);
  • with age;
  • heavy surgeries, long immobilization, considerable injuries, any lower extremity operations. In case of the planned operation it is better to stop Trikvilar's reception in 4-6 weeks prior to it, with resuming of reception of tablets in 14 days later.

It is also necessary to remember about the increased risk of forming of a thromboembolism in the period after the delivery.

Circulator frustration can be also observed at a system lupus erythematosus, a sickemia, a diabetes mellitus, an uraemic hemolitic syndrome, chronic diseases of intestines of inflammatory character (ulcer colitis, an illness Krone).
Increase in weight and frequency of attacks of migraine (can be the cause of cerebrovascular frustration in the future), against reception the COOK, can be treated as a reason for the termination of their reception.

The biochemical indicators able to be signs of the acquired or genetic predisposition to fibrinferments, consist in a gipergomotsisteinemiya; resistance to a protein With (activated); deficit antitrombina-Sh, a protein of S and S, anti-phospholipidic antibodies (lupoid anticoagulant, antibodies to cardiolipin).

New growths

At some researches there are messages on increase of risk of emergence of cancer of neck of uterus and mammary glands against long reception the COOK, though with unproven relationship of cause and effect. This increase of risk of forming of malignant new growths is possible because of the early diagnosis of oncological diseases connected with inspections of a neck of uterus and mammary glands at women before appointment the COOK. Also it is worth noticing that new growths of mammary glands at the patients ever using the COOK were considerably less expressed, than at patients is their not accepting.

In isolated cases at reception the COOK observed developing of hepatic tumors. In case of manifestations of increase in a liver, severe pains in a stomach, symptoms of intra belly bleeding it is necessary to consider a possibility of a tumor of a liver at statement of the differential diagnosis.

Other painful states

Against Trikvilar's use, in the presence the woman has gipertriglitseridemiya (including in the family anamnesis), developing of pancreatitis is possible.

Some insignificant increase of the ABP was peculiar to many women using the COOK. In rare instances noted serious increase in the ABP which demanded cancellation of a contraceptive and transition to treatment of a hypertension. In case of positive reaction of the patient to therapy and stabilization of the ABP, it is possible to resume reception the COOK.

Painful states which progress are included below or develop both during pregnancy, and at use the COOK, though with unproven relationship of cause and effect: a system lupus erythematosus, an itch because of a cholestasia, jaundice, cholelithiasis, a porphyria, an uraemic hemolitic syndrome, Sidengam's chorea; a hearing loss because of an otosclerosis, an illness Krone, herpes of pregnant women, ulcer colitis.

Pathologies of a liver can become the cancellation reason the COOK, before stabilization of indicators of hepatic function.

At for the first time the diagnosed cholestatic jaundice, against the previous reception the COOK or pregnancies, should refuse use of this contraceptive.

Though the COOK also influence tolerance to glucose and resistance to insulin, patients have no need for correction of the mode of reception with a diabetes mellitus which apply low-dosed the COOK (up to 0,05 mg of ethinylestradiol). Despite it, women patients with a diabetes mellitus and accepting the COOK, are obliged to pass regular inspections of the state.

Trikvilar's reception at tendency of the woman to a hloazma, demands from it respect for care in the time spent for the sun and other ultra-violet influence.

Laboratory tests

Use the COOK can exert impact on a number of results of separate laboratory tests, including on the level of plasma transport proteins, indicators of adrenal glands, hepatic and renal function, a thyroid gland, carbohydrate metabolism, parameters of a fibrinolysis and coagulation. These changes, as a rule, are not beyond normal indications.

Impact on a menstrual cycle

At reception the COOK bleedings of irregular character (breakthrough bleedings or the smearing allocations), in particular for initial months of reception of tablets can be observed.

In this regard, it is possible to carry out a reliable assessment of these bleedings only after an adaptation stage, as a rule, making three cycles.

In case of the developing or repeating irregular bleedings, after the previous constant cycles, it is necessary to conduct comprehensive examination to exclude pregnancy or malignant new growths.

At some women accepting Trikvilar, cancellation bleeding during a 7-day interval in reception of tablets does not develop. If at the same time Trikvilar was accepted strictly according to the instruction, without admission of tablets and other negative factors, then approach of pregnancy is improbable. Nevertheless, prior to reception of the following blister of drug, it is better to exclude possible pregnancy.

Medical examinations

If the woman decided to use the COOK including Trikvilar, she needs to pass comprehensive gynecologic and all-medical examination (including cytology of cervical slime and inspection at the mammologist), and also to exclude pathologies of a blood coagulation and possible pregnancy.

In case of Trikvilar's use during a long interval of time, it is necessary to carry out control inspections every 6 months.

The woman has to be warned that the COOK does not protect use from venereal diseases, including HIV infection (AIDS).

Analogs

Coincidence on the ATH code of the 4th level:

Synonyms

Zdravzona

  • Trikvilar No. 21 a tabletkishering Gmbh and To. Produktsions KG

Drugstore of IFC

  • Trikvilar drzh No. 21, Schering AG/Jenapharmgermaniya
to show still

BIOSPHERE

  • Trikvilar No. 21 of a dragee
to show still
Section: Gynecologic Hormonal Contraceptives
in more detail

Education: Graduated from the Vinnytsia national medical university of N. I. Pirogov, pharmaceutical faculty, the higher pharmaceutical education – the specialty "Pharmacist".

Experience: Work in Koneks and Bios-Media pharmacy chains as "Druggist". Work as "Pharmacist" in Avicenna pharmacy chain of the city of Vinnytsia.

PAY ATTENTION! Information on drugs on the website is help generalizing, collected from public sources and can form the basis for making decision on use of medicines it is not aware of treatment. Before medicine use Trikvilar surely consult with the attending physician.