Tri-regol: instructions for use. Hormonal contraceptive Tri-regol

Tablets contain active substances such as And .

Additional components include: talc, colloidal silicon dioxide, lactose monohydrate, corn starch, magnesium stearate.

The shell consists of sucrose, talc, titanium dioxide, macrogol 6000, red iron oxide, copovidone, colloidal silicon dioxide, povidone, sodium carmellose.

Release form

Tri-Regol is available as film-coated tablets.

pharmachologic effect

Three-phase oral contraceptive.

Pharmacodynamics and pharmacokinetics

The drug belongs to contraceptive combined drugs.

Levonorgestrel reduces production gonadotropic , causing the egg to mature more slowly and ovulation does not come.

Ethinylestradiol , in turn, increases the viscosity of the cervical mucus and reduces the likelihood of sperm passing into the uterus.

In addition, Tri-Regol contributes to the normalization of the menstrual cycle, as it supplements the level endogenous hormones .

The drug is well absorbed in the intestine when administered orally. It is processed in the intestines and liver, then excreted through the kidneys and intestines.

Indications for use

The need for oral contraception. Treatment of menstrual disorders.

Contraindications

The use of the drug is contraindicated in:

  • over 40 years of age;
  • And ;
  • heavy and idiopathic jaundice pregnant women in history;
  • diseases of the gallbladder;
  • smoking at the age of 35;
  • thromboembolism and, as well as predisposition to them;
  • in severe form;
  • improper fat metabolism;
  • hydatidiform mole ;
  • otosclerosis with hearing problems;
  • recent surgical operations;
  • lack of an enzyme that is needed to digest milk lactose;
  • hypersensitivity to the components of the drug;
  • liver diseases;
  • severe cardiovascular and cerebrovascular changes in history;
  • vaginal bleeding not established etiology;
  • sickle cell And hemolytic anemia ;
  • malignant tumors;
  • chronic ;
  • Marfan's syndrome ;
  • phlebitis ;
  • extensive injuries.

With caution, this drug should be used when:

  • chronic venous insufficiency lower limbs;
  • chorea minor ;
  • porphyria ;
  • at the stage of compensation (in the absence of vascular complications);
  • scattered ;
  • arterial hypertension (BP up to 160/100 mm Hg);
  • tetany ;
  • mastopathy ;
  • lack of a regular menstrual cycle in adolescence.

Side effects

Side effects of Tri-Regol are usually the following: discomfort when using contact lenses, intermenstrual bleeding, weight changes, nausea, fluid retention, changes in libido, a feeling of tension in the mammary glands, , irritability , irritability, pain in the mammary glands, blurred vision, hypomenorrhea , .

These adverse reactions are temporary and disappear without special treatment. In rare cases, tumors may develop, appear, ulcerative , hepatitis , Crohn's disease , jaundice .

In addition, an increase in the number of triglycerides blood plasma, decreased glucose tolerance, fatigue, increased blood sugar levels, chorea , otosclerosis , pulmonary artery, deep veins of the lower extremities, increased blood pressure, venous thromboembolism , vomit, , pancreatitis , skin rashes, exudative erythema multiforme , hair loss, change in vaginal secretion, chloasma , the appearance of a secret from the mammary glands, vagina.

Possible side effects such as aggravation, hypertrichosis feeling of heaviness in the legs.

Instructions for use Tri-Regol (Method and dosage)

The instruction on Tri-Regol describes that the tablets should be taken one at a time at the same time per day. The course starts from the first day of menstruation and is designed for 21 days. After that, there should be a week break for menstrual-like bleeding. After that, the tablets are taken again from the first package (even if there is still bleeding). First you need to take 6 pink tablets, then - 5 white and after - 10 yellow.

In the package, the order of taking the medicine is indicated by numbers and arrows. If one package contains 28 tablets, after taking the dark yellow ones, you should switch to brown (do not contain hormones), and the next course of 28 days should be started without interruptions.

If the pill is missed (more than 36 hours have passed), the reliability of contraceptive protection is not guaranteed. In the first and second week of the cycle, in case of such a pass, the instruction for the use of Tri-Regol advises taking 2 tablets at once the next day.

If 2 tablets are missed at once in a row, the next 2 days you need to take 2 tablets, then continue the course as usual. If you miss the third week of the course, a seven-day break is not made.

Skipping pills does not apply to brown. They contain iron and are used to maintain continuity.

If the drug is prescribed for treatment, its dosages are adjusted individually.

Overdose

At doses above normal, patients have nausea , headaches , uterine bleeding . In this case, you must immediately consult a doctor. Treatment is symptomatic, gastric lavage is possible.

Interaction

Tri-Regol should be taken with caution in conjunction with:

  • ,Penicillin B
  • antidiabetic medicines for oral use, insulin - dosage adjustment may be necessary;
  • hepatotoxic means - increased risk of increased hepatotoxicity.

Terms of sale

The medicine is sold by prescription only.

Storage conditions

The product must be kept out of the reach of small children. The temperature should not exceed 25 0C.

Time-tested contraceptives with an important female vitamin for caring for an unborn child.

* as well as with therapeutic possibilities
INFORMATION IS PROVIDED STRICTLY
FOR HEALTHCARE PROFESSIONALS


Tri-Regol - instructions for use


REGISTRATION NUMBER:

TRADENAME:

TRI-REGOL®

International non-proprietary name:

ethinylestradiol + levonorgestrel

PHARMACEUTICAL FORM:

Coated tablets

COMPOSITION

Active ingredients:

Tablets I: contain 0.03 mg ethinylestradiol and 0.05 mg levonorgestrel,
Tablets II: contain 0.04 mg ethinylestradiol and 0.075 mg levonorgestrel,
Tablets III: contain 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

Excipients

Tablets I.
Core:
Shell: sucrose, talc, calcium carbonate, titanium dioxide (E171), copovidone, macrogol 6000, colloidal silicon dioxide, povidone, carmellose sodium, iron oxide red (E172).
Tablets II.
Core: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate (33.0 mg).
Shell: sucrose, talc, calcium carbonate, titanium dioxide (E171), copovidone, macrogol 6000, colloidal silicon dioxide, povidone, carmellose sodium.
Tablets III.
Core: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate (33.0 mg).
Shell: sucrose, talc, calcium carbonate, titanium dioxide (E171), copovidone, macrogol 6000, colloidal silicon dioxide, povidone, carmellose sodium, yellow iron oxide (E172).

DESCRIPTION

Tablets I
Pink, round, biconvex film-coated tablets with a glossy surface. On a break in white.
Tablets II
White, round, biconvex film-coated tablets with a glossy surface. On a break in white.
Tablets III
Dark yellow, round, biconvex film-coated tablets with a glossy surface. On a break in white.

PHARMACOTHERAPEUTIC GROUP:

combined contraceptive (estrogen + gestagen).

ATX code: G03AB03

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Combined (three-phase) oral contraceptive estrogen-progestogen drug. When taken, it inhibits the pituitary secretion of gonadotropic hormones.
Sequential administration of film-coated tablets, a drug containing different amounts of progestogen (levonorgestrel) and estrogen (ethinyl estradiol) provides blood concentrations of these hormones close to their concentrations during a normal menstrual cycle, and contributes to the secretory transformation of the endometrium. The contraceptive effect is associated with several mechanisms. Under the influence of levonorgestrel, a blockade of the release of releasing factors (luteinizing and follicle-stimulating hormones) of the hypothalamus occurs, inhibition of the secretion of gonadotropic hormones by the pituitary gland, which leads to inhibition of the maturation and release of an egg ready for fertilization (ovulation).

Ethinylestradiol maintains a high viscosity of cervical mucus (makes it difficult for spermatozoa to enter the uterine cavity). Along with the contraceptive effect, the menstrual cycle is normalized due to the replenishment of the level of endogenous hormones with the hormonal components of Tri-Regol® tablets. In seven-day periods, when another break in taking the drug follows, uterine bleeding occurs.

Pharmacokinetics

Levonorgestrel is rapidly absorbed (less than 4 hours). Levonorgestrel does not have a "first pass" effect through the liver. The half-life is 8-30 hours (average 16 hours). Most of the levonorgestrel in the blood binds to albumin and sex hormone-binding globulin.

Ethinylestradiol is rapidly and almost completely absorbed from gastrointestinal tract. The maximum plasma concentration is reached in the range of 1-1.5 hours. The half-life is 26 ± 6.8 hours. Ethinylestradiol has a “first pass” effect through the liver (the so-called “first pass” effect). Metabolism is carried out in the liver and intestines.

When administered orally, ethinylestradiol is excreted from the blood plasma within 12 hours.
Metabolites of ethinylestradiol: water-soluble derivatives of sulfate or glucuronide conjugation, enter the intestine with bile, where they are disintegrated by intestinal bacteria. 60% of levonorgestrel is excreted by the kidneys, 40% - through the intestines, 40% of ethinylestradiol is excreted by the kidneys and 60% - through the intestines.

INDICATIONS FOR USE

Oral contraception.

CONTRAINDICATIONS

Hypersensitivity to any component of the drug.
Pregnancy, lactation, severe liver disease, liver tumors, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), cholelithiasis, cholecystitis, chronic colitis; the presence or indication in the anamnesis of severe cardiovascular (including decompensated heart defects) and cerebrovascular changes, thromboembolism and a predisposition to them, deep vein phlebitis of the lower extremities, hormone-dependent malignant neoplasms of the genital organs and mammary glands (including suspicion of them), familial forms of hyperlipidemia, arterial hypertension with systolic/diastolic blood pressure of 160/100 mm Hg. and above, surgical interventions, surgical operations on the lower extremities, prolonged immobilization, extensive injuries, pancreatitis (including history), accompanied by severe hypertriglyceridemia and hyperlipidemia, jaundice due to taking medicines containing steroids, severe forms of diabetes mellitus, sickle cell anemia, chronic hemolytic anemia, vaginal bleeding of unknown etiology, migraine, hydatidiform mole, otosclerosis with deterioration during the previous pregnancy(s); idiopathic jaundice of pregnant women, severe pruritus of pregnant women, herpes of pregnant women in anamnesis; smoking over the age of 35, age over 40; lactase deficiency, lactose intolerance, glucose-galactose malabsorption (the dosage form of the drug contains lactose).

CAREFULLY

Compensated diabetes mellitus without vascular complications, arterial hypertension with systolic/diastolic blood pressure up to 160/100 mm Hg, varicose veins, multiple sclerosis, epilepsy, chorea minor, porphyria, tetany, bronchial asthma, adolescence (without regular ovulatory cycles) ), uterine fibroids, mastopathy, depression, tuberculosis.

PREGNANCY AND LACTATION

During pregnancy and lactation, Tri-Regol® is contraindicated.

METHOD OF APPLICATION AND DOSES

Using the drug for the first time:

Take orally, at the same time of the day, if possible in the evening, without chewing and drinking a small amount of liquid.
For the purpose of contraception in the first cycle, Tri-Regol® is prescribed 1 tablet daily. for 21 days, starting from day 1 of the menstrual cycle, then a 7-day break is taken, during which typical menstrual bleeding occurs. The next package containing 21 film-coated tablets should be started on the 8th day after a 7-day break.
The drug is taken as long as there is a need for contraception.
When switching from another oral contraceptive to taking Tri-Regol®, a similar scheme is used.
After the abortion it is recommended to start taking the drug on the same or the next day after the operation.
After childbirth the drug is recommended only for women who are not breastfeeding.
Reception should begin no earlier than the first day of menstruation, cycle.
During lactation, the use of the drug is contraindicated.

If a woman has not taken Tri-Regol® within the prescribed period, you should take the missed pill within the next 12 hours. If 36 hours have passed after taking the pill, contraception cannot be considered reliable. However, in order to avoid intermenstrual bleeding, it is necessary to continue taking the drug from the already started package, minus the missed tablet(s). At this time, it is recommended to additionally use another, non-hormonal method of contraception (for example, barrier).

SIDE EFFECT

Side effects observed with the use of the drug are classified into categories depending on the frequency of their occurrence: very often ≥1 / 10; often >1/100, ≤1/10, sometimes ≥1/1000, ≤1/100; rarely ≥1/10000, ≤1/1000; very rarely ≤1/10000 including individual messages.
Nausea, vomiting, headache, engorgement of the mammary glands, weight gain, decreased libido, depressed mood, chloasma, intermenstrual bleeding, in some cases - swelling of the eyelids, conjunctivitis, blurred vision, discomfort when wearing contact lenses (these phenomena are temporary and disappear after cancellation without prescribing any or therapy). Rarely there are an increase in the concentration of triglycerides, blood glucose, decreased glucose tolerance, increased blood pressure, jaundice, hepatitis, liver adenoma, gallbladder disease (for example, cholelithiasis, cholecystitis), thrombosis and venous thromboembolism, skin rash, hair loss, increased discharge from vagina, vaginal candidiasis, fatigue, diarrhea. With prolonged use, generalized itching, cramps of the calf muscles, hearing loss, an increase in the frequency of epileptic seizures, and coarsening of the voice can very rarely occur.

OVERDOSE

Overdose symptoms: nausea, uterine bleeding.
When the first signs of an overdose appear in the first 2-3 hours, gastric lavage and symptomatic treatment are recommended. There is no antidote.

INTERACTION WITH OTHER DRUGS

The drug should be used with caution while taking:

  • ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone, since these drugs can weaken the contraceptive effect, it is recommended to additionally use a different, non-hormonal contraceptive method;
  • anticoagulants, coumarin or indandione derivatives (there may be a need for an extraordinary determination of the prothrombin index and a change in the dose of the anticoagulant);
  • tricyclic antidepressants, maprotiline, beta-blockers (may increase bioavailability and therefore toxicity);
  • oral hypoglycemic drugs, insulin (there may be a need to change their doses);
  • bromocriptine (decreased effectiveness);
  • drugs with possible hepatotoxic effects, especially dantrolene (risk of increased hepatotoxicity, especially in women over 35 years of age).
  • SPECIAL INSTRUCTIONS

    Before starting the use of the drug, it is necessary to exclude pregnancy, conduct a general medical and gynecological examination (examination of the mammary glands, cytological analysis of the smear).
    While taking the drug, regular gynecological examinations are required every 6 months.
    The use of oral contraceptives is allowed no earlier than 6 months after the transferred viral hepatitis and subject to the normalization of hepatic functions.
    If there is a sharp pain in the upper abdomen, hepatomegaly, or signs of intra-abdominal hemorrhage, a liver tumor may be suspected. In this case, the drug should be discontinued.
    With the appearance of acyclic spotting, it is possible to continue taking the drug Tri-Regol® after the exclusion of organic pathology by the attending physician.
    If violations of liver function are detected during the use of the drug, the question of the advisability of continuing to take Tri-Regol® should be decided.
    In case of vomiting or diarrhea, the drug should be continued, and it is recommended to additionally use another, non-hormonal method of contraception.
    At least 3 months before the planned pregnancy, the drug should be stopped.
    Under the influence of oral contraceptives (due to the estrogen component), some laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, blood coagulation and fibrinolytic factors, levels of lipoproteins and transport proteins) may change. The drug should be stopped immediately in the following cases:
    - with a first-time or increased migraine-like or unusually severe headache, with an acute deterioration in visual acuity, with suspected thrombosis or heart attack;
    - with a sharp increase in blood pressure, the appearance of jaundice or hepatitis without jaundice, the occurrence of generalized itching or an increase in epileptic seizures;
    - at the onset of pregnancy;
    - 6 weeks before the planned operation, with prolonged immobilization (for example, after injuries). The effect of the drug on the ability to drive a car and other mechanisms
    Taking the drug does not affect the ability to drive a car and work with other mechanisms.

    RELEASE FORM

    Coated tablets.
    Tablets I pink - 6 pcs.
    Tablets II, white - 5 pcs.
    Tablets III dark yellow - 10 pcs.
    21 tablets (I, II, III) in Al/PVC blister. 1 or 3 blisters in a cardboard box with instructions for use.

    STORAGE CONDITIONS

    List B.
    At a temperature of 15-30 ° C, out of the reach of children.

    Photo of the drug

    Latin name: Triregol

    ATX code: G03AB03

    Active substance: Ethinylestradiol (Ethinylestradiol), Levonorgestrel (Levonorgestrel)

    Producer: Gedeon Richter (Hungary)

    The description applies to: 24.10.17

    Triregol is a hormonal contraceptive taken orally. It inhibits ovulation, which has a contraceptive effect.

    Active substance

    Ethinylestradiol (Ethinylestradiol), Levonorgestrel (Levonorgestrel).

    Release form and composition

    Available in the form of coated tablets of three types. Each variety has a round, biconvex shape and a glossy surface; on a white break. The package contains 21 tablets of different colors.

    Pink tablets are packed in blisters of 6 pieces.

    White tablets are packed in blisters of 5 pieces.

    Dark yellow tablets are packed in blisters of 10 pieces.

    Indications for use

    Usually the drug is taken as a contraceptive, but there are other indications for taking it. Recommended for dysmenorrhea, premenstrual syndrome, dysfunctional uterine bleeding and menstrual irregularities.

    The drug is recommended for women with a predominant or balanced progestational phenotype. The tool provides the transformation of the uterine mucosa, so it can be used by both young and nulliparous women, and middle-aged women.

    Contraindications

    Pregnancy and lactation, recent hepatitis, liver disease, severe skin itching or history of jaundice, chronic colitis, cholecystitis, cholelithiasis, heart disease, severe endocrine diseases, hypersensitivity to the components of the drug, malignant tumors and different types anemia.

    The drug should be taken with caution in compensated diabetes mellitus without vascular complications, arterial hypertension with systolic / diastolic blood pressure up to 160/100 mm Hg, varicose veins, multiple sclerosis, epilepsy, chorea minor, porphyria, tetany, bronchial asthma, adolescence (without regular ovulatory cycles), uterine myoma, mastopathy, depression, tuberculosis.

    Instructions for use Tri-regol (method and dose)

    The drug should be taken at the same time of the day (preferably in the evening). Tablets are taken orally: swallow whole, do not chew, drink a small amount of liquid.

    For the purpose of contraception in the first cycle, 1 tab. is prescribed daily. per day for 21 days, starting from the 1st day of the menstrual cycle. Then they take a 7-day break, during which menstruation occurs. Reception of the next package must be started on the 8th day after a 7-day break.

    The drug is taken as long as there is a need for contraception.

    When switching from another oral contraceptive to Tri-Regol, a similar scheme is used.

    Reception should begin no earlier than the 1st day of the menstrual cycle.

    If the tablet was missed at the scheduled time, the missed tablet should be taken within the next 12 hours. If the interval between doses is 36 hours, contraception cannot be considered reliable. However, in order to avoid intermenstrual bleeding, it is necessary to continue taking the drug from the already started package, minus the missed tablet(s). At this time, it is recommended to additionally use another, non-hormonal method of contraception (for example, barrier).

    Side effects

    The drug is well tolerated and causes minimal side effects. At the very beginning of taking the drug, the following may occur: side effects:

    • gastrointestinal disorders,
    • headache,
    • breast engorgement,
    • fatigue and mood changes
    • libido disorders and intermenstrual bleeding.

    Discomfort when wearing contact lenses was also rarely noted. In some cases, both an increase and a decrease in body weight are possible, so it is important to monitor your diet and activity while taking the drug. Rarely, impaired glucose tolerance may occur. All side effects disappear after discontinuation of the drug.

    Overdose

    In case of drug overdose, nausea and uterine bleeding are possible.

    When the first signs of an overdose appear in the first 2-3 hours, gastric lavage and symptomatic treatment are recommended. There is no antidote.

    Analogues

    Analogues for the ATX code: Tri-regol 21 + 7, Vesantra, Model Libera, Trikvilar.

    Do not make the decision to change the drug yourself, consult your doctor.

    pharmachologic effect

    Triregol is a three-phase hormonal contraceptive. Contains levonorgestrel and ethinylestradiol. If you take the pills of the drug in the right sequence, then the concentration of hormones in the blood will not differ from that which occurs during a normal menstrual cycle.

    When taken orally, it is rapidly and completely absorbed, and the maximum plasma concentration is reached for ethinylestradiol after 90 minutes, and for levonorgestrel after 2 hours. These substances are metabolized in the liver. The half-life is approximately 2 - 7 hours. Both components are excreted in parallel with feces and urine, and both components of the drug pass into breast milk.

    special instructions

    Before starting the drug, it is necessary to conduct a gynecological and general medical examination to exclude possible contraindications and the presence of pregnancy.

    In the absence of bleeding during the withdrawal of Triregol, continuation of administration is possible only after the possibility of pregnancy has been excluded.

    Women over 30 years of age who take hormonal contraceptives should stop smoking, as this increases the risk of developing thrombosis and thromboembolism.

    When planning pregnancy, it is necessary to stop taking the drug at least 3 months before its onset, while self-cancellation of Tri-regol is not recommended, it is better to do this under the supervision of a doctor. In this case, both the reception and the withdrawal of the drug will be safe and painless.

    During pregnancy and breastfeeding

    The drug is contraindicated during pregnancy and breastfeeding.

    In childhood

    Take with caution in adolescence (without regular ovulatory cycles).

    In old age

    Contraindicated in people over 40 years of age.

    For impaired liver function

    Contraindicated in severe liver disease, liver tumors.

    drug interaction

    With simultaneous use with the drug ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone can weaken the contraceptive effect. These combinations should be used with caution; it is recommended to additionally use a different, non-hormonal method of contraception.

    With simultaneous use with anticoagulants, coumarin or indandione derivatives, an extraordinary determination of the prothrombin index and a change in the dose of the anticoagulant may be required.

    Content

    To prevent spermatozoa from fertilizing the egg during ovulation, gynecologists prescribe Tri-Regol oral contraceptive. The appointment of a medication occurs only after passing the tests and studying the individual data of the patient. Without them, you can not prescribe the drug, and in order to use the remedy correctly, read the instructions for use.

    Instructions for use Tri-Regol

    According to the pharmacological classification, Tri-Regol contraceptives are oral contraceptives of the three-phase type. Each phase of the tablets contains a hormone that inhibits sperm activity and prevents a woman from becoming pregnant. Strict adherence to the instructions with the rules of use will help to avoid unwanted pregnancy.

    Composition and form of release

    Since the drug is three-phase, the number of tablets inside the package is a multiple of three. Composition and description of each:

    Description

    Pink, round biconvex tablets, white inside, glossy surface

    white pills

    Dark yellow shell

    The concentration of ethinylestradiol, mcg per pc.

    The concentration of levonorgestrel, mcg per pc.

    Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, corn starch, talc

    Shell Components

    Sucrose, red iron oxide, talc, calcium carbonate, carmellose sodium, titanium dioxide, povidone, copovidone, colloidal silicon dioxide, macrogol

    Same but without color

    The same, but yellow iron oxide dye

    Package

    6 pcs. in blister

    Pharmacodynamics and pharmacokinetics

    The drug Tri-Regol refers to combined oral contraceptive estrogen-progestin agents that inhibit the pituitary secretion of a dose of hormones. It is necessary to consistently take pills with different contents of progestogen and estrogen. This ensures that the concentration of hormones in the blood is close to their level during a normal menstrual cycle. Due to this, a secretory change in the endometrium occurs.

    The contraceptive effect of Tri-Regol is associated with the mechanism of action: levonorgestrel blocks the release of releasing factors of the luteinizing and follicle-stimulating hormones of the hypothalamus, inhibition of the secretion of gonadotropic hormones by the pituitary gland. This leads to inhibition (oppression) of the maturation and release of the egg (ovulation). Ethinyl estradiol keeps cervical mucus highly viscous, making it difficult for sperm to enter the uterine lining.

    In addition to the contraceptive effect, Tri-Regol is able to normalize the menstrual cycle by replenishing the level of endogenous hormones with its constituent components. After 21 days of admission, a break is made for a week, during which menstrual bleeding occurs. Levonorgestrel is absorbed in four hours, excreted in 32 hours, binds to albumin, globulin.

    Ethinylestradiol reaches its maximum concentration after 1-1.5 hours, is excreted in 52 hours. Metabolism of the substance occurs in the liver and intestines, it is found in the blood plasma within 12 hours after ingestion. Ethinylestradiol, by glucuronide conjugation, breaks down into active metabolites, which are excreted with the kidneys and intestines, similarly to levonorgestrel.

    Indications for use

    According to the instructions for use, Tri-Regol birth control pills have the only indication for use. It consists in oral hormonal contraception - the protection and protection of a woman from pregnancy. Tri-Regol can only be taken by women of childbearing age after being examined by a doctor and examining hormone and blood tests.

    How to take Tri-Regol

    The drug is taken at the same time every evening. Tablets are swallowed whole, not chewed, washed down with water. Every day for 21 days, it is taken on a tablet / day, then a week-long break is made for the onset of menstruation, then the reception is resumed. You can take Tri-Regol as long as you need contraception. When switching from another contraceptive to the drug, the regimen does not change.

    After an abortion, taking the pills begins on the same or next day after the procedure. After childbirth, you can take the remedy only for those who are not breastfeeding. If you do not take the Tri-Regol tablet at the prescribed time, then you should drink it within the next 12 hours. If 36 hours have passed since the reception, contraception is not considered reliable. To avoid intermenstrual spotting, it is recommended to continue taking the already started package minus the missed one. To prevent pregnancy, it is better to use a barrier method of contraception.

    drug interaction

    When using Tri-Regol, you may experience side effects from combination with other drugs. Risky combinations:

    • Ampicillin, Rifampicin, Chloramphenicol, Neomycin, antibiotics from the group of sulfonamides and tetracyclines, tranquilizers, Phenylbutazone weaken the effect of the drug;
    • Indandione, any dose of an anticoagulant, coumarin derivatives, insulin, hypoglycemic drugs require adjustment of the dosage of the drug;
    • Maprotiline, tricyclic antidepressants, beta-blockers increase the toxicity of the agent;
    • the contraceptive reduces the effectiveness of Bromocriptine;
    • Dantrolene increases the risk of hepatotoxicity, especially over the age of 35 years.

    Side effects of Tri-Regol

    Patients taking Tri-Regol note side effects. Common reactions include:

    • breast engorgement, decreased libido;
    • bleeding between periods, increased vaginal discharge, thrush;
    • nausea, vomiting, jaundice, hepatitis;
    • diarrhea, cholecystitis, headache, depression;
    • increased frequency of epileptic seizures, eyelid edema, conjunctivitis;
    • visual impairment, hearing loss;
    • weight gain, increased blood glucose, decreased glucose tolerance;
    • chloasma, skin rash, hair loss, skin itching;
    • increased pressure, thrombosis, muscle cramps, coarsening of the voice.

    Overdose

    Instruction Tri-Regol warns that the symptoms of an overdose of the drug are nausea and uterine bleeding. The woman feels weak, dizzy, her blood pressure drops. In the first 2-3 hours after an overdose is detected, it is recommended to wash the stomach and give activated charcoal. There is no specific antidote.

    Contraindications

    Tri-Regol is prescribed with caution in compensated diabetes mellitus, varicose veins, multiple sclerosis, epilepsy, porphyria, bronchial asthma, uterine myoma, mastopathy, depression, tuberculosis. Contraindications for the use of the drug are:

    • severe diseases, liver tumors;
    • congenital syndromes of hyperbilirubinemia;
    • cholecystitis, cholelithiasis, chronic colitis;
    • decompensated heart disease, thromboembolism;
    • phlebitis of the deep veins of the legs;
    • hormone-dependent tumors or malignant neoplasms of the genital organs and mammary glands;
    • familial form of hyperlipidemia, arterial hypertension;
    • operations, prolonged immobilization, extensive injuries;
    • pancreatitis, jaundice, severe diabetes mellitus;
    • sickle cell or chronic hemolytic anemia, vaginal bleeding;
    • migraine, cystic skid, otosclerosis, herpes of pregnant women;
    • smoking over the age of 35, age over 40;
    • lactose intolerance, any period of pregnancy (when it is detected, the intake is immediately stopped, because the risks of developmental disorders increase to a small extent), lactation;
    • hypersensitivity to components.

    Thanks

    The site provides reference information for informational purposes only. Diagnosis and treatment of diseases should be carried out under the supervision of a specialist. All drugs have contraindications. Expert advice is required!

    Tradename

    Tri-Regol(Tri-regol).

    Pharmacological group

    Hormonal oral contraceptive.

    Release form and composition

    The drug Tri-regol is available in three dosage forms: dragees, tablets and coated tablets.

    One blister contains 21 tablets of three colors: pink - 6 pieces, white - 5 pieces, dark yellow - 10 pieces; packed in a cardboard box. 1 blister of Tri-regol 21 and 7 contains 7 placebo tablets (substance without medicinal properties) reddish brown.

    1 pink tablet includes ethinylestradiol 30 mcg and levonorgestrel 50 mcg. Excipients included in the tablet: lactose monohydrate, colloidal silicon dioxide, talc, magnesium stearate and corn starch. Components of the shell: sucrose, calcium carbonate, talc, copovidone, titanium dioxide (E171), colloidal silicon dioxide, macrogol 6000, povidone, red iron oxide (E172), sodium carmellose. Excipients and shell components are the same for tablets of all colors.

    1 white tablet includes levonorgestrel 75 mcg and ethinylestradiol 40 mcg.

    1 dark yellow tablet includes levonorgestrel 125 mcg and ethinylestradiol 30 mcg.

    1 placebo tablet contains iron fumarate - 76.05 mg. Potato starch is added to auxiliary substances.

    Description of the drug Tri-regol

    The drug Tri-regol is a round tablet coated with three colors (pink, white and dark yellow). The outer surface of the tablet is glossy, inside the substance is white.

    Placebo tablets are produced with a glossy surface of a round shape, on a brown break.

    Pharmacological action of the drug Triregol

    Pharmacodynamics
    Tri-regol belongs to the group of contraceptive combined (three-phase) estrogen-gestagenic drugs. The gestagenic component is represented by levonorgestrel, the estrogenic component is ethinyl estradiol.

    Levonorgestrel, by reducing the production of gonadotropic hormones, leads to a decrease in the rate of maturation of the egg, and prevents ovulation. Ethinylestradiol reduces the possibility of passage of spermatozoa into the uterine cavity, increasing the viscosity of cervical mucus.

    One of the effects of the drug is the normalization of the menstrual cycle, since Tri-regol supplements the level of endogenous hormones due to its components.

    Pharmacokinetics
    Completely absorbed in the intestine when taken orally. It is processed in the liver and intestines, excreted by the kidneys (60% levonorgestrel and 40% ethinylestradiol) and through the intestines (40% levonorgestrel and 60% ethinylestradiol).

    Indications for use

    In gynecological practice, the drug Tri-regol is prescribed for:
    • pregnancy prevention (contraception);
    • treatment of dysfunctional metrorrhagia;
    • treatment of non-organic dysmenorrhea;
    • treatment of premenstrual syndrome;
    • treatment of menstrual disorders.

    Contraindications for use

    The appointment of the drug Tri-regol is contraindicated in the presence of the diseases indicated below:
    • pregnancy and lactation;
    • the presence of hypersensitivity to any component of the drug in the form of allergic reactions;
    • a history of severe itching and severe idiopathic jaundice in pregnancy;
    • liver disease (liver tumors, hepatitis, Gilbert, Rotor and Dubin-Johnson syndromes in history, liver failure);
    • gallbladder diseases: cholelithiasis, cholecystitis;
    • age over 40, smoking at the age of 35 and over;
    • severe cardiovascular (severe arterial hypertension, myocarditis, decompensated heart defects, decompensated chronic heart failure) and cerebrovascular (hemorrhagic and ischemic stroke) changes in history, thromboembolism and thrombosis, as well as a predisposition to them;
    • vaginal bleeding of unknown etiology;
    • severe diabetes mellitus;
    • sickle cell and hemolytic anemia;
    • disorders of fat metabolism;
    • malignant tumors, especially endometrial or breast cancer;
    • cystic skid;
    • chronic colitis;
    • otosclerosis with hearing impairment;
    • inflammation of the walls of the deep veins of the lower extremities (phlebitis);
    • surgical operations (especially on the legs);
    • extensive injuries and prolonged immobilization;
    • lactase deficiency (insufficiency of the enzyme necessary for the digestion of milk lactose).
    Triregol is used with caution in the presence of the following diseases:
    • diabetes mellitus in the compensation stage without vascular complications;
    • chronic venous insufficiency of the lower extremities;
    • arterial hypertension with blood pressure up to 160/100 mm Hg;
    • chorea;
    • porphyria;
    • lack of regular ovulatory cycles in adolescence.

    Dosing regimen of the drug Tri-regol

    Triregol is taken orally. The tablets must be swallowed whole with a small amount of water. It is better to take tablets in the evening, the interval between doses should not exceed 36 hours.

    For the purpose of contraception, Triregol must be taken on the first day of the menstrual cycle. Duration of admission is 21 days followed by a break of 7 days. In the interval between doses, moderate bleeding is noted, as with menstruation. Tablets are taken in strict order, they are numbered according to the days of the menstrual cycle. The drug should be continued on the 8th day. Reception of the drug Tri-regol 21+7 is carried out continuously.

    If you miss a tablet, you must take it within 12 hours, no later. With a break in taking Tri-regol contraceptive pills for 36 hours or more, the drug is continued according to the scheme, excluding the missed pill (it is not taken). In this case, pregnancy is possible, therefore, along with taking Tri-regol, other methods of contraception (preferably barrier ones) should be used.

    The remedy is taken all the time as long as prevention of pregnancy is necessary.

    With a therapeutic purpose, the doctor selects the dose individually in each specific case.

    Side effects of the drug Triregol

    When using Tri-regol, nausea, vomiting, headache, mastalgia (breast engorgement and soreness), mood lability and fatigue, changes in body weight, intermenstrual bleeding, conjunctivitis and temporary visual impairment are possible as side effects.

    Rare side effects include an increase in the concentration of glucose and triglycerides in the blood serum, an increase in blood pressure, changes in the liver (jaundice, hepatitis, liver adenoma), gallbladder disease (cholecystitis, cholelithiasis), thrombosis and venous thromboembolism, skin rash, hair loss , vaginal candidiasis, diarrhea.

    Very rarely, mainly with prolonged use of the drug, the occurrence of spasms of the calf muscles, generalized itching, coarsening of the voice, an increase in the frequency of epileptic seizures, and hearing loss are noted.

    Symptoms of an overdose with Tri-regol

    As a result of an overdose of the drug, nausea and uterine bleeding are noted. In this case, it is necessary to consult a doctor (for gastric lavage and symptomatic therapy.

    Interaction of the drug Triregol with other drugs
    means

    Ampicillin, chloramphenicol, rifampicin, polymyxin B, neomycin, sulfonamides, dihydroergotamine, tetracyclines, tranquilizers, phenylbutazones can reduce the contraceptive effect when taken simultaneously with Tri-Regol, disrupting the balance of microflora.

    When taken simultaneously, Tri-Regol enhances the side effects of hepatotoxic drugs (primarily dantrolene), especially in women over 35 years of age.

    When taking the drug Triregol, it may be necessary to correct the intake of indirect anticoagulants and hypoglycemic drugs, including insulin.

    In the case of diarrhea or vomiting, the absorption of the drug in the intestine is reduced, which leads to a decrease in the contraceptive effect. The drug should be continued, but it is necessary to additionally use a non-hormonal method of contraception.

    If moderate bleeding occurs, it is not necessary to stop the course of taking the drug Triregol.

    It is necessary to immediately stop the course:

    • with a first-time, or becoming more intense, migraine-like headache;
    • at the onset of pregnancy;
    • with the appearance of stabbing pains when coughing or breathing, feelings of tightness and pain in the chest;
    • with acute deterioration in visual acuity;
    • with an increase in epileptic seizures;
    • with suspicion of thrombosis;
    • if a liver tumor is suspected (aching pain in the right hypochondrium, jaundice, liver enlargement);
    • with prolonged immobilization after injuries;
    • 6 weeks before planned surgery.
    Pregnancy and lactation
    The use of the drug Triregol is contraindicated during lactation (excreted in small amounts with breast milk) and during pregnancy. Three months before the onset of a planned pregnancy, you should stop taking the drug.

    Driving vehicles and working with mechanisms
    The drug Tri-regol does not affect the speed of physical and mental reactions.

    Analogues of the drug Tri-regol

    • Triquilar is a therapeutic three-phase contraceptive drug. The active substances and the principle of action are similar to Tri-regol. Manufacturer: Schering, Germany.
    • Triziston refers to therapeutic combined estrogen-gestagen preparations. The action and therapeutic components are identical to Tri-regol, the dosage of active substances is different. Women with regular heavy loads on the vocal cords (professional lecturers, announcers) should not take the drug. Manufacturer: Schering, Germany.
    • Ovidon is a monophasic combined contraceptive drug. Indicated for women of the estrogen phenotype (feminine appearance), since the content of levonorgestrel is increased in the preparation. Producer: Gedeon Richter, Hungary.

    Terms and conditions of storage

    Shelf life - 5 years. After the expiration date, the drug should not be used.
    Tri-regol refers to drugs from list B, which are stored with caution, out of the reach of children and at a temperature of 15 to 30 ° C.

    Conditions for dispensing in pharmacies of the drug Tri-regol

    The drug Tri-regol in the pharmacy network can only be purchased with a doctor's prescription.

    The price of the drug Tri-regol

    The average price for Tri-regol in the Moscow pharmacy chain is:
    Tri-regol birth control pills - 163.78 rubles;
    Tri-regol contraceptive pills, coated 21+7 - 460.53 rubles.
    Share: