What are the three Regol tablets for? Tri-regol - instructions for use, indications, hormone composition, side effects, analogues and price. Method of use of Tri-Regol and dosage

Instructions for medical use of the drug

TRI-REGOL®

Tradename

TRI-REGOL®

International nonproprietary name

Dosage form

Film-coated tablets

Tri-Regol I

One tablet contains

active ingredients: ethinyl estradiol 0.03 mg, levonorgestrel 0.05 mg,

shell composition: sucrose, talc, calcium carbonate, titanium dioxide (E 171), copovidone, macrogol 6000, colloidal anhydrous silicon dioxide, povidone, carmellose sodium, red iron(III) oxide (E172).

Tri-Regol II

One tablet contains

active ingredients: ethinyl estradiol 0.04 mg, levonorgestrel 0.075 mg,

excipients: colloidal silicon dioxide anhydrous, magnesium stearate, talc, corn starch, lactose monohydrate,

shell composition: sucrose, talc, calcium carbonate, titanium dioxide (E 171), copovidone, macrogol 6000, colloidal anhydrous silicon dioxide, povidone, carmellose sodium.

Tri-Regol III

One tablet contains

active ingredients: ethinyl estradiol 0.03 mg, levonorgestrel 0.125 mg,

excipients: colloidal silicon dioxide anhydrous, magnesium stearate, talc, corn starch, lactose monohydrate,

shell composition: sucrose, talc, calcium carbonate, titanium dioxide (E 171), copovidone, macrogol 6000, colloidal anhydrous silicon dioxide, povidone, sodium carmellose, iron(III) oxide yellow (E172).

Description

Tablets, coated pink, round, biconvex with a glossy surface. White at the break (for Tri-Regol I tablets).

White film-coated tablets, round, biconvex with a glossy surface. White on the break (for Tri-Regol II tablets).

The tablets are dark yellow, round, biconvex with a glossy surface. White on the break (for Tri-Regol III tablets).

Pharmacotherapeutic group

Hormonal oral contraceptives. Progestogens and estrogens

(for “calendar” reception)

ATC code G03AB03

Pharmacological properties

Pharmacokinetics

Ethinyl estradiol is rapidly and almost completely absorbed from gastrointestinal tract(Gastrointestinal tract). Bioavailability is about 38-48%, almost completely bound to blood plasma proteins, mainly albumin.

Ethinyl estradiol is broken down by presystemic conjugation, passing through the intestinal wall (first phase of metabolism), then undergoes conjugation in the liver (second phase of metabolism). The most important metabolites of the first phase of metabolism are 2-OH-ethinyl estradiol and 2-methoxy-ethinyl estradiol. Both ethinyl estradiol and the first phase metabolites are excreted as conjugates (sulfates and glucuronides) into bile and undergo enterohepatic circulation. The half-life is 26±6.8 hours. About 40% is excreted in urine and about 60% in feces.

Levonorgestrel is rapidly absorbed from the gastrointestinal tract (complete absorption time less than 4 hours). Bioavailability is almost 100%, due to the absence of first pass metabolism. Most of levonorgestrel is bound to plasma proteins, mainly albumin and sex hormone binding globulin (SHBG).

The half-life of levonorgestrel is characterized by individual variability and ranges from 8 to 30 hours. Levonorgestrel is excreted in urine and feces in the form of metabolites (sulfate and glucuronide conjugates).

Pharmacodynamics

Tri-Regol® is a three-phase combined contraceptive drug that acts by inhibiting the production of gonadotropins, resulting in suppression of ovulation. It increases the viscosity of cervical mucus, which makes it difficult for sperm to pass into the uterine cavity, and also causes changes in the endometrium, which reduces the likelihood of implantation.

Indications for use

Oral contraception

Directions for use and doses

Using the drug for the first time

Take one tablet daily, preferably at the same time of day.

Taking the drug must be started on the first day of the menstrual cycle and continued for 21 days. After this, you must take a seven-day break, during which menstrual-like bleeding occurs. The sequence of taking the drug (first 6 pink, then 5 white and then 10 dark yellow tablets) is indicated by numbers and an arrow on the package. There is no need to use an additional method of contraception.

Next cycles of taking the drug

The next 21-day cycle of taking the drug should begin after a 7-day break. Thus, each cycle begins on the same day of the week.

Transition to taking Tri-Regol® after taking another combination drug:

Tri-Regol® should be taken according to the following schedule: the first Tri-Regol® tablet should be taken on the first day after a seven-day break. If the previous contraceptive contained 22 tablets, then the first Tri-Regol® tablet should be taken on the first day after a six-day break. If the previous contraceptive contained 28 tablets, then the first Tri-Regol® tablet must be taken without interruption. Take the remaining Tri-Regola® tablets according to the above regimen.

Transition to taking the drug Tri-Regol® from the “mini-pill” drug, which contains progestogen

The first Tri-Regol® tablet should be taken on the first day of menstruation, even if the mini-pill has already been taken. Then take the drug according to the above regimen. In this case, there is no need to use an additional method of contraception.

Use of Tri-Regol® after childbirth or after abortion

You can start taking the drug no earlier than the first day of menstruation after the first two-phase cycle. The first two-phase cycle is usually shortened due to premature ovulation. If the drug is started at the first spontaneous bleeding, the drug cannot successfully prevent premature ovulation, so the contraceptive effect is unreliable in the first two weeks of the cycle.

After an abortion or miscarriage in the first trimester, oral contraception can be started immediately.

Special cases requiring the use of additional methods of contraception

Forgotten pills

If a pill was missed within the prescribed period, the missed pill should be taken within 12 hours. In this case, there is no need to use additional methods of contraception. The remaining tablets should be taken at the usual time. If more than 12 hours have passed, you must take the last missed tablet (by skipping the remaining untaken tablets) and continue taking the drug as normal. In this case, additional methods of contraception (barrier methods, spermicides) must be used for the next 7 days.

Gastrointestinal diseases

In the presence of vomiting or diarrhea, the effectiveness of the drug is reduced due to incomplete absorption of the active substances. It is necessary to use additional methods of contraception (barrier methods, spermicides) while symptoms are present and for the next 7 days to prevent premature withdrawal bleeding.

Mild laxatives do not affect the effectiveness of the drug.

Side effects

Nausea, vomiting

Headache

Breast tension

Increase or decrease in body weight, changes in libido

Depressed mood

Chloasma

Intermenstrual bleeding

Complaints when wearing contact lenses

Increased levels of triglycerides, blood glucose, decreased glucose tolerance

Increased blood pressure

Hepatitis, liver adenoma, gallbladder disease, jaundice

Skin rash, skin pigmentation, hair loss

Changes in vaginal secretion, vaginal candidiasis

Thrombosis, thromboembolism

Cramps in calf muscles Oh

Increased fatigue

Contraindications

Hypersensitivity to the components of the drug

Pregnancy and lactation

Severe liver diseases, cholelithiasis, cholecystitis, chronic colitis, liver tumors

Dubin-Johnson, Rotor, Gilbert syndromes

Presence or history of severe cardiovascular diseases, cerebrovascular disorders

Thromboembolism and predisposition to them

Malignant tumors, primarily of the mammary glands or endometrium

Fat metabolism disorder

Severe hypertension

Diabetes mellitus with vascular complications

Sickle cell anemia, chronic hemolytic anemia

Vaginal bleeding of unknown etiology

Migraine

Otosclerosis (which worsened in a previous pregnancy)

Idiopathic jaundice of pregnancy, severe skin itching, history of herpes during pregnancy

Drug interactions

Use the drug with caution simultaneously with:

ampicillin, rifampicin, chloramphenicol, neomycin, penicillin B, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone (the contraceptive effect may be reduced, so it is necessary to use another, non-hormonal contraceptive method),

anticoagulants, coumarin or indanedione derivatives (it is necessary to re-determine the prothrombin time and, if necessary, change the dose of the anticoagulant),

tricyclic antidepressants, maprotiline, beta blockers (their bioavailability and toxicity may increase),

oral antidiabetic drugs, insulin (it may be necessary to change the dose of these drugs),

bromocriptine (reduced effectiveness),

hepatotoxic drugs, especially with dantrolene (the risk of hepatotoxicity increases, especially in women over 35 years of age).

Changes in laboratory parameters: under the influence of the drug (due to the estrogenic component), the level of 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.

special instructions

Before starting a course of taking the drug, you must undergo a general medical and gynecological examination. First of all, it is necessary to measure blood pressure, conduct a laboratory examination of urine for the presence of glucose, monitor liver function, examine the mammary glands and conduct a cytological analysis of a vaginal smear to exclude diseases and to exclude pregnancy.

Particular caution is required when using the drug in the presence of the following diseases: diabetes, arterial hypertension, varicose veins veins, phlebitis, otosclerosis, multiple sclerosis, epilepsy, chorea minor, intermittent porphyria, latent tetany, bronchial asthma, benign uterine tumor, endometriosis or mastopathy, as well as over 40 years of age.

During the period of use of the drug, it is necessary to undergo a medical examination approximately every 6 months.

If you have liver disease, it is necessary to monitor its function every 2-3 months.

After viral hepatitis (after normalization of liver function), oral hormonal contraceptives can be used 6 months after recovery.

After long-term use of oral contraceptives, a rarely benign, in very rare cases a malignant liver tumor can form, which in some cases can lead to life-threatening bleeding. If there is severe pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding, a liver tumor may be suspected. If necessary, the course of taking the drug should be interrupted.

A large number of epidemiological studies have examined the incidence of ovarian, endometrial, cervical, and breast cancer among women taking combined oral contraceptives. Studies have shown that combined oral contraceptives help reduce the risk of ovarian and endometrial cancer.

Some studies have found an increased incidence of cervical cancer among women who took combined oral contraceptives for a long time. However, the relationship between cervical cancer and oral contraceptive use is controversial.

Among women taking combined oral contraceptives, there is an increase in relative risk development of breast cancer. However, the connection between the risk of breast cancer and oral contraception has not yet been proven.

If there is no weaning bleeding, pregnancy must be excluded.

If intermenstrual bleeding occurs, the drug should be continued, since in most cases this bleeding stops spontaneously. If intermenstrual bleeding does not disappear or recurs, a medical examination should be performed to exclude damage to the genital organs.

Among women taking oral contraceptives containing estrogen, the risk of developing thromboembolic diseases (stroke, myocardial infarction, subarachnoid hemorrhage) may increase.

The risk of venous thromboembolic disease reaches its maximum in the first year of taking the drugs.

Some factors increase the incidence of thromboembolic diseases (for example: smoking, obesity, varicose veins, cardiovascular disease, diabetes, migraine). Before starting a course of treatment and in the presence of these factors, it is necessary to assess the benefit/risk ratio of the selected combination contraceptive.

The risk of thromboembolic disease associated with the use of combined oral contraceptives increases with age, especially in combination with smoking. Therefore, women over 35 who are taking oral contraceptives are advised to completely stop smoking.

The presence of thromboembolic diseases at a young age and family history plays a role in the development of thromboembolic diseases.

The drug should be stopped immediately in the following cases

for the first time or worsening migraine-like or unusually severe headache; with acute deterioration of visual acuity; if thrombosis or heart attack is suspected;

with a sharp increase in blood pressure; with the development of jaundice or hepatitis without jaundice; when generalized itching occurs; with epilepsy or increased frequency of epileptic seizures;

before the planned operation (4 weeks before the operation); during prolonged immobilization (for example, after injuries) and in the presence of pregnancy.

Features of the effect of the drug on the ability to drive vehicle and potentially dangerous mechanisms

Studies have not been conducted to study the possible effect of the drug Tri-Regol® on the ability to drive a vehicle and drive potentially dangerous mechanisms.

Instructions

"Tri-regol" is prescribed for the purpose of oral contraception, as well as for dysmenorrhea and premenstrual syndrome. Take the drug at the same time of day, preferably in the evening. For contraception, take 1 tablet daily for 21 days, starting from the first day. At the end of the course, take a break for a week, during which menstruation should begin. On the 8th day, resume taking Tri-Regola. It is not recommended to stop taking the drug without consulting a doctor.

If you missed another pill, take the drug within the next 12 hours. If more than 36 hours have passed, the degree of contraception is significantly reduced. At this time, you should use additional non-hormonal agents. In this case, you need to continue taking Tri-Regol to avoid bleeding between menstrual periods. After an abortion, the appointment is carried out on the day of the abortion or the next day. The use of "Tri-regol" after childbirth is possible only if breastfeeding. WITH therapeutic purpose The drug should be taken only as prescribed by a doctor.

"Tri-Regol" is contraindicated in severe liver diseases (Dubin-Johnson, Gilbert, Rotor syndromes, tumors), cholecystitis, chronic colitis, severe cerebrovascular and cardiovascular diseases, predisposition to thromboembolism, malignant neoplasms (primarily with breast or endometrial cancer), in severe form arterial hypertension, familial forms of hyperlipidemia, with endocrine diseases (including severe diabetes mellitus), with chronic hemolytic and sickle cell anemia, vaginal bleeding of unknown origin, migraines, herpes, idiopathic jaundice, during pregnancy and breastfeeding, with hypersensitivity to components facilities.

"Tri-regol" causes the following side effects: nausea, vomiting, jaundice, swelling of the mammary glands, the appearance of bloody intermenstrual discharge, increased glucose levels, changes in vaginal secretion and libido, headache, decreased emotional background, increased blood pressure, development of venous thromboembolism, thrombosis, changes in body weight, allergic reactions in in the form of rashes and skin itching. Taking the drug should be started after pregnancy has been ruled out, as well as after a series of medical examinations. During the period of using Tri-Regol, you need to undergo gynecological examinations once every six months.

Manufacturer: Gedeon Richter (Gedeon Richter) Hungary

ATC code: G03AB03

Farm group:

Release form: Solid dosage forms. Pills.

General characteristics. Compound:

Pharmacological properties:

Indications for use:

Directions for use and dosage:

Features of application:

Side effects:

Interaction with other drugs:

Contraindications:

Photo of the drug

Latin name: Tri-Regol

ATX code: G03AB03

Active substance: Ethinylestradiol, Levonorgestrel

Manufacturer: Gedeon Richter (Hungary)

Description is valid on: 24.10.17

The drug Tri-Regol is a combined 3-phase contraceptive for oral administration. Instructions for use of Tri-regol contain data on the action of the drug: it suppresses ovulation, blocking the formation of LH and FSH in the pituitary gland, and stimulates the process of secretory transformation of the endometrium. The product helps to increase the viscosity of cervical mucus, creating obstacles to the penetration of sperm.

The drug is distinguished by its ability to reduce the secretion of gonadotropic hormones. And sequential intake of tablets with different contents of levonorgestrel and ethinyl estradiol provides the amount of these hormones close to the indicators of the menstrual cycle, which contributes to the process of secretory transformation of the endometrium.

The impact of Tri-Regol is associated with the action of the following mechanisms:

• levonorgestrel interferes with the release of releasing factors (luteinizing and follicle-stimulating hormones) of the hypothalamus and negatively affects the formation of gonadotropic hormones by the pituitary gland - this causes inhibition of ovulation;
• the substance ethinyl estradiol makes cervical mucus more viscous, which creates obstacles for sperm to enter the uterus.

The abstract contains data that, in addition to the contraceptive effect, the product normalizes the menstrual cycle.

Composition of the drug and release form

The dosage form of the drug is film-coated tablets: round, glossy, biconvex, white at the break (21 tablets in one blister, 1 or 3 blisters in a box). The package contains 3 types of tablets.

Active ingredients of pink tablets (blister pack - 6 pcs.):

• Levonorgestrel in a volume of 50 micrograms;
• Ethinyl estradiol in a volume of 30 mcg.

Active ingredients of white tablets (5 pcs in blister):

• Levonorgestrel in a volume of 75 mcg;
• Ethinyl estradiol in a volume of 40 mcg.

Active ingredients of dark yellow tablets (blister pack - 10 pcs.):

• Levonorgestrel in a volume of 125 mcg;
• Ethinyl estradiol in a volume of 30 micrograms.

Excipients of the drug: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, talc, corn starch.

Shell composition: calcium carbonate, titanium dioxide (E171), copovidone, sucrose, macrogol 6000, talc, povidone, carmellose sodium, colloidal silicon dioxide. In addition, pink tablets contain dye E172 - red iron oxide, dark yellow tablets - yellow iron oxide (E172).

Tri-Regol must be stored at a temperature of +15°C – +25°C.

Instructions for use

First use of Tri-Regol. The drug is used one tablet/day from the first day of the cycle for three weeks. It is also possible to start taking it from days 2 to 7, and in the first cycle it is additionally recommended to use non-hormonal methods of contraception in the first week of the course.

Since the composition of tablets having different colour, varies, it is recommended to take pink tablets for six days, then white tablets for five days, followed by 10 days of dark yellow tablets.

After completing the 3-week course, you should take a break for one week (at which time menstrual-like bleeding usually occurs - most often on the 2-3rd day).

On the first day after the end of the break, if protection is necessary, you should start the 3-week course again. When taken regularly, the contraceptive effect extends during the week-long break.

Switching from another contraceptive: the first tablet should be taken the next day after the last hormone-containing contraceptive tablet - and no later than 1 day after the break when using the previous combined hormonal drug.

Switching from a drug containing only progestogen: you can switch at any time during the menstrual cycle (from an injection - you can switch to Tri-Regol on the day the injection is prescribed, from an intrauterine contraceptive device and implant the next day after their removal). In such a case, it is additionally recommended to use a barrier method of contraception during the week of taking Tri-Regol.

After an abortion or childbirth in the 2nd trimester of pregnancy, use should begin after 3 to 4 weeks for a woman who is not breastfeeding. If oral contraception starts later, then you should additionally use one of the barrier methods of contraception for a week from the start of taking the pills.

Missing a dose: when a woman does not take a pill on time, it must be taken within 12 hours and as quickly as possible. This situation does not require the use of other methods of contraception.

If more than 12 hours have passed, you should immediately take the missed tablet, even if you need to take two tablets a day. Then continue taking the drug as usual. During the week, other methods of contraception are necessary.

Gastrointestinal diseases: the effectiveness of the drug is reduced in the presence of diarrhea or vomiting. This is due to incomplete absorption of the active components of the substances. In this case, the instructions contain instructions on the use of other methods of contraception until the symptoms disappear, as well as over the next week.

Delayed menstrual bleeding: in order to delay menstrual bleeding, you must start using the product from a new package with dark yellow tablets the next day after the end of the previous package. The duration of the delay is determined by the number of dark yellow Tri-Regol tablets taken from the new package. Regular use of the drug can be resumed after a standard one-week break.

Interaction with other tools

You must inform your doctor if you have recently taken or are currently taking other medications.

1. Ampicillin, chloramphenicol, rifampicin, neomycin, tetracyclines, penicillin B, sulfonamides, dihydroergotamine, phenylbutazone, tranquilizers. In this case, the contraceptive effect may be reduced.
2. Anticoagulants, derivatives of indanedione, coumarin. A new determination of the prothrombin time is needed, and the dose of the anticoagulant should be changed if necessary.
3. Insulin, oral antidiabetic agents. It may be necessary to change the dosage of these medications.
4. Tricyclic antidepressants, maprotiline and beta blockers. Their toxicity and bioavailability may increase.
5. Bromocriptine. Efficiency decreases.
6. Hepatotoxic drugs, especially dantrolene. There is an increased risk of hepatotoxicity, this is especially true for women over 35 years of age.

Contraindications

The drug has the following contraindications:

• liver tumors;
• severe liver pathologies;
• chronic colitis;
• cholelithiasis;
• a history of cerebrovascular, severe cardiovascular changes, thromboembolism, as well as a predisposition;
• congenital hyperbilirubinemia (Rotor, Gilbert and Dubin-Johnson syndromes);
• cholecystitis;
• malignant hormone-dependent neoplasms of the mammary glands, genitals (and suspicion of them);
• phlebitis of the deep veins of the lower extremities;
• prolonged immobilization;
• arterial hypertension with diastolic/systolic blood pressure from 100/160 millimeters Hg;
• familial forms of hyperlipidemia;
• operations on the lower extremities;
• hemolytic chronic anemia;
• extensive injuries;
• pancreatitis (as well as a history), which is accompanied by severe hyperlipidemia, hypertriglyceridemia;
• jaundice due to taking drugs with steroids;
• sickle cell anemia;
• severe diabetes mellitus;
• vaginal bleeding of unknown etiology;
• otosclerosis, accompanied by deterioration of the condition during a previous pregnancy;
• hydatidiform mole;
• herpes of pregnant women (history);
• migraine;
• severe skin itching, idiopathic jaundice in pregnant women;
• age from 40 years;
• smoking of the patient over 35 years of age;
• glucose-galactose malabsorption, as well as lactose intolerance and lactase deficiency;
• pregnancy;
• breast-feeding;
• sensitivity to individual components of the drug.

The drug should be taken with caution in the following conditions:

• compensated diabetes mellitus, which is not accompanied by vascular complications;
• epilepsy;
• varicose veins;
• porphyria;
• arterial hypertension with diastolic/systolic blood pressure up to 100/160 millimeters Hg;
• multiple sclerosis;
• mastopathy;
• chorea;
• bronchial asthma;
• tetany;
• adolescence (no regular ovulatory cycles);
• tuberculosis;
• uterine fibroids;
• depression.

Dosage

Under normal conditions, for contraception, a daily dose of one tablet/day is prescribed as part of a 3-week course, then a week break is taken. The next package of 21 film-coated tablets must be taken on the 8th day after the break.

Side effects

Possible side effects from the use of the drug are classified into categories depending on the likelihood of their occurrence:

• very rarely (up to 0.0001%);
• rarely (from 0.0001% to 0.001%);
• sometimes (from 0.001% to 0.01%);
• often (from 0.01% to 0.1%);
• very often (from 0.1%).

Reproductive system: possible – decreased libido, as well as intermenstrual bleeding and engorgement of the mammary glands; less often – vaginal candidiasis, increased vaginal discharge.

Digestive system: may experience nausea, vomiting; less often - liver adenoma, hepatitis, jaundice and gallbladder diseases (for example, cholecystitis, cholelithiasis), diarrhea.

Sense organs: can be observed in some cases, blurred vision, conjunctivitis and swelling of the eyelids, discomfort when wearing lenses can be observed (these are temporary phenomena, they disappear after stopping the drug even without any treatment); with prolonged use, very rarely - hearing loss.

Nervous system: may be observed - depressed mood and headache; with prolonged use, very rarely - an increase in the incidence of epileptic seizures.

Metabolism: possible – increase in body weight; less often – an increase in the concentration of glucose and triglycerides, a decrease in glucose tolerance.

Skin, subcutaneous tissues: chloasma may be observed; less often – hair loss and skin rash; extremely rarely with prolonged use - generalized itching.

Other side effects: rarely - increased fatigue, thrombosis, venous thromboembolism, increased blood pressure; With long-term use, very rarely observed - deepening of the voice and cramps of the calf muscles.

The drug as a whole has positive characteristics. Good tolerance is noted, Tri-Regola. Rare side effects only in the first few months of taking the drug.

Analogues

The drug has the following analogues:

1. Triziston belongs to the group of combined estrogen-progestogen medicines. Medicinal components and the action is identical to Tri-Regol, they differ in the dosage of the active components of the substances. Also, women who have increased stress on the vocal cords (speakers, professional lecturers) should not take the drug. The cost of the drug is from 460 to 520 rubles.
2. Triquilar– a therapeutic three-phase contraceptive agent. The principle of action and active ingredients are similar to Tri-Regol. The cost of the drug is 600 rubles.
3. Ovidon– monophasic combination drug. Differs in indications for use - recommended for women of estrogenic phenotype (with feminine appearance), since the drug contains an increased concentration of levonorgestrel. This is the cheapest analogue of Tri-Regol, the cost of the drug is from 350 to 500 rubles.

Price

The average cost of a package depends on the number of tablets:

• 21 tablets – from 256 to 293 rubles;
• 63 tablets – from 690 to 744 rubles.

Overdose

If the therapeutic dose is significantly exceeded, nausea, vomiting, or even uterine bleeding may occur. In this case, intestinal lavage, gastric lavage, intestinal sorbents and symptomatic therapy are performed.