Certificate of conformity (COC) Tri-regol, pills, 21pcs

Tri-regol, pills, 21pcs

$32.00

Active ingredient:	Ethinylestradiol, Levonorgestrel
Dosage form:	Pills
Indications for use:	Contraception, Menstrual disorders, Premenstrual syndrome

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Categories: Contraceptive, Medication, Obstetrics, gynecology

Description
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Composition

Active ingredients:

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

auxiliary substances

Tablets I. Core: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate (33.0 mg). Shell: sucrose, talc, calcium carbonate, titanium dioxide (E 171), copovidone, macrogol 6000, colloidal silicon dioxide, povidone, sodium carmellose, red iron oxide (E 172).

Tablets II. Core: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate (33.0 mg). Shell: sucrose, talc, calcium carbonate, titanium dioxide (E 171), copovidone, macrogol 6000, colloidal silicon dioxide, povidone, sodium carmellose.

Tablets III. Core: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate (33.0 mg). Shell: sucrose, talc, calcium carbonate, titanium dioxide (E 171), copovidone, macrogol 6000, colloidal silicon dioxide, povidone, sodium carmellose, yellow iron oxide (E 172).

Pharmacological action

Pharmacodynamics

Combined (three-phase) oral contraceptive estrogen is a progestogenic drug. When taken, it inhibits the pituitary secretion of gonadotropic hormones.

Sequential use of coated tablets containing different amounts of progestogen (levonorgestrel) and estrogen (ethinyl estradiol) provides concentrations of these hormones in the blood close to their concentrations during the normal menstrual cycle, and promotes secretory transformation of the endometrium.

The contraceptive effect is associated with several mechanisms. Under the influence of levonorgestrel, there is a blockade of the release of releasing factors (luteinizing and follicle-stimulating hormones) of the hypothalamus, inhibition of the secretion of gonadotropic hormones by the pituitary gland, which leads to inhibition of maturation and release of an egg ready for fertilization (ovulation).

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

Pharmacokinetics

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

Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum plasma concentration is reached in the range of 1-1.5 h. The half-life is 26±6.8 h. 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 taken orally, ethinyl estradiol is released within 12 hours from the blood plasma.

Ethinyl estradiol metabolites: 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 ethinyl estradiol is excreted by the kidneys and 60% – through the intestines.

Indications

Oral contraception.

Use during pregnancy and lactation

Tri-Regol® is contraindicated during pregnancy and lactation.

Contraindications

Hypersensitivity to any component of the drug.

Pregnancy, breast-feeding, severe liver diseases, liver tumors, congenital hyperbilirubinemia (Gilbert’s, Dubin-Johnson and Rotor syndromes), cholelithiasis, cholecystitis, chronic colitis; presence or indication in the anamnesis of severe cardiovascular (including decompensated heart defects) and cerebrovascular changes, thromboembolism and predisposition to them, phlebitis of the deep veins of the lower extremities, hormone-dependent malignancies neoplasms of the genitals and mammary glands (including suspected ones), familial forms of hyperlipidemia, arterial hypertension with systolic/diastolic blood pressure of 160/100 mm Hg and above, surgical interventions, lower limb surgery, prolonged immobilization, extensive injuries, pancreatitis (including in the anamnesis), accompanied by severe hypertriglyceridemia and hyperlipidemia, jaundice due to medication, steroid-containing diseases, severe forms of diabetes mellitus, sickle cell anemia, chronic hemolytic anemia, vaginal bleeding of unknown etiology, migraine, cystic drift, otosclerosis with worsening of the course during the previous pregnancy(s); idiopathic jaundice of pregnant women, severe pruritus of pregnant women, a history of herpes of pregnant women; smoking at the age of over 35 years, age over 40 years; lactase deficiency, lactose intolerance, glucose-galactose malabsorption(the dosage form of the drug contains lactose).

WITH CAUTION

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.

Side effects

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 reports.

Nausea, vomiting, headache, breast engorgement, weight gain, decreased libido, depressed mood, chloasma, intermenstrual bleeding, in some cases – eyelid edema, conjunctivitis, visual impairment, discomfort when wearing contact lenses (these phenomena are temporary and disappear after discontinuation without any therapy).

Rarely there is an increase in the concentration of triglycerides, glucose in the blood, decreased glucose tolerance, increased blood pressure, jaundice, hepatitis, liver adenoma, gallbladder diseases (for example, cholelithiasis, cholecystitis) thrombosis and venous thromboembolism, skin rash, hair loss, increased vaginal discharge, vaginal candidiasis, fatigue, diarrhea.

With prolonged use, generalized itching, calf muscle cramps, hearing loss, an increase in the frequency of epileptic seizures, and a rough voice can very rarely occur.

Interaction

The drug should be used with caution when administered concomitantly:

ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin b, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, of phenylbutazone because these drugs can weaken the contraceptive effect, it is recommended to use a different, non-hormonal contraceptive method;
anticoagulants of coumarin derivatives or indandione (you may need in an extraordinary determination of prothrombin index and the change in the anticoagulant dose);
tricyclic antidepressants, maprotiline, beta-blockers (may increase the bioavailability and therefore toxicity);
oral hypoglycemic drugs, insulin (may need to change the doses);
bromocriptine (lower efficiency);
drugs with a possible hepatotoxic effects, primarily dantrolene (the risk of developing hepatotoxicity, especially in women older than 35 years).

How to take, course of use and dosage

Using the drug for the first time:

Take orally, at the same time of day, if possible in the evening, without chewing and with a small amount of liquid.

For the purpose of contraception in the first cycle, Tri-Regol® is prescribed daily for 1 tab. /day. for 21 days, starting from day 1 of the menstrual cycle, then a 7-day break is taken, during which a typical menstrual bleeding occurs. The next package containing 21 coated tablets should be taken 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 an abortion, it is recommended to start taking the drug on the same or the next day after the operation.

After delivery, the drug is recommended only for women who are not breast-feeding. Reception should be started 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 tablet 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 spotting, 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).

Overdose

Symptoms: nausea, uterine bleeding.

Treatment: if the first signs of overdose appear in the first 2-3 hours, gastric lavage is recommended.

Symptomatic therapy is indicated.

There is no antidote.

Special instructions

Before starting to use 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, a regular gynecological examination is required every 6 months. The use of oral contraceptives is allowed no earlier than 6 months after the transfer of viral hepatitis and provided that liver functions are normalized.

If there is severe 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.

If acyclic spotting occurs, it is possible to continue taking Tri-Regol® after excluding organic pathology by the attending physician.

If liver function disorders are detected during the use of the drug, the question of whether to continue taking 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 discontinued.

Under the influence of oral contraceptives (due to the estrogenic component), some laboratory parameters may change (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, blood clotting and fibrinolytic factors, lipoprotein and transport protein levels).

The drug should be stopped immediately in the following cases::

– with a migraine-like or unusually severe headache that has first occurred or worsened, with acute visual acuity deterioration, with suspected thrombosis or heart attack; – with a sharp increase in blood pressure, jaundice or hepatitis without jaundice, generalized itching or increased frequency of epileptic seizures;- at the onset of pregnancy; – 6 weeks before the planned operation, with prolonged immobilization (for example, after injuries).

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 or work with other mechanisms.