Tri-regol - instructions for use, dose, side effects, contraindications

Core: silicon dioxide, colloidal - 0.275 mg, Magnesium stearate - 0.550 mg, talc - 1.100 mg, corn starch - 19.995 mg, lactose monohydrate - 33,000 mg.

Sheath: sucrose - 22.013 mg. talc - 6.935 mg, calcium carbonate-2.898 mg, titanium dioxide - 1.814 mg, copovidone - 0.828, macrogol 6000 - 0.207 mg, silicon dioxide, colloidal -0.123 mg, povidone - 0.074 mg, carmellose sodium - 0.025 mg, iron oxide red -0.083 mg.

Tablets II.

Core: silicon dioxide, colloidal - 0.275 mg, Magnesium stearate - 0.550 mg, talc - 1,100 mg, corn starch - 19.960 mg, lactose monohydrate - 33,000 mg.

Sheath: sucrose - 22.013 mg, talcum powder - 6,935 mg, calcium carbonate - 2.898 mg, titanium dioxide - 1.897 mg, copovidone -0.828 mg, macrogol 6000 - 0.207 mg, silicon dioxide, colloidal - 0.123 mg, povidone - 0.074 mg, carmellose sodium - 0.025 mg.

Tablets III.

Core: silicon dioxide, colloid - 0.275 mg, magnesium stearate - 0.550 mg, talcum powder - 1,100 mg, corn starch - 19.920 mg, lactose monohydrate - 33,000 mg.

Sheath: sucrose - 22.013 mg. talc - 6,935 mg, calcium carbonate - 2.898 mg, titanium dioxide - 1,317 mg, copovidone - 0.828 mg, macrogol 6000 - 0.207 mg, silicon dioxide, colloidal - 0.123 mg, povidone - 0.074 mg, carmellose sodium 0.025 mg. iron oxide yellow - 0.580 mg.

Description:

Tablets I

Pink, round biconvex tablets, coated with a coating, with a glossy surface. On the fracture is white.

Tablets II

White, round biconvex tablets, coated with a coating, with a glossy surface. On the fracture is white.

Tablets III

Dark yellow round biconvex tablets, covered with a coating, with a glossy surface. On the fracture is white.

Pharmacotherapeutic group:contraceptive combination (estrogen + gestagen).

ATX: & nbsp

G.03.A.B Progestogens and estrogens (combinations for sequential administration)

G.03.A.B.03 Levonorgestrel and ethinyl estradiol

Pharmacodynamics:

Combined (three-phase) oral contraceptive estrogen-progestational drug. At reception oppresses a pituitary secretion of gonadotropic hormones. The sequential reception of coated tablets, a preparation containing different amounts of progestogen (levonorgestrel) and estrogen (ethinyl estradiol) provides the concentration of these hormones in the blood, close to their concentrations during the normal menstrual cycle, and promotes the secretory transformation of the endometrium. The contraceptive effect is associated with several mechanisms. Under the influence of levonorgestrel comes the blockade of releasing the releasing factors (luteinizing and follicle-stimulating hormones) of the hypothalamus, suppressing the secretion of the gonadotrophic hormones by the pituitary gland, which leads to inhibition of maturation and fertilization of the ovum ready for fertilization (ovulation). Ethinylestradiol retains a high viscosity of the cervical mucus (making it difficult for sperm to enter the uterine cavity). Along with the contraceptive effect, the menstrual cycle is normalized by replenishing the level of endogenous hormones with the hormonal components of the Tri-Regol® tablets. In the seven-day periods, when the next break in taking the drug follows, the uterine bleeding occurs.

Pharmacokinetics:

Levonorgestrel is rapidly absorbed (less than 4 hours). Levonorgestrel has no effect of "first passage" through the liver. The half-life is 8-30 hours (an average of 16 hours). Most of the levonorgestrel in the blood binds to albumin and to the globulin that binds the sex hormones. Ethinylestradiol quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in the plasma is achieved in the range of 1-1.5 hours. The half-life period is 26 ± 6.8 hours. Ethinyl estradiol has a "first pass" effect through the liver (so-called. "first pass" Effect). Metabolism is carried out in the liver and intestines.

Ingestion ethinyl estradiol is released within 12 hours from the blood plasma.

Metabolites ethinyl estradiol: water-soluble derivatives of sulfate or glucuronide conjugation, enter the intestines with bile,where they are disintegrated with intestinal bacteria. 60% of levonorgestrel is excreted by the kidneys, 40% through the intestine, 40% of ethinyl estradiol is excreted by the kidneys and 60% by the intestine.

Indications:Oral contraception.

Contraindications:

Hypersensitivity to any component of the drug.

Pregnancy, the period of breastfeeding, severe liver disease, liver tumors, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rothra syndrome), cholelithiasis, cholecystitis, chronic colitis; presence or indication in the history of severe cardiovascular (including decompensated heart diseases) and cerebrovascular changes, thromboembolism and predisposition to them, phlebitis of deep veins of the lower extremities, hormone-dependent malignant neoplasms of genital organs and mammary glands (incl. suspicion of them), family forms of hyperlipidemia, arterial hypertension with siskiskshim / diastolic arterial pressure 160/100 mm Hg. and above, surgical interventions, surgical operations on the lower limbs, prolonged immobilization, extensive injuries, pancreatitis (incl.in the anamnesis), accompanied by severe hypertriglyceridemia and hyperlipidemia, jaundice due to the use of drugs containing steroids, severe forms of diabetes mellitus, sickle cell anemia, chronic hemolytic anemia, vaginal bleeding of unknown etiology, migraine, bladder skeleton, otosclerosis with worsening of flow during the preceding ) of pregnancy (tei); 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 insufficiency, lactose intolerance, glucose-galactose malabsorption (in the drug form of the drug contains lactose).

Carefully:

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

Pregnancy and lactation:

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

Dosing and Administration:

Application of the drug for the first time:

Take inside, at the same time of the day, whenever possible in the evening, without chewing and washing down with a small amount of liquid.

For the purpose of contraception in the first cycle, Tri-Regol® is prescribed daily 1 tablet / day. for 21 days, from the 1st day of the menstrual cycle, then make a 7-day break, during which the typical menstrual bleeding occurs. Receiving the next package containing 21 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 abortion it is recommended to start the drug on the same day or the day after the operation.

After childbirth The drug is recommended only for women who do not breast-feed.

Admission should begin no earlier than the first day of menstruation, a cycle.

During lactation, the use of the drug is contraindicated.

If a woman did not take Tri-Regol® on time, should take the missed tablet within the next 12 hours. If after taking the pill 36 hours pass, contraception can not 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 missing tablet (s). At this time it is recommended to additionally apply another, non-hormonal method of contraception (for example, barrier).

Side effects:Side effects observed with the use of the drug are classified into categories according to 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, 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 withdrawal without prescribing any therapy).Rarely are there concentrations of triglycerides, blood glucose, decreased glucose tolerance, increased blood pressure, jaundice, hepatitis, liver adenoma, gallbladder disease (eg, cholelithiasis, cholecystitis), thrombosis and venous thromboembolism, skin rash, hair loss, increased secretions from vaginal discharge, vaginal candidiasis, increased fatigue, diarrhea. With prolonged admission, it is very rare to experience generalized itching, calf muscle cramps, hearing loss, increased frequency of epileptic seizures, and coarsening of the voice.

Overdose:

Symptoms of an overdose: nausea, uterine bleeding.

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

Interaction:

The drug should be used with caution at simultaneous reception:

- 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 derivatives or indanedione (there may be a need for an early definition of a prothrombin index and a change in the dose of an anticoagulant);

- tricyclic antidepressants, maprotiline, beta-blockers (bioavailability and, therefore, toxicity may increase);

- oral hypoglycemic drugs, insulin (you may need to change their doses);

- bromocriptine (decreased efficacy);

- drugs with possible hepatotoxic effect, especially dantrolene (risk of increased hepatotoxicity, especially in women over 35 years of age).

Special instructions:

Before starting the use of the drug, pregnancy should be excluded, general medical and gynecological examination should be conducted (breast examination, dialogical analysis of the smear).

During the reception of the drug requires regular gynecological examination every 6 months.

The use of oral contraceptives is allowed no earlier than 6 months after the transferred viral hepatitis and on condition of normalization of hepatic functions.

If there is a sharp pain in the upper abdominal areas, hepatomegaly or signs of intra-abdominal hemorrhage, there may be a suspicion of a liver tumor. In this case, the drug should be discontinued.

When acyclic bleeding occurs, it is possible to continue taking Tri-Regol® after excluding organic pathology by the treating physician.

When revealing violations of the liver during the use of the drug should decide whether to continue taking Tri-Regol ®.

AT In the case of vomiting or diarrhea, the drug should be continued, with the addition of another, non-hormonal contraceptive method.

At least 3 months before the planned pregnancy, the drug should be stopped.

Under the influence of oral contraceptives (in connection with the estrogen component), certain laboratory parameters (functional parameters of the liver, kidneys, adrenals, thyroid gland, blood coagulation factors and fibrinolytic factors, levels of lipoproteins and transport proteins) can vary.

The drug should be discontinued immediately in the following cases:

- with a migraine-like or unusually severe headache, with acute worsening of visual acuity, with suspicion of thrombosis or infarct;

- with a sharp increase in blood pressure, the appearance of jaundice or hepatitis without jaundice, the emergence of generalized pruritus or an increase in epileptic seizures;

- at approach of pregnancy;

- 6 weeks before the planned operation, with prolonged immobilization (for example, after injuries).

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive and work with other mechanisms.

Form release / dosage:

The tablets covered with a cover.

Tablets I pink color - 6 pcs. Tablets II white - 5 pcs. Tablets III of dark yellow color - 10 PC.

Packaging:

21 tablets (1, II and III) in a blister of PVC-foil and aluminum foil. 1 or 3 blisters in a cardboard box with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not apply at the end of the period on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015005 / 01

Date of registration:25.05.2009

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER OJSC Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp02.10.2015

Illustrated instructions

Instructions

Tri-regol® (Tri-regol®)