Buy Regulon coated tablets N21

Regulon coated pills N21

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Active ingredients

Desogestrel + Ethinyl Estradiol

Release form

Pills

Composition

Active ingredient: ethinylestradiol 0.03 mg, desogestrel 0.15 mg, excipients: α-tocopherol, 0.08 mg. magnesium stearate, 0.08 mg. colloidal silicon dioxide, 0.8 mg. stearic acid, 0, 8 mg. Povidone, 2.4 mg. potato starch, 8 mg. lactose monohydrate, 67.66 mg. Concentration of active ingredient (mg): 0.18 mg.

Pharmacological effect

Regulon is a combined hormonal contraceptive drug for oral use, the action of which is associated with the inhibition of the effect of gonadotropins and the suppression of ovulation, as well as the prevention of sperm penetration through the cervical canal and implantation of a fertilized egg. Ethinyl estradiol is a synthetic estrogen. Desogestrel is a synthetic progestogen that, after ingestion, inhibits ovulation, has a pronounced progestogenic and anti-estrogenic effect, does not exhibit estrogenic activity, and has a weak androgenic and anabolic activity.

Pharmacokinetics

Suction. Desogestrel is rapidly and almost completely absorbed with further transformation into 3-keto-desogestrel (etonogestrel) - the biologically active metabolite desogestrel. Cmax in the blood plasma - 2 ng / ml is reached 1.5 h after administration (tmax). Bioavailability - 62–81%. Distribution. In the body, 3-keto-desogestrel binds to plasma proteins, mainly albumin and globulins that bind sex hormones (SHBG). Only 2–4% of the total amount of desogestrel in the blood plasma is detected as free steroids, and 40–70% is specifically associated with SHBG. An increase in the concentration of SHBG induced by ethinyl estradiol affects the distribution of plasma proteins, which leads to an increase in the SHBG-bound fraction and a decrease in the fraction bound to albumin. Distribution volume - 1.5 l / kg body weight. Biotransformation. Etonogestrel completely disintegrates by known ways of steroid metabolism. The rate of excretion of metabolites from the blood plasma is approximately 2 ml / min / kg. The interaction of etonogestrel with ethinyl estradiol is not marked. In addition to 3-keto-desogestrel (the formation of which occurs in the liver and intestinal wall), there are other metabolites: 3α-OH-desogestrel, 3β-OH-desogestrel, 3α-OH-5α-H-desogestrel (I phase metabolites). They have no pharmacological activity, they are partially conjugated (phase II of metabolism) into polar metabolites, sulfates and glucuronides. Inference.T1 / 2 3-keto-dezogestrela on average - 30 hours. Metabolites are excreted in urine and feces in the ratio of 6: 4. Equilibrium state. The pharmacokinetics of etonogestrel are influenced by the content of HSPG in the blood plasma, which increases 3-fold when taking ethinyl estradiol. With daily intake, the equilibrium state is reached in the second half of the cycle, when the plasma concentration of etonogestrel increases by 2–3 times. Ethinyl Estradiol Absorption. Ethinyl estradiol is rapidly and almost completely absorbed. Cmax in the blood plasma - 80 pg / ml, achieved in 1-2 hours after ingestion (tmax). Bioavailability due to presystemic conjugation and first-pass effect is about 60%. Distribution. Ethinyl estradiol binds completely to plasma proteins, mainly albumin, and activates plasma SHBG. Distribution volume - 5 l / kg. l Biotransformation. Ethinyl estradiol undergoes presystemic conjugation in the mucous membrane of the small intestine and liver. Ethinyl estradiol is mainly metabolized by aromatic hydroxylation, but it also produces other hydroxylated as well as methylated metabolites, which are detected as free metabolites, as well as conjugated sulfates and glucuronides. The metabolic clearance rate is about 5 ml / min / kg. Inference. Ethinyl estradiol T1 / 2 on average - 24 hours. About 40% of ethinyl estradiol is excreted in the urine and approximately 60% in feces. Equilibrium state. Equilibrium concentration is set on the 3-4th day, while the level of ethinyl estradiol in the blood plasma is 30–40% higher than after a single dose.

Indications

Oral contraception.

Contraindications

The presence of severe or multiple risk factors for venous or arterial thrombosis (in t. Ch. Arterial hypertension is severe or moderate with severity ≥160100 mm Hg. Art.). The presence or indication in the history of the precursors of thrombosis (in t. Ch. Transient ischemic attack, angina). Migraine with focal neurological symptoms, in t. Ch. A history of. Venous or arterial thrombosis thromboembolism (incl. Myocardial infarction, stroke, deep vein thrombosis of the tibia, pulmonary embolism) is currently or in history. The presence of venous thromboembolism in history. Diabetes mellitus (with angiopathy). Pancreatitis (in t. Ch.In history), accompanied by severe hypertriglyceridemia. Dyslipidemia. Severe liver diseases, cholestatic jaundice (including so on. During pregnancy), hepatitis, including so much. A history of (before normalization of functional and laboratory parameters and within 3 months after their normalization). Jaundice when taking GX. Gallstone disease at present or in history. Syndrome of a gangster, a syndrome of a club-johnson, a syndrome of a rotor. Liver tumors (in t. Ch. A history of). Severe itching, otosclerosis or its progression during a previous pregnancy or taking GX. Hormone-dependent malignant neoplasms of the genital organs and mammary glands (including those under suspicion of them). Vaginal bleeding of unknown etiology. Smoking over the age of 35 (more than 15 cigarettes per day). Pregnancy or suspicion of her. Lactation period. Hypersensitivity to the drug. The drug should be prescribed with caution in conditions that increase the risk of developing venous or arterial thrombosis and embolism: age over 35 years, smoking, family history, obesity (body mass index more than 30 kgm2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, fibril auricles, prolonged immobilization, extensive surgery, surgery on the lower limbs, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period, the presence of severe depression (including history), changes in biochemical parameters (resistance of activated protein c, hyperhomocysteinemia, antithrombin iii deficiency, protein c or s deficiency, antiphospholipid antibodies, in. Ch. Antibodies to cardiolipin, in T. Ch. Lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including T. Ch. In the family history), acute and chronic liver diseases.

Precautionary measures

If you forget to take a pill in a timely manner. You can not interrupt the pill for more than 7 days. If you forget to take a pill at the usual time, you should take it within 12 hours. The following pill should be taken at the usual time. In this case, additional barrier methods of contraception are not required.If you forget to take one or more pills, and do not take it within 12 hours, the contraceptive effect may be reduced. It is recommended to take the last missed pill as soon as you remember it, even if it means that you have to take two pills on the same day, and then take the pills as usual. In this case, you must use additional barrier methods of contraception over the next 7 days. If you decide to stop taking Regulon. If you stop taking Regulon pills before the end of the package, the contraceptive effect may be incomplete, so it is recommended to use additional barrier methods of contraception. If you have any questions about taking this drug, contact your doctor. What should be done in case of vomiting or diarrhea. If you have an upset stomach and intestines, accompanied by vomiting and diarrhea, the reliability of the contraceptive effect of Regulon may decrease. If the symptoms of the disorder disappear within 12 hours, take an extra pill from a spare pack and continue taking the other pills at the usual time. If the symptoms of the disorder persist for longer than 12 hours, additional barrier contraceptive methods should be used while you are suffering from a disorder of the gastrointestinal tract, and for the next 7 days.

Use during pregnancy and lactation

Prior to taking Regulon, pregnancy should be excluded. If you have a pregnancy, you should immediately stop taking Regulon. Since the active ingredient of the drug Regulon can penetrate into breast milk and lead to a decrease in the amount of milk, it is not recommended to apply Regulon during breastfeeding.
Dosage and administration
The drug is prescribed on 1 tab. days (if possible at the same time), starting from 1 day of the menstrual cycle for 21 days. This is followed by a 7-day break, during which menstrual bleeding occurs. Then, taking the pills from the next package is resumed (even if the bleeding has not yet stopped). When complying with the rules of admission, the contraceptive effect is maintained for the duration of the 7-day break.If the first pill is taken on day 1 of the menstrual cycle, then no additional contraceptive methods are required. Taking the pills can be started from 2-5 days of menstruation, but in this case, in the first cycle, you need to use additional methods of contraception in the first 7 days of taking the pills. If more than 5 days have passed after the onset of menstruation, the start of taking the drug should be postponed until the next menstruation. After giving birth After giving birth to non-nursing women, the drug can be administered after 21 days. In this case, there is no need to use other methods of contraception. If the drug is prescribed later than 21 days after delivery, then in the first 7 days of administration it is necessary to use additional methods of contraception. If in the postpartum period, sexual contact was preceded by oral contraception, then with the intake of pills, you must wait until the first menstruation occurs. In women who continue breastfeeding, the use of combined oral contraceptives is not recommended, since taking the drug can reduce the release of milk. After an abortion After an abortion, it is recommended to start taking the drug immediately after surgery, and in this case there is no need to use additional methods of contraception. When switching to Regulon When switching to Regulon after taking another estrogen-progestin hormonal contraceptive, the first tablet of Regulon should be taken the next day after completing the course of the previous drug. In the application of additional methods of contraception is not necessary. When switching to Regulon after taking another hormonal contraceptive containing only gestagen, Regulon's first tablet should be taken on the first day of the menstrual cycle. No need for additional contraceptive methods. If you do not experience menstruation while taking the previous drug, you can start taking Regulon on any day of the cycle, but in this case, additional contraceptive methods should be used on the first 7 days of dosing. As an additional method of contraception, the use of a cervical cap with a spermicidal gel, a condom, or abstinence from sexual contact is recommended. The use of the calendar method as an additional method of contraception is not recommended.If necessary, postpone menstruation. If necessary, postpone menstruation, taking pills should be continued without a 7-day break. In this case, intermenstrual bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regulon's regular intake can be restored after the usual 7-day break. In case of skipping the drug In case of skipping the drug, if the delay in taking the pill was no more than 12 hours, then you should take the missed pill and then continue taking it at the usual time. If the delay in taking the pill was more than 12 hours, this is considered to be a skip tablet. The reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended. When skipping 1 tab. In the first or second week of the cycle, it is necessary to take 2 tab. the next day and then continue regular intake, using additional contraceptive methods until the end of the cycle. When skipping 1 tab. in the third week of the cycle, in addition to the measures listed, a 7-day break is excluded. If vomiting or diarrhea appears after taking the drug, absorption of the drug may be incomplete. If the symptoms have stopped within 12 hours, then you need to take another 1 tab extra. After that, you should continue taking the pills in the usual way. If symptoms continue for more than 12 hours, it is necessary to use additional methods of contraception in the next 7 days.

Side effects

Side effects requiring discontinuation of the drug. From the side of the cardiovascular system: arterial hypertension. rarely, arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). very rarely, arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins. On the part of the senses: hearing loss due to otosclerosis. Other: hemolytic uremic syndrome, porphyria. rarely, exacerbation of reactive systemic lupus erythematosus. very rarely - Sydenham's chorea (passing after discontinuation of the drug). Other side effects that are more common, but less severe. The feasibility of continuing the use of the drug is decided individually after consultation with the doctor, based on the ratio polzarisk.On the part of the reproductive system: acyclic bleeding, bloody vaginal discharge, amenorrhea after discontinuation of the drug, a change in the state of vaginal mucus, the development of inflammatory processes in the vagina, candidiasis, tension, pain, an increase in the mammary glands, galactorrhea. On the part of the digestive system: nausea, vomiting, Crohn's disease, ulcerative colitis, the occurrence or worsening of jaundice or itching associated with cholestasis, cholelithiasis. Dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma. From the side of the central nervous system: headache, migraine, mood lability, depression. On the part of the organ of vision: increased sensitivity of the cornea (when wearing contact lenses). On the part of metabolism: fluid retention in the body, a change (increase) in body weight, a decrease in carbohydrate tolerance. Other: allergic reactions.

Overdose

After taking a significant dose of oral contraceptives, no serious adverse events were observed. However, if you took more pills than you should, and found a mistake within 2-3 hours, consult a doctor.

Interaction with other drugs

Please tell your doctor if you are taking or have recently taken any other medications, including over-the-counter medications. The simultaneous use of certain drugs, such as antiepileptic drugs, antibiotics, tranquilizers, and laxatives, may reduce the effectiveness of Regulon. If you are taking medicines that can reduce the contraceptive efficacy of Regulon, you should additionally use a barrier method of contraception while taking another drug. If you have diabetes, you may need to increase your insulin or antidiabetic drug.

special instructions

Before using the drug, it is necessary to conduct general medical (detailed family and personal history, blood pressure measurement, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of cervical smear). A similar study in the period of taking the drug is carried out regularly, every 6 months.The effectiveness of the drug Regulon is reduced in the case of skipping pills, with vomiting and diarrhea, as well as while taking it with other drugs. The effectiveness of Regulon may decrease if, after several months of its use, intermenstrual bleeding occurs. If at the same time during the break does not appear menstrual bleeding, taking pills can be continued only after the exclusion of pregnancy. The risk of arterial or venous thromboembolic diseases increases with age, with smoking, with a family history of thromboembolic diseases, with obesity (body mass index above 30 kg / m 2), with dyslipoproteinemii, with arterial hypertension, with valvular heart disease, with fibrillation atrial, in diabetes mellitus, with prolonged immobilization (after a large surgery, after surgery on the lower limbs, after a serious injury). In the presence of congenital or acquired biochemical defects (resistance to activated protein C, hyperchromocysteinemia, deficiency of proteins C, S, deficiency of antithrombin III, the presence of antiphospholipid antibodies) also increases the risk of developing thromboembolic diseases. Purposeful treatment of the above conditions reduces the risk of blood clots. Pregnancy represents a greater risk of thrombosis than taking hormonal contraceptives. Reception of Regulon should be immediately stopped in the following cases: For the first time, the emergence of a severe headache or an increase in ordinary migraines. Acute deterioration of visual acuity. Suspected myocardial infarction or thrombosis. A sharp increase in blood pressure. The appearance of jaundice or hepatitis without jaundice, intense generalized itching. The occurrence of epilepsy or an increase in epileptic seizures. 4 weeks before the planned surgery and in case of prolonged immobilization (taking Regulon can be resumed after 2 weeks from the moment of remobilization). The development of pregnancy. Application for violations of the liver: Contraindicated in liver failure. Application for violations of renal function: With caution and only after a thorough assessment of the benefits and risks of use should be prescribed the drug for renal failure (including in history).Impact on the ability to drive motor vehicles and control mechanisms: Studies on the effect of the drug Regulon on the ability to drive a car and production mechanisms have not been conducted.

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