Release form, composition and packing
Tablets, film-coated 1 tab. hlormadinon (in the form of acetate) 2 mg ethinyl estradiol 30 mcg. Other ingredients: povidone, corn starch, magnesium stearate, lactose monohydrate.
Clinico-pharmacological group: monophasic oral contraceptive with antiandrogenic properties.
Pharmacological action
Combined contraceptive drug for oral administration. Part of the preparation hlormadinon - progestogen with antiandrogenic properties. Daily dose hlormadinona providing complete suppression of ovulation, is 1.7 mg. Required dose per cycle - 25 mg.
The mechanism of antiandrogenic action associated with the ability to act on specific receptors of the androgens. Ethinylestradiol - a synthetic estrogen, inhibits the secretion of the sebaceous glands of skin, increases the production of binding globulin sex hormone that reduces the amount of free testosterone in blood plasma. Long-term (more than 21 days) use of the drug leads to a decrease in the secretion of follicle stimulating and luteinizing hormones and, consequently, to suppress ovulation and endometrial proliferation and secretory transformation. Simultaneously change the properties of cervical mucus, which is accompanied by difficulty in passing the sperm through the cervical canal and a violation of their mobility.
Receiving Belar helps normalize the menstrual cycle, reduction of blood loss during menstruation, reduce the intensity of premenstrual pains. On the background of the drug may reduce the incidence of iron deficiency anemia, dysmenorrhea, functional ovarian cysts, ectopic pregnancy.
Pharmacokinetics
Suction
After receiving the drug inside hlormadinon and ethinyl estradiol is rapidly and completely absorbed from the gastrointestinal tract. Hlormadinona Cmax achieved within 1-2 hours
Metabolism and Elimination
Hlormadinona metabolites excreted in urine and bile in the ratio 4:6; T1 / 2 is 34 hours Ethinylestradiol biotransformed in the body to form sulfates and glyukuronatov. Ethinyl estradiol metabolites excreted in urine and bile in the ratio 4:6; T1 / 2 was approximately 25 h. Indications - contraception.
Dosing regimen
The drug is starting to take a 1-day menstrual cycle and continue to receive daily (preferably at the same time) within 21 days. Then should make a 7-day break, during which time the bleeding should start bleed.
After a 7-day break should resume taking the drug from the blister, regardless of whether the bleeding has stopped bleed or not. If hormonal contraceptives are not used during the previous menstrual cycle, pill should be started on the first day of normal menstrual cycle (first day of menstruation). Contraceptive action begins with the first day of admission.
If your period lasts longer than one day, the first pill should be taken at the 5 th day of menstruation, regardless of whether or not the bleeding has stopped. In this case, you should use additional, non-hormonal methods of contraception during the first 7 days.
If since the beginning of menstruation has been more than 5 days, then the woman is recommended to start taking the drug with the next menstrual cycle. When switching from another hormonal contraceptive that contains 21 active tablets, you should finish taking all the tablets of the old packaging.
Belar first pill to be taken the next day. There should be no break in the pill, the patient should not wait until the next menstrual cycle. When switching from other hormonal contraceptives containing 28 tablets, the first pill Belarus should take the next day after taking the last active tablet from the packaging prior contraceptive drug (ie after taking 21 active pills). There should be no break in the pill, the patient should not wait until the next menstrual cycle.
In the transition from contraceptives containing only progestin (mini-pill), a woman can start taking the drug Belarus in every day (without break) during the transition from the use of an implant containing the progestogen - the day of his removal, the transition from progestogens in injection form - the date on which should be made following injection. In all cases it is necessary to use additional barrier methods of contraception during the first 7 days of dosing of Belarus. After the abortion I trimester of pregnancy should begin taking the drug immediately after the abortion.
Additional methods of contraception are not required. After birth, women who are not breastfeeding can start taking the drug Belarus at the 21-day 28 postpartum. In this case, additional contraceptive measures should not be taken. If use of the drug in the postpartum period commenced after 28 days after birth, it is necessary to take additional contraceptive measures for 7 days.
If a woman has had sex, then prior to use of the drug to exclude pregnancy and wait until the next menstrual cycle. If the patient has not taken the drug in the usual time, and after the set time of reception is less than 12 hours, the contraceptive effect of the drug remains, and should take the missed tablet as soon as possible.
The next tablet should be taken at the scheduled time. If after a set time receiving more than 12 hours may decrease contraceptive effect of the drug. Should immediately take the missed pill and then continue taking medication at the usual time.
It is necessary to use additional barrier methods of contraception for the next 7 days. If within the 7 days pill box over, then taking pills from the next pack should be started immediately after the pills in the previous package, ie not a break between taking pills from a variety of packages.
If there was no bleed bleeding after the second pack, you should exclude pregnancy. If you experience vomiting or diarrhea while taking tablets of the drug Belar recommended additional methods of contraception, as contraceptive effect of the drug may be reduced due to incomplete removal of active drug substances in the intestine. The tablets should be swallowed whole, opting for one pill that is marked appropriately day of the week. The choice is determined by the direction of the arrow tabs on the packaging.
Side effect
Cardio-vascular system: increased blood pressure, increased risk of thromboembolic disease of the arteries and veins.
From the digestive system: nausea, vomiting, gastro-intestinal disturbances, destruction of bile ducts, liver neoplasms (benign and malignant).
CNS: depression, irritability, headache, blurred vision, tinnitus.
From the genital system: breast engorgement, vaginal discharge, dysmenorrhea.
Dermatological reactions: chloasma, skin dryness, rash, itching, acne, seborrhea.
Other: allergic reactions, back pain.
Contraindications
venous or arterial thrombosis (including history);
Severe or multiple risk factors for thrombosis;
diabetes mellitus with angiopathy;
severe liver disease (including history) to the normalization of liver tests;
Dubin-Johnson syndrome;
Rotor syndrome;
benign or malignant liver tumors (including history);
sickle-cell anemia;
porphyria;
expressed lipid metabolism;
severe arterial hypertension;
atherosclerosis;
migraine;
epilepsy;
hormone-malignant diseases of genital organs or breasts (including suspects);
vaginal bleeding of unknown etiology;
idiopathic jaundice or itching during previous pregnancy;
otosclerosis with hearing loss during the previous pregnancy;
pregnancy (including suspects);
Lactation (breastfeeding);
hypersensitivity to the drug.
Pregnancy and lactation
Belar drug is contraindicated in pregnancy. The drug should be discontinued as soon as pregnancy is diagnosed. Use of the drug in early pregnancy is not an indication for therapeutic abortion. According to available data to date is not noted an increased risk of malignant neoplasms in infants whose mothers used the drug during pregnancy.
Not recommended for drug Belarus during breastfeeding, because the background of his admission fewer milk supply, and changes its texture. While taking the drug during lactation, active substances in small amounts may be excreted in breast milk.
Data that they have a negative impact on the newborn, no.
Use in hepatic dysfunction
Caution should be applied Belarus with renal failure.
Use in renal impairment
Contraindicated in severe liver disease (including history) to the normalization of liver tests.
Cautions
Before the appointment of the drug and at least 1 time per year during its regular use should be a medical examination to exclude possible contraindications.
Tablets, film-coated 1 tab. hlormadinon (in the form of acetate) 2 mg ethinyl estradiol 30 mcg. Other ingredients: povidone, corn starch, magnesium stearate, lactose monohydrate.
Clinico-pharmacological group: monophasic oral contraceptive with antiandrogenic properties.
Pharmacological action
Combined contraceptive drug for oral administration. Part of the preparation hlormadinon - progestogen with antiandrogenic properties. Daily dose hlormadinona providing complete suppression of ovulation, is 1.7 mg. Required dose per cycle - 25 mg.
The mechanism of antiandrogenic action associated with the ability to act on specific receptors of the androgens. Ethinylestradiol - a synthetic estrogen, inhibits the secretion of the sebaceous glands of skin, increases the production of binding globulin sex hormone that reduces the amount of free testosterone in blood plasma. Long-term (more than 21 days) use of the drug leads to a decrease in the secretion of follicle stimulating and luteinizing hormones and, consequently, to suppress ovulation and endometrial proliferation and secretory transformation. Simultaneously change the properties of cervical mucus, which is accompanied by difficulty in passing the sperm through the cervical canal and a violation of their mobility.
Receiving Belar helps normalize the menstrual cycle, reduction of blood loss during menstruation, reduce the intensity of premenstrual pains. On the background of the drug may reduce the incidence of iron deficiency anemia, dysmenorrhea, functional ovarian cysts, ectopic pregnancy.
Pharmacokinetics
Suction
After receiving the drug inside hlormadinon and ethinyl estradiol is rapidly and completely absorbed from the gastrointestinal tract. Hlormadinona Cmax achieved within 1-2 hours
Metabolism and Elimination
Hlormadinona metabolites excreted in urine and bile in the ratio 4:6; T1 / 2 is 34 hours Ethinylestradiol biotransformed in the body to form sulfates and glyukuronatov. Ethinyl estradiol metabolites excreted in urine and bile in the ratio 4:6; T1 / 2 was approximately 25 h. Indications - contraception.
Dosing regimen
The drug is starting to take a 1-day menstrual cycle and continue to receive daily (preferably at the same time) within 21 days. Then should make a 7-day break, during which time the bleeding should start bleed.
After a 7-day break should resume taking the drug from the blister, regardless of whether the bleeding has stopped bleed or not. If hormonal contraceptives are not used during the previous menstrual cycle, pill should be started on the first day of normal menstrual cycle (first day of menstruation). Contraceptive action begins with the first day of admission.
If your period lasts longer than one day, the first pill should be taken at the 5 th day of menstruation, regardless of whether or not the bleeding has stopped. In this case, you should use additional, non-hormonal methods of contraception during the first 7 days.
If since the beginning of menstruation has been more than 5 days, then the woman is recommended to start taking the drug with the next menstrual cycle. When switching from another hormonal contraceptive that contains 21 active tablets, you should finish taking all the tablets of the old packaging.
Belar first pill to be taken the next day. There should be no break in the pill, the patient should not wait until the next menstrual cycle. When switching from other hormonal contraceptives containing 28 tablets, the first pill Belarus should take the next day after taking the last active tablet from the packaging prior contraceptive drug (ie after taking 21 active pills). There should be no break in the pill, the patient should not wait until the next menstrual cycle.
In the transition from contraceptives containing only progestin (mini-pill), a woman can start taking the drug Belarus in every day (without break) during the transition from the use of an implant containing the progestogen - the day of his removal, the transition from progestogens in injection form - the date on which should be made following injection. In all cases it is necessary to use additional barrier methods of contraception during the first 7 days of dosing of Belarus. After the abortion I trimester of pregnancy should begin taking the drug immediately after the abortion.
Additional methods of contraception are not required. After birth, women who are not breastfeeding can start taking the drug Belarus at the 21-day 28 postpartum. In this case, additional contraceptive measures should not be taken. If use of the drug in the postpartum period commenced after 28 days after birth, it is necessary to take additional contraceptive measures for 7 days.
If a woman has had sex, then prior to use of the drug to exclude pregnancy and wait until the next menstrual cycle. If the patient has not taken the drug in the usual time, and after the set time of reception is less than 12 hours, the contraceptive effect of the drug remains, and should take the missed tablet as soon as possible.
The next tablet should be taken at the scheduled time. If after a set time receiving more than 12 hours may decrease contraceptive effect of the drug. Should immediately take the missed pill and then continue taking medication at the usual time.
It is necessary to use additional barrier methods of contraception for the next 7 days. If within the 7 days pill box over, then taking pills from the next pack should be started immediately after the pills in the previous package, ie not a break between taking pills from a variety of packages.
If there was no bleed bleeding after the second pack, you should exclude pregnancy. If you experience vomiting or diarrhea while taking tablets of the drug Belar recommended additional methods of contraception, as contraceptive effect of the drug may be reduced due to incomplete removal of active drug substances in the intestine. The tablets should be swallowed whole, opting for one pill that is marked appropriately day of the week. The choice is determined by the direction of the arrow tabs on the packaging.
Side effect
Cardio-vascular system: increased blood pressure, increased risk of thromboembolic disease of the arteries and veins.
From the digestive system: nausea, vomiting, gastro-intestinal disturbances, destruction of bile ducts, liver neoplasms (benign and malignant).
CNS: depression, irritability, headache, blurred vision, tinnitus.
From the genital system: breast engorgement, vaginal discharge, dysmenorrhea.
Dermatological reactions: chloasma, skin dryness, rash, itching, acne, seborrhea.
Other: allergic reactions, back pain.
Contraindications
venous or arterial thrombosis (including history);
Severe or multiple risk factors for thrombosis;
diabetes mellitus with angiopathy;
severe liver disease (including history) to the normalization of liver tests;
Dubin-Johnson syndrome;
Rotor syndrome;
benign or malignant liver tumors (including history);
sickle-cell anemia;
porphyria;
expressed lipid metabolism;
severe arterial hypertension;
atherosclerosis;
migraine;
epilepsy;
hormone-malignant diseases of genital organs or breasts (including suspects);
vaginal bleeding of unknown etiology;
idiopathic jaundice or itching during previous pregnancy;
otosclerosis with hearing loss during the previous pregnancy;
pregnancy (including suspects);
Lactation (breastfeeding);
hypersensitivity to the drug.
Pregnancy and lactation
Belar drug is contraindicated in pregnancy. The drug should be discontinued as soon as pregnancy is diagnosed. Use of the drug in early pregnancy is not an indication for therapeutic abortion. According to available data to date is not noted an increased risk of malignant neoplasms in infants whose mothers used the drug during pregnancy.
Not recommended for drug Belarus during breastfeeding, because the background of his admission fewer milk supply, and changes its texture. While taking the drug during lactation, active substances in small amounts may be excreted in breast milk.
Data that they have a negative impact on the newborn, no.
Use in hepatic dysfunction
Caution should be applied Belarus with renal failure.
Use in renal impairment
Contraindicated in severe liver disease (including history) to the normalization of liver tests.
Cautions
Before the appointment of the drug and at least 1 time per year during its regular use should be a medical examination to exclude possible contraindications.
No comments:
Post a Comment