Composition, structure and packing
Tablets - 1 tablet.
estriol - 2 mg
30 pcs. - Packaging of cellular outline (1) - packs cardboard. Cream for intravaginal application of 1 g of estriol 1 mg
15 g - tuba (1) complete with applicator - packs cardboard. Vaginal suppositories of a TIS. estriol 500 mcg
5 pcs. - Packaging of cellular contour (3) - bundles of cardboard.
Clinico-pharmacological group: estrogenic drugs
Registration № №:
Tab. 2 mg: 30 pcs. - P № 013327/03, 16.03.05
Vaginal cream 1 mg / 1 g: 15 g of a tuba in compl. with applicator - P № 013327/02, 20.12.07
suppositories vagina. 500 mg: 15 pcs. - P № 013327/01, 06.11.07
Pharmacological action
Estriol is a natural estrogen. Helps restore normal vaginal epithelium during its atrophic changes in the pre-and postmenopausal women, promotes the normalization of the microflora of the vagina, thereby increasing the resistance of the vaginal epithelium to infectious and inflammatory processes. Since estriol has a short duration of action, then taking the drug once in a daily dose does not cause proliferation of the endometrium and does not require additional progestogenic therapy. Consequently, there is no withdrawal bleeding.
Do not have a significant impact on mineral and protein metabolism, blood glucose level, the picture of peripheral blood phosphorus content in blood plasma.
Pharmacokinetics
Absorption
In applying the drug by mouth, as well as local estriol rapidly and almost completely absorbed.
C max estriol in plasma obtained 1 h after ingestion and 1-2 h after intravaginal application. C max values of estriol in plasma after intravaginal application of higher than after administration of the drug inside.
Distribution
Binding to albumin plasma is 90%.
Withdrawal
Putting estriol (in bound form) is mainly the kidneys, and about 2% of output through the intestine unchanged. Derivation of metabolites in the urine begins in a few hours after the application of the drug and lasts 18 hours
Statement
atrophy of the mucous membrane of the lower parts of the urinary tract caused by estrogen deficiency
pre-and postoperative treatment of women in postmenopauznom period during operations vaginal access
infertility caused by cervical factor
diagnostic purposes in unclear results of vaginal smear for cytology
Dosage regimen
Drug is equally effective when administered vaginally, and when (as suppositories and creams) application.
Inside designate the drug in the initial daily dose of 4-8 mg in 1 reception for 2-3 weeks, then gradually reduce the dose to 1-2 mg / day.
Vaginal suppositories are used in a dose of 500 mg / day every day in the first 2-3 weeks, then gradually reduce the dose to 500 mg / day, 2 times a week.
Cream injected intravaginally with 500 mcg daily in the first weeks of treatment with a gradual transition to supporting dose (500 mg / day, 2 times a week).
Side effect
Sometimes (in violation of the dosage): tension, or pain in the breasts, nausea, spots on the skin, cervical mucus hypersecretion.
Rare: headache, hypertension, cramps of calf muscles, blurred vision. Typically, these side effects disappear within the first weeks of treatment.
Contraindications
pregnancy
thrombosis, embolism
marked disturbances of liver function
hormone-dependent tumors of the uterus or mammary glands
uterine bleeding of unknown etiology
Application of pregnancy and breastfeeding
Ovestin is contraindicated in pregnancy.
Cautions
The daily dose should not exceed the ingestion of 8 mg, with the use of intravaginal cream - 1 times / day and 1 candles in the day. The duration of treatment indicated maximal doses should not exceed a few weeks.
It is recommended to closely monitor the patients who have or have had the following conditions: thrombosis, severe liver problems, porphyria, this category includes persons who were observed during previous pregnancies or steriods marked pruritus, cholestatic jaundice, herpes pregnant or otosclerosis.
The patient should consult a physician if relief of symptoms did not come within 2-3 weeks of drug treatment.
Overdose
Currently, cases of overdosing Ovestin not reported.
Drug Interactions
Drug Interactions drug Ovestin not described.
To the top
The drug in the form of tablets dispensed on prescription.
The drug in the form of vaginal creams and vaginal suppositories allowed to use as a non-prescription medicines.
Terms and Conditions of storage
The drug should be stored at room temperature (not above 25 ° C).
Tablets - 1 tablet.
estriol - 2 mg
30 pcs. - Packaging of cellular outline (1) - packs cardboard. Cream for intravaginal application of 1 g of estriol 1 mg
15 g - tuba (1) complete with applicator - packs cardboard. Vaginal suppositories of a TIS. estriol 500 mcg
5 pcs. - Packaging of cellular contour (3) - bundles of cardboard.
Clinico-pharmacological group: estrogenic drugs
Registration № №:
Tab. 2 mg: 30 pcs. - P № 013327/03, 16.03.05
Vaginal cream 1 mg / 1 g: 15 g of a tuba in compl. with applicator - P № 013327/02, 20.12.07
suppositories vagina. 500 mg: 15 pcs. - P № 013327/01, 06.11.07
Pharmacological action
Estriol is a natural estrogen. Helps restore normal vaginal epithelium during its atrophic changes in the pre-and postmenopausal women, promotes the normalization of the microflora of the vagina, thereby increasing the resistance of the vaginal epithelium to infectious and inflammatory processes. Since estriol has a short duration of action, then taking the drug once in a daily dose does not cause proliferation of the endometrium and does not require additional progestogenic therapy. Consequently, there is no withdrawal bleeding.
Do not have a significant impact on mineral and protein metabolism, blood glucose level, the picture of peripheral blood phosphorus content in blood plasma.
Pharmacokinetics
Absorption
In applying the drug by mouth, as well as local estriol rapidly and almost completely absorbed.
C max estriol in plasma obtained 1 h after ingestion and 1-2 h after intravaginal application. C max values of estriol in plasma after intravaginal application of higher than after administration of the drug inside.
Distribution
Binding to albumin plasma is 90%.
Withdrawal
Putting estriol (in bound form) is mainly the kidneys, and about 2% of output through the intestine unchanged. Derivation of metabolites in the urine begins in a few hours after the application of the drug and lasts 18 hours
Statement
atrophy of the mucous membrane of the lower parts of the urinary tract caused by estrogen deficiency
pre-and postoperative treatment of women in postmenopauznom period during operations vaginal access
infertility caused by cervical factor
diagnostic purposes in unclear results of vaginal smear for cytology
Dosage regimen
Drug is equally effective when administered vaginally, and when (as suppositories and creams) application.
Inside designate the drug in the initial daily dose of 4-8 mg in 1 reception for 2-3 weeks, then gradually reduce the dose to 1-2 mg / day.
Vaginal suppositories are used in a dose of 500 mg / day every day in the first 2-3 weeks, then gradually reduce the dose to 500 mg / day, 2 times a week.
Cream injected intravaginally with 500 mcg daily in the first weeks of treatment with a gradual transition to supporting dose (500 mg / day, 2 times a week).
Side effect
Sometimes (in violation of the dosage): tension, or pain in the breasts, nausea, spots on the skin, cervical mucus hypersecretion.
Rare: headache, hypertension, cramps of calf muscles, blurred vision. Typically, these side effects disappear within the first weeks of treatment.
Contraindications
pregnancy
thrombosis, embolism
marked disturbances of liver function
hormone-dependent tumors of the uterus or mammary glands
uterine bleeding of unknown etiology
Application of pregnancy and breastfeeding
Ovestin is contraindicated in pregnancy.
Cautions
The daily dose should not exceed the ingestion of 8 mg, with the use of intravaginal cream - 1 times / day and 1 candles in the day. The duration of treatment indicated maximal doses should not exceed a few weeks.
It is recommended to closely monitor the patients who have or have had the following conditions: thrombosis, severe liver problems, porphyria, this category includes persons who were observed during previous pregnancies or steriods marked pruritus, cholestatic jaundice, herpes pregnant or otosclerosis.
The patient should consult a physician if relief of symptoms did not come within 2-3 weeks of drug treatment.
Overdose
Currently, cases of overdosing Ovestin not reported.
Drug Interactions
Drug Interactions drug Ovestin not described.
To the top
The drug in the form of tablets dispensed on prescription.
The drug in the form of vaginal creams and vaginal suppositories allowed to use as a non-prescription medicines.
Terms and Conditions of storage
The drug should be stored at room temperature (not above 25 ° C).
No comments:
Post a Comment