ESTRAGYN Vaginal cream (2016)
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Περιεχόμενα
Name of the medicinal product
ESTRAGYN Vaginal cream.
Summary product information
Route of Administration Dosage Form/Strength Clinically Relevant Nonmedical Ingredients Intravaginally 0.1%w/w Estrone<br />Vaginal cream Mineral oil, methyl paraben, propyl paraben. For a complete listing ...
Indications and clinical use
Estragyn Vaginal Cream is indicated for the treatment of the symptoms of vulvovaginal atrophy due to estrogen deficiency. Estragyn Vaginal Cream should be prescribed with an appropriate dosage of a progestin ...
Contraindications
Estragyn Vaginal Cream should not be administrated to patients with any of the following conditions: Hypersensitivity to this drug or to any ingredient in the formulation or component of the container. ...
Warnings and precautions
Carcinogenesis and Mutagenesis Breast Cancer Available epidemiological data indicate that the use of combined estrogen plus progestin by postmenopausal women is associated with an increased risk of invasive ...
Adverse reactions
Adverse Drug Reaction Overview See Warnings and Precautions regarding potential induction of malignant neoplasms and adverse effects similar to those of oral contraceptives. The following adverse reactions ...
Drug interactions
Overview Estrogens may diminish the effectiveness of anticoagulant, antidiabetic and antihypertensive agents. Preparations inducing liver enzymes (e.g. barbiturates, hydantoins, carbamazepine, meprobamates, ...
Dosage and administration
Dosing Considerations The treatment is initiated by the patient at a time of day convenient to the patient. Repeat dosages should coincide with this chosen schedule. Estragyn Vaginal Cream should be prescribed ...
Overdosage
Symptoms of overdose Numerous reports of ingestion of large doses of estrogen products and estrogencontaining oral contraceptives by young children have not revealed acute serious ill effects. Over dosage ...
Action and clinical pharmacology
Mechanism of Action Estrogen drug products act by regulating the transcription of a limited number of genes. They may act directly at the cells surface via a non estrogen receptor mechanism or directly ...
Storage and stability
Store at room temperature between 15°C and 30°C. Avoid freezing as it may cause the cream to separate destroying its properties.
Dosage forms, composition and packaging
Estragyn Vaginal Cream is a vaginal cream containing 0.1% estrone. If used continuously then lower the dosage to the lowest amount that controls the symptoms. Estragyn Vaginal Cream comes only in 0.1% ...
Pharmaceutical information
Drug Substance <u>Proper name:</u> Estrone <u>Chemical name:</u> Estra-1,3,5(10)-trien-17-one,3-hydroxy-3-hydroxyestra-1,3,5(10)-trien-17-one [53-16-7] <u>Molecular formula:</u> C<sub>18</sub>H<sub>22 ...
Detailed pharmacology
See Actions and Clinical Pharmacology section under Part I.
Toxicology
Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
Marketing authorization holder
Searchlight Pharma Inc., 1600 Notre Dame St. West., Suite 312, Montréal, Québec, H3J 1M1
Submission control number
195579
Date of revision
August 17, 2016
References
1. Writing Group for the Womens Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the Womens Health Initiative randomized ...
Serious warnings and precautions box
The Womens Health Initiative (WHI) trial examined the health benefits and risks of oral combined estrogen plus progestin therapy (n=16,608) and oral estrogen–alone therapy (n=10,739) in postmenopausal ...
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