OESCLIM Transdermal patch (2017)
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Περιεχόμενα
Name of the medicinal product
OESCLIM Estradiol-17β transdermal system.
Summary product information
Route of Administration Dosage Form/Strength Clinically Relevant Nonmedicinal Ingredients Transdermal Transdermal patch 25, 37.5, 50, 75, 100mcg/24 hrs For a complete listing see Dosage Forms, Composition ...
Indications and clinical use
OESCLIM (Estradiol-17β) is indicated for the relief of menopausal and post menopausal symptoms occurring in naturally or surgically induced estrogen deficiency states. OESCLIM (Estradiol-17β) should be ...
Contraindications
Estrogen and estrogen/progestin combinations are contraindicated in patients with any of the following conditions/disorders: Hypersensitivity to this drug or to any ingredient in the formulation or component ...
Warnings and precautions
General Abnormal vaginal bleeding, due to its prolongation, irregularity or heaviness, occurring during therapy should prompt diagnostic measures like hysteroscopy, endometrial biopsy or curettage to rule ...
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, meprobamate, ...
Dosage and administration
Dosing Considerations The treatment is generally initiated with OESCLIM 25, 37.5 or 50. The initial selection of the dose of estradiol can be based on the type and severity of the patients symptomatology. ...
Overdosage
Symptoms Numerous reports of ingestion of large doses of estrogen products and estrogen-containing oral contraceptives by young children have not revealed acute serious ill effects. Overdosage with estrogen ...
Action and clinical pharmacology
Mechanism of Action OESCLIM delivers estradiol-17β, a physiologic hormone, transdermally into the systemic circulation. Consequently, the estradiol-17β does not undergo first-pass liver and intestinal ...
Storage and stability
Store at room temperature (15–25°C). Avoid freezing. Do not store unpouched. Apply immediately upon removal from the protective pouch. Keep out of the reach of children both before and after use. After ...
Dosage forms, composition and packaging
Dosage forms / Packaging <u>Description:</u> Rectangular transdermal system (11, 16.5, 22, 33 or 44 cm²), with rounded corners, consisting of a transparent adhesive layer laminated onto a beige foam backing. ...
Pharmaceutical information
Drug Substance Proper name: Estradiol hemihydrate (INN) Chemical name: (17β)-Estra-1,3,5(10)-triene-3,17-diol hemihydrate Structural formula: Molecular formula: C<sub>18</sub>H<sub>24</sub>O<sub>2</sub> ...
Detailed pharmacology
Estrogens (naturally occurring, their derivatives or synthetic estrogens) are the basis of postmenopausal Hormonal Replacement Therapy (HRT). Mashchak et al.16 compared the metabolic effects of different ...
Clinical trials
Three clinical trials have been performed in order to evaluate the efficacy and safety of OESCLIM in menopausal patients. The aim of these studies was to evaluate the local skin tolerability of OESCLIM ...
Toxicology
Excess estradiol is one of the pre-disposing factors in the development of certain tumours, principally in the uterus, mammary and pituitary glands. These effects have been studied after long-term administration ...
Marketing authorization holder
Searchlight Pharma Inc., 1600 Notre Dame St. West, Suite 312, Montréal, Québec, H3J 1M1
Submission control number
199389
Date of approval
April 28, 2015
Date of revision
February 23, 2017
References
Baulieu EE. Steroid receptors and hormone receptivity: new approaches in pharmacology and therapeutics. Ed by Inserm. In Hormones and Breast Cancer, 1975, 55, 15-28. Chetowski RJ, Meldrum DR, Steingold ...
Serious warnings and precautions box
The Womens Health Initiative (WHI) trial examined the health benefits and risks of combined estrogen plus progestin therapy (n=16,608) and estrogen-alone therapy (n=10,739) in postmenopausal women aged ...
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