Oestrogel

Oestrogel

estradiol

Manufacturer:

Besins Healthcare

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
17β-estradiol
Indications/Uses
HRT for oestrogen deficiency linked to menopause. Prevention of post-menopausal osteoporosis in women w/ increased risk of fracture & w/ intolerance or contraindication to other treatments for osteoporosis prevention.
Dosage/Direction for Use
Apply 2.5 g daily in the morning or evening, during 24-28 days per mth, over a large surface of clean skin.
Contraindications
Hypersensitivity. History of or current venous or arterial thromboembolic diseases (phlebitis, pulmonary embolism, angina pectoris, MI, cerebral vascular incidents). Breast, uterine or any other oestrogen-dependent cancer. Endometrial hyperplasia. Undiagnosed vag bleeding. Certain liver illnesses. Porphyria.
Special Precautions
Perform medical exam before & periodically during treatment. Irregular bleeding may occur in case of missed dose for several days in a row. Risk of w/drawal symptoms. Wash hands after application. Allow gel to dry for about 2 min before putting on clothing. Do not apply to breasts or mucous membranes. Perform regular breast exam, especially in patients w/ family history of breast cancer or w/ breast cysts or lumps. Increased risk of developing thromboembolic disease, breast or uterine cancer, & CV incident or cerebral vascular problem. Add progestagen treatment during at least 12 days in the cycle in women w/ intact uterus. Caution in case of allergic reactions; jaundice of eyes & skin; significant increase in arterial tension & BP; unusual leg pain, limb weakness; chest pain, irregular pulse, sudden breathlessness; loss of consciousness, confusion, unusually severe headache, vertigo, visual problem, slowness or loss of speech; breast lumps. Caution in patients w/ HTN, diabetes, endometriosis, uterine fibroma, hepatic or biliary problems, epilepsy, migraine or severe headache, renal or cardiac insufficiency, asthma, lupus, otospongiosis; bed-ridden or surgical patients. Do not take during pregnancy or breast-feeding. Limited experience in women >65 yr.
Adverse Reactions
Breast tension, genital bleeding, abdominal pain & swelling, nausea, headache, painful period, vag discharge.
Drug Interactions
Potential interaction w/ carbamazepine, oxcarbazepine, phenobarb, phenytoin, rifabutin, rifampicin, ritonavir, nelfinavir, nevirapine, efavirenz, or St. John's wort.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Presentation/Packing
Form
Oestrogel gel 0.06%
Packing/Price
80 g x 1's
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