Oestrogel

Oestrogel

estradiol

Manufacturer:

Besins Healthcare

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
17 β-estradiol
Indications/Uses
HRT for estrogen deficiency symptoms in postmenopausal or ovariectomized women. Vasomotor (hot flashes, night sweats), genitourinary trophic (vulvovag atrophy, dyspareunia, urinary incontinence), & psychological (sleep disorders, asthenia) disorders. Prevention of osteoporosis in postmenopausal women at high risk of fracture who are intolerant of, or contraindicated to, drugs approved for osteoporosis prevention.
Dosage/Direction for Use
Postmenopausal symptoms Min effective dose: 1.25 g daily (equiv to 0.75 mg of estradiol) for 21-28 days/mth. Ave dose: 2.5 g daily. Prevention of osteoporosis Min effective dose: 2.5 g once daily.
Contraindications
Hypersensitivity. Known or suspected breast cancer; estrogen-dependent malignancies (eg, endometrial cancer). History of breast cancer. Vag bleeding of unknown etiology. Untreated endometrial hyperplasia. Previous or ongoing idiopathic VTE (DVT, pulmonary embolism). Known thrombophilic abnormalities (eg, protein C, protein S or antithrombin deficiency). Recent or ongoing arterial thromboembolic disease (eg, angina, MI). Porphyria. Acute liver disease or history of liver disease, as long as LFTs remain abnormal. Porphyria. Known or suspected pregnancy.
Special Precautions
Discontinue use if breast tension, abdomen swelling, anxiety, irritability occurs. Not to be applied over breast or mucous membranes. Overwt, severe diabetes, high BP, endometriosis, kidney failure or hepatic disorders, epilepsy, asthma, lupus, pituitary tumour, porphyria, otospongiosis. History of CVA (haemorrhage or blood clot); family medical history of breast cancer. Bedridden patient. Scheduled surgery. Periodic medical exam for breast nodule or cyst prior to, or during treatment. Kidney failure or hepatic disorders. Itching during previous pregnancy. Pregnancy & lactation.
Adverse Reactions
Headache, dizziness, nausea, abdominal pain, breast swelling/pain, alopecia, pruritus, wt change, water retention w/ peripheral oedema, vaginitis, dysmenorrhea, menorrhagia, endometrial hyperplasia, anaphylactic reaction.
Drug Interactions
Avoid concomitant use w/ skin medications that alter skin barrier or function (eg, Na lauryl sulphate, benzalkonium or benzethonium Cl, astringents, sunscreens, salicylic acid, lactic acid). Increased metabolism w/ substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes eg, anticonvulsants (eg, phenobarb, phenytoin, carbamazepine) & anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz). Concomitant use w/ ritonavir, nelfinavir. Induced metabolism w/ herbal medicine prep containing St. John's wort (Hypericum perforatum).
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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