Orion Pharma


Concise Prescribing Info
Climacteric syndrome associated w/ natural or artificial menopause.
Dosage/Direction for Use
Usual starting dose: Apply 1 mg daily, readjusted after 2-3 cycles from 0.5-1.5 g daily for continuous or cyclical treatment. Patient w/ intact uterus Combine w/ adequate dose of progestin for adequate duration.
Hypersensitivity. Undiagnosed vag bleeding; confirmed active VTE w/in last 2 yr; history of recurrent VTE or known thrombophillic disease in patients not on anticoagulant treatment; known or suspected breast &/or endometrial cancer sex steroid-influenced malignant conditions. Severe hepatic disease including Dubin-Johnson & Rotor's syndrome.
Special Precautions
Discontinue use if VTE develops. Not to be applied on breasts, face or irritated skin. Treat atypical adenomatous endometrial hyperplasia prior to initiation. Clarify unexpected or prolonged uterine bleeding cause & prodromal vascular occlusion symptoms. Endometriosis; uterine leiomyoma; endometrial hyperplasia, simple glandular hyperplasia or hyperplasia glandularis cystica; CV system diseases eg, cerebrovascular disorders; history of or close family history of thromboembolic disease, breast & ovarian cancer; mild or severe HTN; severe lipid metabolism disturbances & obesity; SLE; porphyria; prolonged immobilisation, major trauma or surgery; migraine or severe headache; benign breast disease; cholestasis; cholelithiasis; DM; asthma; otosclerosis, multiple sclerosis; galactorrhea, elevated prolactin levels; history of herpes gestationis; epilepsy. Perform complete gynecological exam prior to & at least yrly during therapy. Avoid contact w/ eyes. Prolonged use. Concomitant use w/ hormone-replacement therapy. Renal dysfunction. Hepatic function disturbances. Not to be used in women of childbearing potential, during pregnancy & lactation.
Adverse Reactions
Breast tenderness. Headache; oedema, increased wt; unscheduled vag bleeding or spotting; nausea, vomiting, stomach cramps; skin irritation.
Drug Interactions
Reduced effects of antihypertensives, anticoagulants, antidiabetics. Reduced plasma levels w/ potent hepatic enzymes inducers eg, barbiturates, carbamazepine, griseofulvin, rifampicin.
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.
Divigel topical gel 1 mg/g
(single-dose) 28 × 1's
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