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Concise Prescribing Info
Manufacturer
Distributor
Contents
Estradiol
Indications / Uses
Hormone replacement therapy in postmenopausal women w/ at least 6 mth since last menstruation or surgical menopause, w/ or w/o uterus.
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Dosage / Direction for Use
Initially 1 spray once daily to dry & healthy skin of inner forearm, may be increased to 2 sprays depending on clinical response. Max daily dose: 3 sprays.
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Overdosage
View Lenzetto overdosage for action to be taken in the event of an overdose.
Contraindications
Hypersensitivity. Known, past or suspected breast & endometrial cancer; undiagnosed genital bleeding; untreated endometrial hyperplasia. Previous or current venous thromboembolism; known thrombophilic disorders; active or recent arterial thromboembolic disease. Porphyria. History of or acute liver disease.
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Special Precautions
Not to be used as contraceptive. Discontinue use if jaundice/hepatic function deterioration, significant increased BP, new onset of migraine-type headache occurs; if visual exam reveals papilledema or retinal vascular lesions. History of endometrial hyperplasia & carcinoma; risk factors for thromboembolic disorders & estrogen-dependent tumours. Uterine fibroids or endometriosis, HTN, DM w/ or w/o vascular involvement, cholelithiasis, migraine, SLE, epilepsy, asthma, otosclerosis; cardiac dysfunction; preexisting hypertriglyceridemia. Avoid using sunscreen & under extreme temp conditions eg, sauna or sunbathing. Hepatic disorders. Renal dysfunction. Not to be used in pregnancy & lactation. Childn. Women >65 yr.
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Side Effects / Adverse Reactions
Headache; abdominal pain, nausea; rash, pruritus; breast pain & tenderness, uterine/vag bleeding, metrorrhagia; increased/decreased wt.
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Interactions
Increased metabolism w/ CYP450 inducers eg, anticonvulsants (eg, phenobarb, phenytoin, carbamazepine), anti-infectives (eg, rifampicin, rifabutin; nevirapine, efavirenz, ritonavir, nelfinavir). Induced metabolism w/ St. John's wort-containing herbal prep.
X
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Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Storage
View Lenzetto storage conditions for details to ensure optimal shelf-life.
Description
View Lenzetto description for details of the chemical structure and excipients (inactive components).
Mechanism of Action
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ATC Classification
G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Presentation / Packing
FormPacking/Price
Lenzetto transdermal spray
56 spray x 1's



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