Lenzetto Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

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

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Contraindications

Hypersensitivity. Known, past or suspected breast & endometrial cancer; undiagnosed genital bleeding; untreated endometrial hyperplasia. Previous or current VTE; 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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Use In Pregnancy & Lactation

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Adverse Reactions

Headache; abdominal pain, nausea; rash, pruritus; breast pain & tenderness, uterine/vag bleeding, metrorrhagia; increased/decreased wt.

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Drug 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.

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Storage

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Description

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Action

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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.

Regulatory Classification

Presentation/Packing

Form

Lenzetto transdermal spray

Packing/Price

56 spray x 1's

Lenzetto

estradiol

Manufacturer:

Gedeon Richter

Distributor:

Pahang Pharmacy