Gyraxen 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 Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Tamoxifen citrate

Indications/Uses

Treatment of advanced breast cancer in postmenopausal women.

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Dosage/Direction for Use

1-2 tab bid (morning & evening).

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Overdosage

View Gyraxen overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Pre-menopausal patients must undergo a careful exam to exclude any possibility of pregnancy before treatment. Pregnancy.

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Special Precautions

Suppressed menstruation in pre-menopausal patients. Reversible cystic ovarian swelling. Discontinue treatment if hypercalcemia occurs. Monitor patients taking coumarin-type anticoagulants. Increased incidence of endometrial changes including hyperplasia, polyps, cancer & uterine sarcoma (mostly malignant mixed Mullerian tumours). Patient receiving or having previously received Tamoxifen who report abnormal gynaecological symptoms, especially vag bleeding, or who presents w/ menstrual irregularities, vag discharge & symptoms eg, pelvic pain or pressure. Patients at risk of thromboembolism. Stop treatment 6 wk before surgery or long-term immobility. Avoid concomitant use w/ CYP2D6 inhibitors. Lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hot flushes, vag bleeding, pruritus vulvae; GI upset, tumour pain, light headedness, dizziness, rashes, fluid retention; transient falls in platelet count; endometrial hyperplasia, polyps & carcinomas; visual disturbances, corneal changes, cataracts, retinopathy.

Drug Interactions

Increased effect of coumarin-type anticoagulants. Increased risk of thromboembolic events w/ cytotoxic agents. Reduced efficacy w/ SSRI antidepressants, CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, cinacalcet, bupropion). Rifampicin.

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Storage

View Gyraxen storage conditions for details to ensure optimal shelf-life.

Description

View Gyraxen description for details of the chemical structure and excipients (inactive components).

Action

View Gyraxen mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Cancer Hormone Therapy

ATC Classification

L02BA01 - tamoxifen ; Belongs to the class of anti-estrogens. Used in treatment of neoplastic diseases.

Regulatory Classification

Presentation/Packing

Form

Gyraxen film-coated tab 20 mg

Packing/Price

100's

Gyraxen

tamoxifen

Manufacturer:

Korea United Pharma

Distributor:

Qualimed