Dracenax 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 Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Letrozole

Indications/Uses

Adjuvant treatment of postmenopausal women w/ hormone receptor +ve early breast cancer. Extended adjuvant treatment of hormone-dependent early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 yr. 1st-line treatment in postmenopausal women w/ hormone-dependent advanced breast cancer. Advanced breast cancer in women w/ natural or artificially induced postmenopausal status after relapse or disease progression, who have previously been treated w/ antiestrogens.

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Dosage/Direction for Use

Adult & elderly 2.5 mg once daily. Adjuvant setting Recommended to treat for 5 yr or until tumour relapse occurs. Extended adjuvant setting Median duration of treatment: 4 yr. Advanced or metastatic disease Treatment should continue until tumour progression is evident.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Premenopausal endocrine status. Pregnancy & lactation.

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Special Precautions

Reports of osteoporosis &/or bone fractures. Monitor overall bone health during treatment. Only women of confirmed postmenopausal endocrine status should receive letrozole. Avoid co-administration w/ tamoxifen, other anti-estrogens or estrogen-containing therapies. May affect ability to drive or operate machinery. Consider potential risk/benefit in patients w/ CrCl <10 mL/min before administration. Closely supervise treatment in patients w/ severe hepatic impairment (Child-Pugh C).

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypercholesterolemia; hot flush; hyperhidrosis; arthralgia; fatigue including asthenia, malaise. Decreased/increased appetite; depression; headache, dizziness, vertigo; palpitations; HTN; nausea, vomiting, dyspepsia, constipation, diarrhoea, abdominal pain; alopecia, dry skin, rash (including erythematous, maculopapular, psoriaform, & vesicular rash); myalgia, bone pain, osteoporosis, bone fractures, arthritis, back pain; vag haemorrhage; peripheral oedema, chest pain; increased wt; fall.

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Drug Interactions

Diminished pharmacological action w/ tamoxifen, other anti-estrogens or estrogen-containing therapies. Increased serum conc w/ CYP3A4 (eg, ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, & telithromycin) & CYP2A6 (eg, methoxsalen) inhibitors. Decreased serum conc w/ CYP3A4 inducers (eg, phenytoin, rifampicin, carbamazepine, phenobarb, & St. John's wort). Reduced plasma levels w/ tamoxifen. Possible alteration in serum conc of medicinal products whose elimination is mainly dependent on CYP2C19 & w/ narrow therapeutic index (eg, phenytoin, clopidogrel).

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Dracenax detailed prescribing information

Storage

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

Description

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

Action

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MIMS Class

Cancer Hormone Therapy

ATC Classification

L02BG04 - letrozole ; Belongs to the class of enzyme inhibitors. Used in treatment of neoplastic diseases.

Regulatory Classification

Presentation/Packing

Form

Dracenax film-coated tab 2.5 mg

Packing/Price

30's (P7,200/box)

Dracenax

letrozole

Manufacturer:

Sandoz

Distributor:

Zuellig