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Arostanil

Arostanil

exemestane

Manufacturer:

Intas

Distributor:

Sandoz
Concise Prescribing Info
Contents
Exemestane
Indications/Uses
Adjuvant treatment of postmenopausal women w/ oestrogen-receptor +ve invasive early breast cancer following 2-3 yr of initial adjuvant tamoxifen therapy. Advanced breast cancer in women w/ natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy.
Dosage/Direction for Use
Adult & elderly 25 mg tab once daily. Early breast cancer Continue treatment until completion of 5 yr of combined sequential adjuvant hormonal therapy (tamoxifen followed by exemestane), or earlier if tumour relapse occurs. Advanced breast cancer Continue treatment until tumour progression is evident.
Administration
Should be taken with food: Take after a meal.
Contraindications
Hypersensitivity. Pre-menopausal women. Pregnancy & lactation.
Special Precautions
Not to be administered to women w/ premenopausal endocrine status. Assess LH, FSH & oestradiol levels whenever clinically appropriate to ascertain postmenopausal status. +ve doping control test result. Reduction in bone mineral density & increased fracture rate. Assess bone mineral density at commencement of treatment in women w/ osteoporosis or at risk of osteoporosis. May impair ability to drive & use machines. Patients w/ hepatic or renal impairment. Not recommended in childn.
Adverse Reactions
Insomnia; headache; hot flushes; nausea; increased sweating; joint & musculoskeletal pain including arthralgia; fatigue. Anorexia; depression; dizziness, carpal tunnel syndrome; abdominal pain, vomiting, constipation, dyspepsia, diarrhea; rash, alopecia; osteoporosis, fracture; pain, peripheral edema.
Drug Interactions
Reduced AUC & Cmax w/ CYP3A4 inducer eg, rifampicin, anticonvulsants (eg, phenytoin & carbamazepine) & herbal prep containing Hypericum perforatum (St. John's wort). Negated pharmacological action w/ oestrogen-containing medicines. Use cautiously w/ CYP3A4 substrates w/ narrow therapeutic window.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BG06 - exemestane ; Belongs to the class of enzyme inhibitors. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Arostanil FC tab 25 mg
Packing/Price
28's;30's
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