Arodex Tablet
Anastrozole
1mg
Techno Drugs Ltd.
| Pack size | 30's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 50.00 AED |
Indications
Arodex Tablet is used for:
Breast cancer, Ovulation induction
Adult Dose
Oral
Breast Cancer
Adjuvant treatment
Indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
1 mg PO once daily x 5 years
First-line treatment
Indicated for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
1 mg PO once daily; continue until tumor progression
Second-line treatment
Indicated for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy
Note: Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole
1 mg PO once daily; continue until tumor progression
Child Dose
Renal Dose
Renal Impairment
Since only about 10% of anastrozole is excreted unchanged in the urine, the renal impairment does not influence the total body clearance. Dosage adjustment in patients with renal impairment is not necessary.
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity
May cause fetal harm or loss; use is contraindicated in women who are or may become pregnant
Precautions
Increased incidence of ischemic cardiovascular events in women with preexisting ischemic heart disease; use only if benefits greatly outweigh risks
Decreases lumbar spine and total hip bone mineral density; increased risk of fractures and osteoporosis; concurrent use with bisphosphonates may be useful in patients at risk for fractures; follow available guidelines for bone mineral density management in postmenopausal women; patients with preexisting osteopenia are at higher risk for developing osteoporosis
Elevated serum cholesterol reported; monitor closely; use with caution in patients with hyperlipidemias; monitor and manage cholesterol levels with current guidelines for patients with LDL elevations
Affords no clinical benefit to premenopausal women with breast cancer
Increased risk of ischemic cardiovascular events in patients with pre-existing ischemic cardiac disease
Monitoring Parameters
Consider bone mineral density monitoring.
Consider cholesterol monitoring.
Pregnancy-Lactation
Pregnancy
Based on findings from animal studies and mechanism of action, therapy may cause fetal harm when administered to pregnant woman; there are no studies on use in pregnant women
Advise pregnant women and females of reproductive potential of potential risk to a fetus
Verify pregnancy status of females of reproductive potential prior to initiation of therapy
Based on animal studies, therapy can cause fetal harm when administered to a pregnant woman
Advise females of reproductive potential to use effective contraception during treatment and for at least 3 weeks after last dose
Based on studies in female animals, treatment may impair fertility in females of reproductive potential
Animal data
Anastrozole caused embryo-fetal toxicities in rats at maternal exposure that were 9 times the human clinical exposure, based on area under the curve (AUC); in rabbits, anastrozole caused pregnancy failure at doses equal to or greater than 16 times the recommended human dose on a mg/m2 basis
Lactation
There are no data on presence of drug or metabolites in human milk, or effects on breast-fed child or on milk production; because many drugs are excreted in human milk and because of tumorigenicity shown for anastrozole in animal studies, or potential for serious adverse reactions in breast-fed child from treatment, advise lactating women not to breastfeed during treatment and for 2 weeks after last dose
Interactions
Tamoxifen: Do not use it in combination with Anastrozole.
No additional benefit was seen over tamoxifen monotherapy.
Estrogen-containing products: Combination use may diminish the activity of Anastrozole.
Contraindicated (0)
Serious - Use Alternative (10)
bazedoxifene/conjugated estrogens
conjugated estrogens
estradiol
estrogens conjugated synthetic
estrogens esterified
estropipate
ethinylestradiol
etrasimod
palifermin
tamoxifen
Adverse Effects
Side effects of Anastrozole :
>10%
Hot flashes (12-36%),Vasodilation (25-36%),Fatigue (19%),Mood disturbances (19%),Nausea and vomiting (19%),Weakness (16-19%),Arthritis (17%),Pain (17%),Arthralgia (2-15%),Pharyngitis (14%),Depression (13%),Hypertension (2-13%),Bone pain (11%),Increased cough (11%),Osteoporosis (11%),Rash (8-11%)
1-10%
Accidental injury (10%),Back pain (10%),Fracture (10%),Headache (10%),Insomnia (10%),Peripheral edema (10%),Dyspnea (8-10%),Abdominal pain (9%),Infection (9%),Lymphedema (9%),Diarrhea (8-9%),Constipation (7-9%),Breast pain (8%),Dizziness (8%),Urinary tract infection (8%),Chest pain (7%),Dyspepsia (7%),Paresthesia (5-7%),Anxiety (6%),Cataracts (6%),Flu syndrome (6%),Sinusitis (6%),Vulvovaginitis (6%),Xerostomia (6%),Breast neoplasm (5%),Bronchitis (5%),Cyst (5%),Diaphoresis (5%),Neoplasm (5%),Vaginal bleeding (5%),Fractures of spine, hip, or wrist (4%),Ischemic cardiovascular disease (4%),Vaginal hemorrhage (4%),Vaginitis (4%),Leukorrhea (3-4%),Deep vein thrombosis (2%),Endometrial cancer (intact uterus at baseline) (2%),Ischemic cerebrovascular event (2%),Weight gain (2%),Lethargy (1%)
Mechanism of Action
Anastrozole prevents conversion of androstenedione to estrone and testosterone to oestradiol by inhibiting aromatase, thus leading to significantly reduced serum oestradiol concentrations.
Note
Arodex 1mg Tablet manufactured by Techno Drugs Ltd.. Its generic name is Anastrozole. Arodex is availble in Bangladesh.
Farmaco BD drug index information on Arodex Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.