MIDEX
(Instructions for medical use of therapeutic agents)
Registration number Mfg: HP/DRUGS/WL8100-93/15CKS.
Active substance: Anastrozole.
Packaging: Blister pack of tablets.
Dosage: 1 mg/tab of Anastrozole.
Category drugs: nonsteroidal aromatase inhibitors.
Pharmachologic effect: Anastrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.
Anastrozole is used to treat breast cancer in postmenopausal women.
Contraindications: You should not use anastrozole if you are allergic to it, or if you have not yet completed menopause.
Anastrozole is not approved for use in men or children.
You should not take anastrozole if you also take tamoxifen.
Side effects:
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Anastrozole may decrease blood flow to your heart, especially if you have ever had coronary artery disease (clogged arteries). Seek medical attention if you have new or worsening chest pain, or if you feel short of breath.
Anastrozole may cause serious side effects. Call your doctor at once if you have:
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shortness of breath (even with mild exertion), swelling, rapid weight gain;
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numbness, prickly feeling, pain, or weakness in your hands or wrists;
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symptoms of bone fracture--bruising, swelling, tenderness, pain that worsens with movement;
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liver problems--right-sided upper stomach pain, yellowing of your skin or eyes, and not feeling well; or
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signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.
Common side effects of anastrozole may include:
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numbness, tingling, or tickling feeling in your skin;
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hot flashes;
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weakness;
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joint pain or stiffness;
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bone pain, risk of fracture;
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swelling in your arms, legs, or feet;
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sore throat, cough, shortness of breath;
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headache, back pain;
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depression, sleep problems (insomnia);
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high blood pressure;
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nausea, vomiting; or
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rash.
Interaction: Avoid driving or hazardous activity until you know how anastrozole will affect you. Your reactions could be impaired.
Anastrozole may not work as well if you take it together with an estrogen medication (such as hormone replacement therapy, estrogen creams, or birth control pills, injections, implants, skin patches, and vaginal rings or vaginal suppositories).
Other drugs may affect anastrozole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Special instructions: Anastrozole may decrease blood flow to your heart, especially if you have ever had coronary artery disease (clogged arteries). Seek medical attention if you have new or worsening chest pain, or if you feel short of breath.
Dosage:
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Anastrozole is usually taken once per day. Follow your doctor's dosing instructions very carefully.
You may take anastrozole with or without food.
You may need to keep taking this medication for up to 5 years. Follow your doctor's instructions.
Store at room temperature away from moisture and heat.
Initial dose: 1 mg orally taken once a day
Duration of therapy: Until tumor progression (treatment of advanced breast cancer); unknown (adjuvant treatment of early breast cancer)
Uses:
-Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer;
-First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer;
-Second-line treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
AllChem Asia
(GMP Certified company)
Pharma City Road, Selakui,
Uttarakhand 248011, India