Celvista

Celvista

raloxifene

Manufacturer:

Alvogen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Raloxifene HCl
Indications/Uses
Treatment & prevention of osteoporosis in postmenopausal women. Reduction in risk of invasive breast cancer in postmenopausal women w/ osteoporosis or at high risk of breast cancer.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active or past history of venous thromboembolic events, including DVT, pulmonary embolism & retinal vein thrombosis. Hepatic impairment including cholestasis. Severe renal impairment. Unexplained uterine bleeding. Women w/ childbearing potential. Patients w/ endometrial or breast cancer.
Special Precautions
Postmenopausal women w/ history of stroke or other significant risk factors eg, transient ischemic attack or atrial fibrillation. History of oral estrogen-induced hypertriglyceridemia. Discontinue use in case of illness or 3 days prior immobilisation occurs. Breast cancer. Closely monitor serum total bilirubin, γ-glutamyl transferase, alkaline phosphatase, ALT & AST. Monitor serum triglycerides during therapy. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ systemic estrogen. Mild & moderate renal impairment. Not to be used in hepatic & severe renal impairment. Pregnancy. Not recommended during lactation. May affect the development of the baby. Childn.
Adverse Reactions
Vasodilation (hot flushes); GI symptoms eg, nausea, vomiting, abdominal pain, dyspepsia; flu syndrome; increased BP. Headache including migraine; rash; leg cramps; mild breast pain, enlargement & tenderness; peripheral oedema.
Drug Interactions
Reduced absorption & enterohepatic cycling w/ cholestyramine or other anion exchange resins. Reduced peak conc w/ ampicillin. Increased hormone-binding conc of globulin including sex steroid-binding globulins, thyroxine binding globulin & corticosteroid-binding globulin.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
G03XC01 - raloxifene ; Belongs to the class of selective estrogen receptor modulators.
Presentation/Packing
Form
Celvista FC tab 60 mg
Packing/Price
28's
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