Clinical Pharmacology Details


Raloxifene Hcl


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Indications & Dose:

Prevention of non-traumatic vertebral fractures in postmenopausal women of increased risk of osteoporosis.


DOSE


One 60mg tablet daily by oral administration, which may be taken at any time of the day without regard to meals. Calcium supplements are advised in women with a law dietary calcium uptake. 

Contraindications:

History of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. Hypersensitivity to raloxifene or other ingredients in the tablet. Hepatic impairment including cholestrosis. Several general impairment. Unexplained uterine bleeding. 

Side Effects:

Cautions:

Precautions:

Pregnancy and lactation: Risk of venous thrombo-embolic events of any aetiology. Event of an illness or a condition leading to a prolonged period of immobilisation. 


 

Interaction:

Drugs
Cholestyramine: Decreased absorption and enterohepatic cycling of raloxifene


Clofibrate, indomethacin, naproxen, ibuprofen,


diazepam, diazoxide: Possible displacement of these highly protein-bound drugs


Warfarin: Decreased PT 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Depression, insomnia


EENT: Sinusitis


GI: Nausea (8% incidence same as placebo), dyspepsia, vomiting.


GU: Vaginitis, leukorrhea


HEME: Thromboembolism


METAB: Weight gain, peripheral edema, decreased total cholesterol (6%), decreased LDL-C (11%), no effect on HDL-C or triglycerides


MS: Leg cramps (6%)


SKIN: Hot flashes (25%, vs 18% with placebo)

Patient And Carer Advice: