Cal Dex Cmpk
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Questions & Answers
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Uses
Raloxifene Hydrochloride Tablets USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)].
Raloxifene is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3)].
Raloxifene is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see Clinical Studies (14.4)].
The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see ClinicalStudies (14.4)]. Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known.
High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥1.66% (based on the modified Gail model). Among the factors included in the modified Gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. Healthcare professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-545-5979. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.
After an assessment of the risk of developing breast cancer, the decision regarding therapy with raloxifene should be based upon an individual assessment of the benefits and risks.
Raloxifene does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting raloxifene and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene.
Important Limitations of Use for Breast Cancer Risk Reduction
- There are no data available regarding the effect of raloxifene on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of raloxifene.
- Raloxifene is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.
- Raloxifene is not indicated for the reduction in the risk of noninvasive breast cancer.
History
There is currently no drug history available for this drug.
Other Information
Raloxifene Hydrochloride is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:
The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C28H27NO4S•HCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl is an off-white to pale-yellow solid that is very slightly soluble in water.
Raloxifene hydrochloride is supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include pregelatinized starch, lactose monohydrate, citric acid monohydrate, colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, polysorbate 80, hydroxypropyl methyl cellulose, titanium dioxide, and polyethylene glycol.
Sources
Cal Dex Cmpk Manufacturers
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Aspen Veterinary
![Cal Dex Cmpk Injection, Solution [Aspen Veterinary]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cal Dex Cmpk | Actavis Pharma, Inc.
2.1 Recommended DosingThe recommended dosage is one 60 mg raloxifene hydrochloride tablet daily, which may be administered any time of day without regard to meals [see Clinical Pharmacology (12.3)].
For the indications in risk of invasive breast cancer the optimum duration of treatment is not known [see Clinical Studies (14.3, 14.4)].
2.2 Recommendations for Calcium and Vitamin D SupplementationFor either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Total daily intake of calcium above 1500 mg has not demonstrated additional bone benefits while daily intake above 2000 mg has been associated with increased risk of adverse effects, including hypercalcemia and kidney stones. The recommended intake of vitamin D is 400 to 800 IU daily. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) may need additional vitamin D supplements. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
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