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Raloxifene hydrochloride
Overview
What is Evista?
EVISTA (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[]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula CHNOS•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.
EVISTA is supplied in a tablet dosage form for oral administration. Each EVISTA tablet contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include anhydrous lactose, carnauba wax, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.
What does Evista look like?
What are the available doses of Evista?
Tablets (not scored): 60 mg
What should I talk to my health care provider before I take Evista?
How should I use Evista?
EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women
.
The recommended dosage is one 60 mg EVISTA (raloxifene hydrochloride tablets) tablet daily, which may be administered any time of day without regard to meals .
For the indications in risk of invasive breast cancer the optimum duration of treatment is not known
.
What interacts with Evista?
Sorry No Records found
What are the warnings of Evista?
Sorry No Records found
What are the precautions of Evista?
Sorry No Records found
What are the side effects of Evista?
Sorry No records found
What should I look out for while using Evista?
Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Pregnancy, women who may become pregnant, and nursing mothers.
What might happen if I take too much Evista?
In an 8-week study of 63 postmenopausal women, a dose of raloxifene hydrochloride (HCl) 600 mg/day was safely tolerated. In clinical trials, no raloxifene overdose has been reported.
In postmarketing spontaneous reports, raloxifene overdose has been reported very rarely (less than 1 out of 10,000 [<0.01%] patients treated). The highest overdose has been approximately 1.5 grams. No fatalities associated with raloxifene overdose have been reported. Adverse reactions were reported in approximately half of the adults who took ≥180 mg raloxifene HCl and included leg cramps and dizziness.
Two 18-month-old children each ingested raloxifene HCl 180 mg. In these two children, symptoms reported included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, as well as elevation in alkaline phosphatase.
There is no specific antidote for raloxifene.
No mortality was seen after a single oral dose in rats or mice at 5000 mg/kg (810 times the human dose for rats and 405 times the human dose for mice based on surface area, mg/m) or in monkeys at 1000 mg/kg (80 times the AUC in humans).
How should I store and handle Evista?
Store at controlled room temperature, 20º to 25ºC (68º to 77ºF) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20º to 25ºC (68º to 77ºF); that results in a mean kinetic temperature calculated to be not more than 25ºC; and that allows for excursions between 15º and 30ºC (59º and 86ºF) that are experienced in pharmacies, hospitals, and warehouses.Haloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJWHaloperidol Tablets, USP are available containing 5 mg of haloperidol.The 5 mg tablets are orange, round tablets debossed with over on one side of the tablet and scored on the other side. They are available as follows:NDC 67046-268-30blister of 30 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED SEPTEMBER 2008HALO:R17Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--07/2010--NJW
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Raloxifene is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM). The biological actions of raloxifene are largely mediated through binding to estrogen receptors. This binding results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism). The agonistic or antagonistic action of raloxifene depends on the extent of recruitment of coactivators and corepressors to estrogen receptor (ER) target gene promotors.
Raloxifene appears to act as an estrogen agonist in bone. It decreases bone resorption and bone turnover, increases bone mineral density (BMD) and decreases fracture incidence. Preclinical data demonstrate that raloxifene is an estrogen antagonist in uterine and breast tissues. These results are consistent with findings in clinical trials, which suggest that EVISTA lacks estrogen-like effects on the uterus and breast tissue.
Non-Clinical Toxicology
Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.Pregnancy, women who may become pregnant, and nursing mothers.
As adapalene gel has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene gel. If these preparations have been used, it is advisable not to start therapy with adapalene gel until the effects of such preparations in the skin have subsided.
In clinical trials, EVISTA-treated women had an increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism). Other venous thromboembolic events also could occur. A less serious event, superficial thrombophlebitis, also has been reported more frequently with EVISTA than with placebo. The greatest risk for deep vein thrombosis and pulmonary embolism occurs during the first 4 months of treatment, and the magnitude of risk appears to be similar to the reported risk associated with use of hormone therapy. Because immobilization increases the risk for venous thromboembolic events independent of therapy, EVISTA should be discontinued at least 72 hours prior to and during prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest), and EVISTA therapy should be resumed only after the patient is fully ambulatory. In addition, women taking EVISTA should be advised to move about periodically during prolonged travel. The risk-benefit balance should be considered in women at risk of thromboembolic disease for other reasons, such as congestive heart failure, superficial thrombophlebitis, and active malignancy .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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