Raloxifene Hydrochloride (Raloxifene Hydrochloride)

Trade Name : Raloxifene Hydrochloride

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 60 mg/1

RALOXIFENE HYDROCHLORIDE Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Raloxifene Hydrochloride (Raloxifene Hydrochloride) which is also known as Raloxifene Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 60 mg/1 per ml. Read more

Raloxifene Hydrochloride (Raloxifene Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Contraindications, Pregnancy (4.2)u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 06/2018n
  • Warnings and Precautions, Premenopausal Use (5.4) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a006/2018
  • WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE
  • See full prescribing information for complete boxed warning
  • Raloxifene hydrochloride tablets are an estrogen agonist/antagonist indicated for:
  • Important Limitations: Raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. ()
  • Treatment and prevention of osteoporosis in postmenopausal women. ()
  • Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. ()
  • Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. ()
  • 60 mg tablet orally once daily. ()
  • 60 mg, white to off-white, capsule-shaped, film-coated tablets (not scored), debossed with u201c7290u201d on one side of the tablet, and u201c93u201d on the other.
  • Tablets (not scored): 60 mg ()
  • No data
  • Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. ()
  • Pregnancy. (, )
  • No data
  • Venous Thromboembolism
  • Death Due to Stroke
  • Cardiovascular Disease
  • Premenopausal Women
  • Hepatic Impairment
  • Concomitant Use with Systemic Estrogens
  • Hypertriglyceridemia
  • Adverse reactions (> 2% and more common than with placebo) include: hot flashes, leg cramps, peripheral edema, flu syndrome, arthralgia, sweating. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Cholestyramine
  • Warfarin
  • Highly Protein-Bound Drugs
  • No data
  • Pediatric Use:
  • 8.4
  • 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 u2265 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).
  • Raloxifene hydrochloride, USP 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:
  • CHNOSu2022HCl M.W. 510.05
  • The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water.
  • Raloxifene hydrochloride, USP is supplied in a tablet dosage form for oral administration. Each Raloxifene Hydrochloride Tablet USP contains 60 mg of raloxifene HCl, USP which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide.
  • USP Dissolution Test Pending
  • No data
  • No data
  • No data
  • No data
  • See FDA-approved Medication Guide.
  • Physicians should instruct their patients to read the Medication Guide before starting therapy with raloxifene hydrochloride and to reread it each time the prescription is renewed.
  • Raloxifene Hydrochloride (ral-OX-i-FEEN HYE-droe-KLOR-ide) Tablets USP for Oral Use
  • Read the Medication Guide that comes with raloxifene hydrochloride tablets before you start taking them and each time you refill your prescription. The information may have changed. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk with your doctor about raloxifene hydrochloride tablets when you start taking them and at regular checkups.
  • What is the most important information I should know about raloxifene hydrochloride tablets?
  • Serious and life-threatening side effects can occur while taking raloxifene hydrochloride tablets. These include blood clots and dying from stroke:
  • What are raloxifene hydrochloride tablets?
  • Raloxifene hydrochloride tablets are a type of prescription medicine called a Selective Estrogen Receptor Modulator (SERM). Raloxifene hydrochloride tablets are for women after menopause, and have more than one use:
  • Raloxifene hydrochloride tablets are not for use in premenopausal women (women who have not passed menopause).
  • Who should not take raloxifene hydrochloride tablets?
  • Do not take raloxifene hydrochloride tablets if you:
  • What should I tell my doctor before taking raloxifene hydrochloride tablets?
  • Raloxifene hydrochloride tablets may not be right for you. Before taking raloxifene hydrochloride tablets, tell your doctor about all your medical conditions, including if you:
  • Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine. Especially tell your doctor if you take:
  • Raloxifene hydrochloride tablets should not be taken with cholestyramine or estrogens.
  • How should I take raloxifene hydrochloride tablets?
  • What should I avoid while taking raloxifene hydrochloride tablets?
  • What are the possible side effects of raloxifene hydrochloride tablets?
  • Serious and life-threatening side effects can occur while taking raloxifene hydrochloride tablets. These include blood clots and dying from stroke:
  • See u201cu201d
  • The most common side effects of raloxifene hydrochloride tablets are hot flashes, leg cramps, swelling of the feet, ankles, and legs, flu syndrome, joint pain, and sweating. Hot flashes are more common during the first 6 months after starting treatment.
  • These are not all the side effects of raloxifene hydrochloride tablets. Tell your doctor about any side effect that bothers you or that does not go away. If you have any problems or questions that concern you while taking raloxifene hydrochloride tablets, ask your doctor or pharmacist for more information.
  • What else should I know about raloxifene hydrochloride tablets?
  • How should I store raloxifene hydrochloride tablets?
  • General Information about the safe and effective use of raloxifene hydrochloride tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use raloxifene hydrochloride tablets for a condition for which they were not prescribed. Do not give your raloxifene hydrochloride tablets to other people, even if they have the same symptoms you have. They may harm them.
  • This Medication Guide is a summary of the most important information about raloxifene hydrochloride tablets. If you would like more information about raloxifene hydrochloride tablets, talk with your doctor. You can ask your doctor or pharmacist for information about raloxifene hydrochloride tablets that is written for health professionals. For more information, call 1-888-838-2872.
  • What are the ingredients in raloxifene hydrochloride tablets USP?
  • Active Ingredient:
  • Inactive Ingredients:
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured In Croatia By:
  • PLIVA HRVATSKA d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. E 3/2016
  • No data

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