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Alendronate Sodium (Fosamax)

Trade Name : FOSAMAX

Merck Sharp & Dohme Corp.

TABLET

Strength 70 mg/1

ALENDRONATE SODIUM Bisphosphonate [EPC],Diphosphonates [CS]

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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 Alendronate Sodium (Fosamax) which is also known as FOSAMAX and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 70 mg/1 per ml. Read more

Alendronate Sodium (Fosamax) 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

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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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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
  • FOSAMAX is a bisphosphonate indicated for:
  • Limitations of use:Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ()
  • Treatment and prevention of osteoporosis in postmenopausal women (,)
  • Treatment to increase bone mass in men with osteoporosis ()
  • Treatment of glucocorticoid-induced osteoporosis ()
  • Treatment of Paget's disease of bone ()
  • Although alendronate tablets 5 mg, 10 mg, 35 mg, and 40 mg are available in the marketplace, FOSAMAX is no longer marketed in the 5 mg, 10 mg, 35 mg, and 40 mg strengths.
  • Although an oral solution of alendronate may be available in the marketplace, FOSAMAX oral solution is no longer marketed.
  • Treatment of osteoporosis in postmenopausal women and in men: 10 mg daily or 70 mg (tablet or oral solution) once weekly. (,)
  • Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly. ()
  • Glucocorticoid-induced osteoporosis: 5 mg daily; or 10 mg daily in postmenopausal women not receiving estrogen. ()
  • Paget's disease: 40 mg daily for six months. ()
  • Instruct patients to: ()n
  • Tablets: 70 mg ()
  • FOSAMAX is contraindicated in patients with the following conditions:
  • Abnormalities of the esophagus which delay emptying such as stricture or achalasia (,)
  • Inability to stand/sit upright for at least 30 minutes (,,)
  • Do not administer FOSAMAX oral solution to patients at increased risk of aspiration. ()
  • Hypocalcemia (,)
  • Hypersensitivity to any component of this product (,)
  • No data
  • Upper Gastrointestinal Adverse Reactions
  • Hypocalcemia
  • Severe Bone, Joint, Muscle Pain
  • Osteonecrosis of the Jaw
  • Atypical Femur Fractures
  • Most common adverse reactions (greater than or equal to 3%) are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Calcium supplements, antacids, or oral medications containing multivalent cations interfere with absorption of alendronate. (,)
  • Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. (,)
  • No data
  • Pregnancy: Discontinue when pregnancy is recognized. ()
  • FOSAMAX is not indicated for use in pediatric patients. ()
  • FOSAMAX is not recommended in patients with renal impairment (creatinine clearance less than 35 mL/min). (,)
  • Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m) and 966 mg/kg (2898 mg/m), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m).
  • No specific information is available on the treatment of overdosage with FOSAMAX. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
  • Dialysis would not be beneficial.
  • FOSAMAX (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
  • Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.
  • The empirical formula of alendronate sodium is CHNNaOPu20223HO and its formula weight is 325.12. The structural formula is:
  • Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.
  • FOSAMAX tablets for oral administration contain 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 70 mg of free acid, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate.
  • No data
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling ().
  • Instruct patients to read the Medication Guide before starting therapy with FOSAMAX and to reread it each time the prescription is renewed.
  • Distributed by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 1995-2019 Merck Sharp & Dohme Corp., a subsidiary of All rights reserved.
  • uspi-mk0217-mf-1908r026
  • MEDICATION GUIDEFOSAMAX (FOSS-ah-max)n n Tablets
  • Read the Medication Guide that comes with FOSAMAX before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about FOSAMAX.
  • What is the most important information I should know about FOSAMAX?
  • FOSAMAX can cause serious side effects including:
  • Call your doctor right away if you have any of these side effects.
  • What is FOSAMAX?
  • FOSAMAX is a prescription medicine used to:
  • It is not known how long FOSAMAX works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if FOSAMAX is still right for you.
  • FOSAMAX is not for use in children.
  • Who should not take FOSAMAX?
  • Do not take FOSAMAX if you:
  • What should I tell my doctor before taking FOSAMAX?
  • Before you start FOSAMAX, be sure to talk to your doctor if you:
  • Especially tell your doctor if you take:
  • Tell your doctor about all the medicines you take,
  • 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.
  • How should I take FOSAMAX?
  • After swallowing FOSAMAX tablet, wait at least 30 minutes:
  • Do not lie down for at least 30 minutes after you take FOSAMAX and after you eat your first food of the day.
  • If you miss a dose of FOSAMAX, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.
  • If you take too much FOSAMAX, call your doctor. Do not try to vomit. Do not lie down.
  • What are the possible side effects of FOSAMAX?
  • FOSAMAX may cause serious side effects.
  • The most common side effects of FOSAMAX are:
  • You may get allergic reactions, such as hives or swelling of your face, lips, tongue, or throat.
  • Worsening of asthma has been reported.
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of FOSAMAX. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How do I store FOSAMAX?
  • Keep FOSAMAX and all medicines out of the reach of children.
  • General information about the safe and effective use of FOSAMAX.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FOSAMAX for a condition for which it was not prescribed. Do not give FOSAMAX to other people, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes the most important information about FOSAMAX. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about FOSAMAX that is written for health professionals. For more information, go to: www.FOSAMAX.com or call 1-800-622-4477 (toll-free).
  • What are the ingredients in FOSAMAX?
  • Tablets:
  • Active ingredient: alendronate sodium
  • Inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, magnesium stearate.
  • Distributed by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2010-2019 Merck Sharp & Dohme Corp., a subsidiary of All rights reserved.
  • Revised: 08/2019
  • usmg-mk0217-mf-1908r019
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • ONCE WEEKLYFOSAMAX 70 mg(Alendronate SodiumTablets)
  • Dispense the enclosedMedication Guideto each patient.
  • Each tablet contains91.37 mgalendronate sodium(70 mg free acidequivalent)
  • 4 Tablets
  • Dist. by:Merck Sharp & Dohme Corp.,a subsidiary ofMERCK & CO., INC.Whitehouse Station, NJ 08889, USA
  • Manuf. by:Aesica Pharmaceuticals GmbHGalileistrau03b2e 6, 08056 Zwickau, Germany
  • Alendronate Sodium(active ingred.) Made in Ireland.
  • Formulated in Germany.
  • Copyright u00a9 2015 Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co., Inc.All rights reserved.
  • Rx only
  • USUAL ADULTDOSAGE:ONE 70 mg TABLETONCE WEEKLY
  • See accompanyingcircular for completedosage information.

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