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Alendronate Sodium And Cholecalciferol (Fosamax Plus D)

Trade Name : FOSAMAX PLUS D

Merck Sharp & Dohme Corp.

TABLET

Strength 705600 mg/1[iU]/1

ALENDRONATE SODIUM; CHOLECALCIFEROL Bisphosphonate [EPC],Diphosphonates [CS],Vitamin D [CS],Vitamin D [EPC]

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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 And Cholecalciferol (Fosamax Plus D) which is also known as FOSAMAX PLUS D and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 70; 5600 mg/1; [iU]/1 per ml. Read more

Alendronate Sodium And Cholecalciferol (Fosamax Plus D) 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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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
  • FOSAMAX PLUS D is a combination of a bisphosphonate and vitamin D indicated for:
  • Limitations of use:
  • No data
  • 70 mg alendronate/2800 international units vitamin Dor 70u00a0mg alendronate/5600 international units vitamin D tablet once weekly. (, )
  • Instruct patients to: () ttttttttttn
  • Tablets: 70 mg/2800 international units and 70 mg/5600 international units ()
  • FOSAMAX PLUS D 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 (, )
  • 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%) for alendronate 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. (, )
  • Some drugs may impair the absorption or increase the catabolism of cholecalciferol (vitamin D). Additional vitamin D supplementation should be considered. (, , )
  • No data
  • Pregnancy: Discontinue when pregnancy is recognized. ()
  • FOSAMAX PLUS D is not indicated for use in pediatric patients. ()
  • FOSAMAX PLUS D is not recommended in patients with severe renal impairment (creatinine clearance less than 35 mL/min). (, )
  • Alendronate Sodium
  • Significant lethality after single oral doses with alendronate was seen in female rats and mice at 552u00a0mg/kg (3256u00a0mg/m) and 966u00a0mg/kg (2898u00a0mg/m), respectively. In males, these values were slightly higher, 626u00a0and 1280u00a0mg/kg, respectively. There was no lethality in dogs at oral doses up to 200u00a0mg/kg (4000u00a0mg/m).
  • No specific information is available on the treatment of overdosage with alendronate. 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.
  • Cholecalciferol
  • Significant lethality occurred in mice treated with a single high oral dose of calcitriol (4 mg/kg), the hormonal metabolite of cholecalciferol.
  • There is limited information regarding doses of cholecalciferol associated with acute toxicity, although intermittent (yearly or twice yearly) single doses of ergocalciferol (vitamin D) as high as 600,000 international units have been given without reports of toxicity. Signs and symptoms of vitamin D toxicity include hypercalcemia, hypercalciuria, anorexia, nausea, vomiting, polyuria, polydipsia, weakness, and lethargy. Serum and urine calcium levels should be monitored in patients with suspected vitamin D toxicity. Standard therapy includes restriction of dietary calcium, hydration, and systemic glucocorticoids in patients with severe hypercalcemia.
  • Dialysis to remove vitamin D would not be beneficial.
  • FOSAMAX PLUS D contains alendronate sodium, a bisphosphonate, and cholecalciferol (vitamin D).
  • 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.
  • Cholecalciferol (vitamin D) is a secosterol that is the natural precursor of the calcium-regulating hormone calcitriol (1,25 dihydroxyvitamin D).
  • The chemical name of cholecalciferol is (3u03b2,5,7)-9,10-secocholesta-5,7,10(19)-trien-3-ol. The empirical formula of cholecalciferol is CHO and its molecular weight is 384.6. The structural formula is:
  • Cholecalciferol is a white, crystalline, odorless powder. Cholecalciferol is practically insoluble in water, freely soluble in usual organic solvents, and slightly soluble in vegetable oils.
  • FOSAMAX PLUS D for oral administration contains 91.37u00a0mg of alendronate monosodium salt trihydrate, the molar equivalent of 70u00a0mg of free acid, and 70 or 140 mcg of cholecalciferol, equivalent to 2800 or 5600 international units vitamin D, respectively. Each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate, butylated hydroxytoluene, modified food starch, and sodium aluminum silicate.
  • No data
  • No data
  • No data
  • No. 3870 u2014 Tablets FOSAMAX PLUS D 70 mg/2800 international units are white to off-white, modified capsule-shaped tablets with code 710 on one side and an outline of a bone image on the other. They are supplied as follows:
  • NDC
  • No. 6746 u2014 Tablets FOSAMAX PLUS D 70 mg/5600 international units are white to off-white, modified rectangle-shaped tablets with code 270 on one side and an outline of a bone image on the other. They are supplied as follows:
  • NDC
  • NDC
  • Storage
  • Store at 20-25u00b0C (68-77u00b0F), excursions between 15-30u00b0C (59-86u00b0F) are allowed. [See USP Controlled Room Temperature.] Protect from moisture and light. Store tablets in the original blister package until use.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Instruct patients to read the Medication Guide before starting therapy with FOSAMAX PLUS D and to reread it each time the prescription is renewed.
  • Manuf. for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • By:FROSST IBERICA, S.A.28805 Alcalu00e1 de HenaresMadrid, Spain
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2005-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk0217a-t-1908r021
  • Arrayn- Arrayn- u00aen- (alendronate sodium/cholecalciferol)
  • Read the Medication Guide that comes with FOSAMAXu00a0PLUS D 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 PLUS D.
  • What is the most important information I should know about FOSAMAX PLUS D?
  • FOSAMAX PLUS D can cause serious side effects including:
  • Call your doctor right away if you have any of these side effects.
  • What is FOSAMAX PLUS D?
  • FOSAMAX PLUS D is a prescription medicine used to:
  • FOSAMAX PLUS D should not be used to treat vitamin D deficiency.
  • It is not known how long FOSAMAX PLUS D works for the treatment of osteoporosis. You should see your doctor regularly to determine if FOSAMAX PLUS D is still right for you.
  • FOSAMAX PLUS D is not for use in children.n n
  • Who should not take FOSAMAX PLUS D?
  • Do not take FOSAMAX PLUS D if you:
  • What should I tell my doctor before taking FOSAMAX PLUS D?
  • Before you start FOSAMAX PLUS D, 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 PLUS D tablet?
  • After swallowing FOSAMAX PLUS D, wait at least 30 minutes:
  • Do not lie down for at least 30 minutes after you take FOSAMAX PLUS D and after you eat your first food of the day.
  • If you miss a dose of FOSAMAX PLUS D, 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 PLUS D, call your doctor. Do not try to vomit. Do not lie down.n n
  • What are the possible side effects of FOSAMAX PLUS D?
  • FOSAMAX PLUS D may cause serious side effects.
  • The most common side effects of FOSAMAX PLUS D 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 PLUS D. 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 PLUS D?
  • Keep FOSAMAX PLUS D and all medicines out of the reach of children.
  • General information about the safe and effective use of FOSAMAX PLUS D.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FOSAMAX PLUS D for a condition for which it was not prescribed. Do not give FOSAMAX PLUS D 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 PLUS D. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about FOSAMAX PLUS D that is written for health professionals. For more information, go to: www.fosamaxplusd.com or call 1-800-622-4477 (toll-free).n n
  • What are the ingredients in FOSAMAX PLUS D?
  • Active ingredients: alendronate sodium and cholecalciferol (vitamin D).
  • Inactive ingredients: cellulose, lactose, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate, butylated hydroxytoluene, modified food starch, and sodium aluminum silicate.
  • Manuf. for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • By:FROSST IBERICA, S.A.28805 Alcalu00e1 de HenaresMadrid, Spain
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2010-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • Revised: 08/2019
  • usmg-mk0217a-t-1908r016
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • FOSAMAX PLUS D(alendronate sodium/cholecalciferol) tablets
  • 70n 2800n
  • Dispense the enclosedMedication Guide toeach patient.
  • Each tablet contains91.37 mg alendronatesodium (70 mg free acidequivalent) and 70 mcgcholecalciferolequivalent to 2800 IUvitamin D.
  • 710
  • 4 TabletsNo. 3870
  • Rx only
  • USUAL ADULT DOSAGE:ONE 70 mg/2800 IU TABLETONCE WEEKLY
  • See accompanying circularfor dosage information.
  • Manuf. for: Merck Sharp & Dohme Corp.,a subsidiary ofMERCK & CO., INC.Whitehouse Station, NJ 08889, USA
  • By:FROSST IBERICA, S. A.28805 Alcalu00e1 de HenaresMadrid, Spain
  • Made in Spain
  • FOSAMAX PLUS D(alendronate sodium/cholecalciferol) tablets
  • 70n 5600n
  • Dispense the enclosedMedication Guide toeach patient.
  • Each tablet contains91.37 mg alendronatesodium (70 mg free acidequivalent) and 140 mcgcholecalciferolequivalent to 5600 IUvitamin D.
  • 270
  • 4 TabletsNo. 6746
  • Rx only
  • USUAL ADULT DOSAGE:ONE 70 mg/5600 IU TABLET ONCE WEEKLY
  • See accompanying circularfor dosage information.
  • Manuf. for: Merck Sharp & Dohme Corp.,a subsidiary ofMERCK & CO., INC.Whitehouse Station, NJ 08889, USA
  • By:FROSST IBERICA, S. A.28805 Alcalu00e1 de HenaresMadrid, Spain
  • Made in Spain

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