Alendronate Sodium (Binosto)

Trade Name : Binosto

ASCEND Therapeutics

TABLET, EFFERVESCENT

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 (Binosto) which is also known as Binosto and Manufactured by ASCEND Therapeutics. It is available in strength of 70 mg/1 per ml. Read more

Alendronate Sodium (Binosto) 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

Validated Cold Chain Shipment

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
  • BINOSTO is a bisphosphonate indicated for:
  • Limitation of use:n n n n n n Optimal durationnof use has not been determined. For patients at low-risk for fracture,nconsider drug discontinuation after 3 to 5 years of use. (n n n n n n )n nn n nn
  • Treatment of osteoporosis in postmenopausal women (n n n n n n )n n n n n n
  • Treatment to increase bone mass in men with osteoporosisn(n n n n n n )n n n n n n
  • No data
  • 70 mg BINOSTO effervescent tablet once weekly. (n n n n n n , n n n n n n )n n n n n n
  • Instruct patients to: (n n n n n n )n n n n n n n
  • BINOSTO effervescent tablets are round,nflat-faced, white to off-white tablets, 25u00a0mm in diameter, with bevelednedges, with u201cMu201d debossed on one side, containing 91.37u00a0mg of alendronatensodium, which is equivalent to 70 mg of free alendronic acid.
  • Effervescent tablets, 70 mg (n n n n n n )n nn n nn
  • BINOSTO is contraindicated innpatients with the following conditions:
  • Do not administer BINOSTOnto patients at increased risk of aspiration
  • Abnormalities of the esophagus which delay emptying suchnas stricture or achalasia (n n n n n n , n n n n n n )n n n n n n
  • Inability to stand/sit upright for at least 30 minutes (n n n n n n , n n n n n n )n n n n n n
  • Increased risk of aspiration. (n n n n n n )n n n n n n
  • Hypocalcemia (n n n n n n , n n n n n n )n n n n n n
  • Hypersensitivity to any component of this product (n n n n n n , n n n n n n )n n n n n n
  • No data
  • Upper Gastrointestinal Adverse Reactions
  • Hypocalcemia can worsen and must be corrected prior to use.n(n n n n n n )n n n n n n
  • Severe Bone, Joint, Muscle Pain
  • Osteonecrosis of the Jaw
  • Atypical Femur Fractures
  • Sodium Content:
  • The most common adverse reactions (incidence greater than or equal to 3%) are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, and nausea. ( n n n ) n n n n n n
  • No data
  • Calcium supplements, antacids or oral medications containingnmultivalent cations interfere with absorption of alendronate. (n n n n n n )n n n n n n
  • Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatoryndrugs that may worsen gastrointestinal irritation. (n n n n n n , n n n n n n )n n n n n n
  • No data
  • BINOSTO is not indicated for use in pediatric patients.n(n n n n n n )n n n n n n
  • BINOSTO is not recommended in patients with renal impairmentn(creatinine clearance less thanu00a035 mL/min). (n n n n n n , n n n n n n )n n n n n n
  • Significant lethality after single oral dosesnwas seen in female rats and mice at 552 mg/kg (3256 mg/mn n n n n n ) and 966 mg/kg (2898 mg/mn n n n n n ), respectively. In males, these values were slightly higher, 626nand 1280 mg/kg, respectively. There was no lethality in dogs at oralndoses up to 200 mg/kg (4000 mg/mn n n n n n ).n nn n nn
  • No specific information is available onnthe treatment of overdosage with BINOSTO. Hypocalcemia, hypophosphatemia,nand upper gastrointestinal adverse events, such as upset stomach,nheartburn, esophagitis, gastritis, or ulcer, may result from oralnoverdosage. Milk or antacids should be given to bind alendronate.nDue to the risk of esophageal irritation, vomiting should not be inducednand the patient should remain fully upright.
  • Dialysis would not be beneficial.
  • BINOSTO (alendronate sodium) is a bisphosphonatenthat acts as a specific inhibitor of osteoclast-mediated bone resorption.nBisphosphonates are synthetic analogs of pyrophosphate that bind tonthe hydroxyapatite found in bone.
  • Alendronate sodium is chemically described as (4 amino-1-hydroxybutylidene)nbisphosphonic acid, monosodium salt, trihydrate. The molecular formulanof alendronate sodium is Cn n n n n n Hn n n n n n NNaOn n n n n n Pn n n n n n u2022 3Hn n n n n n O and its molecular weight is 325.12. The structuralnformula of alendronate sodium isn nn n nn
  • Alendronate sodium is a white or almost white crystallinenpowder that is soluble in water, very slightly soluble in methanol,nand practically insoluble in methylene chloride.
  • BINOSTO for oral administration is an effervescentntablet formulation that must be dissolved in water before use. Eachnindividual tablet contains 91.37 mg of alendronate sodium, which isnequivalent to 70 mg of free alendronic acid. Each tablet also containsnthe following inactive ingredients: monosodium citrate anhydrous,ncitric acid anhydrous, sodium hydrogen carbonate, and sodium carbonatenanhydrous as buffering agents, strawberry flavor, acesulfame potassium,nand sucralose.
  • Once the effervescentntablet is dissolved in water, the alendronate sodium is present inna citrate-buffered solution.
  • No data
  • No data
  • No data
  • BINOSTO effervescent tablets are round, flat faced, white to off-white tablets with beveled edges and u201cMu201d debossed on one side. BINOSTO effervescent tablets, 70 mg are provided in blisters made of aluminum foil composite, as follows:
  • NDC
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F), excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F), [See USP Controlled Room Temperature.] Protect from moisture. Store tablets in original blister package until use.
  • See FDA-approved patient labeling (Medication Guide).n n n n n n Instructnpatients to read the Medication Guide before starting therapy withnBINOSTO and to reread it each time the prescription is renewed.n nn n nn
  • Medication Guide n n n BINOSTO n n n (BIN n n n n- ) n n n (alendronate sodium) n n n Effervescent Tablets n n n
  • Read the Medication Guide that comes with BINOSTO n n n 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.n nn
  • What is the most important information I should know about BINOSTO Effervescent Tablet?
  • BINOSTO Effervescent Tablet can cause serious side effects, including:
  • Call your doctor right away if you have any of these side effects.
  • What is BINOSTO Effervescent Tablet?
  • BINOSTO is a prescription medicine used to:
  • It is not known how long BINOSTO works for the treatment of osteoporosis. You should see your doctor regularly to determine if BINOSTO is still right for you.
  • BINOSTO is not for use in children.
  • Who should not take BINOSTO Effervescent Tablet?
  • Do not take BINOSTO if you:
  • What should I tell my doctor before taking BINOSTO Effervescent Tablet?
  • Before you start taking BINOSTO, tell your doctor about all of your medical conditions, including if you:
  • Tell your doctor about all medicines you take,
  • Especially tell your doctor if 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 BINOSTO Effervescent Tablet?
  • After you take BINOSTO, wait at least 30 minutes before you:
  • Do not lie down until after you eat your first food of the day.
  • What should I avoid while taking BINOSTO Effervescent Tablet?
  • BINOSTO contains a high amount of salt in each tablet. Avoid eating foods with a high amount of salt if your doctor has told you to limit how much salt you eat.
  • What are the possible side effects of BINOSTO Effervescent Tablet?
  • BINOSTO may cause serious side effects.
  • The most common side effects of BINOSTO are:
  • You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat.
  • Tell your doctor about any side effect that bothers you or that does not go away.
  • These are not all the side effects with BINOSTO. Ask your doctor or pharmacist for more information.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store BINOSTO Effervescent Tablet?
  • Keep BINOSTO and all medicines out of the reach of children.
  • General information about the safe and effective use of BINOSTO Effervescent Tablet
  • This Medication Guide summarizes the most important information about BINOSTO. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about BINOSTO that is written for health professionals.
  • For more information, go to BINOSTO.com, or call 1-877-204-1013.
  • What are the ingredients in BINOSTO Effervescent Tablet?
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured for: n n n ASCEND Therapeuticsn n n Herndon, VA 20170n nn
  • Issued: October 2019
  • Binosto n n n 70 mg Carton n n n 4 Effervescent Tablets n n n NDC 17139u2013400u201304n nn
  • Binosto n n n 70 mg n n n Label Effervescent Tablet n n n NDC 17139u2013400u201300n nn

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