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Alendronate Sodium (Alendronate Sodium)

Trade Name : Alendronate Sodium

NorthStar Rx LLC

TABLET

Strength 10 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 (Alendronate Sodium) which is also known as Alendronate Sodium and Manufactured by NorthStar Rx LLC. It is available in strength of 10 mg/1 per ml. Read more

Alendronate Sodium (Alendronate Sodium) 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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  • Alendronate sodium 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. n
  • Treatment and prevention of osteoporosis in postmenopausal women , n
  • Treatment to increase bone mass in men with osteoporosis n
  • Treatment of glucocorticoid-induced osteoporosis n
  • Treatment of Paget's disease of bone n
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  • Treatment of osteoporosis in postmenopausal women and in men: 10 mg daily or 70 mg tablet once weekly. , n
  • Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly. n
  • Glucocorticoid-induced osteoporosis: 5 mg daily; or 10 mg daily in postmenopausal women not receiving estrogen.u00a0n
  • Paget's disease: 40 mg daily for six months. n
  • Instruct patients to:u00a0n n
  • Tablets: 10 mg, 35 mg, and 70 mg n
  • Alendronate sodium tablets are contraindicated in patients with the following conditions:
  • Abnormalities of the esophagus which delay emptying such as stricture or achalasia , n
  • Inability to stand/sit upright for at least 30 minutes , , n
  • Hypocalcemia , n
  • Hypersensitivity to any component of this product , n
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  • 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. n n n
  • No data
  • Calcium supplements, antacids, or oral medications containing multivalent cations interfere with absorption of alendronate. , n
  • Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. , n
  • No data
  • Pregnancy: Discontinue when pregnancy is recognized. ()
  • Alendronate sodium is not indicated for use in pediatric patients. ()
  • Alendronate sodium 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). n No specific information is available on the treatment of overdosage with alendronate sodium. 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.n Dialysis would not be beneficial.
  • Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-u00admediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. n Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.n The molecular formula of alendronate sodium is CHNNaOPu20223HO and its formula weight is 325.12. The structural formula is:
  • Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.n Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.
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  • Advise the patient to read the . n n Instruct patientsu00a0to read the Medication Guide before starting therapy with alendronate sodium and to reread it each time the prescription is renewed.
  • Alendronate Sodium Tablets, USP(a len' droe nate soe' dee um)u00a0n- Arrayn- alendronate sodium tablets? u00a0n n- Alendronate sodium tablets cn- an cause serious side effects including:n- u00a0
  • 1. u00a0u00a0Esophagus problems.n- Some people who take n- alendronate sodium tablets mn- ay develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed.n- u00a0
  • 2. u00a0u00a0Low calcium levels in your blood (hypocalcemia).
  • Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take alendronate sodium tablets. Take calcium and vitamin D as your doctor tells you to.n n Some people who take alendronate sodium tablets develop severe bone, joint, or muscle pain.n n Severe jaw bone problems may happen when you take alendronate sodium tablets. Your doctor should examine your mouth before you start alendronate sodium tablets. Your doctor may tell you to see your dentist before you start alendronate sodium tablets. It is important for you to practice good mouth care during treatment with alendronate sodium tablets.n n Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.n n n n u00a0Alendronate sodium tablets are a prescription medicine used to:u00a0
  • It is not known how long alendronate sodium tablets work for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if alendronate sodium tabletsu00a0are still right for you.n Alendronate sodium tablets are not for use in children.n
  • Arrayn- Arrayn- Array
  • Especially tell your doctor if you take:u00a0
  • Arrayn- Arrayn- alendronate sodium tablets?n- u00a0
  • After swallowing alendronate sodium tablet, wait at least 30 minutes:u00a0
  • Do not lie down for at least 30 minutes after you take n- alendronate sodium tablets an- nd after you eat your first food of the day.n- Arrayn- alendronate sodium n- tablets? n
  • The most common side effects of n- alendronate sodium tablets n- are:n- u00a0
  • You may get allergic reactions, such as hives or swelling of your face, lips, tongue, or throat.n Worsening of asthma has been reported.n Tell your doctor if you have any side effect that bothers you or that does not go away.n These are not all the possible side effects of alendronate sodium tablets. For more information, ask your doctor or pharmacist.n Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n n n n
  • Keep n- alendronate sodium tablets an- nd all medicines out of the reach of children.n- General information about the safe and effective use of alendronate sodium tablets.n- Arrayn- Medication Guides availableu00a0at u00a0or call 1-800-206-7821.
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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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