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Alendronate Sodium (Alendronate Sodium)

Trade Name : Alendronate Sodium

Aidarex Pharmaceuticals LLC

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 (Alendronate Sodium) which is also known as Alendronate Sodium and Manufactured by Aidarex Pharmaceuticals LLC. It is available in strength of 70 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

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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
  • Alendronate sodium tablets USP are a bisphosphonate indicated for:
  • Important limitations of use: The optimal duration of use has not been determined. The need for continued therapy should be re-evaluated on a periodic basis. ()
  • 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 ()
  • No data
  • Must be taken with 6 to 8 oz plain water at least 30 minutes before the first food, drink, or medication of the day; do not lie down for at least 30 minutes after taking alendronate sodium tablets USP and until after food. ()
  • 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. ()
  • 5 mg, 10 mg, 35 mg, 40 mg and 70 mg tablets ()
  • No data
  • 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
  • Severe irritation of upper gastrointestinal (GI) mucosa can occur. Follow dosing instructions. Use caution in patients with active upper GI disease. Discontinue if new or worsening symptoms occur. ()
  • Hypocalcemia can worsen and must be corrected prior to use. ()
  • Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop. ()
  • Osteonecrosis of the jaw has been reported. ()
  • Atypical femur fractures have been reported. Evaluate new thigh or groin pain to rule out an incomplete femoral fracture. ()
  • Most common adverse reactions (u2265 3%) are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351 or [email protected]; 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. (, )
  • Aspirin and non-steroidal anti-inflammatory drug use may worsen GI irritation; use caution. (, )
  • No data
  • Alendronate sodium is not indicated for use in pediatric patients. ()
  • Alendronate sodium is not recommended in patients with renal impairment (creatinine clearance < 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 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.
  • Dialysis would not be beneficial.
  • 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 structural formula is:
  • CHNNaOPu20223HOu00a0u00a0 M.W. 325.12
  • Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.
  • Each tablet, for oral administration contains 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
  • Alendronate sodium tablets USP meet USP Dissolution Test 2.
  • No data
  • No data
  • No data
  • 70 mg u2013 white to off-white, pillow-shaped, convex, unscored tablet debossed with u201c93u201d on one side and u201c5171u201d on the other side, in unit-of-use blister packages of 4.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • See FDA-approved patient labeling (Medication Guide).
  • Physicians should instruct their patients to read the Medication Guide before starting therapy with alendronate sodium and to reread it each time the prescription is renewed.
  • ALENDRONATE SODIUM TABLETS USP
  • Read the Medication Guide that comes with alendronate sodium tablets before you start taking them 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 alendronate sodium tablets.
  • What is the most important information I should know about alendronate sodium tablets?
  • Alendronate sodium tablets can cause serious side effects including:
  • 1. Esophagus problems.
  • Some people who take alendronate sodium tablets may 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.
  • 2. Low calcium levels in your blood (hypocalcemia).
  • Alendronate sodium tablets may lower the calcium levels in your blood. If you have low blood calcium before you start taking alendronate sodium tablets, it may get worse during treatment. Your low blood calcium must be treated before you take alendronate sodium tablets. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
  • 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.
  • 3. Bone, joint, or muscle pain.
  • Some people who take alendronate sodium tablets develop severe bone, joint, or muscle pain.
  • 4. Severe jaw bone problems (osteonecrosis).
  • 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.
  • 5. Unusual thigh bone fractures.
  • 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.
  • Call your doctor right away if you have any of these side effects.
  • What are alendronate sodium tablets?
  • Alendronate sodium tablets are a prescription medicine used to:
  • 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 tablets are still right for you.
  • Alendronate sodium tablets are not for use in children.
  • Who should not take alendronate sodium tablets?
  • Do not take alendronate sodium tablets if you:
  • What should I tell my doctor before taking alendronate sodium tablets?
  • Before you start alendronate sodium tablets, 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 alendronate sodium tablets?
  • After swallowing alendronate sodium tablets, wait at least 30 minutes:
  • Do not lie down for at least 30 minutes after you take alendronate sodium tablets and after you eat your first food of the day.
  • If you miss a dose of alendronate sodium tablets, 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 many alendronate sodium tablets, call your doctor. Do not try to vomit. Do not lie down.
  • What are the possible side effects of alendronate sodium tablets?
  • Alendronate sodium tablets may cause serious side effects.
  • The most common side effects of alendronate sodium tablets are:
  • You may get allergic reactions, such as hives or, in rare cases, swelling of your face, lips, tongue, or throat.
  • 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 alendronate sodium tablets. 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 alendronate sodium tablets?
  • Keep alendronate sodium tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of alendronate sodium tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use alendronate sodium tablets for a condition for which they were not prescribed. Do not give alendronate sodium tablets to other people, even if they have the same symptoms you have. They may harm them.
  • This Medication Guide summarizes the most important information about alendronate sodium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about alendronate sodium tablets that is written for health professionals.
  • For more information, call 1-888-838-2872, MEDICAL AFFAIRS.
  • What are the ingredients in alendronate sodium tablets?
  • Active ingredient: alendronate sodium
  • Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • TEVA PHARMACEUTICALS USA
  • Sellersville, PA 18960
  • Repackaged By:Aidarex Pharmaceuticals, LLC.Corona, CA 92880
  • Iss. 1/2011
  • Alendronate Sodium Tablets USP 70 mg 4s Box Text
  • NDC 33261--0554-01
  • Once Weekly ALENDRONATE SODIUM Tablets USP70 mg*
  • *Each tablet contains 91.37 mg alendronate sodium trihydrate (70 mg free acid equivalent).
  • USUAL ADULT DOSAGE: ONE 70 mg TABLET ONCE WEEKLY
  • PHARMACIST: Dispense the enclosed Medication Guide to each patient.
  • See accompanying circular for complete dosage information.
  • Unit-of-Use dispense in original package.
  • Important information:
  • Please read the enclosed Medication Guide before taking Once Weekly alendronatesodium tablets. Keep this and all drugs out of the reach of children.Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Rx only
  • 4u00a0TABLETS

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