Label: ALENDRONATE SODIUM tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 1, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Treatment of Osteoporosis in Postmenopausal Women - Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Treatment of Osteoporosis in Postmenopausal Women - The recommended dosage is: • one 70 mg tablet once weekly -                                     or - • one 10 mg tablet once daily - 2.2 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    • 10 mg tablets are white to off-white, circular, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘18’ on the other side. • 35 mg tablets are white to off-white, oval shaped ...
  • 4 CONTRAINDICATIONS
    Alendronate sodium tablets are contraindicated in patients with the following conditions: • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Upper Gastrointestinal Adverse Reactions - Alendronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Calcium Supplements/Antacids - Coadministration of alendronate sodium and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of alendronate ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects - Pregnancy Category C: There are no studies in pregnant women. Alendronate sodium should be used during pregnancy only if the potential benefit justifies ...
  • 10 OVERDOSAGE
    Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m2) and 966 mg/kg (2898 mg/m2), respectively. In males, these values were slightly higher, 626 ...
  • 11 DESCRIPTION
    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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Harderian gland (a retro-orbital gland not present in humans) adenomas were increased in high-dose female mice (p=0.003) in a 92-week ...
  • 14 CLINICAL STUDIES
    14.1 Treatment of Osteoporosis in Postmenopausal Women - Daily Dosing - The efficacy of alendronate 10 mg daily was assessed in four clinical trials. Study 1, a three-year, multicenter ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Alendronate Sodium Tablets USP, 70 mg are white to off-white, oval shaped, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘21’ on the other side. Unit-of-use ...
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-approved patient labeling (Medication Guide). Instruct patients to read the Medication Guide before starting therapy with alendronate sodium and to reread it each time the prescription ...
  • MEDICATION GUIDE
    Alendronate Sodium Tablets, USP - (a len' droe nate soe' dee um) Read the Medication Guide that comes with alendronate sodium tablets before you start taking them and each time you get a ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 70 mg Blister Carton (4 Unit-of-use)
    NDC 71205-048-04 - ONCE WEEKLY - Alendronate Sodium Tablets, USP - 70 mg* PHARMACIST: Dispense the accompanying - Medication Guide to each patient. Rx only                            4 ...
  • INGREDIENTS AND APPEARANCE
    Product Information