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NRA-ALENDRONATE is a brand name for Alendronate (also known as Alendronic Acid), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 07/2024 7 WARNINGS AND PRECAUTIONS 07/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS…
Verbatim from this product's HC label. Tap a section to expand.
). 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥65 years of age): In clinical studies, there was no age-related difference in the efficacy or safety profiles of alendronate sodium (see 14 CLINICAL TRIALS).
2 CONTRAINDICATIONS NRA-Alendronate is contraindicated in patients with • hypersensitivities to this drug or to any ingredient in the formulation, including any non-medicinal NRA-Alendronate (alendronate sodium tablets) Page 5 of 56 ingredient, or component of the container.
For a complete listing, see
1 Adverse Reaction Overview The most common drug related adverse reactions include gastrointestinal disorders (abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer, dysphagia, acid regurgitation, melena, nausea and abdominal distention), musculoskeletal (bone, muscle or joint) pain and headache.
It is important to follow the recommended dosing instructions. 4 Administration. Osteonecrosis of the Jaw and atypical bone fractures have been observed under post marketing seeting. See 7 Warnings and precautions, Musculoskeletal. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Treatment of Osteoporosis Postmenopausal Women:
In two, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational) of virtually identical design, with a total of 994 postmenopausal women, the overall safety profiles of alendronate sodium 10 mg/day and placebo were similar.
0% of 397 patients treated with placebo. Adverse experiences considered by the investigators as possibly, probably, or definitely drug-related in 1% of patients treated with either alendronate sodium 10 mg/day or placebo are presented in the following table.
0 * Considered possibly, probably, or definitely drug-related as assessed by the investigators. One patient treated with alendronate sodium (10 mg/day), who had a history of peptic ulcer disease and gastrectomy and who was taking concomitant acetylsalicylic acid (ASA) developed an anastomotic ulcer with mild hemorrhage, which was considered drug-related.
07/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION......................................................................
4 1 INDICATIONS ....................................................................................................................... 1 Pediatrics .................................................................................................................
2 Geriatrics.................................................................................................................. 4 2 CONTRAINDICATIONS.........................................................................................................
4 4 DOSAGE AND ADMINISTRATION ....................................................................................... 2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration .........................................................................................................
5 Missed Dose............................................................................................................. 6 5 OVERDOSAGE......................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 7 7 WARNINGS AND PRECAUTIONS......................................................................................... 1 Special Populations ................................................................................................
NRA-Alendronate is contraindicated in patients with • hypersensitivities to this drug or to any ingredient in the formulation, including any non-medicinal NRA-Alendronate (alendronate sodium tablets) Page 5 of 56 ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. • the inability to stand or sit upright for at least 30 minutes.
• hypocalcemia (see 7 WARNINGS AND PRECAUTIONS). 58 mL/s (< 35 mL/min) (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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ASA and alendronate sodium were discontinued and the patient recovered. In the two-year extension (treatment years 4 and 5) of the above studies, the overall safety profile of alendronate sodium 10 mg/day was similar to that observed during the three-year placebo-controlled period.
Additionally, the proportion of patients who discontinued alendronate sodium 10 mg/day due to any clinical adverse experience was similar to that during the first three years of the study. 1% of 3223 patients treated with placebo. 7%.
The overall adverse experience profile was similar to that seen in other studies with alendronate sodium 5 or 10 mg/day. In a one-year, double-blind multicenter study, the overall safety and tolerability profiles of alendronate sodium 70 mg once weekly and alendronate sodium 10 mg daily were similar.
1 * Considered possibly, probably, or definitely drug-related as assessed by the investigators.
Men:
In two placebo-controlled, double-blind, multicenter studies in men (a two-year study of alendronate sodium 10 mg/day [n=146] and a one-year study of alendronate sodium 70 mg once weekly [n=109]), the safety profile of alendronate sodium was generally similar to that seen in postmenopausal women.
7% for alendronate sodium 10 mg/day vs. 4% for alendronate sodium 70 mg once weekly vs. 6 % for placebo.
Other Studies in Men and Women:
In a ten-week endoscopy study in men and women (n = 277; mean age: 55) no difference was seen in upper gastrointestinal tract lesions between alendronate soduim 70 mg once weekly and placebo. NRA-Alendronate (alendronate sodium tablets) Page 15 of 56 In an additional one-year study in men and women (n = 335; mean age: 50) the overall safety and tolerability profiles of alendronate soduim 70 mg once weekly were similar to that of placebo and no difference was seen between men and women.
Prevention of Osteoporosis in Postmenopausal Women:
The safety of alendronate soduim 5 […]
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics...........................................................................................................
4 Geriatrics ........................................................................................................... 11 8 ADVERSE REACTIONS........................................................................................................
1 Adverse Reaction Overview................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions .....................................................
5 Post-Market Adverse Reactions ............................................................................ 17 9 DRUG INTERACTIONS .......................................................................................................
2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions .............................................................................. 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions.......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions ........................................................................
20 10 CLINICAL PHARMACOLOGY .............................................................................................. 1 Mechanism of Action .............................................................................................
2 Pharmacodynamics................................................................................................ 3 Pharmacokinetics ..................................................................................................
23 11 STORAGE, STABILITY AND DISPOSAL ............................................................................... 25 PART II: SCIENTIFIC INFORMATION ......................................................................................
26 13 PHARMACEUTICAL INFORMATION .................................................................................. 26 14 CLINICAL TRIALS ................................................................................................................
1 Clinical Trials by Indication .................................................................................... 3 Comparative Bioavailability Studies ...................................................................... 40 15 MICROBIOLOGY .................................................................................................................
41 16 NON-CLINICAL TOXICOLOGY ............................................................................................ 41 17 SUPPORTING PRODUCT MONOGRAPHS .........................................................................
43 PATIENT MEDICATION INFORMATION ................................................................................. 44 PATIENT MEDICATION INFORMATION ................................................................................. 50 NRA-Alendronate (alendronate sodium tablets) Page 4 of 56 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS NRA-Alendronate (alendronate sodium) is indicated […]