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AG-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: 08/2022 7 WARNINGS AND PRECAUTIONS 04/2024 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 AG-Alendronate is contraindicated in patients with • hypersensitivities to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE AG-Alendronate (alendronate sodium tablets) Page 5 of 54 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). 3 Pharmacokinetics, Renal Insufficiency).
1 Dosing Considerations • Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. See 7 WARNINGS AND PRECAUTIONS. • The optimal duration of bisphosphonate treatment for osteoporosis has not been established.
The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of AG-Alendronate on an individual patient basis. • Although no specific studies have been conducted on the effects of switching patients on another therapy for osteoporosis to alendronate sodium there are no known or theoretical safety concerns related to alendronate sodium in patients who previously received any other antiosteoporotic therapy.
2 Recommended Dose and Dosage Adjustment • Treatment of Osteoporosis in Postmenopausal Women and in Men The recommended dosage is one 70 mg tablet once weekly or one 10 mg tablet once daily. • Prevention of Osteoporosis in Postmenopausal Women The recommended dosage is 5 mg once a day.
• Treatment and Prevention of Glucocorticoid-Induced Osteoporosis in Men and Women The recommended dosage is 5 mg once a day, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is 10 mg once a day.
2 Geriatrics).
Pediatrics (< 18 years of age):
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.
AG-Alendronate (alendronate sodium tablets) Page 12 of 54 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. AG-Alendronate (alendronate sodium tablets) Page 13 of 54 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.
04/2024 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 ............................................................................................ 1 Dosing Considerations.....................................................................................................
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 .......................................................................................................
AG-Alendronate is contraindicated in patients with • hypersensitivities to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE AG-Alendronate (alendronate sodium tablets) Page 5 of 54 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.
Other brands of Alendronate in Canada.
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Health Canada has not authorized an indication for pediatric use. 1 Pediatrics). 58 to 1 mL/s [35 to 60 mL/min]). 58 mL/s [< 35 mL/min]) (see 2 CONTRAINDICATIONS). 4 Administration AG-Alendronate must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only.
Other beverages (including mineral water), food, and some medications are known to reduce the absorption of AG-Alendronate (see 9 DRUG INTERACTIONS). Waiting less than 30 minutes will lessen the effect of AG-Alendronate by decreasing its absorption into the body.
AG-Alendronate should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a AG-Alendronate tablet should be swallowed with a full glass of water (200–250 mL).
Patients should not lie down for at least 30 minutes and until after their first food of the day. AG-Alendronate should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences (see 7 WARNINGS AND PRECAUTIONS).
AG-Alendronate tablets should not be chewed, sucked, cut, or crushed. (see 7 WARNINGS AND PRECAUTIONS). 5 Missed Dose Patients should be instructed that if they miss a dose of AG-Alendronate 70 mg once weekly, they should take one dose on the morning after they remember.
They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day. Take AG-Alendronate 5 mg and 10 mg once daily as prescribed. However, if you miss a dose, do not take an extra dose.
Just resume your usual schedule of one tablet once a day.
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. 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 […]
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 ............................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other AG-Alendronate (alendronate sodium tablets) Page 3 of 54 Quantitative Data ..................................................................................................................
5 Post-Market Adverse Reactions .................................................................................... 16 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 ................................................................................
19 10 CLINICAL PHARMACOLOGY................................................................................................... 1 Mechanism of Action ..................................................................................................
2 Pharmacodynamics ..................................................................................................... 3 Pharmacokinetics ........................................................................................................
21 11 STORAGE, STABILITY AND DISPOSAL.................................................................................... 23 PART II: SCIENTIFIC INFORMATION ......................................................................................
24 13 PHARMACEUTICAL INFORMATION ...................................................................................... 24 14 CLINICAL TRIALS ....................................................................................................................
1 Clinical Trials by Indication .......................................................................................... 3 Comparative Bioavailability Studies............................................................................
38 15 MICROBIOLOGY ..................................................................................................................... 39 16 NON-CLINICAL TOXICOLOGY .................................................................................................
39 17 […]