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NB-ALENDRONATE-FC 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: NB-ALENDRONATE-FC (alendronate sodium tablets) is indicated for: • The treatment of osteoporosis in postmenopausal women. o For the treatment of osteoporosis in postmenopausal women, alendronate sodium increases bone mass and prevents fractures, including those of the hip and spine (vertebral compression fractures). •…
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 NB-ALENDRONATE-FC 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
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 setting. 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- NB-ALENDRONATE-FC (alendronate sodium) Page 12 of 44 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.
). 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 NB-ALENDRONATE-FC 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. 2 Geriatrics). 1 Pediatrics). 58 to 1 mL/s [35 to 60 mL/min]). 58 mL/s [< 35 mL/min]) (see 2 CONTRAINDICATIONS).
4 Administration NB-ALENDRONATE-FC 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 NB-ALENDRONATE-FC (see 9 DRUG INTERACTIONS).
Waiting less than 30 minutes will lessen the effect of NB-ALENDRONATE-FC by decreasing its absorption into the body. NB-ALENDRONATE-FC should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a NB-ALENDRONATE-FC tablet NB-ALENDRONATE-FC (alendronate sodium) Page 6 of 44 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. NB-ALENDRONATE-FC 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).
NB-ALENDRONATE-FC 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 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 3,223 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 NB-ALENDRONATE-FC (alendronate sodium) Page 14 of 44 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 sodium 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 sodium 70 mg once weekly were similar to that of placebo and no difference was seen between men and women.
Concomitant Use with Estrogen/Hormone Replacement Therapy:
In two studies (of one- and two-years’ duration) of postmenopausal osteoporotic women (total: n = […]
NB-ALENDRONATE-FC 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 NB-ALENDRONATE-FC 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. 5 OVERDOSAGE No specific information is available on the treatment of overdosage with NB-ALENDRONATE-FC.
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. For the most recent information in the management of a suspected drug overdose, contact your regional poison control center or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669). 37 mg of alendronate sodium, which is the molar equivalent to 70 mg of free acid Hypromellose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Sodium Starch Glycolate, and Starch.
NB-ALENDRONATE-FC (alendronate sodium) Page 7 of 44 NB-ALENDRONATE-FC 70 mg:
Each white, oval-shaped, biconvex coated tablet with "P" logo debossed on one side and "70" on the other side. Available in HDPE bottles of 100 tablets and blisters of 4 tablets. 7 WARNINGS AND PRECAUTIONS General To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, patients should be instructed to swallow each tablet of NB-ALENDRONATE-FC with a full glass of water.
Patients should be instructed not to lie down for at least 30 minutes and until after their first food of the day. Patients should not chew or suck on the tablet because of a potential for oropharyngeal ulceration. Patients should be specifically instructed not to take NB- ALENDRONATE-FC at bedtime or before arising for the day.
Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems. 4 Administration). Causes of osteoporosis other than estrogen deficiency, aging and glucocorticoid use should be considered.
Endocrine and Metabolism Hypocalcemia must be corrected before initiating therapy with NB-ALENDRONATE-FC (see 2 CONTRAINDICATIONS). Other disorders affecting mineral metabolism (such as Vitamin D deficiency) should be treated. In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with NB-ALENDRONATE-FC.
Symptomatic hypocalcemia has been […]