Alendronate Sodium / Cholecalciferol
Pronouncation: (a-LEN-droe-nate SO-dee-um/KOE-le-kal-SIF-er-ole)Class: Biophosphonate combination
Trade Names:
Fosamax Plus D
- Tablets 70 mg alendronate/2,800 units cholecalciferol
Pharmacology
Feedback for Alendronate Sodium/Cholecalciferol
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Inhibits bone resorption and increases bone density.
Indications and Usage
Treatment of osteoporosis in postmenopausal women; treatment to increase bone mass in men with osteoporosis.
Contraindications
Abnormalities of the esophagus that delay esophageal emptying (eg, achalasia, stricture); inability to stand or sit upright for at least 30 min; hypocalcemia; hypersensitivity to any component of the product.
Dosage and Administration
AdultsPO One 70 mg/2,800 unit tablet once weekly.
General Advice
- Administer in the morning at least 30 min before the first beverage, food, or medication of the day.
- Patient should swallow tablet with 6 to 8 oz of water and remain sitting or standing for at least 30 min.
- Patient should receive supplemental calcium if dietary intake is inadequate.
- Do not take the first dose at bedtime or before arising for the day.
Storage/Stability
Store at 59° to 89°F. Protect from moisture and light.
Drug Interactions
Antacids, calcium supplementsAlendronate absorption may be reduced; take alendronate at least 30 min before other medications.
Anticonvulsants, cimetidine, thiazidesMay increase cholecalciferol catabolism.
AspirinIncidence of upper GI adverse reactions may be increased in patients taking more than 10 mg of alendronate daily.
Bile acid sequestrants (eg, cholestyramine, colestipol), mineral oil, olestra, orlistatMay impair cholecalciferol absorption.
NSAIDsUse with caution because of potential GI irritation.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Headache (3%); asthenia, dizziness, malaise, vertigo (postmarketing).
Dermatologic
Photosensitivity, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).
EENT
Episcleritis, scleritis, uveitis (postmarketing).
GI
Abdominal pain (7%); dyspepsia, nausea (4%); constipation, diarrhea, flatulence, gastroesophageal reflux disease (3%); acid regurgitation, esophageal ulcer (2%); abdominal distention, dysphagia, vomiting (1%); duodenal ulcers, esophageal erosions, esophageal perforation or stricture, esophageal ulcers, esophagitis, gastric ulcers, oropharyngeal ulceration (postmarketing).
Lab Tests
Mild, transient decreases in serum calcium (18%) and phosphate (10%); symptomatic hypocalcemia (postmarketing).
Musculoskeletal
Bone, muscle, or joint pain (4%); myalgia (postmarketing).
Miscellaneous
Fever, hypersensitivity (including urticaria and angioedema), localized osteonecrosis of the jaw often associated with tooth extraction and/or local infection with delayed healing, peripheral edema (postmarketing).
Precautions
Pregnancy
Category C.
Lactation
Alendronate: Undetermined.
Cholecalciferol: Excreted in breast milk.
Children
Safety and efficacy not established.
GI disorders
Use with caution in patients with upper GI problems (eg, duodenitis, dysphagia, esophageal disease, gastritis, ulcers).
Hypocalcemia and mineral metabolism (eg, vitamin D deficiency)
Correct before starting treatment.
Nutrition
Patients at increased risk of vitamin D deficiency should receive vitamin D supplementation.
Renal function impairment
Not recommended in severe renal function impairment (Ccr less than 35 mL/min).
Overdosage
Symptoms
Anorexia, hypercalcemia, hypercalciuria, hypocalcemia, hypophosphatemia, lethargy, nausea, polydipsia, polyuria, upper GI adverse reactions (eg, esophagitis, gastritis, heartburn, ulcer, upset stomach), vomiting, weakness.
Patient Information
- Advise patient to read the patient information leaflet before starting therapy and with each refill.
- Instruct patient to take this medication in the morning at least 30 min before the first beverage, food, or medication of the day.
- Instruct the patient to swallow tablet with 6 to 8 oz of water and remain sitting or standing for at least 30 min.
- Advise patient that supplemental calcium may be necessary if dietary intake is inadequate.
- Caution patient not be take this medication at bedtime or before arising for the day.
- Instruct patient that if a dose is missed, to take 1 tablet on the morning after they remember and not to take 2 tablets in the same day but to return to taking 1 tablet once weekly, as originally scheduled.
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