Alendronate Sodium / Cholecalciferol

Pronunciation: (a-LEN-droe-nate SOE-dee-um/KOE-le-kal-SIF-er-ol)Class: Bisphosphonate combination

Trade Names:Fosamax Plus D- Tablets alendronate 70 mg/cholecalciferol 70 mcg- Tablets alendronate 70 mg/cholecalciferol 140 mcg

Fosavance (Canada)

Pharmacology

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

Adults

PO One 70 mg/70 mcg tablet once weekly or one 70 mg/140 mcg 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 plain 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 supplements

Alendronate absorption may be reduced; take alendronate at least 30 min before other medications.

Anticonvulsants, cimetidine, thiazides

May increase cholecalciferol catabolism.

Aspirin

Incidence 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, orlistat

May impair cholecalciferol absorption.

NSAIDs

Use 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%); 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%); joint swelling, 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

Not indicated for use in children.

Elderly

No overall differences in efficacy or safety between patients 65 years of age and older compared with younger patients.

Renal Function

Not recommended in severe renal function impairment (CrCl less than 35 mL/min).

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.

Musculoskeletal pain

Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported 1 day to several months after starting bisphosphonates.

Nutrition

Patients at increased risk of vitamin D deficiency should receive vitamin D supplementation.

Osteonecrosis of the jaw

Has been reported with bisphosphonates. Risk factors include cancer, concomitant therapies (eg, chemotherapy, corticosteroids, or radiotherapy), poor oral hygiene, and comorbid disorders (eg, anemia, coagulopathy, dental disease, infection).

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 plain 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.

Copyright © 2009 Wolters Kluwer Health.