Fosamax Plus D (alendronate sodium/cholecalciferol (vitamin D3))

Dietary intake of ergocalciferol and cholecalciferol varies among individual patients, and dietary intake should always be considered when calculating the appropriate dosage of vitamin D analogs. During therapy with vitamin D analogs, dosage depends on the nature and severity of the patient's hypocalcemia and must be individualized to maintain serum calcium concentrations of 9-10 mg/dL. In the management of hypoparathyroidism, pseudohypoparathyroidism, and familial hypophosphatemia, the range between therapeutic and toxic effects is narrow; however, hypercalcemia may occur at any time when therapeutic doses of vitamin D analogs are used, and careful monitoring is imperative. In the management of secondary hyperparathyroidism, dosage of vitamin D analogs should be individualized according to serum or plasma intact parathyroid hormone (iPTH) concentrations and serum calcium and phosphorus concentrations.

During therapy with vitamin D analogs, patients should receive adequate amounts of calcium through management of diet or administration of calcium supplements; however, overdosage of calcium may lead to hypercalcemia. Dosage of vitamin D analogs should be decreased when symptoms improve and before biochemical normality or complete bone healing has occurred because requirements for vitamin D analogs often decrease after bone healing occurs. In patients who become bedridden (especially children), dosage reduction may occasionally be needed to avoid hypercalcemia.

Dosage of alendronate sodium, which is present as the monosodium trihydrate, is expressed in terms of alendronate.

Vitamin D analogs are usually administered orally; however, calcitriol, doxercalciferol, and paricalcitol may be given by IV injection. Ergocalciferol may be given by IM injection; however, a suitable formulation of the drug for IM injection no longer is commercially available in the US.

Alendronate sodium is administered orally as tablets or oral solution. The drug should be taken only upon rising for the day. Alendronate tablets and oral solution have equivalent bioavailability.

The fixed combination of alendronate sodium and cholecalciferol is administered orally as tablets.

To facilitate absorption of alendronate (alone or in fixed combination with cholecalciferol), the drug should be taken with a full glass (180-240 mL) of plain water at least 30 minutes before the first food, beverage, or other orally administered drug of the day; waiting longer than 30 minutes before eating, drinking, or ingesting another drug will improve absorption of alendronate. To facilitate gastric emptying when alendronate oral solution is given, the patient should drink at least 60 mL (2 ounces, 1/4 cup) of water following administration of the drug. Because of the potential for oropharyngeal irritation or ulceration, patients should be instructed not to suck or chew alendronate tablets. Alendronate (alone or in combination with cholecalciferol) should be administered in an upright position (sitting or standing). Patients should be instructed to avoid lying down for at least 30 minutes following administration and until after the first food of the day to facilitate delivery of the drug to the stomach and minimize potential esophageal irritation. (See Upper GI Effects under Cautions: Warning/Precautions.) In addition, patients should be instructed not to take alendronate (alone or in fixed combination with cholecalciferol) at bedtime or before arising for the day.

If a patient misses a weekly dose of alendronate or alendronate/cholecalciferol, the missed dose should be taken the morning after it is remembered, followed by resumption of the regular weekly schedule. Patients should not take 2 tablets on the same day.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Esophageal abnormalities that delay esophageal emptying (e.g., stricture, achalasia).

Use of alendronate oral solution is contraindicated in patients at increased risk of aspiration.

Inability to stand or sit upright for at least 30 minutes.

Hypocalcemia.

Known hypersensitivity to alendronate or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse effects reported in 3% or more of patients receiving alendronate in clinical studies include abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, and nausea.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The manufacturer states that safety and efficacy of alendronate have not been established in children. In a randomized trial in pediatric patients (4-18 years of age) with osteogenesis imperfecta, treatment with alendronate did not reduce the risk of fracture or bone pain; there was an increased incidence of vomiting in children receiving alendronate compared with placebo.

A characteristic physiognomy, possibly with aortic valvular stenosis, retinopathy, and mental and/or physical retardation, has occurred following prolonged hypercalcemia in infants and in neonates of mothers with hypercalcemia during pregnancy. Hypercalcemia during pregnancy may also lead to suppression of PTH concentrations in the neonate resulting in hypocalcemia, tetany, and seizures. Safe use of calcifediol, calcitriol, dihydrotachysterol (no longer commercially available in the US), paricalcitol, or ergocalciferol during pregnancy has not been established; however, the risks to the mother and fetus from untreated hypoparathyroidism or hypophosphatemia may be greater than those resulting from administration of vitamin D analogs.

There are no studies of alendronate in pregnant women; the drug should be used during pregnancy only if the potential benefits justify the potential risks to the mother and fetus.

Safe use of calcifediol, calcitriol, dihydrotachysterol, doxercalciferol, paricalcitol, or ergocalciferol during lactation has not been established; however, the risks to the mother and fetus from untreated hypoparathyroidism or hypophosphatemia may be greater than those resulting from administration of vitamin D analogs. Large doses of vitamin D analogs should not be administered to nursing women.

It is not known whether alendronate is distributed into human milk. Because many drugs are distributed into human milk, caution is advised when alendronate is used in nursing women.

No substantial differences in safety and efficacy have been observed in geriatric patients relative to younger adults. However, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.