Alendronate Sodium (alendronate sodium)

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

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.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Oral Bisphosphonates/Oral Multivalent Cations

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Multivalent cations may bind to and inhibit the absorption of oral bisphosphonates.(1-6)

CLINICAL EFFECTS: Simultaneous administration of products containing multivalent cations may result in decreased levels of and clinical effects from oral bisphosphonates.(1-6)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Instruct patients to separate the administration times of products containing multivalent cations and oral bisphosphonates. Manufacturer recommendations regarding the separation of administration times of oral bisphosphonates and multivalent cations vary. Do NOT give multivalent cation-containing products: - until at least 30 minutes after taking alendronate(1) - within 2 hours of etidronate(2) - until at least 1 hour after taking ibandronate(3) - until at least 30 minutes after taking risedronate(4) - within 2 hours of tiludronate(5)

DISCUSSION: Multivalent cations may bind to and inhibit the absorption of oral bisphosphonates, resulting in decreased levels of and clinical effects from these agents.(1-6) Administration of aluminum- or magnesium-containing antacids 1 hour before tiludronate decreased the bioavailability of tiludronate by 60%.(5)

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.

• Achalasia of esophagus
• Hypocalcemia
• Stricture of esophagus

• Arthralgia
• Aseptic necrosis of jaw bone
• Atypical femoral fracture
• Barrett's esophagus
• Bed-ridden
• Duodenitis
• Dysphagia
• Esophageal dysmotility
• Esophageal obstruction
• Esophageal ulcer
• Esophagitis
• Gastritis
• Invasive dental procedure
• Peptic ulcer
• Periodontitis
• Vitamin D deficiency

• Atrial fibrillation

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.

Rare or Very Rare

• Angioedema
• Aseptic necrosis of bone in orofacial region
• Aseptic necrosis of jaw bone
• Asthma exacerbation
• Atypical femoral fracture
• Atypical stress fracture
• Cholesteatoma of external ear
• Duodenal ulcer
• Esophageal perforation
• Esophageal ulcer
• Esophagitis
• Gastric ulcer
• Hypersensitivity drug reaction
• Hypocalcemia
• Hypophosphatemia
• Scleritis
• Stevens-johnson syndrome
• Stricture of esophagus
• Toxic epidermal necrolysis
• Urticaria
• Uveitis

More Frequent

• Acute abdominal pain
• Constipation
• Diarrhea
• Dyspepsia
• Gastroesophageal reflux disease
• Musculoskeletal pain
• Nausea

Less Frequent

• Abdominal distension
• Dysphagia
• Flatulence
• Headache disorder
• Vomiting

Rare or Very Rare

• Alopecia
• Arthralgia
• Black tarry stools
• Bone pain
• Dizziness
• Dysgeusia
• Flu-like symptoms
• Gastritis
• Malaise
• Myalgia
• Peripheral edema
• Pruritus of skin
• Skin photosensitivity
• Skin rash
• Vertigo

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.

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.

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.