Alendronate Sodium (alendronate sodium)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Alendronate sodium, a synthetic bisphosphonate analog of pyrophosphate, is a bone resorption inhibitor.
Alendronate sodium, a synthetic bisphosphonate (also referred to as diphosphonate) analog of pyrophosphate, is an inhibitor of osteoclast-mediated bone resorption. Alendronate is structurally and pharmacologically related to etidronate and pamidronate. Unlike pyrophosphate but like etidronate and pamidronate, alendronate is resistant to enzymatic hydrolysis by phosphatases.
Alendronate appears to inhibit bone resorption in a dose-dependent manner and is 100-1000 times more potent than etidronate in this effect. In addition, alendronate is a highly selective inhibitor of bone resorption; data from animals indicate that the dose of alendronate that inhibits bone mineralization is up to 6000 times greater than the dose that inhibits resorption. Alendronate is incorporated into bone and has an estimated terminal elimination half-life of at least 10 years in humans; however, while incorporated into bone matrix, the drug is not pharmacologically active.
USES: Alendronate is used to treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. This medication works by slowing bone loss.
This effect helps maintain strong bones and reduce the risk of broken bones (fractures). Alendronate belongs to a class of drugs called bisphosphonates.
Generic name: alendronate sodium
Pronunciation: (a-LEN-droe-nate)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Alendronate Sodium
Indications
The following indications are listed for Alendronate Sodium:
- Osteoporosis In Male Patient
- Postmenopausal Osteoporosis
Also known as: Osteoporosis In Men, Post-Menopausal Osteoporosis.
Dosing
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.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
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.
Contraindications
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.
Adverse reactions
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.
Precautions
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.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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