Alendronate and cholecalciferol
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From MedlinePlus, U.S. National Library of Medicine
Vitamin D
Dosing in kidney impairment
Renal Impairment FOSAMAX PLUS D is not recommended for patients with creatinine clearance less than 35 mL/min . No dosage adjustment is necessary in patients with creatinine clearance values between 35-60 mL/min [see Clinical Pharmacology ] .
Dosing in liver impairment
Hepatic Impairment Alendronate Sodium As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary [see Clinical Pharmacology ] . Cholecalciferol Vitamin D 3 may not be adequately absorbed in patients who have malabsorption due to inadequate bile production.
Preparation and administration
Important Administration Instructions Instruct patients to do the following: Take FOSAMAX PLUS D at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information ] . Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate [see Drug Interactions ] .
Waiting less than 30 minutes, or taking FOSAMAX PLUS D with food, beverages (other than plain water) or other medications will lessen the effect of alendronate by decreasing its absorption into the body. Take FOSAMAX PLUS D upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX PLUS D tablet should be swallowed with a full glass of water (6-8 ounces).
Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX PLUS D should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences [see Warnings and Precautions and Patient Counseling Information ] .
Administration Instructions for Missed Doses If a once-weekly dose of FOSAMAX PLUS D is missed, instruct patients to take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
Drug interactions
Check alendronate and cholecalciferol against a medication listLabel text (6 paragraphs)
Calcium supplements/antacids or oral medications containing multivalent cations interfere with absorption of alendronate. ( 2.3 , 7.1 ) Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. ( 7.2 , 7.3 ) Some drugs may impair the absorption or increase the catabolism of cholecalciferol (vitamin D 3 ). Additional vitamin D supplementation should be considered. ( 7.4 , 7.5 , 12.3 )
7.1 Calcium Supplements/Antacids Co-administration of FOSAMAX PLUS D and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of alendronate. Therefore, instruct patients to wait at least one-half hour after taking FOSAMAX PLUS D before taking any other oral medications.
7.2 Aspirin In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of FOSAMAX greater than 10 mg and aspirin-containing products.
7.3 Nonsteroidal Anti-Inflammatory Drugs FOSAMAX PLUS D may be administered to patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). In a 3-year, controlled, clinical study (n=2027) during which a majority of patients received concomitant NSAIDs, the incidence of upper gastrointestinal adverse events was similar in patients taking FOSAMAX 5 or 10 mg/day compared to those taking placebo. However, since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with FOSAMAX PLUS D.
7.4 Drugs that May Impair the Absorption of Cholecalciferol Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g., cholestyramine, colestipol) may impair the absorption of vitamin D. Additional vitamin D supplementation should be considered [see Clinical Pharmacology (12.3) ] .
7.5 Drugs that May Increase the Catabolism of Cholecalciferol Anticonvulsants, cimetidine, and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplementation should be considered [see Clinical Pharmacology (12.3) ] .
Supplement interactions
Dietary supplement interactions
1 noted- Magnesium-rich supplements or medications can decrease the absorption of oral bisphosphonates, such as alendronate (Fosamax), that are used to treat osteoporosis. Taking magnesium-rich supplements or medications at least 2 hours before or after oral bisphosphonates can minimize this interaction.
Contraindications
4 CONTRAINDICATIONS FOSAMAX PLUS D is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.1) ] Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] Hypocalcemia [see Warnings and Precautions (5.2) ] Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported [see Adverse Reactions (6.2) ] .
Abnormalities of the esophagus which delay emptying such as stricture or achalasia ( 4 , 5.1 ) Inability to stand/sit upright for at least 30 minutes ( 2.3 , 4 , 5.1 ) Hypocalcemia ( 4 , 5.2 ) Hypersensitivity to any component of this product ( 4 , 6.2 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for alendronate and cholecalciferol. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data on the use of FOSAMAX plus vitamin D use in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue FOSAMAX PLUS D when pregnancy is recognized. Alendronate Sodium In animal reproduction studies, daily oral administration of alendronate to rats from before mating through the end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting at doses equivalent to less than half of the highest recommended 40 mg clinical daily dose (based on body surface area, mg/m 2 ).
Oral administration of alendronate to rats during organogenesis resulted in reduced fetal ossification starting at doses 3 times the 40 mg clinical daily dose. No similar fetal effects were observed in pregnant rabbits dosed orally during organogenesis at doses equivalent to approximately 10 times the 40 mg clinical daily dose. Delayed or failed delivery of offspring, protracted parturition, and late pregnancy maternal and fetal deaths due to maternal hypocalcemia occurred in rats at oral doses as low as one tenth the 40 mg clinical daily dose (see Data ) . Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years.
The amount of bisphosphonate incorporated into adult bone and available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. Consequently, based on the mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.
Cholecalciferol No data are available for cholecalciferol (vitamin D 3 ) in animals. However, administration of high doses of vitamin D 2 to pregnant rabbits resulted in abortions and an increased incidence of fetal aortic stenosis. Administration of high doses of vitamin D 2 to pregnant rats resulted in neonatal death, decreased fetal weight, and impaired osteogenesis of long bones postnatally. (See Data .) The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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