alendronate (Rx)

Brand and Other Names:Fosamax, Binosto, more...Fosamax Plus D
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 5mg (generic)
  • 10mg (generic)
  • 35mg (generic)
  • 40mg (generic)
  • 70mg (generic, Fosamax)

tablet, effervescent

  • 70mg (generic, Binosto)

solution, oral

  • 70mg/75mL (generic, Fosamax)

Osteoporosis

Postmenopausal women

  • Indicated for treatment and prevention of osteoporosis in postmenopausal women
  • Prevention
    • Fosamax: 5 mg PO qDay or 35 mg PO once weekly
  • Treatment
    • Fosamax: 10 mg PO qDay or 70 mg (tablet and oral solution) once weekly
    • Binosto: 70 mg PO once weekly

Men

  • Fosamax: 10 mg PO qDay or 70 mg (tablet and oral solution) once weekly
  • Binosto: 70 mg PO once weekly

Glucocorticoid-Induced Osteoporosis

Fosamax only

Indicated for treatment of glucocorticoid-induced osteoporosis

Males and females: 5 mg PO qDay

Postmenopausal women not on hormone replacement therapy: 10 mg PO qDay

Paget Disease

Fosamax only

Indicated for treatment of Paget disease of bone

40 mg PO qDay for 6 months

Dosing Modifications

Renal impairment

  • Mild-to-moderate renal impairment (CrCl 35-60 mL/min): Dose adjustment not necessary
  • Severe renal impairment (CrCl <35 mL/min): Not recommended

Hepatic impairment

  • No dosage adjustment necessary
  • As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment

Dosing Considerations

Limitation of Use

  • Optimal duration of use not determined; for patients at low-risk for fracture, consider drug discontinuation after 3-5 years of use

Safety and efficacy not established

Osteogenesis Imperfecta (Orphan)

Treatment in pediatric patients aged 4 years or older

Orphan indication sponsor

  • Merck, Sharpe & Dohme Corp; 126 East Lincoln Ave, PO Box 2000; Rahway, NJ 07065-0900

Gaucher Disease (Orphan)

Treatment of bone manifestations of disease

Orphan indication sponsor

  • Richard J Wenstrup, MD; Division of Human Genetics, Children's Hospital Research Foundation; Cincinnati, OH 45229-3039
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Interactions

Interaction Checker

and alendronate

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (1)

            • human parathyroid hormone, recombinant

              alendronate decreases effects of human parathyroid hormone, recombinant by Other (see comment). Contraindicated. Comment: Coadministration of bisphosphonates with rhPTH leads to reduction in rhPTH's calcium sparing effect, which can interfere with the normalization of serum calcium.

            Serious - Use Alternative (0)

              Monitor Closely (18)

              • aluminum hydroxide

                aluminum hydroxide decreases levels of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • calcium acetate

                calcium acetate decreases levels of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium carbonate

                calcium carbonate decreases levels of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium chloride

                calcium chloride decreases levels of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium citrate

                calcium citrate decreases levels of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium gluconate

                calcium gluconate decreases levels of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • deferasirox

                deferasirox, alendronate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.

              • magnesium supplement

                magnesium supplement will decrease the level or effect of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Formation of a chelate reduces absorption of the drug through intestinal tract; administer magnesium 2hr before or 2hr after the bisphosphonate derivative

              • nizatidine

                nizatidine will increase the level or effect of alendronate by unknown mechanism. Use Caution/Monitor.

              • selenium

                selenium will decrease the level or effect of alendronate by cation binding in GI tract. Modify Therapy/Monitor Closely. Avoid administering polyvalent cations 2 hr before or 30 min after alendronate.

              • sodium bicarbonate

                sodium bicarbonate decreases levels of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • sodium citrate/citric acid

                sodium citrate/citric acid decreases levels of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • sodium sulfate/?magnesium sulfate/potassium chloride

                sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of alendronate by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • sodium sulfate/potassium sulfate/magnesium sulfate

                sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of alendronate by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • sucroferric oxyhydroxide

                sucroferric oxyhydroxide decreases levels of alendronate by drug binding in GI tract. Use Caution/Monitor. Do not administer at the same time; take alendronate at least 1 hr before sucroferric oxyhydroxide.

              • trimagnesium citrate anhydrous

                trimagnesium citrate anhydrous decreases levels of alendronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              • voclosporin

                voclosporin, alendronate. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              • zinc

                zinc will decrease the level or effect of alendronate by cation binding in GI tract. Modify Therapy/Monitor Closely. Multivalent cation-containing products may interfere with absorption of alendronate. Administer alendronate at least 30 min before taking any other oral medications.

              Minor (39)

              • aceclofenac

                aceclofenac, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • acemetacin

                acemetacin, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • aspirin

                aspirin, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • aspirin rectal

                aspirin rectal, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • celecoxib

                celecoxib, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • choline magnesium trisalicylate

                choline magnesium trisalicylate, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • diclofenac

                diclofenac, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • diflunisal

                diflunisal, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • entecavir

                alendronate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.

              • etodolac

                etodolac, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • famotidine

                famotidine increases levels of alendronate by unspecified interaction mechanism. Minor/Significance Unknown. Monitor for increase in alendronate side effects.

              • fenoprofen

                fenoprofen, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • flurbiprofen

                flurbiprofen, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • foscarnet

                foscarnet increases effects of alendronate by pharmacodynamic synergism. Minor/Significance Unknown. Risk of severe hypocalcemia.

              • ibuprofen

                ibuprofen, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • ibuprofen IV

                ibuprofen IV, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • ibuprofen/famotidine

                ibuprofen/famotidine increases levels of alendronate by unspecified interaction mechanism. Minor/Significance Unknown. Monitor for increase in alendronate side effects.

              • indomethacin

                indomethacin, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • ketoprofen

                ketoprofen, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • ketorolac

                ketorolac, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • ketorolac intranasal

                ketorolac intranasal, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • levothyroxine

                levothyroxine decreases levels of alendronate by unspecified interaction mechanism. Minor/Significance Unknown. Bioavailability of alendronate decreases slightly.

              • lornoxicam

                lornoxicam, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • meclofenamate

                meclofenamate, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • mefenamic acid

                mefenamic acid, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • meloxicam

                meloxicam, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • nabumetone

                nabumetone, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • naproxen

                naproxen, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • oxaprozin

                oxaprozin, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • parecoxib

                parecoxib, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • piroxicam

                piroxicam, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • salicylates (non-asa)

                salicylates (non-asa), alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • salsalate

                salsalate, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • sulfasalazine

                sulfasalazine, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • sulindac

                sulindac, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • teriparatide

                teriparatide, alendronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.

              • tolfenamic acid

                tolfenamic acid, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

              • tolmetin

                tolmetin, alendronate. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI ulceration.

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              Adverse Effects

              1-10%

              Daily dosing

              • Abdominal pain (2.1-6.6%)
              • Musculoskeletal (bone, muscle or joint) pain (4.1%)
              • Acid regurgitation (2-4.1%)
              • Flatulence (2.6-4.1%)
              • Nausea (0.6-3.6%)
              • Dyspepsia (3.4-3.6%)
              • Constipation (1.3-3.1%)
              • Diarrhea (1.4-3.1%)
              • Headache (0.6-2.6%)
              • Esophageal ulcer (1.5%)
              • Vomiting (1%)
              • Dysphagia (1%)
              • Abdominal distention (1%)

              Weekly dosing

              • Abdominal pain (1.7-3.7%)
              • Musculoskeletal pain (2.9%)
              • Dyspepsia (1.9-2.7%)
              • Acid regurgitation (1.4-1.9%)
              • Nausea (1.4-1.9%)
              • Abdominal distention (1%)
              • Constipation (0.8%)
              • Flatulence (0.4%)
              • Gastritis (0.2%)
              • Muscle pain (0.2%)

              <1%

              Daily dosing

              • Gastroesophageal reflux disease (0.7%)
              • Senses taste perversion (0.5%)
              • Gastritis (0.5%)

              Weekly dosing

              • Musculoskeletal pain (0.8%)
              • Constipation (0.8-0.9%)
              • Flatulence (0.4%)
              • Gastritis (0.2%)
              • Muscle pain (0.2%)
              • Abdominal distention (0.2%)

              Postmarketing Reports

              Body as a whole: Hypersensitivity reactions including urticaria and angioedema; transient myalgia, malaise, asthenia, and fever; symptomatic hypocalcemia; peripheral edema

              Gastrointestinal: Esophagitis, esophageal erosions, esophageal ulcers, esophageal stricture or perforation, and oropharyngeal ulceration; gastric or duodenal ulcers

              Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing

              Musculoskeletal: Bone, joint, and/or muscle pain, occasionally severe, and incapacitating; joint swelling; low-energy femoral shaft and subtrochanteric fractures

              Nervous system: dizziness, vertigo

              Pulmonary: Acute asthma exacerbations

              Skin: Rash (occasionally with photosensitivity), pruritus, alopecia, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis

              Special Senses: Uveitis, scleritis, or episcleritis, cholesteatoma of the external auditory canal (focal osteonecrosis)

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              Warnings

              Contraindications

              Hypersensitivity

              Hypocalcemia

              Abnormalities of the esophagus delaying esophageal emptying such as stricture or achalasia

              Inability to stand or sit upright for 30 minutes

              Cautions

              May cause local irritation of upper GI mucosa

              Take with plain water only, not coffee, juice, or mineral water; sit or stand upright for at least 30 minutes after administration

              Hypocalcemia reported with use of bisphosphonates; correct hypocalcemia prior to therapy; ensure adequate calcium and vitamin D intake

              Conjunctivitis, uveitis, episcleritis, and scleritis reported with alendronate use; perform ophthalmic evaluation in patients with signs of ocular inflammation

              Osteonecrosis of the jaw, can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders; risk of osteonecrosis of the jaw may increase with duration of exposure to bisphosphonates

              Not recommended in severe renal impairment (CrCl <35 mL/min)

              In Paget disease, drug is available only through Paget's Patient Support Program with Pharma Care Specialty Pharmacy (800-238-7828 x58197) distribution system for 40-mg dosage regimen

              Risk of severe bone, joint, or muscle pain; discontinue therapy in patients who experience severe symptoms of pain; avoid use in patients with history of these symptoms in association with bisphosphonate therapy

              Possible increased risk of atypical subtrochanteric and diaphyseal femur fractures; may consider discontinuing therapy after 3-5 years in patients at low-risk for fracture; following discontinuation, re-evaluate fracture risk periodically; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment lasts >5 years; patients with new thigh or groin pain should be evaluated to rule out a femoral fracture

              Use effervescent tablet with caution in sodium-restricted patients (tablet contains 603 mg sodium, equivalent to approximately 1532 of NaCl or salt)

              Drug interaction overview

              Calcium supplements/antacids
              • Coadministration with calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of alendronate
              Aspirin
              • In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of alendronate sodium greater than 10 mg and aspirin-containing products
              Nonsteroidal anti-inflammatory drugs (NSAIDs)
              • Use with caution
              • In a clinical study which a majority of patients received concomitant NSAIDs, the incidence of upper gastrointestinal adverse events was similar in alendronate-treated group compared to placebo
              Levothyroxine
              • Bioavailability of alendronate was slightly decreased when alendronate and levothyroxine were coadministered to healthy subjects
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              Pregnancy & Lactation

              Pregnancy

              Available data on use in pregnant women insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes; discontinue when pregnancy recognized.

              Animal data

              • In animal reproduction studies, daily oral administration to rats from before mating through end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting at doses equivalent to less than half of highest recommended 40 mg clinical daily dose (based on body surface area, mg/m2)
              • Oral administration to rats during organogenesis resulted in reduced fetal ossification starting at doses 3 times clinical daily dose of 40 mg;
              • No similar fetal effects 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
              • Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years; based on 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
              • Impact of variables such as time between cessation of bisphosphonate therapy to conception, particular bisphosphonate used, and route of administration (intravenous versus oral) on risk not studied

              Lactation

              Not known whether drug present in human breast mild, affects milk production or has effects on infants

              Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential effects on breastfed child from drug or underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Bisphosphonate; binds to hydroxyapatite crystals in bone and inhibits osteoclast-mediated bone resorption; decreases mineral release and collagen or matrix breakdown in bone

              Absorption

              Bioavailability (fasting): Women, 0.64%; men, 0.59%; reduced up to 60% by food

              Onset: 3 weeks

              Duration: 12-30 weeks (multiple doses)

              Distribution

              Protein bound: 78%

              Vd: 28 L (exclusive of bone)

              Metabolism

              Not metabolized

              Elimination

              Half-life: Up to 10 years in bone (terminal)

              Excretion: Urine 50%, feces (unabsorbed drug)

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Fosamax oral
              -
              70 mg tablet
              alendronate oral
              -
              70 mg tablet
              alendronate oral
              -
              35 mg tablet
              alendronate oral
              -
              10 mg tablet
              alendronate oral
              -
              35 mg tablet
              alendronate oral
              -
              70 mg tablet
              alendronate oral
              -
              10 mg tablet
              alendronate oral
              -
              35 mg tablet
              alendronate oral
              -
              70 mg tablet
              alendronate oral
              -
              5 mg tablet
              alendronate oral
              -
              70 mg tablet
              alendronate oral
              -
              10 mg tablet
              alendronate oral
              -
              35 mg tablet
              alendronate oral
              -
              70 mg tablet
              alendronate oral
              -
              70 mg tablet
              alendronate oral
              -
              35 mg tablet
              alendronate oral
              -
              40 mg tablet
              alendronate oral
              -
              35 mg tablet
              alendronate oral
              -
              70 mg/75 mL solution
              Binosto oral
              -
              70 mg effervescent tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              alendronate oral

              ALENDRONATE 70 MG WEEKLY SOLUTION - ORAL

              (a-LEN-droe-nate)

              COMMON BRAND NAME(S): Fosamax

              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.

              HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking alendronate and each time you get a refill. Follow the instructions very closely to make sure your body absorbs as much drug as possible and to reduce the risk of injury to your esophagus. If you have any questions, ask your doctor or pharmacist.This medication is taken once per week. Choose the day of the week that best fits your schedule and take it on that day each week.Take this medication by mouth, after getting up for the day and before taking your first food, beverage, or other medication. Drink at least 2 ounces (60 milliliters) of plain water after taking liquid alendronate. Then stay fully upright (sitting, standing, or walking) for at least 30 minutes and do not lie down until after your first food of the day. Alendronate works only if taken on an empty stomach. Wait at least 30 minutes (preferably 1 to 2 hours) after taking the medication before you eat or drink anything other than plain water.Do not take this medication at bedtime or before rising for the day. It may not be absorbed and you may have side effects.Calcium or iron supplements, vitamins, antacids, coffee, tea, soda, mineral water, calcium-enriched juices, and food can decrease the absorption of alendronate. Do not take these for at least 30 minutes (preferably 1 to 2 hours) after taking alendronate.Take this medication regularly to get the most benefit from it. Remember to take it on the same day each week. It may help to mark your calendar with a reminder. Talk to your doctor about the risks and benefits of long-term use of this medication.

              SIDE EFFECTS: Stomach pain, constipation, diarrhea, gas, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: jaw/ear pain, swelling of joints/hands/ankles/feet, increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, black/tarry stools, vomit that looks like coffee grounds.This medication may rarely cause serious irritation and ulcers of the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking alendronate and talk to your doctor or pharmacist right away: new or worsening heartburn, chest pain, pain or difficulty when swallowing.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking alendronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: disorders of the esophagus (such as esophageal stricture or achalasia), trouble swallowing, trouble standing or sitting upright for at least 30 minutes, low calcium levels, kidney problems, stomach/intestinal disorders (such as ulcers).Some people taking alendronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking alendronate before your surgery. Follow all instructions about stopping or starting this medication.This drug is not recommended for use in children. Studies have shown that many children who took this drug had severe side effects such as vomiting, fever, and flu-like symptoms.Caution is advised if you are pregnant or planning to become pregnant in the future. Alendronate may stay in your body for many years. Its effects on an unborn baby are unknown. Discuss the risks and benefits with your doctor before starting treatment with alendronate.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, painful heartburn, pain in the esophagus (chest pain), muscle weakness/cramps, mental/mood changes.

              NOTES: Do not share this medication with others.Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice.Laboratory and/or medical tests (X-rays, height measurement, blood mineral levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it the next morning after you remember. Then go back to your weekly dosing schedule on your usual day of the week. Do not take two doses on the same day.

              STORAGE: Store at room temperature away from light and moisture. Do not freeze or store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
              Additional Offers
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.