Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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)
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
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.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)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Fosamax oral - | 70 mg tablet |  | |
| alendronate oral - | 70 mg tablet |  | |
| alendronate oral - | 35 mg tablet |  | |
| alendronate oral - | 35 mg tablet |  | |
| alendronate oral - | 10 mg tablet |  | |
| alendronate oral - | 70 mg tablet |  | |
| alendronate oral - | 10 mg tablet |  | |
| alendronate oral - | 70 mg tablet |  | |
| alendronate oral - | 70 mg tablet |  | |
| alendronate oral - | 35 mg tablet |  | |
| alendronate oral - | 70 mg/75 mL solution |  | |
| alendronate oral - | 70 mg/75 mL solution |  | |
| alendronate oral - | 35 mg tablet |  | |
| Binosto oral - | 70 mg effervescent tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
alendronate oral
ALENDRONATE - ORAL
(a-LEN-droe-nate)
COMMON BRAND NAME(S): Fosamax
USES: Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time.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.Take this medication by mouth once a day, after getting up for the day and before taking your first food, beverage, or other medication. Take it with a full glass (6-8 ounces or 180-240 milliliters) of plain water. Swallow the tablet whole. Do not chew or suck on it. 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 use it at the same time each morning. 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 last or get worse, 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, increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, swelling of joints/hands/ankles/feet, 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.Tell your doctor if you are pregnant or plan to become pregnant. Alendronate may stay in your body for many years. You should not become pregnant while using alendronate. Discuss the risks and benefits with your doctor.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.Lab and/or medical tests (X-rays, height measurement, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, skip the missed dose. Take your next dose at the regular time the following day. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not 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 January 2023. Copyright(c) 2023 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.
Formulary
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