Dosing & Uses
Dosage Forms & Strengths
tablet
- 5mg (generic)
- 10mg (generic)
- 35mg (generic)
- 40mg (generic)
- 70mg (generic, Fosamax)
tablet, effervescent
- 70mg (generic, Binosto)
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
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious (0)
Monitor Closely (19)
- 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.
- palopegteriparatide
alendronate, palopegteriparatide. Other (see comment). Use Caution/Monitor. Comment: Drugs that affect serum calcium may alter palopegteriparaatide therapeutic response. Measure serum calcium more frequently if coadministered, particularly after these drugs are initiated, discontinued, or dose-adjusted.
- 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)
Administration
Oral Administration
Take upon arising for the day
Take at least 30 min before the first food, beverage, or medication of the day with plain water only
Swallow tablet with a full glass of water (6-8 oz); other beverages (eg, mineral water), food, and some medications are likely to reduce the absorption
Waiting <30 min, or taking with food, beverages (other than plain water) or other medications will reduce the efficacy by decreasing its absorption
Do not take at bedtime or before arising for the day
Failure to follow these instructions may increase the risk of esophageal adverse experiences
Effervescent tablet
- Do not swallow or chew undissolved effervescent tablet or allow effervescent tablet to dissolve in their mouths because of the risk for oropharyngeal irritation
- Dissolve effervescent tablet in 4 oz room temperature plain water only (not mineral water or flavored water)
- Wait >5 min after the effervescence stops and then stir buffered solution for ~10 sec and ingest
Missed doses
- If a once-weekly dose is missed, instruct to take 1 dose on the morning as soon as possible; do not take 2 doses on the same day but should return to taking 1 dose once a week, on originally scheduled day
Storage
Tablet: Store at 20-25C (68-77F), excursions permitted to 15-30C (59-86F); keep in well-closed container
Effervescent tablet
- Store at 20-25ºC (68-77ºF), excursions permitted to 15-30ºC (59-86ºF)
- Protect from moisture
- Store tablets in original blister package until use
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Fosamax oral - | 70 mg tablet |  | |
| Alendronate - | 70 mg tablet |  | |
| Alendronate - | 35 mg tablet |  | |
| Alendronate - | 70 mg tablet |  | |
| Alendronate - | 35 mg tablet |  | |
| Alendronate - | 70 mg tablet |  | |
| Alendronate - | 70 mg tablet |  | |
| Alendronate - | 35 mg tablet |  | |
| Alendronate - | 10 mg tablet |  | |
| Alendronate - | 10 mg tablet |  | |
| Alendronate - | 70 mg/75 mL solution |  | |
| Binosto oral - | 70 mg effervescent tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
Alendronate
COMMON BRAND NAME(S): Binosto; Fosamax
USES: What is alendronate used for? Alendronate is commonly used for the following conditions. Treatment or prevention of osteoporosis in women after menopause ; osteoporosis is a condition in which your bones become thin and weak and may break more easily. Treatment of osteoporosis in men Treatment or prevention of osteoporosis caused by steroid drug therapy Treatment of Paget’s Disease , a condition in which your body’s natural bone-building process is disrupted, causing your bones to become weak and misshapen Alendronate may also be used for other conditions as determined by your healthcare provider. How does alendronate work (mechanism of action)? Alendronate slows the natural breakdown of your bones. This helps them stay stronger and reduces the risk for bone fractures. How is alendronate supplied (dosage forms)? Alendronate is available as Binosto, Fosamax, and generic alendronate in the following dosage forms that are taken by mouth. 5 mg oral tablets 10 mg oral tablets 35 mg oral tablets 40 mg oral tablets 70 mg oral tablets 70 mg effervescent tablets for oral solution 70 mg/75 mL oral solution How should I store alendronate? Oral Tablets and Solution. Alendronate oral tablets and solution should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep tightly closed. Protect from light and moisture. Effervescent Tablets. Alendronate effervescent tablets should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Each effervescent tablet should be kept in the original blister pack until ready to use. Store in a cool, dry place. Protect from light and moisture.
HOW TO USE: liquid or tablet that is swallowed, tablet that is dissolved in water
SIDE EFFECTS: What are the most common side effects of alendronate? The most common side effects of alendronate are listed below. Tell your healthcare provider if you have any of these side effects that bother you. Stomach pain Heartburn Constipation Diarrhea Upset stomach or indigestion Bone, joint, or muscle pain (see below) Nausea There may be other side effects of alendronate that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345. What are the serious side effects of alendronate? While less common, the most serious side effects of alendronate are described below, along with what to do if they happen. Severe Allergic Reactions. Alendronate may cause allergic reactions , which can be serious. Stop taking alendronate and get help right away if you have any of the following symptoms of a serious allergic reaction. Breathing problems or wheezing Racing heart Fever or general ill feeling Swollen lymph nodes Swelling of the face, lips, mouth, tongue, or throat Trouble swallowing or throat tightness Itching, skin rash, or pale red bumps on the skin called hives Nausea or vomiting Dizziness, feeling lightheaded, or fainting Stomach cramps Joint pain Esophagus Problems. Taking alendronate by mouth may irritate the esophagus or upper part of your gastrointestinal (GI) tract. This irritation can be worse in people who already have stomach or esophagus problems. In some cases, it can lead to problems such as ulcers, bleeding, or tears in the esophagus, which may require hospitalization. Stop taking alendronate and call your healthcare provider right away if you have any of the following symptoms. Trouble or pain while swallowing Chest pain New or worsening heartburn Low Calcium Level (Hypocalcemia). Alendronate can cause low calcium levels, also known as hypocalcemia , which can be serious. Decreased calcium levels can cause a rare dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium, or who take some medicines for other heart rhythm problems. Call your healthcare provider if you have any of the following symptoms. Changes in your heart rate or rhythm, such as fast or skipping heartbeat Fainting Numbness, tingling, or burning sensation in your arms, feet, or face (paresthesia) Muscle pain, spasms, twitching, or cramps Seizures Severe Pain in the Bones, Joints, or Muscles. Alendronate may cause severe pain in the bones, joints, or muscles ( musculoskeletal pain ). The pain can be severe enough that it could be difficult to carry out normal activities. Call your healthcare provider if you experience severe pain while on alendronate. Severe Jawbone Problems ( Osteonecrosis ). Alendronate can rarely cause severe jawbone problems, also called osteonecrosis of the jaw. In this condition, your jawbone may get damaged due to reduced blood flow. You may be at higher risk if you are undergoing certain dental procedures (such as a tooth extraction or dental implants), if you have poor oral health, or if you have cancer or certain other conditions. You may be told to see a dentist before starting alendronate and to practice good mouth care. Call your healthcare provider right away if you experience any of the following symptoms of jaw osteonecrosis. Jaw pain or discomfort Mouth sores Loose teeth Unusual Thigh Bone Fractures. Alendronate may cause an increased risk for fractures in your thigh bone, even with a light force. Call your healthcare provider if you experience new or unusual pain in your thigh, hip, or groin.
PRECAUTIONS: Who should not use alendronate? Allergies to Ingredients. People who are allergic to any of the following should not take alendronate. Alendronate Fosamax Binosto Any of the ingredients in the specific product dispensed Your pharmacist can tell you all of the ingredients in the specific alendronate products they stock. Esophagus Problems. Alendronate should not be taken if you have problems with your esophagus. Alendronate can cause irritation, inflammation, or sores in your esophagus if you already have esophagus problems. Unable to Sit Upright or Stand. Alendronate is not recommended if you cannot sit upright or stand for at least 30 minutes. You need to be able to sit upright or stand for this long to reduce your risk of irritation of the esophagus. Low Calcium Levels (Hypocalcemia). Alendronate can cause low calcium levels , also known as hypocalcemia . It should not be used if you have low blood calcium levels. Kidney Problems. Alendronate should not be taken if your kidneys are not working as well as they should be. If there is a concern about the health of your kidneys, your healthcare provider may do tests to determine if they are working well enough for you to take this medicine. Risk of Accidental Inhalation ( Aspiration ). Alendronate oral solution is not recommended if you are at an increased risk of accidentally inhaling the liquid into your airway. This can include those who often have trouble swallowing. What should I know about alendronate before using it? Do not take alendronate unless it has been prescribed to you by a healthcare provider. Take it as prescribed. Do not share alendronate with other people, even if they have the same condition as you. It may harm them. Keep alendronate out of the reach of children. Take alendronate after you get up for the day. Take it on an empty stomach, at least 30 minutes before the first food or drink (other than plain water) of the day and before taking any other medicines or supplements. Alendronate will work only if it is taken on an empty stomach. Do not eat or drink anything except plain water, or take other medicines for at least 30 minutes after taking alendronate. Do not take it with mineral water, coffee, tea, soda, or juice. These may make alendronate not work as well. See the Interactions section for more details. In order to lower the risk of irritation of the esophagus, follow the instructions below for the alendronate product prescribed to you. Oral Tablets. Swallow the tablet whole with a full glass (6 to 8 ounces) of plain water. Effervescent Tablets. Dissolve the tablet in a half glass (4 ounces) of plain water at room temperature (do not use hot or cold water). Wait at least 5 minutes after the bubbling stops to make sure that the tablet has completely dissolved. Stir the mixture for about 10 seconds, then drink the entire liquid. Oral Solution. After taking a dose, drink at least a quarter cup (2 ounces) of plain water to make sure that the medicine washes down completely. Sit upright or stand when you take alendronate and afterwards. Do not lie down for at least 30 minutes after you take your dose of alendronate. You may sit, stand, walk, or do other activities where you are upright (like reading). Do not chew or suck on alendronate tablets, including effervescent tablets. This could lead to irritation or sores in the mouth or throat. If you are taking alendronate oral solution, use an accurate measuring device to measure your dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Ask your pharmacist to recommend an appropriate measuring device. Your healthcare provider may tell you to take calcium and vitamin D supplements while using alendronate. Wait at least 30 minutes after taking a dose of alendronate before taking any other medicines or supplements by mouth. Your healthcare provider may recommend that you have a dental exam before starting treatment with alendronate. Talk with your healthcare provider about how long you should use alendronate. What should I tell my healthcare provider before using alendronate? Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if alendronate is right for you. In particular, make sure that you discuss any of the following. Problems Absorbing Nutrients. Tell your healthcare provider if you have been told that you have malabsorption syndrome , a condition where you have trouble absorbing minerals in the stomach or intestines. Alendronate may increase the risk of side effects if you already have this condition. Esophagus, Stomach, or Intestine Problems. Tell your healthcare provider if you have any problems in your upper digestive tract, including Barrett’s esophagus (a condition where the lining of your esophagus thickens), stomach ulcers, or any inflammation. Alendronate can irritate your digestive tract and worsen these conditions. Planned Dental Surgery. Tell your healthcare provider if you are planning to undergo any dental treatments, such as tooth extraction or dental implant surgery, while using alendronate. Certain dental procedures may increase the risk of osteonecrosis of the jaw. Other Current and Past Health Conditions. Tell your healthcare provider if you have any of the following. Trouble swallowing Low calcium levels (hypocalcemia) Kidney problems Poor oral health or dental problems (including use of dentures) Cancer Blood disorders Other Medicines and Supplements. Alendronate may interact with other medicines and supplements. Before using alendronate, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details. Low Sodium Diet. Each effervescent tablet contains 650 mg of sodium. Tell your healthcare provider if you have to maintain low sodium intake. Pregnancy. It is not known if or how alendronate could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant while taking alendronate, stop taking it right away and contact your healthcare provider. Breastfeeding. It is not known if alendronate passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take alendronate while breastfeeding.
DRUG INTERACTIONS: Does alendronate interact with foods or drinks? Avoid eating food or drinking beverages (including mineral water, coffee, tea, soda, juice, or milk) other than plain water within 30 minutes of taking alendronate, because this may decrease the amount of medicine your body absorbs and make it not work as well. It is unknown if drinking alcohol will affect alendronate. Does alendronate interact with other medicines (drug interactions)? Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are using any of the following before using alendronate. An antacid, supplement, or vitamin containing calcium, aluminum, magnesium, or iron A nonsteroidal anti-inflammatory drug (NSAIDs) such as aspirin, ibuprofen, naproxen, and others, which are contained in many prescription and OTC products for pain, swelling, and fever A corticosteroid, which is a medicine for certain inflammatory conditions Chemotherapy or radiation for treating cancer Levothyroxine, which is a thyroid medicine used to raise your thyroid hormone levels This may not be a complete list of medicines that can interact with alendronate. Always check with your healthcare provider.
OVERDOSE: What should I do if I accidentally use too much alendronate? If you or someone else has used too much alendronate, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222. Do not try to vomit. Do not lie down. What should I do if I miss a dose of alendronate? If you miss a dose of alendronate, do not take it later in the day. Take the missed dose the morning after the day you remember, and then return to your normal schedule. Do not take 2 doses on the same day.
Formulary
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.
