Alendronate 35mg Tablets
It is used to prevent or treat soft, brittle bones (osteoporosis).It is used to treat Paget's disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Bone Resorption Inhibitor
Pharmacologic Class
Bisphosphonate
Pregnancy Category
Category C
FDA Approved
Sep 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Alendronate is a medicine that helps make your bones stronger and less likely to break. It's often used to prevent or treat osteoporosis, a condition that causes bones to become weak and brittle.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Take your medication on an empty stomach, before breakfast, and at least 30 minutes before consuming any food, drink, or other medications.
Remain upright for at least 30 minutes after taking your medication to help prevent irritation.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Swallow your medication whole with a full glass of plain water. Avoid taking it with mineral water, milk, or other beverages.
Do not chew, break, or crush your medication. Also, do not suck on the tablet.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
One time daily dosing: If you forget to take your medication in the morning, skip the missed dose and resume your normal schedule the next morning. Do not take two doses on the same day.
One time weekly dosing: If you miss a dose, take it the next morning after you remember, and then return to your regular schedule. Do not take two doses on the same day.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Take your medication on an empty stomach, before breakfast, and at least 30 minutes before consuming any food, drink, or other medications.
Remain upright for at least 30 minutes after taking your medication to help prevent irritation.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Swallow your medication whole with a full glass of plain water. Avoid taking it with mineral water, milk, or other beverages.
Do not chew, break, or crush your medication. Also, do not suck on the tablet.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
One time daily dosing: If you forget to take your medication in the morning, skip the missed dose and resume your normal schedule the next morning. Do not take two doses on the same day.
One time weekly dosing: If you miss a dose, take it the next morning after you remember, and then return to your regular schedule. Do not take two doses on the same day.
Lifestyle & Tips
- Ensure adequate daily intake of calcium and vitamin D through diet or supplements, as recommended by your doctor.
- Engage in regular weight-bearing exercise (e.g., walking, jogging, dancing) to help maintain bone density.
- Avoid smoking and limit alcohol consumption, as these can negatively impact bone health.
- Maintain good oral hygiene and inform your dentist that you are taking alendronate.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
35 mg orally once weekly
Dose Range:
35 - 35 mg
Condition-Specific Dosing:
osteoporosis_prevention_postmenopausal_women:
35 mg orally once weekly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment (CrCl > 60 mL/min)
Moderate:
No adjustment (CrCl 35-60 mL/min)
Severe:
Contraindicated (CrCl < 35 mL/min)
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Alendronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption. It binds to hydroxyapatite crystals in bone, particularly at sites of active bone turnover. This binding prevents osteoclasts from adhering to the bone surface and inhibits their activity, leading to a net increase in bone mineral density and a reduction in fracture risk.
Pharmacokinetics
Absorption:
Bioavailability:
<1%
Tmax:
0.5-1 hour
FoodEffect:
Significantly reduced by food, beverages (other than plain water), and some medications (e.g., calcium, antacids). Bioavailability is reduced by up to 60% when taken with coffee or orange juice.
Distribution:
Vd:
28 L (excluding bone)
ProteinBinding:
~78%
CnssPenetration:
Limited
Elimination:
HalfLife:
>10 years (terminal, due to bone incorporation)
Clearance:
Not applicable (primarily renal excretion of unchanged drug)
ExcretionRoute:
Renal (unchanged)
Unchanged:
~50% (of absorbed dose)
Pharmacodynamics
OnsetOfAction:
Bone turnover markers decrease within weeks
PeakEffect:
Bone mineral density increases over months to years
DurationOfAction:
Long (due to incorporation into bone matrix)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Black, tarry, or bloody stools
Chest pain
Coughing up blood
Heartburn
Trouble swallowing
Severe pain when swallowing
Sore throat
Vomiting blood or coffee ground-like material
Severe bone, joint, or muscle pain
New or unusual groin, hip, or thigh pain
Mouth sores
Jawbone Problems:
This medication may increase the risk of jawbone problems, particularly with long-term use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting disorders, or infection. The risk may also be higher if you have dental work, chemotherapy, radiation, or take other medications that can cause jawbone problems. If you have any of these conditions or concerns, discuss them with your doctor. If you experience jaw swelling or pain, contact your doctor immediately.
Other Side Effects:
Most people experience few or no side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Headache
Muscle or joint pain
Reporting Side Effects:
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Black, tarry, or bloody stools
Chest pain
Coughing up blood
Heartburn
Trouble swallowing
Severe pain when swallowing
Sore throat
Vomiting blood or coffee ground-like material
Severe bone, joint, or muscle pain
New or unusual groin, hip, or thigh pain
Mouth sores
Jawbone Problems:
This medication may increase the risk of jawbone problems, particularly with long-term use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting disorders, or infection. The risk may also be higher if you have dental work, chemotherapy, radiation, or take other medications that can cause jawbone problems. If you have any of these conditions or concerns, discuss them with your doctor. If you experience jaw swelling or pain, contact your doctor immediately.
Other Side Effects:
Most people experience few or no side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Headache
Muscle or joint pain
Reporting Side Effects:
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, difficulty swallowing, or pain when swallowing (stop taking and call your doctor immediately)
- New or worsening heartburn
- Severe muscle, joint, or bone pain
- New or unusual pain in your hip, groin, or thigh (report immediately)
- Jaw pain, numbness, or swelling (report immediately)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Esophageal problems
+ Difficulty swallowing
+ Low calcium levels
+ Kidney disease
* If you are unable to stand or sit upright for 30 minutes
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Esophageal problems
+ Difficulty swallowing
+ Low calcium levels
+ Kidney disease
* If you are unable to stand or sit upright for 30 minutes
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Be aware that this drug can cause severe esophagus problems, such as irritation, swelling, ulcers, and bleeding. Discuss these potential risks with your doctor to understand the benefits and risks associated with this medication.
If you have asthma, note that drugs like this one can worsen asthma symptoms. Consult your doctor to discuss how to manage your asthma while taking this medication.
Additionally, this drug may increase the risk of fractures, particularly in the legs. Talk to your doctor about this potential risk and how to minimize it.
As directed by your doctor, undergo regular bone density tests to monitor the health of your bones. Discuss the results with your doctor to determine the best course of treatment.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements, and engage in weight-bearing exercises, such as walking or physical therapy, as recommended by your doctor. Adhere to the diet and exercise plan outlined by your doctor to ensure optimal results.
Before starting this medication, schedule a dental exam to ensure your teeth and gums are healthy. Practice good oral hygiene and visit your dentist regularly to prevent any potential dental issues.
If you consume alcohol, consult your doctor to discuss any potential risks or interactions. Smokers should also discuss their smoking habits with their doctor to determine the best approach to managing their health.
This medication is not approved for use in children; however, your doctor may prescribe it if the benefits outweigh the risks. If your child is taking this medication, ask your doctor about the potential benefits and risks, and discuss any concerns you may have.
If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately. Additionally, if you are breast-feeding, inform your doctor to discuss any potential risks to your baby and determine the best course of action.
Be aware that this drug can cause severe esophagus problems, such as irritation, swelling, ulcers, and bleeding. Discuss these potential risks with your doctor to understand the benefits and risks associated with this medication.
If you have asthma, note that drugs like this one can worsen asthma symptoms. Consult your doctor to discuss how to manage your asthma while taking this medication.
Additionally, this drug may increase the risk of fractures, particularly in the legs. Talk to your doctor about this potential risk and how to minimize it.
As directed by your doctor, undergo regular bone density tests to monitor the health of your bones. Discuss the results with your doctor to determine the best course of treatment.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements, and engage in weight-bearing exercises, such as walking or physical therapy, as recommended by your doctor. Adhere to the diet and exercise plan outlined by your doctor to ensure optimal results.
Before starting this medication, schedule a dental exam to ensure your teeth and gums are healthy. Practice good oral hygiene and visit your dentist regularly to prevent any potential dental issues.
If you consume alcohol, consult your doctor to discuss any potential risks or interactions. Smokers should also discuss their smoking habits with their doctor to determine the best approach to managing their health.
This medication is not approved for use in children; however, your doctor may prescribe it if the benefits outweigh the risks. If your child is taking this medication, ask your doctor about the potential benefits and risks, and discuss any concerns you may have.
If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately. Additionally, if you are breast-feeding, inform your doctor to discuss any potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Hypocalcemia (low blood calcium, symptoms may include muscle cramps, tingling, numbness)
- Hypophosphatemia (low blood phosphate)
- Upper gastrointestinal upset (e.g., upset stomach, heartburn, esophagitis, gastritis, ulcer)
What to Do:
If overdose is suspected, seek immediate medical attention. Do not induce vomiting. Administer milk or antacids to bind alendronate. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Calcium supplements
- Antacids
- Mineral supplements (e.g., iron, magnesium)
Moderate Interactions
- Aspirin
- NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
Monitoring
Baseline Monitoring
Bone Mineral Density (BMD)
Rationale: To establish baseline bone health and diagnose osteoporosis/osteopenia.
Timing: Before initiating therapy
Serum Calcium
Rationale: To ensure normocalcemia, as hypocalcemia must be corrected before starting alendronate.
Timing: Before initiating therapy
Serum Vitamin D
Rationale: To ensure adequate vitamin D levels, as deficiency must be corrected.
Timing: Before initiating therapy
Renal Function (CrCl)
Rationale: To assess kidney function, as alendronate is renally eliminated and contraindicated in severe impairment.
Timing: Before initiating therapy
Routine Monitoring
Bone Mineral Density (BMD)
Frequency: Every 1-2 years
Target: Improvement or stabilization of T-score/Z-score
Action Threshold: Significant decline in BMD or new fractures may indicate treatment failure or need for re-evaluation.
Serum Calcium
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Normal range (8.5-10.2 mg/dL)
Action Threshold: Hypocalcemia (e.g., <8.5 mg/dL) requires investigation and correction.
Serum Vitamin D
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Sufficient levels (e.g., >30 ng/mL)
Action Threshold: Deficiency requires supplementation.
Renal Function (CrCl)
Frequency: Periodically (e.g., annually or as clinically indicated), especially in elderly patients
Target: >35 mL/min
Action Threshold: Decline to <35 mL/min requires discontinuation.
Symptom Monitoring
- Dysphagia (difficulty swallowing)
- Odynophagia (painful swallowing)
- Retrosternal pain (chest pain behind the breastbone)
- New or worsening heartburn (signs of esophageal irritation/ulceration)
- Severe musculoskeletal pain (muscle, joint, or bone pain)
- New or unusual pain in the hip, groin, or thigh (potential atypical femur fracture)
- Jaw pain, swelling, numbness, or heaviness (potential osteonecrosis of the jaw)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Alendronate is incorporated into the bone matrix and gradually released over years. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show adverse effects at high doses.
Second Trimester:
Potential for fetal bone effects due to long half-life and bone incorporation.
Third Trimester:
Potential for fetal bone effects and hypocalcemia in the mother and neonate.
Lactation
Not recommended. It is unknown if alendronate is excreted in human milk. Due to its long half-life and potential for serious adverse effects on the nursing infant (e.g., hypocalcemia, bone effects), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for serious adverse effects (e.g., hypocalcemia, bone effects) due to unknown excretion into breast milk and long half-life.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended for routine osteoporosis treatment in children.
Geriatric Use
No dosage adjustment is necessary based on age alone. However, renal function often declines with age, and alendronate is contraindicated in patients with severe renal impairment (CrCl < 35 mL/min). Monitor renal function in elderly patients.
Clinical Information
Clinical Pearls
- Take alendronate first thing in the morning, at least 30 minutes before the first food, beverage, or other medication of the day.
- Take with a full glass (6-8 ounces) of plain water only. Do NOT take with mineral water, coffee, juice, milk, or other beverages.
- Swallow the tablet whole. Do NOT chew, crush, or suck the tablet, as this can cause mouth or throat irritation.
- Remain fully upright (sitting or standing) for at least 30 minutes after taking the dose and until after your first food of the day. Do NOT lie down.
- Do not take any other medications, supplements (especially calcium, iron, magnesium), or food for at least 30 minutes after taking alendronate.
- If a weekly dose is missed, take it on the morning after you remember. Do NOT take two doses on the same day. Return to your regular weekly schedule on your originally chosen day.
- Ensure adequate calcium and vitamin D intake through diet or supplementation, as directed by your healthcare provider.
Alternative Therapies
- Other oral bisphosphonates (e.g., risedronate, ibandronate)
- Intravenous bisphosphonates (e.g., zoledronic acid)
- Denosumab (Prolia)
- Teriparatide (Forteo)
- Abaloparatide (Tymlos)
- Romosozumab (Evenity)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., raloxifene)
Cost & Coverage
Average Cost:
Check current per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.