Alendronate 10mg 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 medication used to strengthen bones and prevent fractures, especially in people with osteoporosis. It works by slowing down the natural process of bone breakdown in your body.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow these instructions carefully:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions closely.
Take your medication on an empty stomach, at least 30 minutes before eating, drinking, or taking any other medications for the day.
After taking your medication, remain upright for at least 30 minutes to help prevent irritation.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
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
To ensure the safety and effectiveness of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications 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 by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these guidelines:
For once-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.
* For once-weekly dosing: If you miss a dose, take it the next morning as soon as 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 these instructions carefully:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions closely.
Take your medication on an empty stomach, at least 30 minutes before eating, drinking, or taking any other medications for the day.
After taking your medication, remain upright for at least 30 minutes to help prevent irritation.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
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
To ensure the safety and effectiveness of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications 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 by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these guidelines:
For once-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.
* For once-weekly dosing: If you miss a dose, take it the next morning as soon as you remember, and then return to your regular schedule. Do not take two doses on the same day.
Lifestyle & Tips
- Take the tablet first thing in the morning, immediately after getting out of bed, with a full glass (6-8 ounces) of plain water only. Do NOT use mineral water, coffee, juice, or milk.
- Swallow the tablet whole; do not chew, crush, or suck on it, as this can cause mouth or throat irritation.
- After taking the tablet, remain in an upright position (sitting or standing) for at least 30 minutes and until after your first food of the day. Do not lie down.
- Do not eat, drink anything other than plain water, or take any other medications (including antacids, calcium supplements, or vitamins) for at least 30 minutes after taking alendronate.
- Ensure adequate intake of calcium and vitamin D through diet or supplements, as recommended by your doctor. These are essential for bone health.
- Maintain good oral hygiene and have regular dental check-ups, especially if you have risk factors for jaw problems.
- Engage in weight-bearing exercise as appropriate for your condition, as this can help strengthen bones.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally once daily for treatment of osteoporosis in postmenopausal women and men, or 5 mg orally once daily for prevention of osteoporosis in postmenopausal women.
Dose Range:
5 - 40 mg
Condition-Specific Dosing:
osteoporosis_treatment:
10 mg orally once daily or 70 mg orally once weekly
osteoporosis_prevention:
5 mg orally once daily or 35 mg orally once weekly
glucocorticoid_induced_osteoporosis:
5 mg orally once daily (10 mg orally once daily for postmenopausal women not receiving estrogen)
pagets_disease:
40 mg orally once daily for 6 months
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (limited use in osteogenesis imperfecta, but not FDA approved for this indication)
Adolescent:
Not established (limited use in osteogenesis imperfecta, but not FDA approved for this indication)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 60 mL/min)
Moderate:
No adjustment needed (CrCl 35-60 mL/min)
Severe:
Contraindicated (CrCl < 35 mL/min)
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Alendronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption. It binds to hydroxyapatite in bone and specifically inhibits the activity of osteoclasts, the cells responsible for bone breakdown. This leads to a net increase in bone mineral density and a reduction in fracture risk.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 0.64% for 10 mg dose (when taken 2 hours before breakfast)
Tmax:
0.5 to 1 hour
FoodEffect:
Significantly reduced by food, beverages (other than plain water), and some medications (e.g., calcium, antacids) if taken within 30 minutes of alendronate.
Distribution:
Vd:
Approximately 28 L (excluding bone)
ProteinBinding:
Approximately 78%
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life >10 years (due to release from bone)
Clearance:
Renal clearance is approximately 200 mL/min in healthy individuals
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
Approximately 100% (of absorbed dose)
Pharmacodynamics
OnsetOfAction:
Weeks to months (for measurable effects on bone turnover markers)
PeakEffect:
Months (for maximal increase in bone mineral density)
DurationOfAction:
Long-lasting due to incorporation into bone matrix; effects persist for months after discontinuation.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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 material that looks like coffee grounds
Severe bone, joint, or muscle pain
New or unusual pain in the groin, hip, or thigh area
Mouth sores
Jawbone Problems
This medication may increase the risk of jawbone problems, particularly with long-term use or in people with certain medical conditions, such as cancer, dental problems, or blood clotting disorders. Other factors that may increase the risk include ill-fitting dentures, anemia, infection, dental work, chemotherapy, radiation, or taking other medications that may cause jawbone problems. If you have any concerns or questions, discuss them with your doctor. Seek medical attention immediately if you experience jaw swelling or pain.
Other Side Effects
As with any medication, you may experience side effects. While many people do not have any side effects or only have mild ones, it is essential to contact your doctor or seek medical help if you experience any of the following:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Headache
Muscle or joint pain
These are not all the possible side effects of this medication. 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 notice any of the following symptoms, contact your doctor or seek medical attention 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 material that looks like coffee grounds
Severe bone, joint, or muscle pain
New or unusual pain in the groin, hip, or thigh area
Mouth sores
Jawbone Problems
This medication may increase the risk of jawbone problems, particularly with long-term use or in people with certain medical conditions, such as cancer, dental problems, or blood clotting disorders. Other factors that may increase the risk include ill-fitting dentures, anemia, infection, dental work, chemotherapy, radiation, or taking other medications that may cause jawbone problems. If you have any concerns or questions, discuss them with your doctor. Seek medical attention immediately if you experience jaw swelling or pain.
Other Side Effects
As with any medication, you may experience side effects. While many people do not have any side effects or only have mild ones, it is essential to contact your doctor or seek medical help if you experience any of the following:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Headache
Muscle or joint pain
These are not all the possible side effects of this medication. 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, new or worsening heartburn, or difficulty/painful swallowing (stop taking and contact your doctor immediately, as these may indicate esophageal irritation or ulceration).
- Severe bone, joint, or muscle pain (contact your doctor).
- New or unusual pain in your thigh, hip, or groin (contact your doctor immediately, as this could be a sign of an atypical femur fracture).
- Jaw pain, swelling, numbness, or a 'heavy jaw' sensation (contact your doctor, as this could be a sign of osteonecrosis of the jaw).
- Blurred vision, eye pain, or redness (rare, but contact your doctor).
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 consulting your doctor first.
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 consulting your doctor first.
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, it is crucial to combine it with calcium and vitamin D supplements, as well as engage in weight-bearing exercises like walking or physical therapy. Adhere to the diet and exercise plan recommended 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 the potential risks and benefits. Smokers should also talk to their doctor about the potential interactions between smoking and this medication.
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 breastfeeding, 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, it is crucial to combine it with calcium and vitamin D supplements, as well as engage in weight-bearing exercises like walking or physical therapy. Adhere to the diet and exercise plan recommended 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 the potential risks and benefits. Smokers should also talk to their doctor about the potential interactions between smoking and this medication.
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 breastfeeding, 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), which may cause muscle cramps, spasms, or numbness/tingling around the mouth or in the fingers and toes.
- Hypophosphatemia (low blood phosphate).
- Upper gastrointestinal adverse events such as upset stomach, heartburn, esophagitis, gastritis, or ulcer.
What to Do:
There is no specific antidote. Management involves symptomatic treatment. Milk or antacids may be given to bind alendronate. Contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Calcium supplements, antacids, and other oral medications containing polyvalent cations (e.g., magnesium, aluminum, iron): Significantly interfere with alendronate absorption if taken concurrently or within 30 minutes. Must be separated by at least 30 minutes.
- Mineral water (high calcium content): Can reduce alendronate absorption if taken within 30 minutes.
Moderate Interactions
- NSAIDs (Nonsteroidal Anti-inflammatory Drugs): Concurrent use may increase the risk of upper gastrointestinal adverse events (e.g., irritation, ulcers).
- H2-receptor antagonists and proton pump inhibitors (PPIs): May slightly increase alendronate absorption, but clinical significance is generally low.
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To ensure appropriate dosing and rule out contraindication (CrCl < 35 mL/min).
Timing: Prior to initiation
Serum calcium, phosphorus, magnesium
Rationale: To correct pre-existing hypocalcemia or other mineral imbalances, which must be corrected before starting therapy.
Timing: Prior to initiation
25-hydroxyvitamin D (Vitamin D levels)
Rationale: To ensure adequate vitamin D status, as vitamin D deficiency impairs calcium absorption and can worsen hypocalcemia.
Timing: Prior to initiation
Dental examination
Rationale: To identify and address any pre-existing dental issues, especially for patients with risk factors for osteonecrosis of the jaw (ONJ).
Timing: Prior to initiation (especially for patients with cancer, on chemotherapy, corticosteroids, or poor oral hygiene)
Routine Monitoring
Serum calcium, phosphorus, magnesium
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Normal physiological range
Action Threshold: Correct any abnormalities (especially hypocalcemia) promptly.
Renal function (CrCl)
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: > 35 mL/min
Action Threshold: Discontinue if CrCl falls below 35 mL/min.
Bone Mineral Density (BMD) via DXA scan
Frequency: Every 1-2 years
Target: Improvement or stabilization of T-score
Action Threshold: Consider alternative therapy if BMD continues to decline or fractures occur.
Symptom Monitoring
- New or worsening heartburn
- Difficulty swallowing (dysphagia)
- Painful swallowing (odynophagia)
- Chest pain (suggestive of esophageal irritation)
- Severe bone, joint, or muscle pain
- New or unusual pain in the thigh, hip, or groin (may indicate atypical femur fracture)
- Jaw pain, swelling, or numbness, or 'heavy jaw' sensation (may indicate osteonecrosis of the jaw)
- Visual disturbances or eye pain (rare, but reported ocular inflammation)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Alendronate should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Bisphosphonates are incorporated into the bone matrix and are gradually released over years. The extent of fetal exposure is unknown.
Trimester-Specific Risks:
First Trimester:
Limited human data. Potential for fetal exposure due to long half-life in bone.
Second Trimester:
Limited human data. Potential for fetal exposure due to long half-life in bone.
Third Trimester:
Limited human data. Potential for fetal exposure due to long half-life in bone. Concerns about potential effects on fetal bone mineralization.
Lactation
L3 (Moderately safe). It is not known whether alendronate is excreted in human milk. Due to its low oral bioavailability and high protein binding, systemic exposure in the infant is expected to be low. However, caution should be exercised when alendronate is administered to a nursing mother.
Infant Risk:
Low risk of adverse effects to the infant due to poor oral absorption and high protein binding, but potential for accumulation in infant bone is unknown.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended. Limited studies in osteogenesis imperfecta have shown mixed results and are not FDA-approved indications.
Geriatric Use
No overall differences in efficacy or safety have been observed between elderly and younger patients. However, elderly patients are more likely to have decreased renal function, so renal function should be monitored (contraindicated if CrCl < 35 mL/min).
Clinical Information
Clinical Pearls
- Strict adherence to administration instructions is crucial to minimize the risk of esophageal adverse events. Emphasize taking with plain water, remaining upright for 30 minutes, and avoiding food/other medications for 30 minutes.
- Ensure patients have adequate calcium and vitamin D intake, as these are foundational for bone health and necessary for alendronate's efficacy.
- Educate patients about the rare but serious adverse events: osteonecrosis of the jaw (ONJ) and atypical femur fractures. Advise them to report any new jaw pain or unusual thigh/groin pain immediately.
- Consider a 'drug holiday' after 5 years of use for low-risk patients and 10 years for high-risk patients, as per clinical guidelines, to reduce the risk of long-term side effects, while balancing fracture risk.
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)
- Calcitonin
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
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.