Alendronate 70mg 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 reduce the risk of fractures, especially in people with osteoporosis. It works by slowing down the natural process where old bone is broken down, allowing new bone to build up and become stronger.
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 to feel better.
Swallow your medication whole with a full glass of plain water. Avoid taking it with mineral water, milk, or any 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
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.
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 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 to feel better.
Swallow your medication whole with a full glass of plain water. Avoid taking it with mineral water, milk, or any 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
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.
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 with a full (6-8 oz) glass of plain water first thing in the morning, at least 30 minutes before the first food, beverage, or other medication of the day.
- Do not lie down for at least 30 minutes after taking the tablet and until after your first food of the day. Remain fully upright (sitting or standing).
- Do not chew or suck the tablet.
- Ensure adequate intake of calcium and vitamin D through diet or supplements, as advised by your doctor.
- Engage in regular weight-bearing exercise (e.g., walking) as tolerated.
- Avoid smoking and excessive alcohol consumption, as these can negatively impact bone health.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
70 mg orally once weekly
Dose Range:
70 - 70 mg
Condition-Specific Dosing:
postmenopausal_osteoporosis_treatment:
70 mg orally once weekly or 10 mg orally once daily
postmenopausal_osteoporosis_prevention:
35 mg orally once weekly or 5 mg orally once daily
male_osteoporosis:
70 mg orally once weekly or 10 mg orally once daily
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
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 35 mL/min)
Moderate:
No adjustment needed (CrCl > 35 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, specifically at sites of active bone remodeling. 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:
0.64% (fasting, oral)
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:
Approximately 78%
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life > 10 years (due to release from bone)
Clearance:
Renal clearance is approximately 200 mL/min
ExcretionRoute:
Renal (unchanged)
Unchanged:
Approximately 50% of absorbed dose
Pharmacodynamics
OnsetOfAction:
Within 3-6 months for BMD increase
PeakEffect:
1-2 years for maximal BMD increase
DurationOfAction:
Effects on bone mineral density persist for several years after discontinuation due to long half-life in bone.
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 notice 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 material that looks like coffee grounds
Severe bone, joint, or muscle pain
New or unusual groin, hip, or thigh pain
Mouth sores
Jawbone Problems: A Potential Risk
This medication may cause jawbone problems, especially with long-term use or in people with certain medical conditions, such as cancer, dental problems, or blood clotting disorders. The risk may also be higher if you have ill-fitting dentures, anemia, or infection, or if you undergo dental work, chemotherapy, radiation, or take other medications that may cause jawbone problems. If you have any concerns or questions, discuss them with your doctor. If you experience jaw swelling or pain, contact your doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to report any concerns to your doctor. If you notice any of the following side effects, or if they bother you or persist, contact your doctor or seek medical help:
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 notice 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 material that looks like coffee grounds
Severe bone, joint, or muscle pain
New or unusual groin, hip, or thigh pain
Mouth sores
Jawbone Problems: A Potential Risk
This medication may cause jawbone problems, especially with long-term use or in people with certain medical conditions, such as cancer, dental problems, or blood clotting disorders. The risk may also be higher if you have ill-fitting dentures, anemia, or infection, or if you undergo dental work, chemotherapy, radiation, or take other medications that may cause jawbone problems. If you have any concerns or questions, discuss them with your doctor. If you experience jaw swelling or pain, contact your doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to report any concerns to your doctor. If you notice any of the following side effects, or if they bother you or persist, contact your doctor or seek medical help:
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:
- Difficulty swallowing (dysphagia)
- Pain when swallowing (odynophagia)
- Pain behind the breastbone (retrosternal pain)
- New or worsening heartburn
- Severe bone, joint, or muscle pain
- New or unusual pain in the hip, groin, or thigh
- Jaw pain, swelling, or numbness, especially after dental procedures
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 symptoms you experienced.
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 symptoms you experienced.
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, including irritation, swelling, ulcers, and bleeding. Discuss these potential risks with your doctor.
If you have asthma, note that medications like this one can worsen asthma symptoms. Consult with your doctor to discuss any concerns.
This medication may increase the risk of fractures, particularly in the legs. Talk to your doctor about this potential risk.
As directed by your doctor, undergo regular bone density tests to monitor your bone health. Discuss any questions or concerns with your doctor.
To maximize the effectiveness of this medication, it is crucial to use it in conjunction with calcium and vitamin D supplements, as well as 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. Additionally, schedule a dental exam before initiating treatment with this medication.
Practice good oral hygiene and schedule regular dental check-ups to maintain healthy teeth and gums.
Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions.
If you smoke, discuss the potential risks and benefits of continuing to smoke while taking this medication with your doctor.
This medication is not approved for use in children; however, your doctor may determine that the benefits outweigh the risks in certain situations. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks. Discuss any questions or concerns you may have with your doctor.
If you become pregnant or suspect you may be pregnant while taking this medication, contact your doctor immediately.
If you are breast-feeding, inform your doctor, as you will need to discuss the potential risks to your baby and determine the best course of action.
Be aware that this drug can cause severe esophagus problems, including irritation, swelling, ulcers, and bleeding. Discuss these potential risks with your doctor.
If you have asthma, note that medications like this one can worsen asthma symptoms. Consult with your doctor to discuss any concerns.
This medication may increase the risk of fractures, particularly in the legs. Talk to your doctor about this potential risk.
As directed by your doctor, undergo regular bone density tests to monitor your bone health. Discuss any questions or concerns with your doctor.
To maximize the effectiveness of this medication, it is crucial to use it in conjunction with calcium and vitamin D supplements, as well as 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. Additionally, schedule a dental exam before initiating treatment with this medication.
Practice good oral hygiene and schedule regular dental check-ups to maintain healthy teeth and gums.
Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions.
If you smoke, discuss the potential risks and benefits of continuing to smoke while taking this medication with your doctor.
This medication is not approved for use in children; however, your doctor may determine that the benefits outweigh the risks in certain situations. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks. Discuss any questions or concerns you may have with your doctor.
If you become pregnant or suspect you may be pregnant while taking this medication, contact your doctor immediately.
If you are breast-feeding, inform your doctor, as you will need to discuss the potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Hypocalcemia (low blood calcium)
- Hypophosphatemia (low blood phosphate)
- Upper gastrointestinal adverse events (e.g., upset stomach, heartburn, esophagitis, gastritis, ulcer)
What to Do:
Call 1-800-222-1222 (Poison Control). Administer milk or antacids to bind alendronate. Do not induce vomiting. Seek immediate medical attention for severe GI symptoms or signs of hypocalcemia (e.g., muscle cramps, tingling).
Drug Interactions
Major Interactions
- Calcium supplements
- Antacids (containing calcium, magnesium, aluminum)
- Mineral supplements (containing calcium, magnesium, aluminum)
- Other oral medications (taken within 30-60 minutes of alendronate)
Moderate Interactions
- NSAIDs (potential for additive GI irritation)
- Proton pump inhibitors (PPIs) (potential for increased risk of atypical femur fractures with long-term co-use, though data is mixed)
- H2-receptor antagonists (H2RAs) (potential for increased risk of atypical femur fractures with long-term co-use, though data is mixed)
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To ensure normocalcemia before initiating therapy, as hypocalcemia must be corrected.
Timing: Before initiation
Serum 25-hydroxyvitamin D
Rationale: To assess vitamin D status, as deficiency must be corrected for optimal alendronate efficacy and to prevent hypocalcemia.
Timing: Before initiation
Renal Function (CrCl)
Rationale: To determine appropriate dosing and identify contraindications (CrCl < 35 mL/min).
Timing: Before initiation
Routine Monitoring
Bone Mineral Density (BMD) via DXA
Frequency: Every 1-2 years initially, then less frequently if stable
Target: Improvement or stabilization of T-score
Action Threshold: Significant decline in BMD or new fractures may indicate treatment failure or need for re-evaluation.
Serum Calcium
Frequency: Periodically, especially if symptoms of hypocalcemia occur
Target: 8.5-10.2 mg/dL
Action Threshold: < 8.5 mg/dL (hypocalcemia) requires intervention.
Serum 25-hydroxyvitamin D
Frequency: Periodically, especially if deficiency was noted at baseline or if patient is at risk
Target: > 30 ng/mL
Action Threshold: < 20 ng/mL (deficiency) requires supplementation.
Renal Function (CrCl)
Frequency: Periodically, especially in elderly or those with changing renal status
Target: > 35 mL/min
Action Threshold: < 35 mL/min (contraindication) requires discontinuation.
Symptom Monitoring
- Dysphagia
- Odynophagia
- Retrosternal pain
- Heartburn (new or worsening)
- Severe musculoskeletal pain
- Jaw pain or swelling (osteonecrosis of the jaw)
- New hip, groin, or thigh pain (atypical femur fracture)
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.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show adverse effects on ossification.
Second Trimester:
Limited human data; animal studies show adverse effects on ossification.
Third Trimester:
Limited human data; animal studies show adverse effects on ossification. Bisphosphonates are incorporated into the bone matrix and gradually released over years. The amount incorporated into maternal bone is a theoretical risk to the fetus.
Lactation
L3 (Moderately Safe). It is not known whether alendronate is excreted in human milk. Due to its low oral bioavailability and high binding to bone, systemic exposure to the infant is expected to be minimal. However, caution should be exercised when alendronate is administered to a nursing mother.
Infant Risk:
Low, but potential for accumulation in infant bone is theoretical. Monitor for GI upset.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.
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, which should be monitored (contraindicated if CrCl < 35 mL/min).
Clinical Information
Clinical Pearls
- Strict adherence to administration instructions (first thing in the morning, full glass of plain water, upright for 30-60 minutes, no food/other meds for 30-60 minutes) is crucial to maximize absorption and minimize esophageal irritation.
- Ensure adequate calcium and vitamin D intake, as these are essential for bone health and alendronate efficacy.
- Patients should be advised to report any new or worsening upper GI symptoms, severe musculoskeletal pain, jaw pain, or new hip/thigh/groin pain immediately.
- Consider a 'drug holiday' after 3-5 years of treatment in low-risk patients to reduce the risk of rare but serious adverse events like ONJ and atypical femur fractures, after discussion with a healthcare provider.
- Dental examination and preventive dental care should be considered before initiating bisphosphonate therapy, especially in patients with risk factors for ONJ.
Alternative Therapies
- Other oral bisphosphonates (e.g., risedronate, ibandronate)
- IV bisphosphonates (e.g., zoledronic acid)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., raloxifene)
- Parathyroid hormone analogs (e.g., teriparatide, abaloparatide)
- RANK ligand inhibitor (e.g., denosumab)
- Sclerostin inhibitor (e.g., romosozumab)
Cost & Coverage
Average Cost:
$10 - $50 per 4 tablets (70mg weekly supply)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or Tier 2 (Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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.