Fosamax 70mg Tablets (4pk)
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
Not available
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 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 discomfort.
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 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
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 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 discomfort.
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 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
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 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 glass (6-8 ounces) of plain water only, first thing in the morning, at least 30 minutes before your first food, drink, or other medication.
- Do not chew or suck the tablet.
- Remain upright (sitting, standing, or walking) for at least 30 minutes after taking the tablet and until after your first food of the day.
- Do not lie down for at least 30 minutes after taking the tablet.
- Do not take alendronate at bedtime or before getting up for the day.
- Ensure adequate intake of calcium and vitamin D through diet or supplements, as recommended by your doctor.
- Engage in weight-bearing exercise as advised by your healthcare provider.
- Maintain good oral hygiene and have regular dental check-ups.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Osteoporosis (treatment): 70 mg orally once weekly. Osteoporosis (prevention): 35 mg orally once weekly. Paget's disease: 40 mg orally once daily for 6 months.
Dose Range:
35 - 70 mg
Condition-Specific Dosing:
postmenopausal_osteoporosis_treatment:
70 mg orally once weekly
postmenopausal_osteoporosis_prevention:
35 mg orally once weekly
male_osteoporosis:
70 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
Adolescent:
Not established (Safety and efficacy not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary (CrCl > 60 mL/min)
Moderate:
No dosage adjustment necessary (CrCl 35-60 mL/min)
Severe:
Contraindicated (CrCl < 35 mL/min) due to lack of experience and potential for accumulation.
Dialysis:
Contraindicated (CrCl < 35 mL/min); not recommended in patients on dialysis.
Hepatic Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
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 bone-resorbing cells. This inhibition leads to a net increase in bone mineral density and a reduction in fracture risk.
Pharmacokinetics
Absorption:
Bioavailability:
0.64% (fasting, women); 0.59% (fasting, men)
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:
>95% (of absorbed dose)
Pharmacodynamics
OnsetOfAction:
Bone resorption markers decrease within 1-2 weeks
PeakEffect:
Maximal suppression of bone resorption markers typically seen within 3-6 months
DurationOfAction:
Effects on bone mineral density persist for several years after discontinuation due to long retention in bone.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
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 immediately:
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: A Potential Risk
This medication may increase the risk of jawbone problems, particularly with long-term use. Your risk may be higher if you have:
Cancer
Dental problems
Ill-fitting dentures
Anemia
Blood clotting problems
Infection
Undergoing dental work, chemotherapy, or radiation
Taking other medications that may 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 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 minor ones, it's essential to report any concerns to your doctor. Common side effects include:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Headache
Muscle or joint pain
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for guidance. 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 immediately:
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: A Potential Risk
This medication may increase the risk of jawbone problems, particularly with long-term use. Your risk may be higher if you have:
Cancer
Dental problems
Ill-fitting dentures
Anemia
Blood clotting problems
Infection
Undergoing dental work, chemotherapy, or radiation
Taking other medications that may 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 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 minor ones, it's essential to report any concerns to your doctor. Common side effects include:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Headache
Muscle or joint pain
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for guidance. 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 or pain when swallowing, chest pain, or new or worsening heartburn (signs of esophageal irritation).
- New or unusual pain in your thigh, hip, or groin (could be a sign of an unusual thigh bone fracture).
- Jaw pain, swelling, numbness, or a feeling of heaviness in the jaw, or loosening of a tooth (could be a sign of osteonecrosis of the jaw).
- Severe bone, joint, or muscle pain.
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. Your doctor will advise you on the frequency and importance of these tests.
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 support your overall bone health.
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 with this medication. Similarly, if you smoke, talk to your doctor about the potential risks and ways to manage them.
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. Your doctor will advise you on the frequency and importance of these tests.
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 support your overall bone health.
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 with this medication. Similarly, if you smoke, talk to your doctor about the potential risks and ways to manage them.
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, e.g., muscle cramps, spasms, numbness, tingling)
- 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.
Drug Interactions
Major Interactions
- Calcium supplements (oral)
- Antacids (containing calcium, magnesium, aluminum)
- Mineral supplements (containing calcium, magnesium, aluminum)
- Other oral medications (taken within 30-60 minutes of alendronate)
Moderate Interactions
- Aspirin/NSAIDs (increased risk of GI irritation)
- H2 blockers/PPIs (potential for increased GI irritation, though less clear interaction)
Confidence Interactions
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To ensure normocalcemia before initiating therapy, as hypocalcemia must be corrected.
Timing: Before first dose
Serum 25-hydroxyvitamin D
Rationale: To ensure adequate vitamin D levels, as deficiency can impair alendronate efficacy and worsen hypocalcemia.
Timing: Before first dose
Renal Function (CrCl)
Rationale: To assess kidney function, as alendronate is contraindicated in severe renal impairment.
Timing: Before first dose
Dental Examination
Rationale: To identify and address any pre-existing dental issues, especially for patients at risk of osteonecrosis of the jaw (ONJ).
Timing: Before initiation, especially for high-risk patients
Routine Monitoring
Serum Calcium
Frequency: Periodically, especially if symptoms of hypocalcemia occur
Target: 8.5-10.2 mg/dL
Action Threshold: <8.5 mg/dL (correct with calcium/vitamin D supplementation)
Serum 25-hydroxyvitamin D
Frequency: Annually or as clinically indicated
Target: >30 ng/mL
Action Threshold: <30 ng/mL (supplementation needed)
Bone Mineral Density (BMD)
Frequency: Every 1-2 years (DEXA scan)
Target: Improvement or stabilization of T-score
Action Threshold: Significant decline in BMD (consider adherence, secondary causes, or alternative therapy)
Renal Function (CrCl)
Frequency: Periodically, especially in elderly or those with changing renal status
Target: >35 mL/min
Action Threshold: <35 mL/min (discontinue alendronate)
Symptom Monitoring
- New or worsening heartburn
- Difficulty swallowing (dysphagia)
- Painful swallowing (odynophagia)
- Chest pain (retrosternal)
- New or unusual pain in the thigh, hip, or groin (potential atypical femoral fracture)
- Jaw pain, swelling, numbness, or loosening of a tooth (potential osteonecrosis of the jaw)
- Severe or incapacitating bone, joint, and/or muscle pain
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy. While human data are limited, animal studies show reproductive toxicity. Bisphosphonates are incorporated into the bone matrix and are gradually released over years, potentially exposing the fetus. The decision to use should weigh potential benefits against risks.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show adverse effects on ossification.
Second Trimester:
Potential for fetal exposure due to long half-life in bone.
Third Trimester:
Potential for fetal exposure; theoretical risk of hypocalcemia in the neonate.
Lactation
Not recommended during breastfeeding. It is unknown if alendronate is excreted in human milk. Due to its long half-life and potential for serious adverse effects in the infant, 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:
Unknown; theoretical risk of adverse effects on bone and mineral metabolism in the infant.
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. Adherence to dosing instructions is crucial due to potential for esophageal adverse events.
Clinical Information
Clinical Pearls
- Strict adherence to dosing instructions (first thing in the morning, plain water only, upright for 30-60 minutes, no food/other meds for 30-60 minutes) is critical to maximize absorption and minimize esophageal irritation.
- Ensure adequate calcium and vitamin D intake before and during therapy to optimize efficacy and prevent hypocalcemia.
- Patients should be advised to report any new or worsening pain in the thigh, hip, or groin, as this could indicate an atypical femoral fracture.
- A dental examination should be considered prior to initiating alendronate, especially in patients with risk factors for osteonecrosis of the jaw (e.g., cancer, chemotherapy, corticosteroids, poor oral hygiene).
- Consider a 'drug holiday' after 3-5 years of treatment for low-risk patients to reduce the risk of long-term adverse effects like ONJ and AFF, but this decision should be individualized and discussed with a specialist.
Alternative Therapies
- Other oral bisphosphonates (e.g., risedronate, ibandronate)
- Intravenous 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)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or Tier 2/3 (Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 is a patient fact sheet that provides crucial information. It is vital to 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, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to 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, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity consumed, and the time it occurred.