Fosamax 35mg 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
Category C
FDA Approved
Nov 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, allowing your body to build and maintain stronger bones.
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 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 by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you take your medication once daily and miss a dose in the morning, skip the missed dose and resume your normal schedule the next morning. Do not take two doses on the same day.
If you take your medication once weekly and miss a dose, take the missed dose the next morning 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 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 by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you take your medication once daily and miss a dose in the morning, skip the missed dose and resume your normal schedule the next morning. Do not take two doses on the same day.
If you take your medication once weekly and miss a dose, take the missed dose the next morning and then return to your regular schedule. Do not take two doses on the same day.
Lifestyle & Tips
- Ensure adequate 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 excessive 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
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
35 mg orally once weekly
Dose Range:
35 - 70 mg
Condition-Specific Dosing:
postmenopausal_osteoporosis_prevention:
35 mg orally once weekly
postmenopausal_osteoporosis_treatment:
70 mg orally once weekly
male_osteoporosis_treatment:
70 mg orally once weekly
glucocorticoid_induced_osteoporosis:
5 mg orally once daily or 35 mg orally once weekly (for postmenopausal women not receiving estrogen)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required (CrCl > 35 mL/min)
Moderate:
No dosage adjustment required (CrCl > 35 mL/min)
Severe:
Contraindicated (CrCl < 35 mL/min)
Dialysis:
Contraindicated (CrCl < 35 mL/min)
Hepatic Impairment:
Mild:
No dosage adjustment required
Moderate:
No dosage adjustment required
Severe:
No dosage adjustment required
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:
<1% (oral, fasting)
Tmax:
0.5-1 hour
FoodEffect:
Significantly reduced by food, beverages (other than plain water), and some medications (e.g., calcium, antacids). Must be taken on an empty stomach with plain water.
Distribution:
Vd:
Not available (primarily distributes to bone)
ProteinBinding:
~78%
CnssPenetration:
Limited
Elimination:
HalfLife:
Plasma half-life: ~2 hours; Terminal half-life (from bone): >10 years
Clearance:
Renal clearance is proportional to GFR
ExcretionRoute:
Renal (unchanged)
Unchanged:
>95% (renally excreted)
Pharmacodynamics
OnsetOfAction:
Bone resorption inhibition observed within weeks
PeakEffect:
Maximal effect on bone turnover markers typically seen within 3-6 months
DurationOfAction:
Effects on bone mineral density persist for months to years after discontinuation due to long bone half-life.
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 pain in the groin, hip, or thigh
Mouth sores
Jawbone Problems: A Potential Risk
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 this risk include ill-fitting dentures, anemia, infection, dental work, chemotherapy, radiation, or 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 immediately.
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. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Headache
Muscle or joint pain
Reporting Side Effects
If you have questions about side effects or want to report any concerns, 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 pain in the groin, hip, or thigh
Mouth sores
Jawbone Problems: A Potential Risk
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 this risk include ill-fitting dentures, anemia, infection, dental work, chemotherapy, radiation, or 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 immediately.
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. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Headache
Muscle or joint pain
Reporting Side Effects
If you have questions about side effects or want to report any concerns, 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 or pain when swallowing, chest pain, or new or worsening heartburn (stop taking and contact doctor immediately)
- New or unusual pain in your thigh, hip, or groin (could be a sign of an unusual thigh bone fracture)
- Jaw pain, numbness, or swelling (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 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, 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.
There is a potential increased risk of fractures, particularly in the legs, associated with this drug. Talk to your doctor about this 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, 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 assess the health of your teeth and gums. 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. Additionally, if you smoke, talk to your doctor about the potential risks associated with smoking while taking 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. Discuss any concerns or questions you have with your doctor.
If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately. If you are breastfeeding, inform your doctor, as they 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, 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.
There is a potential increased risk of fractures, particularly in the legs, associated with this drug. Talk to your doctor about this 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, 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 assess the health of your teeth and gums. 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. Additionally, if you smoke, talk to your doctor about the potential risks associated with smoking while taking 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. Discuss any concerns or questions you have with your doctor.
If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately. If you are breastfeeding, inform your doctor, as they 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, may cause 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 (iron, magnesium, zinc)
Moderate Interactions
- NSAIDs (increased risk of GI irritation)
- Aspirin (increased risk of GI irritation)
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To ensure normocalcemia before initiating therapy, as hypocalcemia must be corrected.
Timing: Before initiation of therapy
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 of therapy
Renal Function (e.g., Serum Creatinine, CrCl)
Rationale: To assess kidney function, as alendronate is renally cleared and contraindicated in severe renal impairment.
Timing: Before initiation of therapy
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)
25-hydroxyvitamin D
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: >30 ng/mL
Action Threshold: <30 ng/mL (supplementation recommended)
Bone Mineral Density (BMD) via DXA
Frequency: Every 1-2 years
Target: Improvement or stabilization of T-score
Action Threshold: Continued bone loss or new fractures may indicate need for re-evaluation of therapy.
Symptom Monitoring
- New or worsening heartburn
- Difficulty swallowing (dysphagia)
- Painful swallowing (odynophagia)
- Chest pain (especially retrosternal)
- New or unusual pain in the thigh, hip, or groin (potential atypical femur fracture)
- Jaw pain, swelling, or numbness (potential osteonecrosis of the jaw)
- Muscle or joint pain (severe or incapacitating)
Special Patient Groups
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. 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 gradually released over years. The extent of fetal exposure is unknown.
Trimester-Specific Risks:
First Trimester:
Limited human data; potential for fetal harm cannot be ruled out.
Second Trimester:
Limited human data; potential for fetal harm cannot be ruled out.
Third Trimester:
Limited human data; potential for fetal harm cannot be ruled out. Potential for hypocalcemia in the mother and/or fetus.
Lactation
It is not known whether alendronate is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from alendronate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Generally not recommended.
Infant Risk:
Unknown; potential for serious adverse effects.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.
Geriatric Use
No overall differences in efficacy or safety have been observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is not necessary based on age, but renal function should be monitored as it declines with age.
Clinical Information
Clinical Pearls
- Administer alendronate first thing in the morning, at least 30 minutes before the first food, beverage, or other medication of the day, with plain water only (not mineral water, coffee, juice, or milk).
- Swallow the tablet whole with a full glass (6-8 oz or 180-240 mL) of plain water. Do not chew, crush, or suck the tablet.
- Remain in an upright position (sitting or standing) for at least 30 minutes after taking the dose and until after the first food of the day to minimize the risk of esophageal irritation.
- Do not lie down for at least 30 minutes after taking the dose.
- Do not take alendronate at bedtime or before rising for the day.
- If a weekly dose is missed, take it on the morning after it is remembered. Do not take two doses on the same day. Return to taking one dose once a week on the chosen day, as originally scheduled.
- Ensure adequate calcium and vitamin D intake, as supplementation may be necessary.
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:
$15 - $50 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 amount, and the time it occurred.