Fosamax Plus D Tablets (2800)
It is used to treat soft, brittle bones (osteoporosis).
Drug Class
Bone Resorption Inhibitor; Vitamin
Pharmacologic Class
Bisphosphonate; Vitamin D Analog
Pregnancy Category
Category C
FDA Approved
Apr 2005
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fosamax Plus D is a medication used to treat or prevent osteoporosis, a condition that makes bones thin and brittle. It contains two active ingredients: alendronate, which helps strengthen your bones by slowing down bone loss, and vitamin D3 (cholecalciferol), which helps your body absorb calcium, an important mineral for strong bones.
How to Use This Medicine
To take this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Take the medication on an empty stomach, at least 30 minutes before consuming your first food, drink, or other medications of the day. After taking the medication, remain upright for at least 30 minutes and until you have eaten your first meal of the day.
Take the medication with a full glass of plain water, avoiding mineral water, milk, or other beverages. Swallow the medication whole, without chewing, breaking, or crushing it. Do not suck on the medication. Continue taking the medication as directed by your doctor or healthcare provider, even if you are feeling well.
To store this medication, keep it in its original container at room temperature, protected from light. If you miss a dose, take it the next morning as soon as you remember, and then resume your regular dosing schedule. Do not take two doses on the same day.
Take the medication with a full glass of plain water, avoiding mineral water, milk, or other beverages. Swallow the medication whole, without chewing, breaking, or crushing it. Do not suck on the medication. Continue taking the medication as directed by your doctor or healthcare provider, even if you are feeling well.
To store this medication, keep it in its original container at room temperature, protected from light. If you miss a dose, take it the next morning as soon as you remember, and then resume your regular dosing 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 or standing) for at least 30 minutes after taking the tablet and until after your first food of the day.
- Do NOT lie down until after your first food of the day.
- Do NOT take with mineral water, coffee, tea, juice, or milk.
- Ensure adequate calcium intake through diet or supplements (if recommended by your doctor).
- Engage in 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:
One 70 mg/2800 IU tablet orally once weekly
Dose Range:
70 - 70 mg
Condition-Specific Dosing:
osteoporosis_treatment_and_prevention_in_postmenopausal_women:
One 70 mg/2800 IU tablet orally once weekly
osteoporosis_in_men:
One 70 mg/2800 IU tablet orally once weekly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary (CrCl > 60 mL/min)
Moderate:
No dosage adjustment necessary (CrCl 35-60 mL/min)
Severe:
Not recommended (CrCl < 35 mL/min) due to lack of experience and potential for alendronate accumulation
Dialysis:
Not recommended
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 localizes preferentially to sites of bone resorption, under the osteoclasts, and inhibits osteoclast activity. Cholecalciferol (Vitamin D3) is metabolized in the liver to 25-hydroxyvitamin D3 (calcifediol) and then in the kidney to 1,25-dihydroxyvitamin D3 (calcitriol), which is the active form. Calcitriol promotes the absorption of calcium and phosphate from the small intestine and regulates bone mineralization.
Pharmacokinetics
Absorption:
Bioavailability:
Alendronate: <1% (0.64% for women, 0.6% for men) when taken 2 hours before breakfast; Cholecalciferol: Readily absorbed from the GI tract, requires bile salts.
Tmax:
Alendronate: 0.5-2 hours; Cholecalciferol: 4-5 hours (for 25-hydroxyvitamin D3)
FoodEffect:
Alendronate: Severely reduced absorption (by up to 90%) when taken with food, beverages other than plain water, or certain medications. Cholecalciferol: Enhanced by fatty meals.
Distribution:
Vd:
Alendronate: Not determined (primarily distributes to bone); Cholecalciferol: Extensively distributed to adipose tissue and muscle.
ProteinBinding:
Alendronate: ~78% (to plasma proteins); Cholecalciferol: Primarily bound to vitamin D-binding protein (DBP) and albumin.
CnssPenetration:
Alendronate: Limited; Cholecalciferol: Limited
Elimination:
HalfLife:
Alendronate: Terminal half-life >10 years (due to release from bone); Cholecalciferol: ~24 hours (for parent compound), 2-3 weeks (for 25-hydroxyvitamin D3)
Clearance:
Alendronate: Renal clearance is proportional to GFR; Cholecalciferol: Not readily quantifiable
ExcretionRoute:
Alendronate: Primarily renal (unchanged); Cholecalciferol: Primarily fecal (as metabolites)
Unchanged:
Alendronate: >95% (in urine)
Pharmacodynamics
OnsetOfAction:
Alendronate: Bone resorption inhibition begins within weeks; Cholecalciferol: Effects on calcium absorption seen within days to weeks.
PeakEffect:
Alendronate: Maximal effect on bone mineral density (BMD) seen at 1-2 years; Cholecalciferol: Peak 25(OH)D levels typically achieved within 3-5 months of consistent dosing.
DurationOfAction:
Alendronate: Long-lasting, persists for months after discontinuation due to bone binding; Cholecalciferol: Depends on storage and metabolism.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Black, tarry, or bloody stools
Chest pain
Coughing up blood
Heartburn
Trouble swallowing
Severe pain when swallowing
Sore throat
Vomiting blood or coffee ground-like material
Severe bone, joint, or muscle pain
New or unusual groin, hip, or thigh pain
Mouth sores
Jawbone Problems: A Potential Risk
This medication may cause jawbone problems, particularly 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 dental work, chemotherapy, radiation, or take other medications that can 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 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, contact your doctor or seek medical help if they bother you or do not go away:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
* 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 experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Black, tarry, or bloody stools
Chest pain
Coughing up blood
Heartburn
Trouble swallowing
Severe pain when swallowing
Sore throat
Vomiting blood or coffee ground-like material
Severe bone, joint, or muscle pain
New or unusual groin, hip, or thigh pain
Mouth sores
Jawbone Problems: A Potential Risk
This medication may cause jawbone problems, particularly 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 dental work, chemotherapy, radiation, or take other medications that can 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 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, contact your doctor or seek medical help if they bother you or do not go away:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
* 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)
- Severe bone, joint, or muscle pain
- 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 jaw bone damage)
- Signs of low calcium (hypocalcemia) such as muscle cramps, spasms, or tingling/numbness in fingers or around the mouth.
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 problems 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 problems 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.
This drug can cause severe esophagus problems, such as irritation, swelling, ulcers, and bleeding. Be sure to discuss these potential risks with your doctor.
If you have asthma, be aware that this medication can worsen your condition. Consult with your doctor to discuss any concerns.
There is a potential increased risk of fractures, particularly in the legs, associated with this medication. Talk to your doctor about this risk.
As directed by your doctor, undergo regular bone density tests to monitor your bone health. Discuss any questions or concerns with your doctor.
Additionally, have your blood work checked as instructed by your doctor, and consult with them to review the results.
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.
If you are taking other sources of vitamin D, inform your doctor to avoid any potential interactions.
Before starting this medication, schedule a dental exam and maintain good oral hygiene by visiting your dentist regularly. Also, consult with your doctor before consuming alcohol.
If you smoke, discuss the potential risks and benefits of continuing to smoke while taking this medication 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 they will need to discuss the potential risks and benefits of continuing to take this medication while nursing your baby.
This drug can cause severe esophagus problems, such as irritation, swelling, ulcers, and bleeding. Be sure to discuss these potential risks with your doctor.
If you have asthma, be aware that this medication can worsen your condition. Consult with your doctor to discuss any concerns.
There is a potential increased risk of fractures, particularly in the legs, associated with this medication. Talk to your doctor about this risk.
As directed by your doctor, undergo regular bone density tests to monitor your bone health. Discuss any questions or concerns with your doctor.
Additionally, have your blood work checked as instructed by your doctor, and consult with them to review the results.
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.
If you are taking other sources of vitamin D, inform your doctor to avoid any potential interactions.
Before starting this medication, schedule a dental exam and maintain good oral hygiene by visiting your dentist regularly. Also, consult with your doctor before consuming alcohol.
If you smoke, discuss the potential risks and benefits of continuing to smoke while taking this medication 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 they will need to discuss the potential risks and benefits of continuing to take this medication while nursing your baby.
Overdose Information
Overdose Symptoms:
- Hypocalcemia (low blood calcium) with symptoms like muscle cramps, tingling, numbness
- Hypophosphatemia (low blood phosphate)
- Upper gastrointestinal upset (e.g., heartburn, esophagitis, gastritis, ulcer)
What to Do:
Seek immediate medical attention. Milk or antacids may be given to bind alendronate. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Calcium supplements, antacids, and other oral medications containing polyvalent cations (e.g., magnesium, aluminum, iron): Significantly interfere with alendronate absorption. Must separate administration by at least 30 minutes.
- NSAIDs (non-steroidal anti-inflammatory drugs): Increased risk of upper GI adverse events when used concomitantly with alendronate.
Moderate Interactions
- Thiazide diuretics: May increase risk of hypercalcemia with cholecalciferol.
- Phenytoin, barbiturates: May increase metabolism of cholecalciferol, reducing its effectiveness.
- Orlistat, cholestyramine, mineral oil: May reduce absorption of cholecalciferol.
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To ensure normocalcemia before initiating therapy, as alendronate can exacerbate hypocalcemia.
Timing: Prior to first dose
Serum 25-hydroxyvitamin D (25[OH]D)
Rationale: To assess vitamin D status and ensure sufficiency, as vitamin D deficiency should be corrected prior to or concurrently with alendronate therapy.
Timing: Prior to first dose
Renal Function (CrCl)
Rationale: To determine appropriate dosing and identify contraindications (CrCl < 35 mL/min).
Timing: Prior to first dose
Dental Examination
Rationale: To assess oral health and identify risk factors for osteonecrosis of the jaw (ONJ), especially in patients with comorbidities or on concomitant medications.
Timing: Prior to first dose, if clinically indicated
Routine Monitoring
Serum Calcium
Frequency: Periodically, especially if symptoms of hypocalcemia occur or if patient has predisposing conditions.
Target: 8.5-10.2 mg/dL
Action Threshold: <8.5 mg/dL (investigate and correct)
Serum 25-hydroxyvitamin D (25[OH]D)
Frequency: Annually or as clinically indicated to ensure vitamin D sufficiency.
Target: >30 ng/mL
Action Threshold: <20 ng/mL (consider additional supplementation)
Bone Mineral Density (BMD) by DXA
Frequency: Every 1-2 years after initiation of therapy.
Target: Improvement or stabilization of T-score
Action Threshold: Significant decline in BMD (investigate adherence, secondary causes, or consider alternative therapy)
Renal Function (CrCl)
Frequency: Periodically, especially in elderly patients or those with risk factors for renal decline.
Target: >35 mL/min
Action Threshold: <35 mL/min (discontinue therapy)
Symptom Monitoring
- New or worsening heartburn
- Dysphagia (difficulty swallowing)
- Odynophagia (painful swallowing)
- Retrosternal pain
- Severe musculoskeletal pain
- Unusual thigh, hip, or groin pain (potential atypical femoral fracture)
- Jaw pain, swelling, numbness, or loosening of a tooth (potential osteonecrosis of the jaw)
- Signs of hypocalcemia (e.g., muscle cramps, tingling, numbness)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Alendronate is incorporated into the bone matrix and gradually released over years, potentially exposing the fetus. Cholecalciferol in appropriate doses is generally safe.
Trimester-Specific Risks:
First Trimester:
Limited human data. Animal studies show adverse effects at high doses of alendronate.
Second Trimester:
Potential for fetal exposure to alendronate released from maternal bone.
Third Trimester:
Potential for fetal exposure to alendronate released from maternal bone.
Lactation
L3 (Moderate risk). Alendronate is minimally excreted into breast milk. Cholecalciferol and its metabolites are excreted into breast milk. Use with caution; monitor infant for adverse effects.
Infant Risk:
Low systemic exposure to alendronate in breastfed infants. Cholecalciferol in breast milk is generally considered safe and beneficial for the infant, but excessive maternal dosing could lead to high infant levels.
Pediatric Use
Safety and efficacy 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, elderly patients are more likely to have decreased renal function, which should be monitored. No dosage adjustment is needed based on age alone.
Clinical Information
Clinical Pearls
- Strict adherence to dosing instructions (first thing in the morning, plain water only, upright for 30 minutes, 30 minutes before food/drink/meds) is crucial to maximize absorption and minimize esophageal adverse events.
- Ensure adequate calcium and vitamin D intake (from diet or supplements) in patients taking this medication, as it is essential for bone health and to prevent hypocalcemia.
- Patients should be advised to report any new or worsening severe musculoskeletal pain, as this can be a symptom of atypical femoral fracture or other adverse events.
- A dental examination should be considered prior to initiating therapy, especially in patients with risk factors for osteonecrosis of the jaw (ONJ).
- If a dose is missed, take one tablet on the morning after it is remembered. Do not take two tablets on the same day. Return to taking one tablet once a week on the originally chosen day.
Alternative Therapies
- Other oral bisphosphonates (e.g., risedronate, ibandronate)
- IV bisphosphonates (e.g., zoledronic acid)
- Denosumab (Prolia)
- Teriparatide (Forteo), Abaloparatide (Tymlos) (anabolic agents)
- Romosozumab (Evenity)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., raloxifene)
- Standalone Vitamin D supplements (e.g., cholecalciferol, ergocalciferol)
Cost & Coverage
Average Cost:
Not available (highly variable) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for generic), Tier 3 (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you 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 detailed information, including the substance taken, the amount, and the time it occurred.