Fosamax Plus D Tablets (5600)

Alendronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption. It binds to hydroxyapatite in bone and inhibits the activity of osteoclasts, thereby decreasing bone turnover and increasing bone mineral density. Cholecalciferol (Vitamin D3) is a fat-soluble vitamin that is metabolized in the liver to 25-hydroxyvitamin D3 and then in the kidneys to 1,25-dihydroxyvitamin D3 (calcitriol), the active form of vitamin D. Calcitriol promotes the absorption of calcium and phosphate from the gastrointestinal tract and regulates their homeostasis, which is essential for bone mineralization.

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Black, tarry, or bloody stools
Chest pain
Coughing up blood
Heartburn
Trouble swallowing
Severe pain when swallowing
Sore throat
Vomiting blood or 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, 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 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 have mild ones, it's essential to contact your doctor or seek medical help if you experience any of the following:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
* Muscle or joint pain

This is not an exhaustive list of possible 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.

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 you experienced, including any symptoms that occurred.
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 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 with 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. Also, have your blood work checked as instructed by your doctor to ensure safe treatment.

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 like walking or physical therapy. Adhere to the diet and exercise plan recommended by your doctor to support your overall health.

If you are taking other sources of vitamin D, inform your doctor to avoid excessive intake. Before starting this medication, schedule a dental exam and maintain good oral hygiene by visiting your dentist regularly. Discuss your alcohol consumption with your doctor, as it may interact with this medication.

If you smoke, consult with your doctor about the potential risks and benefits of continuing to smoke while taking this medication.

If you are pregnant or become pregnant while taking this drug, immediately contact your doctor. Additionally, if you are breast-feeding, inform your doctor to discuss the potential risks to your baby and determine the best course of action.

• Not available (no absolute contraindications for drug interactions, but contraindications exist for patient conditions like hypocalcemia, esophageal abnormalities)

• Calcium supplements (oral)
• Antacids (containing calcium, magnesium, aluminum)
• Other oral medications (taken within 30 minutes of alendronate)
• Mineral supplements (containing calcium, magnesium, aluminum)

• Aspirin and NSAIDs (increased risk of GI irritation with alendronate)
• H2 blockers (e.g., ranitidine, cimetidine - may increase alendronate bioavailability slightly)
• Proton Pump Inhibitors (e.g., omeprazole - may increase alendronate bioavailability slightly)

• Not available

• New or worsening heartburn
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Retrosternal pain (chest pain behind the breastbone)
• New or unusual hip, groin, or thigh pain (potential atypical femoral fracture)
• Jaw pain, swelling, or numbness (potential osteonecrosis of the jaw)
• Muscle cramps or spasms (potential hypocalcemia)
• Signs of hypercalcemia (e.g., nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion)

Category C. There are no adequate and well-controlled studies in pregnant women. Alendronate is incorporated into the bone matrix and released over years. The clinical significance of this is unknown. Use only if the potential benefit justifies the potential risk to the fetus.

Alendronate is minimally excreted into breast milk. Cholecalciferol and its metabolites are excreted into breast milk. The amount of alendronate transferred to the infant is expected to be very low. The amount of vitamin D transferred is generally considered safe at recommended doses. Use with caution.

Safety and effectiveness have not been established in pediatric patients. Not indicated for use in children.

No overall differences in efficacy or safety were 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 necessary based on age alone.

• Strict adherence to administration instructions is crucial to minimize the risk of esophageal adverse events. Patients must take the tablet with a full glass of plain water, remain upright for at least 30 minutes, and not eat or drink anything else (except plain water) for at least 30 minutes after taking the dose.
• Ensure patients have adequate calcium and vitamin D intake (from diet or supplements) in addition to this medication, unless contraindicated.
• Patients should be advised to report any new or unusual pain in the hip, groin, or thigh, as this could be a symptom of an atypical femoral fracture.
• A dental examination should be considered prior to initiation of bisphosphonate therapy, especially in patients with risk factors for osteonecrosis of the jaw (ONJ).

• 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 inhibitors (e.g., denosumab)
• Sclerostin inhibitors (e.g., romosozumab)
• Vitamin D supplements (e.g., cholecalciferol, ergocalciferol)
• Calcium supplements

If your symptoms or health issues persist or worsen, it's 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 provides crucial information. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.