Alendronate 70mg/75ml Solution

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 reduces bone turnover, leading to a net gain in bone mineral density and a reduction in fracture risk.

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:

This medication may increase the risk of jawbone problems, particularly with long-term use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting disorders, or infection. 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 of these conditions or concerns, discuss them with your doctor. If you experience jaw swelling or pain, contact your doctor immediately.

Other Side Effects:

Most people experience few or no side effects while taking this medication. However, some people may experience:

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

If any of these side effects or other symptoms bother you or do not go away, contact your doctor or seek medical help. Not all possible side effects are listed here. If you have questions about side effects, contact your doctor.

Reporting Side Effects:

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.

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 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, you should be aware that drugs like this one can worsen asthma symptoms. 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 and any concerns you may have.

Your doctor may recommend a bone density test to monitor your bone health while taking this medication. Be sure to follow their instructions and discuss any questions or concerns with your doctor.

To get the most benefit from 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, as directed by your doctor.

Follow the diet and exercise plan recommended by your doctor, and schedule a dental exam before starting this medication. It is also essential to practice good oral hygiene and visit your dentist regularly.

Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions. If you smoke, you should also discuss this with your doctor, as smoking may affect your treatment.

This medication is not approved for use in children; however, your doctor may determine that the benefits outweigh the risks in certain cases. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks, and discuss any questions or 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, you should discuss any potential risks to your baby with your doctor.

• Calcium supplements
• Antacids
• Mineral supplements (e.g., iron, magnesium)
• Any food or beverage (other than plain water)

• NSAIDs (increased risk of GI irritation/ulceration)
• Aspirin (increased risk of GI irritation/ulceration)

• New or worsening heartburn
• Difficulty swallowing (dysphagia)
• Painful swallowing (odynophagia)
• Chest pain
• New or unusual hip, groin, or thigh pain (potential atypical femoral fracture)
• Jaw pain or swelling
• Numbness or heavy sensation in the jaw
• Loose teeth
• Muscle cramps or spasms
• Numbness or tingling around the mouth, fingers, or toes (signs of hypocalcemia)

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 fetus. Bisphosphonates are incorporated into the bone matrix and gradually released over years. The amount of bisphosphonate incorporated into maternal bone and then released during pregnancy is directly related to the dose and duration of bisphosphonate use.

L3 (Moderately Safe). It is not known whether alendronate is excreted in human milk. Because many drugs are excreted in human milk and because of 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.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended. Bisphosphonates may interfere with bone mineralization in growing children.

No overall differences in efficacy or safety were observed between elderly and younger patients. No dosage adjustment is necessary based on age, but greater sensitivity of some older individuals cannot be ruled out. Renal function should be assessed.

• Strict adherence to administration instructions is crucial to maximize absorption and minimize esophageal irritation. Emphasize taking with plain water only, remaining upright for 30 minutes, and waiting 30 minutes before other food/meds.
• Ensure patients have adequate calcium and vitamin D intake, as these are essential for bone health and to prevent hypocalcemia.
• Counsel patients on the rare but serious risks of osteonecrosis of the jaw (ONJ) and atypical femoral fractures. Advise them to report any jaw pain or new hip/thigh pain immediately.
• Consider a 'drug holiday' after 5 years of treatment for low-risk patients with osteoporosis, as the drug has a long half-life in bone and benefits may persist. This decision should be individualized and made by a specialist.
• Alendronate oral solution is a good alternative for patients who have difficulty swallowing tablets, but the strict administration requirements still apply.

• 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 inhibitors (e.g., denosumab)
• Sclerostin inhibitors (e.g., romosozumab)

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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.