Pamidronate Sol3mg/ml, 10ml

Pamidronate is a bisphosphonate that inhibits osteoclastic bone resorption. It binds to hydroxyapatite crystals in bone, particularly at sites of high bone turnover, and inhibits the formation and dissolution of these crystals. This leads to a reduction in osteoclast activity, number, and lifespan, thereby decreasing bone resorption and calcium release from bone.

Urgent 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 immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of electrolyte imbalance: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision.
Signs of a urinary tract infection (UTI): blood in the urine, painful or burning urination, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Signs of low thyroid levels: constipation, sensitivity to cold, memory problems, mood changes, or abnormal sensations such as burning, numbness, or tingling.
Vomiting blood or coffee ground-like material.
Black, tarry, or bloody stools.
Rapid or irregular heartbeat.
Fever.
Shortness of breath.
Swelling.

Important Warnings

This medication may increase the risk of fractures, particularly in the leg. Inform your doctor if you experience any new or unusual pain in the groin, hip, or thigh area. Additionally, this medication may cause jawbone problems, especially with prolonged use, cancer, dental issues, ill-fitting dentures, anemia, blood clotting disorders, or infections. The risk may also be higher if you undergo dental procedures, chemotherapy, radiation, or take other medications that can affect the jawbone. Discuss these potential risks with your doctor, and seek medical attention immediately if you experience jaw swelling or pain.

Other Possible Side Effects

While many people may not experience any side effects or only mild ones, it is essential to be aware of the following potential side effects:

Constipation, stomach pain, nausea, vomiting, or decreased appetite.
Back, bone, joint, or muscle pain.
Dizziness, drowsiness, fatigue, or weakness.
Headache.
Excessive sweating.
Sleep disturbances.
Cough.
Runny nose.
* Irritation at the injection site.

If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. 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 symptoms you experienced as a result of the allergy.
If you have kidney disease, as this may affect your ability to take this medication.

This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you are experiencing

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication in combination with all your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and dental exams should be performed as directed by your doctor to ensure your overall health.

To maintain good oral health, practice proper dental care and schedule regular dental check-ups. Additionally, follow your doctor's instructions regarding calcium and vitamin D supplementation to support your bone health.

Be aware that this medication may cause kidney problems, including kidney failure, in some individuals. If you have a history of kidney issues, notify your doctor promptly.

If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may pose a risk to the unborn baby.

If you are breast-feeding, consult your doctor to discuss any potential risks to your baby and determine the best course of action.

• Thalidomide (increased risk of renal dysfunction in multiple myeloma patients)
• Other nephrotoxic drugs (e.g., aminoglycosides, loop diuretics, NSAIDs) - increased risk of renal toxicity

• Calcium-containing products (e.g., calcium supplements, antacids) - may interfere with calcium-lowering effect
• Magnesium-containing products (e.g., magnesium supplements, antacids) - may interfere with calcium-lowering effect
• Phosphate-containing products (e.g., phosphate supplements) - may interfere with calcium-lowering effect

• Signs and symptoms of hypocalcemia (e.g., paresthesias, muscle cramps, tetany, seizures)
• Signs and symptoms of osteonecrosis of the jaw (ONJ) (e.g., jaw pain, swelling, numbness, feeling of heaviness in the jaw, exposed bone)
• New or unusual pain in the thigh, hip, or groin (may indicate atypical femur fracture)
• Signs of infusion-related reactions (e.g., fever, flu-like symptoms, bone/joint/muscle pain)
• Signs of ocular inflammation (e.g., conjunctivitis, uveitis, scleritis)

Pamidronate is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. Bisphosphonates are incorporated into the bone matrix and gradually released over years. The amount of bisphosphonate incorporated into maternal bone is directly related to the total dose and duration of bisphosphonate use. There is a theoretical risk of fetal harm (e.g., hypocalcemia, skeletal abnormalities) if a woman becomes pregnant after completing a bisphosphonate course.

It is not known whether pamidronate is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, 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.

Safety and effectiveness in pediatric patients have not been established for approved indications. However, pamidronate has been used off-label in pediatric patients for severe hypercalcemia and osteogenesis imperfecta. Close monitoring of renal function and electrolytes is crucial due to limited data and potential for adverse effects.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Renal function should be monitored closely in elderly patients, as they are more likely to have decreased renal function.

• Always ensure adequate hydration before and during pamidronate infusion to minimize the risk of renal toxicity.
• Infuse pamidronate slowly over the recommended duration (e.g., 2-4 hours for 90 mg) to reduce the risk of renal impairment and infusion-related reactions (e.g., fever, flu-like symptoms).
• Correct pre-existing hypocalcemia, hypophosphatemia, or hypomagnesemia before initiating pamidronate therapy.
• Patients should maintain good oral hygiene and have regular dental check-ups. Any invasive dental procedures should be avoided during treatment if possible, especially in cancer patients.
• Educate patients to report any new or unusual pain in the thigh, hip, or groin, as this could be a sign of an atypical femur fracture.
• For hypercalcemia of malignancy, the full calcium-lowering effect may not be observed for 4-7 days after treatment. Repeat doses should not be given sooner than 7 days.

• Other bisphosphonates (e.g., Zoledronic acid, Ibandronate, Alendronate)
• Denosumab (monoclonal antibody, RANKL inhibitor)
• Calcitonin (for acute hypercalcemia)
• Cinacalcet (for hypercalcemia in primary hyperparathyroidism or parathyroid carcinoma)
• Glucocorticoids (for hypercalcemia associated with certain malignancies)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.