Pamidronate 9mg/ml Sol Inj, 10ml

Pamidronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption. It binds to hydroxyapatite crystals in bone, particularly at sites of high bone turnover. This binding prevents osteoclasts from adhering to the bone surface and inhibits their activity, leading to a decrease in bone resorption and a reduction in calcium release from bone. It also has anti-tumor effects in some bone metastases models.

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 or seek immediate 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 or dizziness, fainting, or changes in vision.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, 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 burning, numbness, or tingling sensations.
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. If you have any concerns or questions, discuss them with your doctor. Seek immediate medical attention if you experience jaw swelling or pain.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or persist:

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.

Reporting Side Effects

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 symptoms you experienced.
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 medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

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 conducted 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 has been associated with kidney problems, including kidney failure, in some cases. If you have a history of kidney issues, notify your doctor promptly.

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

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

• Other bisphosphonates (increased risk of adverse effects, especially renal toxicity)
• Thalidomide (increased risk of renal dysfunction in multiple myeloma patients)

• Aminoglycosides (may prolong hypocalcemia)
• Loop diuretics (may increase risk of hypocalcemia)
• Nephrotoxic drugs (e.g., NSAIDs, cisplatin, cyclosporine, amphotericin B) - increased risk of renal toxicity

• Signs of hypocalcemia (e.g., muscle cramps, paresthesias, tetany, seizures)
• Signs of renal dysfunction (e.g., decreased urine output, edema, fatigue)
• Bone pain (may initially worsen, then improve)
• Fever, flu-like symptoms (acute phase reaction)
• Jaw pain, swelling, numbness (signs of osteonecrosis of the jaw)
• New or unusual thigh, hip, or groin pain (atypical femoral fracture)

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 and subsequently released is directly related to the dose and duration of bisphosphonate use. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Pamidronate is classified as L3 (Moderately Safe) by LactMed, but caution is advised. It is unknown if pamidronate is excreted in human milk. Bisphosphonates are poorly absorbed orally, so infant exposure via breast milk is likely low. However, due to the potential for serious adverse reactions in the nursing infant and the long half-life in bone, 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 off-label for severe hypercalcemia or osteogenesis imperfecta, with highly individualized dosing and close monitoring due to potential for growth plate abnormalities and other long-term effects on bone.

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, as elderly patients are more likely to have decreased renal function.

• Always ensure adequate hydration before and during pamidronate infusion to minimize renal toxicity.
• Infusion rate is crucial: rapid infusion can increase the risk of renal impairment and acute phase reactions. Adhere to recommended infusion times (e.g., 2-4 hours for 90 mg).
• Monitor serum calcium, phosphate, magnesium, and creatinine closely, especially after the first dose and before subsequent doses.
• Pre-existing dental issues should be addressed before starting pamidronate, especially for long-term use, due to the risk of osteonecrosis of the jaw (ONJ).
• Patients should be advised to report any new or unusual pain in the thigh, hip, or groin, as this could indicate an atypical femoral fracture.
• Acute phase reactions (fever, flu-like symptoms, myalgia, arthralgia) are common, especially after the first dose, and can be managed with acetaminophen or NSAIDs.

• Zoledronic acid (another potent bisphosphonate, often preferred for hypercalcemia of malignancy and bone metastases due to longer duration of action and lower dose)
• Denosumab (RANK ligand inhibitor, alternative for bone metastases and hypercalcemia of malignancy)
• Calcitonin (for acute hypercalcemia, rapid onset but short duration)
• Gallium nitrate (for hypercalcemia of malignancy, less common now)
• Mithramycin (plicamycin) (for hypercalcemia of malignancy, rarely used due to toxicity)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. 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 the 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 pour them down the 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.