Pamidronate 6mg/ml Sol, 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. It also directly inhibits osteoclast activity and proliferation, leading to a decrease in bone resorption and a reduction in calcium release from bone.

Serious 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, 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 kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Balance problems
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe nausea or vomiting
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or near-fainting
+ Changes in vision
Signs of a urinary tract infection (UTI), such as:
+ 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, including:
+ Constipation
+ Sensitivity to cold
+ Memory problems
+ Mood changes
+ 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. If you experience new or unusual pain in the groin, hip, or thigh, inform your doctor promptly.

Additionally, this medication may cause jawbone problems, especially with prolonged use or in individuals with certain medical conditions, such as cancer, dental problems, or blood clotting disorders. The risk may also be higher if you have dental work, undergo chemotherapy or 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

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Constipation
Stomach pain
Upset stomach
Nausea or vomiting
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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 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 medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication in combination with your other medications and health conditions.

Remember, do not start, stop, or change the dosage 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 monitor your health. Practicing good oral hygiene and scheduling frequent dental check-ups is crucial. Additionally, follow your doctor's instructions regarding calcium and vitamin D supplementation.

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, it is vital to 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.

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

• Aminoglycosides (additive hypocalcemic effect)
• Loop diuretics (may increase risk of hypocalcemia)

• Symptoms of hypocalcemia (e.g., paresthesias, muscle cramps, tetany, seizures)
• Signs of renal dysfunction (e.g., decreased urine output, edema)
• Bone, joint, or muscle pain (severe or incapacitating)
• Symptoms of osteonecrosis of the jaw (e.g., jaw pain, swelling, numbness, loose teeth, exposed bone)
• New or unusual thigh, hip, or groin pain (potential atypical femur fracture)
• Fever or flu-like symptoms (common acute phase reaction)

Pamidronate is Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. Bisphosphonates are incorporated into the bone matrix and are gradually released over weeks to years. The amount of bisphosphonate incorporated into maternal bone and subsequently released is directly related to the total dose and duration of bisphosphonate use. There are no adequate and well-controlled studies in pregnant women.

It is not known whether pamidronate 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 pamidronate, 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 in pediatric patients have not been established. Use in children is generally limited to severe hypercalcemia where benefits outweigh risks, and under close specialist supervision. Long-term effects on bone development are unknown.

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

• Always ensure adequate hydration before, during, and after pamidronate infusion to minimize the risk of renal toxicity.
• Infusion rates are critical; rapid infusion can increase the risk of renal impairment and acute phase reactions.
• Patients should be advised to maintain good oral hygiene and report any jaw pain or dental issues promptly due to the risk of osteonecrosis of the jaw (ONJ).
• Monitor serum calcium, phosphate, magnesium, and potassium closely, especially in the days following infusion, and supplement as needed.
• Acute phase reactions (fever, flu-like symptoms, myalgia, arthralgia) are common, especially with the first dose, and can be managed with acetaminophen.
• Patients should be instructed to report any new hip, thigh, or groin pain, as this could indicate an atypical femur fracture.

• Zoledronic acid (another potent bisphosphonate, often preferred due to shorter infusion time and higher potency)
• Denosumab (monoclonal antibody, RANKL inhibitor, for bone metastases and hypercalcemia of malignancy)
• Calcitonin (for acute hypercalcemia, rapid but short-lived effect)
• Gallium nitrate (for hypercalcemia of malignancy, less common now)
• Mithramycin (plicamycin) (for hypercalcemia of malignancy, rarely used due to toxicity)
• Hydration and loop diuretics (initial management for hypercalcemia)

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 reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. 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 quantity, and the time it was ingested.