Pamidronate 90/10ml Inj, 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 and number, thereby decreasing bone resorption and calcium release from bone.

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 notice any of the following symptoms, contact your doctor or seek medical attention right away:

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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Signs of electrolyte problems: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance changes, 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 groin, hip, or thigh pain. 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 cause jawbone problems. Discuss these factors with your doctor and report any jaw swelling or pain immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you encounter 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 list is not exhaustive, and you may experience other 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 allergic reaction you experienced, including any symptoms that occurred.
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 in combination with your other medications and health conditions.

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 monitor your health. Practicing good oral hygiene and scheduling frequent dental check-ups is crucial. Additionally, adhere to your doctor's recommendations 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 potential risks to your baby and determine the best course of action.

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

• Aminoglycosides (may cause additive hypocalcemia)
• Loop diuretics (may enhance calcium excretion, leading to hypocalcemia)
• Nephrotoxic drugs (e.g., NSAIDs, cyclosporine, amphotericin B - increased risk of renal impairment)

• Signs of hypocalcemia (e.g., muscle cramps, spasms, paresthesias, tetany)
• Signs of renal dysfunction (e.g., decreased urine output, edema)
• Signs of osteonecrosis of the jaw (e.g., jaw pain, swelling, numbness, loose teeth, exposed bone)
• Flu-like symptoms (fever, chills, myalgia, arthralgia)
• Bone, joint, or muscle pain (severe and incapacitating)
• New or unusual thigh, hip, or groin pain (potential 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 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 is a theoretical risk of fetal harm (e.g., hypocalcemia, renal tubular dysfunction) if a woman becomes pregnant after completing bisphosphonate therapy.

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 for conditions like severe osteogenesis imperfecta or hypercalcemia is off-label and requires careful consideration of risks vs. benefits, often with specialized dosing and monitoring.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients are more likely to have decreased renal function, so dose selection should be cautious, and renal function should be monitored.

• Always ensure adequate hydration before, during, and after pamidronate infusion to minimize renal toxicity.
• Correct pre-existing hypocalcemia, hypophosphatemia, or hypomagnesemia before administering pamidronate.
• Infuse pamidronate slowly over the recommended time (e.g., 2 hours for 90 mg) to reduce the risk of renal impairment and infusion-related reactions.
• Flu-like symptoms (fever, myalgia, arthralgia) are common after the first dose and usually resolve within 24-48 hours; they can be managed with acetaminophen.
• Emphasize good oral hygiene and regular dental check-ups, especially for cancer patients, to mitigate the risk of ONJ.
• Educate patients to report any new or unusual pain in the thigh, hip, or groin immediately, as this could indicate an atypical femoral fracture.

• Zoledronic acid (another potent bisphosphonate, often preferred for bone metastases and hypercalcemia of malignancy due to once-monthly dosing)
• Denosumab (monoclonal antibody, RANKL inhibitor, alternative for bone metastases and hypercalcemia)
• Calcitonin (for acute hypercalcemia, less potent)
• Gallium nitrate (for hypercalcemia, less common)
• Mithramycin (plicamycin) (for hypercalcemia, rarely used due to toxicity)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities have drug take-back programs in place.

Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is crucial to 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to ensure prompt and effective treatment.