Zemplar 2mcg/ml Inj , 1ml

Paricalcitol is a synthetic analog of calcitriol, the active form of vitamin D. It selectively activates the vitamin D receptor (VDR) in the parathyroid glands, leading to a reduction in parathyroid hormone (PTH) synthesis and secretion. It also has effects on bone and intestine, but with less calcemic activity compared to calcitriol, thus reducing the risk of hypercalcemia.

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 notice 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 high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Abnormal heartbeat
Seizures
Frequent urination
Weight loss
Decreased appetite
Unusual thirst
Swelling
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
Fever or chills

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Diarrhea
Upset stomach or vomiting
Dizziness or headache
Nose or throat irritation
Trouble sleeping
Joint pain
Eye redness

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
Certain health conditions, including high calcium levels or high vitamin D levels.
* If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems 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 change the dose 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. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

If you are currently taking other supplements that contain vitamin D, consult with your doctor to avoid excessive intake. Additionally, if you are using antacids or other products that contain aluminum, inform your doctor, as this may interact with your medication.

Consuming grapefruit juice or eating grapefruit regularly may also interact with this medication, so it is crucial to discuss this with your doctor. To maximize the effectiveness of your treatment, adhere to the diet plan recommended by your doctor.

If you are pregnant or planning to become pregnant, notify your doctor immediately. You will need to have a detailed discussion about the potential benefits and risks associated with using this medication during pregnancy to make an informed decision.

• High-dose calcium supplements or calcium-containing phosphate binders (increased risk of hypercalcemia)
• Digitalis glycosides (increased risk of digitalis toxicity if hypercalcemia occurs)

• Ketoconazole and other strong CYP3A4 inhibitors (may increase paricalcitol exposure, requiring dose adjustment)
• Other vitamin D analogs (additive effects, increased risk of hypercalcemia/hyperphosphatemia)

• Magnesium-containing antacids (increased risk of hypermagnesemia in dialysis patients)

• Symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, lethargy, muscle weakness, polyuria, polydipsia, confusion)
• Symptoms of hyperphosphatemia (e.g., pruritus, bone pain, vascular calcification symptoms)

Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development (e.g., skeletal abnormalities, reduced fetal weight) at doses higher than human therapeutic doses. Hypercalcemia in the mother during pregnancy may result in fetal hypercalcemia or other adverse effects.

It is not known whether paricalcitol is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., hypercalcemia), 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 efficacy have not been established in pediatric patients. Use is generally not recommended.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, due to the higher prevalence of decreased renal, hepatic, or cardiac function, and concomitant disease or other drug therapy in elderly patients, dose selection should be cautious, generally starting at the low end of the dosing range.

• Paricalcitol is a selective VDR activator, meaning it has a more targeted effect on PTH suppression with less impact on serum calcium and phosphorus compared to non-selective vitamin D analogs like calcitriol.
• Dosing is highly individualized and requires frequent monitoring of iPTH, calcium, and phosphorus levels.
• It is crucial to manage serum calcium and phosphorus levels within target ranges before and during paricalcitol therapy to minimize the risk of hypercalcemia and hyperphosphatemia.
• Patients should be educated on the importance of dietary restrictions (especially phosphorus) and adherence to phosphate binder regimens.
• If hypercalcemia or hyperphosphatemia occurs, the dose of paricalcitol should be reduced or temporarily suspended until levels normalize.

• Calcitriol (Rocaltrol, Calcijex)
• Doxercalciferol (Hectorol)
• Cinacalcet (Sensipar) - a calcimimetic, not a vitamin D analog, but also used for secondary hyperparathyroidism.

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; do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct 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 call 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 was taken to ensure prompt and effective treatment.