Parical I.V. Injection Solution Iceren Ampul 10 Mcg/Ml

Description

In the realm of chronic kidney disease (CKD), secondary hyperparathyroidism stands as a formidable adversary, wreaking havoc on the delicate balance of calcium and phosphate homeostasis. However, a beacon of hope has emerged in the form of paricalcitol, a synthetic vitamin D analog that has garnered significant attention for its remarkable efficacy in combating this debilitating condition.

Developed by the Turkish pharmaceutical company Vem Ilac, paricalcitol represents a groundbreaking advancement in the management of secondary hyperparathyroidism, a common complication that arises as renal function deteriorates. This innovative medication harnesses the power of vitamin D, a vital nutrient essential for maintaining calcium and phosphate equilibrium within the body.

Parical I.V. Injection Molecular Mechanisms

At the heart of paricalcitol’s therapeutic prowess lies its unique ability to mimic the biological activity of vitamin D while exhibiting a higher affinity for the vitamin D receptor. This selective binding triggers a cascade of molecular events that ultimately suppress the excessive production and secretion of parathyroid hormone, a hallmark of secondary hyperparathyroidism.

By effectively lowering parathyroid hormone levels, paricalcitol not only alleviates the symptoms associated with this condition but also mitigates the long-term complications, such as renal osteodystrophy, cardiovascular calcification, and metabolic disturbances. This targeted approach underscores paricalcitol’s potential to revolutionize the management of secondary hyperparathyroidism and improve the overall quality of life for patients grappling with chronic kidney disease.

Dosage and Administration

Paricalcitol is available in both oral and intravenous formulations, offering healthcare professionals the flexibility to tailor treatment plans to individual patient needs and clinical circumstances.

Oral Administration

For patients with Stage 3 or 4 CKD, the initial oral dosing is guided by baseline intact parathyroid hormone (iPTH) levels. Those with iPTH levels ≤ 500 pg/mL typically commence treatment with 1 mcg daily or 2 mcg three times a week, while individuals with higher levels may require 2 mcg daily or 4 mcg three times a week.

In the advanced Stage 5 CKD, the starting dose (in micrograms) is calculated by dividing the baseline iPTH level (pg/mL) by 80, administered orally three times a week.

Intravenous Administration

For intravenous administration, the initial dose for adults ranges from 0.04 to 0.1 mcg/kg, injected as a bolus dose through a hemodialysis vascular access port at any time during dialysis. The maximum frequency is every other day, ensuring optimal therapeutic levels are maintained.

Pediatric dosing, based on a small clinical trial, ranges from 0.04 to 0.08 mcg/kg three times per week, depending on baseline iPTH levels, underscoring the importance of individualized treatment approaches.

Dose adjustments may be necessary every 2 to 4 weeks, guided by parathyroid hormone levels and clinical response, ensuring that each patient receives the most appropriate and effective treatment regimen.

Safety Considerations and Side Effects

While paricalcitol has demonstrated a favorable safety profile, it is imperative for healthcare professionals and patients to be aware of potential side effects and contraindications. Individuals with severe liver disease, active liver disease, or hypersensitivity to paricalcitol or its components should avoid this medication.

Common side effects associated with paricalcitol include headache, nausea, vomiting, edema, dizziness, joint pain, and respiratory symptoms. While these adverse effects are generally mild and manageable, more serious reactions, such as blurred vision, difficulty swallowing, fever, rash, and cardiovascular disturbances, may occur and require prompt medical attention.

Special precautions should be taken for patients with liver or kidney impairment, anemia, glucose-6-phosphate dehydrogenase deficiency, alcohol consumption, or nutritional imbalances, as these conditions may increase the risk of adverse effects or alter the medication’s pharmacokinetics.

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Paricalcitol: A Comprehensive Overview

Aspect	Details
Dosage Forms	Oral capsules, intravenous injection
Indications	Prevention and treatment of secondary hyperparathyroidism in chronic kidney disease
Oral Administration	Stage 3 or 4 CKD: 1-4 mcg daily or 2-4 mcg three times a week Stage 5 CKD: Starting dose (mcg) = baseline iPTH (pg/mL) / 80, three times a week
Intravenous Administration	Adults: 0.04-0.1 mcg/kg bolus during hemodialysis, every other day Pediatrics: 0.04-0.08 mcg/kg three times per week
Common Side Effects	Headache, nausea, vomiting, edema, dizziness, joint pain, respiratory symptoms
Serious Side Effects	Blurred vision, swallowing difficulties, fever, rash, cardiovascular disturbances
Contraindications	Severe liver disease, active liver disease, hypersensitivity
Precautions	Liver or kidney impairment, anemia, G6PD deficiency, alcohol consumption, nutritional imbalances
Storage	Room temperature, away from heat and light, avoid freezing

Availability and Cost Considerations

Paricalcitol is available under the brand name Zemplar, as well as through several generic manufacturers, including Amneal Pharmaceuticals, Aurobindo Pharma Ltd, Bionpharma, Dr. Reddy’s Laboratories, Marksans Pharma, Rising Pharmaceuticals, and Teva Pharmaceuticals USA. These generic versions offer a more affordable alternative to the brand-name product, potentially increasing accessibility for patients.

However, it is important to note that the cost of paricalcitol can vary depending on factors such as insurance coverage and the pharmacy where the prescription is filled. Consulting with healthcare providers or pharmacists is advisable to obtain the most accurate and up-to-date information on pricing and availability in specific regions or healthcare systems.

Embracing a Multidisciplinary Approach

The management of secondary hyperparathyroidism in chronic kidney disease requires a comprehensive and multidisciplinary approach, with paricalcitol serving as a powerful tool in the arsenal of healthcare professionals. Nephrologists, endocrinologists, and other specialists must work in close collaboration to develop individualized treatment plans that address the unique needs and circumstances of each patient.

Dietary modifications, lifestyle adjustments, and regular monitoring of biochemical parameters are essential components of a holistic treatment strategy. By integrating paricalcitol into a well-rounded care plan, healthcare teams can optimize outcomes and improve the overall quality of life for patients grappling with this debilitating condition.

Conclusion

As research continues to unravel the intricacies of paricalcitol’s therapeutic potential, healthcare professionals and patients alike can embrace this innovative treatment with confidence, knowing that it represents a significant stride forward in the quest to improve the lives of those affected by chronic kidney disease and its associated complications.