Parical I.V. Injection Solution Iceren Ampul 5 Mcg/Ml

Description

Composition

Each 1 ml ampoule of Parical I.V. Injection Solution contains a meticulously formulated blend of active and inactive ingredients. At its core lies 5 mcg of parikalsitol, the active substance that drives its therapeutic efficacy. Complementing this potent compound are excipients such as ethanol (20% h/h), propylene glycol (30% h/h), and purified water, carefully selected to ensure optimal delivery and stability.

Addressing a Pressing Medical Need

Secondary hyperparathyroidism is a complex condition that often accompanies chronic kidney disease, particularly in patients undergoing dialysis. This disorder is characterized by an excessive production of parathyroid hormone (PTH), which can lead to a host of complications, including bone disease, cardiovascular issues, and metabolic disturbances. Parical I.V. Injection Solution emerges as a beacon of hope, offering a targeted approach to managing this debilitating condition.

Mechanism of Action

Parikalsitol, the active ingredient in Parical I.V. Injection Solution, exerts its therapeutic effects by mimicking the actions of vitamin D in the body. This synthetic compound binds to vitamin D receptors, triggering a cascade of cellular responses that ultimately regulate the production and secretion of PTH. By modulating PTH levels, Parical I.V. Injection Solution helps restore the delicate balance of calcium and phosphorus homeostasis, alleviating the symptoms and complications associated with secondary hyperparathyroidism.

Dosage and Administration

The optimal dosage of Parical I.V. Injection Solution is carefully tailored to each patient’s unique clinical profile and disease severity. For adults, the initial dose ranges from 0.04 to 0.1 mcg/kg (2.8 to 7 mcg), administered as a bolus dose through a hemodialysis vascular access port at any time during dialysis. The maximum frequency is every other day.

In the case of pediatric patients aged 5 to 18 years, the initial dose is determined by the baseline levels of intact parathyroid hormone (iPTH). If the baseline iPTH is less than 500 pg/mL, the recommended initial dose is 0.04 mcg/kg three times per week. However, if the baseline iPTH is 500 pg/mL or higher, the initial dose is increased to 0.08 mcg/kg three times per week. Like in adults, the medication is injected as a bolus dose through a hemodialysis vascular access port at any time during dialysis, with a maximum frequency of every other day.

It is crucial to note that these dosage guidelines are general recommendations, and the exact dosage may vary depending on individual patient needs. Close collaboration with healthcare providers is essential to ensure optimal treatment outcomes.

Contraindications and Precautions

While Parical I.V. Injection Solution offers a promising therapeutic option, it is essential to consider potential contraindications and exercise caution in certain situations. The medication is contraindicated in patients who are allergic to parikalsitol or any of the excipients present in the formulation. Additionally, it should not be used in patients with excessively high levels of calcium or vitamin D in their blood.

Patients with pre-existing heart conditions who are being treated with certain digitalis derivatives should inform their healthcare providers, as these medications can cause a decrease in blood calcium levels and increase the risk of unwanted effects.

Side Effects

Like any medication, Parical I.V. Injection Solution may elicit certain adverse effects, and patients should remain vigilant throughout their treatment journey. Common side effects include cardiovascular effects, such as alterations in heart rate, flu-like symptoms (fever, chills, and body aches), mucosal ulcers, respiratory distress, and seizures (although rare).

Hypercalcemia, or high calcium levels in the blood, is another potential side effect that requires close monitoring. Symptoms of hypercalcemia can include frequent urination, constipation, muscle weakness, confusion, and fatigue.

It is crucial for patients to promptly report any untoward reactions to their healthcare providers, as early intervention can mitigate the risk of complications and ensure optimal treatment outcomes.

Monitoring and Management

Effective management of secondary hyperparathyroidism with Parical I.V. Injection Solution requires a collaborative approach between patients and their healthcare team. Regular blood tests are essential to monitor the levels of parathyroid hormone, calcium, and phosphorus in the blood, ensuring that the medication is achieving its desired effects and allowing for timely adjustments if necessary.

Dietary restrictions may also be recommended to limit the intake of phosphorus, as high levels of this mineral can exacerbate the complications associated with secondary hyperparathyroidism. Patients may be advised to limit their consumption of high-phosphorus foods such as tea, soda, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, cereals, nuts, and grains.

In some cases, the use of phosphate-binding medicines may be necessary to control phosphorus levels effectively. If patients are taking calcium-based phosphate binders, the dosage may need to be adjusted to maintain optimal calcium levels in the body.

Drug Interactions

Like many medications, parikalsitol, the active ingredient in Parical I.V. Injection Solution, may interact with other drugs, potentially altering their efficacy or increasing the risk of adverse effects. Patients who are being treated with certain digitalis derivatives should inform their healthcare providers, as these medications can cause a decrease in blood calcium levels and increase the risk of unwanted effects.

Additionally, if patients are taking another drug that contains paracetamol, they should disclose this information to their healthcare provider, as it may increase the risk of liver damage. Ongoing alcohol consumption or excessive alcohol use (if you consume 3 cups or more alcoholic drinks every day) may also increase the risk of liver damage and should be avoided or minimized during treatment with Parical I.V. Injection Solution.

It is essential to provide a comprehensive list of all medications, supplements, and substances consumed to healthcare providers to ensure appropriate monitoring and management of potential drug interactions.

Parical I.V. Injection 5 Mcg/Ml Storage

While specific storage instructions for Parical I.V. Injection Solution were not available, most injectable medications require careful handling and storage to maintain their potency and safety. In general, these medications should be stored in a cool, dry place, away from direct sunlight and heat. They should not be frozen unless specified by the manufacturer, and it is crucial to keep them out of reach of children and pets.

Adherence to proper storage and handling guidelines is essential to ensure the efficacy and integrity of Parical I.V. Injection Solution throughout its shelf life.

Conclusion

Parical I.V. Injection 5 Mcg/Ml stands as a testament to the relentless pursuit of medical innovation, offering a glimmer of hope for patients grappling with the challenges of secondary hyperparathyroidism associated with chronic kidney disease.

Through its precise formulation and targeted mechanism of action, this remarkable medication aims to restore the delicate balance of calcium and phosphorus homeostasis, alleviating the debilitating symptoms and complications that often accompany this condition.

However, it is crucial to approach treatment with Parical I.V. Injection Solution with a collaborative and vigilant mindset. Close monitoring, adherence to dosage guidelines, and open communication with healthcare providers are essential to ensure optimal outcomes and minimize the risk of adverse effects.

As the medical community continues to explore the therapeutic potential of Parical I.V. Injection Solution, it stands as a beacon of hope, illuminating the path towards improved quality of life for those affected by chronic kidney disease and secondary hyperparathyroidism.

Parical I.V. Injection 5 Mcg/Ml Key Information

Please note that this information is intended to be used as a guide and does not replace professional medical advice. Always consult with your healthcare provider for personalized advice and guidance.