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Cinacalcet 5 mg/mL Oral Suspension

Cinacalcet 5 mg/mL Oral Suspension is a liquid dosage form where the active ingredient, cinacalcet, is uniformly dispersed in a liquid medium, ensuring a homogeneous mixture for precise administration. This formulation is primarily used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, hypercalcemia in patients with parathyroid carcinoma, and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy.

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Cinacalcet
Suspension
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Formula Information

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Cinacalcet 5 mg/mL Oral Suspension is a customized liquid medication formulated to manage conditions associated with elevated parathyroid hormone (PTH) levels, such as secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, hypercalcemia in patients with parathyroid carcinoma, and severe hypercalcemia in primary hyperparathyroidism when surgical intervention is not an option.

This liquid dosage form provides an alternative for patients who have difficulty swallowing tablets or require precise dosing adjustments. By dispersing the active ingredient uniformly throughout the liquid medium, the suspension ensures consistent dosing with each administration, enhancing therapeutic efficacy and patient compliance.

Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid gland to extracellular calcium. This action leads to decreased secretion of PTH, ultimately reducing serum calcium and phosphorus levels. Controlling PTH levels is crucial in preventing complications such as bone disease and cardiovascular calcification associated with chronic kidney disease.

For patients, it is important to take this medication exactly as prescribed by your healthcare provider. Shake the bottle well before each use to ensure the medication is evenly distributed. Use a proper measuring device to ensure accurate dosing. Potential side effects may include nausea, vomiting, low calcium levels (hypocalcemia), and muscle cramps. Regular monitoring of calcium and phosphorus levels is essential during treatment to adjust dosing and minimize adverse effects.

Prescribers should consider the individualized dosing requirements when prescribing Cinacalcet Oral Suspension. Starting doses and titration should be based on serum calcium and PTH levels. The compounding of this suspension allows for

Drug Interactions

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Cinacalcet is a calcimimetic agent primarily used to treat conditions such as secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, hypercalcemia in patients with parathyroid carcinoma, and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. When considering the use of Cinacalcet 5 mg/mL Oral Suspension, it is crucial to be aware of potential drug interactions that may affect the efficacy and safety of the treatment.

Cinacalcet is metabolized primarily by the cytochrome P450 enzyme CYP3A4, and to a lesser extent by CYP1A2 and CYP2D6. Therefore, drugs that inhibit or induce these enzymes can significantly alter the plasma concentration of cinacalcet. Strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin, may increase cinacalcet levels, potentially leading to an increased risk of adverse effects such as hypocalcemia. Conversely, CYP3A4 inducers like rifampin and phenytoin may decrease cinacalcet levels, reducing its therapeutic efficacy.

Additionally, cinacalcet is a potent inhibitor of CYP2D6. Caution is advised when it is co-administered with drugs that are metabolized by CYP2D6, especially those with a narrow therapeutic index, such as tricyclic antidepressants, beta-blockers, and certain antiarrhythmics. The interaction may lead to increased plasma concentrations of these drugs, necessitating dose adjustments and careful monitoring for adverse effects.

Patients taking medications that can lower serum calcium levels, such as bisphosphonates or loop diuretics, should be monitored closely when starting cinacalcet, as the combination may exacerbate hypocalcemia. Regular monitoring of serum calcium levels is recommended to ensure they remain within the target range and to adjust the cinacalcet dose as necessary.

Furthermore, cinacalcet may interact with other medications that affect cardiac conduction, such as antiarrhythmics and certain antipsychotics, due to its potential to cause hypocalcemia, which can prolong the QT interval. Patients on such medications should be monitored for signs of cardiac arrhythmias, and ECG monitoring may be warranted in some cases.

For both patients and prescribers, it is essential to review all current medications, including over-the-counter drugs and supplements, to identify potential interactions before starting cinacalcet. If you have any questions or need further information regarding drug interactions with Cinacalcet 5 mg/mL Oral Suspension, please reach out to us at Bayview Pharmacy. We are here to assist you in ensuring safe and effective use of this medication.

How Does it Work

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Cinacalcet 5 mg/mL Oral Suspension is a liquid dosage form designed to provide a uniform and homogeneous mixture of the active ingredient, cinacalcet, dispersed throughout a liquid medium. This formulation is particularly beneficial for patients who have difficulty swallowing tablets or require precise dosing adjustments. The oral suspension allows for flexible dosing, which can be tailored to the specific needs of the patient, ensuring optimal therapeutic outcomes.

Cinacalcet is a calcimimetic agent that works by modulating the activity of the calcium-sensing receptors (CaSR) on the surface of the parathyroid gland. These receptors play a crucial role in regulating parathyroid hormone (PTH) secretion. By enhancing the sensitivity of these receptors to extracellular calcium, cinacalcet effectively reduces the levels of PTH, calcium, and phosphorus in the blood. This mechanism of action is particularly useful in treating conditions such as secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, and hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism when parathyroidectomy is not an option.

For patients with secondary hyperparathyroidism, cinacalcet helps to manage the overproduction of PTH, which can lead to bone disease and cardiovascular complications. By lowering PTH levels, cinacalcet helps to maintain bone health and reduce the risk of cardiovascular events. In cases of hypercalcemia associated with parathyroid carcinoma or primary hyperparathyroidism, cinacalcet effectively lowers elevated calcium levels, thereby alleviating symptoms and preventing complications associated with hypercalcemia.

The oral suspension form of cinacalcet provides a convenient and effective means of administration, especially for pediatric patients or those with swallowing difficulties. The liquid formulation ensures that the medication is evenly distributed, allowing for accurate dosing and consistent therapeutic effects. Patients and prescribers can benefit from the flexibility of dosing adjustments, which can be made based on the patient's response and laboratory results.

If you have any questions or require further information about Cinacalcet 5 mg/mL Oral Suspension, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with any inquiries or concerns you may have regarding this formulation and its use in treating the specified disease states.

Other Uses

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Cinacalcet 5 mg/mL Oral Suspension is primarily used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, hypercalcemia in patients with parathyroid carcinoma, and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. However, this formulation may have other potential uses that are being explored or considered by healthcare professionals. One such area of interest is the management of hypercalcemia associated with other conditions, such as familial hypocalciuric hypercalcemia (FHH), where traditional treatments may not be suitable or effective. In these cases, cinacalcet may help to lower calcium levels by increasing the sensitivity of the calcium-sensing receptors on the parathyroid gland, thereby reducing parathyroid hormone (PTH) secretion.

Additionally, there is ongoing research into the use of cinacalcet for the treatment of certain bone disorders, such as osteoporosis, where it may help to regulate calcium and phosphate metabolism, potentially improving bone density and reducing fracture risk. While these uses are not yet standard practice, they highlight the potential versatility of cinacalcet in managing calcium-related disorders beyond its current indications. For patients who have difficulty swallowing pills or require precise dosing adjustments, the oral suspension form provides a convenient and flexible option, ensuring accurate dosing and improved adherence to treatment regimens.

It is important for both patients and prescribers to be aware of the potential off-label uses of cinacalcet and to consider the benefits and risks associated with its use in these contexts. As with any medication, the decision to use cinacalcet for conditions other than its approved indications should be based on a thorough evaluation of the patient's specific medical needs and circumstances, as well as a careful consideration of the available clinical evidence. If you have any questions or need further information about the use of cinacalcet oral suspension, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with any inquiries or concerns you may have.

Frequently Asked Questions

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What is Cinacalcet 5 mg/mL Oral Suspension?

Cinacalcet 5 mg/mL Oral Suspension is a liquid dosage form where the active ingredient, Cinacalcet, is uniformly dispersed in a liquid medium to create a homogeneous mixture for easy administration.

How should I store Cinacalcet Oral Suspension?

Store Cinacalcet Oral Suspension at room temperature, away from direct sunlight and moisture. Ensure the bottle is tightly closed when not in use to maintain its stability and effectiveness.

How do I administer Cinacalcet Oral Suspension?

Administer the prescribed dose of Cinacalcet Oral Suspension using a calibrated measuring device, such as an oral syringe or dosing cup, to ensure accuracy. Follow your healthcare provider's instructions for dosage and frequency.

Can Cinacalcet Oral Suspension be mixed with food or drinks?

It is generally recommended to administer Cinacalcet Oral Suspension directly without mixing it with food or drinks to ensure the full dose is consumed. Consult your healthcare provider for specific instructions.

What should I do if I miss a dose of Cinacalcet Oral Suspension?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

Are there any side effects associated with Cinacalcet Oral Suspension?

Common side effects may include nausea, vomiting, and dizziness. If you experience severe side effects or signs of an allergic reaction, contact your healthcare provider immediately.

Can children use Cinacalcet Oral Suspension?

Cinacalcet Oral Suspension may be prescribed for children under specific circumstances. Always follow the guidance of a healthcare provider regarding its use in pediatric patients.

Is it safe to use Cinacalcet Oral Suspension during pregnancy or breastfeeding?

Consult your healthcare provider before using Cinacalcet Oral Suspension if you are pregnant or breastfeeding, as they can provide guidance based on your specific situation and health needs.

How does Cinacalcet Oral Suspension work?

Cinacalcet works by decreasing levels of parathyroid hormone (PTH), calcium, and phosphorus in the body, which helps manage conditions like secondary hyperparathyroidism and parathyroid carcinoma.

What should I do if I experience an overdose of Cinacalcet Oral Suspension?

If you suspect an overdose, seek immediate medical attention. Symptoms of overdose may include muscle spasms, tingling, or numbness. It is important to follow the prescribed dosage to avoid complications.

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Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.

No compounded medications are reviewed by the FDA for safety or efficacy.