Parical I.V. Injection 2 Mcg/Ml is primarily indicated for the prevention and treatment of secondary hyperparathyroidism in patients aged 5 years and older with chronic kidney disease on dialysis. It is also used for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever when other routes of administration are not possible.

Dosage and Administration

The solution is administered as an intravenous infusion within 15 minutes. The dosage is adjusted according to the patient’s weight, with a minimum dose interval of 4 hours and a maximum of 4 doses per day.

Contraindications

Paricalcitol should not be used in the following cases:

Allergy to Paricalcitol, paracetamol, propacetamol hydrochloride, or any other ingredients
Severe liver disease or active liver disease

Warnings and Precautions

Special care should be taken when using Paricalcitol in the following situations:

Concomitant use of other drugs containing paracetamol
Liver impairment
Severe kidney impairment
Anemia
Lack of the enzyme glucose 6-phosphate dehydrogenase (G6PD)
Ongoing alcohol consumption or excessive alcohol intake
Anorexia or an unbalanced/insufficient diet
Dehydration

Mechanism of Action in Treating Secondary Hyperparathyroidism

Paricalcitol works by inhibiting the secretion of parathyroid hormone (PTH) through binding to the vitamin D receptor. This action is particularly useful in treating secondary hyperparathyroidism, a common complication of chronic kidney disease (CKD).

In CKD, the diseased kidneys progressively lose their ability to hydroxylate the 1 position of 25-hydroxyvitamin D (25[OH]D3), which inhibits the production of the active vitamin D molecule 1,25-dihydroxyvitamin D (1,25[OH]2D3; calcitriol). The resultant suboptimal levels of 1,25-dihydroxyvitamin D play a major role in the early development of secondary hyperparathyroidism by decreasing intestinal absorption of calcium and resulting in PTH production and hyperproliferation of parathyroid cells.

Paricalcitol, being a vitamin D analog, can bind to the vitamin D receptor and mimic the action of active vitamin D, thereby helping to regulate PTH levels. Clinical studies have shown that Paricalcitol-treated patients achieved a 50% reduction from baseline PTH significantly faster than those treated with calcitriol, with fewer sustained episodes of hypercalcemia and/or increased calcium-phosphorus (Ca×P) product.

Long-term Safety and Efficacy Studies

Several long-term studies have been conducted to evaluate the safety and efficacy of Parical I.V. Injection 2 Mcg/Ml:

1. A multicenter study lasting up to 13 months in 164 end-stage renal disease (ESRD) patients on hemodialysis showed that Paricalcitol rapidly and effectively suppressed intact parathyroid hormone (iPTH) levels with no unexpected adverse events.

2. A study in children with stages 3–5 chronic kidney disease demonstrated that oral Paricalcitol reduced iPTH levels and was well-tolerated.

3. A clinical trial evaluated the safety and efficacy of Paricalcitol capsules in reducing serum intact parathyroid hormone levels in ESRD subjects on peritoneal dialysis.

4. A meta-analysis found that Paricalcitol is effective in lowering PTH in patients with CKD not yet on dialysis and is also effective in lowering proteinuria in diabetic CKD patients. However, it identified a safety signal of an elevated calcium-phosphate product and a trend towards the development of hypercalcemia.

Common Side Effects

Like any medication, Paricalcitol can cause side effects. Some of the more common side effects include:

Blurred vision
Cough or hoarseness
Difficulty swallowing
Dizziness
Fever or chills
Headache
Hives
Itching
Lower back or side pain
Nervousness
Pain
Painful or difficult urination
Pounding in the ears
Puffiness or swelling of the eyelids, face, lips, or tongue
Shortness of breath
Skin rash
Slow or fast heartbeat
Swelling
Tightness in the chest
Unusual tiredness or weakness

Less common side effects may include nausea, vomiting, swelling in the hands or feet, dizziness or spinning sensation, joint pain, and runny nose.

It’s important to note that this is not an exhaustive list, and other side effects may occur. Patients should always consult their healthcare provider for personalized advice and monitoring.

Benefits of Parical I.V. Injection 2 Mcg/Ml

The primary benefits of Parical I.V. Injection Solution Iceren Ampul 2 Mcg/Ml include:

Treatment of secondary hyperparathyroidism associated with chronic kidney disease.
Regulation of calcium and phosphate levels, safeguarding against renal osteodystrophy and preserving bone health.
Reduction of parathyroid hormone levels, helping to maintain a balance of calcium and phosphorus in the body.
Safe and effective treatment for secondary hyperparathyroidism in patients with chronic kidney disease, as demonstrated by long-term studies.

Use in Specific Patient Populations

Elderly Patients

Studies have shown that elderly patients undergoing hemodialysis due to chronic kidney disease and receiving Paricalcitol experienced better overall survival compared to those receiving other vitamin D receptor activators.

Pregnant Women

The use of Paricalcitol in pregnant women is not recommended unless the potential benefit outweighs the risk to the fetus. Animal studies have shown decreased fetal viability and increased newborn mortality at maternally toxic doses, with the drug crossing the placental barrier.

It’s crucial to consult with a healthcare provider to ensure the appropriate use of Parical I.V. Injection 2 Mcg/Ml, considering individual patient circumstances and potential risks or benefits.

Parical I.V. Injection 2 Mcg/Ml at a glance

Side Effects	Dosage	Benefits	Usage	Contraindications
Blurred vision, cough, difficulty swallowing, dizziness, fever, headache, hives, itching, pain, shortness of breath, skin rash, swelling, tightness in the chest, tiredness	Adjusted according to weight, minimum dose interval of 4 hours, maximum 4 doses per day	Treatment of secondary hyperparathyroidism, regulation of calcium and phosphate levels, reduction of parathyroid hormone levels	Intravenous infusion within 15 minutes	Allergy to Paricalcitol or ingredients, severe liver disease

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