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calcifediol

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Overview

What is Rayaldee?

Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D.

Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is:

RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. Each capsule contains the following excipients: mineral oil, monoglycerides and diglycerides, paraffin, hypromellose, lauroyl polyoxylglycerides, dehydrated alcohol and butylated hydroxytoluene. The capsule shells contain modified starch, carrageenan, sodium phosphate, dibasic, sorbitol sorbitan solution, FD&C Blue #1, titanium dioxide and purified water. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation.



What does Rayaldee look like?



What are the available doses of Rayaldee?

Extended-release 30 mcg capsules ()

What should I talk to my health care provider before I take Rayaldee?

Teratogenic Effects - Pregnancy Category C:

When calcifediol was given orally to bred rabbits on the 6th through the 18th day of gestation, gross visceral and skeletal examination of pups indicated that the compound was teratogenic at doses of 25 and 50 mcg/kg/day. A dose of 5 mcg/kg/day was not teratogenic. In a similar study in rats, calcifediol was not teratogenic at doses up to and including 60 mcg/kg/day.

Labor and Delivery:

How should I use Rayaldee?

RAYALDEE is a vitamin D analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.

Limitations of Use

RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.

RAYALDEE

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2.2

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2.2


What interacts with Rayaldee?

Sorry No Records found


What are the warnings of Rayaldee?

Sorry No Records found


What are the precautions of Rayaldee?

Sorry No Records found


What are the side effects of Rayaldee?

Sorry No records found


What should I look out for while using Rayaldee?

None.


What might happen if I take too much Rayaldee?

Excessive administration of RAYALDEE can cause hypercalciuria, hypercalcemia, hyperphosphatemia, or oversuppression of intact PTH. Common symptoms of vitamin D overdosage may include constipation, decreased appetite, dehydration, fatigue, irritability, muscle weakness, or vomiting.

Treatment of acute accidental overdosage with RAYALDEE should consist of general supportive measures. If the overdosage is discovered within a short time, induce emesis or perform gastric lavage to prevent further absorption. Obtain serial serum and urine calcium measurements, and assess any electrocardiographic abnormalities due to hypercalcemia. Discontinue supplemental calcium. Treat with standard medical care if persistent and markedly elevated serum calcium levels occur.

Calcifediol is not significantly removed by dialysis.


How should I store and handle Rayaldee?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.RAYALDEE is supplied as 30 mcg calcifediol in blue, oval extended-release capsules, imprinted O:Bottles of 30 []Bottles of 60 []Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [].RAYALDEE is supplied as 30 mcg calcifediol in blue, oval extended-release capsules, imprinted O:Bottles of 30 []Bottles of 60 []Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [].RAYALDEE is supplied as 30 mcg calcifediol in blue, oval extended-release capsules, imprinted O:Bottles of 30 []Bottles of 60 []Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [].RAYALDEE is supplied as 30 mcg calcifediol in blue, oval extended-release capsules, imprinted O:Bottles of 30 []Bottles of 60 []Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Calcifediol (25-hydroxyvitamin D) is a prohormone of the active form of vitamin D, calcitriol (1,25‑dihydroxyvitamin D). Calcifediol is converted to calcitriol by cytochrome P450 27B1 (CYP27B1), also called 1-alpha hydroxylase, primarily in the kidney. Calcitriol binds to the vitamin D receptor in target tissues and activates vitamin D responsive pathways that result in increased intestinal absorption of calcium and phosphorus and reduced parathyroid hormone synthesis.

Non-Clinical Toxicology
None.

See .

Hypercalcemia may occur during RAYALDEE treatment []. Acute hypercalcemia may increase the risk of cardiac arrhythmias and seizures and may potentiate the effect of digitalis on the heart []. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. Severe hypercalcemia may require emergency attention.

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium containing preparations, thiazide diuretics, or other vitamin D compounds. In addition, high intake of calcium and phosphate concomitantly with vitamin D compounds may lead to hypercalciuria and hyperphosphatemia. In these circumstances, frequent serum calcium monitoring and RAYALDEE dose adjustments may be required. Patients with a history of hypercalcemia prior to initiating therapy with RAYALDEE should be monitored more frequently for possible hypercalcemia during therapy.

Patients should be informed about the symptoms of elevated serum calcium, which include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, and weight loss.

The following important adverse reactions are discussed in greater detail in other sections of the label:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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