Calcitriol (Calcitriol)

Trade Name : Calcitriol

West-Ward Pharmaceuticals Corp.

CAPSULE

Strength 0.25 ug/1

CALCITRIOL Cholecalciferol [CS],Vitamin D3 Analog [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Calcitriol (Calcitriol) which is also known as Calcitriol and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 0.25 ug/1 per ml. Read more

Calcitriol (Calcitriol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg. Calcitriol Capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil. Gelatin capsule shells contain gelatin, glycerin (anhydrous), and titanium dioxide, with the following dyes: FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition to the ingredients listed above, each tablet contains Opacode (Black) monogramming ink. Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water and SDA 35A alcohol.
Calcitriol is a white to almost white crystal which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is soluble in organic solvents but practically insoluble in water. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1u03b1, 3u03b2, 25-triol and has the following structural formula:
CHOn
The other names frequently used for calcitriol are 1u03b1, 25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D,1,25-DHCC, 1,25(OH)D and 1,25-diOHC.

Man's natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin D (cholecalciferol). Vitamin D must be metabolically activated in the liver and the kidney before it is fully active as a regulator of calcium and phosphorus metabolism at target tissues. The initial transformation of vitamin D is catalyzed by a vitamin D-25-hydroxylase enzyme (25-OHase) present in the liver, and the product of this reaction is 25-hydroxyvitamin D [25-(OH)D]. Hydroxylation of 25-(OH)D occurs in the mitochondria of kidney tissue, activated by the renal 25-hydroxyvitamin D-1 alpha-hydroxylase (alpha-OHase), to produce 1,25-(OH)D (calcitriol), the active form of vitamin D. Endogenous synthesis and catabolism of calcitriol, as well as physiological control mechanisms affecting these processes, play a critical role regulating the serum level of calcitriol. Physiological daily production is normally 0.5 to 1 mcg and is somewhat higher during periods of increased bone synthesis (eg, growth or pregnancy).

The two known sites of action of calcitriol are intestine and bone. A calcitriol receptor-binding protein appears to exist in the mucosa of human intestine. Additional evidence suggests that calcitriol may also act on the kidney and the parathyroid glands. Calcitriol is the most active known form of vitamin D in stimulating intestinal calcium transport. In acutely uremic rats calcitriol has been shown to stimulate intestinal calcium absorption.
The kidneys of uremic patients cannot adequately synthesize calcitriol, the active hormone formed from precursor vitamin D. Resultant hypocalcemia and secondary hyperparathyroidism are a major cause of the metabolic bone disease of renal failure. However, other bone-toxic substances which accumulate in uremia (eg, aluminum) may also contribute.
The beneficial effect of calcitriol in renal osteodystrophy appears to result from correction of hypocalcemia and secondary hyperparathyroidism. It is uncertain whether calcitriol produces other independent beneficial effects. Calcitriol treatment is not associated with an accelerated rate of renal function deterioration. No radiographic evidence of extraskeletal calcification has been found in predialysis patients following treatment. The duration of pharmacologic activity of a single dose of calcitriol is about 3 to 5 days.

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Calcitriol capsules should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of calcitriol in patients with known hypersensitivity to calcitriol (or drugs of the same class) or any of the inactive ingredients is contraindicated.

Overdosage of any form of vitamin D is dangerous (see ). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis and other soft-tissue calcification. . Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition.
Calcitriol is the most potent metabolite of vitamin D available. The administration of calcitriol to patients in excess of their daily requirements can cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Therefore, pharmacologic doses of vitamin D and its derivatives should be withheld during calcitriol treatment to avoid possible additive effects and hypercalcemia. If treatment is switched from ergocalciferol (vitamin D) to calcitriol, it may take several months for the ergocalciferol level in the blood to return to the baseline value (see ).
Calcitriol increases inorganic phosphate levels in serum. While this is desirable in patients with hypophosphatemia, caution is called for in patients with renal failure because of the danger of ectopic calcification. A non-aluminum phosphate-binding compound and a low-phosphate diet should be used to control serum phosphorus levels in patients undergoing dialysis.
Magnesium-containing preparations (eg, antacids) and calcitriol should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.
Studies in dogs and rats given calcitriol for up to 26 weeks have shown that small increases of calcitriol above endogenous levels can lead to abnormalities of calcium metabolism with the potential for calcification of many tissues in the body.

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Arrayn- Cholestyramine
Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of calcitriol (see and : ).

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Since calcitriol is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general, similar to those encountered with excessive vitamin D intake, ie, hypercalcemia syndrome or calcium intoxication (depending on the severity and duration of hypercalcemia) (see ). Because of the short biological half-life of calcitriol, pharmacokinetic investigations have shown normalization of elevated serum calcium within a few days of treatment withdrawal, ie, much faster than in treatment with vitamin D preparations.
The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:
Early:
Late:
In clinical studies on hypoparathyroidism and pseudohypoparathyroidism, hypercalcemia was noted on at least one occasion in about 1 in 3 patients and hypercalciuria in about 1 in 7 patients. Elevated serum creatinine levels were observed in about 1 in 6 patients (approximately one half of whom had normal levels at baseline).
In concurrent hypercalcemia and hyperphosphatemia, soft-tissue calcification may occur; this can be seen radiographically (see ).
In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine (see : ).
Hypersensitivity reactions (pruritus, rash, urticaria, and very rarely severe erythematous skin disorders may occur in susceptible individuals. One case of erythema multiforme and one case of allergic reaction (swelling of lips and hives all over the body) were confirmed by rechallenge.

Administration of calcitriol to patients in excess of their daily requirements can cause hypercalcemia, hypercalciuria and hyperphosphatemia. Since calcitriol is a derivative of vitamin D, the signs and symptoms of overdose are the same as for an overdose of vitamin D (see ). High intake of calcium and phosphate concomitant with calcitriol may lead to similar abnormalities. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg/dL. High levels of calcium in the dialysate bath may contribute to the hypercalcemia (see ).

The optimal daily dose of calcitriol must be carefully determined for each patient. Calcitriol capsules should be administered orally. Calcitriol therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium.
The effectiveness of calcitriol therapy is predicated on the assumption that each patient is receiving an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.
Because of improved calcium absorption from the gastrointestinal tract, some patients on calcitriol may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplements at all.
During the titration period of treatment with calcitriol, serum calcium levels should be checked at least twice weekly. When the optimal dosage of calcitriol has been determined, serum calcium levels should be checked every month (or as given below for individual indications). Samples for serum calcium estimation should be taken without a tourniquet.

Calcitriol Capsules
0.25 mcg capsules are supplied as yellow, oval soft gelatin capsules, imprinted with u201c547u201d in black ink
NDC 0054-0007-13: Bottle of 30 Capsules
NDC 0054-0007-25: Bottle of 100 Capsules
Calcitriol Capsules should be protected from light.
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from light.

Mfd. by: n
Pharma Solutions, LLC
St. Petersburg, FL 33716
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003059/06
Revised September 2017

Calcitriol Capsules, .25 mcg
0054-0007-13, Rx Only

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Calcitriol (Calcitriol)

Trade Name : Calcitriol

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Calcitriol (Calcitriol)

Trade Name : Calcitriol

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

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