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Calcitriol (Calcitriol)

Trade Name : Calcitriol

Teva Pharmaceuticals USA, Inc.

CAPSULE, LIQUID FILLED

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 Teva Pharmaceuticals USA, Inc.. 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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. It is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol. Each capsule also contains the following inactive ingredients: butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants, and triglycerides (medium chain). Gelatin capsule shell contains gelatin, glycerol, mannitol, red iron oxide, sorbitanhydrides, sorbitol, superior polyols, titanium dioxide and yellow iron oxide. Imprinting ink contains propylene glycol, shellac modified, and titanium dioxide.
  • Calcitriol is a white, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively 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:
  • CHOM.W. 416.65
  • 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.
  • Manu2019s 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 Dis 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)Doccurs 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 1.0 mcg and is somewhat higher during periods of increased bone synthesis (e.g., growth or pregnancy).
  • No data
  • Calcitriol capsules should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of calcitriol capsules 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 (e.g., 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.
  • No data
  • 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, i.e., 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, i.e., 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 n n ).
  • 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.
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA Pharmaceuticals USA, Inc. atu00a0 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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 capsules must be carefully determined for each patient. Calcitriol can be administered orally as a capsule (0.25 mcg or 0.50 mcg). 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 capsule 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 supplementation 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 are available as follows:
  • 0.25 mcg - opaque, red-brown and yellow-brown, two-tone, oval, soft, gelatin capsules, imprinted u201c93u201d and u201c657u201d, in bottles of 100 (NDC 0093-7352-01).
  • 0.5 mcg - opaque, brown and pink, two-tone, oblong, soft, gelatin capsules, imprinted u201c93u201d and u201c658u201d, in bottles of 100 (NDC 0093-7353-01).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. n
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • No data
  • Manufactured In Germany By:
  • Catalent Germany Eberbach GmbH
  • Eberbach, Baden 69412, Germany
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. I 8/2019
  • NDCn- 7352
  • Calcitriol Capsules 0.25 mcg
  • Rx only
  • 100 CAPSULES
  • TEVA
  • Arrayn- Array
  • NDCn- 7353
  • Calcitriol Capsules 0.5 mcg
  • Rx only
  • 100 CAPSULES
  • TEVA

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