Calcitriol (Page 4 of 4)

Treatment of Hyperphosphatemia in Predialysis Patients

If serum phosphorus levels exceed 5.0 mg/dL to 5.5 mg/dL, a calcium-containing phosphate-binding agent (ie, calcium carbonate or calcium acetate) should be taken with meals. Serum phosphorus levels should be determined as described earlier (see PRECAUTIONS: Laboratory Tests). Aluminum-containing gels should be used with caution as phosphate-binding agents because of the risk of slow aluminum accumulation.

Treatment of Accidental Overdosage of Calcitriol

The treatment of acute accidental overdosage of calcitriol should consist of general supportive measures. If drug ingestion is discovered within a relatively short time, induction of emesis or gastric lavage may be of benefit in preventing further absorption. If the drug has passed through the stomach, the administration of mineral oil may promote its fecal elimination. Serial serum electrolyte determinations (especially calcium), rate of urinary calcium excretion, and assessment of electrocardiographic abnormalities due to hypercalcemia should be obtained. Such monitoring is critical in patients receiving digitalis. Discontinuation of supplemental calcium and a low-calcium diet are also indicated in accidental overdosage. Due to the relatively short duration of the pharmacological action of calcitriol, further measures are probably unnecessary. Should, however, persistent and markedly elevated serum calcium levels occur, there are a variety of therapeutic alternatives which may be considered, depending on the patient’s underlying condition. These include the use of drugs such as phosphates and corticosteroids as well as measures to induce an appropriate forced diuresis. The use of peritoneal dialysis against a calcium-free dialysate has also been reported.

DOSAGE AND ADMINISTRATION

The optimal daily dose of calcitriol must be carefully determined for each patient. Calcitriol can be administered orally as a capsule (0.25 mcg or 0.50 mcg). Calcitriol Capsule 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 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.

Dialysis Patients

The recommended initial dose of calcitriol is 0.25 mcg/day. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease state is not observed, dosage may be increased by 0.25 mcg/day at 4 to 8 week intervals. During this titration period, serum calcium levels should be obtained at least twice weekly, and if hypercalcemia is noted, the drug should be immediately discontinued until normocalcemia ensues (see PRECAUTIONS: General). Phosphorus, magnesium, and alkaline phosphatase should be determined periodically.

Patients with normal or only slightly reduced serum calcium levels may respond to Calcitriol doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.

Oral calcitriol may normalize plasma ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyperfunction, oral calcitriol may be useful to maintain normocalcemia, but has not been shown to be adequate treatment for hyperparathyroidism.

Hypoparathyroidism

The recommended initial dosage of calcitriol is 0.25 mcg/day given in the morning. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease is not observed, the dose may be increased at 2- to 4-week intervals. During the dosage titration period, serum calcium levels should be obtained at least twice weekly and, if hypercalcemia is noted, calcitriol should be immediately discontinued until normocalcemia ensues (see PRECAUTIONS: General). Careful consideration should also be given to lowering the dietary calcium intake. Serum calcium, phosphorus, and 24-hour urinary calcium should be determined periodically.

Most adult patients and pediatric patients age 6 years and older have responded to dosages in the range of 0.5 mcg to 2 mcg daily. Pediatric patients in the 1 to 5 year age group with hypoparathyroidism have usually been given 0.25 mcg to 0.75 mcg daily. The number of treated patients with pseudohypoparathyroidism less than 6 years of age is too small to make dosage recommendations.

Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of calcitriol may be needed.

Predialysis Patients

The recommended initial dosage of calcitriol is 0.25 mcg/day in adults and pediatric patients 3 years of age and older. This dosage may be increased if necessary to 0.5 mcg/day.

For pediatric patients less than 3 years of age, the recommended initial dosage of calcitriol is 10 to 15 ng/kg/day.

HOW SUPPLIED

Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with CAL1 in black ink; bottles of 30 (NDC 69452-207-13), and bottles of 100 (NDC 69452-207-20).

Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange-red, oval capsules, imprinted with CAL2 in black ink; bottles of 30 (NDC 69452-208-13), and bottles of 100 (NDC 69452-208-20).

Calcitriol Capsules should be protected from light.

Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature].

REFERENCE

  1. Jones CL, et al. Comparisons between oral and intraperitoneal 1,25-dihydroxyvitamin D3 therapy in children treated with peritoneal dialysis. Clin Nephrol. 1994; 42:44-49.

Manufactured for:

Bionpharma Inc.

600 Alexander Road Princeton,

NJ 08540, USA

Rev. 05/18

Package Label — Principal Display Panel – 0.25 mcg, 100’s Label

NOC 69452-207-20

Calcitriol Capsules

0.25 mcg

Rx only

100 Capsules

BIONPHARMA

0.25 mcg, 100's Label
(click image for full-size original)

Package Label — Principal Display Panel – 0.5 mcg, 100’s Label

NOC 69452-208-20

Calcitriol Capsules

0.5 mcg

Rx only

100 Capsules

BIONPHARMA

0.5 mcg, 100's Label
(click image for full-size original)

CALCITRIOL
calcitriol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-207
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL (CALCITRIOL) CALCITRIOL 0.25 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN
GLYCERIN
SORBITOL
SORBITAN
MANNITOL
WATER
FD&C YELLOW NO. 6
FD&C RED NO. 40
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color ORANGE (light orange) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code CAL1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-207-13 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC None
2 NDC:69452-207-20 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091174 06/12/2018
CALCITRIOL
calcitriol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL (CALCITRIOL) CALCITRIOL 0.50 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN
GLYCERIN
SORBITOL
SORBITAN
MANNITOL
WATER
FD&C YELLOW NO. 6
FD&C RED NO. 40
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color ORANGE (dark orange-red) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code CAL2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-208-13 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC None
2 NDC:69452-208-20 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091174 06/12/2018
Labeler — BIONPHARMA INC. (079637826)
Registrant — BIONPHARMA INC. (079637826)
Establishment
Name Address ID/FEI Operations
Patheon Softgels Inc. 002193829 MANUFACTURE (69452-207), MANUFACTURE (69452-208)

Revised: 06/2018 BIONPHARMA INC.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.