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Dosage of Calcibest in details
The optimal daily dose of Calcibest (Calcibest) must be carefully determined for each patient. Calcibest (Calcibest) can be administered orally either as a capsule (0.25 mcg or 0.50 mcg) or as an oral solution (1 mcg/mL). Calcibest (Calcibest) therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium.
The effectiveness of Calcibest (Calcibest) 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 Calcibest (Calcibest) 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 Calcibest (Calcibest), serum calcium levels should be checked at least twice weekly. When the optimal dosage of Calcibest (Calcibest) 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.
The recommended initial dose of Calcibest (Calcibest) 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. Phosphorus, magnesium, and alkaline phosphatase should be determined periodically.
Patients with normal or only slightly reduced serum calcium levels may respond to Calcibest (Calcibest) doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.
Oral Calcibest (Calcibest) may normalize plasma ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyperfunction, oral Calcibest (Calcibest) may be useful to maintain normocalcemia, but has not been shown to be adequate treatment for hyperparathyroidism.
The recommended initial dosage of Calcibest (Calcibest) 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, Calcibest (Calcibest) should be immediately discontinued until normocalcemia ensues. 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 Calcibest (Calcibest) may be needed.
The recommended initial dosage of Calcibest (Calcibest) 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 Calcibest (Calcibest) is 10 to 15 ng/kg/day.
Capsules: 0.25 mcg Calcibest in soft gelatin, light orange, oval capsules, imprinted with Calcibest (Calcibest) 0.25 ROCHE; bottles of 30 (NDC 0004-0143-23), and bottles of 100 (NDC 0004-0143-01).
Capsules: 0.5 mcg Calcibest in soft gelatin, dark orange, oblong capsules, imprinted with Calcibest (Calcibest) 0.5 ROCHE; bottles of 100 (NDC 0004-0144-01).
Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of Calcibest; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 0004-9115-00).
Calcibest (Calcibest) Capsules and
Oral Solution should be protected from light.
Store at 59° to 86° F (15° to 30° C).
Distributed by: Roche Laboratories Inc., 340 Nutley Street, New Jersey, NJ 07110-1199. Revised: July 2004. FDA Rev date: 7/7/2004
What other drugs will affect Calcibest?
Tell your doctor about all other medicines you use, especially:
digoxin (digitalis, Lanoxin, Lanoxicaps);
cholestyramine (Questran, Prevalite);
seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton);
steroids such as prednisone, fluticasone (Advair, Flovent), mometasone (Asmanex, Nasonex), dexamethasone (Cortastat, DexPak, Decadron) and others; or
a (water pill) diuretic such as hydrochlorothiazide (HCTZ, Esidrix, Hydrodiuril, Microzide,Oretic), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.
This list is not complete and other drugs may interact with Calcibest. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of Calcibest.
The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of Calcibest, but may reduce endogenous plasma levels of 25(OH)D3 by accelerating metabolism. Since blood level of Calcibest will be reduced, higher doses of Calcibest may be necessary if these drugs are administered simultaneously.
Thiazides are known to induce hypercalcemia by the reduction of calcium excretion in urine. Some reports have shown that the concomitant administration of thiazides with Calcibest causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary.
Calcibest dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias.
Ketoconazole may inhibit both synthetic and catabolic enzymes of Calcibest. Reductions in serum endogenous Calcibest concentrations have been observed following the administration of 300 mg/day to 1200 mg/day ketoconazole for a week to healthy men. However, in vivo drug interaction studies of ketoconazole with Calcibest have not been investigated.
A relationship of functional antagonism exists between vitamin D analogues, which promote calcium absorption, and corticosteroids, which inhibit calcium absorption.
Since Calcibest also has an effect on phosphate transport in the intestine, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration.
Since Calcibest is the most potent active metabolite of vitamin D3, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with Calcibest to avoid possible additive effects and hypercalcemia.
Uncontrolled intake of additional calcium-containing preparations should be avoided.
Magnesium-containing preparations (e.g., antacids) may cause hypermagnesemia and should therefore not be taken during therapy with Calcibest by patients on chronic renal dialysis.
- DailyMed. "CALCITRIOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "FXC9231JVH: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Vitamins". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Calcibest are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Calcibest. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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Information checked by Dr. Sachin Kumar, MD Pharmacology