Calcitriol 1 ug/mL
Calcitriol · SOLUTION · Patrin Pharma, Inc
Calcitriol is a solution containing calcitriol at 1 ug/mL, taken oral. Manufactured by Patrin Pharma, Inc.
Key Facts
- Brand Name
- Calcitriol
- Generic Name
- Calcitriol
- NDC Code (Product)
39328-042- Manufacturer
- Patrin Pharma, Inc
- Strength
- 1 ug/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203973
- Drug Class
- Vitamin D3 Analog [EPC]
- Marketing Start
- 08/14/2023
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Validus Pharmaceuticals, Inc.
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP: 5/31/2014; ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_28, EXP: 5/13/2014.
Boehringer Ingelheim Roxane Inc
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Validus Pharmaceuticals, Inc.
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Aidapak Services, LLC
Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC 00172524160, Pedigree: AD46414_7, EXP: 5/16/2014; BENAZEPRIL HCL, Tablet, 5 mg, NDC 65162075110, Pedigree: AD52778_7, EXP: 5/20/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003615, EXP: 6/25/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Predialysis Patients Calcitriol Oral Solution is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol Oral Solution is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Calcitriol Oral Solution administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients Calcitriol Oral Solution is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
Dosage & Administration
DOSAGE AND ADMINISTRATION The optimal daily dose of Calcitriol Oral Solution must be carefully determined for each patient. Calcitriol Oral Solution can be administered as an oral solution (1 mcg/mL). Calcitriol Oral Solution 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 Oral Solution 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 Oral Solution 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 Oral Solutio…
Warnings
WARNINGS Overdosage of any form of vitamin D is dangerous (see OVERDOSAGE ). 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. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg 2 /dL 2 . Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition. Calcitriol Oral Solution is the most potent metabolite of vitamin D available. The administration of Calcitriol Oral Solution 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 Oral Solution treatment to avoid possible additive effects and hypercalcemia. If treatment is switched from ergocalciferol (vitamin D 2 ) to calcitriol, it may take several months for the ergocalciferol level in the blood to return to the baseline value (see OVERDOSAGE ). Calcitriol increases inorganic phosphate levels…
Contraindications
CONTRAINDICATIONS Calcitriol Oral Solution should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of Calcitriol Oral Solution in patients with known hypersensitivity to Calcitriol Oral Solution (or drugs of the same class) or any of the inactive ingredients is contraindicated.
Adverse Reactions
ADVERSE REACTIONS Since Calcitriol Oral Solution 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 WARNINGS ). 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 3 preparations. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include: Early : weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia, abdominal pain or stomach ache. Late : polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT (AST) and SGPT (ALT), ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias…
Frequently Asked Questions
What is Calcitriol used for?
Calcitriol contains Calcitriol. It is a solution taken oral. Consult your doctor for specific uses.
Is Calcitriol a controlled substance?
Calcitriol is not classified as a controlled substance by the DEA.
What is the generic name for Calcitriol?
The generic name for Calcitriol is Calcitriol. There are 1 other brand versions of Calcitriol.
What is the NDC code for Calcitriol 1 ug/mL?
The NDC (National Drug Code) for Calcitriol 1 ug/mL is 39328-042, listed by Patrin Pharma, Inc.