mental retardation. Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with Ergocalciferol Capsules, USP may cause hypercalcemia. persist for two or more months after cessation of treatment. WARNING: DO NOT EXCEED RECOMMENDED DOSAGE. Having the right amount of vitamin D, calcium, and phosphorus is important for building and keeping strong bones. Last updated on Nov 1, 2021. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. Prevalence of cardiovascular risk factors and the serum levels of 25-hydroxyvitamin D in the United States: data from the third National Health and Nutrition Examination Survey. Therapeutic dosing (ie, high-dose ergocalciferol): Oral: 50,000 units once weekly (or 5,000 to 7,000 units once . In our study, treatments 1 and 2 reflect the NKF KDOQI guidelines for vitamin D repletion in severe and moderate vitamin D insufficiency, respectively. has not identified differences in responses between the elderly and younger Blood calcium and phosphorus determinations must be made . For vitamin D resistant rickets: Adults12,000 to 500,000 international units (IU) per day. Cannell JJ, Hollis BW. vitamins, including vitamin D preparations. IN VITAMIN D RESISTANT RICKETS THE RANGE BETWEEN respond differently from younger subjects. Your child's dose will depend on age, weight, diet, and other factors. Measure liquid medicine carefully. Treatments 1 and 2 were predominantly prescribed by nephrologists. . Regimens with >600,000 IU of ergocalciferol given for a mean of 60 40 days achieved sufficiency in 64% of cases, without vitamin D toxicity. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). In Argentinean children, a single 150,000-IU oral dose of ergocalciferol safely maintained 25-OHD levels at a mean of 18.7 ng/mL but did not improve serum PTH concentrations (31). biologically active metabolites of vitamin D occurs in two steps. Although most of the regimens increased the mean 25-OHD levels, the majority of the regimens did not achieve vitamin D sufficiency (25-OHD values 30 ng/mL). on the cap and body. Levels for 25-OHD were determined by Quest liquid chromatography-mass spectrometry (83%) or Diasorin radioimmunoassay (17%) during the study period. Calcium intake should be adequate. when no permanent damage has occurred. Ergocalciferol may also be used for purposes not listed in this medication guide. Ask a doctor or pharmacist before taking any multivitamins, mineral supplements, or antacids while you are taking ergocalciferol. Some examples of published regimens for the correction of vitamin D status in healthy adults include 50,000 IU of ergocalciferol once a week for 8 weeks (12) or 50,000 IU of ergocalciferol twice a week for 5 weeks (13). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. All rights reserved. Your medication may look different. During pregnancy, doses of vitamin D greater than the recommended dietary allowance should be used only when clearly needed. Hypoparathyroidism: 50,000 to 200,000 IU units daily concomitantly with calcium lactate 4 g, six times per day. sharing sensitive information, make sure youre on a federal Do not use medications containing calcitriol while using vitamin D. This medication may interfere with certain laboratory tests (including cholesterol tests), possibly causing false test results. and significantly increase urinary calcium excretion. Descriptive statistics were used for demographic and laboratory data. Copyright (c) 2023 First Databank, Inc. With appropriate therapy, recovery is the usual outcome when no permanent damage has occurred. The American College of Rheumatology (ACR) recommends optimizing dietary intake of calcium (1-1.2 g daily) and vitamin D (600-800 units daily) in all patients receiving long-term glucocorticoid therapy (defined as a daily dosage equivalent to 2.5 mg of prednisone or higher for 3 months). Generic ergocalciferol is covered by most Medicare and insurance plans, but some . Vieth R. Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety. DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. phosphate from bone and probably increase the reabsorption of calcium and The range between therapeutic and toxic doses is narrow. Additionally, a 10-day high-dose course of ergocalciferol (50,000 IU daily) showed sustained elevation in 25-OHD levels at 4 months (32). Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys. This content does not have an Arabic version. metabolites promote the active absorption of calcium and phosphorus by the small Vitamin D Ergocalciferol Description Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. The effects of administered vitamin D can 50,000 to 200,000 international units (1250 to 5000 mcg) orally daily, concomitantly with calcium lactate 4 g, six times per day Comments: The range between therapeutic and toxic doses is narrow. In the current study, we sought to determine which vitamin D repletion regimens were in use at a large academic-affiliated Veterans Affairs Medical Center (VAMC). Blood calcium and phosphorus prevent serious toxic effects. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. restriction and/or administration of aluminum gels as intestinal phosphate Last updated on Mar 1, 2023. The LD50 in animals is unknown. Ergocalciferol systemic 50,000 intl units (0140). Gastrointestinal: Nausea, anorexia, The various reasons for determining the 25-OHD included evaluations for osteoporosis, chronic kidney disease, and myalgias. You may report side effects to Health Canada at 1-866-234-2345. Kaiser Permanente is not responsible for the content or policies of external websites. X-rays of the bones should be taken every month until condition is corrected and Treatment 4 also included all regimens that totaled 400,000 IU of ergocalciferol given within an 8-week period. with symptomatic and supportive treatment. increase renal calcium excretion. Up to 70 years: 15 mcg (600 international units) orally daily The Institute of Medicine recommends that most adults and children consume 200 to 600 IU of vitamin D daily; however, this recommendation assumes that the individual is vitamin D sufficient initially. If you are taking the rapidly-dissolving tablets, dry your hands before handling the medication. Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia. Additionally, a 10-day high-dose course of ergocalciferol (50,000 IU daily) showed sustained elevation in 25-OHD levels at 4 months . We have determined that no standard regimen exists for correction of vitamin D insufficiency in our hospital. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Quartiles 1 through 4 consisted of those patients with greater than a 200% increase in 25-OHD, those with a 90% to 200% increase, those with a 33% to 89% increase, and those with less than a 33% increase in 25-OHD, respectively. Copyright 1996-2023 Cerner Multum, Inc. Before taking vitamin D, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products (such as calcitriol); or if you have any other allergies. Do not store in the bathroom. and the initiation of its action in the body due to the necessity of synthesis Too much vitamin D could harm an unborn baby, and your dose needs may be different during pregnancy. Calcium intake should be adequate. 300,000 units once, or in divided doses over several days; after 3 months, initiate maintenance dose of 600 units daily. HDPE Bottles of 100 capsules (NDC 23155-809-01) Your doctor will determine how long to treat you with this medicine. Only 1 patient in our study reached vitamin D sufficiency with use of the vitamin D2 50,000-IU once weekly regimen; therefore, we are unable to draw conclusions regarding its efficacy. It may be used in kidney disease to keep calcium levels normal and allow normal bone growth. Certain medications (bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat) can decrease the absorption of vitamin D. Take your doses of these medications as far as possible from your doses of vitamin D (at least 2 hours apart, longer if possible). The effect of high-dose vitamin D supplementation on serum vitamin D levels and milk calcium concentration in lactating women and their infants. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Blood calcium and phosphorus . Clinical studies of Ergocalciferol Capsules, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. in excess of 400 USP Units of vitamin D daily during pregnancy has not been Adults50,000 to 200,000 international units (IU) ergocalciferol and 4 grams (g) calcium lactate 6 times a day. Heaney RP, Dowell MS, Hale CA, Bendich A. Calcium absorption varies within the reference range for serum 25-hydroxyvitamin D. Heaney RP. Portions of this document last updated: Feb. 01, 2023. Serious side effects Other side effects Professional info Applies to ergocalciferol: oral capsule, oral capsule liquid filled, oral liquid, oral solution, oral tablet. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. Studies have demonstrated that serum 25-OHD levels of 30 to 32 ng/mL result in maximal suppression of PTH, optimal intestinal calcium absorption, and prevention of fractures (1,20-22). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Caution is advised if you have diabetes, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Grey A, Lucas J, Horne A, Gamble G, Davidson JS, Reid IR. bones in infants and children (dwarfism). Follow your doctor's orders or the directions on the label. National Kidney Foundation K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Patients who had a 25-OHD determination as part of a work-up for malabsorptive disorders were excluded from the study. Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and The National Kidney Foundation has published guidelines (NKF KDOQI) for the correction of vitamin D insufficiency in patients with chronic kidney disease (8). Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations. should be avoided unless, in the judgment of the physician, potential benefits Vitamin D repletion in patients with primary hyperparathyroidism and coexistent vitamin D insufficiency. Bone demineralization (osteoporosis) in The dose of this medicine will be different for different patients. The Ergocalciferol is vitamin D2. Institute of Medicine. A loop diuretic (furosemide or ethacrynic acid) may be given with the saline infusion to further increase renal calcium excretion. Malabanan et al (12) reported that ergocalciferol in a dosage of 50,000 IU once a week for 8 weeks (treatment 4 in our study) was an effective regimen to improve vitamin D status and decrease PTH levels in patients managed in an osteoporosis clinic in Boston. If you have any unusual effects, contact your doctor or pharmacist promptly. Some studies suggest that vitamin D repletion with ergocalciferol may lower PTH levels in stages 3 or 4 chronic kidney disease (glomerular filtration rate 30 to 59 and 15 to 29 mL/min, respectively) (25,26), whereas others do not (27). 1.25 mg (50,000 USP Units) DESCRIPTION Ergocalciferol Capsules, USP, are a synthetic calcium regulator for oral administration. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. appropriate regimens. Comments: Recommended Daily Allowance: 15 mcg (600 international units) daily An official website of the United States government. It is affected by air and by light. We recorded demographic information for each study subject; the amount of vitamin D prescribed; the study subjects 25-hydroxyvitamin D (25-OHD) and parathyroid hormone (PTH) levels before and after treatment with vitamin D; basic laboratory values including total calcium, albumin, and creatinine; and the specialty of the prescribing physician. determinations must be made every 2 weeks or more frequently if necessary. For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. This quartile also had the highest percentage of patients receiving 600,000 IU of vitamin D. In this study, there were no cases of vitamin D toxicity. Treatments 1, 2, and 3 resulted in a statistically significant increase in serum 25-OHD (P<.01) (Table 2). Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. Caution should be exercised when ergocalciferol capsules are Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Ergocalciferol is vitamin D2. SigmaPharm Laboratories, LLC. We received approval by the Emory University Institutional Review Board and the Atlanta Research and Development Committee to conduct this study. first step should be hydration of the patient. In this study, regimens that contained at least 600,000 IU of ergocalciferol appeared to be the most effective in achieving vitamin D sufficiency. Soft Tissues: Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Many people using this medication do not have serious side effects. Ask your doctor or pharmacist how long you should wait between doses and for help finding a dosing schedule that will work with all your medications. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. It may help to mark your calendar with a reminder. Therefore, we and other investigators suggest that vitamin D sufficiency be defined as serum 25-OHD 30 ng/mL (16). Although some evidence indicates that cholecalciferol (vitamin D3) may be more bioavailable than ergocalciferol (16), it is not widely available by prescription in the United States. Canada residents can call a provincial poison control center. Tolerable Upper Intake Level: 100 mcg (4000 international units) daily. You should not take ergocalciferol if you have had an allergic reaction to vitamin D, or if you have: high levels of vitamin D in your body (hypervitaminosis D); high levels of calcium in your blood (hypercalcemia); or. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Open in a separate window. This content does not have an English version. These guidelines base the treatment of vitamin D on the severity of vitamin D insufficiency (severe, <5 ng/mL; moderate, 5 to 15 ng/mL; and mild, 16 to 30 ng/mL). Store at room temperature away from moisture, heat, and light. Store vitamin D products (except alfacalcidol) at room temperature away from light and moisture. In some cases, there may be a very small difference in amount between safe and dangerous doses of this medicine. lactate 4 g, six times per day. Patients who did not have a 25-OHD determination (n = 41) were excluded from analysis. unknown. Monitoring of the infant's serum calcium concentration is required in that case (Goldberg, 1972). Select one or more newsletters to continue. Of the 265 patients included in this study, 66% had both pretreatment and posttreatment 25-OHD levels. Sign In The https:// ensures that you are connecting to the The toxic oral dose of ergocalciferol in the dog is 4 mg/kg. Over 70 years: 20 mcg (800 international units) orally daily greater frequency of decreased hepatic, renal, or cardiac function, and of In addition to treatment regimen, we also tested total dose of vitamin D received, rapidity of repletion, timing of dose (monthly, weekly, daily, and so forth), and dosing regimen (using the 4 most common methods) as potential exposure variables, with vitamin D sufficiency as the outcome variable. cautious, usually starting at the low end of the dosing range, reflecting the To treat hypoparathyroidism the dose of Drisdol is 50,000 to 200,000 IU units daily taken with calcium lactate 4 g, six times per day.
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