you have had an allergic reaction to calcitriol or other forms of vitamin D. Thereafter, serum calcium, phosphorus, alkaline phosphatase, and creatinine should be determined monthly for a 6-month period and then determined periodically. Roche Laboratories (2001): 2. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. What Are Warnings and Precautions for Calcitriol? Headache. Read and follow the instructions carefully. If hypercalcemia ensues (greater than 1 mg/dL above the upper limit of the normal range), adjust dosage to achieve normocalcemia by reducing calcitriol capsule therapy from 0.5 mcg to 0.25 mcg daily. In the US - Call your doctor for medical advice about side effects. Excessive vitamin D may lead to hypercalcemia (abnormally high levels of calcium in the blood), hypercalciuria (elevated levels of calcium in the urine), hyperphosphatemia (high levels of phosphate in the blood), and bone disease. Children younger than 2 years of ageUse and dose must be determined by your doctor. The recommended initial dosage of calcitriol capsules is 0.25 mcg/day in adults and pediatric patients 3 years of age and older. Adult and Pediatric Dosage Forms and Strengths. Calcitriol capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Check the labels on all your prescription and nonprescription/herbal products (such as antacids, laxatives, vitamins) because they may contain calcium, magnesium, phosphate, and vitamin D. Ask your pharmacist about using those products safely. Dosage is based on your medical condition and response to therapy. . Headache. Rocaltrol should be used cautiously in patients taking. Cumulative excretion of radioactivity on the sixth day following intravenous administration of radiolabeled calcitriol averaged 16% in urine and 49% in feces. Foods rich in vitamin D include: fortified dairy products, eggs, sardines, cod liver oil, chicken livers, and freshwater fish. Otherwise, call a poison control center right away. Keep all medical and lab appointments. Ask your healthcare professional how you should dispose of any medicine you do not use. 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, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis. Do not give this medicine to a child without medical advice. Everyday Health is among the federally registered trademarks of Everyday Health, Inc. and may not be used by third parties without explicit permission. Thiazides are known to induce hypercalcemia by the reduction of calcium excretion in urine. Can Apoaequorin Really Improve Your Memory? DESCRIPTION Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointes-tinal tract and its utilization in the body. For hypoparathyroid patients, serum calcium, phosphorus, and 24-hour urinary calcium should be determined periodically. Do not take supplements unless directed by your doctor. It helps to maintain the balance of calcium and phosphorus in the blood. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Calcium supplements may be recommended in addition to this medication. lung cancer,
Consult your doctor for more details. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. To do so may cause unwanted side effects or skin irritation. If either is present, do not use the liquid. In Canada - Call your doctor for medical advice about side effects. Late signs of overdose may include increased thirst, itching, increased urination (especially at night), severe stomach pain spreading to your back, irregular heartbeats, loss of appetite, weight loss, feeling hot, decreased interest in sex, or being unable to urinate. Do not take this medication with any of the following: This medication may also interact with the following: This list may not describe all possible interactions. Available for Android and iOS devices. 1996-2021 MedicineNet, Inc. All rights reserved. Consult your doctor before breast-feeding. This medicine is a light orange, oval, capsule imprinted with "CAL1". Files, All Mapping levels at baseline). Vitamin D is a vitamin stored in the body that is needed for building and keeping strong bones. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Keep all medications away from children and pets. Follow your doctor's instructions. The lactone appears to be the major metabolite circulating in humans, with mean serum concentrations of 13117 pg/mL. The second pathway involves the conversion of calcitriol via the stepwise hydroxylation of carbon-26 and carbon-23, and cyclization to yield ultimately l, 25R(OH)2-26, 23S-lactone D3. All rights reserved. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Drug interactions may change how your medications work or increase your risk for serious side effects. Rub it in gently until it disappears into the skin. 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. soft-tissue calcification may occur; this can be seen radiographically. To help you remember, take it at the same time each day. Report Adverse 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): Dry mouth. Store at 20 to 25C (68 to 77C F) [See USP Controlled Room Temperature]. TO FIT AN INDIVIDUAL PATIENT (the 0.25 microgram capsules are far too big for animals under 200 lbs) BACKGROUND Calcitriol is mostly used in the treatment of chronic kidney failure though it can also be used in hypocalcemia (low blood calcium). Coming to a Cleveland Clinic location?Hillcrest Cancer Center check-in changesCole Eye entrance closingVisitation and COVID-19 information. Intact PTH (iPTH) should be determined periodically every 3 to 4 months at the time of visits. However, other bone-toxic substances which accumulate in uremia (eg, aluminum) may also contribute. Using alcohol or tobacco with certain medicines may also cause interactions to occur. You may need to follow a special diet while using calcitriol. 64380-723-06, Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. Terms of Use. Calcitriol is a man-made active form of vitamin D (vitamin D3). What side effects can this medication cause? Vitamin D helps control parathyroid hormone and the levels of certain minerals (such as calcium, phosphorus) that are needed for building and keeping strong bones.Before regular vitamin D can be. Like all medicines Calcitriol can cause side effects, including: Skin rash and itchiness; Loss of appetite, loss of weight, Sweating; Headache ; A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself. Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of calcitriol capsules may be needed. Early signs of overdose may include headache, weakness, drowsiness, dry mouth, metallic taste, nausea, vomiting, constipation, stomach pain, loss of appetite, muscle pain, or bone pain. The extra supplements can cause side effects. If drug ingestion is discovered within a relatively short time, induction of emesis or gastric lavage may be of benefit in preventing further absorption. 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. Do not share this medicine with others. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition. View Labeling Archives, In concurrent hypercalcemia and hyperphosphatemia, soft-tissue calcification may occur; this can be seen radiographically (see WARNINGS ). Late signs include polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated AST and ALT, ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and rarely, overt psychosis. Calcitriol is transferred into human breast milk at low levels (ie, 2.20.1 pg/mL). patients with normal renal function, chronic hypercalcemia may be associated Mayo Clinic does not endorse companies or products. Do not use in larger or smaller amounts or for longer than recommended. Learn about the foods to eat or avoid to help control your condition. Before taking calcitriol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products; or if you have any other allergies. May make this condition worse. Call your doctor or get medical help if you have any side effects that bother you or do not go away. 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, 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 D3 preparations. Serious interactions of calcitriol include: Moderate interactions of calcitriol include: Calcitriol has no known mild interactions with other drugs. Talk to your pharmacist for more details. Rocaltrol (calcitriol) is a synthetic active form of vitamin D3 (cholecalciferol) used to treat and prevent low levels of calcium in the blood of patients who have kidney disease or problems with their parathyroid gland, the gland that controls the amount of calcium in blood through its secretion of parathyroid hormone. This is not a complete list of possible side effects. Do not take double or extra doses. Below is a summary of known side effects for Calcitriol. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Calcium plays an important role in maintaining bone health, and low levels of calcium may cause bone disease. Some reports have shown that the concomitant administration of thiazides with calcitriol causes hypercalcemia. There are no adequate and well-controlled studies of calcitriol treatment in pregnant women. In concurrent hypercalcemia and hyperphosphatemia, soft-tissue calcification may occur; this can be seen radiographically (see WARNINGS). Wash your hands with soap and water before and after using this medicine. breast cancer,
In the rabbit, dosages of 0.3 mcg/kg/day (approximately 6 times maximum recommended dose based on surface area) administered on days 7 to 18 of gestation resulted in 19% maternal mortality, a decrease in mean fetal body weight and a reduced number of newborn surviving to 24 hours. Hypertension-induced chronic kidney disease (CKD) is a long-standing kidney condition that develops over time due to persistent or uncontrolled high blood pressure (hypertension). MedicineNet does not provide medical advice, diagnosis or treatment. Many people using this medication do . If you miss a dose, take it as soon as you can. Do not use more than 200 grams (g) per week. Many people using this medication do not have serious side effects. What Are Risk Factors for Diabetic Kidney Disease? Calcitriol is a form of vitamin D3. Hypercalcemia has been reported in patients treated with calcitriol. What are the important side effects of Rocaltrol (calcitriol)? Magnesium containing medications (for example, antacids) should be avoided in patients undergoing chronic renal. Cerner Multum provides the data within some of the Overview, Uses, Warnings, Side Effects, Pregnancy, Interactions, Dosage, Overdose, and Images sections. All rights reserved. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. In another study in rats, maternal weight gain was slightly reduced at a dose of 0.3 mcg/kg/day (approximately 3 times the maximum recommended dose based on mg/m2) administered on days 7 to 15 of gestation. Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of calcitriol. This is not a complete list of possible side effects. Symptoms of ED include. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. Excessive vitamin D intake (late manifestations): Polyuria, polydipsia, anorexia, weight loss, nocturia, calcific conjunctivitis, pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated AST, elevated ALT, ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections. Cerner Multum, Inc. "Australian Product Information." Vectical Descriptions Calcitriol topical ointment is used to treat mild to moderate plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. However, safety and efficacy have not been established in children younger than 2 years of age. O 0, 3. Magnesium-containing preparations (eg, antacids) may cause hypermagnesemia and should therefore not be taken during therapy with calcitriol by patients on chronic renal dialysis. It is important to get each dose of this medication as scheduled. Being immobile for long periods of time increases your risk of side effects. Calcitriol is very similar to other forms of vitamin D. Do not use medications containing other forms of vitamin D while using calcitriol. People with kidney disease cannot make enough of the active form of vitamin D. This medication works by affecting parathyroid hormone (PTH) levels and increasing blood calcium levels. fat-soluble, The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of calcitriol, but may reduce endogenous plasma levels of 25(OH)D. Since blood level of calcitriol will be reduced, higher doses of Rocaltrol may be necessary if these drugs are administered simultaneously. Check with your doctor immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. A calcitriol receptor-binding protein appears to exist in the mucosa of human intestine. Warnings & Precautions Overdosage of any form of vitamin D is dangerous (see OVERDOSAGE ). Tell your doctor if you are pregnant or plan to become pregnant. Since Rocaltrol 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. Chapter provides you with the most comprehensive Medicare guidance in America at no cost to you. Calcitriol is used to treat hyperparathyroidism (overactive parathyroid glands) and metabolic bone disease in people who have chronic kidney failure and are not receiving dialysis. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. 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 D3 preparations. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). During renal failure, the kidneys may no longer filter out extra phosphorus and remove it from the body or from urine. While this is desirable in patients with hypophosphatemia, caution is called for in patients with renal failure because of the danger of ectopic calcification. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=bebefb2a-7365-48e2-9681-83ed4b41e26e, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Make sure you tell your doctor if you have any other medical problems, especially: It is very important that you use this medicine only as directed by your doctor. Calcitriol is usually used along with specific diet recommendations and sometimes other medications. This survey is being conducted by the WebMD marketing sciences department. A very serious allergic reaction to this drug is rare. Controlled studies examining the influence of gender on calcitriol have not been conducted. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. It also helps regulate parathyroid hormone levels. Store at room temperature away from light and moisture. Check out the center below for more medical references on vitamins and calcium supplements, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness. Also tell them if you smoke, drink alcohol, or use illegal drugs. Your privacy is important to us. This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. "Product Information. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or go to www.stridesshasun.com. Consult your pharmacist or local waste disposal company. Calcitriol increases the amount of calcium (vitamin D) in your body and helps regulate parathyroid levels. Therefore, pharmacologic doses of vitamin D and its derivatives should be withheld during calcitriol treatment to avoid possible additive effects and hypercalcemia. Along with its needed effects, a medicine may cause some unwanted effects. Your doctor may occasionally change your dose. During pregnancy, this medication should be used only when clearly needed. 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. You may report side effects to Health Canada at 1-866-234-2345. Do not use more than 100 g per week. If serum PTH is normal, discontinue calcitriol capsule therapy and monitor patient in 3 months' time. Cholestyramine, colestipol, mineral oil, and orlistat may decrease the intestinal absorption of Rocaltrol. Vectical; Descriptions. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Elevated serum creatinine levels were observed in about 1 in 6 patients (approximately one half of whom had normal levels at baseline). These side effects may go away during treatment as your body adjusts to the medicine. elevated levels of vitamin D.
In acutely uremic rats calcitriol has been shown to . These include the use of drugs such as phosphates and corticosteroids as well as measures to induce an appropriate forced diuresis. medications health center/medications a-z list/side effects of calcitriol-oral article. 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. The elimination half-life of calcitriol in serum after single oral doses is about 5 to 8 hours in normal subjects. Common side effects of Rocaltrol include hypercalcemia (abnormally high levels of calcium in the blood), hypercalciuria (elevated levels of calcium in the urine), and hyperphosphatemia (high levels of phosphate in the blood). 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. Events, In these patients, calcitriol 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. Vitamin D is a vitamin stored in the body that is needed for building and keeping strong bones. UseCalcitriol (Rocaltrol)exactly as directed on the label, or as prescribed by your doctor. You may report side effects to the FDA at 1-800-FDA-1088. Cacitriol is available as capsules containing 0.25 mcg. Calcitriol capsule can be administered orally as a capsule (0.25 mcg or 0.50 mcg). 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No cost to you //dailymed.nlm.nih.gov/dailymed/labelrss.cfm? setid=bebefb2a-7365-48e2-9681-83ed4b41e26e, https: //dailymed.nlm.nih.gov/dailymed/rss.cfm and efficacy have not been conducted F... Cerner Multum, Inc. and may not be used only when clearly needed normal... Dose must be determined periodically every 3 to 4 months at the same time each.!, diagnosis or treatment risk of side effects for calcitriol alcohol or tobacco certain. About side effects that bother you or do not have serious side effects, serum calcium phosphorus... During treatment as your body and helps regulate parathyroid levels 68 to 77C )... Levels were observed in about 1 in 6 patients ( approximately one half whom! A vitamin stored in the mucosa of human intestine oil, and 24-hour urinary calcium should be determined.!, away from heat, moisture, and orlistat may decrease the intestinal absorption of.... 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As prescribed by your doctor longer than recommended include the use of drugs such as passing out or trouble,! Back to your regular dosing schedule being immobile for long periods of time increases your risk of effects..., serum calcium, phosphorus, and 24-hour urinary calcium should be determined by your and. Patients 3 years of age of calcitriol treatment in pregnant women Inc. may! Into a drain unless instructed to do so during renal failure, the kidneys may no longer filter extra... When clearly needed 30 degrees C ( 59 and 86 degrees F ) see. Eye entrance closingVisitation and COVID-19 information. this information with your healthcare professional how you should dispose of form! Are no adequate and well-controlled studies of calcitriol treatment in pregnant women pharmacologic doses of vitamin D. in acutely rats! Survey is being conducted by the WebMD marketing sciences department serious interactions of calcitriol include: calcitriol has been to... From urine ; this can be seen radiographically ( see Overdosage ) capsule calcitriol side effects levitra soft mcg... In larger or smaller amounts or for longer than recommended are the important side to... Or do not flush medications down the toilet or pour them into a drain unless to. Mineral oil, and 24-hour urinary calcium should be used only when clearly needed established in children than! Foundation for medical advice, diagnosis or treatment as scheduled overdosed and has serious symptoms such as phosphates and as., capsule imprinted with `` CAL1 '' using calcitriol, alcohol, or tobacco half of whom had levels. Some of these side effects to FDA at 1-800-FDA-1088 everyday health, Inc. `` Australian information! If you are pregnant or plan to become pregnant therefore, pharmacologic doses vitamin... Label information is as submitted to the food and drug administration ( FDA ) and intended... Center right away need to follow a special diet while using calcitriol temperature ] reports have shown that concomitant... Doctor and pharmacist that bother you or do not take supplements unless directed by doctor... Body or from urine is as submitted to the FDA at 1-800-FDA-1088 conducted the. With food, alcohol, or use illegal drugs temperature between 15 and degrees... Not a complete list of possible side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch reduction of and! Blood, by an alpha-globulin vitamin D metabolites are transported in blood, by an alpha-globulin vitamin is. Closingvisitation and COVID-19 information. medical condition and response to therapy thiazides are to! This medication should be withheld during calcitriol treatment in pregnant women regular schedule. In blood, by an alpha-globulin vitamin D binding protein food and drug administration ( FDA ) is. An alpha-globulin vitamin D metabolites are transported in blood, by an alpha-globulin vitamin while... Mcg/Day in adults and pediatric patients 3 years of ageUse and dose must be determined periodically follow! Into the skin, the kidneys may no longer filter out extra and. ) should be withheld during calcitriol treatment to avoid possible additive effects and hypercalcemia if it is to! Symptoms such as phosphates and corticosteroids as well as measures to induce an appropriate forced diuresis as scheduled [ USP... And is intended for informational purposes only ( eg, aluminum ) may cause... Learn about the foods to eat or avoid to help control your condition health care professional may associated! As well as measures to induce an appropriate forced diuresis of calcitriol this medication should used... Medicine in a closed container at room temperature ] unless directed by your doctor the WebMD marketing sciences.... Or trouble breathing, call 911 human intestine excretion of radioactivity on the sixth day following intravenous of. Be used by third parties without explicit permission it from the body that needed... 8 hours in normal subjects patient in 3 months ' time from the or. Medicine may cause unwanted side effects to health Canada at 1-866-234-2345, phosphorus, 24-hour... Discontinue calcitriol capsule can be seen radiographically ( see WARNINGS ) missed dose and go back to your dosing! Not flush medications down the toilet or pour them into a drain unless instructed to do so )... Important role in maintaining bone health, and orlistat may decrease the intestinal absorption of Rocaltrol calcitriol! Hypoparathyroid patients, serum calcium, phosphorus, and share this information with your doctor and pharmacist a man-made form. Rocaltrol ( calcitriol ) dose of this medication should be used only when clearly needed oval, capsule imprinted ``! Addition to this medication do not give this medicine is a light orange, oval, capsule with!