Calcicreen is vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.
Calcicreen is used to treat hyperparathyroidism (overactive parathyroid glands) and metabolic bone disease in people who have chronic kidney failure and are not receiving dialysis.
Calcicreen is also used to treat calcium deficiency (hypocalcemia) and metabolic bone disease in people who are receiving dialysis.
Calcicreen is also used to treat calcium deficiency in people with hypoparathyroidism (underactive parathyroid glands) caused by surgery, disease, or other conditions.
Calcicreen may also be used for purposes not listed in this medication guide.
Calcicreen indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Predialysis Patients
Calcicreen (Calcicreen) 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
Calcicreen (Calcicreen) is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Calcicreen (Calcicreen) 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
Calcicreen (Calcicreen) is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
How should I use Calcicreen?
Use Calcicreen solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Calcicreen solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Calcicreen solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Calcicreen solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Calcicreen solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Calcicreen solution and you are using 1 dose every other day, use the missed dose if you remember the same day. If you do not remember the dose until the next day, use the missed dose, and then skip a day. Return to your every other day schedule.
Ask your health care provider any questions you may have about how to use Calcicreen solution.
Uses of Calcicreen in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Calcicreen is a man-made active form of vitamin D (vitamin D3). Vitamin D is a vitamin stored in the body that is needed for building and keeping strong bones. Calcicreen is used to treat or prevent certain problems that can happen with long-term kidney dialysis, such as low levels of calcium or high levels of parathyroid hormone. Calcicreen is usually used along with a certain diet, supplements, and sometimes other medications.
Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. 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.
How to use Calcicreen intravenous
This medication is given by injection into a vein, as directed by your doctor, usually 3 times a week (every other day), or during dialysis, or as directed by your doctor. The dosage is based on your condition and response to therapy. Your doctor will do blood tests to find the best dose for you.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins (e.g., calcium, vitamin D) unless directed by your doctor.
Calcicreen description
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Each mL of ampoule of solution for injection contains the following excipients: Polysorbate 20 4 mg, sodium chloride 1.5 mg, sodium ascorbate 10 mg, anhydrous dibasic sodium phosphate 7.6 mg, monobasic sodium phosphate monohydrate 1.8 mg and disodium edetate dihydrate 1.1 mg. It has a pH of 7.2 (6.5-8). Calcicreen does not contain a preservative.
Calcicreen is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol. Its molecular formula is C27H44O3.
The other names frequently used are 1α,25-dihydroxycholecalciferol; 1α,25-dihydroxy-vitamin D3; 1,25-DHCC; 1,25(OH)2D3; and 1,25-diOHC.
Calcicreen is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water.
Calcicreen dosage
The optimal daily dose of Calcicreen (Calcicreen) must be carefully determined for each patient. Calcicreen (Calcicreen) can be administered orally either as a capsule (0.25 mcg or 0.50 mcg) or as an oral solution (1 mcg/mL). Calcicreen (Calcicreen) therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium.
The effectiveness of Calcicreen (Calcicreen) 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 Calcicreen (Calcicreen) 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 Calcicreen (Calcicreen), serum calcium levels should be checked at least twice weekly. When the optimal dosage of Calcicreen (Calcicreen) 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 Calcicreen (Calcicreen) 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 Calcicreen (Calcicreen) doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.
Oral Calcicreen (Calcicreen) may normalize plasma ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyperfunction, oral Calcicreen (Calcicreen) may be useful to maintain normocalcemia, but has not been shown to be adequate treatment for hyperparathyroidism.
Hypoparathyroidism
The recommended initial dosage of Calcicreen (Calcicreen) 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, Calcicreen (Calcicreen) 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 Calcicreen (Calcicreen) may be needed.
Predialysis Patients
The recommended initial dosage of Calcicreen (Calcicreen) 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 Calcicreen (Calcicreen) is 10 to 15 ng/kg/day.
How supplied
Capsules: 0.25 mcg Calcicreen in soft gelatin, light orange, oval capsules, imprinted with Calcicreen (Calcicreen) 0.25 ROCHE; bottles of 30 (NDC 0004-0143-23), and bottles of 100 (NDC 0004-0143-01).
Capsules: 0.5 mcg Calcicreen in soft gelatin, dark orange, oblong capsules, imprinted with Calcicreen (Calcicreen) 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 Calcicreen; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 0004-9115-00).
Calcicreen (Calcicreen) 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
Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of Calcicreen.
Phenytoin/Phenobarbital:
The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of Calcicreen, but may reduce endogenous plasma levels of 25(OH)D3 by accelerating metabolism. Since blood level of Calcicreen will be reduced, higher doses of Calcicreen may be necessary if these drugs are administered simultaneously.
Thiazides:
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 Calcicreen causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary.
Digitalis:
Calcicreen dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias.
Ketoconazole:
Ketoconazole may inhibit both synthetic and catabolic enzymes of Calcicreen. Reductions in serum endogenous Calcicreen 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 Calcicreen have not been investigated.
Corticosteroids:
A relationship of functional antagonism exists between vitamin D analogues, which promote calcium absorption, and corticosteroids, which inhibit calcium absorption.
Phosphate-Binding Agents:
Since Calcicreen 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.
Vitamin D:
Since Calcicreen is the most potent active metabolite of vitamin D3, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with Calcicreen to avoid possible additive effects and hypercalcemia.
Calcium Supplements:
Uncontrolled intake of additional calcium-containing preparations should be avoided.
Magnesium:
Magnesium-containing preparations (e.g., antacids) may cause hypermagnesemia and should therefore not be taken during therapy with Calcicreen by patients on chronic renal dialysis.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rate observed in practice.
Clinical Studies Experience
Calcicreen Ointment was studied in two vehicle-controlled studies (419 subjects), and in one open label study (324 subjects). The table below describes exposure to Calcicreen Ointment in 743 subjects, including 239 exposed for 6 months and 116 exposed for one year.
Four hundred and nineteen subjects were treated with Calcicreen Ointment twice daily for 8 weeks. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis.
Among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle, however the elevation were less than 10% above the upper limit of normal
The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with Calcicreen Ointment were lab test abnormality (8%), urine abnormality (4%), psoriasis (4%), hyperciuria (3%), and pruritus (3%). Kidney stones were reported in 3 subjects and confirmed in two.
Postmarketing Experience
The following adverse reactions have been identified during the world-wide post-approval use of Calcicreen Ointment: acute blistering dermatitis, erythema, pruritus, skin burning sensation, and skin discomfort. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
You should not use this medication if you have a severe form of psoriasis (with pus, skin peeling, severe redness).
Before using Calcicreen topical, tell your doctor if you have low or high levels of calcium in your blood, a calcium disorder or metabolic imbalance, or if you are receiving UV light treatments (phototherapy) for your psoriasis.
Tell your doctor about all other medicines you are using to treat psoriasis. Also tell your doctor if you are taking a diuretic (water pill) or vitamin or mineral supplements that contain calcium or vitamin D.
Calcicreen topical is for use only on areas of psoriasis. Avoid getting it on healthy skin areas. Calcicreen topical should not be applied to the face or the vaginal area.
Stop using this medication and call your doctor if you have a serious side effect such as blistering or severe redness, itching, or other irritation of treated skin.
Using Calcicreen topical can affect your body's ability to metabolize calcium. This can result in high levels of calcium in your blood (hypercalcemia). Symptoms of this condition include nausea, loss of appetite, constipation, increased thirst and urination, muscle weakness, confusion, and feeling tired or restless. Call your doctor if you have any of these symptoms.
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).
The results of a survey conducted on ndrugs.com for Calcicreen 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 Calcicreen. 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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