Drug Summary
What Is Calciferol?
Calciferol (ergocalciferol) is vitamin D2 used to treat hypoparathyroidism (decreased functioning of the parathyroid glands), and is also used to treat rickets (softening of the bones caused by vitamin D deficiency) or low levels of phosphate in the blood (hypophosphatemia). Calciferol is available in generic form.
What Are Side Effects of Calciferol?
Vitamin D at normal doses usually has no side effects.
Contact your doctor if you have any serious side effects of Calciferol, including:
- thinking problems,
- changes in behavior,
- irritability,
- urinating more than usual,
- chest pain,
- shortness of breath, or
- early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).
Too much vitamin D can cause harmful high calcium levels. Tell your doctor if you have signs of high vitamin D/calcium levels including nausea, vomiting, constipation, loss of appetite, increased thirst, increased urination, mental/mood changes, or unusual tiredness.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Calciferol
To treat Vitamin D resistant rickets the dose of Calciferol is 12,000 to 500,000 USP units daily. To treat hypoparathyroidism, the dose is 50,000 to 200,000 USP units daily taken with calcium lactate 4 g, six times per day. The range between therapeutic and toxic doses is narrow. Dosage must be individualized under close medical supervision.
What Drugs, Substances, or Supplements Interact with Calciferol?
Calciferol may interact with sucralfate, mineral oil (sometimes taken as a laxative), seizure medication, steroids, digoxin or diuretics (water pills). Tell your doctor all medications you are taking.
Calciferol During Pregnancy or Breastfeeding
During pregnancy, doses of vitamin D greater than the recommended dietary allowance should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Calciferol (ergocalciferol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Description for Calciferol
ERGOCALCIFEROL (ergocalciferol) CAPSULES, USP, is a synthetic calcium regulator for oral administration.
Ergocalciferol (ergocalciferol) is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils.
It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity.
There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity.
One USP Unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 IU.
Each softgel, for oral administration, contains Ergocalciferol (ergocalciferol) , USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil.
Ergocalciferol (ergocalciferol) , also called vitamin D2, is 9, 10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 ≤ ,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula:
Inactive Ingredients: Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1.
Uses for Calciferol
Ergocalciferol (ergocalciferol) is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
Dosage for Calciferol
THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.
Vitamin D Resistant Rickets
12,000 to 500,000 USP units daily.
Hypoparathyroidism
50,000 to 200,000 USP units daily concomitantly with calcium lactate 4 g, six times per day.
DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.
Calcium intake should be adequate. Blood calcium and phosphorous determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.
HOW SUPPLIED
Each green, oval softgel is imprinted with PA140 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol (ergocalciferol) , USP, and is available in bottles of 100 or 1000 Softgels.
Store at controlled room temperature 15°-30°C (59°-86°F).
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP.
Manufactured by : Banner Pharmacaps, Inc., 4125 Premier Drive, High Point, NC 27265. FDA revision date: n/a
Side Effects for Calciferol
Hypervitaminosis D is characterized by effects on the following organ system:
Renal
Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death.
CNS
Mental retardation.
Soft Tissues
Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs.
Skeletal
Bone demineralization (osteoporosis) in adults occurs concomitantly.
Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism), vague aches, stiffness, and weakness.
Gastrointestinal
Nausea, anorexia, constipation.
Metabolic
Mild acidosis, anemia, weight loss.
Drug Interactions for Calciferol
Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations.
Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol (ergocalciferol) may cause hypercalcemia.
Warnings for Calciferol
Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted.
Keep out of the reach of children.
Precautions for Calciferol
General
Vitamin D administration from fortified foods, dietary supplements, self-administered and prescription drug sources should be evaluated. Therapeutic dosage should be readjusted as soon as there is clinical improvement. Dosage levels must be individualized and great care exercised to prevent serious toxic effects. IN VITAMIN D RESISTANT RICKETS THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. When high therapeutic doses are used progress should be followed with frequent blood calcium determinations.
In the treatment of hypoparathyroidism, intravenous calcium, parathyroid hormone, and/or dihy-drotachysterol may be required.
Maintenance of a normal serum phosphorous level by dietary phosphate restriction and/or administration of aluminum gels as intestinal phosphate binders in those patients with hyperphosphatemia as frequently seen in renal osteodystrophy is essential to prevent metastatis calcification.
Adequate dietary calcium is necessary for clinical response to vitamin D therapy.
Protect from light.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate the drug's potential in these areas.
Pregnancy
Pregnancy Category C
Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation. 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. The safety in excess of 400 USP units of vitamin D daily during pregnancy has not been established.
Nursing Mothers
Caution should be exercised when ergocalciferol (ergocalciferol) is administered to a nursing woman. In a mother given large doses of vitamin D, 25-hydroxycholecalciferol (ergocalciferol) appeared in the milk and caused hypercalcemia in her child. Monitoring of the infants serum calcium concentration is required in that case (Goldberg, 1972).
Pediatric Use
Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION).
Overdose Information for Calciferol
The effects of administered vitamin D can persist for two or more months after cessation of treatment.
Hypervitaminosis D is characterized by:
- Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis.
- Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, or irreversible renal insufficiency which may result in death.
- Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Bone demineralization (osteoporosis) in adults occurs concomitantly.
- Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism).
The treatment of hypervitaminosis D with hypercalcemia consists in immediate withdrawal of the vitamin, a low calcium diet, generous intake of fluids, along with symptomatic and supportive treatment. Hypercalcemic crisis with dehydration, stupor, coma, and azotemia requires more vigorous treatment. The first step should be hydration of the patient. Intravenous saline may quickly and significantly increase urinary calcium excretion. A loop diuretic (furosemide or ethacrynic acid) may be given with the saline infusion to further increase renal calcium excretion. Other reported therapeutic measures include dialysis or the administration of citrates, sulfates, phosphates, corticosteroids, EDTA (ethylenediaminetetraacetic acid), and mithramycin via appropriate regimens. With appropriate therapy, recovery is the usual outcome when no permanent damage has occurred. Deaths via renal or cardiovascular failure have been reported.
The LD50 in animals is unknown. The toxic oral dose of ergocalciferol (ergocalciferol) in the dog is 4 mg/kg.
Contraindications for Calciferol
Ergocalciferol (ergocalciferol) is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
Clinical Pharmacology for Calciferol
The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol (ergocalciferol) takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorous by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules.
There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.
Patient Information for Calciferol
No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
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