Ergocalciferol

Store at room temperature.

Protect from light and moisture.

Dispense in a tight, light-resistant container.

Keep this and all medications out of the reach of children.

Your pharmacist can provide more information about ergocalciferol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends.

Tell your doctor about all other medicines you use, especially:

• sucralfate (Carafate);

• mineral oil (sometimes taken as a laxative);

• seizure medication;

• steroids (prednisone and others);

• digoxin (digitalis, Lanoxin); or

• a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor HCT, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

This list is not complete and other drugs may interact with ergocalciferol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

General

Measure serum calcium, phosphorus, and BUN concentrations every 2 weeks or more frequently if needed.a b d

The manufacturers recommend radiographic examination of the bones in patients with familial hypophosphatemia or hypoparathyroidism every month until the condition stabilizes and is corrected.a b d

Adequate dietary calcium is necessary for clinical response to vitamin D therapy.b d

Administration

Usually administered orally once daily.a May be administered IM in some patients (e.g., those with GI, liver, or biliary disease associated with malabsorption of vitamin D analogs), and according to the manufacturers, these patients should not receive oral ergocalciferol.a

Dosage

Activity of ergocalciferol may be expressed in terms of USP or International Units (IU, units) which are equivalent; 1 unit of vitamin D equals the biologic activity of 25 ng.c

Each mg of ergocalciferol is equivalent to 40,000 USP units; each mcg of the drug is equivalent to 40 USP units.a

Dosage expressed by weight (mg, mcg) or units.a

Dosage depends on nature and severity of hypocalcemia.a c Individualize dosage to maintain serum calcium concentrations of 9–10 mg/dL.a c

Pediatric Patients

1.25–5 mg daily with calcium supplements.a

Prolonged administration of dosages >2.5 mg daily may increase risk of toxicity; gradually decrease dosage as serum calcium concentrations approach normal. a

Initially, 1–2 mg daily with phosphate supplements.a

May increase daily dosage in 250- to 500-mcg increments at 3- to 4-month intervals until an adequate response is obtained.a

After growth is complete, may reduce dosage.a

625 mcg to 1.25 mg daily have been used. a

25 mcg daily has been used and resulted in normal serum calcium and phosphate concentrations in about 10 days, radiographic evidence of bone healing within 2–4 weeks, and complete healing within 6 months.a

50–125 mcg daily has been used for 6–12 weeks for more prompt healing.a

May discontinue drug, if healing has occurred with therapy and correction of diet.a

Children: 250–625 mcg daily.a

A single 7.5- to 15-mg dose (in oil solution) has been given when compliance was not predictable.a

Infants with tetany and rickets: Initially administer calcium to control tetany then 50–125 mcg daily (until bones have healed) or 250 mcg daily for about 3 weeks.a

75–125 mcg daily; some may require up to 1.5 mg daily.a

0.1–1 mg daily has been used to maintain normal serum calcium concentrations.a

AAP recommends that all infants, children, and adolescents have a minimum intake of 400 units daily. Replaces the previous recommendation of a minimum intake (adequate intake) of 200 units daily.

Breastfed or partially breastfed infants: AAP recommended supplemental dosage is 400 units daily; start in the first few days of life. Continue until the child is weaned and consumes ≥1 L or quart of vitamin D-fortified formula or milk daily.

Infants and older children who consume <1 L of vitamin D-fortified formula or milk daily: AAP recommends supplemental dosage of 400 units daily.

Adolescents who do not consume 400 units of vitamin D daily from vitamin D-fortified milk or foods: AAP recommends supplemental dosage of 400 units daily.

Children at increased risk for vitamin D deficiency (e.g., those with fat malabsorption, those receiving anticonvulsant therapy): Higher dosages may be needed.

Adults

625 mcg to 5 mg (up to 10 mg) daily with calcium supplements and/or IM or IV PTH.a b d

Prolonged administration of dosages >2.5 mg daily may increase risk of toxicity; gradually decrease dosage as serum calcium concentrations approach normal.a

250 mcg to 1.5 mg (up to 12.5 mg) daily with phosphate supplementsa c d (usually 1–2 g of elemental phosphorus daily) to maintain serum phosphorus concentrations of at least 3 mg/dL.c

1.25–5 mg (up to 10 mg) daily have been used along with treatment for acidosis.a

25 mcg daily has been used resulting in normal serum calcium and phosphorus concentrations in about 10 days, radiographic evidence of bone healing within 2–4 weeks, and complete healing within 6 months.a

50–125 mcg daily has been used for 6–12 weeks for more prompt healing.a

May discontinue drug, if healing has occurred with therapy and correction of diet.a

250 mcg to 7.5 mg.a

250 mcg daily.a

50 mcg to 1.25 mg daily.a

25 mcg daily or 250 mcg weekly has been used for prevention in those receiving long-term anticonvulsant therapy.a

250 mcg to 1.5 mg daily; some may require up to 12.5 mg daily.a

Prolonged administration of dosages >2.5 mg daily may result in toxicity.a

Initially, 500 mcg daily for early renal osteodystrophy then adjust according to serum calcium concentration.a

May require 250 mcg to 7.5 mg daily (up to 12.5 mg daily to maintain normal serum calcium concentrations).a

25–250 mcg daily or 1.25 mg 2 times weekly has been used with calcium and fluoride supplements.a

The AI of vitamin D (in terms of cholecalciferol or ergocalciferol) to prevent osteomalacia in healthy adults through 50 years of age is 5 mcg (200 units) daily, while for healthy adults 51–70 or older than 70 years of age is 10 (400 units) or 15 mcg (600 units) daily, respectively.

Because exposure to sunlight is decreased markedly during the winter, adults can become vitamin D deficient. Therefore, to cover the needs of nearly all adults, they should get supplementation. Pregnant and lactating women do not appear to have an increased requirement for vitamin D; however, daily vitamin D supplied by postnatal vitamins is not considered excessive.

Prescribing Limits

Pediatric Patients

Chronic daily ingestion of 25 mcg daily may result in hypervitaminosis D.c

Adults

Chronic daily ingestion of 1.25–2.5 mg daily may result in hypervitaminosis D.c

• Importance of diet and calcium supplementation regimen adherence to achieve a clinical response to vitamin D therapy.c

• Importance of immediate reporting of potential manifestations of hypercalcemia.c

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b d

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast feed.b d

• Importance of informing patients of other precautionary information.b d (See Cautions.)

The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of Ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxy- vitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus 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.

Ergocalciferol Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

The effects of administered vitamin D can persist for two or more months after cessation of treatment.

Hypervitaminosis D is characterized by:

1. Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis.
2. 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.
3. Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Bone demineralization (osteoporosis) in adults occurs concomitantly.
4. 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 of 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 in the dog is 4 mg/kg.

Each green, oval softgel capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of Ergocalciferol, USP.

Bottles of 100 Softgel Capsules (NDC 51991-604-01).

Store at 20°- 25°C (68°-77°F) [See USP Controlled Room Temperature].

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP.

To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc., at 1-800-367-3395 or go to www.bpirx.com. or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Manufactured by: Swiss Caps AG
Kirchberg, Switzerland
Distributed by: Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Rev. 05/17
0308-01

Dietary supplement: For use as a vitamin D supplement.

Familial hypophosphatemia: Treatment of familial hypophosphatemia.

Hypoparathyroidism: Treatment of hypoparathyroidism.

Rickets: Treatment of refractory rickets, also known as vitamin D-resistant rickets.

There are no dosage adjustments provided in the manufacturer’s labeling.

Vitamin D is found in egg yolks, fatty fish, fortified milk, fortified cereal, and infant formulas; it is also produced by exposure to sunlight (IOM 2011). Multivitamin supplements containing vitamin D may be required for breast fed infants, those ingesting <1,000 ml/day of vitamin D-fortified formula or milk, adolescents who do not obtain 400 units/day through vitamin D-fortified milk (100 units/8 ounce serving), and children at increased risk of vitamin D deficiency.

Supplemental calcium and/or phosphorous may be required depending on the indication for therapy. Alternately, a low phosphate diet and/or the use of a nonaluminum-binding agent may be required.