ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration.

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, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil.

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.

Last updated on RxList: 12/29/2008

Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

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.

Each green, oval softgel is imprinted with PA140 and contains 1.25 mg (50,000 USP units vitamin D) of 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

Last updated on RxList: 12/29/2008

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.

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 may cause hypercalcemia.

Last updated on RxList: 12/29/2008

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.

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 is administered to a nursing woman. In a mother given large doses of vitamin D, 25-hydroxycholecalciferol 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).

Last updated on RxList: 12/29/2008

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 in the dog is 4 mg/kg.

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

Last updated on RxList: 12/29/2008

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-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.

Last updated on RxList: 12/29/2008

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 12/29/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

VITAMIN D - ORAL

COMMON BRAND NAME(S): Drisdol, Maximum D3

USES: Vitamin D is used to treat and prevent bone disorders caused by low levels of vitamin D in the body (e.g., rickets, osteomalacia). It is also used with other medications to treat low levels of calcium or phosphate caused by certain disorders (e.g., hypoparathyroidism, pseudohypoparathyroidism, familial hypophosphatemia). Vitamin D helps your body absorb calcium and phosphorus. Having the right amounts of vitamin D, calcium, and phosphorus is important for building and keeping strong bones.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Vitamin D may also be used with calcium to treat or prevent bone loss (osteoporosis). It is also used in patients with kidney disease to keep calcium levels normal and allow normal bone growth.

HOW TO USE: Take the tablet, capsule, or liquid form of this medication by mouth with or without food as directed on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist. If your doctor has prescribed this medication to you, take as directed. Measure the liquid medication with the dropper provided, or use a medication-measuring spoon/device to make sure you have the correct dose.

If your doctor has prescribed this medication, the dosage is based on your medical condition and response to therapy.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins unless ordered by your doctor.

If you think you may have a serious medical problem, seek immediate medical attention.

SIDE EFFECTS: If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: nausea/vomiting, loss of appetite, unusual weight loss, constipation, increased thirst, increased urination, change in the amount of urine, bone/muscle pain, headache, mental/mood changes, weakness, tiredness, fast/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking vitamin D, tell your doctor or pharmacist if you are allergic to tartrazine (in some of the tablet/capsule forms); or to propylene glycol (in the liquid form); or if you have any other allergies. People who are allergic to aspirin are frequently allergic to tartrazine.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high calcium/vitamin D levels (hypercalcemia/hypervitaminosis D), difficulty absorbing nutrition from food (malabsorption syndrome).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, kidney stones, liver disease, certain bowel diseases (Crohn's disease, Whipple's disease), low levels of bile, untreated phosphate imbalance, heart/blood vessel disease, certain immune system disorder (sarcoidosis), limited or no ability to walk (immobility).

During pregnancy, doses of vitamin D greater than the recommended dietary allowance should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: If you are taking this medication under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because a very serious interaction may occur: other vitamin D products (e.g., calcitriol).

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: digoxin, phosphate binders, thiazide diuretics (e.g., hydrochlorothiazide).

Certain medications can decrease the absorption of vitamin D (bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat). Therefore, separate your doses of these medications as far as possible from your doses of vitamin D (at least 2 hours apart, longer if possible). It may be easiest to take vitamin D at bedtime if you are also taking these other medications. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.

Check the labels on all your prescription and nonprescription/herbal products (e.g., antacids, laxatives, vitamins) because they may contain calcium, phosphate, or vitamin D. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including cholesterol test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: weakness, headache, loss of appetite, nausea/vomiting, increased urination, increased thirst.

NOTES: Keep all regular medical and laboratory appointments. If your doctor has prescribed this medication, laboratory and/or medical tests (e.g., calcium/ phosphorus levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Foods rich in vitamin D include: fortified dairy products, eggs, sardines, cod liver oil, chicken livers, and fatty fish. Vitamin D is also made by the body as a result of exposure to the sun.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. If you have any questions about storage, ask your pharmacist. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.