Label: ERGOCALCIFEROL capsule, liquid filled

Rx only

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 D 2is 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 D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU.

Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil.

Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) 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.

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.

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

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

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.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.

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 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 LD 50in animals is unknown. The toxic oral dose of ergocalciferol in the dog is 4 mg/kg.

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 1,250 mcg (50,000 USP units vitamin D) of ergocalciferol, USP, and is available in

NDC: 70518-0177-00

NDC: 70518-0177-01

NDC: 70518-0177-02

NDC: 70518-0177-03

NDC: 70518-0177-04

NDC: 70518-0177-05

PACKAGING: 4 in 1 BOTTLE PLASTIC

PACKAGING: 12 in 1 BOTTLE PLASTIC

PACKAGING: 4 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

PACKAGING: 30 in 1 BLISTER PACK

Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature].

Protect from light and moisture.

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Ergocalciferol

GENERIC: Ergocalciferol

DOSAGE: CAPSULE, LIQUID FILLED

ADMINSTRATION: ORAL

NDC: 70518-0177-0

NDC: 70518-0177-1

NDC: 70518-0177-2

NDC: 70518-0177-3

NDC: 70518-0177-4

NDC: 70518-0177-5

COLOR: green

SHAPE: OVAL

SCORE: No score

SIZE: 13 mm

IMPRINT: PA140

PACKAGING: 4 in 1 BOTTLE PLASTIC

PACKAGING: 12 in 1 BOTTLE PLASTIC

PACKAGING: 4 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• ERGOCALCIFEROL 1.25mg in 1

INACTIVE INGREDIENT(S):

• SOYBEAN OIL
• GELATIN
• GLYCERIN
• WATER
• D&C YELLOW NO. 10
• FD&C BLUE NO. 1