Drisdol

Drisdol is a form of Vitamin D, specifically Vitamin D2, that is a prescription medication used to treat hypoparathyroidism (underactive parathyroid), rickets (softening and weakening of the bones) not responding to other medications, and familial hypophosphatemia (low levels of phosphate). Drisdol belongs to a group of drugs called vitamin D analogs, which work by providing the body necessary levels of vitamin D for those who are deficient in this particular vitamin.

This medication comes in capsule form and is typically taken once a day, with or without food.

There are no common side effects in taking Drisdol reported. Rather, serious side effects may occur if too much of the medication is taken.

Serious side effects have been reported with ergocalciferol. See “Drug Precautions” section.

There are no common side effects in taking ergocalciferol reported. Rather, serious side effects may occur if too much of the medication is taken. In order to avoid toxicity from ergocalciferol, vitamin D intake from outside sources (e.g., fortified foods or dietary supplements) should be evaluated by your doctor before to determine an appropriate dose.

This is not a complete list of ergocalciferol side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking ergocalciferol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have heart problems
• have kidney problems
• have liver problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed.

In a mother given large doses of vitamin D, a small amount of vitamin D appeared in the breast milk, which led to excess levels of calcium in her child. Monitoring of the infant's calcium level was required in that case, and may be necessary for other mothers taking 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.

Ergocalciferol is vitamin D2. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Ergocalciferol is used to treat hypoparathyroidism (decreased functioning of the parathyroid glands).

Ergocalciferol is also used to treat rickets (softening of the bones caused by vitamin D deficiency) or low levels of phosphate in the blood (hypophosphatemia).

Ergocalciferol may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• thinking problems, changes in behavior, feeling irritable;

• urinating more than usual;

• chest pain, feeling short 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).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

A vitamin D analog.a

• 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-dihydroxyvitamin 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.

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.

THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

Vitamin D Resistant Rickets: 12,000 to 500,000 IU units daily.

Hypoparathyroidism: 50,000 to 200,000 IU 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 phosphorus 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.

Applies to ergocalciferol: compounding powder, injectable solution, oral capsule, oral solution, oral tablet

Metabolic

Rare (less than 0.1%): Hypercalcemia
Frequency not reported: Hypervitaminosis D[Ref]

Hypervitaminosis D is characterized by: 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; mental retardation; widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs; bone demineralization (osteoporosis) in adults; decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism), vague aches, stiffness, and weakness; nausea, anorexia, constipation; and mild acidosis, anemia, and weight loss.[Ref]

Genitourinary

Rare (less than 0.1%): Hypercalciuria[Ref]

Dermatologic

Rare (less than 0.1%): Pruritus, rash, urticaria[Ref]

Some side effects of Drisdol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.