NOTICE TO PATIENTS AND HEALTH CARE PROFESSIONALS: Validus is no longer manufacturing or distributing this product. This website is maintained solely for reference purposes. Patients — Validus recommends that you talk to your Health Care Professional about alternative therapies.

HOW SHOULD THIS MEDICINE BE USED?

Drisdol® (ergocalciferol, USP) capsules should be taken exactly as prescribed by your doctor. Your dosage is based on your medical condition, diet, age, and response to treatment.

Vitamin D should not be given to infants who have high levels of calcium.

KEEP DRISDOL CAPSULES OUT OF REACH OF CHILDREN

Drisdol capsules are best absorbed when taken with or after a meal, but they may be taken with or without food.

Certain medications can increase the absorption of vitamin D. Ask your doctor or pharmacist if any other medications or over-the-counter supplements or herbal preparations will affect absorption of Drisdol capsules, and, if so, ask your doctor or pharmacist for an appropriate dosing schedule. Make sure that you tell your doctor about all prescription and over-the-counter medicines, and herbal and dietary supplements that you are taking.

In addition, you can be receiving vitamin D from other sources including fortified foods. Make sure that you tell your doctor about any fortified foods that you may be taking.

If you are taking Drisdol capsules for the treatment of vitamin D resistant rickets, you should be aware that there is a very narrow range in the dose you can receive where it will help you before the dose is toxic to your body.

Your doctor will monitor the phosphorus levels in your body and may prescribe supplementation to maintain normal phosphorus levels.

Excessive vitamin D during pregnancy has been shown to cause fetal abnormalities.  You should avoid vitamin D in doses above the recommended dietary amount unless your doctors believes that the benefit clearly outweighs the risk of taking the medicine.

Your doctor will only prescribe Drisdol capsules (and with caution) if you are nursing, as large doses of vitamin D have been shown to pass through to breast milk.

The dose of vitamin D given to children must be individualized for each patient.

Older patients may absorb vitamin D more quickly than younger patients. If you are older, your doctor may start you on a low dose of Drisdol capsules and slowly increase your dose based on your response.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

To make sure that you can safely take Drisdol capsules, tell your doctor if you have any of these conditions:

  • Heart disease
  • Coronary artery disease
  • Kidney disease
  • An electrolyte imbalance, including high phosphate levels
  • A calcium imbalance

You should also tell your doctor:

  • If you are pregnant, planning to become pregnant or are breast feeding
  • If you are taking prescription or nonprescription medicines, herbal preparations or dietary supplements
  • If you have allergies to medicines, foods, or other substances, including any vitamin D products

TAKING OTHER MEDICINES:

Drug interactions may change how your medicines work or increase your risk for serious side effects. Do not start, stop or change the dosage of any medications without your doctor’s approval. Check the labels on all of your prescription and nonprescription products because they may contain vitamin D.

You should also check with your doctor for a dosing schedule for Drisdol capsules and any other medicines or supplements so that you can reduce the potential for side effects.

Mineral oil interferes with the absorption of Drisdol capsules into your body.

If you are taking diuretics containing thiazide to treat low levels of parathyroid hormone, Drisdol capsules may cause an excessive increase in the amount of calcium in your body.

THIS LIST IS NOT COMPLETE AND OTHER DRUGS MAY INTREACT WITH DRISDOL CAPSULES. TELL YOUR DOCTORS ABOUT ALL MEDICINES YOU USE. THIS INCLUDES PRESCRIPTION, OVER-THE-COUNTER, VITAMIN, AND HERBAL PRODUCTS. DO NOT START A NEW MEDICATION WITHOUT TELLING YOUR DOCTOR.

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IMPORTANT SAFETY INFORMATION

Download Full Prescribing Information

Drisdol® (ergocalciferol, USP) Capsules

WHAT ARE DRISDOL CAPSULES USED FOR?

Drisdol® (ergocalciferol, USP) capsules are used to treat hypoparathyroidism (low levels of parathyroid hormone), which result in calcium and phosphorus deficiencies, refractory rickets, also known as vitamin D resistant rickets, and inherited phosphate deficiency.

WHEN SHOULD I NOT TAKE THE DRUG?

Do not take Drisdol capsules if you have ever had an allergic reaction to vitamin D or, if you have:

WHAT WARNINGS SHOULD I KNOW ABOUT DRISDOL CAPSULES?

Vitamin D should be strictly restricted in infants that have excessive calcium levels from unknown causes.

KEEP OUT OF REACH OF CHILDREN

Care should be taken to consider all sources of vitamin D, including from fortified foods, dietary supplements, and prescription drugs. Too much vitamin D can result in vitamin D toxicity. Your doctor must evaluate you and determine your dosage of Drisdol capsules based on the total amount of vitamin D you are getting from all sources.

If you are taking Drisdol capsules for the treatment of vitamin D resistant rickets, you should be aware that there is a very narrow range in the dose you can receive where it will help you versus the dose that is toxic.

If you have low levels of parathyroid hormone, your doctor may prescribe other treatments, including calcium injection, parathyroid hormone, and/or dihydrotachysterol.

Your doctor will monitor the phosphorus levels in your body and may prescribe supplementation to maintain normal phosphorus levels.

Excessive vitamin D during pregnancy has been shown to cause fetal abnormalities. Therefore, use of vitamin D in doses above the recommended dietary amount should be avoided unless your doctor believes  that the benefit clearly outweighs the risk of taking the medicine.

Your doctor will only prescribe Drisdol capsules with caution if you are nursing, as large doses of vitamin D have been shown to pass through to breast milk.

The dose of vitamin D given to children must be individualized for the specific patient.

Older patients may absorb vitamin D more quickly than younger patients.  If you are older, your doctor may start you on a low dose of Drisdol capsules and slowly increase your dose based on your response.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

To make sure that you can safely take Drisdol capsules, tell your doctor if you have any of these conditions:

You should also tell your doctor:

WHAT OTHER MEDICATIONS MIGHT INTERACT WITH DRISDOL CAPSULES?

Mineral oil interferes with the absorption of Drisdol capsules into your body

If you are taking diuretics containing thiazide to treat low levels of parathyroid hormone, Drisdol capsules may cause an excessive increase in the amount of calcium in your body.

WHAT ARE THE SIDE EFFECTS OF DRISDOL CAPSULES?

Seek medical attention if you have any of these side effects:

SEEK EMERGENCY MEDICAL HELP IF YOU HAVE:

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 Validus Pharmaceuticals LLC at 1-866-982-5438.

WHAT IF I OVERDOSE?

Contact 1-800-222-1222 (Poison Control Hotline) or go to the emergency room immediately if you suspect that you have an overdose of Drisdol Capsules.

If you have vitamin D toxicity with high calcium levels in your blood, immediately stop vitamin D treatment, follow a low calcium diet, and drink a lot of fluids.

Excessive calcium levels can cause dehydration, stupor, coma, and high nitrogen levels in the blood. Treatment of excessive calcium is hydration (usually by IV) to increase calcium excretion through the urine.

With appropriate therapy, recovery from overdose is the usual outcome and no permanent damage will occur, although death via kidney and heart failure has occurred.

The effects of excessive vitamin D can last for 2 months after treatment.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch