Pronunciation:

er-goe-kal-SIF-er-ol

Brand Names:

• Calciferol
• Drisdol
• Vitamin D
• Radiostol Forte

Dosage Forms:

• Capsule
• Liquid
• Solution
• Capsule, Liquid Filled
• Tablet

Classifications:

Therapeutic—

Nutritive Agent

Pharmacologic—

Vitamin D

Uses of This Medicine:

Ergocalciferol capsule is used to treat hypoparathyroidism (underactive parathyroid glands), refractory rickets (vitamin D resistant rickets), and familial hypophosphatemia (low phosphorus in the blood).

Ergocalciferol oral liquid is a dietary supplement that is used to treat vitamin D deficiency.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ergocalciferol in the pediatric population.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ergocalciferol in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erdafitinib

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal sensitivity to the toxic effects of vitamin D or
• Hypercalcemia (high calcium levels in the blood) or
• Hypervitaminosis D (high vitamin D levels in the body) or
• Malabsorption syndrome (trouble absorbing food)—Should not be used in patients with these conditions.

• Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including bronchial asthma) in patients with this condition.

• Kidney disease—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Oral liquid:

• Use the dropper that comes with the package to measure your dose.
• Follow the instructions on the medicine label if you are using this medicine without a prescription.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For hypoparathyroidism:
    • Adults—50,000 to 200,000 international units (IU) ergocalciferol and 4 grams (g) calcium lactate 6 times a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For vitamin D resistant rickets:
    • Adults—12,000 to 500,000 international units (IU) per day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

• For oral dosage form (solution):
  • For vitamin D supplement:
    • Adults—2 drops or 0.05 milliliters (mL) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests are needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Bloody or cloudy urine

blurred vision

decrease in height

dizziness

drowsiness

dry mouth

frequent urination

increased thirst

increased urge to urinate during the night

increased volume of pale, dilute urine

loss of appetite

nervousness

pain in the back, ribs, arms, or legs

pain in the lower back or side

pounding in the ears

slow growth in children

slow or fast heartbeat

swelling of the face, fingers, or lower legs

trouble breathing

unusual tiredness or weakness

vomiting

waking to urinate at night

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Constipation

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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