Pronunciation:

koe-le-kal-SIF-er-ol

Brand Names:

• Delta D3
• D-Vi-Sol

Dosage Forms:

• Oil
• Wafer
• Capsule
• Tablet
• Capsule, Liquid Filled
• Tablet, Chewable
• Suspension
• Tablet, Disintegrating
• Solution

Classifications:

Therapeutic—

Nutritive Agent

Pharmacologic—

Vitamin D

Uses of This Medicine:

Cholecalciferol is a dietary supplement that is used to treat vitamin D deficiency. It is also used with calcium to maintain bone strength.

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

Before Using This Medicine:

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, 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 cholecalciferol in children.

Older adults—

No information is available on the relationship of age to the effects of cholecalciferol in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 receiving this dietary supplement, 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 dietary supplement 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

If you are using this medicine without a prescription, follow the instructions on the package.

The chewable wafer must be chewed or crushed. Do not swallow the wafer whole.

Using the oral liquid:

• Use the dropper that comes with the package to measure your dose.
• Adults and adolescents: Drop the liquid directly into the mouth or mix it with food or other liquids (eg, water or juice).
• Children 2 years of age and older: Drop the liquid directly into the mouth, mix it with food or other liquids (eg, water or juice), or take it from a spoon.
• Children younger than 2 years of age: Place one drop of the liquid on the pacifier, mother's nipple, or bottle nipple and allow baby to suck for at least 30 seconds.

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 vitamin D deficiency:
  • For oral dosage form (capsules):
    • Adults—One capsule containing 5000 international units (IU) once a day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—One drop containing 1000 international units (IU) once a day or 2 times per day.
    • Infants and children—One drop containing 400 IU once a day.
  • For oral dosage form (wafer):
    • Children 6 years of age and older—One wafer containing 14,000 international units (IU) once a week for 6 weeks.
    • Children younger than 6 years of age—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. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

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

Cough

difficulty swallowing

dizziness

fast heartbeat

hives or itching

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

skin rash

tightness in the chest

unusual tiredness or weakness

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.