Description
Cholecalciferol is a dietary supplement that is used to treat vitamin D deficiency. It is also used with calcium to maintain bone strength.
Cholecalciferol tablet is also used to treat hypoparathyroidism (underactive parathyroid glands), refractory rickets (vitamin D resistant rickets), and familial hypophosphatemia (low phosphorus in the blood).
This medicine is available both over-the-counter (OTC) and with your doctor's prescription.
This product is available in the following dosage forms:
- Suspension
- Oil
- Wafer
- Capsule
- Tablet
- Capsule, Liquid Filled
- Tablet, Chewable
- Solution
- Tablet, Disintegrating
Before Using
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cholecalciferol in children.
Geriatric
No information is available on the relationship of age to the effects of cholecalciferol in geriatric patients.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Decalcitrol® 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.
Breastfeeding
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.
Drug Interactions
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
- Fosphenytoin
- Phenytoin
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.
Other Medical Problems
The presence of other medical problems may affect the use of this dietary supplement. 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.
- Bone problems or
- Calcium disorder or
- Cancer or
- Kidney disease—Use with caution. May make these conditions worse.
Proper Use
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.
Swallow the tablet whole. Do not chew it.
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 (tablets):
- Adults—Dose is based on your condition and must be determined by your doctor. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- 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.
- For oral dosage form (capsules):
- For hypoparathyroidism, vitamin D resistant rickets:
- For oral dosage form (tablets):
- Adults—Dose is based on your condition and must be determined by your doctor. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
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
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. 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
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
- chest tightness
- cough
- decreased amount of urine
- difficulty swallowing
- dizziness
- dry mouth
- fast heartbeat
- headache
- hives, itching, or skin rash
- increased blood pressure
- increased thirst
- increased volume of pale, dilute urine
- loss of appetite
- lower back or side pain
- nausea
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- slow or fast heartbeat
- swelling of the face, fingers, or lower legs
- trouble breathing
- unusual tiredness or weakness
- vomiting
- 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.
DRG-20088484
