D-Vi-Sol

In the U.S.

• Calciferol
• Delta D3
• DHT
• DHT Intensol
• Drisdol
• Hectorol
• Rayaldee
• Rocaltrol
• Vitamin D
• Zemplar

In Canada

• D-Vi-Sol
• Radiostol Forte

Available Dosage Forms:

• Capsule, Liquid Filled
• Capsule
• Solution
• Tablet
• Capsule, Extended Release
• Oil
• Liquid
• Wafer
• Tablet, Chewable

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Problems in children have not been reported with intake of normal daily recommended amounts. Some studies have shown that infants who are totally breast-fed, especially with dark-skinned mothers, and have little exposure to sunlight may be at risk of vitamin D deficiency. Your health care professional may prescribe a vitamin/mineral supplement that contains vitamin D. Some infants may be sensitive to even small amounts of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol. Also, children may show slowed growth when receiving large doses of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol for a long time.

Studies on doxercalciferol or paricalcitol have been done only in adult patients, and there is no specific information comparing the use of doxercalciferol or paricalcitol in children with use in other age groups.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. Studies have shown that older adults may have lower blood levels of vitamin D than younger adults, especially those who have little exposure to sunlight. Your health care professional may recommend that you take a vitamin supplement that contains vitamin D.

Pregnancy

It is especially important that you are receiving enough vitamin D when you become pregnant and that you continue to receive the right amounts of vitamins throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother.

You may need vitamin D supplements if you are a strict vegetarian (vegan-vegetarian) and/or have little exposure to sunlight and do not drink vitamin D-fortified milk.

Taking too much alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol can also be harmful to the fetus. Taking more than your health care professional has recommended can cause your baby to be more sensitive than usual to its effects, can cause problems with a gland called the parathyroid, and can cause a defect in the baby's heart.

Doxercalciferol or paricalcitol have not been studied in pregnant women. However, studies in animals have shown that paricalcitol causes problems in newborns. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast Feeding

It is especially important that you receive the right amounts of vitamins so that your baby will also get the vitamins needed to grow properly. Infants who are totally breast-fed and have little exposure to the sun may require vitamin D supplementation. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Only small amounts of alfacalcidol, calcifediol, calcitriol, or dihydrotachysterol pass into breast milk and these amounts have not been reported to cause problems in nursing babies.

It is not known whether doxercalciferol or paricalcitol passes into breast milk. Be sure you have discussed the risks and benefits of the supplement with your doctor.

Interactions with 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 any of these dietary supplements, 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 dietary supplements in this class 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.

• Boceprevir
• Brivaracetam
• Carbamazepine
• Clarithromycin
• Clobazam
• Clonazepam
• Clorazepate
• Cobicistat
• Conivaptan
• Diazepam
• Eslicarbazepine Acetate
• Ethosuximide
• Ethotoin
• Ezogabine
• Felbamate
• Fosphenytoin
• Gabapentin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lacosamide
• Lamotrigine
• Levetiracetam
• Lopinavir
• Lorazepam
• Methsuximide
• Midazolam
• Nefazodone
• Nelfinavir
• Oxcarbazepine
• Perampanel
• Phenobarbital
• Phenytoin
• Posaconazole
• Pregabalin
• Primidone
• Ritonavir
• Rufinamide
• Saquinavir
• Stiripentol
• Telaprevir
• Telithromycin
• Tiagabine
• Topiramate
• Valproic Acid
• Vigabatrin
• Voriconazole
• Zonisamide

Interactions with Food/Tobacco/Alcohol

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 dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease—Alfacalcidol, calcifediol, calcitriol, or dihydrotachysterol may cause hypercalcemia (high blood levels of calcium), which may make these conditions worse.

• Kidney disease—High blood levels of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol may result, which may increase the chance of side effects.

• Sarcoidosis—May increase sensitivity to alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol and increase the chance of side effects

This section provides information on the proper use of a number of products that contain vitamin d and related compounds. It may not be specific to D-Vi-Sol. Please read with care.

For use as a dietary supplement:

• Do not take more than the recommended daily amount. Vitamin D is stored in the body, and taking too much over a period of time can cause poisoning and even death.

If you have any questions about this, check with your health care professional.

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.
• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

While you are taking alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, doxercalciferol or paricalcitol , your health care professional may want you to follow a special diet or take a calcium supplement. Be sure to follow instructions carefully. If you are already taking a calcium supplement or any medicine containing calcium, make sure your health care professional knows.

Dosing

The dose medicines in this class 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 these medicines. 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 alfacalcidol
• To treat bone disease in kidney patients undergoing kidney dialysis:
  • For oral dosage form (capsules):
    • Adults and teenagers—At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
  • For oral dosage form (drops):
    • Adults and teenagers—At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
  • For oral dosage form (solution):
    • Adults and teenagers—At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
  • For parenteral dosage form (injection):
    • Adults and teenagers—At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 12 mcg a week.
• To treat diseases in which calcium is not used properly by the body:
  • For oral dosage form (capsules):
    • Adults and teenagers—At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.
  • For oral dosage form (drops):
    • Adults and teenagers—At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.
  • For oral dosage form (solution):
    • Adults and teenagers—At first, 0.25 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.

For calcifediol
• To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis:
  • For oral dosage form (capsules):
    • Adults, teenagers, and children over 10 years of age—At first, 300 to 350 micrograms (mcg) a week, taken in divided doses either once a day or every other day. Your doctor may change your dose if needed.
    • Children 2 to 10 years of age—50 mcg a day.
    • Children up to 2 years of age—20 to 50 mcg a day.
• To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis:
  • For oral dosage forms (capsules and solution):
    • Adults, teenagers, and children—At first, 0.25 micrograms (mcg) a day. Your doctor may change your dose if needed.
  • For parenteral dosage forms (injection):
    • Adults and teenagers—At first, 0.5 mcg injected into a vein three times a week. Your doctor may change your dose if needed.
    • Children—Use and dose must be determined by your doctor.

For dihydrotachysterol
• To treat diseases in which calcium is not used properly by the body:
  • For oral dosage forms (capsules, solution, or tablets):
    • Adults and teenagers—At first, 100 micrograms (mcg) to 2.5 milligrams (mg) a day. Your doctor may change your dose if needed.
    • Children—At first, 1 to 5 mg a day. Your doctor may change your dose if needed.

For doxercalciferol
• To treat an overactive parathyroid gland in patients with kidney failure:
  • For oral dosage form (capsules):
    • Adults—10 micrograms (mcg) three times weekly at dialysis. The doctor may change your dose if needed.
    • Children—Use and dose must be determined by your doctor.

For ergocalciferol
• The amount of vitamin D to meet normal daily recommended intakes will be different for different individuals. The following information includes only the average amounts of vitamin D.
• To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
  • For oral dosage form (capsules):
    For the U.S.
    • Adults and teenagers—5 to 10 micrograms (mcg) (200 to 400 Units) per day.
    • Pregnant and breast-feeding females—10 mcg (400 Units) per day.
    • Children 4 to 10 years of age—10 mcg (400 Units) per day.
    • Children birth to 3 years of age—7.5 to 10 mcg (300 to 400 Units) per day.
    For Canada
    • Adults and teenagers—2.5 to 5 mcg (100 to 200 Units) per day.
    • Pregnant and breast-feeding females—5 to 7.5 mcg (200 to 300 Units) per day.
    • Children 7 to 10 years of age—2.5 to 5 mcg (100 to 200 Units) per day.
    • Children 4 to 6 years of age—5 mcg (200 Units) per day.
    • Children birth to 3 years of age—5 to 10 mcg (200 to 400 Units) per day.
• To treat deficiency:
  • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.
• To treat diseases in which calcium and phosphate are not used properly by the body:
  • Adults and teenagers—At first, 1000 to 500,000 Units a day. The doctor may change your dose if needed.
  • Children—At first, 1000 to 200,000 Units a day. The doctor may change your dose if needed.

For paricalcitol
• To treat an overactive parathyroid gland in patients with kidney failure:
  • For oral dosage form (capsules):
    • Adults—1 to 2 micrograms (mcg) one time per day or 2 to 4 mcg three times a week (not more often than every other day). The doctor may change your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For parenteral dosage form (injection):
    • Adults—0.04 to 0.1 micrograms (mcg) per kg no more than every other day during dialysis. The doctor may change your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

For use as a dietary supplement: If you miss taking a dietary supplement for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this dietary supplement, try to remember to take it as directed every day.

If you are taking this medicine for a reason other than as a dietary supplement and you miss a dose and your dosing schedule is:

• One dose every other day—Take the missed dose as soon as possible if you remember it on the day it should be taken. However, if you do not remember the missed dose until the next day, take it at that time. Then skip a day and start your dosing schedule again. Do not double doses
• One dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• More than one dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. 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.

If you have any questions about this, check with your health care professional.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Along with its needed effects, a dietary supplement may cause some unwanted effects. Alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, and ergocalciferol do not usually cause any side effects when taken as directed. However, taking large amounts over a period of time may cause some unwanted effects that can be serious.

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

• High blood pressure
• high fever
• irregular heartbeat
• stomach pain (severe)

Check with your doctor as soon as possible if any of the following side effects occur:

• Bone pain
• constipation (especially in children or adolescents)
• diarrhea
• drowsiness
• dryness of mouth
• headache (continuing)
• increased thirst
• increase in frequency of urination, especially at night, or in amount of urine
• irregular heartbeat
• itching skin
• loss of appetite
• metallic taste
• muscle pain
• nausea or vomiting (especially in children or adolescents)
• unusual tiredness or weakness

• Bone pain
• calcium deposits (hard lumps) in tissues outside of the bone
• cloudy urine
• drowsiness
• increased sensitivity of eyes to light or irritation of eyes
• itching of skin
• loss of appetite
• loss of sex drive
• mood or mental changes
• muscle pain
• nausea or vomiting
• protein in the urine
• redness or discharge of the eye, eyelid, or lining of the eyelid
• runny nose
• 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.

• It is used to treat or prevent vitamin D deficiency.

• If you have an allergy to cholecalciferol or any other part of D-Vi-Sol (cholecalciferol drops).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Malabsorption syndrome, overactive parathyroid gland, sarcoidosis, too much vitamin D or calcium in your body, or Williams syndrome.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take D-Vi-Sol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid other sources of vitamin D.
• Follow the diet and workout plan that your doctor told you about.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using D-Vi-Sol while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take D-Vi-Sol.
• Measure liquid doses carefully. Use the measuring device that comes with this medicine.
• Shake well before use.
• You may put D-Vi-Sol right in the mouth or you may mix it with formula, fruit juice, cereal or other food, water or juice. Take the whole dose.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.