Rocaltrol

Calcitriol is a prescription medication used for various conditions. It can be used to treat and prevent low levels of calcium in the blood of patients whose kidneys or parathyroid glands are not functioning well. Calcitriol can also be used to treat plaque psoriasis.

Calcitriol belongs to a group of drugs called vitamin D analogs. In treating hypocalcemia, it works by restoring levels of calcium in the blood. It is not well understood how calcitriol works to treat plaque psoriasis.

This medication comes in capsule and oral solution forms and is taken once daily or every other day.

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

This medication addictionally comes in ointment form and is applied to the affected skin twice a day. It is not to be used in the mouth, on the eyes, or intravaginally.

Common side effects of calcitriol capsule, oral solution, and injectable forms include weakness, fatigue, nausea, and headache.

Common side effects of calcitriol ointment include psoriasis, elevated levels of calcium in the urine, and itching.

Oral/Injectable:

Calcitriol is a prescription medication used to treat

• low calcium levels in patients with certain conditions
• elevated parathyroid hormone levels

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Topical:

Calcitriol is a prescription medication used to treat mild to moderate plaque psoriasis in adults 18 years and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Aphena Pharma Solutions - Tennessee, Inc.

• Kaiser Foundation Hospitals

• Roche Laboratories

• Roche Pharmaceuticals

• Validus Pharmaceuticals, Inc.

Oral/Injectable:

Common side effects of calcitriol capsule, oral solution, and injection include the following:

• weakness
• headacha
• nausea
• vomiting
• dry mouth
• constipation
• muscle pain
• bone pain
• metallic taste
• anorexia
• stomach pain
• upset stomach

Topical:
Common side effects of calcitriol ointment include the following:

• psoriasis
• itching
• lab test abnormalities
• urine test abnormalities
• high levels of calcium in the urine

This is not a complete list of calcitriol side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with calcitriol.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antacids
• calcium supplements
• cholestyramine (Questran)
• colestipol (Colestid)
• digoxin (Lanoxin)
• thiazide diuretics ('water pills') such as chlorothiazide (Diuril), hydrochlorothiazide (Microzide, Oretic, many combination products), indapamide, and metolazone (Zaroxolyn)
• ketoconazole (Nizoral)
• lanthanum (Fosrenol)
• laxatives
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
• other forms of vitamin D
• phenobarbital (Donnatal)
• phenytoin (Dilantin)
• sevelamer (Renagel)
• ergocalciferol (Drisdol, Calciferol) 

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with this medication, and certain precautions should be followed:

Oral/Injectable:

• Overdosage of any form of vitamin D is dangerous. Calcitriol is a form of vitamin D. Tell your doctor if you experience signs/symptoms of vitamin D toxicity including dehydration, vomiting, decreased appetite, irritability, constipation, fatigue, muscle weakness). 
• It is recommended to avoid all non-prescription medications to avoid elevated phosphate levels in the body.

Do not take this medication if you

• are allergic to calcitriol or to any of its ingredients
• have hypercalcemia or evidence of vitamin D toxicity

Topical

• Avoid excessive exposure of calcitriol ointment treated areas to either natural or artificial sunlight.
• Taking this medication may alter the way your body processes calcium. Your doctor will want to monitor if these changes occur.

Do not take this medication if you are allergic to calcitriol or to any of its ingredients

Oral/Injectable:

Calcitriol will work only if you get the right amount of calcium from the foods you eat. If you get too much calcium from foods, you may experience serious side effects of calcitriol, and if you do not get enough calcium from foods, calcitriol will not control your condition. Your doctor will tell you which foods are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor can prescribe or recommend a supplement.

If you are being treated with dialysis (process of cleaning the blood by passing it through a machine), your doctor may also prescribe a low-phosphate diet. Follow these directions carefully.

If you do not have kidney disease, you should drink plenty of fluids while taking calcitriol. If you have kidney disease, talk to your doctor about how much fluid you should drink each day.

Topical:

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before taking calcitriol,

• tell your doctor and pharmacist if you are allergic to calcitriol, other forms of vitamin D such as calcifediol (Calderol), dihydrotachysterol (Hytakerol, DHT), doxercalciferol (Hectorol), ergocalciferol (Drisdol, Calciferol), paricalcitol (Zemplar) or any other medications or vitamins.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.
• tell your doctor or pharmacist if you are taking ergocalciferol (Drisdol, Calciferol) or have stopped taking it in the past few months.Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• you should know that many nonprescription medications are not safe to take with calcitriol. Ask your doctor before you take any nonprescription medications while you are taking calcitriol.
• tell your doctor if you have recently had surgery or are unable to move around for any reason and if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking calcitriol, call your doctor. You should not breastfeed while you are taking calcitriol.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking calcitriol.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Oral:

• Calcitriol comes as a capsule and a solution (liquid) to take by mouth. It usually is taken once a day or once every other day in the morning with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take calcitriol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Injectable:

• This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Topical:

• Calcitriol comes as an ointment to apply to the skin. It is usually applied two times a day, in the morning and evening. Apply calcitriol ointment at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply calcitriol ointment exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor. Your doctor will tell you how much ointment to apply. Do not use more than two tubes of calcitriol ointment per week.
• Apply calcitriol ointment to the areas of skin affected by psoriasis. Do not apply calcitriol ointment to healthy skin or anywhere on your face, eyes, lips, or vagina. Do not swallow the medication.
• Apply the ointment to the affected skin and gently rub the ointment into the skin until no medication is visible. Do not cover the skin where you applied calcitriol ointment with a bandage or dressing unless your doctor tells you that you should. Wash your hands well with soap and water after you apply calcitriol ointment.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Oral:

• For dialysis patients, the recommended starting dose of calcitriol is 0.25 mcg/day. If a satisfactory response is not achieved, the dosage may be increased to 0.5 mcg/day.
• For treating hyperparathyroidism, the recommended starting dose is 0.25 mcg/day. The usual dosage range for adults is 0.5 to 2 mcg/day.
• For predialysis patients, the recommended dose range is 0.25 to 0.5 mcg/day.

​Injectable:

• This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Topical:

• Calcitriol is usually applied two times a day, in the morning and evening. Apply calcitriol ointment at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply calcitriol ointment exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor. Your doctor will tell you how much ointment to apply. Do not use more than two tubes of calcitriol ointment per week.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Oral:

• Keep all appointments with your doctor and the laboratory. 
• Store at room temperature.
• Keep this and all other medications out of the reach of children.
• It is advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. recommended daily allowance (RDA) for calcium in adults is 800 mg to 1200 mg.

Injectable:

• It is advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. recommended daily allowance (RDA) for calcium in adults is 800 mg to 1200 mg.
• Keep all appointments with your doctor and the laboratory. 

Topical:

• Keep all appointments with your doctor and the laboratory. 
• Do not freeze or refrigerate.
• Store at room temperature.
• Keep this and all other medications out of the reach of children.