Rocaltrol

• Rocaltrol^®

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Antacids
• Calcium supplements
• Questran (cholestyramine)
• Colestid (colestipol hydrochloride)
• Lanoxin (digoxin)
• Diuretics (water pills)
• Nizoral (ketoconazole)
• Fosrenol (lanthanum carbonate)
• Laxatives
• Oral steroids, such as Decadron or Dexone (dexamethasone), Medrol (methylprednisolone), or Deltasone (prednisone)
• Other forms of vitamin D
• Luminal or Solfoton (phenobarbital)
• Dilantin (phenytoin)
• Renagel (sevelamer hydrochloride)
• Drisdol or Calciferol (ergocalciferol)

Calcitriol and Other Interactions

Calcitriol may cause drowsiness.

Don't drive, operate machinery, or perform other tasks that require alertness until you know how this medicine affects you.

Calcitriol and Alcohol

Alcohol may increase your risk of developing certain side effects while taking calcitriol.

Don't consume alcoholic beverages while using this medicine without first discussing it with your doctor.

Your pharmacist can provide more information about calcitriol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Since Rocaltrol (calcitriol) is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general, similar to those encountered with excessive vitamin D intake, ie, hypercalcemia syndrome or calcium intoxication (depending on the severity and duration of hypercalcemia) (see WARNINGS). Because of the short biological half-life of calcitriol, pharmacokinetic investigations have shown normalization of elevated serum calcium within a few days of treatment withdrawal, ie, much faster than in treatment with vitamin D3 preparations.

The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:

Early: weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia, abdominal pain or stomach ache.

Late: polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT (AST) and SGPT (ALT), ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.

In clinical studies on hypoparathyroidism and pseudohypoparathyroidism, hypercalcemia was noted on at least one occasion in about 1 in 3 patients and hypercalciuria in about 1 in 7 patients. Elevated serum creatinine levels were observed in about 1 in 6 patients (approximately one half of whom had normal levels at baseline).

In concurrent hypercalcemia and hyperphosphatemia, soft-tissue calcification may occur; this can be seen radiographically (see WARNINGS).

In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine (see PRECAUTIONS: General).

Hypersensitivity reactions (pruritus, rash, urticaria, and very rarely severe erythematous skin disorders) may occur in susceptible individuals. One case of erythema multiforme and one case of allergic reaction (swelling of lips and hives all over the body) were confirmed by rechallenge.

Read the entire FDA prescribing information for Rocaltrol (Calcitriol)

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.
 

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink plenty of fluids unless your doctor has told you to restrict your fluid intake.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to a serious electrolyte imbalance.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

Calcitriol is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

If you need to be on bed-rest or have any type of surgery, your dose or testing needs may change. Follow your doctor's instructions.

Store at room temperature away from moisture, light, and heat.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using calcitriol and call your doctor at once if you have a serious side effect such as:

• weakness, headache, drowsiness;

• nausea, vomiting, stomach pain, constipation;

• loss of appetite;

• dry mouth, increased thirst;

• metallic taste in your mouth;

• urinating more than usual;

• fast, slow, or uneven heart rate;

• changes in behavior;

• muscle pain, bone pain, muscle weakness, loss of height;

• slow growth (in a child taking calcitriol); or

• severe pain in your upper stomach spreading to your back.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medicines you use, especially:

• digoxin (digitalis, Lanoxin, Lanoxicaps);

• cholestyramine (Questran, Prevalite);

• ketoconazole (Nizoral);

• lanthanum (Fosrenol);

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton);

• steroids such as prednisone, fluticasone (Advair, Flovent), mometasone (Asmanex, Nasonex), dexamethasone (Cortastat, DexPak, Decadron) and others; or

• a (water pill) diuretic such as hydrochlorothiazide (HCTZ, Esidrix, Hydrodiuril, Microzide,Oretic), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

This list is not complete and other drugs may interact with calcitriol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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.

Applies to calcitriol: oral capsules, oral solution, parenteral injection

Side effects include:

Excessive vitamin D intake (early manifestations): weakness, headache, somnolence, nausea, dry mouth, constipation, muscle or bone pain, metallic taste.

Excessive vitamin D intake (late manifestations): polyuria, polydipsia, anorexia, weight loss, nocturia, calcific conjunctivitis, pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated AST, elevated ALT, ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections.