Rocaltrol

DRUG DESCRIPTION

Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Rocaltrol (calcitriol) is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol and as an oral solution containing 1 mcg/mL of calcitriol. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil, and the oral solution contains a fractionated triglyceride of palm seed oil. Gelatin capsule shells contain glycerin, parabens (methyl and propyl) and sorbitol, with the following dye systems: 0.25 mcg - FD&C Yellow No. 6 and titanium dioxide; 0.5 mcg - FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. The oral solution contains no additional adjuvants or coloring principles.

Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1?, 3?, 25-triol and has the following structural formula:

Rocaltrol (calcitriol) Structural Formula Illustration

The other names frequently used for calcitriol are 1?,25-dihydroxy-cholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.

What are the possible side effects of calcitriol (Rocaltrol)?

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 taking calcitriol and call your doctor at once if you have any of these serious side effects:

  • increased thirst,
  • urinating more than usual;
  • pain in your lower back;
  • fast, slow, or uneven heart rate;
  • weakness, drowsiness, changes in behavior;
  • bone pain, muscle weakness, loss of height;
  • nausea,...

Read All Potential Side Effects and See Pictures of Rocaltrol

What are the precautions when taking calcitriol (Rocaltrol)?

Before taking calcitriol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high calcium levels.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heartbeat, coronary artery disease), kidney disease, kidney stones.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed (immobile) for a...

Read All Potential Precautions of Rocaltrol


Rocaltrol Consumer (continued)

SIDE EFFECTS: Calcitriol does not usually have side effects. Your doctor may check your calcium and phosphate blood levels and adjust your dose if you have side effects.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: loss of appetite, back/bone/joint/muscle pain, constipation, dry mouth, eye pain/redness/sensitivity to light, headache, fast/slow/irregular heartbeat, nausea/vomiting/diarrhea, sleepiness, stomach/abdominal pain, increased thirst, change in the amount of urine, weakness.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking calcitriol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high calcium levels.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heartbeat, coronary artery disease), kidney disease, kidney stones.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed (immobile) for a long time. Being immobile for long periods of time increases your risk of side effects.

Be sure to drink plenty of fluids unless otherwise directed by your doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Rocaltrol Patient Information Including Side Effects

Brand Names: Rocaltrol

Generic Name: calcitriol (oral) (Pronunciation: kal si TRYE ol)

  • What is calcitriol (Rocaltrol)?
  • What are the possible side effects of calcitriol (Rocaltrol)?
  • What is the most important information I should know about calcitriol (Rocaltrol)?
  • What should I discuss with my healthcare provider before taking calcitriol (Rocaltrol)?
  • How should I take calcitriol (Rocaltrol)?
  • What happens if I miss a dose (Rocaltrol)?
  • What happens if I overdose (Rocaltrol)?
  • What should I avoid while taking calcitriol (Rocaltrol)?
  • What other drugs will affect calcitriol (Rocaltrol)?
  • Where can I get more information?

What is calcitriol (Rocaltrol)?

Calcitriol is vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Calcitriol is used to treat calcium deficiency with hypoparathyroidism (decreased functioning of the parathyroid glands) and metabolic bone disease in people with chronic kidney failure.

Calcitriol may also be used for other purposes not listed in this medication guide.

What are the possible side effects of calcitriol (Rocaltrol)?

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 taking calcitriol and call your doctor at once if you have any of these serious side effects:

  • increased thirst,
  • urinating more than usual;
  • pain in your lower back;
  • fast, slow, or uneven heart rate;
  • weakness, drowsiness, changes in behavior;
  • bone pain, muscle weakness, loss of height;
  • nausea, constipation, loss of appetite, weight loss;
  • slow growth (in a child taking calcitriol); or
  • dry mouth or a metallic taste.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about calcitriol (Rocaltrol)?

Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your blood.

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. Becoming dehydrated while taking calcitriol can lead to an electrolyte imbalance.

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different minerals and some types can cause serious side effects if you take them together with calcitriol.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

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.

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