What does calcitrol do?

Contents

CALCITRIOL 0.5 MICROGRAM CAPSULES

Rocaltrol® 0.5 microgram Capsules
2883
18.08.16
(calcitriol)
PATIENT INFORMATION LEAFLET
Read all of the leaflet carefully before you start taking this medicine
because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
This medicine is available using the above name but will be referred to as
Rocaltrol throughout the following leaflet. Other strength of 0.25 microgram
is also available.
What is in this leaflet
1. What Rocaltrol is and what it is used for
2. What you need to know before you take Rocaltrol
3. How to take Rocaltrol
4. Possible side effects
5. How to store Rocaltrol
6. Contents of the pack and other information
1. WHAT ROCALTROL IS AND WHAT IT IS USED FOR
Rocaltrol contains a medicine called calcitriol. This belongs to a group of
medicines called ‘vitamin D metabolites’.
Rocaltrol is used to treat the following:
– Bone disease in people with kidney problems (renal osteodystrophy).
– Weakening of the bones in women after the menopause (change of life).
This is also known as post-menopausal osteoporosis.
Rocaltrol works by making your body absorb more calcium from your diet.
This helps to form healthy bones and reduce bone damage.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROCALTROL
Do not take Rocaltrol:
if you are allergic (hypersensitive) to:
– Calcitriol or any of the other ingredients of this medicine (listed in section
6).
– Other ‘vitamin D metabolite’ medicines (used to treat bone disease).
These include alfacalcidol and colecalciferol. Do not take Rocaltrol if any
of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Rocaltrol.
Do not take Rocaltrol if:
– You have high levels of calcium in your blood (hypercalcaemia).
– You have extra deposits of calcium in your body (metastatic calcification).
– You are unwell because of high levels of vitamin D in your body.
Do not take Rocaltrol if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Rocaltrol.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rocaltrol if:
– You are finding it difficult to move about (for example, after an operation).
– You have kidney problems (the doctor may need to monitor the phosphate
levels in your blood and diet).
Other medicines and Rocaltrol
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes medicines that you buy without a
prescription and herbal medicines. This is because Rocaltrol can affect the
way some medicines work. Also some other medicines can affect the way
Rocaltrol works.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
– Other medicines containing vitamin D.
– Diuretics, also called ‘water tablets’ (used to treat high blood pressure).
These include bendroflumethiazide, chlortalidone and indapamide.
– Medicines like digoxin or digitoxin (used to treat heart disease).
– Medicines containing magnesium, such as antacids (used to treat
indigestion).
– Steroid medicines, such as hydrocortisone, prednisolone and
dexamethasone.
– Cholestyramine, or other ‘ion-exchange resins’ (used to treat high levels
of cholesterol in your blood).
– Phosphate (the doctor may need to monitor phosphate levels in your
blood).
Also tell your doctor or pharmacist if you have taken a medicine containing
vitamin D over the last few months that has long-lasting effects. These
medicines include ergocalciferol and colecalciferol.
Rocaltrol with food and drink
– Do not take any vitamin or food supplements that contain vitamin D while
you are taking Rocaltrol.
– Do not eat food which has vitamin D added (food which is ‘fortified’ with
vitamin D) while you are taking Rocaltrol.
– It is very important to keep to any diet that your doctor has given to you.
– If you change how much calcium or vitamin D you have in your diet this
can increase the risk of side effects (for example, if you eat more dairy
products like milk and cheese, or take vitamins without your doctor
knowing).
– Drink plenty of fluids (such as water) as it is important not to become
dehydrated. This does not apply if you have kidney problems.
Pregnancy and breast-feeding
– Talk to your doctor before taking Rocaltrol if you are pregnant, think you
are pregnant, or plan to get pregnant. Your doctor will then decide if you
should take Rocaltrol.
– You can take Rocaltrol if you are breast-feeding. However, your doctor will
take blood samples from you and your child to check that there are no
unwanted effects.
Driving and using machines
Rocaltrol is not likely to affect you being able to drive or use any tools or
machines.
Rocaltrol contains sorbitol
Rocaltrol contains sorbitol, which is a type of sugar. If you have been told by
your doctor that you cannot tolerate or digest some sugars (have an
intolerance to some sugars), talk to your doctor before taking this medicine.
3. HOW TO TAKE ROCALTROL
Always take this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure.
Swallow the capsules whole with a little water.
While you are taking Rocaltrol, your doctor will want you to have regular
blood tests to check that the level of calcium in your blood does not get too
high.
Bone disease in people with kidney problems (renal osteodystrophy)
– The usual starting dose for adults and elderly people is one 0.25
microgram capsule once a day.
– After 2 to 4 weeks your doctor may start increasing your dose slowly by
0.25 microgram at a time.
– Eventually, depending on your blood test results, your doctor may need to
adjust your dose again. He or she may ask you to take Rocaltrol two or
three times a week instead of every day. The maximum dose each week
is 12 micrograms.
Bone disease after the menopause (post-menopausal osteoporosis)
– The usual dose for adult and elderly women is one 0.25 microgram
capsule twice a day.
If you take more Rocaltrol than you should
– If you take more Rocaltrol than you should, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you.
– If you take too many capsules, you may get too much calcium in your
blood (hypercalcaemia). The signs include loss of appetite, weight loss,
feeling sick, being sick, constipation, headache and feeling sluggish,
drowsy or weak.
If you forget to take Rocaltrol
– If you forget to take a dose, skip the missed dose. Then take your next
dose as normal.
– Do not take a double dose (two doses at the same time) to make up for a
forgotten dose.
If you stop taking Rocaltrol
Do not stop taking Rocaltrol without talking to your doctor. This is because
weakness of your bones needs long term treatment.
If someone else takes your Rocaltrol capsules by mistake, they should talk
to a doctor or go to a hospital straight away.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines this medicine can cause side effects, although not
everybody gets them.
The following side effects may happen rarely with this medicine:
High levels of calcium in your blood
– The signs include loss of appetite, weight loss, feeling sick, being sick,
headache and feeling sluggish, drowsy or weak.
– Very high levels of calcium in your blood may lead to high temperature
(fever), feeling thirsty, dehydration, passing more water than normal,
wetting the bed, constipation, stomach pain, blockage of the bowel and an
uneven heart beat. There may be infections in the bladder and normal
growth may stop.
– Occasionally, mental problems may occur. Also there may be deposits of
calcium in areas other than your bone (for example, in your kidneys as
‘kidney stones’). Your doctor may change your dose of Rocaltrol if this
happens.
Kidney
– Changes in how well your kidney is working (shown by blood tests).
Allergic reactions
– The signs can include itchy skin, skin rashes and reddening of the skin
(which may be severe).
If any of the side effects become serious or troublesome, or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:

By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE ROCALTROL
– Keep this medicine out of the sight and reach of children.
– Do not use this medicine after the expiry date which is stated on the
carton, after EXP. The expiry date refers to the last day of that month.
– Do not store above 25°C.
– Store in their original package
– Keep blisters in the outer carton to protect from light and moisture.
– Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
– If the capsules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Rocaltrol contains
The active substance is calcitriol.
Each soft capsule contains 0.5 microgram calcitriol.
Other ingredients are butylhydroxyanisole (E320), butylhydroxytoluene
(E321), medium-chain triglycerides, gelatin, glycerol, karion 83 (contains
sorbitol (E420), mannitol, hydrogenated hydrolysed starch), titanium dioxide
(E171), red iron oxide (E172) and yellow iron oxide (E172).
What Rocaltrol looks like and contents of the pack
Rocaltrol 0.5 microgram Capsules are soft capsules that are brown-orange
to red-orange in colour at both lengths.
Rocaltrol Capsules are supplied in PVC/aluminium blister packs containing
20, 30 or 100 capsules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Roche Farma S.A., C/Severo Ochoa, 13 – Pol. Industrial Leganes, 28914
Madrid, Spain.
or
F. Hoffmann – La Roche Ltd., Grenzacherstrasse, 124, Basilea CH-4070,
Switzerland.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM
PL 20636/2883
Leaflet revision and issue date (Ref) 18.08.16
Rocaltrol is a trademark of Roche Products Limited.
Calcitriol 0.5 microgram Capsules
2883
18.08.16
PATIENT INFORMATION LEAFLET
Read all of the leaflet carefully before you start taking this medicine
because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
This medicine is available using the above name but will be referred to as
Calcitriol throughout the following leaflet. Other strength of 0.25 microgram
is also available.
What is in this leaflet
1. What Calcitriol is and what it is used for
2. What you need to know before you take Calcitriol
3. How to take Calcitriol
4. Possible side effects
5. How to store Calcitriol
6. Contents of the pack and other information
1. WHAT CALCITRIOL IS AND WHAT IT IS USED FOR
Calcitriol contains a medicine called calcitriol. This belongs to a group of
medicines called ‘vitamin D metabolites’.
Calcitriol is used to treat the following:
– Bone disease in people with kidney problems (renal osteodystrophy).
– Weakening of the bones in women after the menopause (change of life).
This is also known as post-menopausal osteoporosis.
Calcitriol works by making your body absorb more calcium from your diet.
This helps to form healthy bones and reduce bone damage.
Also tell your doctor or pharmacist if you have taken a medicine containing
vitamin D over the last few months that has long-lasting effects. These
medicines include ergocalciferol and colecalciferol.
Calcitriol with food and drink
– Do not take any vitamin or food supplements that contain vitamin D while
you are taking Calcitriol.
– Do not eat food which has vitamin D added (food which is ‘fortified’ with
vitamin D) while you are taking Calcitriol.
– It is very important to keep to any diet that your doctor has given to you.
– If you change how much calcium or vitamin D you have in your diet this
can increase the risk of side effects (for example, if you eat more dairy
products like milk and cheese, or take vitamins without your doctor
knowing).
– Drink plenty of fluids (such as water) as it is important not to become
dehydrated. This does not apply if you have kidney problems.
Pregnancy and breast-feeding
– Talk to your doctor before taking Calcitriol if you are pregnant, think you
are pregnant, or plan to get pregnant. Your doctor will then decide if you
should take Calcitriol.
– You can take Calcitriol if you are breast-feeding. However, your doctor will
take blood samples from you and your child to check that there are no
unwanted effects.
Driving and using machines
Calcitriol is not likely to affect you being able to drive or use any tools or
machines.
Calcitriol contains sorbitol
Calcitriol contains sorbitol, which is a type of sugar. If you have been told by
your doctor that you cannot tolerate or digest some sugars (have an
intolerance to some sugars), talk to your doctor before taking this medicine.
3. HOW TO TAKE CALCITRIOL
Always take this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure.
Swallow the capsules whole with a little water.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCITRIOL
Do not take Calcitriol:
if you are allergic (hypersensitive) to:
– Calcitriol or any of the other ingredients of this medicine (listed in section
6).
– Other ‘vitamin D metabolite’ medicines (used to treat bone disease).
These include alfacalcidol and colecalciferol. Do not take Calcitriol if any
of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Calcitriol.
Do not take Calcitriol if:
– You have high levels of calcium in your blood (hypercalcaemia).
– You have extra deposits of calcium in your body (metastatic calcification).
– You are unwell because of high levels of vitamin D in your body.
Do not take Calcitriol if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Calcitriol.
Warnings and precautions
Talk to your doctor or pharmacist before taking Calcitriol if:
– You are finding it difficult to move about (for example, after an operation).
– You have kidney problems (the doctor may need to monitor the phosphate
levels in your blood and diet).
Other medicines and Calcitriol
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes medicines that you buy without a
prescription and herbal medicines. This is because Calcitriol can affect the
way some medicines work. Also some other medicines can affect the way
Calcitriol works.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
– Other medicines containing vitamin D.
– Diuretics, also called ‘water tablets’ (used to treat high blood pressure).
These include bendroflumethiazide, chlortalidone and indapamide.
– Medicines like digoxin or digitoxin (used to treat heart disease).
– Medicines containing magnesium, such as antacids (used to treat
indigestion).
– Steroid medicines, such as hydrocortisone, prednisolone and
dexamethasone.
– Cholestyramine, or other ‘ion-exchange resins’ (used to treat high levels
of cholesterol in your blood).
– Phosphate (the doctor may need to monitor phosphate levels in your
blood).
While you are taking Calcitriol, your doctor will want you to have regular
blood tests to check that the level of calcium in your blood does not get too
high.
Bone disease in people with kidney problems (renal osteodystrophy)
– The usual starting dose for adults and elderly people is one 0.25
microgram capsule once a day.
– After 2 to 4 weeks your doctor may start increasing your dose slowly by
0.25 microgram at a time.
– Eventually, depending on your blood test results, your doctor may need to
adjust your dose again. He or she may ask you to take Calcitriol two or
three times a week instead of every day. The maximum dose each week
is 12 micrograms.
Bone disease after the menopause (post-menopausal osteoporosis)
– The usual dose for adult and elderly women is one 0.25 microgram
capsule twice a day.
If you take more Calcitriol than you should
– If you take more Calcitriol than you should, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you.
– If you take too many capsules, you may get too much calcium in your
blood (hypercalcaemia). The signs include loss of appetite, weight loss,
feeling sick, being sick, constipation, headache and feeling sluggish,
drowsy or weak.
If you forget to take Calcitriol
– If you forget to take a dose, skip the missed dose. Then take your next
dose as normal.
– Do not take a double dose (two doses at the same time) to make up for a
forgotten dose.
If you stop taking Calcitriol
Do not stop taking Calcitriol without talking to your doctor. This is because
weakness of your bones needs long term treatment.
If someone else takes your Calcitriol capsules by mistake, they should talk
to a doctor or go to a hospital straight away.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines this medicine can cause side effects, although not
everybody gets them.
The following side effects may happen rarely with this medicine:
High levels of calcium in your blood
– The signs include loss of appetite, weight loss, feeling sick, being sick,
headache and feeling sluggish, drowsy or weak.
– Very high levels of calcium in your blood may lead to high temperature
(fever), feeling thirsty, dehydration, passing more water than normal,
wetting the bed, constipation, stomach pain, blockage of the bowel and an
uneven heart beat. There may be infections in the bladder and normal
growth may stop.
– Occasionally, mental problems may occur. Also there may be deposits of
calcium in areas other than your bone (for example, in your kidneys as
‘kidney stones’). Your doctor may change your dose of Calcitriol if this
happens.
Kidney
– Changes in how well your kidney is working (shown by blood tests).
Allergic reactions
– The signs can include itchy skin, skin rashes and reddening of the skin
(which may be severe).
If any of the side effects become serious or troublesome, or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:

By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE CALCITRIOL
– Keep this medicine out of the sight and reach of children.
– Do not use this medicine after the expiry date which is stated on the
carton, after EXP. The expiry date refers to the last day of that month.
– Do not store above 25°C.
– Store in their original package
– Keep blisters in the outer carton to protect from light and moisture.
– Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
– If the capsules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Calcitriol contains
The active substance is calcitriol.
Each soft capsule contains 0.5 microgram calcitriol.
Other ingredients are butylhydroxyanisole (E320), butylhydroxytoluene
(E321), medium-chain triglycerides, gelatin, glycerol, karion 83 (contains
sorbitol (E420), mannitol, hydrogenated hydrolysed starch), titanium dioxide
(E171), red iron oxide (E172) and yellow iron oxide (E172).
What Calcitriol looks like and contents of the pack
Calcitriol 0.5 microgram Capsules are soft capsules that are brown-orange
to red-orange in colour at both lengths.
Calcitriol Capsules are supplied in PVC/aluminium blister packs containing
20, 30 or 100 capsules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Roche Farma S.A., C/Severo Ochoa, 13 – Pol. Industrial Leganes, 28914
Madrid, Spain.
or
F. Hoffmann – La Roche Ltd., Grenzacherstrasse, 124, Basilea CH-4070,
Switzerland.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM
PL 20636/2883
Leaflet revision and issue date (Ref) 18.08.16

Rocaltrol

Brand Names: Rocaltrol

Generic Name: calcitriol (vitamin D3)

  • 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 (Rocaltrol)?

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 hyperparathyroidism (overactive parathyroid glands) and metabolic bone disease in people who have chronic kidney failure and are not receiving dialysis.

Calcitriol is also used to treat calcium deficiency (hypocalcemia) and metabolic bone disease in people who are receiving dialysis.

Calcitriol is also used to treat calcium deficiency in people with hypoparathyroidism (underactive parathyroid glands) caused by surgery, disease, or other conditions.

Calcitriol may also be used for 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 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.

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

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

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.

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 type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb 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. Follow your diet and medication routines very closely. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Calcitriol oral solution

What is this medicine?

CALCITRIOL (kal si TRYE ole) is a man made form of vitamin D. Vitamin D is necessary to maintain the right amount of calcium in the body for strong bones and teeth. It helps your body keep the proper levels of calcium and phosphorus and maintain healthy bones. This medicine is used to treat low calcium in the blood and in the treatment of hyperparathyroidism.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Rocaltrol

What should I tell my health care provider before I take this medicine?

They need to know if you have any of the following conditions:

  • kidney disease

  • parathyroid disease

  • receiving dialysis treatment

  • an unusual or allergic reaction to vitamin D, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Use a specially marked spoon, or container to measure the dose. Household spoons are not accurate. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • vitamin D

This medicine may also interact with the following medications:

  • calcium supplements

  • cholestyramine

  • corticosteroids

  • digoxin

  • ketoconazole

  • magnesium supplements

  • phenobarbital

  • phenytoin

  • phosphate-binding agents

  • some antacids

  • thiazide diuretics

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need to have important lab work done while you are taking this medicine.

You will need to be on a special diet while you are taking this medicine. Do not take any non-prescription medicines that have vitamin D, phosphorus, magnesium, or calcium including antacids, unless directed by your doctor. Limit the amount of calcium you get each day as directed. The extra supplements can cause side effects.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • bone pain

  • increased thirst

  • increased urination (especially at night)

  • irregular heartbeat, high blood pressure

  • redness, blistering, peeling or loosening of the skin, including inside the mouth

  • seizures

  • unexpected weight loss

  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation

  • dry mouth

  • headache

  • loss of appetite

  • metallic taste

  • stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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What is calcitriol?

Calcitriol (brand names: Rocaltrol®, Calcijex®) is a form of vitamin D used to treat low blood calcium associated with low parathyroid gland function. It may also be helpful in treating chronic kidney disease, certain cancers such as mast cell tumors, and certain skin diseases.

Its use in cats and dogs to treat low blood calcium is ‘off label’ or ‘extra label’. Many drugs are commonly prescribed for off label use in veterinary medicine. In these instances, follow your veterinarian’s directions and cautions very carefully as their directions may be significantly different from those on the label.

How is calcitriol given?

Calcitriol is given by mouth in the form of a capsule or liquid. It should be given on an empty stomach preferably at bedtime. However, if your pet vomits or acts sick after dosing on an empty stomach, give future doses with food or a treat. Measure liquid forms carefully. Do not give calcium supplements while using this medication. It can also given by injection in the hospital setting.

This medication should take effect within 1 to 2 days; however, effects may not be obvious for several weeks. Effects also may not be noted outwardly and therefore laboratory tests may need to be done to evaluate this medication’s effectiveness.

What if I miss giving my pet the medication?

If you miss a dose, give it when you remember, but if it is close to the time for the next dose, skip the dose you missed and give it at the next scheduled time, and return to the regular dosing schedule. Never give your pet two doses at once or give extra doses.

Are there any potential side effects?

Side effects are uncommon if the dose is appropriate. Doses that are too high may cause side effects such as increased drinking and urination, and lack of appetite. If the dose is not high enough, signs such as muscle tremors, twitching, facial itching, stiffness, weakness, unsteadiness, or seizures may occur.

This short-acting medication should stop working within 24 hours, although effects can be longer in pets with liver or kidney disease.

Are there any risk factors for this medication?

Calcitriol should not be used in pets that are allergic to it or those with high blood calcium, vitamin D toxicity, or malabsorption syndrome (cannot adequately absorb nutrients from the gastrointestinal tract). It should be used with extreme caution in pets with high blood phosphorus levels, pregnant or lactating pets, or in pets that are prone to calcium oxalate urinary stones.

Are there any drug interactions I should be aware of?

The following medications should be used with caution when given with calcitriol: calcium-containing phosphorus binding agents, barbiturates, corticosteroids, digoxin, verapamil, magnesium-containing antacids, phenytoin, primidone, or thiazide diuretics.

Be sure to tell your veterinarian about any medications (including vitamins, supplements, or herbal therapies) that your pet is taking.

Is there any monitoring that needs to be done with this medication?

Ionized blood calcium levels, blood phosphorus levels, and kidney values may be checked by your veterinarian prior to your pet starting this medication. These levels and values should be monitored after one week of treatment, and then every 2-4 weeks. Blood parathyroid hormone levels should also be monitored. Your veterinarian may monitor your pet to be sure that the medication is working.

How do I store calcitriol?

Store at room temperature between 59°F and 86°F (15°C and 30°C), and protect from light.

What should I do in case of emergency?

If you suspect an overdose or an adverse reaction to the medication, call your veterinary office immediately. If they are not available, follow their directions in contacting an emergency facility.

Contributors: Rania Gollakner, BS, DVM © Copyright 2019 LifeLearn Inc. Used and/or modified with permission under license.

“Calcitriol” Is Not Synonymous with “Vitamin D”

Regarding the recent article by Shaygannejad et al. , we are writing to express serious concerns about the portrayal of the intervention and the authors’ interpretation and discussion of the findings. Of predominate concern is that the authors utilized a calcitriol intervention in their study but referred to it as “vitamin D”. The erroneous use of the term “vitamin D” is of concern for several reasons.

Firstly, vitamin D is the biologically inactive form that can be synthesized in the skin when exposed to ultraviolet B radiation and is found in foods. In order to produce the active metabolite, calcitriol (or 1,25-dihydroxyvitamin D; 1,25(OH)2D), vitamin D must be hydroxylated in two subsequent reactions by two separate hydroxylases. The second hydroxylation step—conversion of 25-hydroxyvitamin D to 1,25(OH)2D via 1α-hydroxylase—is under tight regulatory control. By providing adequate substrate (i.e., vitamin D), circulating 25(OH)D concentrations increase and cells are able to locally produce and use 1,25(OH)2D in a self-regulated manner without affecting circulating levels of calcitriol. In contrast, supplying calcitriol directly produces a systemic increase in calcitriol, thus bypassing the key regulatory steps and increases risk of hypercalcemia. On the other hand, supplementation with vitamin D is quite safe at levels up to 10,000 IU/d . Wingerchuk et al. have previously demonstrated the risk of hypercalcemia with calcitriol treatment in patients with MS. With this sole exception , none of the published vitamin D-related trials in patients with MS have administered calcitriol; the authors failed to note this or compare the findings of their calcitriol intervention to the only other published calcitriol intervention in MS. The differences in the safety profile and activity of vitamin D versus calcitriol alone are significant and necessitate accurate nomenclature.

Next, the authors indicate “no unusual or unexpected safety risks found with vitamin D therapy in our study population with RRMS”; however, not only did they administer calcitriol rather than vitamin D, but also no characterization of the dosage nor description of the rationale for the selected dosage was present. Furthermore, since there is neither mention of serum calcium, urine calcium nor 1,25(OH)2D levels in response to therapy dose, we cannot assess the effect of oral calcitriol supplementation on biochemical outcomes in these patients.

Overall, the authors’ naivety regarding metabolism of vitamin D is evidenced in that they (i) neglected to monitor calcium or calcitriol levels when treating with calcitriol, (ii) monitored 25(OH)D levels—which are the biomarker of vitamin D status in the normal situation but are not relevant during calcitriol therapy, and (iii) directly compare studies of supplementation with vitamin D, calcitriol, and alphacalcidiol (a synthetic analogue of calcitriol) without distinguishing the various forms and their inherently different activity.

In conclusion, the work presented here “a calcitriol intervention in adults with MS” cannot be directly compared with the majority of the previous vitamin D-related MS interventions in the literature. Barring instances of genetic mutations causing dysfunction of the 1-alpha hydroxylase, at present, there is no rationale to support the use of calcitriol over vitamin D.

Authors’ Contribution

The authors contributed equally.

What is it used for?

  • Correcting calcium levels and weakening of bone caused by kidney failure (renal osteodystrophy).
  • Osteoporosis in women who have passed the menopause.

How does it work?

Rocaltrol capsules contain the active ingredient calcitriol, which is the active form of vitamin D. (Calcitriol capsules are also available without a brand name, ie as the generic medicine.)

Vitamin D is normally obtained primarily from sunlight acting on the skin. It is also consumed in the diet in oily fish and milk products. This vitamin is converted first in the liver and then in the kidneys to its active form, calcitriol. Calcitriol acts as a hormone in the body, controlling the absorption of calcium and phosphate from the gut, the levels of calcium and phosphate in the blood and the normal healthy turnover of bone.

People who have reduced kidney function can’t convert enough vitamin D into calcitriol. This can lead to problems with calcium and phosphate metabolism, reduced absorption of calcium and phosphate from the gut, low levels of calcium in the blood and various bone disorders.

Standard vitamin D supplements are no use for people with reduced kidney function, because their kidneys can’t convert the vitamin into its active form. In this situation, taking calcitriol is a better way of directly increasing the amount of active vitamin D in the body, which in turn increases the level of calcium and phosphate in the blood and helps reduce bone breakdown.

Calcitriol is also given to provide a more rapid increase in active vitamin D and hence calcium, in postmenopausal women with osteoporosis. This provides a quicker response than giving normal dietary vitamin D supplements.

How do I take it?

  • Rocaltrol capsules can be taken either with or without food.
  • The dose prescribed will depend on the condition being treated and the amount of calcium in your blood. Follow the instructions given by your doctor.

Warning!

  • You will need to have regular blood tests to check the level of calcium and phosphate in your blood while you are taking this medicine.
  • You should not take vitamin supplements that contain vitamin D or eat food that has been fortified with vitamin D while you are taking this medicine as this can result in your calcium level rising too high.
  • It is also important to stick to the diet recommended by your doctor and avoid suddenly increasing your calcium intake while taking this medicine, for example by eating more dairy products such as cheese and milk, or taking extra calcium supplements or large amounts of calcium-containing antacids. This can increase the chance of your calcium level rising too high. Ask your doctor or pharmacist for more advice.
  • Tell your doctor if you get any of the following symptoms while taking this medicine, as these could suggest that the level of calcium in your blood has risen too high: needing to pass urine more often than usual, feeling thirsty, dry mouth, metallic taste in your mouth, headache, feeling weak, pain in your muscles or bones, feeling sick or vomiting, constipation.

Use with caution in

  • Decreased kidney function.
  • People with kidney stones.
  • People taking digoxin.

Not to be used in

  • People who have a high level of calcium in their blood (hypercalcaemia).
  • People with a high level of calcium in their body tissues (calcification).
  • People with vitamin D poisoning.
  • Rocaltrol capsules contain sorbitol and may not be suitable for people with a hereditary intolerance to fructose.
  • Rocaltrol capsules are not recommended for children.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • The safety of this medicine in pregnancy has not been established. It should be used with caution during pregnancy, and only if the benefits to the mother outweigh any possible risks to the developing baby. Seek medical advice from your doctor or pharmacist.
  • This medicine may pass into breast milk in small amounts. This could affect calcium levels in a nursing infant so it is important to get advice from your doctor before taking this medicine if you are breastfeeding.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

  • High level of calcium in the blood (hypercalcaemia – see warning section above for symptoms to look out for).
  • High level of calcium in the urine.
  • High blood phosphate content (hyperphosphataemia).
  • Rash or hives.
  • Itching.
  • Deposition of calcium in the kidneys (nephrocalcinosis).

The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe.

You should not take other vitamin D supplements in combination with this medicine. This includes multivitamins that contain vitamin D and foods that are fortified with vitamin D. See warning section above.

You should only take calcium supplements that have been prescribed by your doctor while you are taking this medicine. Don’t take additional supplements that contain calcium and avoid taking large amounts of calcium-containing antacids, as these could cause your calcium level too rise too high.

Thiazide diuretics, such as bendroflumethiazide, reduce the amount of calcium excreted in the urine, and this can increase the amount of calcium in the blood. If you are taking a thiazide diuretic in combination with this medicine you should have regular blood tests to monitor the level of calcium in your blood.

People taking digoxin or other cardiac glycosides may have an increased risk of abnormal heart rhythms if they experience abnormally high blood calcium levels while taking this medicine.

The following medicines may decrease the absorption of vitamin D from the gut and should not be taken at the same time of day as this medicine:

  • colestipol
  • colestyramine
  • orlistat.

If you are taking any of the following medicines you may need a larger than normal dose of calcitriol. Ask your doctor for advice:

  • carbamazepine
  • phenobarbital
  • phenytoin.

Other medicines containing the same active ingredient

Calcitriol capsules are also available without a brand name, ie as the generic medicine.

Last updated 07.03.2012

Calcitriol

Generic Name: calcitriol (vitamin D3) oral/injection (kal si TRYE ol)
Brand Name: Calcijex, Rocaltrol

Medically reviewed by Drugs.com on Oct 9, 2019 – Written by Cerner Multum

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What is calcitriol?

Calcitriol is vitamin D3. Vitamin D helps your body absorb calcium from the stomach.

Calcitriol is used to treat hyperparathyroidism (overactive parathyroid glands) and metabolic bone disease in people who have chronic kidney failure and are not receiving dialysis.

Calcitriol is also used to treat calcium deficiency in people with hypoparathyroidism (underactive parathyroid glands) caused by surgery, disease, or other conditions.

Calcitriol is also used to treat calcium deficiency (hypocalcemia) and metabolic bone disease in people who are receiving dialysis.

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

Important Information

You should not use calcitriol if you have high levels of calcium or vitamin D in your blood, or if you have ever had an allergic reaction to calcitriol or other forms of vitamin D.

Before taking this medicine

You should not use calcitriol if:

  • you have high levels of calcium or vitamin D in your blood; or

  • you have had an allergic reaction to calcitriol or other forms of vitamin D.

Tell your doctor about all your medical conditions or allergies.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using calcitriol.

Do not give this medicine to a child without medical advice.

How should I use calcitriol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Calcitriol oral is taken by mouth.

Measure oral liquid carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Calcitriol injection is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You will need frequent medical tests.

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

You may need to follow a special diet while using calcitriol. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your condition.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking calcitriol. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure.

If you need major surgery or will be on long-term bed rest, your dose or testing needs may change. Follow your doctor’s instructions.

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

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Early signs of overdose may include headache, weakness, drowsiness, dry mouth, metallic taste, nausea, vomiting, constipation, stomach pain, loss of appetite, muscle pain, or bone pain.

Late signs of overdose may include increased thirst, itching, increased urination (especially at night), severe stomach pain spreading to your back, irregular heartbeats, loss of appetite, weight loss, feeling hot, decreased interest in sex, or being unable to urinate.

What should I avoid while using calcitriol?

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

Ask your doctor before using an antacid or laxative, especially if you are on dialysis. Taking antacids or laxatives that contain magnesium may increase your blood levels of magnesium, which could affect your heart or blood pressure.

Calcitriol side effects

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

Stop using calcitriol and call your doctor at once if you have:

  • dehydration symptoms–feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  • high calcium levels–nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling; or

  • low calcium level–muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Calcitriol can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using calcitriol.

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.

What other drugs will affect calcitriol?

Tell your doctor about all your other medicines, especially:

This list is not complete. Other drugs may affect calcitriol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 3.01.

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More about calcitriol

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  • Drug class: vitamins

Consumer resources

  • Calcitriol Capsules
  • Calcitriol Injection Solution
  • Calcitriol Oral Solution

Other brands: Rocaltrol, Calcijex

Professional resources

  • Calcitriol (AHFS Monograph)
  • … +4 more

Related treatment guides

  • Hypoparathyroidism
  • Hypocalcemia
  • Renal Osteodystrophy
  • Rickets
  • Secondary Hyperparathyroidism

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