Osteodiol

Osteodiol

calcitriol

Manufacturer:

Teva

Distributor:

KLN Pharma
Full Prescribing Info
Contents
Calcitriol.
Description
Each Osteodiol capsule contains either 0.25 micrograms or 0.5 micrograms of the active ingredient Calcitriol Ph. Eur.
Osteodiol is a vitamin D product.
Excipients/Inactive Ingredients: Fractionated coconut oil, butylated hydroxyanisole (E320), butylated hydroxytoluene (E321), gelatine, glycerol, sorbitol and the dyes titanium dioxide (E171) and quinoline yellow (E104). The 0.5 microgram capsule also include the dye patent blue (E131). Both strengths of capsule are printed with black ink which contains shellac and black iron oxide (E172).
Indications/Uses
Osteodiol capsules are used to treat a form of bone disease called renal osteodystrophy which is found in patients with chronic kidney failure. The lower strength of Osteodiol capsules (0.25 mcg) are also used to treat post menopausal osteoporosis, which is the weakening of bones in women following the "change of life". Ask the doctor or pharmacist for additional information.
Dosage/Direction for Use
The doctor will decide which dose is suitable. Always follow the doctor's instructions and those which are on the label. If the patient does not understand the instructions, or in case of doubt, ask the doctor or pharmacist.
The capsules should be swallowed with a drink of water.
The usual dosage instructions are given as follows: Adults: Renal osteodystrophy: Initially one 0.25 microgram capsule per day. If necessary, the doctor may increase the dosage by 0.25 micrograms at 2-4 week intervals to find the correct dose.
Post menopausal osteoporosis: One 0.25 microgram capsule twice a day.
Children: For use in children, please consult the doctor.
At the beginning of the treatment calcium levels in the blood should be measured regularly. The dosage of calcitriol can then be adjusted to achieve the correct response. When the correct dosage has been found the calcium levels may continue to be measured but less often. Also, if the doctor thinks it is necessary he/she may prescribe extra calcium supplements to be taken during the treatment.
Continue to take the capsules for as long as the doctor has advised. If the patient forgets to take a capsule, take one as soon as it is remembered, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.
If the patient sees another doctor or goes into hospital, let him or the staff know what medicines are being taken.
Overdosage
If the patient (or someone else) accidentally swallows a lot of the capsules all together, or if a child has swallowed any of the capsules, contact the nearest hospital casualty department or the doctor immediately.
Special Precautions
Before taking Osteodiol: Is the patient sensitive to any of the ingredients in the medicine?
Is the patient allergic to any vitamin D products e.g. alfacalcidol?
Is the patient pregnant or breastfeeding?
Does the patient suffer from high levels of calcium in the blood or tissues?
Is the patient taking phosphate binding agents e.g. aluminum hydroxide, calcium carbonate?
Is the patient taking any barbiturates e.g. amylobarbitone, phenobarbitone?
Is the patient taking any anticonvulsants e.g. phenytoin, clonazepam?
If the answer to any of these questions is yes, do not take Osteodiol before talking to the doctor or pharmacist.
Do not take any other product either containing or "fortified" with Vitamin D at the same time as taking Osteodiol.
Side Effects
Like many other medicines, it may occasionally cause side-effects in some people.
The patient may experience hypercalcaemia (high levels of calcium in the blood) which may cause nausea, vomiting, loss of appetite, weakness, headache, sleepiness or apathy. Other side effects such as dehydration, thirst, excessive urination and/or an increased need to pass water during the night, an irregular heartbeat, stomach pain, a swollen stomach or constipation may also be experienced.
Rarely, calcium may become deposited in parts of the body other than the bone, or, mental health problems may occur. Very rarely, an increased level of some of the liver enzymes may be found in the liver function tests but this effect is mild and reversible. If the patient has this or any other effect, whilst taking Osteodiol, tell the doctor immediately. Also, if the patient feels unwell in any other way, tell the doctor.
Storage
These capsules should be stored in the package or container supplied, below 25°C. Do not transfer them to another container. Keep them in a secure place where children cannot get them.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
A11CC04 - calcitriol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Presentation/Packing
Form
Osteodiol cap 0.25 mcg
Packing/Price
100's
Form
Osteodiol cap 0.5 mcg
Packing/Price
100's
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