Consumer medicine information

OsteVit-D One-A-Week

Colecalciferol

BRAND INFORMATION

Brand name

OsteVit-D One-A-Week

Active ingredient

Colecalciferol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using OsteVit-D One-A-Week.

What is in this leaflet

This leaflet answers some common questions about OsteVit-D One-A-Week capsules.

It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking OsteVit-D One-A-Week against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine. You may need to read it again.

What OsteVit-D One-A-Week is used for

OsteVit-D One-A-Week capsules contain cholecalciferol.

Cholecalciferol is another name for vitamin D3.

OsteVit-D One-A-Week is used, as directed by your medical practitioner or pharmacist, for (a) treatment of vitamin D deficiency in adults and adolescents and (b) for the prevention of vitamin D deficiency in high risk individuals.

Vitamin D3 is a fat-soluble vitamin that helps your body absorb calcium and phosphorus, for strong, healthy bones and teeth. A diet with not enough calcium can lead to osteoporosis later in life. Adequate vitamin D and calcium is needed to help build strong bones and assist in the prevention of osteoporosis. OsteVit-D One-A-Week is not a source of calcium.

It is unlikely that adequate vitamin D levels can be achieved through the diet.

The main source of vitamin D is from the sun, however deficiency is common and it should not be assumed that Australians get enough vitamin D from the sun. People who may be at risk of being deficient are the elderly (particularly those in residential care), people with skin conditions where avoidance of sunlight is advised, those with dark skin (particularly if veiled), and those with malabsorption.

Ask your pharmacist or doctor if you have any questions about this medicine.

OsteVit-D One-A-Week capsules are only available from your pharmacist.

Before you take/give OsteVit-D One-A-Week

This product should be taken on pharmacist or medical advice.

When you must not take it

Do not take this product if you have an allergy or are hypersensitive to:

  • any medicine containing cholecalciferol
  • any of the ingredients listed at the end of this leaflet.

Do not give this medicine to a child under the age of 12 years.

Do not take this medicine if your doctor has told you that you have high calcium and/or vitamin D levels in your blood.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • kidney disease
  • kidney stones
  • heart disease
  • long-standing high calcium levels in the blood
  • any condition that makes it hard for your body to absorb nutrients from food (malabsorption)

Tell your pharmacist or doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your pharmacist or doctor can discuss with you the risks and benefits involved.

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking OsteVit-D One-A-Week.

Taking other medicines

Tell your pharmacist or doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Some medicines and OsteVit-D One-A-Week may interfere with each other.

These include:

  • Thiazides (medications used for high blood pressure and fluid build-up).
  • Medicines used to treat seizures such as carbamazepine, phenobarbital, phenytoin and primidone.
  • Calcium or phosphates supplements.
  • Orlistat (weight loss medicine).
  • Antacids (medicines used to treat indigestion eg Gaviscon, Mylanta).
  • Bile acid sequestrants (eg cholestyramine, colestipol).

These medicines may be affected by OsteVit-D One-A Week or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your pharmacist or doctor will have more information on medicines to be careful with or avoid while taking this medicine.

How to take OsteVit-D One-A Week

Follow all directions given to you by your pharmacist or doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box and leaflet, ask your pharmacist or doctor for help.

How much to take

Adults and children 12 years and over: 1 capsule once weekly as directed by your medical practitioner or pharmacist.

When to take it

Can be taken with or without food. Vitamin D is best absorbed when taken after a meal so this is the best time to take it, unless otherwise directed by your pharmacist or doctor.

Take your medicine on the same day each week. It will help you remember when to take it. It may help to mark your calendar with a reminder.

If you need to take an antacid, take it at least 2 hours before or 2 hours after your dose of OsteVit-D One-A-Week.

How long to take it

Continue taking your medicine for as long as your pharmacist or doctor tells you. The recommended dose for maintaining vitamin D levels is 1 capsule per week.

If you forget to take it

Take it as soon as you remember, and then go back to taking your medicine as you would normally.

If you are not sure what to do, ask your pharmacist or doctor.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (call 13 11 26 in Australia) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much OsteVit-D One-A Week. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using OsteVit-D One-A-Week

Things you must do

If you are about to be started on any new medicine, remind your pharmacist or doctor that you are taking Ostevit-D One-A-Week.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Your medical practitioner should monitor your urine and serum calcium, vitamin D and parathyroid hormone (PTH) levels whilst you are taking OsteVit-D One-A-Week in order to assess your response to treatment.

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not take more than the recommended dose unless your pharmacist or doctor tells you to.

Side effects

Most people do not commonly experience side effects with vitamin D, unless too much is taken.

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking OsteVit-D One-A-Week.

Do not be alarmed by the following list of side effects. You may not experience any of them. The list includes rare side effects that usually result from long-term intake of very high doses of vitamin D.

Ask your pharmacist or doctor to answer any questions you may have.

Tell your pharmacist or doctor if you notice any of the following and they worry you:

  • loss of appetite
  • metallic taste in mouth
  • weight loss
  • stomach pain
  • nausea
  • vomiting
  • constipation
  • urinating more than usual
  • muscle or bone pain

Other side effects not listed above may also occur in some people.

After using OsteVit-D One-A Week

Storage

Keep your capsules in the pack until it is time to take it. If you take the capsules out of the pack they may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 30ºC. Protect from light after opening.

Do not store this medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above theground is a good place to store medicines.

Disposal

If your pharmacist or doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

OsteVit-D One-A-Week are pale yellow transparent oil filled soft gelatin capsules with ‘7000’ printed in black ink.

Ingredients

Each capsule contains 175 mcg of cholecalciferol (vitaminD3 7000IU) as the active ingredient.

It also contains:

  • soya oil
  • coconut oil
  • gelatin
  • glycerol
  • black printing ink (Opacode S-1-17823)

This medicine does not contain gluten, yeast, sugar or sweeteners, starch, lactose and flavours.

Distributor

Key Pharmaceuticals Pty Ltd
12 Lyonpark Rd, Macquarie Park
NSW 2113

® = Registered Trademark

AUST R number: 256292

This leaflet was prepared in August 2015.

Published by MIMS September 2024

BRAND INFORMATION

Brand name

OsteVit-D One-A-Week

Active ingredient

Colecalciferol

Schedule

S3

 

1 Name of Medicine

Colecalciferol.

2 Qualitative and Quantitative Composition

Each capsule contains colecalciferol 175 mcg (equivalent to vitamin D3 7000 IU).

Excipients with known effect.

Nil. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Soft capsule.
Pale-yellow transparent oil filled soft capsule with '7000' printed in black ink.

4 Clinical Particulars

4.1 Therapeutic Indications

For:
(a) The treatment of vitamin D deficiency in adults and adolescents as directed by your medical practitioner or pharmacist; and
(b) The prevention of vitamin D deficiency in high-risk individuals under the supervision of a medical practitioner or pharmacist.

4.2 Dose and Method of Administration

Adults and adolescents over 12 years of age: one capsule once weekly as directed by your medical practitioner or pharmacist.
OsteVit-D One-A-Week can be taken with or without a meal.

4.3 Contraindications

Hypercalcaemia. Hypersensitivity to vitamin D or any of the excipients. Colecalciferol should not be used in patients with severe renal impairment.
Hypervitaminosis D.

4.4 Special Warnings and Precautions for Use

Identified precautions.

OsteVit-D One-A-Week should be given with care to patients with impaired renal function or calculi or heart disease who might be at increased risk of organ damage if hypercalcaemia occurred. Chronic hypercalcaemia can result in calcium deposits in many tissues, such as the arteries, kidneys and other soft tissue which may lead to hypertension and renal failure. Plasma phosphate concentrations should be controlled in these patients during vitamin D therapy to reduce the risk of ectopic calcification. Renal and cardiovascular damage may occur because of ectopic calcification.
Vitamin D3 may increase the magnitude of hypercalcemia and/or hypercalciuria when administered to patients with diseases associated with unregulated overproduction of calcitriol (e.g. leukaemia, lymphoma, sarcoidosis).
Urine and serum calcium, vitamin D and parathyroid hormone (PTH) levels should be monitored whilst taking OsteVit-D One-A-Week in order to assess the patients' response to treatment.
Avoid taking further medications including OTC and health food preparations that contain vitamin D.
Patients with malabsorption may not adequately absorb vitamin D3.

Use in the elderly.

OsteVit-D One-A-Week can be used in the elderly with caution due to the associated decrease in renal function.

Paediatric use.

OsteVit-D One-A-Week is not indicated for use in children under 12 years of age.

Effects on laboratory tests.

Urinary calcium, phosphate, albumin, BUN, serum cholesterol, AST (SGOT) and ALT (SGPT) concentrations may increase.
Serum alkaline phosphatase concentrations may decrease.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Orlistat, bile acid sequestrants (e.g. cholestyramine, colestipol), antacids, calcium and phosphate supplements may impair the absorption of vitamin D.
There is an increased risk of hypercalcaemia with thiazide diuretics, calcium or phosphate supplements.
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D through P450 interactions.
There is no interaction between the selective estrogen receptor modulator, raloxifene and colecalciferol.
Isoniazid may reduce the effectiveness of colecalciferol.
Concomitant treatment with rifampicin, phenytoin or barbiturates can decrease the effect of colecalciferol due to metabolic activation.
Concomitant use of vitamin D supplements with vitamin D analogues is not recommended due to the additive effect and increased risk of side effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No effects have been observed in reproductive fertility studies with colecalciferol.
Vitamin D3 is a therapeutic good which is exempted from pregnancy classification by TGA.
There is no available data on the teratogenic effects of colecalciferol. However, hypercalcaemia during pregnancy may lead to congenital disorders in the offspring and neonatal hypoparathyroidism. Despite these risks, untreated maternal hypothyroidism possesses a greater risk to the fetus than the potential hypercalcaemia from vitamin D therapy.
The use of vitamin D3 supplements during pregnancy is well tolerated, with little risk of adverse outcomes during pregnancy for the mother and neonate. Limited evidence shows that maternal vitamin D supplementation is associated with reduced risk of pre-eclampsia and gestational diabetes mellitus for the mother. There were also improved health outcomes for the neonate including reduced risk of pre-term birth and small for gestational age and, increased length and head circumference.
 Vitamin D is distributed into breastmilk, and its concentration appears to correlate with vitamin D levels in the serum of exclusively breast-fed infants. The American Academy of Pediatrics considers the use of vitamin D to be usually compatible with breast feeding, although they and others recommend that the infant be closely monitored for hypercalcaemia or clinical manifestation of vitamin D toxicity if the mother is receiving pharmacological doses of vitamin D.
There is limited evidence that shows vitamin D supplementation in breastfeeding mothers may increase vitamin D levels in breast-fed infants and decrease the incidence of vitamin D insufficiency.
Vitamin D supplementation amongst breastfeeding mothers is generally well tolerated by both mother and breast-fed infants.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions of vitamin D are rare and usually result from long-term intake at levels well above the current recommended dose of OsteVit-D One-A-Week. See Table 1.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Inter-individual tolerance to vitamin D varies considerably; infants and children are generally more susceptible to its toxic effects.
Excessive intake of Vitamin D leads to the development of hypercalcaemia and its associated effects including hypercalciuria, hyperphosphataemia, ectopic calcification, and renal and cardiovascular damage.
Symptoms of overdose may include anorexia, lassitude, nausea and vomiting, bone pain, weight loss, diarrhoea, polyuria, nocturia, sweating, headache, thirst, somnolence, constipation, muscle weakness, apathy, proteinuria, depression, vague aches, stiffness, anaemia, hypertension, cardiac arrhythmias, urinary tract infections and vertigo.
If symptoms arise, discontinue administration of vitamin D and give large quantities of fluids and electrolytes. The patient should be placed on a low calcium diet.
For vitamin D medicated hypercalcaemia: Corticosteroids rapidly reduce hypercalcaemia in severe conditions. Oral sodium cellulose phosphate, which binds calcium in the GI tract, and a low-calcium diet may also be considered. Oral chloroquine or hydroxychloroquine have been used in hypercalcaemia associated with sarcoidosis. Ketoconazole may be useful as an alternative to corticosteroids.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Colecalciferol, the 'natural' form of vitamin D, is found in a limited range of foods (mainly milk and dairy products, fortified margarine, fatty fish and eggs). The major source of vitamin D in humans is formed through the action of ultraviolet light on 7-dehydrocholesterol in the skin to form provitamin D3 which is then converted to colecalciferol.
Vitamin D is important in the regulation of calcium and phosphate metabolism and to optimise bone health and muscle function. Vitamin D deficiency causes secondary hyperparathyroidism which leads to cortical bone loss, osteoporosis and fractures. It may also cause fatigue, muscle weakness, increased body sway and falls.

Clinical trials.

The therapeutic basis for colecalciferol supplementation in the maintenance of vitamin D levels and for the prevention of vitamin D deficiency is well understood. The dosage for the preventative management of vitamin D deficiency is usually Vit D3 1000 IU/day. There is inference from literature based data, summarised below, to permit flexibility in the dosing frequency e.g. Vit D3 7000 IU/week, while still maintaining dosage at a daily average of Vit D3 1000 IU.
One study with 48 women compared the efficacy of the same cumulative dose when given daily, weekly or monthly at 1,500 IU, 10,500 IU or 45,000 IU respectively. There were increases in serum 25(OH)D levels in all groups, however there were no significant longer-term differences between the dosage regimens. The study concluded that the related dosing intervals can be selected freely to optimise an individual's adherence with long-term vitamin D supplementation.
338 male and female subjects participating in a randomised trial were given either 600 IU/day, 4200 IU/week, 18,000 IU/month or placebo. After 4 months, the mean serum 25(OH)D levels increased from a baseline of 25.0 nanomol/L to 62.5 nanomol/L (after daily vitamin D3 69.9 nanomol/L, weekly 67.2 nanomol/L and monthly 53.1 nanomol/L).
A double-blind, placebo controlled trial with 226 male and female subjects investigated a weekly dose of 8400 IU against a placebo. Following 16 weeks of treatment, serum 25(OH)D concentrations rose significantly (from 13.9 to 26.2 nanogram/mL) in patients treated with 8400 IU vitamin D3, but not in the placebo treated group. The weekly dose of colecalciferol appeared to reach steady state after 8 weeks and was found to be well tolerated. The incidence of hypercalcaemia, hypercalciuria or kidney stones did not differ between the two groups and there were no laboratory, clinical or serious adverse events in the colecalciferol group.
A short-term pilot study and a long-term safety study assessed the safety of weekly vitamin D supplementation amongst adolescents aged 10-17 years old. Out of 340 subjects exposed to weekly vitamin D supplementation for up to 1 year, 7 (2%) subjects presented with serum calcium levels that are above the upper limit of normophysiological levels for children (10.7 mg/dL), however these were observed in all three groups - placebo, low dose (1400 IU weekly) and high dose (14,000 IU weekly) vitamin D groups. None of these children displayed elevated levels of serum 25(OH)D. Five subjects (1.5%) from the high dose vitamin D group exhibited increased serum 25(OH)D levels at the cessation of the 1 year study, but none had concomitant hypercalcaemia. These studies found that once weekly dosing of 14,000 IU for up to 1 year was well tolerated by adolescents and resulted in increases in vitamin D levels.
A randomised, placebo-controlled trial study amongst 107 postmenopausal women with hypovitaminosis D assessed the efficacy of four different vitamin D regimens, corresponding to an average daily dose of 1000 IU/day; single oral dose of colecalciferol 300,000 IU; colecalciferol 100,000 IU every two months; once weekly colecalciferol 7000 IU; and weekly oral calcifediol 7000 IU. Once weekly colecalciferol 7000 IU induced a greater and faster increase of serum vitamin D levels, compared to monthly or single-dose colecalciferol doses. The increase in serum vitamin D levels was associated with improvements in lower limb muscle function. The larger increase of serum vitamin D levels observed with once weekly colecalciferol was associated with a greater improvement of muscle strength.

5.2 Pharmacokinetic Properties

Absorption.

Colecalciferol is well absorbed from the gastrointestinal tract. Bile is essential for adequate intestinal absorption; therefore absorption may be decreased in patients with decreased fat absorption due to hepatic insufficiency. Patients with renal insufficiency will have decreased ability to form the active 1,25-dihydroxyvitamin D metabolite.
The absorption of colecalciferol is unaffected by the ingestion of food. OsteVit-D can be taken with or without food.

Distribution.

Vitamin D and its metabolites circulate in the blood bound to specific α-globulin. Vitamin D can be stored in adipose and muscle tissue for long periods of time. It is slowly released from such storage sites and from the skin. Colecalciferol has a slow onset and a long duration of action.

Metabolism.

Colecalciferol is hydroxylated in the liver by the enzyme vitamin D 25-hydroxylase to form 25-hydroxycolecalciferol (25 (OH)D). This compound undergoes further hydroxylation in the kidneys by the enzyme vitamin D 1-hydroxylase, under the influence of parathyroid hormone, to form the active metabolite 1,25-dihydroxycolecalciferol (calcitriol or 25 (OH)2 D). Further metabolism also occurs in the kidneys, including the formation of the 1,24,25-trihydroxy derivatives. Colecalciferol disappears from plasma with a half-life of 19 to 48 hours but is stored in fat deposits throughout the body for prolonged periods.

Excretion.

Excretion of vitamin D and its metabolites is mainly in the bile and faeces. Small amounts are eliminated in the urine. There is some enterohepatic recycling but it is considered to have a negligible contribution to vitamin D status. Vitamin D is also excreted in breast milk.
Its half-life has been estimated at between 15 and 50 days.

5.3 Preclinical Safety Data

Genotoxicity.

Calcitriol, the hormonal metabolite of colecalciferol, has been found not to be genotoxic in the Ames microbial mutagenesis assay with or without metabolic activation, and in an in vivo micronucleus assay in mice.

Carcinogenicity.

No data are available regarding the use of colecalciferol and carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Soya oil, gelatin, glycerol, fractionated coconut oil, Opacode monogramming ink S-1-17823 black, purified water.
See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light after opening.

6.5 Nature and Contents of Container

OsteVit-D One-A-Week soft capsules are packaged in Aclar/Aluminium blisters and Aclar film is comprised of polyvinyl chloride (PVC) and polychlorotrifluoroethylene (PCTFE). Blisters are packaged in a carton in packs of 3, 5, 10, 15, 20, 30, 45 and 50 capsules per carton.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


Chemical Name: Colecalciferol (5Z,7E)-9,10-Secocholesta-5,7,10(19)-trien-3β-ol.
Molecular Formula: C27H44O.
Molecular Weight = 384.6.

CAS number.

67-97-0.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes