Consumer medicine information

OsteVit-D One-A-Week

Colecalciferol

BRAND INFORMATION

Brand name

OsteVit-D One-A-Week

Active ingredient

Colecalciferol

Schedule

FULL CMI

OSTEVIT-D^® ONE-A-WEEK

Active ingredient(s): Colecalciferol 175mcg equivalent to Vitamin D3 7000IU

Consumer Medicine Information (CMI)

This leaflet provides important information about using OsteVit-D One-A-Week capsules. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using OsteVit-D One-A-Week capsules.

1. Why am I using OsteVit-D One-A-Week Capsules?

OsteVit-D One-A-Week capsules contain the active ingredient colecalciferol. Colecalciferol 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.

2. What should I know before I use OsteVit-D One-A-Week Capsules?

Warnings

Do not use Ostevit-D One-A-Week capsules if:

you are allergic to colecalciferol, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
your doctor has told you that you have high calcium (hypercalcaemia) and / or vitamin D levels (hypervitaminosis) in your blood.

Check with your doctor or pharmacist if you:

have any other 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)
have leukaemia, lymphoma, sarcoidosis.
take any medicines for any other condition
Take other medicines, including OTC and health food preparations that contain vitamin D

Do not give to children under the age of 12 years.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows sign of tampering.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Vitamin D3 is a therapeutic good which is exempted from pregnancy classification by TGA.

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

In particular, you should tell your doctor or pharmacist if you are using:

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 phosphate supplements
Orlistat (weight loss medicine)
Antacids (medicines used to treat indigestion eg Gaviscon, mylanta)
Bile acid sequestrants (eg cholestyramine, colestipol)
Isoniazid

Some medicines may interfere with OsteVit-D One-A-Week capsules and affect how it works.

You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor or pharmacist will advise you.

Medicines that may increase the effect of OsteVit D One-A-Week include

There is an increased risk of hypercalcaemia with thiazide diuretics, calcium or phosphate supplements.

Medicines that may reduce the effect of OsteVit D One-A-Week include:

Orlistat (weight loss medicine)
Cholestyramine (bile acid sequestrants)
Colestipol (bile acid sequestrants)
Antacids (medicines used to treat indigestion eg Gaviscon, mylanta)
Calcium and phosphate supplements (may impair absorption of vitamin D)
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D through P450 interactions.
Isoniazid may reduce the effectiveness of colecalciferol.
Concomitant treatment with rifampicin, phenytoin or barbiturates can decrease the effect of colecalciferol due to metabolism activation.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affects OsteVit-D One-A-Week capsules.

4. How do I use OsteVit-D One-A-Week Capsules?

How much to take / use

Adults and adolescents over 12 years of age: one capsule once weekly as directed by your medical practitioner or pharmacist.
Follow the instructions provided with the medicine.
Do not exceed the recommended dosage.

When to take / use OsteVit-D One-A-Week capsules

OsteVit-D One-A-Week capsules should be taken with or without a meal.
Take your medicine on the same day each week.
Continue taking your medicine for as long as your pharmacist or doctor tells you.

If you use too much OsteVit-D One-A-Week capsules

If you think that you have used too much Ostevit-D One-A-Week capsules, you may need urgent medical attention.

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.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using OsteVit-D One-A-Week Capsules

Things you should do

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 levels while you are taking Ostevit-D One-A-Week in order to assess your response to treatment.

Remind any doctor, dentist or pharmacist you visit that you are using OsteVit-D One-A-Week capsules.

Things you should not do

Do not give your medicine to anymore 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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how OsteVit-D One-A-Week capsules affects you.

Looking after your medicine

Keep your capsules in the pack until it is time to take it.
Keep your medicine in a cool dry place where the temperature stays below 25°C.Protect from light after opening.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Adverse Event	Frequency Category
Adverse Event	Uncommon (affecting ≥1/1000 and <1 in 100 people)	Rare (affecting ≥1/10,000 and <1/1000 people)
Metabolism and nutrition disorders	Hypercalcaemia Hypercalciuria
Skin and Subcutaneous disorders		Pruritus Rash Urticaria

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available behind-the-counter without a doctor's prescription.

What OsteVit-D One-A-Week Capsules contains

Active ingredient (main ingredient)	Colecalciferol 175mcg
Other ingredients (inactive ingredients)	Soya oil Gelatin Glycerol Fractionated coconut oil Opacode monogramming ink S-1-1-17823 Black Purified water

Do not take this medicine if you are allergic to any of these ingredients.

What OsteVit-D One-A-Week capsules looks like

OsteVit-D One-A-Week is a pale-yellow transparent oil filled soft gelatin capsule with ‘7000’ printed in black ink. (Aust R 256292).

Who distributes OsteVit-D One-A-Week capsules

Key Pharmaceuticals Pty Ltd
MQX4, 1 Giffnock Avenue
Macquarie Park NSW 2113

This leaflet was revised in July 2024.

Published by MIMS September 2024

BRAND INFORMATION

Brand name

OsteVit-D One-A-Week

Active ingredient

Colecalciferol

Schedule

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.

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OsteVit-D One-A-Week

Colecalciferol

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BRAND INFORMATION

OsteVit-D One-A-Week 175 mcg Capsules