Drugs List

Administration

For oral administration.

Reconstitution

Contraindications

Hypercalcaemia (>10.5mg/dl)

Hypercalciuria (300mg or 7.5mmol/24 hours)

Severe renal impairment

Nephrolithiasis

Calcium lithiasis

Calcification of tissues

Prolonged immobilisation accompanied by hypercalciuria and/or hypercalcaemia

Hypervitaminosis D

Children under 18 years

Pregnancy - see 'Pregnancy' section

Breast feeding - see 'Lactation' section

The powder for suspension contains sucrose and should not be given to patients with hereditary fructose intolerance.

Precautions and Warnings

Use with caution in patients with mild to moderate renal impairment or patients with a predisposition to urinary calculi. Serum and urinary calcium should be adequately monitored in these patients to prevent the onset of hypercalcaemia.

Treatment must be interrupted if urinary calcium exceeds 7.5mmol/24 hours (300mg/24 hours).

Use with caution in patients with cardiovascular disease. Monitoring of ECG and serum calcium may be necessary in these patients.

Concurrent vitamin D compounds or their derivatives should be withheld during treatment, including foods fortified with vitamin D.

The suspension contains the colouring agent E110 (sunset yellow FCF), which may trigger allergic-type reactions including asthma. These reactions are more common in people allergic to aspirin.

The powder for suspension contains sucrose use with caution in patients with glucose-galactose malabsorption syndrome.

Monitor serum and urinary calcium in patients with sarcoidosis because of possible increased metabolism of vitamin D to its active form.

Pregnancy and Lactation

Pregnancy

Not indicated for use during pregnancy as the daily dose of vitamin D should not exceed 600i.u.

Animal studies have shown that vitamin D overdose during pregnancy leads to teratogenic effects. There are no studies in human pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Not indicated for use during lactation as the daily dose of vitamin D should not exceed 600 i.u.

There are no studies in human lactation.

Vitamin D and its metabolites pass into breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Nausea
Constipation
Diarrhoea
Epigastric pain
Anaphylactic reaction
Urticaria
Hypercalcaemia
Anorexia
Vomiting
Headache
Weakness
Thirst
Polyuria
Abdominal pain
Cardiac arrhythmias
Fatigue
Hypercalciuria
Allergic dermatitis
Bone pain
Nephrocalcinosis
Mental disturbance
Weight loss
Sweating
Vertigo
Renal calculi

Presentation

Powder for oral suspension

Each sachet contains calcium phosphate 3100mg (equivalent to 1200mg or 30mmol of elemental calcium) with colecalciferol (vitamin D3) 20micrograms (equivalent to 800 i.u.).

Drugs List

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For oral administration.

Reconstitution

Contraindications

Hypercalcaemia (>10.5mg/dl)

Hypercalciuria (300mg or 7.5mmol/24 hours)

Severe renal impairment

Nephrolithiasis

Calcium lithiasis

Calcification of tissues

Prolonged immobilisation accompanied by hypercalciuria and/or hypercalcaemia

Hypervitaminosis D

Children under 18 years

Pregnancy - see 'Pregnancy' section

Breast feeding - see 'Lactation' section

The powder for suspension contains sucrose and should not be given to patients with hereditary fructose intolerance.

Precautions and Warnings

Use with caution in patients with mild to moderate renal impairment or patients with a predisposition to urinary calculi. Serum and urinary calcium should be adequately monitored in these patients to prevent the onset of hypercalcaemia.

Treatment must be interrupted if urinary calcium exceeds 7.5mmol/24 hours (300mg/24 hours).

Use with caution in patients with cardiovascular disease. Monitoring of ECG and serum calcium may be necessary in these patients.

Concurrent vitamin D compounds or their derivatives should be withheld during treatment, including foods fortified with vitamin D.

The suspension contains the colouring agent E110 (sunset yellow FCF), which may trigger allergic-type reactions including asthma. These reactions are more common in people allergic to aspirin.

The powder for suspension contains sucrose use with caution in patients with glucose-galactose malabsorption syndrome.

Monitor serum and urinary calcium in patients with sarcoidosis because of possible increased metabolism of vitamin D to its active form.

Pregnancy and Lactation

Pregnancy

Not indicated for use during pregnancy as the daily dose of vitamin D should not exceed 600i.u.

Animal studies have shown that vitamin D overdose during pregnancy leads to teratogenic effects. There are no studies in human pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Not indicated for use during lactation as the daily dose of vitamin D should not exceed 600 i.u.

There are no studies in human lactation.

Vitamin D and its metabolites pass into breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Nausea
Constipation
Diarrhoea
Epigastric pain
Anaphylactic reaction
Urticaria
Hypercalcaemia
Anorexia
Vomiting
Headache
Weakness
Thirst
Polyuria
Abdominal pain
Cardiac arrhythmias
Fatigue
Hypercalciuria
Allergic dermatitis
Bone pain
Nephrocalcinosis
Mental disturbance
Weight loss
Sweating
Vertigo
Renal calculi

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Reference Sources

British National Formulary, 61st Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.