Drugs List

Therapeutic Indications

Uses

Vitamin A and D deficiency: Prophylaxis

Contraindications

Children under 6 years
Hypervitaminosis A
Hypervitaminosis D
Hypercalcaemia
Hypercalciuria
Severe renal impairment

Precautions and Warnings

Breastfeeding
Cardiovascular disorder
Hepatic impairment
Osteoporosis
Pregnancy
Renal impairment
Sarcoidosis

Contains soya or soya derivative
Breastfeeding: Hypercalcaemia of infant possible if mother taking vitamin D
Monitor plasma calcium in patients receiving pharmacological doses of drug
Monitor serum and urinary calcium in patients with sarcoidosis
Monitor serum calcium levels in patients with renal impairment
Monitor serum phosphate levels in patients with renal impairment
Neonate exposed in utero: High doses of vitamin A may be harmful
Prolonged use or excessive doses may cause hypervitaminosis
Advise patient not to exceed stated dose

Risk of cardiac arrhythmias in patients treated with digitalis and other cardiac glycosides. In such cases, strict medical supervision is required and monitor ECG and calcium if necessary.

Pregnancy and Lactation

Pregnancy

Use retinol and colecalciferol with caution during pregnancy.

The manufacturer advises that doses of vitamins A and D in excess of those recommended should be avoided during pregnancy unless the clinical condition of the women requires treatment with vitamins A and D.

Large doses of vitamin A (exceeding 10,000units) have been found to be teratogenic if administered during the first trimester of pregnancy.

Studies have shown safe use of doses of vitamin D up to 4000units during pregnancy although studies in animals have shown reproductive toxicity.

Lactation

Use retinol and colecalciferol with caution during breastfeeding.

The manufacturer advises that the patient either discontinues from retinol and colecalciferol therapy or discontinues breastfeeding.

Vitamin A is present in human breast milk. Effects on exposed infants are unknown.

Vitamin D and its metabolites are excreted in breast milk. Large doses of vitamin D in breastfeeding mothers may cause hypercalcaemia in infants. Doses in excess of those recommended should be avoided during breastfeeding.

Side Effects

Decreased appetite
Hepatic disorders
Hypercalcaemia
Hypercalciuria
Hypervitaminosis A
Intracranial hypertension
Irritability
Pruritus
Rash
Skin disorder
Urticaria
Vomiting

Presentation

Oral formulations containing retinol palmitate and colecalciferol.

Drugs List

Therapeutic Indications

Uses

Vitamin A and D deficiency: Prophylaxis

Dosage

Adults

Children

Contraindications

Children under 6 years
Hypervitaminosis A
Hypervitaminosis D
Hypercalcaemia
Hypercalciuria
Severe renal impairment

Precautions and Warnings

Breastfeeding
Cardiovascular disorder
Hepatic impairment
Osteoporosis
Pregnancy
Renal impairment
Sarcoidosis

Contains soya or soya derivative
Breastfeeding: Hypercalcaemia of infant possible if mother taking vitamin D
Monitor plasma calcium in patients receiving pharmacological doses of drug
Monitor serum and urinary calcium in patients with sarcoidosis
Monitor serum calcium levels in patients with renal impairment
Monitor serum phosphate levels in patients with renal impairment
Neonate exposed in utero: High doses of vitamin A may be harmful
Prolonged use or excessive doses may cause hypervitaminosis
Advise patient not to exceed stated dose

Risk of cardiac arrhythmias in patients treated with digitalis and other cardiac glycosides. In such cases, strict medical supervision is required and monitor ECG and calcium if necessary.

Pregnancy and Lactation

Pregnancy

Use retinol and colecalciferol with caution during pregnancy.

The manufacturer advises that doses of vitamins A and D in excess of those recommended should be avoided during pregnancy unless the clinical condition of the women requires treatment with vitamins A and D.

Large doses of vitamin A (exceeding 10,000units) have been found to be teratogenic if administered during the first trimester of pregnancy.

Studies have shown safe use of doses of vitamin D up to 4000units during pregnancy although studies in animals have shown reproductive toxicity.

Lactation

Use retinol and colecalciferol with caution during breastfeeding.

The manufacturer advises that the patient either discontinues from retinol and colecalciferol therapy or discontinues breastfeeding.

Vitamin A is present in human breast milk. Effects on exposed infants are unknown.

Vitamin D and its metabolites are excreted in breast milk. Large doses of vitamin D in breastfeeding mothers may cause hypercalcaemia in infants. Doses in excess of those recommended should be avoided during breastfeeding.

Side Effects

Decreased appetite
Hepatic disorders
Hypercalcaemia
Hypercalciuria
Hypervitaminosis A
Intracranial hypertension
Irritability
Pruritus
Rash
Skin disorder
Urticaria
Vomiting

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 ).

Further Information

Last Full Review Date: December 2019

Reference Sources

Summary of Product Characteristics: Retinol and Colecalciferol 4500 IU/450 IU Capsules, Soft. Tor Generics Ltd. Revised May 2019.