Drugs List

Therapeutic Indications

Uses

Prophylaxis and treatment of hyperphosphataemia in patients with advanced renal failure undergoing dialysis.

Administration

For oral use

To be taken with food to achieve the maximum phosphate-binding effect.

Tablets should be swallowed whole and should not be chewed due to their bitter taste. For patients that have difficulty in swallowing the tablets whole, they can be broken in half and taken with food.

Contraindications

Hypercalcaemia

Hypercalciuria

Hypophosphataemia

Children aged under 18 years

Precautions and Warnings

Pregnancy (see 'Pregnancy' section)
Breastfeeding (see 'Lactation' section)

Advise the patient on phosphate intake.

Monitor serum calcium and phosphate levels to determine efficacy of therapy and prevent hypercalcaemia. Monitoring should be more frequent after initiation of the therapy e.g. in weekly intervals or every 2 weeks for three months. After this monthly intervals should be sufficient, depending on the medical condition of the patient and at the discretion of the physician.
The serum calcium times phosphate levels (CA x P) should not exceed 4.51 mmol squared/square litre. Maintenance of serum phosphorous less than 1.78 mmol/l is generally considered as a clinically acceptable outcome of treatment with phosphate binders.

Calcium salts should generally be avoided in patients with or a history of renal calculi, and given cautiously in osteoporosis due to immobilisation, and patients with diseases associated with hypercalcaemia such as sarcoidosis and some malignancies.

Chronic overdose of calcium preparations in uraemic patients can cause soft tissue calcifications.

Warn patient about signs of hypercalcaemia and to advise doctor if they occur.

ECG and calcium monitoring is warranted when calcium containing agents are combined with cardiac glycosides.

Reduce dose or temporarily withdraw treatment if hypercalcaemia occurs.

Increased amounts of calcium salts in the gastro-intestinal tract may result in the precipitation of fatty acids and bile acids as calcium salt, this may lead to constipation. Therefore, use with caution in stenosis of the large intestine and constipation.

Concomitant vitamin D, should be initiated under specialist supervision due to the increased risk of hypercalcaemia occurring.

Avoid antacids containing calcium, as this may add to the calcium load.

Caution in long term therapy: calcium toxicity has not been evaluated with this product.

Patients should be advised not to take any other oral medication within 1-2 hours before and after taken this product.

Some brands contain sucrose, therefore use with caution in patients with hereditary fructose intolerance and glucose-galactose malabsorption.

Pregnancy and Lactation

Pregnancy

Use only if considered essential, safety has not been established. If administered serum calcium levels should be monitored regularly.

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 at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Lactation

Use only if considered essential, safety has not been established. If administered serum calcium levels should be administered regularly.

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
Vomiting
Diarrhoea
Constipation
Belching
Bloated feeling
Pruritus
Allergic reaction
Hypercalcemia

Presentation

Capsule containing 667mg calcium acetate (equivalent to 169mg calcium)
Film-coated tablets containing 475mg calcium acetate (equivalent to 120.25mg calcium)
Film-coated tablets containing 660mg calcium acetate (equivalent to 167mg calcium)
Film-coated tablets containing 960mg calcium acetate (equivalent to 240.50mg calcium)
Tablets containing 1000mg calcium acetate (equivalent to 250mg calcium)

Drugs List

Therapeutic Indications

Uses

Prophylaxis and treatment of hyperphosphataemia in patients with advanced renal failure undergoing dialysis.

Dosage

Initial dose varies with products (see below for guidance).

In all cases increased as necessary to achieve the desired serum phosphate levels, provided that hypercalcaemia does not occur.

Adults

Elderly

Children

Administration

For oral use

To be taken with food to achieve the maximum phosphate-binding effect.

Tablets should be swallowed whole and should not be chewed due to their bitter taste. For patients that have difficulty in swallowing the tablets whole, they can be broken in half and taken with food.

Contraindications

Hypercalcaemia

Hypercalciuria

Hypophosphataemia

Children aged under 18 years

Precautions and Warnings

Pregnancy (see 'Pregnancy' section)
Breastfeeding (see 'Lactation' section)

Advise the patient on phosphate intake.

Monitor serum calcium and phosphate levels to determine efficacy of therapy and prevent hypercalcaemia. Monitoring should be more frequent after initiation of the therapy e.g. in weekly intervals or every 2 weeks for three months. After this monthly intervals should be sufficient, depending on the medical condition of the patient and at the discretion of the physician.
The serum calcium times phosphate levels (CA x P) should not exceed 4.51 mmol squared/square litre. Maintenance of serum phosphorous less than 1.78 mmol/l is generally considered as a clinically acceptable outcome of treatment with phosphate binders.

Calcium salts should generally be avoided in patients with or a history of renal calculi, and given cautiously in osteoporosis due to immobilisation, and patients with diseases associated with hypercalcaemia such as sarcoidosis and some malignancies.

Chronic overdose of calcium preparations in uraemic patients can cause soft tissue calcifications.

Warn patient about signs of hypercalcaemia and to advise doctor if they occur.

ECG and calcium monitoring is warranted when calcium containing agents are combined with cardiac glycosides.

Reduce dose or temporarily withdraw treatment if hypercalcaemia occurs.

Increased amounts of calcium salts in the gastro-intestinal tract may result in the precipitation of fatty acids and bile acids as calcium salt, this may lead to constipation. Therefore, use with caution in stenosis of the large intestine and constipation.

Concomitant vitamin D, should be initiated under specialist supervision due to the increased risk of hypercalcaemia occurring.

Avoid antacids containing calcium, as this may add to the calcium load.

Caution in long term therapy: calcium toxicity has not been evaluated with this product.

Patients should be advised not to take any other oral medication within 1-2 hours before and after taken this product.

Some brands contain sucrose, therefore use with caution in patients with hereditary fructose intolerance and glucose-galactose malabsorption.

Pregnancy and Lactation

Pregnancy

Use only if considered essential, safety has not been established. If administered serum calcium levels should be monitored regularly.

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 at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Lactation

Use only if considered essential, safety has not been established. If administered serum calcium levels should be administered regularly.

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

Effects on Ability to Drive and Operate Machinery

There are no known effects on the ability to drive or operate machinery.

Counselling

Advise patients of the signs of possible symptoms of hypercalcaemia.

Advise patient to seek medical advice prior to taking any vitamin D supplements or antacids containing calcium.

Patients should be advised not to take any other oral medication within 1-2 hours before and after taken this product.

Side Effects

Nausea
Vomiting
Diarrhoea
Constipation
Belching
Bloated feeling
Pruritus
Allergic reaction
Hypercalcemia

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 ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Shelf Life and Storage

Storage requirements vary according to brand. See product literature for details.

Further Information

Last Full Review Date: March 2011

Reference Sources

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

Summary of Product Characteristics: Everose 660mg tablets. Fresenius Medical Care. Revised October 2007.

Summary of Product Characteristics: Phosex 1000mg tablets. Vitaline Pharma UK. Revised May 2010.

Summary of Product Characteristics: Phoslo 667mg capsule, hard. Fresenius Medical Care. Revised August 2007.

Summary of Product Characteristics: Renacet 475mg tablets. RenaCare NephroMed GmbH. Revised June 2010.

Summary of Product Characteristics: Renacet 950mg tablets. RenaCare NephroMed GmbH. Revised June 2010.