Sodium acid phosphate with sodium phosphate oral formulations
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing sodium acid phosphate with sodium phosphate.
Drugs List
Therapeutic Indications
Uses
Bowel evacuation - prior to investigative procedure
Bowel evacuation - prior to surgical procedure
Dosage
Adults
Oral solution
The dosing schedule should be started the day before the hospital appointment.
If the hospital appointment is before 12 noon the dosage instructions for morning appointments should be followed, and for appointments after 12 noon the dosage instructions for an afternoon appointment should be followed.
Morning Appointment: Day before appointment
7am: In place of breakfast drink at least one full glass of clear liquid or water, more if desired.
1st dose: Straight after breakfast, dilute the contents of one bottle (45ml) in half a glass (120ml) of cold water. Drink this solution followed by one full glass (240ml) of cold water, more if desired.
1pm lunch: In place of lunch, drink at least three full glasses (720ml) of clear liquid or water, more if desired.
7pm supper: In place of supper, drink at least one full glass of clear liquid or water, more if desired.
2nd dose: Straight after supper, dilute the contents of the second bottle (45ml) in half a glass (120ml) of cold water. Drink this solution followed by one full glass (240ml) of cold water, more if desired.
Additional water or clear liquids may be taken up until midnight if necessary.
Afternoon appointment: Day before appointment
1pm lunch: A light snack may be taken. After lunch no more solid food must be taken until after the hospital appointment.
7pm supper: In place of supper drink at least one full glass of clear liquid or water, more if desired.
1st dose: Straight after supper, dilute the contents of one bottle (45ml) in half a glass (120ml) of cold water. Drink this solution followed by one full glass (240ml) cold water, more if desired.
During the evening, drink at least three full glasses of water or clear liquid before going to bed.
Afternoon appointment: Day of appointment
7am breakfast: In place of breakfast drink at least one full glass of clear liquid or water, more if desired.
2nd dose: Straight after breakfast. Dilute the contents of the second bottle (45ml) in half a glass (120ml) of cold water. Drink this solution followed by one full glass (240ml) cold water.
More water or clear liquid may be taken up until 8am.
Tablets
Evening before colonoscopy procedure
4 tablets to be taken with 250ml of water or other clear liquid. Repeat every 15mins until a total of 20 tablets have been taken.
Day of the colonoscopy procedure (3 to 5 hours before)
4 tablets to be taken with 250ml of water or other clear liquid. Repeat every 15mins until a total of 12 tablets have been taken.
or alternative regimen
Early morning colonoscopy procedure
All the tablets may be taken the night before but with an interval of at least 4 hours between the beginning of the intake of the first 20 tablets and the intake of the last 12 tablets. At each stage 4 tablets should be taken with 250ml of water or other clear liquid every 15 minutes.
Additional Dosage Information
"Clear liquids" include water, clear soup, strained fruit juices without pulp, black tea or black coffee, clear carbonated and non-carbonated soft drinks.
As much extra liquids as possible should be drunk in order to replace the fluids lost during bowel movements and to help ensure that the bowel will be clean for the procedure.
After the procedure the patient should be encouraged to continue drinking plenty of fluid in order to replace the fluid lost.
A bowel movement usually occurs from 30 minutes to 6 hours after the preparation has been taken.
Administration
No solid food should be taken from the start of the course of treatment until after the procedure.
Contraindications
Abdominal pain of unknown cause
Ascites
Children under 18 years
Nausea
Suspected gastrointestinal obstruction
Vomiting
Chronic constipation
Congestive cardiac failure
Decreased gastrointestinal motility
Gastrointestinal obstruction
Gastrointestinal perforation
Hypercalcaemia
Hyperparathyroidism
Hyponatraemia
Inflammatory bowel disease
Megacolon
Nephrocalcinosis
Paralytic ileus
Severe renal impairment
Uncontrolled cardiac failure
Precautions and Warnings
Coronary artery bypass graft
Debilitation
Elderly
Patients over 75 years
Predisposition towards electrolyte imbalance
Restricted sodium intake
Adrenal insufficiency
Alcohol withdrawal syndrome
Breastfeeding
Cardiac arrhythmias
Cardiac surgery
Cardiomyopathy
Cardiovascular disorder
Colostomy
Dehydration
Diabetes mellitus
Electrolyte imbalance
Hepatic impairment
History of major gastrointestinal surgery
History of seizures
Hypertension
Hypotension
Ileostomy
Myocardial infarction
Pregnancy
Renal impairment
Syndrome of inappropriate ADH secretion
Toxic colitis
Uncontrolled hypothyroidism
Unstable angina
Contains more than 1 mmol (23 mg) sodium per dose
Advise ability to drive/operate machinery may be affected by side effects
Correct hypovolaemia prior to administration
Maintain adequate hydration of patient prior / during treatment
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Restore electrolyte & fluid balance in case of dehydration
Oral solution contains sodium benzoate
Oral medications given < 1 hr before treatment may be rendered ineffective
Assess renal function prior to prescribing in the elderly
Evaluate renal function before and during treatment
Measure electrolytes before & after use where risk of electrolyte imbalance
Diabetic control may need adjustment
Advise patient to expect frequent loose stools
Advise patient of appropriate fluid / dietary intake prior to procedure
Baseline and post-treatment electrolyte levels (e.g. sodium, potassium, calcium, chloride, bicarbonate, phosphate, blood urea nitrogen and creatinine values) should be obtained in this group and other at-risk populations as the risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium may lead to hypernatraemia, hyperphosphataemia, hypocalcaemia, hypokalaemia and acidosis. Slight QT interval prolongation may rarely occur as a result of the electrolyte imbalances such as hypocalcaemia or hypokalaemia. Correct electrolyte imbalances before treatment.
Very rarely, single or multiple aphthoid-like punctiform lesions located in the rectosigmoid region have been observed by endoscopy. These were either lymphoid follicles or discrete inflammatory infiltrates or epithelial congestions/changes revealed by the colonic preparation. These abnormalities are not clinically significant and disappear spontaneously without any treatment.
The preparation should not be given at the same time as other sodium phosphate containing products. In rare serious cases clinical consequences including fatalities have been seen when they have been given additionally to patients with renal impairment or bowel obstruction.
Caution is advised when the bowel cleansing treatment is used in patients taking ACE inhibitors, angiotensin-II receptor antagonists and NSAIDs due to the risk of dehydration and hypovolaemia. Consider withholding these drugs on the day and for up to 72 hours after the procedure. Caution is also advised in patients already receiving diuretics which may be associated with hypokalaemia. Consider withholding diuretics on the day that the bowel cleansing preparation is given.
Consider diagnosis of ischaemic colitis in the case of severe and or persistent abdominal pain with or without rectal bleeding after administration of this preparation.
Bowel cleansing agents should not be considered as treatments for constipation.
Pregnancy and Lactation
Pregnancy
Use the preparation with caution during pregnancy.
The manufacturers recommend that the preparation is not used during pregnancy unless clearly necessary. At the time of writing there is no clinical data on the use of the treatment during pregnancy. The potential risk for humans is unknown.
Lactation
Use the preparation with caution during breastfeeding.
The manufacturers advise that if you are breastfeeding, that the breast milk should be expressed and discarded from the first dose to 24 hours after receiving the second dose of the bowel cleansing solution and that breast-feeding should not occur during this period. At the time of writing there is no information on the use of the bowel cleansing preparation during breastfeeding, and it is unknown if the preparation is excreted in human milk.
Counselling
Patient should be warned to expect frequent, liquid stools and should have a toilet facility available following administration.
The patient should be advised to drink as much liquid as possible in order to avoid dehydration and to help ensure the bowel will be clean for the procedure.
Patients should be advised of the importance of following the recommended fluid regimen.
After the procedure, patients should be encouraged to drink plenty of fluid in order to replenish the fluid lost during treatment.
Solid food must not be taken during the dosing period and clear liquid or water should be substituted for meals.
The patient should be advised to stop treatment and contact a doctor immediately if there is no bowel movement within 6 hours of taking the treatment as dehydration could occur.
Advise the patient that the treatment may cause dizziness and as such may have an effect on driving and/or operating machinery.
The patient should be warned that the efficacy of regularly taken oral drugs such as oral contraceptives, antiepileptics, antidiabetics or antibiotics may be reduced or completely absent and that they should avoid taking them one hour before or after administration of the bowel cleansing treatment.
Advise the patient to withhold taking ACE inhibitors, angiotensin-II receptor antagonists and NSAIDs on the day the bowel cleansing treatment is used and for up to 72 hours after the procedure. The patient should also be advised to withhold taking diuretics on the day that the bowel cleansing preparation is given.
Side Effects
Abdominal distension
Abdominal pain
Acidosis
Allergic dermatitis
Anaphylaxis
Aphthoid ileal ulcers
Arrhythmias
Asthenia
Bloating
Bronchospasm
Chest pain
Chills
Colonic lesions
Coma
Confusion
Convulsions
Dehydration
Diarrhoea
Dizziness
Dysphagia
Dyspnoea
Electrolyte disturbances
Headache
Hypernatraemia
Hypersensitivity reactions
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hyponatraemia
Hypotension
Increase in blood urea nitrogen
Increase in creatinine
Loss of consciousness (transient)
Metabolic acidosis
Muscle cramps
Myocardial infarction
Nausea
Nephrocalcinosis
Nephropathy
Paraesthesia
Pharyngeal oedema
Prolongation of QT interval
Pruritus
Rash
Renal failure
Renal tubular necrosis
Swelling of lips and face
Tetany
Throat tightness
Tingling sensation
Tonic-clonic seizures (generalised)
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: March 2021
Reference Sources
Summary of Product Characteristics: Coloclear 1500mg Tablets. Laboratoires Mayoly Spindler. Revised September 2020
Summary of Product Characteristics: Phospho-soda 24.4g/10.8g oral solution. Casen-Recordati S.L. Revised May 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 26 March 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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