Picoprep

Picoprep

Manufacturer:

Ferring

Distributor:

DCH Auriga - Universal
/
Four Star
Full Prescribing Info
Contents
Sodium picosulfate, light magnesium oxide, anhydrous citric acid.
Description
Each sachet contains sodium picosulfate 10 mg, light magnesium oxide 3.5 g and anhydrous citric acid 12 g. It also contains the following excipients: Potassium hydrogen carbonate, sodium saccharin, natural spray dried orange flavour which contains acacia gum, lactose, ascorbic acid and butylated hydroxyanisole.
Action
Pharmacotherapeutic Group: Contact laxatives. ATC Code: A06A B58.
Pharmacology: Pharmacodynamics: The active components of Picoprep are sodium picosulfate and magnesium citrate. Sodium picosulfate is a locally acting stimulant cathartic, which after bacterial cleavage in the colon, forms the active laxative compound, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), which has a dual-action with stimulation of the mucosa of both the large intestine and of the rectum. Magnesium citrate acts as an osmotic laxative by retaining moisture in the colon. The combined action of the 2 substances is of a 'washing out' effect combined with peristaltic stimulation to clear the bowel.
The product is not intended for use as a routine laxative.
Pharmacokinetics: Both active components are locally active in the colon and neither are absorbed in any detectable amounts.
Indications/Uses
To clean the bowel prior to x-ray examination or endoscopy; to clean the bowel prior to surgery, when judged clinically necessary (see Precautions).
Dosage/Direction for Use
Adults: There are 2 dosing regimens, each requires 2 separate dosing times: The preferred method is the “split-dose” method and consists of 2 separate doses: The 1st dose during the evening before the procedure and the 2nd dose the next day, during the morning prior to the procedure.
The alternative method is the “day-before” method and consists of 2 separate doses: The 1st dose during the afternoon or early evening before the procedure and the 2nd dose 6 hrs later during the evening before the procedure.
Additional fluids must be consumed after every dose in both dosing regimens. Instruct patients to consume only clear liquids (no solid food or milk) on the day before the procedure up until 2 hrs before the time of the procedure. Instruct patients that if they experience severe bloating, distention or abdominal pain following the 1st dose, delay the 2nd dose until their symptoms resolve.
Split-Dose Dosing Regimen (Preferred Method): The split-dose regimen is the preferred dosing method. Instruct patients to take 2 separate doses in conjunction with fluids, as follows: Take the 1st dose during the evening before the procedure (eg, 5-9 PM) followed by at least five 250 mL drinks of clear liquids before bed. Consume clear liquids within 5 hrs.
Take 2nd dose, the next day approximately 5 hrs before the procedure followed by at least three 250 mL drinks of clear liquids before the procedure. Consume clear liquids within 5 hrs up until 2 hrs before the time of the procedure.
Day-Before Dosing Regimen (Alternative Method): The day-before regimen is the alternative dosing method for patients for whom the split-dosing is inappropriate. Instruct patients to take 2 separate doses in conjunction with fluids, as follows: Take the 1st dose in the afternoon or early evening (eg, 4-6 PM) before the procedure followed by at least five 250 mL drinks of clear liquids before the next dose. Consume clear liquids within 5 hrs.
Take the 2nd dose approximately 6 hrs later in the late evening (eg, 10 PM-12 AM), the night before the procedure followed by three 250 mL drinks of clear liquids before bed. Consume clear liquids within 5 hrs.
Children: The 1st dose reconstituted in water as directed, taken before 8 AM on the day before the procedure. Second (2nd) dose 6-8 hrs later. ≥9 years: Adult dose; 4-9 years: 1 sachet morning, ½ sachet afternoon; 2-4 years: ½ sachet morning, ½ sachet afternoon; 1-2 years: ¼ sachet morning, ¼ sachet afternoon.
Administration: Oral.
Reconstitution: Reconstitute the Picoprep right before each administration. Do not prepare the solution in advance.
Fill a cup with cold water (approximately 150 mL) and pour in the contents of 1 packet of Picoprep.
Stir for 2-3 min. The reconstituted Picoprep solution may become slightly warm as the powder dissolves.
Overdosage
Overdosage would lead to profuse diarrhoea. Treatment is by general supportive measures and maintenance of fluid intake.
Contraindications
Hypersensitivity to any of the ingredients of Picoprep. Congestive cardiac failure; gastric retention; gastrointestinal ulceration; toxic colitis; toxic megacolon; ileus; nausea and vomiting; acute surgical abdominal conditions eg, acute appendicitis; known or suspected gastrointestinal obstruction or perforation; severe dehydration; rhabdomyolysis; hypermagnesemia; active inflammatory bowel disease.
In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.
Special Precautions
Because a clinically relevant benefit of bowel cleansing prior to elective, open colorectal surgery could not be proven, bowel cleansers should only be administered before bowel surgery, if clearly needed. The risks of the treatment should be carefully weighed against possible benefits and needs depending on surgical procedures performed.
Recent gastrointestinal surgery. Care should also be taken in patients with renal impairment, heart disease or inflammatory bowel disease.
Use with caution in patients on drugs that might affect water and/or electrolyte balance eg, diuretics, corticosteroids, lithium (see Interactions).
Picoprep may modify the absorption of regularly prescribed oral medication and should be used with caution eg, there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy (see Interactions).
An inadequate oral intake of water and electrolytes could create clinically significant, deficiencies, particularly in less fit patients. In this regard, children, the elderly, debilitated individuals and patients at risk of hypokalaemia may need particular attention. Prompt corrective action should be taken to restore fluid/electrolyte balance in patients with signs or symptoms of hyponatraemia.
The period of bowel cleansing should not exceed 24 hrs because longer preparation may increase the risk of water and electrolyte imbalance.
Picoprep contains potassium 5 mmol (or 195 mg) per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Picoprep contains lactose as a component of the flavour. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Picoprep.
Picoprep should not be used as a routine laxative.
Effects on the Ability to Drive or Operate Machinery: Not applicable.
Use in pregnancy & lactation: For Picoprep, no clinical data on exposed pregnancy are available. Studies in animals have shown reproductive toxicity. As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of Picoprep during pregnancy.
There is no experience with the use of Picoprep in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with Picoprep may be considered for females who are breastfeeding.
Use In Pregnancy & Lactation
For Picoprep, no clinical data on exposed pregnancy are available. Studies in animals have shown reproductive toxicity. As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of Picoprep during pregnancy.
There is no experience with the use of Picoprep in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with Picoprep may be considered for females who are breastfeeding.
Adverse Reactions
Diarrhoea and faecal incontinence are the primary clinical effect of Picoprep. Isolated cases of severe diarrhoea have been reported post-marketing.
Hyponatraemia has been reported with or without associated convulsions. In epileptic patients, there have been isolated reports of seizure/grand mal convulsion without associated hyponatraemia. There have been isolated reports of anaphylactoid reaction.
The frequencies of the adverse reactions are based on post-marketing experience. (See table.)

Click on icon to see table/diagram/image
Drug Interactions
As a purgative, Picoprep increases the gastrointestinal transit rate. The absorption of other orally administered medicines (eg, antiepileptics, contraceptives, antidiabetics, antibiotics) may therefore be modified during the treatment period (see Precautions). Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hrs before and not <6 hrs after administration of Picoprep to avoid chelation with magnesium.
The efficacy of Picoprep is lowered by bulk-forming laxatives.
Care should be taken with patients already receiving drugs which may be associated with hypokalaemia (eg, diuretics or corticosteroids, or drugs where hypokalaemia is a particular risk ie, cardiac glycosides). Caution is also advised when Picoprep is used in patients on nonsteroidal anti-inflammatory drugs (NSAIDs) or drugs known to induce syndrome of inappropriate antidiuretic hormone secretion (SIADH) eg, tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.
Incompatibilities: Not applicable.
Storage
Store below 30°C. Protect from moisture.
Shelf-Life: 3 years. Once the sachet has been opened, use immediately and discard any unused powder or solution.
ATC Classification
A06AB58 - sodium picosulfate, combinations ; Belongs to the class of contact laxatives.
Presentation/Packing
Powd for oral soln (sachet, white crystalline powder) 2's.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in