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Picoprep

Picoprep

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per sachet Na picosulfate 10 mg, light Mg oxide 3.5 g, anhydrous citric acid 12 g
Indications/Uses
Cleanse the bowel prior to X-ray exam or endoscopy. Cleanse the bowel prior to surgery when judged clinically necessary.
Dosage/Direction for Use
Adult (including elderly) Split dosing regimen (evening before & day of the procedure) 1st sachet is taken the night before the procedure & 2nd is taken the next day, in the morning prior to procedure. On the day before the procedure: 1st reconstituted sachet in the late afternoon/evening (eg, 5:00-9:00 pm) followed by at least five 250 mL drinks of clear liqd, spread over several hr. On the day of the procedure: 2nd reconstituted sachet in the morning (5-9 hr before the procedure) followed by at least three 250 mL drinks of clear liqd, spread over several hr. Clear liqd may be consumed until 2 hr before the procedure. Day-before dosing regimen (evening before the procedure only) 1st sachet is taken in the afternoon or early evening & 2nd is taken approx 6 hr later, the night before the procedure. On the day before the procedure: 1st reconstituted sachet in the afternoon or early evening (eg, 4:00-6:00 pm) followed by at least five 250 mL drinks of clear liqd, spread over several hr. 2nd reconstituted sachet is taken in the late evening (eg, 10:00 pm-12:00 am) followed by at least three 250 mL drinks of clear liqd, spread over several hr. Clear liqd may be consumed until 2 hr before the procedure.
Administration
Should be taken on an empty stomach: Reconstitute 1 sachet in 1 cup of water (approx 150 mL) & stir for 2-3 min until soln becomes an off-white, cloudy liqd w/ faint orange odour. If soln is warm, let it cool before drinking. Reconstitute soln right before administration, do not prepare in advance. Take adequate amount of clear liqd (eg, soft drinks, clear soup, tea, coffee w/o milk/soy/cream, fruit juice w/o pulp & water).
Contraindications
Hypersensitivity. Congestive cardiac failure, gastric retention, GI ulceration, toxic colitis & megacolon, ileus, nausea & vomiting, acute surgical abdominal conditions (eg, acute appendicitis), known or suspected GI obstruction or perforation, severe dehydration, rhabdomyolysis, hypermagnesemia, active inflammatory bowel disease. Severely reduced renal function; Mg accumulation in plasma may occur.
Special Precautions
Carefully weigh possible benefits & needs depending on surgical procedures to be performed. Adequately hydrate before, during & after use. Debilitated patients, those w/ low body wt & at risk of hypokalaemia or hyponatremia; take prompt corrective action to restore fluid/electrolyte balance in patients w/ signs or symptoms of hypokalaemia or hyponatremia. Drinking only water to replace fluid loss may lead to electrolyte imbalance which may lead to complications (eg, seizures & coma) in severe cases; rarely, may cause severe/life-threatening electrolyte problems or impaired renal function in fragile or debilitated patients. Patients w/ recent GI surgery, renal impairment, heart disease or inflammatory bowel disease. Concomitant use w/ drugs that might affect water &/or electrolyte balance (eg, diuretics, corticosteroids, lithium). Patients on antiepileptics w/ previously controlled epilepsy. History of seizures or risk of seizure eg, co-medication w/ TCAs, alcohol or benzodiazepine w/drawal, known or suspected hyponatremia. Increased risk of arrhythmias (eg, history of prolonged QT, uncontrolled arrhythmias, recent MI, unstable angina, CHF or cardiomyopathy). Concurrent use w/ additional stimulant laxatives may increase risk of colonic mucosal aphthous ulcerations. Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients w/ known or suspected inflammatory bowel disease. Patients w/ impaired gag reflex & those prone to regurgitation or aspiration. Period of bowel cleansing should not be >24 hr. Contains K 5 mmol/sachet; patients w/ reduced kidney function or those on controlled K diet. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Not to be used as routine laxative. Avoid use during pregnancy. Lactation. Childn. Elderly.
Adverse Reactions
Hypermagnesaemia; headache; vomiting, nausea, abdominal pain.
Drug Interactions
May decrease absorption of antiepileptics, contraceptives, antidiabetics & antibiotics during treatment period. Tetracycline & fluoroquinolones, Fe, digoxin, chlorpromazine & penicillamine should be taken at least 2 hr before & not <6 hr after administration of Picoprep due to potential chelation w/ Mg. Reduced efficacy by bulk-forming laxatives; antibiotics. Concomitant use w/ medications that increase risk for fluid & electrolyte disturbances or seizure, arrhythmias & prolonged QT; w/ drugs associated w/ hypokalaemia (eg, diuretics or corticosteroids; cardiac glycosides). May increase risk of water retention &/or electrolyte imbalance w/ NSAIDs or SIADH-inducing drugs (eg, TCAs, SSRIs, antipsychotics & carbamazepine).
MIMS Class
Laxatives, Purgatives
ATC Classification
A06AB58 - sodium picosulfate, combinations ; Belongs to the class of contact laxatives.
Presentation/Packing
Form
Picoprep powd for oral soln
Packing/Price
2's
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