- Approval Id
- 07b2f3a9cc04e8a9
- Drug Name
- PICO-SWIFT POWDER FOR ORAL SOLUTION
- Product Name
- PICO-SWIFT POWDER FOR ORAL SOLUTION
- Approval Number
- SIN17163P
- Approval Date
- 2025-01-16
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- POWDER, FOR SOLUTION
- Dosage
- <p><strong>POSOLOGY AND METHOD OF ADMINISTRATION</strong><br>
<strong><u>Method of administration</u></strong><br>
Route of administration: Oral</p>
<p>A low residue diet is recommended on the day prior to the hospital procedure. A clear liquid diet is recommended on the day of the procedure. To avoid dehydration it is important to follow the liquid intake recommendation as advocated together with the PICO-SWIFT dosing whilst the effects of PICO-SWIFT persist (see section Posology). Apart from the liquid intake together with the treatment regimen (PICO-SWIFT + additional liquids), a normal, thirst driven intake of clear liquids is recommended.</p>
<p>Clear liquids should include a variety of fruit juice without pulp, soft drinks, clear soup, tea, coffee (without milk, soy or cream) and water. Do not drink only water.</p>
<p><strong><u>Posology</u></strong><br>
<u>Directions for reconstitution:</u><br>
Reconstitute the Sodium Picosulfate powder right before each administration. Do not prepare the solution in advance. Reconstitute the contents of one sachet in a cup of water (approximately 150ml). Stir for 2–3 minutes, the solution should now become an off-white, cloudy liquid with a faint odour of orange. Drink the solution. If it becomes warm, wait until it cools sufficiently to drink.</p>
<p><u>Adults (including the elderly):</u><br>
(if the procedure is scheduled for the afternoon, it is recommended that the Split-Dose regimen should be used):</p>
<p><strong>Split-Dose Regimen (evening-before and day of the procedure)</strong><br>
The first PICO-SWIFT sachet is taken the night before the procedure, and the second is taken the next day, in the morning prior to the procedure.<br>
<em>On the day before the procedure – 1 sachet:</em></p>
<ul>
<li>The first reconstituted sachet is taken in the evening (e.g. 5:00 to 9:00 PM), followed by at least five 250 ml drinks of clear liquids, spread over several hours.</li>
</ul>
<p><em>On the day of the procedure – 1 sachet:</em></p>
<ul>
<li>The second reconstituted sachet is taken in the morning (5–9 hours before the procedure), followed by at least three 250 ml drinks of clear liquids, spread over several hours.</li>
<li>Clear liquids may be consumed until 2 hours before the time of the procedure.</li>
</ul>
<p>or</p>
<p><strong>Day-Before Regimen (evening-before the procedure only)</strong><br>
The first PICO-SWIFT sachet is taken in the afternoon or early evening and the second is taken approximately 6 hours later, the night before the procedure.<br>
<em>On the day before the procedure – 2 sachets:</em></p>
<ul>
<li>The first reconstituted sachet is taken in the afternoon or early evening (e.g. 4:00 to 6:00PM), followed by at least five 250 ml drinks of clear liquids, spread over several hours.</li>
<li>The second reconstituted sachet is taken in the late evening (e.g., 10:00PM to 12:00AM), followed by at least three 250 ml drinks of clear liquids, spread over several hours.</li>
<li>Clear liquids may be consumed until 2 hours before the time of the procedure.</li>
</ul>
<p><u>Paediatric population</u>:<br>
The safety and efficacy of Sodium picosulfate in paediatric patients has not been established.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>THERAPEUTIC INDICATIONS</strong><br>
To clean the bowel prior to X-ray examination or endoscopy.<br>
To clean the bowel prior to surgery when judged clinically necessary (see section Special Warnings and Precautions for Use regarding open colorectal surgery – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<ul class="dash">
<li>Hypersensitivity to any of the ingredients of the product</li>
<li>Congestive cardiac failure</li>
<li>Gastric retention</li>
<li>Gastro-intestinal ulceration</li>
<li>Toxic colitis</li>
<li>Toxic megacolon</li>
<li>Ileus</li>
<li>Nausea and vomiting</li>
<li>Acute surgical abdominal conditions such as acute appendicitis</li>
<li>Known or suspected gastro-intestinal obstruction or perforation.</li>
<li>Severe dehydration</li>
<li>Rhabdomyolysis</li>
<li>Hypermagnesemia</li>
<li>Active inflammatory bowel disease</li>
<li>In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.</li>
</ul>
- Atc Code
- A06AB58
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
