Picosulfuric acid

Overview

Picosulfuric acid is found in laxative products. Sodium picosulfate is a used to treat constipation or induce colon cleansing to prepare the large bowels before colonoscopy or surgery. The combination product containing sodium picosulfate and magnesium citrate was introduced to the Canadian market in 2005 and has been used in European countries for many years.

Indication

Sodium picosulfate, in combination with magnesium oxide and anhydrous citric acid, is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients ages 9 years and older.

Associated Conditions

Constipation

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Lubiprostone for Functional Constipation in the Under 18 Years Patients	2021/12/03	NCT05144295	Phase 3	Completed	Alexandria University
Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery	2020/10/20	NCT04593446	Phase 2	UNKNOWN	National Cancer Center, Korea
Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy	2019/11/06	NCT04153084	N/A	UNKNOWN	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Comparison of Different Low Volume Solutions Prior to Colonoscopy	2018/10/09	NCT03698474	Phase 4	Completed	Tomas Bata Hospital, Czech Republic
Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-endoscopy Bowel Preparation	2017/03/08	NCT03074448	Phase 3	Completed	Kaiser Clinic and Hospital
Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation	2016/12/01	NCT02979223	Phase 2	Completed	National Cancer Center, Korea
Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy	2016/11/04	NCT02956057	Phase 4	Completed	Tomas Bata Hospital, Czech Republic
Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females	2014/08/08	NCT02211911	Phase 1	Completed	Boehringer Ingelheim
Preparation Prior to Colonoscopy in Children	2013/12/11	NCT02009202	Not Applicable	Completed	Skane University Hospital
A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy	2013/11/14	NCT01984008	Phase 3	Completed	Universal Integrated Corp.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CLENPIQ	Ferring Pharmaceuticals Inc.	55566-6800	ORAL	10 mg in 175 mL	8/31/2023
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	Camber Pharmaceuticals, Inc.	31722-874	ORAL	10 mg in 16.1 g	8/11/2022
CLENPIQ	Ferring Pharmaceuticals Inc.	55566-6700	ORAL	10 mg in 160 mL	10/31/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
PICOPREP Powder for Oral Solution	Ferring Pharmaceuticals (China) Co., Ltd.	SIN14303P	POWDER, FOR SOLUTION	10 mg	1/30/2013
PICO-SWIFT POWDER FOR ORAL SOLUTION	IND-SWIFT LIMITED	SIN17163P	POWDER, FOR SOLUTION	10 mg	1/16/2025

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
APOHEALTH Picosulfate Prep powder for oral solution	405192	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/21/2023
DULCOLAX SP DROPS 7.5mg/mL sodium picosulfate oral liquid bottle	133243	Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare	Medicine	A	11/27/2006
PICOSALAX powder for oral administration	138775	Ferring Pharmaceuticals Pty Ltd	Medicine	A	5/15/2007
Dendy Picolax Oral Powder	54113	Dendy Pharmaceuticals Pty Ltd	Medicine	A	12/12/1995
PREPKIT ORANGE powder for oral liquid sachet composite pack	370153	Fresenius Kabi Australia Pty Ltd	Medicine	A	6/24/2021
PICOTOL Sodium Picosulfate Effervescent Powder for Oral Liquid sachet	228217	Mega Lifesciences (Australia) Pty Ltd	Medicine	A	9/19/2014
NEO PICO ORAL DROPS sodium picosulfate 7.5 mg/mL oral liquid bottle	355352	Neo Health (OTC) Pty Ltd	Medicine	A	2/22/2021
CONSTILIEVE ORAL DROPS sodium picosulfate 7.5 mg/mL oral liquid bottle	468050	Neo Health (OTC) Pty Ltd	Medicine	A	11/11/2024
PICOPREP ORANGE powder for oral liquid sachet	363537	Fresenius Kabi Australia Pty Ltd	Medicine	A	4/28/2021
Chemists' Own Picosulfate Prep powder for oral solution	405094	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/20/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ORAL PURGATIVE	odan laboratories ltd	02370271	Powder For Solution - Oral	10 MG / PCK	11/16/2011
CITRACLEEN	laboratorios casen-fleet, s.l.u.	02437880	Powder For Solution - Oral	10 MG / 15.08 G	N/A
PURG-ODAN	odan laboratories ltd	02317966	Powder For Solution - Oral	10 MG / SACHET	2/16/2009
PICO-SALAX	Ferring Inc	02254794	Powder For Solution - Oral	10 MG / SACHET	11/25/2004
PICOFLO	Pharmascience Inc	02358298	Powder For Solution - Oral	10 MG / SACHET	3/25/2011
PICODAN	odan laboratories ltd	02300583	Powder For Solution - Oral	10 MG / PCK	10/17/2007

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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