MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE (sodium phosphate, dibasic, anhydrous)
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate tablets are used for cleansing the colon in adults who are preparing for a colonoscopy. This medication helps patients by clearing the bowel to ensure the area is ready for a medical examination. It acts as an osmotic laxative to facilitate the necessary preparation required before the procedure.
How MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE Works
This medication works by using the osmotic effect of sodium to increase water retention within the colon. This physiological process results in loose stools, which helps clear the digestive tract.
Details
- Status
- Prescription
- First Approved
- 2011-12-30
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE Approval History
What MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE Treats
2 indicationsMONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Colon cleansing
- Colonoscopy preparation
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE Boxed Warning
BOXED WARNING WARNING: ACUTE PHOSPHATE NEPHROPATHY There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis [see Warnings and Precautions ( 5.1 )] . While some cases have occurred in patients witho...
BOXED WARNING WARNING: ACUTE PHOSPHATE NEPHROPATHY There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis [see Warnings and Precautions ( 5.1 )] . While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions ( 5.1 )]. Advise patients of the importance of following the recommended split dosage regimen and the importance of adequate hydration before, during and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Avoid additional sodium phosphate- based purgative or enema products [see Dosage and Administration ( 2.1 , 2.2 )] . WARNING: ACUTE PHOSPHATE NEPHROPATHY See full prescribing information for complete boxed warning. Rare, serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. ( 5.1 ) Patients at increased risk include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medic
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE FDA Label Details
Indications & Usage
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE is indicated for the treatment of Colon cleansing; Colonoscopy preparation.
BOXED WARNING WARNING: ACUTE PHOSPHATE NEPHROPATHY There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, for colon cleansing prior to colonoscopy. So...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.