MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
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
1 FDA approvalsOriginally approved for its first indication in 2011 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 2011)
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
Active Pipeline
Ongoing clinical trials by development phase
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
ProIndications & Usage
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.
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.