Monobasic Sodium Phosphate And Dibasic Sodium Phosphate Interactions

Brand names: Monobasic Sodium Phosphate And Dibasic Sodium Phosphate

Route: Oral

FDA Black Box 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 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

Contraindications

4 CONTRAINDICATIONS Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are contraindicated in the following conditions: History of acute phosphate nephropathy [see Warnings and Precautions (5.1) ] Gastrointestinal (GI) obstruction [see Warnings and Precautions (5.7) ] Gastric bypass or stapling surgery Bowel perforation Toxic colitis Toxic megacolon Hypersensitivity to sodium phosphate salts or any component of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Warnings and Precautions (5.7) ]. Biopsy-proven acute phosphate nephropathy ( 4 , 5.1 ) Gastrointestinal (GI) obstruction ( 4 , 5.7 ) Gastric bypass or stapling surgery ( 4 ) Bowel perforation ( 4 ) Toxic colitis ( 4 ) Toxic megacolon ( 4 ) Hypersensitivity to sodium phosphate salts or any components of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets ( 4 , 5.7 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no available data on sodium phosphate use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with sodium phosphate. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

1 interaction on record