Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
Generic: MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
Basic Information
Manufacturer
Lupin Pharmaceuticals,Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
e2fcc382-6fac-4438-ad02-ebc8528dd59a
Indications & Usage
1 INDICATIONS AND 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.
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.
Adverse Reactions
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders [see Warnings and Precautions (5.1) ] Cardiac Arrhythmias [see Warnings and Precautions (5.2) ] Seizures [see Warnings and Precautions (5.3) ] Use in Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.4) ] Colonic Mucosal Ulceration and Inflammatory Bowel Disease [see Warnings and Precautions (5.5) ] Aspiration [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥3%) are: bloating, nausea, abdominal pain, and vomiting.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals Inc.
at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets was evaluated in two randomized, investigator-blinded, active controlled trials in 931 adult patients undergoing elective colonoscopy.
The mean age of the study population was 60 years (range 20 to 89 years), 88% of patients were Caucasian and 55% were female [see Clinical Studies (14) ] .
Table 1 shows the most common adverse reactions reported in greater than 3% of patients by treatment group in Study 1 [see Clinical Studies (14) ].
Since diarrhea was considered as a part of the efficacy of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, diarrhea was not defined as an adverse event in this clinical trial.
1 Reported in more than 3% of patients in at least one treatment group 2 Another oral formulation of monobasic sodium phosphate and dibasic sodium phosphate Table 1: Common Adverse Reactions 1 in Patients Undergoing Colonoscopy in Study 1 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 32 tabs (48 g) N=272 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 40 tabs (60 g) N=265 Sodium Phosphate2 40 tabs (60 g) N=268 Bloating 31% 39% 41% Nausea 26% 37% 30% Abdominal Pain 23% 24% 25% Vomiting 4% 10% 9% Electrolyte Abnormalities in Study 1 Hyperphosphatemia A total of, 96%, 96%, and 93% of patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, respectively, developed hyperphosphatemia (defined as phosphate level > 5.1 mg/dL) on the day of the colonoscopy.
In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets had baseline mean phosphate levels of 3.5, 3.5, and 3.6 mg/dL and subsequently developed mean phosphate levels of 7.6, 7.9, and 7.1 mg/dL, respectively, on the day of the colonoscopy.
Hyperkalemia A total of 20%, 22%, and 18% of patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, respectively, developed hypokalemia (defined as a potassium level < 3.4 mEq/L) on the day of the colonoscopy.
In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets all had baseline potassium levels of about 4.3 mEq/L and then developed a mean potassium level of 3.7 mEq/L on the day of the colonoscopy.
Several patients on all three sodium phosphate regimens developed hypocalcemia and hypernatremia that did not require treatment.
The Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage regimen was associated with an increased risk of adverse reactions compared to the 48- gram dosage regimen and a similar overall response rate [see Clinical Studies (14) ] .
Therefore, the Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage is not a recommended regimen [see Dosage and Administration (2.2) ].
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity reactions : anaphylaxis, angioedema (swelling of the lips, tongue and face), rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, and paresthesia.
Cardiovascular: Arrhythmias Nervous system: Seizures Renal: Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals Inc.
at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets was evaluated in two randomized, investigator-blinded, active controlled trials in 931 adult patients undergoing elective colonoscopy.
The mean age of the study population was 60 years (range 20 to 89 years), 88% of patients were Caucasian and 55% were female [see Clinical Studies (14) ] .
Table 1 shows the most common adverse reactions reported in greater than 3% of patients by treatment group in Study 1 [see Clinical Studies (14) ].
Since diarrhea was considered as a part of the efficacy of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, diarrhea was not defined as an adverse event in this clinical trial.
1 Reported in more than 3% of patients in at least one treatment group 2 Another oral formulation of monobasic sodium phosphate and dibasic sodium phosphate Table 1: Common Adverse Reactions 1 in Patients Undergoing Colonoscopy in Study 1 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 32 tabs (48 g) N=272 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 40 tabs (60 g) N=265 Sodium Phosphate2 40 tabs (60 g) N=268 Bloating 31% 39% 41% Nausea 26% 37% 30% Abdominal Pain 23% 24% 25% Vomiting 4% 10% 9% Electrolyte Abnormalities in Study 1 Hyperphosphatemia A total of, 96%, 96%, and 93% of patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, respectively, developed hyperphosphatemia (defined as phosphate level > 5.1 mg/dL) on the day of the colonoscopy.
In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets had baseline mean phosphate levels of 3.5, 3.5, and 3.6 mg/dL and subsequently developed mean phosphate levels of 7.6, 7.9, and 7.1 mg/dL, respectively, on the day of the colonoscopy.
Hyperkalemia A total of 20%, 22%, and 18% of patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, respectively, developed hypokalemia (defined as a potassium level < 3.4 mEq/L) on the day of the colonoscopy.
In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets all had baseline potassium levels of about 4.3 mEq/L and then developed a mean potassium level of 3.7 mEq/L on the day of the colonoscopy.
Several patients on all three sodium phosphate regimens developed hypocalcemia and hypernatremia that did not require treatment.
The Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage regimen was associated with an increased risk of adverse reactions compared to the 48- gram dosage regimen and a similar overall response rate [see Clinical Studies (14) ] .
Therefore, the Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage is not a recommended regimen [see Dosage and Administration (2.2) ].
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity reactions : anaphylaxis, angioedema (swelling of the lips, tongue and face), rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, and paresthesia.
Cardiovascular: Arrhythmias Nervous system: Seizures Renal: Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis.