Monobasic Sodium Phosphate and Dibasic Sodium Phosphate

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Overview

What is Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet is a purgative used to clean the colon prior to colonoscopy. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are manufactured with a highly soluble tablet binder and does not contain microcrystalline cellulose (MCC). Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are white to off-white modified oval shaped, biconvex, bisect on one side and plain on the other debossed “N” on the left side of bisect and “03” on the right side of the bisect. Each Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet contains 1.102 grams of monobasic sodium phosphate, USP and 0.398 grams of dibasic sodium phosphate, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000; and magnesium stearate. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet is gluten-free.

The structural and molecular formulae and molecular weights of the active ingredients are shown below:

Monobasic sodium phosphate, USP

Molecular Formula: NaHPO• HO

Molecular Weight: 137.99

Dibasic sodium phosphate, USP

Molecular Formula: NaHPO

Molecular Weight: 141.96

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are for oral administration only.

What does Monobasic Sodium Phosphate and Dibasic Sodium Phosphate look like?

What are the available doses of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

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What should I talk to my health care provider before I take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

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How should I use Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

The recommended dose of monobasic sodium phosphate and dibasic sodium phosphate tablets for colon cleansing for adult patients is 32 tablets (48 grams of sodium phosphate) taken orally with a total of 2 quarts of clear liquids in the following manner:

Patients should be advised of the importance of taking the recommended fluid regimen. It is recommended that patients receiving monobasic sodium phosphate and dibasic sodium phosphate tablets be advised to adequately hydrate before, during, and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets.

Patients should not use monobasic sodium phosphate and dibasic sodium phosphate tablets for colon cleansing within seven days of previous administration. No additional enema or laxative is required, and patients should be advised NOT to take additional agents, particularly those containing sodium phosphate.

What interacts with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

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What are the warnings of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

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What are the precautions of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

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What are the side effects of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

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What should I look out for while using Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

Monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in patients with biopsy-proven acute phosphate nephropathy.

Monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients.

Administration of sodium phosphate products prior to colonoscopy for colon cleansing has resulted in fatalities due to significant fluid shifts, severe electrolyte abnormalities, and cardiac arrhythmias. These fatalities have been observed in patients with renal insufficiency, in patients with bowel perforation, and in patients who misused or overdosed sodium phosphate products. It is recommended that patients receiving monobasic sodium phosphate and dibasic sodium phosphate tablets be advised to adequately hydrate before, during, and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets.

Considerable caution should be advised before monobasic sodium phosphate and dibasic sodium phosphate tablets are used in patients with the following illnesses: severe renal insufficiency (creatinine clearance less than 30 mL/minute), congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute bowel obstruction, pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome.

Consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in patients who may be at increased risk for serious adverse events, including those with history of renal insufficiency, history of-or at greater risk of-acute phosphate nephropathy, known or suspected electrolyte disorders, seizures, arrhythmias, cardiomyopathy, prolonged QT, recent history of a MI and those with known or suspected hyperphosphatemia, hypocalcemia, hypokalemia, and hypernatremia. Also if patients develop vomiting and/or signs of dehydration then measure post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN).

Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders

There have been rare, but serious, reports of renal failure, acute phosphate nephropathy, and nephrocalcinosis in patients who received oral sodium phosphate products (including oral sodium phosphate solutions and tablets) for colon cleansing prior to colonoscopy. These cases often resulted in permanent impairment of renal function and several patients required long-term dialysis. The time to onset is typically within days; however, in some cases, the diagnosis of these events has been delayed up to several months after the ingestion of these products. Patients at increased risk of acute phosphate nephropathy may include patients with the following: hypovolemia, baseline kidney disease, increased age, and patients using medicines that affect renal perfusion or function [such as diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs (NSAIDs).

Use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in patients with impaired renal function, patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking concomitant medications that may affect electrolyte levels (such as diuretics). Patients with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with monobasic sodium phosphate and dibasic sodium phosphate tablets.

Seizures

There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of sodium phosphate products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Monobasic sodium phosphate and dibasic sodium phosphate tablets should be used with caution in patients with a history of seizures and in patients at higher risk of seizure [patients using concomitant medications that lower the seizure threshold (such as tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia].

Cardiac Arrhythmias

There have been rare, but serious, reports of arrhythmias associated with the use of sodium phosphate products. Monobasic sodium phosphate and dibasic sodium phosphate tablets should be used with caution in patients with higher risk of arrhythmias (patients with a history of cardiomyopathy, patients with prolonged QT, patients with a history of uncontrolled arrhythmias, and patients with a recent history of a myocardial infarction). Pre-dose and post-colonoscopy ECGs should be considered in patients with high risk of serious, cardiac arrhythmias.

What might happen if I take too much Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

There have been no reported cases of overdosage with monobasic sodium phosphate and dibasic sodium phosphate tablets. Purposeful or accidental ingestion of more than the recommended dosage of monobasic sodium phosphate and dibasic sodium phosphate tablets might be expected to lead to severe electrolyte disturbances, including hyperphosphatemia, hypocalcemia, hypernatremia, or hypokalemia, as well as dehydration and hypovolemia, with attendant signs and symptoms of these disturbances. Certain severe electrolyte disturbances resulting from overdose may lead to cardiac arrhythmias, seizure, renal failure, and death. The patient who has taken an overdosage should be monitored carefully, and treated symptomatically for complications until stable.

How should I store and handle Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?

StorageStore at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature].StorageStore at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature].Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are supplied in child-resistant bottles containing 100 tablets. Each tablet contains 1.102 g monobasic sodium phosphate, USP and 0.398 g dibasic sodium phosphate, USP for a total of 1.5 g of sodium phosphate per tablet. Each bottle contains two silica desiccant packets, which should not be ingested.NDC 40032-030-24 (100 tablets)Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are supplied in child-resistant bottles containing 100 tablets. Each tablet contains 1.102 g monobasic sodium phosphate, USP and 0.398 g dibasic sodium phosphate, USP for a total of 1.5 g of sodium phosphate per tablet. Each bottle contains two silica desiccant packets, which should not be ingested.NDC 40032-030-24 (100 tablets)

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Monobasic sodium phosphate and dibasic sodium phosphate tablets, a dosing regimen containing 48 grams of sodium phosphate (32 tablets), induces diarrhea, which effectively cleanses the entire colon. Each administration has a purgative effect for approximately 1 to 3 hours. The primary mode of action is thought to be through the osmotic effect of sodium, causing large amounts of water to be drawn into the colon, promoting evacuation.

Non-Clinical Toxicology

Monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in patients with biopsy-proven acute phosphate nephropathy.

Monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients.

Administration of sodium phosphate products prior to colonoscopy for colon cleansing has resulted in fatalities due to significant fluid shifts, severe electrolyte abnormalities, and cardiac arrhythmias. These fatalities have been observed in patients with renal insufficiency, in patients with bowel perforation, and in patients who misused or overdosed sodium phosphate products. It is recommended that patients receiving monobasic sodium phosphate and dibasic sodium phosphate tablets be advised to adequately hydrate before, during, and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets.

Considerable caution should be advised before monobasic sodium phosphate and dibasic sodium phosphate tablets are used in patients with the following illnesses: severe renal insufficiency (creatinine clearance less than 30 mL/minute), congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute bowel obstruction, pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome.

Consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in patients who may be at increased risk for serious adverse events, including those with history of renal insufficiency, history of-or at greater risk of-acute phosphate nephropathy, known or suspected electrolyte disorders, seizures, arrhythmias, cardiomyopathy, prolonged QT, recent history of a MI and those with known or suspected hyperphosphatemia, hypocalcemia, hypokalemia, and hypernatremia. Also if patients develop vomiting and/or signs of dehydration then measure post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN).

Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders

There have been rare, but serious, reports of renal failure, acute phosphate nephropathy, and nephrocalcinosis in patients who received oral sodium phosphate products (including oral sodium phosphate solutions and tablets) for colon cleansing prior to colonoscopy. These cases often resulted in permanent impairment of renal function and several patients required long-term dialysis. The time to onset is typically within days; however, in some cases, the diagnosis of these events has been delayed up to several months after the ingestion of these products. Patients at increased risk of acute phosphate nephropathy may include patients with the following: hypovolemia, baseline kidney disease, increased age, and patients using medicines that affect renal perfusion or function [such as diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs (NSAIDs).

Use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in patients with impaired renal function, patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking concomitant medications that may affect electrolyte levels (such as diuretics). Patients with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with monobasic sodium phosphate and dibasic sodium phosphate tablets.

Seizures

There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of sodium phosphate products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Monobasic sodium phosphate and dibasic sodium phosphate tablets should be used with caution in patients with a history of seizures and in patients at higher risk of seizure [patients using concomitant medications that lower the seizure threshold (such as tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia].

Cardiac Arrhythmias

There have been rare, but serious, reports of arrhythmias associated with the use of sodium phosphate products. Monobasic sodium phosphate and dibasic sodium phosphate tablets should be used with caution in patients with higher risk of arrhythmias (patients with a history of cardiomyopathy, patients with prolonged QT, patients with a history of uncontrolled arrhythmias, and patients with a recent history of a myocardial infarction). Pre-dose and post-colonoscopy ECGs should be considered in patients with high risk of serious, cardiac arrhythmias.

When given concurrently the following drugs may interact with thiazide diuretics.

Alcohol, barbiturates, or narcotics

Antidiabetic drugs

Other antihypertensive drugs

Cholestyramine and colestipol resins

Corticosteroids, ACTH

Pressor amines (e.g., norepinephrine)

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)

Lithium

Non-steroidal Anti-inflammatory Drugs

Patients should be instructed to drink 8 ounces of clear liquids with each 4-tablet dose of monobasic sodium phosphate and dibasic sodium phosphate tablets. Patients should take a total of 2 quarts of clear liquids with monobasic sodium phosphate and dibasic sodium phosphate tablets. Inadequate fluid intake, as with any effective purgative, may lead to excessive fluid loss, hypovolemia, and dehydration. Dehydration from purgation may be exacerbated by inadequate oral fluid intake, vomiting, and/or use of diuretics.

Patients should be instructed not to administer additional laxative or purgative agents, particularly additional sodium phosphate-based purgative or enema products.

Prolongation of the QT interval has been observed in some patients who were dosed with sodium phosphate colon preparations. QT prolongation with sodium phosphate tablets has been associated with electrolyte imbalances, such as hypokalemia and hypocalcemia. Monobasic sodium phosphate and dibasic sodium phosphate tablets should be used with caution in patients who are taking medications known to prolong the QT interval, since serious complications may occur. Pre-dose and post-colonoscopy ECGs should be considered in patients with known prolonged QT.

Administration of monobasic sodium phosphate and dibasic sodium phosphate tablets may induce colonic mucosal aphthous ulcerations, since this endoscopic finding was observed with other sodium phosphate cathartic preparations. In the monobasic sodium phosphate and dibasic sodium phosphate tablets clinical program, aphthous ulcers were observed in 3% of patients who took the 48 gram monobasic sodium phosphate and dibasic sodium phosphate tablets dosing regimen. This colonoscopic finding should be considered in patients with known or suspected inflammatory bowel disease.

Because published data suggest that sodium phosphate absorption may be enhanced in patients experiencing an acute exacerbation of chronic inflammatory bowel disease, monobasic sodium phosphate and dibasic sodium phosphate tablets should be used with caution in such patients.

Abdominal bloating, abdominal pain, nausea, and vomiting were the most common adverse events reported with the use of monobasic sodium phosphate and dibasic sodium phosphate tablets. Dizziness and headache were reported less frequently. 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 the clinical studies. Table 2 shows the most common adverse events associated with the use of 48 grams of monobasic sodium phosphate and dibasic sodium phosphate tablets, 60 grams of monobasic sodium phosphate and dibasic sodium phosphate tablets, and 60 grams of Visicol in the colon preparation trials (n=931).

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following adverse events have been identified during post-approval use of monobasic sodium phosphate and dibasic sodium phosphate tablets. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to monobasic sodium phosphate and dibasic sodium phosphate tablets, or a combination of these factors.

General:

Hypersensitivity reactions including anaphylaxis, rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, paresthesia and swelling of the lips and tongue, and facial swelling.

Cardiovascular:

Nervous System:

Renal:

Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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