MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) (SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Lupin Pharmaceuticals,Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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)]. 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. Risk Summary There are no data available to assess the presence of sodium phosphate in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets and any potential adverse effects on the breastfed child from Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Of the 599 patients in clinical trials receiving at least 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, 134 (22%) were 65 years of age or older, while 27 (5%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients. However, the mean phosphate levels in geriatric patients were greater than the phosphate levels in younger patients after Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets administration. The mean colonoscopy-day phosphate levels in patients 18-64, 65-74, and ≥ 75 years old who received the recommended Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets dosage regimen in Study 1were 7.0, 7.3, and 8.0 mg/dL, respectively. After Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets administration, the mean phosphate levels in patients 18-64, 65-74, and ≥ 75 years old were 7.4, 7.9, and 8.0 mg/dL, respectively. Greater sensitivity of some older individuals cannot be ruled out; therefore, use Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with caution in geriatric patients. Advise geriatric patients to adequately hydrate before, during, and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. Since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients [see Warnings and Precautions (5.1)]. Sodium phosphate is substantially excreted by the kidney. Use Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with caution in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients [see Warnings and Precautions (5.1), Drug Interactions (7.1)] .

Product summary:

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are white to off-white uncoated tablet, modified oval shaped, biconvex, bisect on one side and plain on the other. Debossed "N" on the left side of the 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, NF; and magnesium stearate, NF. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets is packaged in a multi-dose, child-resistant bottle containing 100 tablets: NDC 43386-030-01. Each bottle contains two silica desiccant packets, which should not be ingested. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard any unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE -
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLET
LUPIN PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONOBASIC SODIUM
PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR MONOBASIC SODIUM PHOSPHATE AND DIBASIC
SODIUM
PHOSPHATE TABLETS
MONOBASIC SODIUM
PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL:2006
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 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])_. _(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 PRODUCTS. (2.1,2.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.7) 11/2018
INDICATIONS AND USAGE
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.
(1)
DOSAGE AND ADMINISTRATION
Important Administration Instructions:
Two doses of Monobasi