Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F) (SODIUM CATION - UNII:LYR4M0NH37)
Novel Laboratories, Inc.
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.105 g
ORAL
PRESCRIPTION DRUG
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. 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. Laxatives and purgatives (including monobasic sodium phosphate and dibasic sodium phosphate tablets) have the potential for abuse by bulimia nervosa patients who frequently have binge eating and vomiting.
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) Store at 25°C (77°F); excursions permitted to 15°-30° C (59°-86°F) [See USP Controlled Room Temperature]. Discard any unused portion. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873
Abbreviated New Drug Application
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE - MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLET Novel Laboratories, Inc. ---------- MEDGUIDE Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets Read the Medication Guide that comes with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets before you take it and each time you take it. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, ask your doctor or pharmacist. What is the most important information I should know about Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets? Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets can cause serious side effects, including: Serious kidney problems. Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, to clean your colon before a colonoscopy. These kidney problems can sometimes lead to kidney failure or the need for dialysis for a long time. These problems often happen within a few days, but sometimes may happen several months after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Conditions that can make you more at risk for having serious kidney problems with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets include if you: • lose too much body fluid (dehydration) • have slow moving bowels • have bowels blocked with stool (constipation) • have severe stomach pain or bloating • have any disease that causes bowel irritation (colitis) • have kidney disease • have heart failure • take water pills or non-steroidal anti-inflammatory drugs (NSAIDS). Your age may also affect your risk for having kidney problems with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Before you start taking Monobasic Sodium Lesen Sie das vollständige Dokument
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE - MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLET NOVEL LABORATORIES, INC. ---------- UNKNOWN TITLE Rx Only BOXED WARNING There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. 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 nonsteriodal anti-inflammatory drugs [NSAIDs]). _See _WARNINGS. It is important to use the dose and dosing regimen as recommended (pm/am split dose). _See_DOSAGE AND ADMINISTRATION. DESCRIPTION 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 Pho Lesen Sie das vollständige Dokument