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:

Novel Laboratories, Inc.

INN (International Name):

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Composition:

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.105 g

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 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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE - MONOBASIC
SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLET
Novel Laboratories, Inc.
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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

Summary of Product characteristics

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE - MONOBASIC
SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLET
NOVEL LABORATORIES, INC.
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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