OSMOPREP- sodium phosphate, monobasic, monohydrate, sodium phosphate, dibasic anhydrous 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:

Physicians Total Care, Inc.

INN (International Name):

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Composition:

SODIUM CATION 1.102 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. OsmoPrep Tablets are contraindicated in patients with biopsy-proven acute phosphate nephropathy. OsmoPrep Tablets are contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients. Laxatives and purgatives (including OsmoPrep) have the potential for abuse by bulimia nervosa patients who frequently have binge eating and vomiting.

Product summary:

OsmoPrep Tablets are supplied in child-resistant bottles containing 32 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet. Rx only. 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: WellSpring Pharmaceutical Canada Corp. Oakville, Ontario Canada L6H 1M5 for: Salix Pharmaceuticals, Inc. Morrisville, NC 27560 Made in Canada VENART-30-4/Mar. 2009 Product protected by US Patent No. 5,616,346 and other pending applications. Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK     74146

Authorization status:

New Drug Application

Patient Information leaflet

Physicians Total Care, Inc.
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Medication Guide
OsmoPrep® (AhZ-MŌ-prěp) (sodium phosphate monobasic monohydrate,
USP and sodium phosphate
dibasic anhydrous, USP) Tablets
Read the Medication Guide that comes with OsmoPrep 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 OsmoPrep, ask your
doctor or pharmacist.
What is the most important information I should know about OsmoPrep?
OsmoPrep 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 OsmoPrep, to clean your colon
before 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
OsmoPrep.
Conditions that can make you more at risk for having serious kidney
problems with OsmoPrep 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
OsmoPrep.
Before you start taking OsmoPrep tell your doctor if you:
•
have kidney problems.
•
take any medicines for blood pressure, heart disease, or kidney
disease.
Severe fluid loss. People who take medicines that contain sodium
phosphate can have severe loss of body
fluid, with severe changes in body salts in the blood, and abnormal
heart rhythms. These problems can
lead to death.
Tell your doctor if you have any of these symptoms of loss of too much
body fluid (dehydration) while
taking OsmoPrep:
•
vomiting
•
dizziness
•

Summary of Product characteristics

OSMOPREP - SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE,
DIBASIC
ANHYDROUS TABLET
PHYSICIANS TOTAL CARE, INC.
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WARNINGS
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
OsmoPrep
(sodium phosphate monobasic monohydrate, USP, and sodium phosphate
dibasic
anhydrous, USP) is a purgative used to clean the colon prior to
colonoscopy. OsmoPrep is
manufactured with a highly soluble tablet binder and does not contain
microcrystalline cellulose (MCC).
OsmoPrep Tablets are oval, white to off-white compressed tablets,
debossed with “SLX” on one side
of the bisect and “102” on the other side of the bisect. Each
OsmoPrep tablet contains 1.102 grams of
sodium phosphate monobasic monohydrate, USP and 0.398 grams of sodium
phosphate dibasic
anhydrous, USP for a total of 1.5 grams of sodium phosphate per
tablet. Inert ingredients include
polyethylene glycol 8000, NF; and magnesium stearate, NF. OsmoPrep is
gluten-free.
The structural and molecular formulae and molecular weights of the
active ingredients are shown
below:
Sodium phosphate monobasic monohydrate, USP
Molecular Formula: NaH PO • H O
Molecular Weigh