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) (PHOSPHATE ION - UNII:NK08V8K8HR), SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) (PHOSPHATE ION - UNII:NK08V8K8HR)

Available from:

Salix Pharmaceuticals, Inc.

INN (International Name):

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Composition:

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.102 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OsmoPrep® is indicated for cleansing of the colon as a preparation for colonoscopy in adults. OsmoPrep is contraindicated in the following conditions: 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 determinat

Product summary:

OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) tablets are supplied as 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 1.5 gram tablet contains 1.102 grams of sodium phosphate monobasic monohydrate, USP and 0.398 grams of sodium phosphate dibasic anhydrous, USP. OsmoPrep is packaged in a multi-dose, child-resistant bottle containing 100 tablets: NDC 65649-701-41. 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:

New Drug Application

Patient Information leaflet

Salix Pharmaceuticals, Inc.
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Medication Guide
OsmoPrep® (AHHZ-MO-PREP)
(sodium phosphate monobasic monohydrate and sodium phosphate dibasic
anhydrous)
tablets
Read this Medication Guide before you start taking OsmoPrep. This
information does not take the place
of talking with your doctor about your medical condition or your
treatment.
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 the 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 a blockage in your intestine (bowel obstruction)
•
have any disease that causes bowel inflammation (colitis)
•
have kidney disease or kidney problems
•
have heart failure
•
take water pills, high blood pressure medicine, or nonsteroidal
anti-inflammatory drugs (NSAIDs)
Increased age may increase your risk for having serious kidney
problems with OsmoPrep.
Severe fluid loss (dehydration) and severe changes in body salts in
the blood (electrolytes). People who
take medicines to clean their colon before a colonoscopy, including
OsmoPrep, can have severe loss of
body fluid, with severe changes in body salts in the blood. These
changes can be serious and can cause:
•
abnormal heart rhythms
•
kidney problems
•
seizures. This can happen even if you have never had a seizure.
Tell your doctor if you have any of these symptoms of loss of too much
body fluid (dehydration) while
taking OsmoPrep:
•
vomiting
•
urinating less often than normal
•
dizziness
•
headache
See “W

Summary of Product characteristics

OSMOPREP- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE,
DIBASIC
ANHYDROUS TABLET
SALIX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OSMOPREP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OSMOPREP.
OSMOPREP (SODIUM PHOSPHATE MONOBASIC MONOHYDRATE AND SODIUM PHOSPHATE
DIBASIC ANHYDROUS) TABLETS,
FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
WARNING: ACUTE PHOSPHATE NEPHROPATHY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
OsmoPrep is an osmotic laxative indicated for cleansing of the colon
as a preparation for colonoscopy in adults. (1)
DOSAGE AND ADMINISTRATION
Important Administration Instructions:
•
•
•
Dosage Regimen (2.2)
The recommended adult dosage is 32 tablets taken orally with a total
of 2 quarts of clear liquids in the following manner:
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 1.5 g of sodium phosphate (3)
CONTRAINDICATIONS
•
•
•
•
•
RARE, SERIOUS REPORTS OF ACUTE PHOSPHATE NEPHROPATHY IN PATIENTS WHO
RECEIVED ORAL SODIUM
PHOSPHATE PRODUCTS, INCLUDING OSMOPREP, 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
OSMOPREP. AVOID ADDITIONAL
SODIUM PHOSPHATE-BASED PRODUCTS. (2.1, 2.2)
Warnings and Precautions (5.7) 11/2018
Two dos