SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID- sodium picosulfate, magnesium oxide and anhydrous citric acid pow

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

SODIUM PICOSULFATE (UNII: LR57574HN8) (DEACETYLBISACODYL - UNII:R09078E41Y), MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838), ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Disponibil de la:

Camber Pharmaceuticals, Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is contraindicated in the following conditions: • Patients with severe renal impairment (creatinine clearance less than 30 mL/minute) which may result in accumulation of magnesium  [see Warnings and Precautions ( 5.4)] • Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6)] • Bowel perforation [see Warnings and Precautions ( 5.6)] • Toxic colitis or toxic megacolon • Gastric retention • Hypersensitivity to any of the ingredients in sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution  [see Advers

Rezumat produs:

How Supplied Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid for Oral Solution is supplied in a carton containing 2 packets, each holding 16.1 grams of  powder in orange flavor, along with a pre-marked dosing cup. Each packet for orange flavor contains 10 mg of sodium picosulfate, 3.5 g of magnesium oxide and 12 g anhydrous citric acid. The excipients for orange flavor contains glyceryl behenate, orange flavor, potassium bicarbonate and saccharin sodium. The orange flavor contains dl-alpha-Tocopherol and maize maltodextrin. Orange flavor: Kit, 2 packets and cup                                                           NDC 31722-874-16 Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID -
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID POWDER,
METERED
CAMBER PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM PICOSULFATE,
MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID FOR ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SODIUM PICOSULFATE,
MAGNESIUM OXIDE
AND ANHYDROUS CITRIC ACID FOR ORAL SOLUTION.
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID FOR ORAL
SOLUTION
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral
solution is a combination of
sodium picosulfate, a stimulant laxative, and magnesium oxide and
anhydrous citric acid which form
magnesium citrate, an osmotic laxative, indicated for cleansing of the
colon as a preparation for
colonoscopy in adults and pediatric patients ages 9 years and older.
(1)
DOSAGE AND ADMINISTRATION
Preparation and Administration
• Each packet of sodium picosulfate, magnesium oxide and anhydrous
citric acid must be dissolved with
water prior to ingestion and administered according to the dosing
regimen. Direct ingestion of the
undissolved powder may increase the risk of nausea, vomiting and
dehydration. ( 2.2, 5.8)
• Two doses (one packet per dose) of sodium picosulfate, magnesium
oxide and anhydrous citric acid for
oral solution are required for a complete preparation for colonoscopy.
The preferred method is the “Split-
Dose” method. The alternative is the “Day Before” method. ( 2.1)
• Additional fluids must be consumed after every dose of sodium
picosulfate, magnesium oxide and
anhydrous citric acid for oral solution in both dosing regimens. (
2.1, 5.1)
• Do not take oral medications within 1 hour of start of each dose.
( 2.1, 7.2)
• If taking tetracycline or fluoroquinolone antibiotics, iron,
digoxin, chlorpromazine, or penicillamine, take
these medications at least 2 hours