Usual Adult Dose for Bowel Preparation

Oral tablets:
Evening before colonoscopy: 4 tablets (3 grams) with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets
Next morning (starting 3 to 5 hours before procedure): 4 tablets with 8 ounces of clear liquids every 15 minutes for a total of 12 tablets

Enema: 1 bottle, rectally

Comments:

• Examples of clear liquids include water, flavored water, lemonade (no pulp), ginger ale, and apple juice.
• Do not drink any liquids colored red or purple.
• Advise patients of the importance of taking the recommended fluid regimen.
• Advise patients to adequately hydrate before, during, and after using this drug.
• This regimen should not be repeated within 7 days of a previous administration.
• No additional enema or laxative is required; advise patients not to take additional agents, particularly those containing sodium phosphate.

Use(s): Cleansing of the colon as preparation for colonoscopy

Usual Adult Dose for Constipation

Enema: 1 bottle, rectally, once daily

Oral liquid: 1 tablespoon orally, diluted in 8 ounces of cool water, followed by at least one additional 8 ounce glass of water
Maximum dose: 2 or 3 tablespoons per 24 hours

Comments:

• There is significant loss of fluid with this product; to prevent dehydration, drink plenty of clear liquids after use.

Use(s): Relief of occasional constipation

Usual Pediatric Dose for Constipation

Adult Enema:
12 years and older: 1 bottle, rectally, once daily

• Use the children's enema for children under 12 years old

Children's Enema:
5 to 11 years: 1 bottle, rectally, once daily
2 to 5 years: One half of a bottle, rectally, once daily

• Not for use in children under 2 years old

Oral liquid:
12 years and older: 1 tablespoon orally, diluted in 8 ounces of cool water; maximum of 2 or 3 tablespoons per 24 hours
10 to 11 years: 1 tablespoon orally, diluted in 8 ounces of cool water; maximum of 1 tablespoon per 24 hours
5 to 9 years: One and a half TEASPOONs orally, diluted in 8 ounces of cool water; maximum of one and a half teaspoons per 24 hours

• Not for use in children under 5 years old.
• All doses should be followed by at least one additional 8 ounce glass of water

Comments:

• There is significant loss of fluid with this product; to prevent dehydration, drink plenty of clear liquids after use.

Use(s): Relief of occasional constipation

Renal Dose Adjustments

Use with caution.

• Since the inorganic form of phosphate is excreted almost entirely by the kidneys, patients with renal disease may have difficulty excreting a large phosphate load.
• Use with caution in impaired renal function (creatinine clearance under 30 mL/min), patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (e.g. dehydration), or with concomitant medications affecting electrolyte levels (e.g. diuretics).

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING(S):

• There have been rare but serious reports of acute phosphate nephropathy in patients receiving oral sodium phosphate products for colon cleansing prior to colonoscopy.
• Some cases have resulted in permanent renal function impairment and some patients required long-term dialysis.
• While some cases have occurred in patients without identifiable risk factors, patients at increased risk may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, baseline kidney disease, and those using medications that affect renal perfusion or function (e.g. diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).

Recommendation:

• It is important to use the dose and dosing regimen as recommended (PM/am split dose).

CONTRAINDICATIONS:

• Biopsy-proven acute phosphate nephropathy
• Gastrointestinal obstruction
• Gastric bypass or stapling surgery
• Bowel perforation
• Toxic colitis
• Toxic megacolon
• Hypersensitivity to any of the ingredients

Safety and efficacy have not been established in patients younger than 2 years.

• The manufacturer product information should be consulted, as not all formulations are approved for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Patient advice:

• Using more than one enema in 24 hours can be harmful.
• Taking more of this oral product than the recommended dose can be harmful.