Fleet (Sodium Phosphates)

FLEET® PHOSPHO®-SODA

Johnson & Johnson• Merck

Sodium Phosphates

Laxative

Action And Clinical Pharmacology: Depending on dosage, sodium phosphates oral solution is useful as a laxative in the relief of constipation, or as a bowel evacuant for a variety of diagnostic, surgical and therapeutic indications. Dibasic sodium phosphate and monobasic sodium phosphate are poorly absorbed from the gastrointestinal tract and retain water in the lumen of the intestine. When administered orally, they produce a bowel movement in 0.5 to 6 hours, depending on dosage.

Indications And Clinical Uses: As a laxative, for the relief of occasional constipation. As a purgative, for use as part of a bowel cleansing regimen in preparing the patient for surgery or for preparing the colon for x-ray or endoscopic examination.

Contra-Indications: Do not use this product in patients who have kidney disease or are on a sodium-restricted diet, unless directed by a physician.

Manufacturers’ Warnings In Clinical States: Do not exceed recommended dose unless directed by a physician. Serious side effects may occur from excessive dosage.

Do not use in patients with congenital megacolon or congestive heart failure, as hypernatremic dehydration may occur. Use with caution in patients with impaired renal function as hypocalcemia, hyperphosphatemia, hypernatremia and acidosis may occur.

Since Fleet Phospho-Soda contains dibasic sodium phosphate and monobasic sodium phosphate, there is a risk of acute elevation of sodium concentration in the serum and consequent dehydration, particularly in children with megacolon. Additional fluids by mouth are recommended where appropriate.

In addition, elevated levels of serum phosphates and decreased levels of serum calcium have been reported in patients with renal disease (and with prolonged use).

Do not use a laxative product when nausea, vomiting, or abdominal pain is present unless directed by a physician. Patients who have noticed a sudden change in bowel habits that persists over a period of 2 weeks should consult a physician before using a laxative. Rectal bleeding or failure to have a bowel movement may indicate a serious condition. Laxative products should not be used longer than 1 week unless directed by a physician.

Precautions: Fleet Phospho-Soda is not recommended for pregnant or nursing women, or children under 5 years old, except on the advice of a physician.

Symptoms And Treatment Of Overdose: Symptoms: Overdosage with Fleet Phospho-Soda may cause hypocalcemia, hyperphosphatemia, hypernatremia, hypernatremic dehydration and acidosis.

Treatment: Hypocalcemia, Hyperphosphatemia, Hypernatremia and Acidosis: Calcium, phosphate, chloride and sodium levels should be carefully monitored. Immediate corrective action should be taken to restore electrolyte balance with appropriate fluid replacements.

Hypernatremic Dehydration: Calcium, phosphate, chloride and sodium levels should be carefully monitored. Promptly administer parenteral fluids with lower concentrations of sodium and chloride than extracellular fluid (40 to 50 mEq/L) and moderate concentration of potassium (20 to 30 mEq/L) administered at a rate of 3 000 to 4 000 mL/mof body surface during the first 12 to 24 hours dependent on the severity of dehydration and the clinical response.

Dosage And Administration: Do not exceed single daily dosage

Directions for Use: Best if taken on an empty stomach; upon rising, 30 minutes before a meal, or at bedtime for overnight action. Dilute recommended dosage with 1/2 glass (120 mL) cool water. Drink, then follow with 1 glass (240 mL) cool water.

Availability And Storage: Unflavored: Each 5 mL contains: monobasic sodium phosphate 2.4 g and dibasic sodium phosphate 0.9 g in a stable, buffered, aqueous solution. Nonmedicinal ingredients: sodium benzoate. Plastic bottles of 45 mL.

Ginger-lemon Flavor: Each 5 mL contains: monobasic sodium phosphate 2.4 g and dibasic sodium phosphate 0.9 g in a stable, buffered, aqueous solution. Nonmedicinal ingredients: ginger-lemon flavor, glycerin, saccharin sodium and sodium benzoate. Plastic bottles of 45 mL.

FLEET® PHOSPHO®-SODA Johnson & Johnson Merck Sodium Phosphates Laxative

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