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Professional Drug Information > Emetrol

Fructose, Dextrose, and Phosphoric Acid (Oral-Local )


VA CLASSIFICATION
Primary: GA609

Commonly used brand name(s): Emetrol.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiemetic. —

Indications

Accepted

—Fructose, dextrose, and phosphoric acid oral solution is used for the symptomatic relief of nausea and vomiting. However, to date, there is insufficient evidence to establish effectiveness (FDA Category III). {02} {03}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Fructose: 180.16
    Dextrose: 198.17
    Phosphoric acid: 98.0

Mechanism of action/Effect:

Exact mechanism has not been determined. Appears to have a direct local action on the wall of the gastrointestinal tract that reduces smooth muscle contraction and delays gastric emptying time through the high osmotic pressure exerted by the solution of simple sugars. Phosphoric acid is added to adjust pH to between 1.5 and 1.6. {02} {03}

Absorption:

Fructose—Slowly absorbed from gastrointestinal tract. {05}

Dextrose—Rapidly absorbed from gastrointestinal tract. {05}

Biotransformation:

Fructose—Hepatic, by phosphorylation; partly converted to liver glycogen and glucose. {05}

Dextrose—Hepatic; metabolized to carbon dioxide and water. {05}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans.

Studies have not been done in animals.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

In infants and children up to 3 years of age with vomiting, caution is recommended because of the risk of fluid and electrolyte loss {03}; these patients should be referred to a physician.


Geriatrics


In geriatric patients with vomiting, caution is recommended because of the risk of fluid and electrolyte loss {03}; these patients should be referred to a physician.


Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Glucose    (blood concentrations may be elevated {04})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:
» Appendicitis, symptoms of or
» Inflamed bowel, symptoms of{03}    (proper diagnosis required or severe condition may develop)


» Fructose intolerance, hereditary    (severe side effects may occur {01})


Risk-benefit should be considered when the following medical problems exist
» Diabetes mellitus    (condition may be aggravated because of solution's high carbohydrate content {04})


Intolerance to dextrose or phosphoric acid


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Fructose intolerance (fainting; swelling of face, arms, and legs; unusual bleeding; vomiting; weight loss; yellow eyes or skin)



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
—more frequent with large doses{05}    
Diarrhea
    
stomach or abdominal pain





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Fructose, Dextrose, and Phosphoric Acid (Oral).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Intolerance to fructose, dextrose, or phosphoric acid





Use in children—Risk of fluid and electrolyte loss due to vomiting






Use in the elderly—Risk of fluid and electrolyte loss due to vomiting
Other medical problems, especially diabetes mellitus, symptoms of appendicitis, or inflamed bowel

Proper use of this medication
Following physician's or manufacturer's instructions

Not diluting or taking fluids before or after dose

» Proper dosing

» Proper storage

Precautions while using this medication
» Checking with physician if symptoms do not improve or become worse

» Not taking if symptoms of appendicitis or inflamed bowel are present; checking with physician for proper diagnosis


Side/adverse effects
Signs of potential side effects, especially fructose intolerance


General Dosing Information
The fructose, dextrose, and phosphoric acid oral solution should not be diluted. Also, oral fluids should not be taken immediately before or for at least 15 minutes after the dose. {04}


Oral Dosage Forms

FRUCTOSE, DEXTROSE, AND PHOSPHORIC ACID ORAL SOLUTION

Usual adult and adolescent dose
Antiemetic—Oral, 15 to 30 mL. Dose may be repeated every fifteen minutes until distress subsides, but should not be taken for more than one hour (five doses) without consulting a physician. {01}

Note: For morning sickness, dose should be taken on arising and repeated every three hours as needed. {02}


Usual pediatric dose
Antiemetic
Children up to 3 years of age: Use is not recommended.

Children over 3 years of age: Oral, 5 to 10 mL. Dose may be repeated every fifteen minutes until distress subsides, but should not be taken for more than one hour (five doses) without consulting a physician. {01}


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


1.87 grams of fructose, 1.87 grams of dextrose, and 21.5 mg of phosphoric acid, per 5 mL (OTC) [Emetrol]

Canada—


1.87 grams of fructose, 1.87 grams of dextrose, and 21.5 mg of phosphoric acid, per 5 mL (OTC) [Emetrol]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.



Revised: 05/12/1993



References
  1. Emetrol product labeling (Bock Pharmacal—US), Rec 2/93.
  1. Facts & Comparisons, St. Louis, MO: J.B. Lippincott, 1989.
  1. Handbook of non-prescription drugs. 8th ed. Washington DC: Am Pharm Assoc, 1989: 107.
  1. Emetrol product labeling (Adria Labs—Canada), Rec 2/93.
  1. Reynolds J, ed. Martindale—The extra pharmacopeia. 29th ed. London: The Pharmaceutical Press, 1989: 1264, 1265, 1600.
  1. Am Med Assoc Drug Evaluations. 5th ed. Chicago: Am Med Assoc: 522.
  1. Berkow R, ed. The Merck manual of diagnosis and therapy. 16th ed. Rahway, NJ: Merck & Co, 1992.