CARBOHYDRATESAND ELECTROLYTES (Systemic)

Some commonly used brand names are:

In the U.S.?

• Infalyte ³
• Kao Lectrolyte ¹
• Naturalyte ¹
• Oralyte ¹
• Pedialyte ¹
• Pedialyte Freezer Pops ¹
• Rehydralyte ¹
• Resol ? ¹

In Canada?

• Lytren ¹
• Gastrolyte ²
• Pedialyte ¹
• Rapolyte ²

Other commonly used names are oral rehydrationsalts, ORS-bicarbonate, and ORS-citrate. ?

Category

• Electrolyte replenisher?Dextrose and Electrolytes; Oral Rehydration Salts; Rice Syrup Solidsand Electrolytes

Description

Carbohydrateand electrolytes combination is used to treat or prevent dehydration (theloss of too much water from the body) that may occur with severe diarrhea,especially in babies and young children. Although this medicine does not immediatelystop the diarrhea, it replaces the water and some important salts (electrolytes),such as sodium and potassium, that are lost from the body during diarrhea,and helps prevent more serious problems. Some carbohydrate and electrolytessolutions may also be used after surgery when food intake has been stopped.

This medicine is available without a prescription; however, your doctormay have special instructions on the proper use and dose for you or your child.

Carbohydrate and electrolytes combination is available in the followingdosage forms:

Oral
• Solution (U.S. and Canada)
• Powder for oral solution (Canada)

Before Using This Medicine

If you are taking this medicinewithout a prescription, carefully read and follow any precautions on the label.For carbohydrate and electrolytes solutions, the following should be considered:

Allergies?Tell your health care professional if you have everhad any unusual or allergic reaction to medicines containing potassium, sodium,citrates, rice, or sugar. Also tell your health care professional if you areallergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy?Carbohydrate and electrolytes solutions have notbeen shown to cause birth defects or other problems in humans.

Breast-feeding?This medicine has not been reported to cause problemsin nursing babies. Breast-feeding should continue, if possible, during treatmentwith carbohydrate and electrolytes solution.

Children?This medicine has been tested in children and, ineffective doses, appears to be safe and effective in children. This medicinehas not been tested in premature infants.

Older adults?This medicine has been tested and has been shownto be well tolerated by older people.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of carbohydrate and electrolytes solutions. Makesure you tell your doctor if you have any other medical problems, especially:

• Difficult urination?This condition may prevent the carbohydrateand electrolytes solution from working properly

• Inability to drink or
• Vomiting (severe and continuing)?Treatment by injection mayneed to be given to patients with these conditions

• Intestinal blockage?Carbohydrate and electrolytes solutionmay be harmful if given to patients with this condition

Proper Use of This Medicine

For patientsusing the commercial powder form of this medicine:

• Add 7 ounces of boiled, cooled tap water to the entire contents ofone powder packet. Shake or stir the container for 2 or 3 minutes until allthe powder is dissolved.
• Do not add more water to the solution after it is mixed.
• Do not boil the solution.
• Make and use a fresh solution each day.

For patients using the freezer pop form ofthis medicine:

• Pops should be removed from the box before being placed in the freezer.The pops should be frozen before separating.
• The freezer pop can be eaten without freezing, but tastes best whenfrozen. To eat the frozen pop, cut the top of the wrapper open and push thepop from the bottom of the plastic sleeve.
• To drink as a liquid, cut the top of the wrapper open and pour theunfrozen pop into a cup or glass.

For patients using the powder form of thismedicine distributed by the World Health Organization(WHO):

• Add the entire contents of one powder packet to enough drinking waterto make one quart (32 ounces) or liter of solution. Shake the container for2 or 3 minutes until all the powder is dissolved.
• Do not add more water to the solution after it is mixed.
• Do not boil the solution.
• Make and use a fresh solution each day.

Babies and small children should be given the solution slowly, in smallamounts, with a spoon, as often as possible, during the first 24 hours ofdiarrhea.

Take as directed. Do not take it for a longer time than your doctor hasrecommended. To do so may increase the chance of side effects.

Dosing?The dose of these combination medicines willbe different for different patients. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of these medicines. If your doseis different, do not change it unless your doctor tells you to do so.

For dextrose and electrolytes and for rice syrup solids and electrolytes
• For rehydration (to replace the water and some important salts [electrolytes]):
  • For oral dosage form (solution):
    • Adults and children over 10 years of age?Dose is based on bodyweight and must be determined by your doctor. At first, the usual dose is50 to 100 milliliters (mL) per kilogram (kg) (23 to 45 mL per pound) of bodyweight taken over four to six hours. Your doctor may change the dose dependingon your thirst and your response to the treatment.
    • Children up to 2 years of age?The dose is based on body weightand must be determined by your doctor. At first, the usual dose is 75 mL perkg (34 mL per pound) of body weight during the first eight hours and 75 mLper kg (34 mL per pound) of body weight during the next sixteen hours. Yourdoctor may change the dose depending on your thirst and your response to thetreatment. However, the dose is usually not more than 100 mL in any 20-minuteperiod.
    • Children 2 to 10 years of age?Dose is based on body weightand must be determined by your doctor. At first, the usual dose is 50 mL perkg (23 mL per pound) of body weight taken over the first four to six hours.Then, the dose is 100 mL per kg (45 mL per pound) of body weight taken overthe next eighteen to twenty-four hours. Your doctor may change the dose dependingon your thirst and your response to the treatment. However, the dose is usuallynot more than 100 mL in any 20-minute period.
  • For oral dosage form (solution for freezerpop):
    • Children up to 1 year of age?Use must be determined by yourdoctor.
    • Children older than 1 year of age?Freezer pop may be givenas often as desired.

For oral rehydration salts
• For rehydration (to replace the water and some important salts [electrolytes]):
  • For oral dosage form (solution):
    • Adults and teenagers?Dose is based on body weight and mustbe determined by your doctor. At first, the usual dose is 50 to 100 milliliters(mL) of solution per kilogram (kg) (23 to 45 mL per pound) of body weighttaken over four to six hours. Your doctor may change the dose depending onyour thirst and your response to the treatment.
    • Children?Dose is based on body weight and must be determinedby your doctor. At first, the usual dose is 50 to 100 mL per kg (23 to 45mL per pound) of body weight taken over the first four hours. Your doctormay change the dose depending on your thirst and your response to the treatment.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the powder packets in the bathroom, near the kitchensink, or in other damp places. Heat or moisture may cause the medicine tobreak down.
• Store the liquid in the refrigerator. However, keep the medicinefrom freezing.
• Make a fresh solution each day. Discard unused solution at the endof each day. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Eat softfoods, if possible, such as rice cereal, bananas, cooked peas or beans, andpotatoes to keep up nutrition until the diarrhea stops and regular food andmilk can be taken again. Breast-fed infants should be given breast milk betweendoses of the solution.

If your diarrhea does not improve in 1 or 2 days, or if it becomes worse,check with your doctor.

Also, check with your doctor immediately ifyour baby or child appears to have severe thirst, doughy skin, sunken eyes,dizziness or lightheadedness, tiredness or weakness, irritability, difficulturination, loss of weight, or convulsions (seizures). These signs may meanthat too much water has been lost from the body.

For patients (except nursing babies) using the powderform of this medicine:

• Drink plain water whenever thirsty between doses of solution.

For patients taking the premixed liquid formof this medicine:

• Do not drink fruit juices or eat foods containing added salt untilthe diarrhea has stopped.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Symptoms of too much sodium (salt) in the body

Convulsions (seizures); dizziness; fast heartbeat; high blood pressure; irritability; muscle twitching; restlessness; swellingof feet or lower legs; weakness

Symptoms of too much fluid in the body

Puffy eyelids

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if thefollowing side effect continues or is bothersome:

More common

Vomiting (mild)

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.