Pedia-Pop

In the U.S.

• CeraLyte 70
• Cera Sport
• Hydra-1
• HydraLife
• Pedia-Pop

In Canada

• Gastrolyte

Available Dosage Forms:

• Powder for Suspension
• Solution
• Powder for Solution
• Packet
• Tablet

Carbohydrate and electrolytes combination is used to treat or prevent dehydration (the loss of too much water from the body) that may occur with severe diarrhea, especially in babies and young children. Although this medicine does not immediately stop 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 electrolytes solutions may also be used after surgery when food intake has been stopped.

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

This medicine has been tested and has been shown to be well tolerated by older people.

Pregnancy

Carbohydrate and electrolytes solutions have not been shown to cause birth defects or other problems in humans.

Breast Feeding

This medicine has not been reported to cause problems in nursing babies. Breast-feeding should continue, if possible, during treatment with carbohydrate and electrolytes solution.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Amantadine
• Atropine
• Belladonna
• Belladonna Alkaloids
• Benztropine
• Biperiden
• Clidinium
• Darifenacin
• Dicyclomine
• Eplerenone
• Fesoterodine
• Glycopyrrolate
• Hyoscyamine
• Methscopolamine
• Oxybutynin
• Procyclidine
• Scopolamine
• Solifenacin
• Tolterodine
• Trihexyphenidyl
• Trospium

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril
• Amiloride
• Amygdalin
• Benazepril
• Canrenoate
• Captopril
• Cilazapril
• Deferoxamine
• Delapril
• Digoxin
• Eltrombopag
• Elvitegravir
• Enalaprilat
• Enalapril Maleate
• Fosinopril
• Gefitinib
• Imidapril
• Indomethacin
• Ketoconazole
• Ledipasvir
• Levomethadyl
• Licorice
• Lisinopril
• Mefenamic Acid
• Moexipril
• Mycophenolate Mofetil
• Mycophenolic Acid
• Pazopanib
• Pentopril
• Perindopril
• Phenytoin
• Quinapril
• Quinine
• Raltegravir
• Ramipril
• Rilpivirine
• Spirapril
• Spironolactone
• Temocapril
• Trandolapril
• Triamterene
• Vismodegib
• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Difficult urination—This condition may prevent the carbohydrate and electrolytes solution from working properly.

• Inability to drink or
• Vomiting (severe and continuing)—Treatment by injection may need to be given to patients with these conditions.

• Intestinal blockage—Carbohydrate and electrolytes solution may be harmful if given to patients with this condition.

This section provides information on the proper use of a number of products that contain carbohydrate and electrolyte combination. It may not be specific to Pedia-Pop. Please read with care.

For patients using the commercial powder form of this medicine:

• Add 7 ounces of boiled, cooled tap water to the entire contents of one powder packet. Shake or stir the container for 2 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.

For patients using the freezer pop form of this 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 when frozen. To eat the frozen pop, cut the top of the wrapper open and push the pop from the bottom of the plastic sleeve.
• To drink as a liquid, cut the top of the wrapper open and pour the unfrozen pop into a cup or glass.

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

• Add the entire contents of one powder packet to enough drinking water to make one quart (32 ounces) or liter of solution. Shake the container for 2 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 small amounts, with a spoon, as often as possible, during the first 24 hours of diarrhea.

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

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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 body weight and must be determined by your doctor. At first, the usual dose is 50 to 100 milliliters (mL) per kilogram (kg) (23 to 45 mL per pound) of body weight taken over four to six hours. Your doctor may change the dose depending on your thirst and your response to the treatment.
    • Children 2 to 10 years of age—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 50 mL per kg (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 over the next eighteen to twenty-four hours. Your doctor may change the dose depending on your thirst and your response to the treatment. However, the dose is usually not more than 100 mL in any 20-minute period.
    • Children up to 2 years of age—The dose is based on body weight and must be determined by your doctor. At first, the usual dose is 75 mL per kg (34 mL per pound) of body weight during the first eight hours and 75 mL per kg (34 mL per pound) of body weight during the next sixteen hours. Your doctor may change the dose depending on your thirst and your response to the treatment. However, the dose is usually not more than 100 mL in any 20-minute period.
  • For oral dosage form (solution for freezer pop):
    • Children older than 1 year of age—Freezer pop may be given as often as desired.
    • Children up to 1 year of age—Use must be determined by your doctor.

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 must be 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 weight taken over four to six hours. Your doctor may change the dose depending on your thirst and your response to the treatment.
    • Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 50 to 100 mL per kg (23 to 45 mL per pound) of body weight taken over the first four hours. Your doctor may change the dose depending on your thirst and your response to the treatment.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Make a fresh solution each day. Discard unused solution at the end of each day. Be sure that any discarded medicine is out of the reach of children.

Eat soft foods, if possible, such as rice cereal, bananas, cooked peas or beans, and potatoes to keep up nutrition until the diarrhea stops and regular food and milk can be taken again. Breast-fed infants should be given breast milk between doses 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 if your baby or child appears to have severe thirst, doughy skin, sunken eyes, dizziness or lightheadedness, tiredness or weakness, irritability, difficult urination, loss of weight, or convulsions (seizures). These signs may mean that too much water has been lost from the body.

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

• Drink plain water whenever thirsty between doses of solution.

For patients taking the premixed liquid form of this medicine:

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

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 may need medical attention.

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

• Convulsions (seizures)
• dizziness
• fast heartbeat
• high blood pressure
• irritability
• muscle twitching
• restlessness
• swelling of feet or lower legs
• weakness

• Puffy eyelids

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Vomiting (mild)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.