Sodium phosphate dibasic and sodium phosphate monobasic (Rectal)

Sodium phosphate dibasic and sodium phosphate monobasic combination is a laxative used to relieve occasional constipation in adults and children.

This medicine is available without a doctor's prescription.

It is very important for your doctor to check your progress during regular visits. This will help your doctor see if the medicine is working correctly and to decide if you or your child should keep using it.

Tell your doctor if you or your child has already used a laxative for more than 1 week.

Call your doctor immediately if you or your child has rectal bleeding, has not had a bowel movement within 30 minutes of using the enema, or shows signs of dehydration (for example, confusion, less urination, feeling thirsty, or vomiting). These may be signs of a serious condition.

Do not use this medicine if you or your child is using another product that contains sodium phosphate.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems that would make sodium phosphate dibasic and sodium phosphate monobasic combination ineffective in children. However, this medicine is not recommended for children younger than 2 years old.

Geriatric

There is no information available on how age affects the use of sodium phosphate dibasic and sodium phosphate monobasic combination in older patients.

Interactions with Medicines

Some medicines should not be used together, while others can be used together even if there may be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Dehydration or
• Kidney disease or
• Stomach or bowel problems (including abdominal or stomach pain, nausea, vomiting, or a sudden change in bowel habits lasting more than 2 weeks)—Use with caution. May worsen these conditions.

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 immediately if any of the following side effects occur:

Incidence not known

• Bleeding in the rectum
• confusion
• decreased urination
• dizziness
• dry mouth
• fainting
• increase in heart rate
• lightheadedness
• rapid breathing
• sunken eyes
• thirst
• unusual tiredness or weakness
• wrinkled skin

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.

Available Dosage Forms:

• Enema

Therapeutic Class: Colorectal Agent

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Tell your doctor if you or your child is on a sodium-restricted diet.

Follow the instructions on the medicine label if you are using this medicine without a prescription.

To use:

• This medicine is for rectal use only. Do not swallow the medicine.
• Wash your hands with soap and water before and after you use this medicine.
• Lie on your left side with your left leg straight or slightly bent, and your right knee bent upward. Insert the applicator tip into your rectum about an inch. Gently squeeze the bottom of the bottle to release the enema.
• Remove the bottle and throw it away.
• You may need to hold the liquid in your rectum for several minutes or hours. This may be difficult or feel uncomfortable. It should become easier to do as you continue to use the medicine.
• If your child is using one-half bottle: Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow your doctor's directions.
• Do not use more than one bottle of enema in 24 hours. Do not use if the seal of the bottle enema is broken or missing.

Dosing

The dose of this medicine 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 this medicine. 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 rectal dosage form (enema):For relief of constipation: Adults and children 12 years of age and older—One bottle of Fleet® saline enema. Children 5 to 11 years of age—One bottle of Pedia-Lax™ enema or as directed by your doctor. Children 2 to 5 years of age—One-half bottle of Pedia-Lax™ enema. Children younger than 2 years of age—Use is not recommended.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.