Pedia-Lax

Description

Pedia-Lax® is a rectal laxative formulated as liquid glycerin suppositories designed for pediatric use. Each package contains six applicators, with each applicator delivering 4 ml of the active ingredient. This product is intended for the relief of constipation in infants and young children.

Uses and Indications

This drug is indicated for the relief of occasional constipation. It generally produces a bowel movement within 15 minutes to 1 hour after administration.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

For children aged 2 to under 6 years, the recommended dosage is one suppository per day, or as directed by a healthcare professional. For children under 2 years of age, it is advised to consult a physician prior to administration.

When administering the laxative, it is crucial to follow specific instructions to ensure safety and effectiveness. Prior to insertion, the orange protective shield must be removed. The healthcare provider should hold the unit upright, grasping the bulb with one hand while using the other hand to gently pull the orange protective shield away. With steady pressure, the tip should be inserted into the rectum using a slight side-to-side movement, ensuring that the tip is directed toward the navel.

If resistance is encountered during insertion, the procedure should be discontinued, as forcing the tip may result in injury. Insertion may be facilitated if the child bears down as if having a bowel movement, which helps to relax the anal muscles. The bulb should be squeezed until nearly all liquid is expelled. While maintaining pressure on the bulb, the tip should be removed from the rectum, and the unit should be discarded. It is not necessary to empty the unit completely, as it contains more liquid than is required for effective use, and a small amount will remain after squeezing.

For optimal positioning during administration, the child may be placed on their left side with knees bent and arms resting comfortably. Alternatively, the knee-chest position can be utilized, where the child kneels and lowers their head and chest forward until the left side of their face rests on a surface, with the left arm folded comfortably.

Contraindications

Use of this product is contraindicated in children who exhibit rectal bleeding or have not experienced a bowel movement within one hour of administration. Additionally, consultation with a healthcare professional is advised prior to use in children presenting with abdominal pain, nausea, or vomiting; a sudden change in bowel habits lasting more than two weeks; or if a laxative has been used for more than one week. If constipation persists after one week of use, it is recommended to contact the child's doctor.

Warnings and Precautions

For rectal use only, this product may cause rectal discomfort or a burning sensation. Healthcare professionals should advise caregivers to monitor for these potential side effects.

It is essential to exercise caution when administering this laxative, particularly in pediatric patients. Caregivers should consult a physician prior to use if the child presents with any of the following conditions: abdominal pain, nausea, or vomiting; a sudden change in bowel habits lasting more than two weeks; or if a laxative has been used for more than one week. Should constipation persist after one week of use, it is imperative to contact the child's doctor for further evaluation.

Caregivers must be instructed to discontinue use and seek medical advice if the child experiences rectal bleeding or fails to have a bowel movement within one hour of administration. These symptoms may indicate a serious underlying condition that requires prompt medical attention.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product may experience adverse reactions, which can vary in seriousness.

Warnings indicate that the product is intended for rectal use only and may cause rectal discomfort or a burning sensation. These reactions should be monitored closely, especially in pediatric patients.

It is advised that a doctor be consulted before using any laxative if the child presents with abdominal pain, nausea, or vomiting, experiences a sudden change in bowel habits lasting more than two weeks, has already used a laxative for more than one week, or if constipation persists after one week of use.

Patients should discontinue use and seek medical attention if they experience rectal bleeding or do not have a bowel movement within one hour of using the product, as these symptoms may indicate a serious underlying condition.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pedia-Lax (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be evaluated by a healthcare professional before using any laxative, particularly if they present with abdominal pain, nausea, vomiting, a sudden change in bowel habits lasting more than two weeks, or if they have already used a laxative for more than one week. If constipation persists after one week of use, it is important to contact the child's doctor.

In cases where rectal bleeding occurs or if there is no bowel movement within one hour of using this product, the use of the laxative should be discontinued, and a doctor should be consulted.

For dosing, the recommended single daily dosage for children aged 2 to under 6 years is one suppository per day, or as directed by a healthcare professional. For children under 2 years of age, consultation with a doctor is advised prior to use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of Pedia-Lax Liquid Glycerin Suppositories during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product. Currently, there are no specific studies available that assess the effects of glycerin on fetal development, and therefore, the potential risks to the fetus remain unknown.

Healthcare professionals should advise pregnant individuals to use this product only if clearly needed and after thorough consultation with their healthcare provider. There are no specific dosage modifications recommended for pregnant individuals.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding, as the effects on the nursing infant are not well studied.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay. It is recommended to reach out to a Poison Control Center at 1-800-222-1222 for expert guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management protocols based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed.

Patients should be instructed to discontinue use and consult a physician if the child experiences rectal bleeding or does not have a bowel movement within one hour of using the product, as these symptoms may indicate a serious condition.

Additionally, healthcare providers should recommend that patients consult a doctor before using any laxative if the child has abdominal pain, nausea, or vomiting; experiences a sudden change in bowel habits lasting more than two weeks; has already used a laxative for more than one week; or if constipation persists after one week of use.

Storage and Handling

The product is supplied in a carton that is sealed for safety. It is essential to inspect the carton prior to use; if the seal, which features the Fleet emblem on either the bottom or top flap, is broken or missing, the product should not be used.

Storage conditions should ensure the integrity of the seal and the product. It is recommended to store the product in a cool, dry place, away from direct sunlight and moisture, to maintain its efficacy and safety. Special handling precautions should be taken to avoid damage to the carton and its seal.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Pedia-Lax, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)