Pedia-Lax

Description

Pedia-Lax® is a glycerin laxative formulated as liquid glycerin suppositories. Each package contains six applicators, with each applicator delivering 4 mL of the active ingredient. This product is designed for pediatric use to provide relief from constipation.

Uses and Indications

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

There are no 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 doctor prior to administration.

Prior to administering the laxative, it is essential to remove the orange protective shield from the unit. The healthcare professional should hold the unit upright, grasping the bulb with one hand while using the other hand to gently pull the orange protective shield away.

To administer the suppository, the tip should be inserted into the rectum with 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 to prevent injury from forcing the tip. Insertion may be facilitated if the child bears down as if having a bowel movement, which helps to relax the anal muscles.

The healthcare professional should squeeze the bulb until nearly all of the liquid is expelled. While continuing to apply pressure to 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 those who have been using a laxative 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 consult a physician prior to administering any laxative if the child presents with abdominal pain, nausea, or vomiting. Additionally, a sudden change in bowel habits lasting more than two weeks or the use of a laxative for more than one week warrants medical consultation. If constipation persists after one week of use, it is imperative to contact the child's doctor for further evaluation.

Caregivers should 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. These symptoms may suggest a serious underlying condition that requires further evaluation.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. 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

For rectal use only. Pediatric patients should be advised to consult a doctor before using any laxative if they present with abdominal pain, nausea, vomiting, a sudden change in bowel habits lasting more than 2 weeks, or if they have already used a laxative for more than 1 week. If constipation persists after one week of use, it is important to contact the child's doctor.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if the child experiences rectal bleeding or does not have a bowel movement within 1 hour of using this product.

The recommended single daily dosage is as follows: for children aged 2 to under 6 years, 1 suppository, or as directed by a doctor. For children under 2 years, consultation with a doctor is necessary before administration.

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

There is no specific information available regarding the use of PEDIA-LAX glycerin liquid during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding or effects on breastfed infants.

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 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 overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor 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 ask 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 imperative that healthcare professionals inspect the carton prior to use. If the seal, which features the Fleet emblem on either the bottom or top flap, is found to be broken or missing, the product should not be used.

Storage conditions for this product have not been specified; however, it is advisable to store it in a cool, dry place, away from direct sunlight and moisture to maintain its integrity. Special handling requirements include ensuring that the seal remains intact until the product is ready for use.

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)