Glycerin

Description

Children Glycerin Suppository is a pharmaceutical formulation designed for rectal administration. It contains glycerin as the active ingredient, which acts as a hyperosmotic laxative. The suppository is intended to relieve occasional constipation in pediatric patients. The product is typically shaped for ease of insertion and is formulated to dissolve upon contact with body temperature, facilitating the evacuation of stool.

Uses and Indications

This drug is indicated for the relief of occasional constipation (irregularity). It generally produces a bowel movement within ¼ to 1 hour of administration.

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.

The route of administration involves inserting one suppository well into the rectum. It is important to note that the suppository is designed to dissolve only partially, which will produce a laxative effect that may not be immediately noticeable.

Contraindications

Laxative products are contraindicated for use beyond one week unless directed by a healthcare professional. Prolonged use may lead to dependency or other adverse effects.

In pediatric patients, the use of laxatives should be discontinued and a healthcare provider consulted if rectal bleeding occurs or if there is a failure to have a bowel movement following administration. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

For rectal use only. It is imperative that healthcare professionals advise patients to adhere strictly to this route of administration to ensure safety and efficacy.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers are encouraged to contact a Poison Control Center at 1-800-222-1222 without delay.

Laxative products should not be utilized for periods exceeding one week unless specifically directed by a healthcare provider. Prolonged use may lead to dependency or other adverse effects.

Healthcare professionals should instruct patients to discontinue use and consult a physician if rectal bleeding occurs or if there is a failure to have a bowel movement following the use of a laxative. These symptoms may indicate a serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients using this product should be aware that it is intended for rectal use only. It is important to monitor for any serious adverse reactions. Patients should discontinue use and consult a healthcare professional if they experience rectal bleeding or if there is a failure to have a bowel movement after using the laxative, as these symptoms may indicate a serious underlying condition.

Before using this product, patients are advised to seek medical advice if they have a history of stomach pain, nausea, or vomiting. Additionally, individuals who have noticed a sudden change in bowel habits lasting more than two weeks should also consult a healthcare provider prior to use.

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 Glycerin (glycerin suppositories). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to under 6 years may be administered 1 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.

While using this product, pediatric patients may experience rectal discomfort or a burning sensation. It is important to discontinue use and seek medical advice if rectal bleeding occurs or if the child does not have a bowel movement after using the laxative, as these symptoms may indicate a serious condition.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of Glycerin suppositories during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should exercise caution when considering the use of this medication in pregnant patients due to the lack of data on potential risks or fetal impacts. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

Healthcare professionals should also consider contacting a poison control center for guidance on specific interventions and management strategies tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to inform patients that laxative products should not be used for longer than one week unless specifically directed by a physician.

Providers should instruct patients to discontinue use and consult a doctor if their child experiences rectal bleeding or does not have a bowel movement after using the laxative, as these symptoms may indicate a serious medical condition. Additionally, patients should be made aware that the use of this product may result in rectal discomfort or a burning sensation.

Healthcare providers should also recommend that patients consult a doctor prior to use if they have any of the following conditions: stomach pain, nausea, vomiting, or if they have noticed a sudden change in bowel habits that persists for more than two weeks.

Storage and Handling

The product is supplied in packaging that includes a Lot Number and Expiration Date, which can be found on the wrapper or box. It is essential to store the product at room temperature, ensuring that the temperature does not exceed 30˚ C (86˚ F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)