Cvs Pharmacy Childrens Glycerin Suppositories

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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 of administration.

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

Dosage and Administration

For children aged 2 to under 6 years, the recommended single daily dosage is 1 suppository, or as directed by a healthcare professional. For children under 2 years, it is advised to consult a doctor prior to administration.

The administration of the suppository should be performed using one of the following positions for optimal comfort and effectiveness:

1. Left-side position: Position the child on their left side with knees bent and arms resting comfortably.

2. Knee-chest position: Have the child kneel and then lower their head and chest forward until the left side of their face is resting on a surface, with the left arm folded comfortably.

When administering the laxative, the following steps should be adhered to:

• Prior to insertion, remove the green protective cover. This can be done by holding the unit upright, grasping the bulb with one hand, twisting the green cover one revolution with the other hand, and then pulling it off to discard.

• Gently insert the tip into the rectum with a slight side-to-side movement, ensuring the tip is pointed toward the navel. If resistance is encountered, discontinue use to avoid injury.

• Insertion may be facilitated if the child bears down as if having a bowel movement, which helps relax the muscles around the anus.

• Squeeze the bulb until nearly all liquid is expelled. While maintaining pressure on the bulb, carefully remove the tip from the rectum and discard the unit. It is not necessary to empty the unit completely, as a small amount of liquid will remain after squeezing.

Contraindications

Use of this product is contraindicated in patients experiencing rectal bleeding or those who have not had a bowel movement after using a laxative.

Consult a healthcare professional prior to use if the patient has 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.

Warnings and Precautions

The product is intended for rectal use only. Healthcare professionals should be aware that its application may lead to rectal discomfort or a burning sensation. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Patients should be advised to discontinue use and consult a physician if they experience rectal bleeding or if there is no bowel movement following the use of a laxative. These symptoms may signify a serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients using this product may experience adverse reactions, which can include rectal discomfort or a burning sensation, particularly with rectal use. It is important for patients to be aware of specific symptoms that warrant immediate medical consultation. Patients should stop using this product and consult a doctor if they experience rectal bleeding or if there is no bowel movement after the use of a laxative, as these symptoms may indicate a serious condition.

Additionally, patients are advised to seek medical advice before using any laxative if they have abdominal pain, nausea, or 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. These precautions are essential to ensure the safe use of the product and to mitigate potential risks associated with its use.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Pharmacy Childrens Glycerin Suppositories (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to under 6 years may be administered 1 suppository or as directed by a healthcare professional. For children under 2 years of age, it is recommended to consult a doctor prior to use.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific details regarding the use of this product during pregnancy. There are no contraindications noted for pregnant patients, nor are there any associated risks to the fetus identified in the available data. Additionally, no dosage modifications or special precautions for use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

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 context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Healthcare professionals are advised to exercise caution and consider the possibility of overdosage when administering this medication. In the absence of detailed guidance, it is recommended that clinicians monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, standard supportive measures should be implemented. This may include symptomatic treatment and monitoring of vital signs. Healthcare providers should also consider consulting a poison control center or a medical toxicologist for further management recommendations tailored to the specific clinical situation.

As always, maintaining open communication with patients regarding the importance of adhering to prescribed dosages is essential in preventing potential overdosage incidents.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 doctor if they experience rectal bleeding or if there is no bowel movement after using a laxative, as these symptoms may indicate a serious condition.

It is important for healthcare providers to recommend that patients ask a doctor before using any laxative if they have abdominal pain, nausea, or vomiting; if they have experienced a sudden change in bowel habits lasting more than two weeks; or if they have already used a laxative for more than one week.

Storage and Handling

The product is supplied in a format that ensures safety and efficacy. It should be stored at room temperature, away from direct sunlight and moisture. To maintain product integrity, it is essential to keep the container out of reach of children.

The packaging is designed to be tamper evident; therefore, if the bottle is found to be open, it should not be used. Additionally, any unused portion of the product must be discarded after use to ensure safety and prevent contamination.

Additional Clinical Information

The product is intended for rectal use only and may cause discomfort or a burning sensation in patients. Clinicians should advise patients to consult a doctor before using any laxative if they experience 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.

Patients should be instructed to discontinue use and seek medical attention if they experience rectal bleeding or do not have a bowel movement after using the laxative, as these symptoms may indicate a serious condition. It is important to keep the product out of reach of children, and in the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)