Fleet

Description

No description information is available for the specified drug.

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 adults and children aged 6 years and older, the recommended dosage is one suppository per 24 hours, or as directed by a healthcare professional. For children aged 2 to under 6 years, Fleet® Pedia-Lax™ Suppositories should be utilized. In the case of children under 2 years, it is advised to consult a healthcare provider prior to administration.

The suppository should be inserted well up into the rectum to ensure effective laxative action. It is important to note that the suppository is designed to dissolve only partially, which may not be visibly apparent during use.

Contraindications

Laxative products are contraindicated in patients experiencing abdominal pain, nausea, or vomiting unless directed by a physician.

Additionally, the use of this product should be discontinued and a healthcare professional consulted if rectal bleeding occurs or if there is no bowel movement within 1 hour of administration.

Caution is advised, and a physician should be consulted prior to use in individuals with a sudden change in bowel habits lasting more than 2 weeks or those who have been using a laxative for more than 1 week.

Warnings and Precautions

For rectal use only. It is imperative that laxative products are not utilized in the presence of abdominal pain, nausea, or vomiting unless specifically directed by a healthcare professional.

Healthcare providers should advise patients to seek medical consultation prior to using any laxative if they experience a sudden change in bowel habits lasting more than two weeks or if they have been using a laxative for more than one week.

During the use of this product, patients may experience rectal discomfort or a burning sensation. Should any of the following occur, it is essential to discontinue use and consult a healthcare provider immediately: rectal bleeding, failure to achieve a bowel movement within one hour of administration, or any other concerning symptoms, as these may indicate a serious underlying condition.

This product must be kept out of reach of children. 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 rectal discomfort or a burning sensation. These reactions are generally considered common and may vary in intensity among individuals.

It is important for patients to be aware of specific symptoms that warrant immediate medical attention. Patients should stop using the product and consult a doctor if they experience rectal bleeding or if there is no bowel movement within 1 hour of using the product. The presence of these symptoms may indicate a serious underlying condition that requires further evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 to under 6 years may use Fleet® Pedia-Lax™ Suppositories as directed. For children under 2 years, it is recommended to consult a doctor prior to use. In patients aged 6 years and older, the dosage is typically 1 suppository or as directed by a healthcare professional.

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

Pregnant patients should exercise caution when considering the use of laxative products. The use of laxatives is not recommended in the presence of abdominal pain, nausea, or vomiting unless directed by a healthcare professional. Additionally, it is advised that pregnant patients consult their healthcare provider before using any laxative if they experience a sudden change in bowel habits lasting more than two weeks or if they have been using a laxative for more than one week.

In the event of rectal bleeding or failure to have a bowel movement within one hour of using a laxative, pregnant patients should discontinue use and seek medical advice, as these symptoms may indicate a serious underlying condition. It is also important to keep laxative products out of reach of children, and in cases of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) should be made.

Lactation

Lactating mothers are advised to consult a doctor prior to using this product. Currently, there is no specific information available regarding the potential for excretion of glycerin suppositories in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 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

Postmarketing experience has identified rectal discomfort or a burning sensation as potential adverse events associated with the use of this product. Additionally, it is advised that users discontinue use and seek medical consultation if rectal bleeding occurs. Users should also consult a healthcare professional if no bowel movement is achieved within one hour of product application.

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 not to use laxative products if they are experiencing abdominal pain, nausea, or vomiting unless directed by a healthcare professional. It is important to counsel patients to stop using the product and consult a doctor if they experience rectal bleeding or if they do not have a bowel movement within one hour of using the product, as these symptoms may indicate a serious condition.

While using this product, patients may experience rectal discomfort or a burning sensation. Healthcare providers should encourage patients to ask a doctor before using any laxative if they have 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 tightly sealed container to ensure safety and integrity. It is essential to store the container in a cool, dry place, away from excessive heat. The mouth of the jar is sealed for safety; therefore, if the foil imprinted with the green Fleet® emblem is missing or torn, the product should not be used. Proper handling and storage conditions are crucial to maintain the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)