Fleet

Description

Fleet Laxative is presented in the form of liquid glycerin suppositories, specifically designed for adult use. Each package contains four suppositories, with each suppository containing 7.5 ml of the active ingredient. The formulation is intended to provide effective relief from constipation through rectal administration.

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 of administration.

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

Dosage and Administration

Adults and children aged 6 years and older are advised to use 1 suppository or as directed by a healthcare professional. For children aged 2 to under 6 years, Fleet® Pedia-Lax® Liquid is recommended. Consultation with a doctor is necessary for children under 2 years of age.

For administration, the patient may assume one of two positions: the left-side position or the knee-chest position. In the left-side position, the patient should lie on their left side with the right knee bent and arms resting comfortably. In the knee-chest position, the patient should 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, it is crucial to follow these steps carefully:

1. Caution: Remove the orange protective shield before inserting the suppository.

2. Hold the unit upright, grasping the bulb with fingers. With the other hand, grasp the orange protective shield and pull gently to remove it.

3. With steady pressure, insert the tip into the rectum using a slight side-to-side movement, ensuring the tip is pointed toward the navel.

4. Do not force the applicator tip into the rectum, as this may cause injury. Insertion may be facilitated if the patient bears down as if having a bowel movement, which helps relax the muscles around the anus.

5. Squeeze the bulb until nearly all liquid is expelled. While continuing to squeeze the bulb, remove the tip from the rectum and discard the unit. It is not necessary to empty the unit completely, as it contains more liquid than needed for effective use, and a small amount will remain after administration.

Contraindications

Use of this product is contraindicated in patients experiencing abdominal pain, nausea, or vomiting unless directed by a physician.

Additionally, discontinue use and consult a healthcare professional if rectal bleeding occurs or if there is no bowel movement within 1 hour of administration.

Patients should seek medical advice before using any laxative if they have experienced a sudden change in bowel habits lasting more than 2 weeks or if they have been using a laxative for more than 1 week.

Warnings and Precautions

The use of this product is associated with certain warnings and precautions that healthcare professionals should be aware of to ensure patient safety.

Rectal discomfort or a burning sensation may occur with the use of this product. It is intended for rectal use only. Healthcare professionals should advise patients not to use this product in the presence of abdominal pain, nausea, or vomiting unless specifically directed by a physician.

Patients should be instructed to consult a healthcare provider prior to using any laxative if they experience a sudden change in bowel habits lasting more than two weeks or if they have already been using a laxative for more than one week.

In the event of rectal bleeding or if there is no bowel movement within one hour of using this product, patients should discontinue use and seek medical advice. These symptoms may indicate a serious underlying condition that requires further evaluation.

It is imperative to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients may experience adverse reactions associated with the use of this product. Notably, some individuals may report rectal discomfort or a burning sensation. These reactions should be monitored closely.

In the event of rectal bleeding or the absence of a bowel movement within one hour of using this product, patients are advised to discontinue use and consult a healthcare professional, as these symptoms may indicate a serious underlying condition.

Additionally, patients should seek medical advice before using any laxative 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.

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

Pediatric Use

Pediatric patients aged 2 to under 6 years should use Fleet Pedia-Lax Liquid for appropriate treatment. For children under 2 years, it is advised to consult a doctor prior to use. In patients aged 6 years and older, the recommended dosage is 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

There are no specific statements regarding the use of Fleet Glycerin Liquid during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should exercise caution when prescribing this medication to pregnant patients. The absence of data does not imply safety; therefore, the potential risks and benefits should be carefully considered in the context of individual patient circumstances. Women of childbearing potential should be informed of the lack of specific pregnancy-related information and encouraged to discuss any concerns with their healthcare provider.

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 when considering the use of this product during lactation.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert text. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance may necessitate individualized assessment and monitoring based on clinical judgment.

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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed reports of rectal discomfort and burning sensation associated with the use of Fleet Glycerin Liquid. These events were reported voluntarily or identified through surveillance programs.

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.

Patients should be informed not to use this product if they are experiencing abdominal pain, nausea, or vomiting unless directed by a healthcare professional. It is important to counsel patients to discontinue use 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.

Additionally, healthcare providers should encourage patients to ask a doctor before using any laxative 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. This precaution helps ensure the safe and effective use of laxatives.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light to prevent degradation.

To ensure safety, it should be kept out of reach of children. Once opened, the product should be discarded to avoid any potential risks associated with prolonged exposure to air or contamination.

Additional Clinical Information

The route of administration for the product is rectal. Clinicians may direct patients to visit the website www.fleetlabs.com for a detailed step-by-step instructional video on how to use Fleet products. No additional information is available regarding laboratory tests, abuse information, or postmarketing experience.

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)