Glycerin

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Glycerin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Glycerin is a Laxative that is FDA approved for the treatment of constipation. Common adverse reactions include rectal discomfort or a burning sensation, diarrhea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

relieves occasional constipation (irregularity) • generally produces bowel movement in 1/4 to 1 hour

Directions

insert 1 suppository well up into rectum and retain for 15 minutes • it need not melt to produce laxative action

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Glycerin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glycerin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

relieves occasional constipation (irregularity) • generally produces bowel movement in 1/4 to 1 hour

Directions

insert 1 suppository well up into rectum and retain for 15 minutes • it need not melt to produce laxative action

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Glycerin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glycerin in pediatric patients.

Contraindications

There is limited information regarding Glycerin Contraindications in the drug label.

Warnings

  • For rectal use only

Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks

When using this product you may have rectal discomfort or a burning sensation

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Glycerin in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

rectal discomfort or a burning sensation, diarrhea

Drug Interactions

There is limited information regarding Glycerin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • IF PREGNANT OR BREAST FEEDING
ask a health professional before use.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Glycerin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Glycerin during labor and delivery.

Nursing Mothers

  • IF PREGNANT OR BREAST FEEDING
ask a health professional before use.

Pediatric Use

There is no FDA guidance on the use of Glycerin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Glycerin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Glycerin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Glycerin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Glycerin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Glycerin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Glycerin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Glycerin in patients who are immunocompromised.

Administration and Monitoring

Administration

  • rectal

Monitoring

There is limited information regarding Monitoring of Glycerin in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Glycerin in the drug label.

Overdosage

  • If swallowed, get medical help or contact a Poison Control Center right away.

Pharmacology

There is limited information regarding Glycerin Pharmacology in the drug label.

Mechanism of Action

Structure

  • ACTIVE INGREDIENT (IN EACH SUPPOSITORY)

Glycerin, USP 2.1 grams INACTIVE INGREDIENT purified water, sodium hydroxide, stearic acid

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Glycerin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Glycerin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Glycerin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Glycerin in the drug label.

How Supplied

Storage

There is limited information regarding Glycerin Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Glycerin |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

File:Glycerin01.png
This image is provided by the National Library of Medicine.
File:Glycerin01.png
This image is provided by the National Library of Medicine.

{{#ask: Label Page::Glycerin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Glycerin in the drug label.

Precautions with Alcohol

  • Alcohol-Glycerin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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