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    Glycerin

    From Wikidoc - Reading time: 5 min

    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

    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

    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
    • 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.

    Postmarketing Experience

    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

    Monitoring

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

    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

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    Template:Chembox header2 | Glycerol
    Identifiers
    3D model (JSmol)
    ChEBI
    ChEMBL
    ChemSpider
    DrugBank
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    KEGG
    UNII
    Properties
    C3H8O3
    Molar mass 92.09 g·mol−1
    Hazards
    Template:Chembox header2 | Except where noted otherwise, data are given for
    materials in their standard state
    (at 25 °C, 100 kPa)

    Infobox disclaimer and references

    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

    There is limited information regarding Glycerin How Supplied in the drug label.

    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

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    This image is provided by the National Library of Medicine.

    Ingredients and Appearance

    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

    There is limited information regarding the look alike drug names.

    Drug Shortage Status

    Price

    References

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

    1. 1.0 1.1 1.2 1.3 1.4 Template:PGCH
    2. Template:Cite doi
    3. Lide, D. R., ed. (1994). CRC Handbook of Data on Organic Compounds (3rd ed.). Boca Raton, FL: CRC Press. p. 4386.
    4. "Glycerin suppository".
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