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Chlorcyclizine

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

Overview

Chlorcyclizine is a antihistamine that is FDA approved for the treatment of hay fever or other upper respiratory allergies. Common adverse reactions include excitability, drowsiness.

Adult Indications and Dosage

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Directions

  • Do not exceed recommended dosage.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Directions

  • Do not exceed recommended dosage.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Contraindications

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

Warnings

Warnings

  • Do not exceed recommended dosage.
  • Do not take this product unless directed by a doctor if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
  • Ask a doctor before use if you are taking sedatives or tranquilizers
  • When using this product
excitability may occur, especially in children
may cause drowsiness
alcohol, sedatives and tranquilizers may increase drowsiness effect
  • Use caution when driving a motor vehicle or operating machinery.
  • If pregnant or breast-feeding, ask a health professional before use.
  • Keep out of reach of children.
  • In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Adverse Reactions

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Chlorcyclizine in the drug label.

Drug Interactions

Drug Interactions

    Use in Specific Populations

    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 Chlorcyclizine in women who are pregnant.

    Labor and Delivery

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

    Geriatic Use

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

    Gender

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

    Race

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

    Renal Impairment

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

    Hepatic Impairment

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

    Females of Reproductive Potential and Males

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

    Immunocompromised Patients

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

    Administration and Monitoring

    Administration and Monitoring

    Administration

    • Oral

    Monitoring

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

    IV Compatibility

    IV Compatibility

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

    Overdosage

    Overdosage

    There is limited information regarding Overdose of Chlorcyclizine in the drug label.

    Pharmacology

    Pharmacology

    Mechanism of Action

    There is limited information regarding Chlorcyclizine Mechanism of Action in the drug label.

    Structure

    ACTIVE INGREDIENTS (IN EACH IMMEDIATE-RELEASE TABLET)
    • Chlorcyclizine HCl 25 mg
    INACTIVE INGREDIENTS
    • Lake Blend Green, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

    Pharmacodynamics

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

    Pharmacokinetics

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

    Nonclinical Toxicology

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

    Clinical Studies

    Clinical Studies

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

    How Supplied

    How Supplied

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

    Storage

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

    Images

    Images

    Drug Images

    {{#ask: Page Name::Chlorcyclizine |?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

    PRINCIPAL DISPLAY PANEL – 30 TABLET CARTON

    NDC 58407-025-30

    AHIST™

    Antihistamine

    Each tablet contains:

    Chlorcyclizine HCl 25 mg

    MAGNA Pharmaceuticals, Inc. Louisville, KY 40299

    30 Tablets

    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::Chlorcyclizine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

    Patient Counseling Information

    Patient Counseling Information

    QUESTIONS OR COMMENTS?

    Call 1-888-206-5525

    www.magnaweb.com

    Precautions with Alcohol

    Precautions with Alcohol

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

    Brand Names

    Look-Alike Drug Names

    Look-Alike Drug Names

    There is limited information regarding Chlorcyclizine Look-Alike Drug Names in the drug label.

    Drug Shortage Status
    Price

    Price

    References

    References

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

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