Chlorcyclizine

Chlorcyclizine
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

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

FDA-Labeled Indications and Dosage (Adult)

Indications

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

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

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

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

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

Clinical Trials Experience

• excitability
• drowsiness

Postmarketing Experience

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

Drug Interactions

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

• Oral

Monitoring

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

IV Compatibility

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

Overdosage

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

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

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

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

Drug Images

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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.

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Patient Counseling Information

QUESTIONS OR COMMENTS?

Call 1-888-206-5525

www.magnaweb.com

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

• AHIST®

Look-Alike Drug Names

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

Drug Shortage Status

Price

References

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