Cetirizine hydrochloride

Cetirizine hydrochloride
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: Kiran Singh, M.D. [2]

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Overview

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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
• Itchy, watery eyes

itching of the nose or throat

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Indications and Dosage

• Perennial allergic rhinitis: 5-10 mg ORALLY once daily
• Seasonal allergic rhinitis: 5-10 mg ORALLY once daily
• Urticaria, chronic: 5-10 mg ORALLY once daily

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Cetirizine hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• Perennial allergic rhinitis: (12 yrs and older) 5-10 mg ORALLY once daily
• Perennial allergic rhinitis: (6-11 yrs) 5-10 mg ORALLY once daily (1-2 tsp (5 mg/5 mL solution))
• Perennial allergic rhinitis: (2-5 yrs) 2.5-5 mg ORALLY once daily (0.5-1 tsp (5 mg/5 mL solution)) or 2.5 mg ORALLY twice daily
• Perennial allergic rhinitis: (6-23 months) 2.5 mg (0.5 tsp (5 mg/5 mL solution)) ORALLY once daily; the dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day given as 2.5 mg every 12 hours
• Seasonal allergic rhinitis: (12 yrs and older) 5-10 mg ORALLY once daily
• Seasonal allergic rhinitis: (6-11 yrs) 5-10 mg ORALLY once daily (1-2 tsp (5 mg/5 mL solution))
• Seasonal allergic rhinitis: (2-5 yrs) 2.5-5 mg ORALLY once daily (0.5-1 tsp (5 mg/5 mL solution)) or 2.5 mg ORALLY twice daily
• Urticaria, chronic: (12 yrs and older) 5-10 mg ORALLY once daily
• Urticaria, chronic: (6-11 yrs) 5-10 mg ORALLY once daily (1-2 tsp (5 mg/5 mL solution))
• Urticaria, chronic: (2-5 yrs) 2.5-5 mg ORALLY once daily (0.5-1 tsp (5 mg/5 mL solution)) or 2.5 mg ORALLY twice daily
• Urticaria, chronic: (6-23 months) 2.5 mg (0.5 tsp (5 mg/5 mL solution)) ORALLY once daily; the dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day given as 2.5 mg every 12 hours

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Cetirizine hydrochloride Contraindications in the drug label.

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

if breast feeding, not recommended if pregnant, ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Cetirizine hydrochloride Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Cetirizine hydrochloride Postmarketing Experience in the drug label.

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Cetirizine hydrochloride in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cetirizine hydrochloride in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Cetirizine hydrochloride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Cetirizine hydrochloride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Cetirizine hydrochloride in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Cetirizine hydrochloride Administration in the drug label.

Monitoring

There is limited information regarding Cetirizine hydrochloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Cetirizine hydrochloride and IV administrations.

Overdosage

There is limited information regarding Cetirizine hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

CetirizineCetirizine
Systematic (IUPAC) name
(±)-[2-[4-[(4-chlorophenyl)phenylmethyl]-1- piperazinyl]ethoxy]acetic acid
Identifiers
CAS number	83881-51-0
ATC code	R06AE07
PubChem	2678
DrugBank	DB00341
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	388.89
SMILES	eMolecules & PubChem
Synonyms	Alerid, Alatrol, Alzene, Cetirizina, Cetirin, Cetzine, Cetirizin, Cezin, Histazine, Humex, Letizen, Razene, Reactine, Zyrtec, Zirtec, Zodac, Zirtek, Zynor, Zyrlek, Zyllergy
Pharmacokinetic data
Bioavailability	well absorbed
Protein binding	~93%
Metabolism	Excreted mainly unchanged
Half life	8.3 Hours
Excretion	Urine (mainly), hepatic or excrement (Small amounts)
Therapeutic considerations
Licence data	US
Pregnancy cat.	B(US)
Legal status	GSL(UK) OTC(US) OTC in Canada
Routes	Oral

Mechanism of Action

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

Structure

There is limited information regarding Cetirizine hydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Cetirizine hydrochloride Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Cetirizine hydrochloride Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Cetirizine hydrochloride Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Cetirizine hydrochloride Clinical Studies in the drug label.

How Supplied

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

Storage

Store between 20° to 25°C (68° to 77°F)

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Cetirizine hydrochloride Patient Counseling Information in the drug label.

Precautions with Alcohol

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

Brand Names

There is limited information regarding Cetirizine hydrochloride Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Cetirizine hydrochloride 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.