Cetirizine hydrochloride: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|authorTag={{KS}}
|OTC=Yes
|genericName=cetirizine hydrochloride
|aOrAn=an
|drugClass=antihistamine
|indicationType=treatment
|indication=of symptoms due to [[hay fever]] or other [[allergies|upper respiratory allergies]] such as [[runny nose]], sneezing, [[itchy]] watery eyes
|adverseReactions=[[xerostomia]], [[asthenia]], [[headache]],  sedated, [[somnolence]], [[fatigue]], oculogyric crisis
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
Line 7: Line 14:
:*Runny nose
:*Runny nose
:*Sneezing
:*Sneezing
:*Itching of the nose or throat
:*Itchy, watery eyes
:*Itchy, watery eyes
itching of the nose or throat
 
|offLabelAdultGuideSupport===Indications and Dosage==
==Dosage==
* Perennial allergic rhinitis: 5-10 mg ORALLY once daily
 
* Seasonal allergic rhinitis: 5-10 mg ORALLY once daily
'''Adults'''
* Urticaria, chronic: 5-10 mg ORALLY once daily
 
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Cetirizine hydrochloride in adult patients.
* One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
|offLabelPedGuideSupport=* 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))
'''Adults 65 years and over'''
* 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
* Ask a doctor
* 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
'''Consumers with liver or kidney disease'''
* Seasonal allergic rhinitis: (6-11 yrs) 5-10 mg ORALLY once daily (1-2 tsp (5 mg/5 mL solution))
* Ask a doctor
* 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
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Cetirizine hydrochloride in adult patients.
* Urticaria, chronic: (12 yrs and older) 5-10 mg ORALLY once daily
|offLabelAdultNoGuideSupport===Indications==
* Urticaria, chronic: (6-11 yrs) 5-10 mg ORALLY once daily (1-2 tsp (5 mg/5 mL solution))
* [[allergic rhinitis|Perennial allergic rhinitis]]
* 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
* [[allergic rhinitis|Seasonal allergic rhinitis]]
* 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
* [[Urticaria]], chronic
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Cetirizine hydrochloride in pediatric patients.
|fdaLIADPed===Indications==
* Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
:*Runny nose
:*Sneezing
:*Itchy, watery eyes
 
==Dosing==
'''Children 6 years and over'''
 
* One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
 
'''Children under 6 years of age'''
* Ask a doctor
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Cetirizine hydrochloride in pediatric patients.
|offLabelPedNoGuideSupport===Indications==
* [[allergic rhinitis|Perennial allergic rhinitis]]
* [[allergic rhinitis|Seasonal allergic rhinitis]]
* [[Urticaria]], chronic
|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.
|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.


Line 33: Line 58:


'''When using this product'''
'''When using this product'''
drowsiness may occur
 
avoid alcoholic drinks
* Drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
* Avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
* 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.
'''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 pregnant or breast-feeding''':


if breast feeding, not recommended
* If breast feeding, not recommended
if pregnant, ask a health professional before use
* 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
'''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
|postmarketing======Common side effects=====
* '''Gastrointestinal''': [[xerostomia]]
* '''Neurologic''': [[asthenia]], [[headache]],  sedated, [[somnolence]]
* '''Other''': [[fatigue]]
=====Serious side effect=====
*'''Ophthalmic''': oculogyric crisis
|administration=Oral
|drugBox={{Drugbox2
|drugBox={{Drugbox2
| verifiedrevid = 460026203
| verifiedrevid = 460026203
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|storage=Store between 20° to 25°C (68° to 77°F)
|storage=Store between 20° to 25°C (68° to 77°F)
|alcohol=Alcohol-Cetirizine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=Alcohol-Cetirizine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=zyrtec
}}
{{LabelImage
|fileName=Cetirizine ingredients and appearance.png
}}
{{LabelImage
|fileName=Cetirizine fig01.jpg
}}
}}
[[Category:Ethers]]
[[Category:H1 receptor antagonists]]
[[Category:Drug]]

Latest revision as of 18:55, 18 August 2015

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]

Disclaimer

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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

Cetirizine hydrochloride is an antihistamine that is FDA approved for the treatment of of symptoms due to hay fever or other upper respiratory allergies such as runny nose, sneezing, itchy watery eyes. Common adverse reactions include xerostomia, asthenia, headache, sedated, somnolence, fatigue, oculogyric crisis.

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

Dosage

Adults

  • One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

Adults 65 years and over

  • Ask a doctor

Consumers with liver or kidney disease

  • Ask a doctor

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Indications

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • Runny nose
  • Sneezing
  • Itchy, watery eyes

Dosing

Children 6 years and over

  • One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

Children under 6 years of age

  • Ask a doctor

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Indications

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

Common side effects
Serious side effect
  • Ophthalmic: oculogyric crisis

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

Oral

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

Template:Px
Template:Px
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

{{#ask: Page Name::Cetirizine hydrochloride |?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

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

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

zyrtec

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.

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 |Label Page=Cetirizine hydrochloride
 |Label Name=Cetirizine ingredients and appearance.png

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{{#subobject: 

 |Label Page=Cetirizine hydrochloride
 |Label Name=Cetirizine fig01.jpg

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