cetirizine hydrochloride


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cetirizine hydrochloride

All-Day Allergy, Aller-Relief, Allergy Relief, Benadryl Allergy Oral Solution (UK), Benadryl One a Day (UK), Piriteze (UK), Pollenshield Hayfever (UK), Reactine, Zirtec (UK), Zyrtec

Pharmacologic class: Histamine1-receptor antagonist (peripherally selective)

Therapeutic class: Allergy, cold, and cough agent; antihistamine

Pregnancy risk category B

Action

Antagonizes histamine's effects at histamine1-receptor sites, preventing allergic response. Also has mild bronchodilatory effects and blocks histamine-induced bronchoconstriction in asthma.

Availability

Syrup: 5 mg/5 ml

Tablets: 5 mg, 10 mg

Indications and dosages

Allergic symptoms caused by histamine release
Adults and children older than age 6: 5 to 10 mg P.O. daily
Children ages 2 to 5: 2.5 to 5 mg P.O. daily

Dosage adjustment

• Renal impairment
• Hepatic impairment

Contraindications

• Hypersensitivity to drug or hydroxyzine
• Acute asthma attacks
• Angle-closure glaucoma
• Pyloroduodenal obstruction
• Breastfeeding

Precautions

Use cautiously in:
• renal impairment, significant hepatic dysfunction
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established).

Administration

• Give with or without food.
• Administer at same time each day.

Adverse reactions

CNS: dizziness, drowsiness, fatigue

CV: palpitations, edema

EENT: pharyngitis

GI: nausea, vomiting, abdominal distress, dry mouth

Musculoskeletal: myalgia, joint pain

Respiratory: bronchospasm

Skin: photosensitivity, rash, angioedema

Other: fever

Interactions

Drug-drug.CNS depressants: additive CNS effects

Theophylline: decreased cetirizine clearance

Drug-diagnostic tests.Allergy skin tests: false-negative results

Drug-behaviors.Alcohol use: additive CNS effects

Sun exposure: photosensitivity

Patient monitoring

• Monitor creatinine levels in patients with renal dysfunction.
• Assess hepatic enzyme levels in patients with hepatic disease.

Patient teaching

• Tell patient to take with full glass of water.
• Inform patient that drug may impair alertness and that alcohol may exaggerate this effect.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

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In this experimental study, cetirizine hydrochloride has been observed as suitable drug to prepare its gel for transdermal drug delivery on the basis of its physical, chemical, and biopharmaceutical features (Khan et al.
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Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride tablets (OTC), 5 mg and 10 mg ("Cetirizine Tablets").
8 February 2010 - India-based Aurobindo Pharma Limited (BOM: 524804) said Thursday it has obtained final approval from the US Food and Drug Administration (FDA) for Cetirizine Hydrochloride Solution 1mg/mL (over-the-counter (OTC)).
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Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for prescription Cetirizine Hydrochloride Syrup, 1 mg / 1 mL ("cetirizine syrup").
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Food and Drug Administration has granted tentative approval for the Company's ANDA for Cetirizine Hydrochloride Tablets, 5 mg and 10 mg.