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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References in periodicals archive ?
Taro previously received approval for cetirizine hydrochloride oral solution in April 2008.
Cetirizine Hydrochloride is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
We are pleased to receive this final approval for Cetirizine Hydrochloride Oral Solution that has proven its clinical value and utility in both adults and children.
announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Chewable Tablets, "over-the-counter", (OTC), 5 mg and 10 mg (Cetirizine HCl Chewable).
We feel that Cetirizine HCl Chewable complements our previously announced FDA final approval of Cetirizine Hydrochloride Tablets, 5 mg and 10 mg, and both products will be positive additions to our portfolio by expanding our product offerings.
We are pleased to receive this final approval for Cetirizine Hydrochloride Tablets (OTC) 5mg and 10mg, that has proven its clinical value and utility in both adults and children.
Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.
Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.
The product will be marketed under store brand labels and is comparable to McNeil Consumer Healthcare's Cetirizine Hydrochloride Tablets, 5 and 10 mg, which will be marketed as Zyrtec(R) Tablets, indicated for allergy and hives relief.
announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Chewable Tablets, 5 mg and 10 mg (Cetirizine HCl Chewable).
Cetirizine Hydrochloride Syrup is indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens such as ragweed, grass and tree pollens in adults and children 2 years of age and older.
Mylan Also Announces Tentative Approval for Cetirizine Hydrochloride Tablets and Sertraline Hydrochloride Tablets