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Cetirizine (Systemic)

Pronunciation

(se TI ra zeen)

Index Terms

  • Cetirizine Hydrochloride
  • P-071
  • UCB-P071

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as hydrochloride:

ZyrTEC Allergy: 10 mg

Solution, Oral, as hydrochloride:

All Day Allergy Childrens: 5 mg/5 mL (118 mL) [contains methylparaben, propylene glycol, propylparaben]

All Day Allergy Childrens: 5 mg/5 mL (118 mL) [dye free, gluten free; contains methylparaben, propylene glycol, propylparaben; grape flavor]

All Day Allergy Childrens: 5 mg/5 mL (118 mL [DSC]) [dye free, gluten free, sugar free; contains propylene glycol, sodium benzoate]

Cetirizine HCl Allergy Child: 5 mg/5 mL (120 mL) [alcohol free, dye free, gluten free, sugar free; contains methylparaben, propylene glycol, propylparaben; grape flavor]

Cetirizine HCl Allergy Child: 5 mg/5 mL (120 mL) [alcohol free, sugar free; contains methylparaben, propylene glycol, propylparaben]

Cetirizine HCl Childrens: 5 mg/5 mL (118 mL) [contains methylparaben, propylene glycol, propylparaben]

Cetirizine HCl Hives Relief: 5 mg/5 mL (120 mL) [alcohol free, sugar free; contains methylparaben, propylene glycol, propylparaben; grape flavor]

Generic: 5 mg/5 mL (120 mL, 473 mL)

Syrup, Oral, as hydrochloride:

Cetirizine HCl Childrens Alrgy: 5 mg/5 mL (118 mL, 120 mL) [contains methylparaben, propylene glycol, propylparaben; grape flavor]

ZyrTEC Childrens Allergy: 5 mg/5 mL (118 mL [DSC]) [contains methylparaben, propylene glycol, propylparaben; banana-grape flavor]

ZyrTEC Childrens Allergy: 5 mg/5 mL (118 mL) [dye free, sugar free; contains propylene glycol, sodium benzoate]

ZyrTEC Childrens Allergy: 5 mg/5 mL (118 mL [DSC]) [dye free, sugar free; contains propylene glycol, sodium benzoate; bubble-gum flavor]

ZyrTEC Childrens Allergy: 5 mg/5 mL (5 mL [DSC], 118 mL) [dye free, sugar free; contains propylene glycol, sodium benzoate; grape flavor]

ZyrTEC Childrens Hives Relief: 5 mg/5 mL (118 mL [DSC]) [grape flavor]

Generic: 5 mg/5 mL (5 mL [DSC], 120 mL, 473 mL [DSC], 480 mL)

Tablet, Oral, as hydrochloride:

All Day Allergy: 10 mg

ZyrTEC Allergy: 10 mg

ZyrTEC Hives Relief: 10 mg [DSC]

Generic: 5 mg, 10 mg

Tablet Chewable, Oral, as hydrochloride:

All Day Allergy Childrens: 10 mg [tutti-frutti flavor]

ZyrTEC Childrens Allergy: 5 mg [DSC] [grape flavor]

ZyrTEC Childrens Allergy: 10 mg [DSC] [contains fd&c blue #2 aluminum lake; grape flavor]

Generic: 5 mg, 10 mg

Tablet Disintegrating, Oral, as hydrochloride:

ZyrTEC Allergy: 10 mg

ZyrTEC Allergy Childrens: 10 mg [DSC]

ZyrTEC Allergy Childrens: 10 mg [citrus flavor]

Brand Names: U.S.

  • All Day Allergy Childrens [OTC]
  • All Day Allergy [OTC]
  • Cetirizine HCl Allergy Child [OTC]
  • Cetirizine HCl Childrens Alrgy [OTC]
  • Cetirizine HCl Childrens [OTC]
  • Cetirizine HCl Hives Relief [OTC]
  • ZyrTEC Allergy Childrens [OTC]
  • ZyrTEC Allergy [OTC]
  • ZyrTEC Childrens Allergy [OTC]
  • ZyrTEC Childrens Hives Relief [OTC] [DSC]
  • ZyrTEC Hives Relief [OTC] [DSC]

Pharmacologic Category

  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, Second Generation
  • Piperazine Derivative

Pharmacology

Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract

Absorption

Rapid

Distribution

Children: 0.7 L/kg ; Adults: 0.56 L/kg (Simons 1999)

Metabolism

Limited hepatic

Excretion

Urine (70%; 50% as unchanged drug); feces (10%)

Onset of Action

Suppression of skin wheal and flare: 0.7 hours (Simons, 1999)

Time to Peak

Serum: 1 hour

Duration of Action

Suppression of skin wheal and flare: ≥24 hours (Simons, 1999)

Half-Life Elimination

Children: 6.2 hours; Adults: 8 hours

Protein Binding

Plasma: Mean: 93%

Use: Labeled Indications

Upper respiratory allergies: Temporarily relieves symptoms of upper respiratory allergies.

Urticaria: Relieves itching due to urticaria.

Contraindications

Hypersensitivity to cetirizine, hydroxyzine, or any component of the formulation

Dosing: Adult

Upper respiratory allergies, urticaria: Oral: 5 to 10 mg once daily, depending upon symptom severity (maximum dose: 10 mg daily)

Dosing: Geriatric

Upper respiratory allergies, urticaria: Oral: 5 mg once daily (maximum dose: 5 mg daily). The previously available prescription product recommended a maximum dose of 10 mg once daily in patients <77 years of age or 5 mg once daily in patients ≥77 years of age (Zyrtec Prescribing Information, 2006).

Dosing: Pediatric

Upper respiratory allergies, urticaria: Oral:

Infants 6 to <12 months: 2.5 mg once daily

Children 12 months to <2 years: 2.5 mg once daily; may increase to a maximum dose of 2.5 mg every 12 hours if needed

Children 2 to 5 years: Initial: 2.5 mg once daily; may be increased to a maximum dose of 2.5 mg every 12 hours or 5 mg once daily

Children ≥6 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; however, the following adjustments have been recommended (Aronoff, 2007):

Adults:

GFR >50 mL/minute: No dosage adjustment necessary.

GFR ≤50 mL/minute: 5 mg once daily

Intermittent hemodialysis: 5 mg once daily; 5 mg 3 times per week may also be effective.

Peritoneal dialysis: 5 mg once daily.

Infants, Children, and Adolescents:

GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.

GFR 10 to 29 mL/minute/1.73 m2: Decrease dose by 50%.

GFR <10 mL/minute/1.73 m2: Not recommended.

Intermittent hemodialysis or peritoneal dialysis: Decrease dose by 50%.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

May be administered with or without food.

Chewable tablet: Chew tablet before swallowing; may be taken with or without water.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Test Interactions

May cause false-positive serum TCA screen. May suppress the wheal and flare reactions to skin test antigens.

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

Disease-related concerns:

• Hepatic impairment: Use with caution.

• Renal impairment: Use with caution; consider dosage adjustment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.

Special populations:

• Elderly: Use with caution in elderly patients; may be more sensitive to adverse effects.

Monitoring Parameters

Relief of symptoms, sedation and anticholinergic effects

Pregnancy Considerations

Maternal use of cetirizine has not been associated with an increased risk of major malformations. Cetirizine may be used for the treatment of rhinitis and urticaria during pregnancy (NAEPP 2005; Wallace 2008; Zuberbier 2014).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue or dry mouth. Have patient report immediately to prescriber severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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