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Cetirizine Hydrochloride / Pseudoephedrine Hydrochloride

Pronunciation: se-TIR-i-zeen HYE-droe-KLOR-ide/SOO-doe-e-FED-rin HYE-droe-KLOR-ide
Class: Upper respiratory combinations

Trade Names

Zyrtec-D 12 Hour
- Tablets, extended-release cetirizine hydrochloride 5 mg/pseudoephedrine hydrochloride 120 mg

Reactine Allergy & Sinus (Canada)

Indications and Usage

Relief of nasal and non-nasal symptoms associated with seasonal or perennial allergic rhinitis.

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Contraindications

Narrow-angle glaucoma; urinary retention; severe hypertension; severe coronary artery disease; patients receiving MAOIs or within 14 days of stopping such treatment; hypersensitivity to any component of the product, adrenergic agents, or other drugs of similar chemical structure; manifestations of patient idiosyncrasy to adrenergic agents, including arrhythmias, dizziness, insomnia, tremor, or weakness.

Dosage and Administration

Adults and Children 12 yr of age and older Maximum dose

Cetirizine 20 mg/day; pseudoephedrine 240 mg/day

Usual dosage

One 12-h tablet (cetirizine 5 mg/pseudoephedrine 120 mg) by mouth twice a day.

Hepatic or Renal Function Impairment
Adults and Children 12 yr of age and older

PO One 12-h tablet (cetirizine 5 mg/pseudoephedrine 120 mg) once daily in patients on hemodialysis (CrCl less than 7 mL/min), with hepatic function impairment, or with decreased renal function (CrCl 11 to 31 mL/min).

General Advice

  • May be taken with or without food.
  • Patients must swallow ER tablet whole and should not break or chew.

Storage/Stability

Store at 68° to 77°F.

Drug Interactions

Antihypertensive agents that interfere with sympathetic activity (eg, mecamylamine, methyldopa, reserpine)

Antihypertensive effects of these agents may be reduced.

Digitalis

Increased ectopic pacemaker activity.

MAOIs (eg, phenelzine)

Coadministration is contraindicated with pseudoephedrine and for 14 days after stopping the MAOI.

Sympathomimetic amines

Additive or potentiated effects on the CV system.

Laboratory Test Interactions

Positive reactions to skin tests may be prevented or diminished.

Adverse Reactions

CNS

Insomnia (4%); fatigue, somnolence (2%); dizziness (1%).

EENT

Pharyngitis (2%); epistaxis (1%).

GI

Dry mouth (4%).

Respiratory

Sinusitis (1%).

Miscellaneous

Accidental injury (1%).

Precautions

Pregnancy

Category C .

Lactation

Both ingredients are excreted in breast milk.

Children

Safety and efficacy not established in children younger than 12 yr of age.

Elderly

Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Special Risk Patients

Use with caution in patients with diabetes mellitus, hypertension, hyperthyroidism, increased IOP, ischemic heart disease, prostatic hypertrophy, or renal function impairment.

Cognitive and motor impairment

Caution patients about operating potentially hazardous machinery (eg, driving) until they know whether the drug impairs their ability. Avoid use of alcohol.

Overdosage

Symptoms

Cetirizine

Drowsiness, irritability, somnolence.

Pseudoephedrine

Anxiety, cardiac arrhythmias, circulatory collapse, coma, convulsions, difficulty in micturition, giddiness, headache, insomnia, muscular weakness, nausea, palpitations, precordial pain, respiratory failure, restlessness, sweating, tachycardia, tenseness, thirst, toxic psychosis with delusions and hallucinations, vomiting.

Patient Information

  • Instruct patient regarding how to store, administer, and dispose of outdated medication.

Copyright © 2009 Wolters Kluwer Health.

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