Cetirizine Hydrochloride / Pseudoephedrine Hydrochloride

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

Indications and Usage

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

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

PO One 12-h tablet (cetirizine 5 mg/pseudoephedrine 120 mg) twice daily.

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

General Advice

• May be taken with or without food.
• Patients must swallow extended-release tablet whole and not break or chew.

Storage/Stability

Store at 68° to 77°F.

Drug Interactions

Antihypertensive effects of these agents may be reduced.

Increased ectopic pacemaker activity.

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

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

Drowsiness, irritability, somnolence.

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.

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