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Zyrtec-D (Cetirizine and Pseudoephedrine) – Oral

STORAGE: Store at 20°C to 25°C (68° to 77°F)

Zyrtec-D

Zyrtec-D is a prescription medicine used to treat the symptoms of sneezing, itching, watery eyes and a runny nose associated with allergies (Allergic Rhinitis). Zyrtec-D may be used alone or with other medications.

Zyrtec-D belongs to a class of drugs called Antihistamine/Decongestant Combos.

It is not known if Zyrtec-D is safe and effective in children younger than 12 years of age.

What are the possible side effects of Zyrtec-D?

Zyrtec-D may cause serious side effects including:

fast, pounding, or uneven heartbeats,
weakness,
tremors,
severe restless feeling,
hyperactivity,
extreme feeling of fear or confusion,
vision problems,
little or no urinating,
severe headache,
buzzing in your ears,
chest pain, and
shortness of breath

Get medical help right away, if you have any of the symptoms listed above.

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The most common side effects of Zyrtec-D include:

dizziness,
drowsiness,
tired feeling,
sleep problems (insomnia),
dry mouth,
nausea,
stomach pain,
constipation, and
trouble concentrating

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Zyrtec-D. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

ZYRTEC-D® (cetirizine, pseudoephedrine) Tablets (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) Extended Release Tablets for oral administration contain 5 mg of cetirizine hydrochloride for immediate release and 120 mg of pseudoephedrine hydrochloride for extended release in a bilayer tablet. Tablets also contain as inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

Cetirizine hydrochloride, one of the two active components of ZYRTEC-D (cetirizine, pseudoephedrine) Tablets, is an orally active and selective H₁-receptor antagonist. The chemical name is (+/-)- [2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C₂₁H₂₅ClN₂O₃•2HCl. The molecular weight is 461.82. Cetirizine hydrochloride is a white, crystalline powder and is water-soluble.

Pseudoephedrine hydrochloride, the other active ingredient of ZYRTEC-D (cetirizine, pseudoephedrine) Tablets, is an adrenergic (vasoconstrictor) agent with the chemical name (1S.2S)-2-methylamino-1-phenyl-1-propanol hydrochloride. The molecular weight is 201.70. The molecular formula is C₁₀H₁₅NO•HCl. Pseudoephedrine hydrochloride occurs as fine, white to off-white crystals or powder, having a faint characteristic odor. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in chloroform.

Active Ingredients

Active ingredient (in each extended release tablet)	Purpose
Cetirizine HCl 5 mg	Antihistamine
Pseudoephedrine HCl 120 mg mg	Nasal decongestant

Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Indications & Dosage

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INDICATIONS

ZYRTEC-D® (cetirizine, pseudoephedrine) Tablets should be administered when both the antihistaminic properties of cetirizine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired.

ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are indicated for the relief of nasal and non-nasal symptoms associated with seasonal or perennial allergic rhinitis in adults and children 12 years of age and older.

DOSAGE AND ADMINISTRATION

Do not break or chew tablet; swallow tablet whole

Adults and Children 12 Years and over:
take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours

Adults 65 years and over:
Ask a doctor

Children under 12 years of age:
Ask a doctor

Consumers with liver or kidney disease:
Ask a doctor

ZYRTEC-D (cetirizine, pseudoephedrine) Tablets may be given with or without food.

HOW SUPPLIED

ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are white, round, biconvex, bilayer tablets containing 5 mg cetirizine hydrochloride in an immediate release layer and 120 mg pseudoephedrine hydrochloride in an extended release layer. ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are supplied in high-density polyethylene bottles of 100 tablets fitted with polypropylene child-resistant closures (NDC 0069-1630-66).

ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are engraved with ZYRTEC-D (cetirizine, pseudoephedrine) on one side.

STORAGE: Store at 20°C to 25°C (68° to 77°F)

For questions contact McNEIL-PPC, Inc at 1.800.343.7805

QUESTION

Side Effects

SIDE EFFECTS

ZYRTEC-D (cetirizine, pseudoephedrine) Tablets

In two double-blind, placebo-controlled trials (n = 2094) in which 701 patients with seasonal allergic rhinitis were treated with ZYRTEC-D (cetirizine, pseudoephedrine) Tablets (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) twice daily for two weeks, the percent of patients who withdrew prematurely due to adverse events was 2.0% in the ZYRTEC-D (cetirizine, pseudoephedrine) group, compared with 1.1% in the placebo group. All adverse events that were reported by greater than 1% of patients in the ZYRTEC-D (cetirizine, pseudoephedrine) group are listed in Table 1.

TABLE 1. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN SEASONAL ALLERGIC RHINITIS TRIALS OF ZYRTEC-D (cetirizine, pseudoephedrine) TABLETS AT RATES OF 1% OR GREATER (PERCENT INCIDENCE)

ADVERSE EXPERIENCE	ZYRTEC-D	PLACEBO
(n = 701)	(n = 696)
Insomnia	4.0	0.6
Dry Mouth	3.6	0.4
Fatigue	2.4	0.9
Somnolence	1.9	0.1
Pharyngitis	1.7	1.1
Epistaxis	1.1	0.9
Accidental Injury	1.1	0.4
Dizziness	1.1	0.1
Sinusitis	1.0	0.6

ZYRTEC Tablets

Controlled and uncontrolled clinical trials of cetirizine conducted in the United States and Canada included more than 6000 patients aged 12 years and older, with more than 3900 receiving cetirizine at doses of 5 to 20 mg per day. The duration of treatment ranged from 1 week to 6 months, with a mean exposure of 30 days.

Most adverse reactions reported during therapy with cetirizine were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving cetirizine 5 mg or 10 mg was not significantly different from placebo (2.9% vs. 2.4%, respectively).

The most common adverse reaction in patients aged 12 years and older that occurred more frequently on cetirizine than placebo was somnolence. The incidence of somnolence associated with cetirizine was dose related, 6% in placebo, 11% at 5 mg and 14% at 10 mg. Discontinuations due to somnolence for cetirizine were uncommon (1.0% on cetirizine vs. 0.6% on placebo). Fatigue and dry mouth also appeared to be treatment-related adverse reactions. There were no differences by age, race, gender or by body weight with regard to the incidence of adverse reactions.

Table 2 lists adverse experiences in patients aged 12 years and older that were reported for cetirizine 5 and 10 mg in controlled clinical trials in the United States and were more common with cetirizine than placebo.

In addition, headache and nausea occurred in more than 2% of the patients, but were more common in placebo patients.

The following events were observed infrequently (less than 2%), in 3982 adults and children 12 years and older or in 659 pediatric (6 to 11 years) patients who received cetirizine in U.S. trials, including an open study of six months duration. A causal relationship of these infrequent events with cetirizine administration has not been established.

Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.

Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine, myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.

Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

Body as a Whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of cetirizine has been reported.

In foreign marketing experience or experience in the post market period, the following additional rare, but potentially severe adverse events have been reported: anaphylaxis, cholestasis, glomerulonephritis, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, thrombocytopenia, aggressive reaction and convulsions.

Pseudoephedrine hydrochloride may cause mild CNS stimulation in hypersensitive patients.

Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, nausea, drowsiness, tachycardia, palpitation, pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic drugs have also been associated with other untoward effects such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.

Drug Interactions

DRUG INTERACTIONS

Cetirizine hydrochloride and pseudoephedrine hydrochloride do not influence the pharmacokinetics of each other when administered concomitantly.

No clinically significant drug interactions have been found with cetirizine and theophylline at a low dose, azithromycin, ketoconazole, or erythromycin. There was a small decrease in the clearance of cetirizine caused by a 400 mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect.

Due to the pseudoephedrine component, ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are contraindicated in patients taking monoamine oxidase (MAO) inhibitors and for 14 days after stopping use of an MAO inhibitor. Concomitant use with antihypertensive drugs that interfere with sympathetic activity (e.g., methyldopa, mecamylamine, and reserpine) may reduce their antihypertensive effects. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. Care should be taken in the administration of ZYRTEC-D (cetirizine, pseudoephedrine) Tablets concomitantly with other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient (see WARNINGS).

WARNINGS

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy (see CONTRAINDICATIONS). Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly are more likely to have adverse reactions to sympathomimetic amines.

Precautions

PRECAUTIONS

Due to its pseudoephedrine component, ZYRTEC-D (cetirizine, pseudoephedrine) Tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy (see WARNINGS and CONTRAINDICATIONS). Patients with decreased renal function should be given a lower initial dose (one tablet per day) because they have reduced elimination of cetirizine and pseudoephedrine (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Activities Requiring Mental Alertness

In clinical trials, the occurrence of somnolence has been reported in some patients taking cetirizine or ZYRTEC-D (cetirizine, pseudoephedrine) Tablets; due caution should therefore be exercised when driving a car or operating potentially dangerous machinery after taking ZYRTEC-D (cetirizine, pseudoephedrine) Tablets. Concurrent use of ZYRTEC-D (cetirizine, pseudoephedrine) Tablets with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

OVERDOSE

Information regarding acute overdosage is limited to experience with cetirizine alone and the marketing history of pseudoephedrine hydrochloride.

Overdosage has been reported with cetirizine. In one adult patient who took 150 mg of cetirizine, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an 18-month-old pediatric patient who took an overdose of cetirizine (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness. Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to cetirizine. Cetirizine is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested. The acute minimal lethal oral doses in mice and rats were 237 and 562 mg/kg, respectively (approximately 95 and 460 times the maximum recommended daily dose in adults on a mg/m 2 basis). In rodents, the target of acute toxicity was the central nervous system, and the target of multiple-dose toxicity was the liver.

In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.

Contraindications

CONTRAINDICATIONS

ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are contraindicated in patients with a known hypersensitivity to any of its ingredients or to hydroxyzine.

Due to its pseudoephedrine component, ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment (see PRECAUTIONS, Drug Interactions section). It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include insomnia, dizziness, weakness, tremor, or arrhythmias.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Mechanisms of Action

Cetirizine, a metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of H₁ receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and Ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical trials, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H₁ receptors. Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H₁ receptors.

Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects.

The bioavailability of cetirizine hydrochloride and pseudoephedrine hydrochloride from ZYRTEC-D (cetirizine, pseudoephedrine) Tablets is not significantly different from that achieved with separate administration of a cetirizine 5 mg tablet and a pseudoephedrine 120 mg extended release caplet. Co-administration of cetirizine and pseudoephedrine does not significantly affect the bioavailability of either component.

Following a single dose of the ZYRTEC-D (cetirizine, pseudoephedrine) Tablet, a mean peak plasma concentration (Cmax) of 114 ng/mL at a time (Tmax) of 2.2 hours postdose was observed for cetirizine and a mean Cmax of 309 ng/mL at a Tmax of 4.4 hours postdose was observed for pseudoephedrine.

When healthy volunteers were administered multiple doses of the ZYRTEC-D (cetirizine, pseudoephedrine) Tablet to reach steady-state concentrations (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg twice daily for seven days), a mean Cmax of 178 ng/mL was observed for cetirizine and 526 ng/mL for pseudoephedrine.

Food had no significant effect on the extent of cetirizine absorption (AUC), but Tmax was delayed by 1.8 hours and Cmax was decreased by 30%. Food had no significant effect on the pharmacokinetics of pseudoephedrine. ZYRTEC-D (cetirizine, pseudoephedrine) Tablets may be given with or without food (see DOSAGE AND ADMINISTRATION).

The mean plasma protein binding of cetirizine is 93%, independent of concentration in the range of 25-1000 ng/mL, which includes the therapeutic plasma levels observed. The apparent volume of distribution (V/F) of pseudoephedrine has been reported to be 2.6-3.3 L/kg. No plasma protein binding data in humans are available.

A human mass balance study of cetirizine in 6 healthy male volunteers indicated that 70% of the administered radioactivity was recovered in the urine and 10% in the feces. Approximately 50% of the radioactivity was identified in the urine as unchanged drug. Most of the rapid increase in peak plasma radioactivity was associated with parent drug, suggesting low first pass metabolism. Cetirizine is metabolized to a limited extent by oxidative O-dealkylation to a metabolite with negligible antihistaminic activity. The enzyme or enzymes responsible for this metabolism have not been identified.

One to seven percent of the pseudoephedrine dose appeared to be metabolized to norpseudoephedrine by N-demethylation after a single dose.

Elimination

After administration of the ZYRTEC-D (cetirizine, pseudoephedrine) Tablet, the mean elimination half-life of cetirizine was 7.9 hours and the mean elimination half-life of pseudoephedrine was 6.0 hours.

It was reported that 0.4-0.7% of the pseudoephedrine dose was estimated to be excreted in the breast milk over 24 hours after a single dose. The pattern of the relative milk/plasma drug concentration profile showed that pseudoephedrine concentrations in milk were 2- to 3-fold higher than those in plasma.

DRUG INTERACTIONS

Pharmacokinetic interaction trials with cetirizine in adults were conducted with pseudoephedrine, antipyrine, ketoconazole, erythromycin and azithromycin. No interactions were observed. In a multiple dose study of theophylline (400 mg once daily for 3 days) and cetirizine (20 mg once daily for 3 days), a 16% decrease in the clearance of cetirizine was observed. The disposition of theophylline was not altered by concomitant cetirizine administration.

Pediatrics: Although cetirizine pharmacokinetics have been studied in children, ZYRTEC-D (cetirizine, pseudoephedrine) Tablets contain 120 mg of pseudoephedrine hydrochloride, which exceeds the recommended dose for patients less than 12 years of age. Therefore, ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are not recommended for patients under 12 years of age.

Geriatrics: Following a single, 10-mg oral dose of cetirizine, the elimination half-life was prolonged by 50% and the apparent total body clearance was 40% lower in 16 geriatric subjects with a mean age of 77 years compared to 14 adult subjects with a mean age of 53 years. The decrease in cetirizine clearance in these elderly volunteers may be related to decreased renal function.

The pharmacokinetics of pseudoephedrine has not been adequately studied in geriatric subjects.

Gender: The effect of gender on cetirizine or pseudoephedrine pharmacokinetics has not been adequately studied.

Race: The effect of race on cetirizine or pseudoephedrine pharmacokinetics has not been adequately studied.

Renal Impairment: The kinetics of cetirizine were studied following multiple, oral, 10-mg daily doses of cetirizine for 7 days in 7 normal volunteers (creatinine clearance 89-128 mL/min), 8 patients with mild renal function impairment (creatinine clearance 42-77 mL/min) and 7 patients with moderate renal function impairment (creatinine clearance 11-31 mL/min). The pharmacokinetics of cetirizine were similar in patients with mild impairment and normal volunteers. Moderately impaired patients had a 3-fold increase in half-life and a 70% decrease in clearance compared to normal volunteers.

Patients on hemodialysis (n=5) given a single, 10-mg dose of cetirizine had a 3-fold increase in half-life and a 70% decrease in clearance compared to normal volunteers. Less than 10% of the administered dose was removed during the single dialysis session.

About 55-75% of an administered dose of pseudoephedrine hydrochloride is excreted unchanged in the urine; the remainder is apparently metabolized in the liver. Therefore, pseudoephedrine may accumulate in patients with renal insufficiency.

Dosing adjustment is necessary in patients with moderate or severe renal impairment and in patients on dialysis (see DOSAGE AND ADMINISTRATION).

Hepatic Impairment: Sixteen patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis), given 10 or 20 mg of cetirizine as a single, oral dose had a 50% increase in half-life along with a corresponding 40% decrease in clearance compared to 16 healthy subjects.

The effect of hepatic impairment on pseudoephedrine pharmacokinetics is unknown.

Dosing adjustment may be necessary in patients with hepatic impairment (see DOSAGE AND ADMINISTRATION).

Pharmacodynamics: Trials in 69 adult normal volunteers (aged 20-61 years) showed that cetirizine at doses of 5 and 10 mg inhibited the skin wheal and flare caused by the intradermal injection of histamine. The onset of this activity after a single 10-mg dose occurred within 20 minutes in 50% of subjects and within one hour in 95% of subjects; this activity persisted for at least 24 hours. The effects of intradermal injection of various other mediators or histamine releasers were also inhibited by cetirizine. In mildly asthmatic subjects, cetirizine at 5 to 20 mg blocked bronchoconstriction due to nebulized histamine, with virtually total blockade after a 20 mg dose. In trials conducted for up to 12 hours following cutaneous antigen challenge, the late phase recruitment of eosinophils, neutrophils and basophils, components of the allergic inflammatory response, was inhibited by cetirizine at a dose of 20 mg. The clinical significance of these findings is not known.

In four clinical trials in healthy adult males, no clinically significant mean increases in QTc were observed in cetirizine treated subjects. In the first study, a placebo-controlled crossover trial, cetirizine was given at doses up to 60 mg per day, 6 times the maximum clinical dose, for 1 week, and no significant mean QTc prolongation occurred. In the second study, a crossover trial, cetirizine 20 mg and erythromycin (500 mg every 8 hours) were given alone and in combination. There was no significant effect on QTc with the combination or with cetirizine alone. In the third trial, also a crossover study, cetirizine 20 mg and ketoconazole (400 mg per day) were given alone and in combination. Cetirizine caused a mean increase in QTc of 9.1 msec from baseline after 10 days of therapy. Ketoconazole also increased QTc by 8.3 msec. The combination caused an increase of 17.4 msec, equal to the sum of the individual effects. Thus, there was no significant drug interaction on QTc with the combination of cetirizine and ketoconazole. In the fourth study, a placebo-controlled parallel trial, cetirizine 20 mg was given alone or in combination with azithromycin (500 mg as a single dose on the first day followed by 250 mg once daily). There was no significant increase in QTc with cetirizine 20 mg alone or in combination with azithromycin.

In a six-week, placebo-controlled study of 186 patients (aged 12-64 years) with allergic rhinitis and mild to moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms and did not alter pulmonary function. This study supports the safety of administering cetirizine to allergic rhinitis patients with mild to moderate asthma.

ZYRTEC-D (cetirizine, pseudoephedrine) Tablets: Two multicenter, randomized, double-blind, placebo-controlled clinical trials (n = 1094 and n = 1000) comparing ZYRTEC-D (cetirizine, pseudoephedrine) Tablets (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) to active control and placebo for two weeks in patients 12 years and older with seasonal allergic rhinitis were conducted in the United States. In the two trials, 390 patients were aged 12 to 17 years. The primary efficacy measure in both trials was the mean change from baseline in the subject-rated Total Symptom Severity Complex (TSSC) score, which included the following symptoms: sneezing, runny nose, itchy nose, itchy eyes, watery eyes, postnasal drip, and nasal congestion. In both trials patients who received ZYRTEC-D (cetirizine, pseudoephedrine) showed a significant reduction in the TSSC score compared to those who received placebo.

Zyrtec Tablets: Nine multicenter, randomized, double-blind, clinical trials comparing cetirizine 5 to 20 mg to placebo in patients 12 years and older with seasonal or perennial allergic rhinitis were conducted in the United States. Five of these showed significant reductions in symptoms of allergic rhinitis, 3 in seasonal allergic rhinitis (1 to 4 weeks in duration) and 2 in perennial allergic rhinitis for up to 8 weeks in duration. In general, the 10 mg dose was more effective than the 5 mg dose and the 20 mg dose gave no added effect. Some of these trials included pediatric patients aged 12 to 16 years.

Zyrtec-D (Cetirizine and Pseudoephedrine) – Oral

Karen Berger, PharmD, is a community pharmacist and medical writer/reviewer.

Published on July 21, 2022

Femi Aremu, PharmD, is a professional pharmacist with experience in clinical and community pharmacy. He currently practices in Chicago, Illinois.

Additional Content by IBM Micromedex ®
Table of Contents
Table of Contents

What Is Zyrtec-D?

Zyrtec -D ( cetirizine and pseudoephedrine ) is a combination medication used to temporarily relieve symptoms from hay fever, or allergies (e.g., sneezing; itchy nose, throat, and eyes; watery eyes; and a runny or stuffy nose).

Zyrtec-D blocks the effects of histamine (a substance produced in the body in response to allergens) and reduces swelling in the nasal passages to relieve sinus congestion and pressure, making it easier to breathe through the nose.

Note that Zyrtec-D is not the same as Zyrtec. Zyrtec is an over-the-counter (OTC) medication that only contains cetirizine (antihistamine). The D in Zyrtec-D stands for decongestant because it also includes the decongestant pseudoephedrine. This article will focus on Zyrtec-D. Zyrtec-D is available as an extended-release tablet that is taken by mouth.

Cetirizine

Cetirizine is a second-generation antihistamine. Second-generation antihistamines cause less sedation (drowsiness) than first-generation antihistamines, such as Benadryl (diphenhydramine). As an antihistamine, cetirizine works by blocking the effects of histamine to reduce allergy symptoms.

Pseudoephedrine

Pseudoephedrine is a decongestant. It works by shrinking swollen nasal membranes, which helps reduce swelling and congestion and makes it easier to breathe through the nose.

Because it contains pseudoephedrine, Zyrtec-D must be sold from behind the pharmacy counter by law. Pseudoephedrine can be used to make methamphetamine (an illegal drug also known as meth). For this reason, people who purchase medications containing pseudoephedrine can only buy a certain amount each month and must show photo identification. Zyrtec-D does not require a prescription in most states, but some may require one.

Drug Facts

Generic Name: Cetirizine and pseudoephedrine

Brand Name(s): Zyrtec-D

Drug Availability: Behind the pharmacy counter, subject to certain requirements and sale limitations

Therapeutic Classification: Antihistamine and decongestant

Available Generically: Yes

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Cetirizine and pseudoephedrine

Dosage Form(s): Extended-release tablet

What Is Zyrtec-D Used For?

Zyrtec-D is used to temporarily relieve allergy/hay fever symptoms, including:

Runny or stuffy nose
Sneezing
Watery, itchy eyes
Itchy nose and throat

How to Take Zyrtec-D

Read the information label and take it as directed. Do not take more than the appropriate dose.

For adults and adolescents 12 years or older, take one tablet every 12 hours. Do not exceed two tablets per day (24 hours). Swallow the tablet whole. Do not chew, crush, or break them.

One side effect of this medication is drowsiness, which can be enhanced by alcohol and other drugs used for sleep, anxiety, and severe pain. Avoid combining these substances and try not to do any activities that may be dangerous while experiencing drowsiness until you know Zyrtec-D will affect you.

Storage

Store Zyrtec-D at room temperature. Keep out of sight and reach of children and pets.

How Long Does Zyrtec-D Take to Work?

Zyrtec-D starts to relieve symptoms in about an hour. You may need to take Zyrtec-D regularly to keep allergy symptoms at bay. Ask your healthcare provider when you should start taking Zyrtec-D and how long you should take it. Many healthcare providers recommend starting allergy medicine about two weeks before symptoms are expected to begin.

What Are the Side Effects of Zyrtec-D?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 1-800-FDA-1088.

Like other medications, Zyrtec-D can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication. Side effects can occur from one or both ingredient(s) in Zyrtec-D.

Common Side Effects

Common side effects of Zyrtec-D include:

Anxiety
Sedative effects, like dizziness or drowsiness
Dry mucous membranes
Headache
Increased blood pressure
Gastrointestinal effects, like nausea, vomiting, or diarrhea
Sore throat
Stomach pain
Heart palpitations (feeling like the heart is beating fast, fluttering, or pounding) or tachycardia (fast heart rate)
Tremor (involuntary shaking)
Trouble sleeping
Trouble urinating

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include:

Hypersensitivity reaction or anaphylaxis: Symptoms can include rash, hives, swelling around the lips, tongue, and face, difficulty breathing, and require emergency medical attention.
Arrhythmia (irregular heartbeat)
Bronchospasm (tightening of the airways, which can cause wheezing and coughing)
Hemolytic anemia (this occurs when red blood cells are destroyed faster than they are made)
Liver problems
High or low blood pressure
Seizures
Severe skin reaction
Fainting
Low platelet levels, which can cause bleeding and bruising

Long-Term Side Effects

While many people tolerate Zyrtec-D well, long-term or delayed side effects are possible. These may include:

Report Side Effects

Zyrtec-D may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Zyrtec-D Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex ®

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Swallow the extended-release tablet whole. Do not crush, break, or chew before swallowing.

For oral dosage form (extended release tablets):
- For relief of symptoms from seasonal or yearly allergies:
  - Adults and children 12 years of age and older—Take one tablet two times a day with or without food.
  - Children 4 to 12 years of age—Use and dose must be determined by your doctor.
  - Children and infants up to 4 years of age—Use is not recommended .
  Modifications
  
  Consult a healthcare provider about dosing:
  - For children under age 12
  - If you are 65 or older
  - If you have kidney or liver problems
  - If you are pregnant
  People who are breastfeeding should not use Zyrtec-D.
  
  Missed Dose
  
  If you miss a dose of Zyrtec-D, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Do not double up on doses to make up for a missed dose.
  
  Overdose: What Happens If I Take Too Much Zyrtec-D?
  
  Although Zyrtec-D is generally safe to take, it is possible to overdose if consumed in high amounts.
  
  Overdoses have been reported with cetirizine alone. Doses ranging from 150 milligrams (mg) to 180 milligrams have been observed to cause adverse reactions in people. Signs that you have taken too much cetirizine can include:
  - Sleepiness
  - Restlessness
  - Irritability
  The maximum dose of pseudoephedrine is:
  - 240 milligrams for adults
  - 120 milligrams for children 6 to 12 years
  - 60 milligrams for children 2 to 5 years
  Symptoms of a pseudoephedrine overdose can include, but are not limited to:
  - Headache
  - Dizziness
  - Anxiety
  - Sedation
  - High or low blood pressure
  - Nausea or vomiting
  In children, signs of a pseudoephedrine overdose are more likely to include:
  - Dry mouth
  - Wide, rigid pupils
  - Hot flushes
  - Fever
  - Digestive tract problems
  What Happens If I Overdose on Zyrtec-D?
  
  If you think you or someone else may have overdosed on Zyrtec-D, call a healthcare provider or the Poison Control Center (800-222-1222).
  
  If someone collapses or isn’t breathing after taking Zyrtec-D, call 911 immediately.
  
  Precautions
  
  Drug Content Provided and Reviewed by IBM Micromedex ®
  
  The antihistamine in this medicine will add to the effects of alcohol and other CNS depressants including tricyclic antidepressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are other antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Examples of Tricyclic antidepressants are amitriptyline [e.g. Elavil], amoxapine [e.g. Asendin], clomipramine [e.g. Anafranil], desipramine [e.g. Pertofrane], doxepine [e.g. Sinequan], imipramine [e.g. Tofranil], nortriptyline [e.g. Aventyl], protriptyline [Vivactil], trimipramine [e.g. Surmontil]. Check with your doctor before taking any of the above while you are taking this medicine.
  
  The antihistamine in this medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
  
  Antihistamines may cause dryness of the mouth, nose, and throat. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
  
  The decongestant in this medicine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.
  
  What Are Reasons I Shouldn’t Take Zyrtec-D?
  
  Zyrtec-D is not appropriate for everyone. You should not take this medication if allergic to cetirizine, pseudoephedrine, or any inactive ingredients in Zyrtec-D. People allergic to Vistaril (hydroxyzine) also should not take Zyrtec-D.
  
  Others who should not take Zyrtec-D include those:
  - With heart disease
  - With angle-closure glaucoma
  - Who have taken an antidepressant in the monoamine oxidase inhibitor (MAOI) class in the past 14 days
  - In the first trimester of pregnancy
  - With uncontrolled or severely high blood pressure
  - Who have difficulty urinating
  Zyrtec-D may be used cautiously in some people only if the healthcare provider determines it is safe. This includes those:
  - With arrhythmia (irregular heartbeat)
  - Who drink alcohol
  - Who use other medications that cause central nervous system (CNS) depression, which means the brain activity is slowed down, potentially enhancing the effects of drowsiness and slowed breathing
  - With diabetes
  - With kidney or liver problems
  - With high blood pressure
  - With hyperthyroidism
  - In the second or third trimester of pregnancy
  - Who are outside of the recommended age of use of 12 to 65
  What Other Medications May Interact With Zyrtec-D?
  
  Tell your healthcare provider about all your medicines, including prescription drugs, OTC products, and vitamins or supplements.
  
  Zyrtec-D should not be used with the following drugs because of the risk of severe high blood pressure:
  - Migranal, Trudhesa (dihydroergotamine), an analgesic used to treat migraines
  - MAOI drugs, such as Azilect (rasagiline), Marplan (isocarboxazid), Nardil (phenelzine), or Parnate (tranylcypromine), should not be used within 14 days of Zyrtec-D
  Triptan medications, commonly prescribed for migraine, can also increase blood pressure and should only be used with Zyrtec-D if approved by your healthcare provider. Examples of triptans include Imitrex (sumatriptan) and Maxalt (rizatriptan).
  
  Alcohol and drugs that cause CNS depression should not be taken with Zyrtec-D. Examples include:
  - Benzodiazepines (drugs used for anxiety), such as Valium (diazepam) or Xanax (alprazolam)
  - Muscle relaxants such as Flexeril (cyclobenzaprine) or Skelaxin (metaxalone)
  - Opioid pain medications like codeine, oxycodone, OxyContin (oxycodone), Percocet (oxycodone/acetaminophen), Ultram (tramadol), and Anexsia (hydrocodone/acetaminophen)
  - Sleeping medications such as Ambien (zolpidem) or Lunesta (eszopiclone)
  Do not use Zyrtec-D with other antihistamines or decongestants.
  
  Other drug interactions may occur with Zyrtec-D. Consult your healthcare provider for a complete list of drug interactions.
  
  What Medications Are Similar?
  
  Zyrtec-D contains two ingredients: cetirizine and pseudoephedrine.
  
  Cetirizine is a second-generation antihistamine that causes less drowsiness than first-generation antihistamines, such as Benadryl. Zyrtec (without the -D suffix) is an OTC antihistamine. It contains cetirizine without pseudoephedrine. Other OTC second-generation antihistamines include:
  - Allegra (fexofenadine)
  - Claritin (loratadine)
  - Xyzal (levocetirizine)
  These single-ingredient antihistamines are available in a variety of formulations, such as oral tablets, dissolving tablets, and oral liquid.
  
  Clarinex (desloratadine) is a second-generation antihistamine available by prescription.
  
  Similar to Zyrtec-D, some of these are also available as a combination product with pseudoephedrine (and also kept behind the counter like Zyrtec-D):
  - Allegra-D (fexofenadine and pseudoephedrine)
  - Claritin-D (loratadine and pseudoephedrine)
  Clarinex-D is available by prescription and contains desloratadine and pseudoephedrine.
  
  Pseudoephedrine is also commonly known as Sudafed. However, due to the meth epidemic, several forms of Sudafed now exist. Sudafed (pseudoephedrine) products are available behind the pharmacy counter (and may need a prescription in some states). Sudafed PE contains a different decongestant called phenylephrine and is available OTC by itself and in many combination products for flu, cough, and cold.
  
  The medication selection for these products can be extensive and overwhelming, so consult your pharmacist if you need help finding a product.
  
  Frequently Asked Questions
  
  What is Zyrtec-D used for?
  
  Zyrtec-D helps with symptoms of allergy and sinus congestion, such as runny or stuffy nose, itchy/watery eyes, and sneezing.
  
  How does Zyrtec-D work?
  
  Zyrtec-D contains two ingredients. Cetirizine is an antihistamine. It blocks histamine, helping to prevent allergy symptoms. The second ingredient is pseudoephedrine, which is a decongestant. It helps shrink swollen nasal passages, reducing congestion and making it easier to breathe out of the nose.
  
  What drugs should not be taken with Zyrtec-D?
  
  Zyrtec-D interacts with various drugs, such as MAOI antidepressants, anxiety medications, triptans for migraine, and opioid pain medications. Alcohol also should not be mixed with Zyrtec-D. Before taking Zyrtec-D, ask your healthcare provider if it is safe for you to take with your other prescribed and OTC medications.
  
  How long does it take for Zyrtec-D to work?
  
  Zyrtec-D can start working as quickly as an hour. However, you may need to take it regularly to prevent allergy symptoms. Ask your healthcare provider when you should start (and stop) taking it.
  
  What are the side effects of Zyrtec-D?
  
  Common side effects include stomach problems like stomach pain, nausea, vomiting, and diarrhea. Headache, drowsiness, and dizziness are also common side effects. Consult your healthcare provider for more information about side effects.
  
  Why is Zyrtec-D only available from behind the pharmacy counter?
  
  Pseudoephedrine can be made into the illegal drug methamphetamine (also known as meth). In response to the increasing use of illegal meth in the United States, Congress passed the Combat Methamphetamine Epidemic Act of 2005. This law was passed to prevent people from using pseudoephedrine to make meth. Because of this law, any medication that contains pseudoephedrine, including Zyrtec-D, must be sold behind the counter. This law also limits the amount of the medication any individual can purchase and requires photo identification. In most states, Zyrtec-D does not require a prescription, but certain states may require a prescription.
  
  How Can I Stay Healthy While Taking Zyrtec-D?
  
  Talk to your healthcare provider about the best treatment for allergies. It is helpful to see an allergist/immunologist, who can perform allergy testing, and recommend the best treatment for you. If you are at risk of a severe allergic reaction, be sure to carry an epinephrine injection everywhere you go. Wear a medical alert if you have ever had a serious allergic reaction.
  
  In addition to taking Zyrtec-D, you can try some other nonmedicinal measures to prevent allergy symptoms:
  - Monitor pollen and mold counts in weather reports. There are various apps that you can use to do this, along with general news and weather information.
  - Close windows and doors at home and in your car when your allergies are bothering you.
  - After spending time outside, take a shower (wash both your body and hair) and put on clean clothes.
  - Wear an N95 mask when spending time or working outside.
  - Use an air purifier and/or a humidifier.
  Medical Disclaimer
  
  Verywell Health’s drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provide. Consult your healthcare provide before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.
  
  10 Sources
  
  Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. DailyMed. Label: Zyrtec-D Allergy Plus Congestion – cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release.
  2. Epocrates. Zyrtec-D Allergy & Congestion.
  3. Barnes CL, McKenzie CA, Webster KD, Poinsett-Holmes K. Cetirizine: a new, nonsedating antihistamine. Ann Pharmacother. 1993;27(4):464-470. doi:10.1177/106002809302700414
  4. Prescribers’ Digital Reference. Cetirizine hydrochloride/pseudoephedrine hydrochloride – drug summary.
  5. U.S. Food and Drug Administration. Legal requirements for the sale and purchase of drug products containing pseudoephedrine, ephedrine, and phenylpropanolamine.
  6. Epocrates. Zyrtec-D Allergy & Congestion.
  7. Food and Drug Administration. Zyrtec-D 12 Hour (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) extended release tablets for oral use.
  8. Głowacka K, Wiela-Hojeńska A. Pseudoephedrine-benefits and risks. Int J Mol Sci. 2021;22(10):5146. doi:10.3390/ijms22105146
  9. Food and Drug Administration. Migranal label.
  10. American College of Allergy, Asthma & Immunology website. Seasonal allergies.
  By Karen Berger, PharmD
  Karen Berger, PharmD, is a community pharmacist and medical writer/reviewer.

Zyrtec-D (Cetirizine and Pseudoephedrine) – Oral

Zyrtec-D

What are the possible side effects of Zyrtec-D?

DESCRIPTION

3 pharmacies near 97222 have coupons for All Day Allergy-D (Brand Names:Zyrtec-D for 12 Tablets Extended Release 12 Hour)

INDICATIONS

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

QUESTION

SIDE EFFECTS

DRUG INTERACTIONS

WARNINGS

PRECAUTIONS

OVERDOSE

CONTRAINDICATIONS

CLINICAL PHARMACOLOGY

Zyrtec-D (Cetirizine and Pseudoephedrine) – Oral

What Is Zyrtec-D?

Cetirizine

Pseudoephedrine

Drug Facts

What Is Zyrtec-D Used For?

How to Take Zyrtec-D

Storage

How Long Does Zyrtec-D Take to Work?

What Are the Side Effects of Zyrtec-D?

Common Side Effects

Severe Side Effects

Long-Term Side Effects

Report Side Effects

Dosage: How Much Zyrtec-D Should I Take?

Modifications

Missed Dose

Overdose: What Happens If I Take Too Much Zyrtec-D?

What Happens If I Overdose on Zyrtec-D?

Precautions

What Are Reasons I Shouldn’t Take Zyrtec-D?

What Other Medications May Interact With Zyrtec-D?

What Medications Are Similar?

Frequently Asked Questions

How Can I Stay Healthy While Taking Zyrtec-D?

Medical Disclaimer

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