Zyrtec-D

Pregnancy Category: C

Lactation: Each ingredient is distributed in breast milk, caution advised

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Do not use cetirizine and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious side effects can occur if you take pseudoephedrine before the MAO inhibitor has cleared from your body.

You should not use cetirizine and pseudoephedrine if you are allergic to either drug, or if you have:

• narrow-angle glaucoma;
• severe high blood pressure (hypertension);
• severe coronary artery disease;
• if you are unable to urinate; or
• if you are allergic to hydralazine (Atarax, Vistaril).

Ask a doctor or pharmacist about using cetirizine and pseudoephedrine if you have:

• heart disease, coronary artery disease, high blood pressure, or heart rhythm disorder;
• diabetes;
• a thyroid disorder;
• glaucoma;
• kidney or liver disease;
• an enlarged prostate; or
• problems with urination.

FDA pregnancy category C. It is not known whether cetirizine and pseudoephedrine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Cetirizine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from cetirizine and pseudoephedrine.

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)

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.

TABLE 2. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN PLACEBO-CONTROLLED UNITED STATES CETIRIZINE TRIALS (MAXIMUM DOSE OF 10 MG) AT RATES OF 2% OR GREATER (PERCENT INCIDENCE)

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.

Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.

Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

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.

Reticuloendothelial: lymphadenopathy.

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.

Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.

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.

Read the entire FDA prescribing information for Zyrtec-D (Cetirizine, Pseudoephedrine)

• Allergy (Allergies)
• Allergy Drugs: Prescription and OTC
• Common Cold
• Hay Fever (Allergic Rhinitis)

Zyrtec-D is an over-the-counter (OTC) medication used for the treatment of hay fever, seasonal allergies, hives, and nasal congestion in adults and children 12 years of age and older. 

It is a single product containing 2 ingredients: Cetirizine and Pseudoephedrine.

Cetirizine belongs to a group of drugs called antihistamines. These works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Pseudoephedrine belongs to a group of drugs called nasal decongestant. These work by causing narrowing of the blood vessels in the nasal passages.

This medication comes as an extended-release tablet to take by mouth, and is usually taken once to twice a day with or without food. Do not chew, divide, or break Zyrtec extended-release tablets. Swallow extended release tablets whole.

Common side effects include drowsiness, headaches, increase in blood pressure, and dry mouth. Do not drive or operate heavy machinery until you know how Zyrtec affects you.

• McNeil Consumer Healthcare Division of McNeil-PPC, Inc.

Zyrtec-D is part of the drug class:

• Piperazine derivatives

Seek emergency medical attention if you think you have used too much of this medicine.

In the U.S.

• ZyrTEC-D

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Antihistamine/Decongestant Combination

Pharmacologic Class: Cetirizine

Chemical Class: Cetirizine

Dosing

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 .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.