Pediatric studies were conducted with cetirizine hydrochloride. More
than 1300 pediatric patients aged 6 to 11 years with more than 900
treated with cetirizine hydrochloride at doses of 1.25 to 10 mg per day
were included in controlled and uncontrolled clinical trials conducted
in the United States. The duration of treatment ranged from 2 to 12
weeks. Placebo-controlled trials up to 4 weeks duration included 168
pediatric patients aged 2 to 5 years who received cetirizine, the
majority of whom received single daily doses of 5 mg. A
placebo-controlled trial 18 months in duration included 399 patients
aged 12 to 24 months treated with cetirizine (0.25 mg/kg bid), and
another placebo-controlled trial of 7 days duration included 42
patients aged 6 to 11 months who were treated with cetirizine (0.25
mg/kg bid).
The majority of adverse reactions reported in
pediatric patients aged 2 to 11 years with cetirizine hydrochloride
were mild or moderate. In placebo-controlled trials, the incidence of
discontinuations due to adverse reactions in pediatric patients
receiving up to 10 mg of cetirizine hydrochloride was uncommon (0.4% on
cetirizine hydrochloride vs. 1.0% on placebo).
Table 1 lists
adverse experiences which were reported for cetirizine hydrochloride 5
and 10 mg in pediatric patients aged 6 to 11 years in
placebo-controlled clinical trials in the United States and were more
common with cetirizine hydrochloride than placebo. Of these, abdominal
pain was considered treatment-related and somnolence appeared to be
dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg. The
adverse experiences reported in pediatric patients aged 2 to 5 years in
placebo-controlled trials were qualitatively similar in nature and
generally similar in frequency to those reported in trials with
children aged 6 to 11 years.
In the placebo-controlled trials
of pediatric patients 6 to 24 months of age, the incidences of adverse
experiences, were similar in the cetirizine and placebo treatment
groups in each study. Somnolence occurred with essentially the same
frequency in patients who received cetirizine and patients who received
placebo. In a study of 1 week duration in children 6 to 11 months of
age, patients who received cetirizine exhibited greater
irritability/fussiness than patients on placebo. In a study of 18
months duration in patients 12 months and older, insomnia occurred more
frequently in patients who received cetirizine compared to patients who
received placebo (9.0% v. 5.3%). In those patients who received 5 mg or
more per day of cetirizine as compared to patients who received
placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) occurred
more frequently.
The following events were observed infrequently (less than 2%), in either 3982 adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received cetirizine hydrochloride in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with cetirizine hydrochloride 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 hydrochloride has been reported.
Post-Marketing Experience
In the post-marketing period, the following additional rare, but potentially severe adverse events have been reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide and thrombocytopenia.