ALLERGY RELIEF (cetirizine hcl)

There are 0 contraindications.

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min

There are 6 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
Glaucoma
Hepatic failure
Kidney disease with reduction in glomerular filtration rate (GFr)
Renal disease with moderate to severe function impairment
Urinary retention

There are 22 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare

Abnormal hepatic function tests Acute bacterial otitis media Acute generalized exanthematous pustulosis Anaphylaxis Angioedema Bronchospastic pulmonary disease Cardiac arrhythmia Cholestasis Dehydration Edema Glomerulonephritis Hearing loss Hemolytic anemia Hepatitis Hypersensitivity drug reaction Palpitations Seizure disorder Thrombocytopenic disorder Tongue swelling Tonic clonic seizure Upper respiratory infection Urticaria

There are 91 less severe adverse reactions.

More Frequent	Less Frequent
Drowsy Dry nose Dry throat Headache disorder Xerostomia	Acute abdominal pain Back pain Conjunctivitis Diarrhea Dizziness Drowsy Dysmenorrhea Dyspepsia Epistaxis Fatigue Headache disorder Insomnia Myalgia Nausea Pharyngitis Sinusitis Skin rash Viral infection Vomiting Xerostomia

Rare/Very Rare

Abdominal pain with cramps Acne vulgaris Acute cognitive impairment Aggressive behavior Agitation Alopecia Anorexia Anticholinergic toxicity Blurred vision Bronchitis Concentration difficulty Constipation Cough Cramps in legs Dizziness Dream disorder Dry nose Dry throat Dysgeusia Dyskinesia Dyspepsia Dyspnea Dysuria Earache Epistaxis Eructation Euphoria Excitement Fatigue Fever Flatulence Gastritis Hallucinations Headache disorder Hemorrhoids Hyperhidrosis Hyperkinesis Increased appetite Insomnia Malaise Memory impairment Nausea Nervousness Nightmares Pain Palpitations Parosmia Pharyngitis Pruritus of skin Sedation Skin photosensitivity Skin rash Stomatitis Syncope Tachycardia Tinnitus Tongue discoloration Tremor Unsteady gait Urinary incontinence Urinary retention Visual changes Voice change Vomiting Weight gain Xerostomia

Reproduction studies in mice receiving fexofenadine doses up to 3730 mg/kg (approximately 10-15 times the maximum recommended daily oral human dosage of fexofenadine hydrochloride in adults) have not revealed evidence of adverse or teratogenic effects during gestation. Reproduction studies in rats and rabbits using oral terfenadine dosages up to 300 mg/kg resulting in fexofenadine exposure levels calculated to be about 3-4 and 25-31 times, respectively, those resulting from the maximum recommended daily oral human dosage of fexofenadine hydrochloride in adults have not revealed evidence of teratogenicity. However, in rats, oral terfenadine dosages of 150 mg/kg, resulting in fexofenadine exposure levels calculated to be about 3-4 times those resulting from the maximum recommended daily oral human dosage of fexofenadine hydrochloride in adults (based on comparison of the AUC), were associated with decreased weight gain and neonatal survival in the pups.

Reproduction studies in rats and rabbits using terfenadine and pseudoephedrine hydrochloride in a fixed-combination ratio of 1:2 at dosages of 150/300 (corresponding to fexofenadine AUCs of about 3-4 times the maximum recommended adult therapeutic value and to pseudoephedrine hydrochloride dosages about 10 times the maximum recommended human adult daily oral dosage, on a mg/m2 basis) and 100/200 mg/kg daily (corresponding to fexofenadine AUCs of about 8-10 times the maximum recommended adult therapeutic value and to pseudoephedrine hydrochloride dosages about 15 times the maximum recommended human adult daily oral dosage, on a mg/m2 basis), respectively, have revealed evidence of reduced fetal weight; delayed ossification with wavy ribs also was observed in rats receiving the drug at these dosages. There are no adequate and controlled studies to date using fexofenadine in pregnant women, and fexofenadine hydrochloride alone or in fixed combination with pseudoephedrine hydrochloride should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. An increased incidence of hypospadias in male infants born to women who received loratadine during pregnancy was reported in one study.

However, analysis of data from the National Birth Defects Prevention Study (NBDPS) indicated that use of loratadine during early pregnancy was not associated with an increased risk of second- or third-degree hypospadias. In addition, in 2 small prospective cohort studies that surveyed pregnant women who contacted a teratology information service, use of loratadine during the first trimester of pregnancy was not associated with major congenital anomalies and did not affect the rate of live birth, gestational age at birth, and birth weight. Despite these findings, it should be noted that interpretation of these results is limited by the statistical limitations of the studies (i.e., small sample size, inadequate power, reliance on patient recall of drug use, exclusion criteria).

The 2 prospective cohort studies were powered to detect statistical significance only if a substantial (i.e., approximately threefold) increase in the overall rate of major congenital anomalies was observed; the study that relied on NBDPS data excluded first-degree hypospadias because of the difficulty of detecting this mildest form in routine surveillance, making it difficult to determine the relationship between loratadine and this form of hypospadias. Thus, while these data may be useful, further study is needed to completely rule out the teratogenic risk of loratadine. Because there are no adequate and controlled studies to date using loratadine in pregnant women, loratadine alone or in fixed combination with pseudoephedrine hydrochloride should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

Reproduction studies in rats and rabbits using loratadine dosages up to 75 and 150 times, respectively, the maximum daily human dosage on a mg/m2 basis have not revealed evidence of harm to the fetus. Reproduction studies in mice, rats, and rabbits using oral cetirizine hydrochloride dosages up to 96, 225, and 135 mg/kg daily, respectively (approximately 40, 180, and 220 times, respectively, the maximum recommended daily oral dosage in adults on a mg/m2 basis), have not revealed evidence of teratogenicity. Because there are no adequate and controlled studies to date using cetirizine in pregnant women and animal studies are not always predictive of human response, cetirizine hydrochloride should be used during pregnancy only when clearly needed.

Cetirizine hydrochloride in combination with pseudoephedrine has been shown to increase the number of fetal skeletal malformations (rib distortions) and variants (unossified sternebrae) in rats when given orally in a fixed-combination ratio at a dosage of 6/154 mg/kg (approximately 5 times the maximum recommended adult dosage on a mg/m2 basis). These effects were not observed at a dosage of 1.6/38 mg/kg (approximately the maximum recommended adult dosage on a mg/m2 basis).

Reproduction studies in rabbits using cetirizine hydrochloride and pseudoephedrine hydrochloride in a fixed-combination ratio at a dosage of up to 6/154 mg/kg (approximately 10 times the maximum recommended adult dosage on a mg/m2 basis) have not revealed evidence of harm to the fetus. There are no adequate and controlled studies to date using cetirizine hydrochloride and pseudoephedrine hydrochloride in pregnant women, and the fixed combination should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

It is not known if fexofenadine hydrochloride is distributed into breast milk; however, pseudoephedrine hydrochloride distributes into breast milk. Since there are no adequate and controlled studies to date on the use of fexofenadine during lactation in humans and because many drugs are excreted in human milk, the manufacturer states that fexofenadine alone or in fixed combination with pseudoephedrine hydrochloride should be used with caution in nursing women, and a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. Loratadine and desloratadine distribute readily into breast milk, achieving concentrations that are equivalent to those in plasma (i.e., a milk to plasma AUC ratio of 1.17 and 0.85, respectively).

The manufacturer states that about 0.03% of a single 40-mg dose of loratadine was distributed into breast milk as loratadine and desloratadine over 48 hours. Pseudoephedrine also distributes readily into breast milk.

Caution should be exercised when loratadine is administered alone or in fixed combination with pseudoephedrine to a nursing woman, and a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. In lactating beagles, about 3% of a cetirizine dose was distributed in milk. In mice, cetirizine caused retarded pup weight gain during lactation when dams were receiving a cetirizine hydrochloride dosage of 96 mg/kg daily (about 40 times the maximum recommended daily dosage in adults on a mg/m2 basis).

In rats, cetirizine hydrochloride and pseudoephedrine hydrochloride caused retarded pup weight gain and decreased viability during lactation when administered orally to dams in fixed combination at a dosage of 6/154 mg/kg (approximately 5 times the maximum recommended adult dosage on a mg/m2 basis) but not when administered at a dosage of 1.6/38 mg/kg (approximately the maximum recommended adult dosage on a mg/m2 basis). Cetirizine is distributed into human milk.

Pseudoephedrine also distributes into human milk. Therefore, use of cetirizine hydrochloride alone or in combination with pseudoephedrine hydrochloride in nursing women is not recommended.

No enhanced Geriatric Use information available for this drug.