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Drug overview for WAL-ZYR (CETIRIZINE) (cetirizine hcl):
Generic name: cetirizine HCl (seh-TEER-ah-zeen)
Drug class: Antihistamines
Therapeutic class: Respiratory Therapy Agents
Cetirizine, a piperazine-derivative, has been classified as a second generation antihistamine.
Cetirizine shares the uses of other antihistamines, including the management of seasonal or perennial allergic rhinitis and chronic idiopathic urticaria. For additional information on these and other uses of antihistamines, see Uses in the Antihistamines General Statement 4:00.
Generic name: cetirizine HCl (seh-TEER-ah-zeen)
Drug class: Antihistamines
Therapeutic class: Respiratory Therapy Agents
Cetirizine, a piperazine-derivative, has been classified as a second generation antihistamine.
Cetirizine shares the uses of other antihistamines, including the management of seasonal or perennial allergic rhinitis and chronic idiopathic urticaria. For additional information on these and other uses of antihistamines, see Uses in the Antihistamines General Statement 4:00.
DRUG IMAGES
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The following indications for WAL-ZYR (CETIRIZINE) (cetirizine hcl) have been approved by the FDA:
Indications:
Allergic rhinitis
Chronic idiopathic urticaria
Perennial allergic rhinitis
Seasonal allergic rhinitis
Professional Synonyms:
Atopic rhinitis
Intermittent allergic rhinitis
Non-seasonal allergic rhinitis
Periodic runny nose
Seasonal allergy
Indications:
Allergic rhinitis
Chronic idiopathic urticaria
Perennial allergic rhinitis
Seasonal allergic rhinitis
Professional Synonyms:
Atopic rhinitis
Intermittent allergic rhinitis
Non-seasonal allergic rhinitis
Periodic runny nose
Seasonal allergy
The following dosing information is available for WAL-ZYR (CETIRIZINE) (cetirizine hcl):
The manufacturer states that patients 12 years of age or older who have impaired renal function (e.g., creatinine clearance of 11-31 mL/minute) or hepatic impairment or who are undergoing hemodialysis (creatinine clearance of less than 7 mL/minute), should receive a cetirizine hydrochloride dosage of 5 mg daily. The manufacturer also states that children 6-11 years of age with impaired renal or hepatic function should use the lower recommended dosage (5 mg once daily). The manufacturer states that use of cetirizine hydrochloride in children younger than 6 years of age with impaired renal or hepatic function is not recommended because administration of doses smaller than 2.5
mg is difficult and not reliable, and pharmacokinetic data are lacking in this patient population.
When extended-release tablets of cetirizine hydrochloride in fixed combination with pseudoephedrine hydrochloride are used in patients 12 years of age or older who have impaired renal function (i.e., creatinine clearance of 11-31 mL/minute) or hepatic impairment or who are undergoing hemodialysis (creatinine clearance of less than 7 mL/minute), the recommended cetirizine hydrochloride dosage is 5 mg once daily.
mg is difficult and not reliable, and pharmacokinetic data are lacking in this patient population.
When extended-release tablets of cetirizine hydrochloride in fixed combination with pseudoephedrine hydrochloride are used in patients 12 years of age or older who have impaired renal function (i.e., creatinine clearance of 11-31 mL/minute) or hepatic impairment or who are undergoing hemodialysis (creatinine clearance of less than 7 mL/minute), the recommended cetirizine hydrochloride dosage is 5 mg once daily.
Cetirizine is administered orally. Cetirizine oral solution (syrup) should be administered using the measuring device (i.e., cup) provided by the manufacturer. Cetirizine chewable tablets may be administered with or without water.
Tablets containing cetirizine hydrochloride in fixed combination with pseudoephedrine hydrochloride should be swallowed intact and patients should be instructed not to break or chew such tablets. The manufacturer states that the time of administration of cetirizine may be adjusted for individual patient requirements. Although food may decrease peak plasma concentrations of cetirizine and lengthen the time to achievement of peak plasma concentrations, the manufacturer states that cetirizine may be administered without regard to food because food does not affect the extent of absorption of the drug when administered as conventional or chewable tablets. The oral bioavailability of cetirizine hydrochloride conventional tablets is comparable to that of the oral solution and to that of the chewable tablets (administered with or without water).
Tablets containing cetirizine hydrochloride in fixed combination with pseudoephedrine hydrochloride should be swallowed intact and patients should be instructed not to break or chew such tablets. The manufacturer states that the time of administration of cetirizine may be adjusted for individual patient requirements. Although food may decrease peak plasma concentrations of cetirizine and lengthen the time to achievement of peak plasma concentrations, the manufacturer states that cetirizine may be administered without regard to food because food does not affect the extent of absorption of the drug when administered as conventional or chewable tablets. The oral bioavailability of cetirizine hydrochloride conventional tablets is comparable to that of the oral solution and to that of the chewable tablets (administered with or without water).
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| WAL-ZYR 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CETIRIZINE HCL 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| RA CETIRIZINE HCL 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
The following drug interaction information is available for WAL-ZYR (CETIRIZINE) (cetirizine hcl):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Radioactive Iodide/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1,2) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1,2 PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1,2) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1,2) |
ADREVIEW, HICON, JEANATOPE, MEGATOPE, SODIUM IODIDE I-123, SODIUM IODIDE I-131 |
There are 0 moderate interactions.
The following contraindication information is available for WAL-ZYR (CETIRIZINE) (cetirizine hcl):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
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 3 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 |
| Urinary retention |
The following adverse reaction information is available for WAL-ZYR (CETIRIZINE) (cetirizine hcl):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 17 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute generalized exanthematous pustulosis Anaphylaxis Bronchospastic pulmonary disease Cardiac arrhythmia Cholestasis Dehydration Edema Glomerulonephritis Hearing loss Hemolytic anemia Hepatitis Palpitations Seizure disorder Thrombocytopenic disorder Tongue swelling Tonic clonic seizure |
There are 52 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Drowsy Dry nose Dry throat Xerostomia |
| Rare/Very Rare |
|---|
|
Acne vulgaris Acute cognitive impairment Aggressive behavior Alopecia Anorexia Anticholinergic toxicity Blurred vision Constipation Cramps in legs Dizziness Dysgeusia Dyskinesia Dyspepsia Dysuria Eructation Euphoria Excitement Flatulence Gastritis Hallucinations Headache disorder Hemorrhoids Hyperhidrosis Increased appetite Memory impairment Nervousness Nightmares Parosmia Skin photosensitivity Skin rash Stomatitis Syncope Tachycardia Tinnitus Tongue discoloration Tremor Unsteady gait Urinary retention Visual changes Vomiting Weight gain |
The following precautions are available for WAL-ZYR (CETIRIZINE) (cetirizine hcl):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| Cetirizine (Oral, IV) | 1 Day – 179 Days | Safety and efficacy not established in infants age <6 months. |
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.
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.
| Drug/Drug Class | Severity | Precaution Description | Pregnancy Category Description |
|---|---|---|---|
| Cetirizine | 2 | Insufficient human data available on developmental toxicity risk | No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information. |
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.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
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.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Cetirizine | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Probably compatible: may cause sedation in nursing infant. |
No enhanced Geriatric Use information available for this drug.
Precaution Exists
Geriatric management or monitoring precaution exists.
Precaution Exists
Geriatric management or monitoring precaution exists.
| Drug Name | Narrative | REN | HEP | CARDIO | NEURO | PULM | ENDO |
|---|---|---|---|---|---|---|---|
| Cetirizine | Increased risk for neurological side effects. Dosage adjustment may be required. | Y | N | N | Y | N | N |
The following prioritized warning is available for WAL-ZYR (CETIRIZINE) (cetirizine hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for WAL-ZYR (CETIRIZINE) (cetirizine hcl)'s list of indications:
| Allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| J30.5 | Allergic rhinitis due to food |
| J30.8 | Other allergic rhinitis |
| J30.81 | Allergic rhinitis due to animal (cat) (dog) hair and dander |
| J30.89 | Other allergic rhinitis |
| J30.9 | Allergic rhinitis, unspecified |
| Chronic idiopathic urticaria | |
| L50.1 | Idiopathic urticaria |
| Perennial allergic rhinitis | |
| J31.0 | Chronic rhinitis |
| Seasonal allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
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