Children's Cetirizine Hcl (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.

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).

Because cetirizine is metabolized only minimally in the liver and is excreted mainly unchanged in urine, the drug may have a low potential for adverse drug interactions associated with metabolic enzyme systems.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Agents That Affect Iodide/Radioactive 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)

CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1)

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) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(2) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(3)

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)

Agents That Affect Iodide/Sodium Iodide I 131

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) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(3) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(4)

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)

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Disease of liver

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

Rare or 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

More Frequent

• Drowsy
• Dry nose
• Dry throat
• Xerostomia

Less Frequent

• Acute abdominal pain
• Diarrhea
• Epistaxis
• Fatigue
• Insomnia
• Nausea
• Pharyngitis

Rare or 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

No enhanced messaging available.

No enhanced messaging available.

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.

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 messaging available.