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Drug overview for LEVOCETIRIZINE DIHYDROCHLORIDE (levocetirizine dihydrochloride):
Generic name: LEVOCETIRIZINE DIHYDROCHLORIDE (lee-voh-seh-TEER-ah-zeen)
Drug class: Antihistamines
Therapeutic class: Respiratory Therapy Agents
Levocetirizine dihydrochloride, the R-enantiomer of cetirizine, is a second generation antihistamine.
No enhanced Uses information available for this drug.
Generic name: LEVOCETIRIZINE DIHYDROCHLORIDE (lee-voh-seh-TEER-ah-zeen)
Drug class: Antihistamines
Therapeutic class: Respiratory Therapy Agents
Levocetirizine dihydrochloride, the R-enantiomer of cetirizine, is a second generation antihistamine.
No enhanced Uses information available for this drug.
DRUG IMAGES
LEVOCETIRIZINE 5 MG TABLET
The following indications for LEVOCETIRIZINE DIHYDROCHLORIDE (levocetirizine dihydrochloride) have been approved by the FDA:
Indications:
Allergic rhinitis
Chronic idiopathic urticaria
Professional Synonyms:
None.
Indications:
Allergic rhinitis
Chronic idiopathic urticaria
Professional Synonyms:
None.
The following dosing information is available for LEVOCETIRIZINE DIHYDROCHLORIDE (levocetirizine dihydrochloride):
The manufacturer states that a 5-mg dose of levocetirizine dihydrochloride administered as the commercially available oral solution containing 2.5 mg/5 mL is bioequivalent to a 5-mg tablet.
Levocetirizine dihydrochloride is administered orally once daily in the evening without regard to meals. The drug is commercially available as tablets or an oral solution. Levocetirizine tablets are scored and can be broken in half (each half providing a dose of 2.5 mg).
Levocetirizine dihydrochloride tablets should be stored at 20-25degreesC. Levocetirizine dihydrochloride oral solution should be stored at 20-25degreesC (excursions permitted to 15-30degreesC). Levocetirizine is also commercially available in various over-the-counter (OTC) preparations. See the FDA Orange Book and the manufacturer's drug facts for information.
Levocetirizine dihydrochloride tablets should be stored at 20-25degreesC. Levocetirizine dihydrochloride oral solution should be stored at 20-25degreesC (excursions permitted to 15-30degreesC). Levocetirizine is also commercially available in various over-the-counter (OTC) preparations. See the FDA Orange Book and the manufacturer's drug facts for information.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LEVOCETIRIZINE 5 MG TABLET | Maintenance | Adults take 1 tablet (5 mg) by oral route once daily in the evening |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LEVOCETIRIZINE 5 MG TABLET | Maintenance | Adults take 1 tablet (5 mg) by oral route once daily in the evening |
The following drug interaction information is available for LEVOCETIRIZINE DIHYDROCHLORIDE (levocetirizine dihydrochloride):
There are 0 contraindications.
There are 2 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) 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) |
ADREVIEW, JEANATOPE, MEGATOPE, SODIUM IODIDE I-123, VOLUMEX |
| Sodium Iodide I 131/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) 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) |
HICON, SODIUM IODIDE I-131 |
There are 0 moderate interactions.
The following contraindication information is available for LEVOCETIRIZINE DIHYDROCHLORIDE (levocetirizine dihydrochloride):
Drug contraindication overview.
*Known hypersensitivity (e.g., urticaria, anaphylaxis) to levocetirizine or any ingredient in the formulation, or to cetirizine. *Adults and pediatric patients 12 years of age and older with end-stage renal disease (creatinine clearance less than 10 mL/minute) or undergoing hemodialysis. *Pediatric patients 6 months to 11 years of age with renal impairment.
*Known hypersensitivity (e.g., urticaria, anaphylaxis) to levocetirizine or any ingredient in the formulation, or to cetirizine. *Adults and pediatric patients 12 years of age and older with end-stage renal disease (creatinine clearance less than 10 mL/minute) or undergoing hemodialysis. *Pediatric patients 6 months to 11 years of age with renal impairment.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 2 (mild) GFR 60-89 ml/min |
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
There are 0 moderate contraindications.
The following adverse reaction information is available for LEVOCETIRIZINE DIHYDROCHLORIDE (levocetirizine dihydrochloride):
Adverse reaction overview.
Adverse effects reported in 2% or more of patients 12 years of age and older receiving levocetirizine dihydrochloride (2.5 or 5 mg daily) in clinical trials and occurring more frequently than placebo include somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis. Adverse effects reported in 2% or more of pediatric patients 6-12 years of age receiving levocetirizine dihydrochloride (5 mg daily) in clinical trials and occurring more frequently than placebo include pyrexia, cough, somnolence, and epistaxis. Adverse effects reported in 2% or more of pediatric patients 1-5 years of age receiving levocetirizine dihydrochloride (1.25 mg twice daily) in a safety trial and occurring more frequently than with placebo include pyrexia, diarrhea, vomiting, and otitis media.
Adverse effects reported in 3% or more of pediatric patients 6-11 months of age receiving levocetirizine dihydrochloride (1.25 mg once daily) in a safety trial and occurring more frequently than placebo include diarrhea and constipation.
Adverse effects reported in 2% or more of patients 12 years of age and older receiving levocetirizine dihydrochloride (2.5 or 5 mg daily) in clinical trials and occurring more frequently than placebo include somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis. Adverse effects reported in 2% or more of pediatric patients 6-12 years of age receiving levocetirizine dihydrochloride (5 mg daily) in clinical trials and occurring more frequently than placebo include pyrexia, cough, somnolence, and epistaxis. Adverse effects reported in 2% or more of pediatric patients 1-5 years of age receiving levocetirizine dihydrochloride (1.25 mg twice daily) in a safety trial and occurring more frequently than with placebo include pyrexia, diarrhea, vomiting, and otitis media.
Adverse effects reported in 3% or more of pediatric patients 6-11 months of age receiving levocetirizine dihydrochloride (1.25 mg once daily) in a safety trial and occurring more frequently than placebo include diarrhea and constipation.
There are 11 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Acquired dystonia Acute generalized exanthematous pustulosis Anaphylaxis Angioedema Cholestasis Extrapyramidal disease Glomerulonephritis Hepatitis Oculogyric crisis Seizure disorder Suicidal ideation |
There are 43 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cough Drowsy Epistaxis Fatigue General weakness Pharyngitis |
Fever Xerostomia |
| Rare/Very Rare |
|---|
|
Aggressive behavior Agitation Arthralgia Blurred vision Constipation Depression Diarrhea Dizziness Dysgeusia Dyskinesia Dyspnea Dysuria Edema Hallucinations Hypotension Increased appetite Insomnia Motor tic disorder Myalgia Myoclonus Nausea Nightmares Palpitations Paresthesia Pruritus of skin Skin rash Syncope Tachycardia Tremor Urinary retention Urticaria Vertigo Visual changes Vomiting Weight gain |
The following precautions are available for LEVOCETIRIZINE DIHYDROCHLORIDE (levocetirizine dihydrochloride):
Safety of levocetirizine has not been established in children younger than 6 months of age. Efficacy of levocetirizine dihydrochloride 1.25 mg once daily (in pediatric patients 6 months to 5 years of age) and levocetirizine dihydrochloride 2.5
mg once daily (in pediatric patients 6-11 years of age) for the management of allergic rhinitis is based on extrapolation of the demonstrated efficacy of the 5-mg daily dosage in pediatric patients 12 years of age and older and on pharmacokinetic comparisons in adults and children. Efficacy of levocetirizine dihydrochloride 1.25 mg once daily (in pediatric patients 6 months to 5 years of age), levocetirizine dihydrochloride 2.5
mg once daily (in pediatric patients 6-11 years of age), and levocetirizine dihydrochloride 5 mg once daily (in pediatric patients 12-17 years of age) for the management of chronic idiopathic urticaria is based on extrapolation of the demonstrated efficacy of the 5-mg daily dosage in adults and/or on pharmacokinetic comparisons in adults and children. A cross-study comparison of pharmacokinetic data indicate that systemic exposure (i.e., AUC) to levocetirizine was approximately 2-fold higher in pediatric patients 6-11 years of age with seasonal allergic rhinitis receiving a single 5-mg dose compared with that reported in adults receiving the same dose. Data from a retrospective population pharmacokinetic analysis indicate that administration of levocetirizine dihydrochloride 1.25 mg once daily in children 6 months to 5 years of age results in plasma levocetirizine concentrations that are comparable to those observed in adults receiving the drug at a dosage of 5 mg once daily.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
mg once daily (in pediatric patients 6-11 years of age) for the management of allergic rhinitis is based on extrapolation of the demonstrated efficacy of the 5-mg daily dosage in pediatric patients 12 years of age and older and on pharmacokinetic comparisons in adults and children. Efficacy of levocetirizine dihydrochloride 1.25 mg once daily (in pediatric patients 6 months to 5 years of age), levocetirizine dihydrochloride 2.5
mg once daily (in pediatric patients 6-11 years of age), and levocetirizine dihydrochloride 5 mg once daily (in pediatric patients 12-17 years of age) for the management of chronic idiopathic urticaria is based on extrapolation of the demonstrated efficacy of the 5-mg daily dosage in adults and/or on pharmacokinetic comparisons in adults and children. A cross-study comparison of pharmacokinetic data indicate that systemic exposure (i.e., AUC) to levocetirizine was approximately 2-fold higher in pediatric patients 6-11 years of age with seasonal allergic rhinitis receiving a single 5-mg dose compared with that reported in adults receiving the same dose. Data from a retrospective population pharmacokinetic analysis indicate that administration of levocetirizine dihydrochloride 1.25 mg once daily in children 6 months to 5 years of age results in plasma levocetirizine concentrations that are comparable to those observed in adults receiving the drug at a dosage of 5 mg once daily.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Available data are insufficient to establish a drug-associated risk of miscarriage, birth defects, or adverse maternal or fetal outcomes with levocetirizine use during pregnancy. Animal reproductive studies have shown no evidence of fetal harm with administration of levocetirizine to pregnant rats and rabbits during the period of organogenesis at doses up to 390 times and 470 times, respectively, the maximum recommended human dose (MRHD). In mice who received cetirizine during late gestation and the lactation period, cetirizine administration at a dose 25 times the MRHD had no effects on pup development; however, lower pup weight was observed during lactation when a dose 95 times the MRHD was administered.
Levocetirizine is expected to be distributed into human milk (since cetirizine is distributed into milk). Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for levocetirizine and any potential adverse effects on the breast-fed child from levocetirizine or from the underlying maternal condition.
Experience from clinical trials in patients 65 years of age and older is insufficient to determine whether geriatric patients respond differently than younger adults. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. Dosage of levocetirizine generally should be selected with caution in geriatric patients because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy. Periodic monitoring of renal function may be useful.
The following prioritized warning is available for LEVOCETIRIZINE DIHYDROCHLORIDE (levocetirizine dihydrochloride):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for LEVOCETIRIZINE DIHYDROCHLORIDE (levocetirizine dihydrochloride)'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 |
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