Levocetirizine dihydrochloride
What is Levocetirizine dihydrochloride?[edit | edit source]
- Levocetirizine dihydrochloride are a histamine H1-receptor antagonist used for the treatment of allergic rhinitis (hay fever), chronic idiopathic urticaria.
What are the uses of this medicine?[edit | edit source]
Levocetirizine dihydrochloride tablets are indicated for:
- the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
- the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older.
- the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
How does this medicine work?[edit | edit source]
- The dihydrochloride salt form of the active levorotatory enantiomer of cetirizine, levocetirizine; a third generation, non-sedating, selective histamine H1 receptor antagonist, with antihistamine, anti-inflammatory and potential anti-angiogenic activities.
- Levocetirizine competes with endogenous histamine for binding at peripheral H1-receptor sites on the effector cell surface.
- This prevents the negative symptoms associated with histamine release and an allergic reaction.
- In addition, as histamine plays an important role in angiogenesis during an allergic inflammatory reaction, blocking the action of histamine may modulate the expression of proangiogenic factors and thus may prevent angiogenesis.
- As a third-generation histamine H1 receptor antagonist, levocetirizine has fewer side effects than most second-generation antihistamines.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients who:
- known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine.
- end-stage renal disease (CLCR < 10 mL/min) and patients undergoing hemodialysis.
- Children 6 months to 11 years of age with impaired renal function.
What drug interactions can this medicine cause?[edit | edit source]
- No in vivo drug-drug interaction studies have been performed with levocetirizine.
Is this medicine FDA approved?[edit | edit source]
- Levocetirizine was approved for medical use in the United States in 2007.
How should this medicine be used?[edit | edit source]
Recommended dosage:
- Adults and children 12 years of age and older: 5 mg once daily in the evening.
- Children 6 to 11 years of age: 2.5 mg once daily in the evening.
Renal Impairment:
- Adjust the dose in patients 12 years of age and older with decreased renal function.
- Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended;
- Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended;
- Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended;
- End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.
Administration:
- Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed.
- Levocetirizine dihydrochloride tablets can be taken without regard to food consumption.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As Immediate release breakable (scored) tablets, 5 mg
This medicine is available in fallowing brand namesː
- Xyzal ; Xyzal Allergy 24 Hr
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older
- pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age.
What special precautions should I follow?[edit | edit source]
- Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking levocetirizine dihydrochloride tablets.
- Avoid concurrent use of alcohol or other central nervous system depressants with levocetirizine dihydrochloride tablets.
- Cetirizine and levocetirizine have been linked to rare, isolated instances of clinically apparent acute liver injury.
What to do in case of emergency/overdose?[edit | edit source]
Symptoms of overdosage may include:
- drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children.
Management of overdosage:
- There is no known specific antidote to levocetirizine dihydrochloride tablets.
- Should overdose occur, symptomatic or supportive treatment is recommended.
- Levocetirizine dihydrochloride tablets are not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.
Can this medicine be used in pregnancy?[edit | edit source]
- There are no adequate and well-controlled studies in pregnant women.
- Pregnancy Category B
Can this medicine be used in children?[edit | edit source]
- The safety of levocetirizine dihydrochloride tablets 5 mg once daily was evaluated in pediatric patients 6 to 12 years of age.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredient:
- LEVOCETIRIZINE DIHYDROCHLORIDE
Inactive ingredients:
- CELLULOSE, MICROCRYSTALLINE
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- HYPROMELLOSES
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOL 400
Who manufactures and distributes this medicine?[edit | edit source]
Manufactured by:
- Rottendorf Pharma GmbH
- Ennigerloh, Germany
- Made in Germany
Distributed by:
- Perrigo
- Allegan, MI
What should I know about storage and disposal of this medication?[edit | edit source]
- Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).
Levocetirizine dihydrochloride Resources | ||
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