Benadryl One

Benadryl One

cetirizine

Manufacturer:

Johnson & Johnson

Distributor:

Johnson & Johnson
Full Prescribing Info
Contents
Cetirizine HCl.
Description
Cetirizine HCl is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H1) receptor sites. Cetirizine HCl is considered a long-acting nonsedating antihistamine and has some mast-cell stabilizing activity.
Action
Cetirizine HCl is a long-acting antihistamine causing little or no drowsiness. It does not demonstrate any antimuscarinic activity. It competes reversibly with histamines which are released from mast cells. Once bound to H1-receptor sites in the tissues, cetirizine HCl inhibits histamine-induced allergic reactions by blocking eosinophil infiltration to the site of allergen-induced cutaneous reactions.
Indications/Uses
Symptomatic relief of allergic conditions including rhinitis and chronic urticaria.
Dosage/Direction for Use
Adults and children ≥6 years: 10 mg/day or as prescribed by a physician. There was no additional benefit seen in increasing dose of cetirizine HCl to 20 mg.
Seasonal Rhinitis: Dose should be given at the beginning of hay fever season when pollens are still few.
Hepatic and Renal Impairment: Dose should be reduced to ½ their usual dose per day.
Administration: May be administered with or without food, as it will not affect absorption of cetirizine HCl.
Overdosage
Overdosage of cetirizine HCl (180 mg) caused restlessness, irritability and drowsiness in an 18-month old child. In adults, drowsiness upon ingestion of 150 mg cetirizine HCl has been reported.
A case of a hypokalemic dialyzed patient with chronic renal failure was reported to develop symptomatic episodes of Torsades de pointes after overdosage with cetirizine HCl.
Contraindications
Cetirizine HCl is contraindicated to those who are allergic to hydroxyzine or any component of Benadryl One.
Cetirizine HCl is not recommended to be given to hypokalemic patients with chronic renal failure undergoing hemodialysis. (See Overdosage.)
Use in Children: It should not be given to children with hepatic and renal impairment who are <6 years. Infants and children must not be given cetirizine HCl as this may increase risk of experiencing antimuscarinic effects.
Special Precautions
Effects on the Ability to Drive or Operate Machinery: Cetirizine HCl should be used with caution in patients who requires mental alertness or physical coordination in their work eg, drivers or machine operators since it may cause drowsiness.
Use in Pregnancy: No data is available on the safety of administration of cetirizine HCl in pregnant women apart from an animal study which reveals absence of teratogenicity. As such, cetirizine HCl must be given to pregnant patients only when necessary.
Use in Lactation: Cetirizine HCl is excreted in breast milk. Thus, use in lactating mothers is not recommended.
Use in Elderly: Cetirizine HCl must be used with caution in elderly patients who most likely have impaired renal and hepatic function. Since the drug is metabolized through the renal mechanism, t½ of cetirizine HCl in such patients will be prolonged. Dose of the drug must be reduced in elderly patients.
Adverse Reactions
Cetirizine HCl, though considered as nonsedating antihistamine, was found to cause drowsiness in some people.
Recurrent acute hepatitis developed in 1 patient taking cetirizine HCl for control of seasonal allergic rhinitis.
Other adverse effects associated with the use of cetirizine HCl are irritability, insomnia, somnolence, fatigue, dry mouth, pharyngitis, dizziness, headache, abdominal pain, cough, diarrhea, epistaxis, bronchospasm, nausea and vomiting, and hypersensitivity manifested by urticaria and fixed drug eruptions.
Although cetirizine HCl has low potential for severe hepatotoxicity, the possibility of developing autoimmune-mediated hepatotoxicity should be considered when administering the drug. A patient under long-term treatment with cetirizine HCl for atopic dermatitis was reported to have developed life-threatening hepatitis.
Drug Interactions
Sedation may be enhanced upon concomitant use of antihistamines in general with central nervous system (CNS) depressants eg, barbiturates, alcohol, hypnotic, opioid analgesics, anxiolytic sedatives and neuroleptics.
The use of cetirizine HCl with drugs that inhibit the cytochrome P-450 microsomal enzymes eg, azithromycin, erythromycin and ketoconazole, did not cause clinically significant changes.
Effects of alcohol and other CNS depressants are enhanced by cetirizine HCl.
Pharmacokinetic properties of ritonavir, HIV protease inhibitors, are not affected by cetirizine HCl.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Presentation/Packing
FC tab 10 mg x 100's.
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