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Zyriz

Zyriz

cetirizine

Manufacturer:

Interphil

Distributor:

Cathay YSS
Full Prescribing Info
Contents
Cetirizine hydrochloride.
Description
Each film coated tablet contains 10 mg Cetirizine Hydrochloride (HCl), USP.
Action
It is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H1) receptor sites. Cetirizine hydrochloride is considered a long acting non-sedating antihistamine and has some mast-cell stabilizing activity.
Cetirizine hydrochloride is long-acting antihistamine causing little or no drowsiness. It does not demonstrate any antimuscarinic activity. This drug competes reversibly with histamines which are released from mast cells. Once bound to H1 receptor sites in the tissues, cetirizine hydrochloride inhibits histamine-induced allergic reactions by blocking eosinophil infiltration to the size of allergen-induced cutaneous reactions.
Indications/Uses
Cetirizine hydrochloride is used for the symptomatic relief of allergic conditions including rhinitis and chronic urticaria.
Dosage/Direction for Use
Cetirizine hydrochloride is given orally at 10 mg per day or 5 mg twice a day for adults and children 6 years and older. There was no additional benefit seen in increasing dose of cetirizine hydrochloride to 20 mg.
Or as prescribed by the physician.
Hepatic impairment (patients with liver problems or disease). The dose should be reduced to half their usual dose per day.
Renal impairment (patients with kidney problems or disease). The dose should be reduced to half their usual dose per day.
Seasonal Rhinitis: It is recommended that cetirizine hydrochloride be given at the beginning of the hay fever season when pollens are still few.
Cetirizine Hydrochloride may be administered with or without food as it will not affect absorption of the drug.
Missed Dose: If the patient misses a dose, do not take a double dose to make up for a forgotten dose, just resume the schedule and go on as before.
Overdosage
Overdose of cetirizine hydrochloride (180 mg) caused restlessness, irritability and drowsiness in an 18-month old child. In adults, drowsiness, upon ingestion of 150 mg cetirizine hydrochloride), has been reported.
A case of hypokalemic dialyzed patient with chronic renal failure, was reported to develop symptomatic episodes of torsades de pointes after overdosage with cetirizine hydrochloride.
Consult a doctor if the patient has taken more than the recommended dosage. In the event of overdose get medical help or contact Poison Control Center right away.
If symptoms persists or conditions when worsen while taking the medication, or if new symptoms occur, stop using and consult a doctor.
Contraindications
Cetirizine Hydrochloride is contraindicated to those who are allergic to cetirizine, hydroxyzine, piperazine derivatives or any component of the formulation.
Cetirizine Hydrochloride is not recommended to be given to hypokalemic patients with chronic renal failure undergoing hemodialysis. (See Overdosage.)
It should not be given to children with hepatic and renal impairment who are younger than 6 years of age.
Special Precautions
Precaution is recommended if alcohol is taken concomitantly. If signs and symptoms such as formation of small pustules occur with or without pyrexia or erythema, then treatment with cetirizine should be discontinued and a physician should be consulted.
Effects on the Ability to Drive or Operate Machinery: Cetirizine hydrochloride should be used with caution in patients who require mental alertness or physical coordination in their work such as drivers or machine operators since it may cause drowsiness.
Use in Pregnancy: No data is available on the safety of administration of cetirizine hydrochloride in pregnant women apart from animal study which reveals absence of teratogenicity. As such, cetirizine hydrochloride must be given to pregnant patients only when necessary. Ask a physician before use if pregnant.
Use in Lactation: Cetirizine hydrochloride is excreted in breast milk. Thus, use in lactating mothers is not recommended. Ask physician before use if breastfeeding.
Use in Children: Use in infants and children must not be given cetirizine hydrochloride as this may increase the risk of experiencing antimuscarinic effects.
Use in the Elderly: Cetirizine hydrochloride 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, half-life of cetirizine hydrochloride in such patients will be prolonged. Dose of the drug must be reduced in elderly patients.
Precaution is recommended if alcohol is taken concomitantly. If signs and symptoms such as formation of small pustules occur with or without pyrexia or erythema, then treatment with cetirizine should be discontinued and a physician should be consulted.
Use In Pregnancy & Lactation
Use in Pregnancy: No data is available on the safety of administration of cetirizine hydrochloride in pregnant women apart from animal study which reveals absence of teratogenicity. As such, cetirizine hydrochloride must be given to pregnant patients only when necessary. Ask a physician before use if pregnant.
Use in Lactation: Cetirizine hydrochloride is excreted in breast milk. Thus, use in lactating mothers is not recommended. Ask physician before use if breastfeeding.
Adverse Reactions
Cetirizine hydrochloride, though considered as a "non-sedating" antihistamine, was found to cause drowsiness in some people.
Recurrent acute hepatitis developed in one patient taking cetirizine hydrochloride for control of seasonal allergic rhinitis.
Other adverse effects associated with the use of the cetirizine hydrochloride are irritability, insomnia, somnolence, fatigue, dry mouth, pharyngitis, dizziness, headache, abdominal pain, cough, diarrhea, epistaxis, bronchospasm, nausea and vomiting and hypersensitivity manifested by urticarial and fixed drug eruptions, nervousness, rashes, anaphylactic shock, aggression, hallucination, dysgeusia, dyskinesia, dystonia, memory impairment, syncope, tremor, eye pain, eye swelling, vision blurred, hepatic function abnormal, pruritus, urticaria, acute generalized exanthematous pustulosis, arthralgia, enuresis, urinary retention, erectile dysfunction, malaise, feeling abnormal, pruritus upon withdrawal, weight increased. Although cetirizine hydrochloride has low potential for hepatotoxicity, the possibility of developing autoimmune-mediated hepatotoxicity should be considered when administering the drug. A patient under long-term treatment with cetirizine hydrochloride 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 depressants such as barbiturates, alcohol, hypnotics, opioid analgesics, anxiolytics sedatives and neuroleptics.
The use of cetirizine hydrochloride with drugs that inhibit the cytochrome P450 microsomal enzymes such as azithromycin, erythromycin and ketoconazole, did not cause clinically significant changes.
Effects of alcohol and other CNS depressants are enhanced by cetirizine hydrochloride.
Pharmacokinetic properties of ritonavir, HIV protease Inhibitor, are not affected by cetirizine hydrochloride.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Presentation/Packing
Form
Zyriz FC tab 10 mg
Packing/Price
100's
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