Setin: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Cetirizine diHCl

Indications/Uses

Symptomatic treatment of seasonal allergic rhinitis w/ or w/o allergic conjunctivitis, perennial allergic rhinitis as well as pruritus & other allergic urticaria symptoms including insect bites in adults & childn ≥2 yr. Chronic idiopathic urticaria.

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Dosage/Direction for Use

Tab Adult & childn >12 yr 1 tab daily. Childn 6-12 yr ½ tab bid. Oral soln Adult & childn >12 yr 10 mL once daily. Childn 6-12 yr 5 mL bid, 2-6 yr 2.5 mL bid. Syr Adult & childn >6 yr 10 mL daily. Childn 2-6 yr 2.5 mL bid or 5 mL daily. Renal impairment Mild to normal w/ CrCl 50 to ≥80 mL/min 10 mg once daily, moderate w/ CrCl 30-49 mL/min 5 mg once daily, severe w/ CrCl <30 mL/min 5 mg once every 2 days.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity to cetirizine diHCl, hydroxyzine or any piperazine derivatives. Severe renal impairment w/ CrCl <10 mL/min.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Setin detailed prescribing information

Special Precautions

Blurred vision, confusion & dysuria. Pruritus & urticaria. Increased risk of urinary retention in patients w/ predisposing factors or urinary retention (eg, spinal cord lesion, prostatic hyperplasia). Patients w/ narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bronchial asthma, increased IOP, thyroid dysfunction, CV disease & HTN; epilepsy & at risk of convulsion. Not to drink alcohol or anything mixed w/ alcohol. Avoid concomitant use w/ CNS suppressants eg, alcohol, sedatives, tranquilizers. May affect ability to drive & use machine. Renal & hepatic impairment. Not to be used in 1st trimester pregnancy & lactation. Not to be used in childn <2 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Tachycardia; hypersensitivity, anaphylactic shock; paraesthesia, convulsions, dysgeusia, dyskinesia, dystonia, syncope, tremor, amnesia, memory impairment; abnormal hepatic function, increased transaminases, γ-glutamyl transferase, blood bilirubin & alkaline phosphatase, hepatitis; arthralgia; dysuria, enuresis, urinary retention; thrombocytopenia; agitation, aggression, confusion, depression, hallucination, insomnia, tics, suicidal ideation, nightmare; accommodation disorder, blurred vision, oculogyration; diarrhea; pruritus, rash, urticaria, angioedema, fixed drug eruption, acute generalized exanthematous pustulosis; increased appetite; vertigo; increased wt; asthenia, malaise, oedema.

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Drug Interactions

Decreased clearance w/ theophylline. Increased exposure w/ ritonavir. Altered disposition of ritonavir. Additive CNS depression w/ CNS depressants eg, alcohol, sedatives, tranquilizers.

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Storage

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Description

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Action

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MIMS Class

Antihistamines & Antiallergics

ATC Classification

R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.

Thai FDA Category

Presentation/Packing

Form

Setin FC tab 10 mg

Packing/Price

1 × 10's;10 × 10's

Form

Setin oral soln 1 mg/mL

Packing/Price

100 mL x 1's;60 mL x 1's

Form

Setin syr 5 mg/5 mL

Packing/Price

60 mL x 1's

Setin

cetirizine

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical