ZISTAN 2/MG/5/ML SYRUP 100ML

Indications

Approved Uses

Symptomatic relief of allergic conditions including seasonal/perennial allergic rhinitis (including vasomotor rhinitis), allergic conjunctivitis, and urticaria/pruritic allergic skin conditions; may also be used for symptomatic relief of common cold allergy-type symptoms (e.g., sneezing, rhinorrhea).

Dosage & Administration

Dosing by Condition

Allergic symptoms (rhinitis/urticaria/pruritus/cold-related sneezing/rhinorrhea): Adults and ≥12 years: 4 mg (10 mL) every 4-6 hours PRN; max 24 mg/day. Children 6-11 years: 2 mg (5 mL) every 4-6 hours PRN; max 12 mg/day. Children 2-5 years: 1 mg (2.5 mL) every 4-6 hours PRN; max 6 mg/day.

Initial Dose

Adults: 10ml (4mg) every 4-6 hours

Maintenance Dose

Adults: 10ml (4mg) every 4-6 hours as needed

Maximum Dose

Adults and children 12 years and over: 24mg per day (12 teaspoonfuls/60ml); Children 6-12 years: 12mg per day (6 teaspoonfuls/30ml); Children under 6 years: Consult a doctor

Children's Dosage

Children 6-12 years: 5ml (2mg) every 4-6 hours, max 12mg/day. Children 2-6 years: 2.5ml (1mg) every 4-6 hours, max 6mg/day. Not recommended under 2 years without medical supervision

How to Take

Oral use; shake well before each dose; measure with a calibrated measuring spoon/cup or oral syringe; may be taken with or without food.

Side Effects

Common Side Effects

Drowsiness, sedation, dizziness, dry mouth, dry nose, dry throat, blurred vision, urinary retention, constipation, headache, nausea

Safety & Warnings

Contraindications

Hypersensitivity to chlorpheniramine (or excipients); use in neonates/premature infants; concomitant or recent (within 14 days) MAO inhibitor therapy; narrow-angle glaucoma; urinary retention/bladder neck obstruction (including symptomatic prostatic hypertrophy); stenosing peptic ulcer; pyloroduodenal obstruction.

Warnings & Precautions

May cause significant drowsiness-avoid driving/operating machinery; avoid alcohol and other sedatives/CNS depressants. Use caution in glaucoma/increased intraocular pressure, prostatic hypertrophy/bladder neck obstruction, asthma/COPD, cardiovascular disease/hypertension, hyperthyroidism, and hepatic/renal impairment; paradoxical excitation may occur in children; do not exceed recommended dose; avoid use in neonates/premature infants.

Age Restriction

Not recommended in children <2 years unless directed/supervised by a physician.

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

MAO inhibitors (avoid; may prolong/intensify anticholinergic/CNS effects); alcohol and other CNS depressants (e.g., opioids, benzodiazepines, barbiturates, hypnotics/sedatives) increase sedation/respiratory depression; other anticholinergics and tricyclic antidepressants increase anticholinergic effects.

Interaction Severity

MAJOR: Concomitant MAO inhibitors or use within 14 days-avoid due to potentiation of anticholinergic/CNS effects and possible severe reactions. MODERATE: Alcohol and other CNS depressants (opioids, benzodiazepines, sedatives)-additive sedation/respiratory/CNS depression risk. MODERATE: Other anticholinergics (including TCAs)-additive anticholinergic adverse effects (urinary retention, constipation, blurred vision).

Food Interaction

No restriction

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Children 6-12 years: 5ml (2mg) every 4-6 hours, max 12mg/day. Children 2-6 years: 2.5ml (1mg) every 4-6 hours, max 6mg/day. Not recommended under 2 years without medical supervision

Liver Impairment

No specific dose adjustment defined; use with caution in hepatic impairment (consider lower dose/longer interval if clinically needed).

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose.

Stopping the Medicine

Safe to stop anytime

Overdose

Symptoms: marked drowsiness to coma or paradoxical excitation (especially in children), anticholinergic toxicity (dry mouth, mydriasis, flushing, hyperthermia, tachycardia, urinary retention), hallucinations, seizures, respiratory depression. Management: urgent medical care/poison center; supportive care (airway/ventilation, fluids), activated charcoal if appropriate after recent ingestion; treat seizures with benzodiazepines; manage hyperthermia/arrhythmias as indicated.

Patient Counseling

May cause drowsiness/dizziness-avoid driving or hazardous tasks until effects are known; avoid alcohol and other sedatives; measure doses with a calibrated device and do not exceed recommended dosing; seek advice before use if glaucoma, urinary retention/BPH, severe asthma/COPD, or if taking MAOIs; store below 30°C and protect from light; keep out of reach of children.

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

Competitive H1-receptor antagonist (inverse agonist) that blocks histamine-mediated effects in respiratory mucosa, vasculature, and skin, reducing sneezing, rhinorrhea, itching, and wheal/flare responses.

Onset of Action

Approximately 30 minutes (range ~15-60 minutes).

Duration of Effect

4-6 hours.

Bioavailability

25-50%.

Excretion

Primarily renal (urinary) excretion, mostly as metabolites with a small fraction unchanged.

Protein Binding

Approximately 70% (about 69-72%)

Product Information

Available Dosage Forms

For this SFDA-registered product: Syrup only.

Composition per Dose

Each 5ml: 2mg chlorpheniramine maleate

Generic Availability

Yes

Symptom Target

Allergy, Runny Nose

Sedating

Yes

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