RxIndia
Loading clinical data...
Loading clinical data...
Authoritative Clinical Reference
OTC (Over-the-Counter); Schedule H for certain fixed-dose combinations
Oral
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Adults and Adolescents ≥12 years:
Parameter Recommendation
Starting dose 10 mg orally once daily
Titration Not required
Usual maintenance dose 10 mg once daily
Maximum dose 10 mg/day
Clinical Notes:
Adults and Adolescents ≥12 years:
Parameter Recommendation
Starting dose 10 mg orally once daily
Titration May increase to 20 mg/day under specialist supervision if inadequate response
Usual maintenance dose 10 mg once daily
Maximum dose 20 mg/day (off-label; specialist discretion)
Clinical Notes:
Adults:
Parameter Recommendation
Starting dose 10 mg orally once daily
Titration Not applicable
Usual maintenance dose 10 mg once daily
Maximum dose 10 mg/day
Clinical Notes:
Secondary Indications – Adults Only (Off-label)
Indication Dose Duration Notes Evidence Basis
Allergic Conjunctivitis (oral adjunct) 10 mg once daily Short-term (days to weeks) OFF-LABEL; adjunctive to topical therapy Indian specialist practice
Insect Bite Reactions 10 mg once daily 3–7 days OFF-LABEL Common Indian dermatology practice
Refractory Chronic Urticaria Up to 20 mg/day (may divide 10 mg BD) Individualised OFF-LABEL; Specialist only International urticaria guidelines; Indian dermatology practice
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
Indications: Allergic Rhinitis, Chronic Urticaria, Atopic Dermatitis (pruritus relief)
| Age Group | Dose (mcg/kg/day) | Typical Total Daily Dose | Clinical Notes |
|---|
6–12 months Oral Drops (10 mg/mL) 2.5 mg (0.25 mL) once daily Specialist supervision recommended
1–2 years Oral Drops or Syrup 2.5 mg once daily Use calibrated dropper/syringe
2–5 years Syrup (5 mg/5 mL) 2.5 mg once daily OR 2.5 mg twice daily (max 5 mg/day) Once daily preferred; split if sedation
6–11 years Syrup or Tablet 5 mg once daily OR 5 mg twice daily (max 10 mg/day) Adjust based on severity and response
≥12 years Tablet or Syrup 10 mg once daily Adult dosing applies
Dosing Pattern for Paediatrics (General):
Parameter Recommendation
Starting dose Age-appropriate dose as per table above
Titration Usually not required; may increase frequency in older children if needed
Usual maintenance dose As per starting dose
Maximum dose Age-specific as above
Safety Monitoring in Children:
Age Restriction Statement:
Not recommended below 6 months of age. Use in infants 6–12 months should be under paediatrician supervision only.
Secondary Indications – Paediatrics (Off-label)
Indication Age Dose Duration Notes Evidence Basis
Refractory Chronic Urticaria >6 years Up to 0.5 mg/kg/day in divided doses Short-term escalation OFF-LABEL; Specialist only Indian paediatric immunology practice
| eGFR (ml/min/1.73m²) | Recommendation |
|---|
50 No adjustment required (10 mg once daily)
30–50 5 mg once daily
10–30 5 mg every alternate day
<10 (including dialysis) Avoid use or use with extreme caution; specialist input required
Notes:
| Hepatic Impairment | Recommendation |
|---|---|
| Mild impairment | No dose adjustment required |
| Moderate impairment | Use with caution; consider reducing to 5 mg once daily |
| Severe impairment | Avoid use or initiate at 5 mg every alternate day under specialist supervision |
Notes:
Parameter Details
Risk Category Generally considered safe; no formal Indian category; equivalent to former US FDA Category B
Overall Safety No evidence of teratogenicity in human or animal studies
Recommendation May be used if antihistamine required; benefit should outweigh potential risk
Preferred Alternatives Chlorpheniramine preferred by some obstetricians in first trimester (longer safety track record)
Trimester Considerations Safer option among second-generation antihistamines throughout pregnancy
Monitoring Monitor for maternal sedation; routine fetal monitoring sufficient
Parameter Details
Breastfeeding Compatibility Compatible; excreted in breast milk in low concentrations
Milk Levels Low (estimated infant dose ~0.3% of maternal dose)
Preferred Alternatives Loratadine (if less sedation desired in infant); both acceptable
Infant Monitoring Observe for drowsiness, irritability, feeding difficulties, or changes in sleep pattern
Recommendation May use during breastfeeding; single daily dose preferred
Parameter Recommendation
Starting dose 5 mg once daily
Titration Increase to 10 mg only if tolerated and eGFR permits
Special Considerations Mandatory renal function assessment before prescribing
Monitoring Watch for sedation, confusion, dry mouth, urinary retention
Fall Risk Increased compared to younger adults; counsel patient and caregivers
Polypharmacy Caution Assess for additive anticholinergic or sedative effects with other medications
Interacting Drug/Class Mechanism/Effect Management
Alcohol Enhanced CNS depression; increased sedation and psychomotor impairment Avoid concurrent use
Hydroxyzine Duplicate pharmacology; excessive antihistaminic and sedative effects Avoid combination
Strong CNS depressants (benzodiazepines, opioids, barbiturates) Additive sedation and respiratory depression Avoid or use with extreme caution
Strong anticholinergics Increased risk of urinary retention, dry mouth, constipation Avoid combination, especially in elderly
Interacting Drug/Class Effect Management
Theophylline (>400 mg/day) Slight reduction in cetirizine clearance (~16%) Monitor; usually no dose adjustment needed
Macrolide antibiotics (erythromycin, azithromycin) Theoretical additive anticholinergic effects; no major QT interaction Monitor for dry mouth, urinary symptoms
Ritonavir May modestly increase cetirizine levels Monitor for adverse effects
Other antihistamines Additive effects; increased sedation Avoid unnecessary combination
Anticholinergic drugs (TCA, antimuscarinics) Additive anticholinergic burden Use with caution, especially in elderly
Adverse Effect Notes
Anaphylaxis/severe hypersensitivity Rare; discontinue immediately and treat as emergency
Seizures Rare; mainly in predisposed individuals, children, or overdose
Severe urinary retention Rare; more likely in elderly males with prostatic hypertrophy
Hepatitis (idiosyncratic) Very rare; monitor for jaundice, elevated transaminases
Aggressive behaviour/agitation Rare; mainly in children (paradoxical reaction)
Orofacial dyskinesia Very rare; reported with long-term high-dose use
| Timing | Parameters |
|---|---|
| Baseline | Serum creatinine and eGFR (mandatory in elderly and those with suspected renal impairment) |
After initiation Assess for sedation and efficacy at 1–2 weeks; sedation usually diminishes over time
Long-term use Periodic renal function in elderly or at-risk patients (annually); reassess need for continued therapy every 6–12 months
Chronic Urticaria Urticaria Activity Score (UAS7) for objective monitoring
Fixed-Dose Combinations:
| Formulation | Approximate Price (per tablet) |
|---|---|
| Tablets 10 mg | ₹1–3 per tablet |
| Tablets 5 mg | ₹0.50–2 per tablet |
| Syrup 5 mg/5 mL (30 mL) | ₹15–35 per bottle |
| Syrup 5 mg/5 mL (60 mL) | ₹25–50 per bottle |
| Oral Drops 10 mg/mL (10–15 mL) | ₹30–60 per bottle |
NLEM Status: Cetirizine is included in NLEM 2022; price ceiling under NPPA applies to scheduled formulations. Widely available in government supply.
cetirizine; antihistamine; H1-blocker; allergic rhinitis; chronic urticaria; atopic dermatitis; second-generation antihistamine; paediatric-safe; renal-adjustment; OTC; NLEM India
RxIndia v1.0 — 10 Jan 2025
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
Help us improve our clinical database for the medical community.