ARTIZ 10/MG TAB 30/TAB

Indications

Approved Uses

Relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis, and treatment of uncomplicated skin manifestations of chronic idiopathic urticaria (including pruritus).

Off-Label Uses

Off-label: symptomatic relief of pruritus in atopic dermatitis and other pruritic dermatoses; insect-bite hypersensitivity reactions. Not a substitute for epinephrine in anaphylaxis (may be used only as an adjunct for cutaneous symptoms).

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥12 years (allergic rhinitis or chronic urticaria): 10 mg once daily (or 5 mg once daily if sensitive to sedation). Children 6-11 years: 5-10 mg/day (e.g., 5 mg once daily, may increase to 10 mg/day). Children 2-5 years (liquid formulations): 2.5 mg once daily, may increase to 5 mg/day.

Initial Dose

5mg or 10mg once daily.

Maintenance Dose

5mg or 10mg once daily.

Maximum Dose

10 mg once daily for allergic rhinitis and urticaria; dosing up to 20 mg daily is not supported in the provided authoritative sources for standard use

Dose Adjustment Notes

Dose reduction is required in renal impairment (e.g., consider 5 mg once daily when CrCl is reduced); hepatic impairment alone usually does not require adjustment, but reduce dose when hepatic impairment coexists with renal impairment.

How to Take

Swallow 1 film‑coated tablet (10 mg) whole with water; may be taken with or without food; take once daily at the same time each day (evening dosing may be preferred if drowsiness occurs).

Side Effects

Common Side Effects

Somnolence, fatigue, dry mouth, headache, dizziness; may also cause pharyngitis/sore throat and gastrointestinal upset (e.g., nausea/abdominal pain).

Safety & Warnings

Contraindications

Hypersensitivity to cetirizine, hydroxyzine, or any piperazine derivatives, severe renal impairment (CrCl < 10 ml/min).

Warnings & Precautions

Use caution and adjust dose in renal impairment; caution in hepatic impairment mainly when renal impairment coexists; may cause somnolence-avoid driving/machinery until effects known; avoid alcohol/other CNS depressants; caution in urinary retention risk (e.g., prostatic hyperplasia/spinal cord lesions) and in seizure risk; extra caution in elderly due to reduced renal function.

Age Restriction

Cetirizine is approved in pediatrics down to 6 months for some indications, but this 10 mg film‑coated tablet is generally intended for adults and children ≥12 years (younger children should use age-appropriate liquid/5 mg formulations).

Driving Warning

May Cause Drowsiness

Drug Interactions

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Pregnancy Category B

Breastfeeding

Not recommended; cetirizine has been reported to be excreted in human breast milk.

Liver Impairment

No adjustment for hepatic impairment alone; if hepatic impairment coexists with renal impairment, adjust based on renal function (often 5 mg once daily depending on CrCl).

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next dose, skip the missed dose and resume the regular schedule-do not double doses.

Patient Counseling

Take 1 tablet (10 mg) once daily; can be taken with or without food. May cause drowsiness-avoid driving/operating machinery until you know your response; avoid alcohol and other sedatives. Do not exceed 10 mg/day. If you have kidney impairment, seek medical advice as dose reduction may be needed. Seek medical advice if symptoms persist/worsen or if you develop signs of an allergic reaction.

Monitoring Requirements

No routine monitoring required; monitor renal function in patients with known renal impairment

Pharmacology

Mechanism of Action

Selective peripheral H1‑receptor antagonist that blocks histamine-mediated symptoms (itching, sneezing, rhinorrhea, wheal/flare) with relatively low CNS penetration compared with first‑generation antihistamines.

Onset of Action

20-60 minutes.

Duration of Effect

Approximately 24 hours.

Half-Life

Approximately 8 hours in healthy adults (typical range ~7-10 hours).

Metabolism

Minimal/limited hepatic metabolism (minor oxidative pathways such as O-dealkylation); largely excreted unchanged and not subject to extensive first-pass metabolism.

Excretion

Primarily renal: ~70% recovered in urine, with roughly 50-60% as unchanged drug; fecal excretion ~10%.

Protein Binding

Approximately 93%.

Product Information

Available Dosage Forms

For ARTIZ specifically: film‑coated tablet (oral). For cetirizine generally: tablets/capsules, oral solution/syrup (and some markets have chewable/ODT); it is not an ophthalmic product and not used as an IV injection.

Composition per Dose

Each film-coated tablet: 10 mg cetirizine hydrochloride

Generic Availability

Yes

OTC Alternatives

Other OTC second‑generation antihistamines: loratadine 10 mg, fexofenadine 120/180 mg, levocetirizine 5 mg (and desloratadine where available).

Symptom Target

Allergy, Runny Nose

Sedating

Yes

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