Cetirizine Hydrochloride 1 mg/mL Solution
Other active recalls for Cetirizine Hydrochloride (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Cetirizine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Cetirizine is also used to treat urticaria (hives; itchy raised red bumps on skin). Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine. This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read th...
Read the full MedlinePlus article ↗- Cetirizine is an antihistamine that helps with allergies and hives. Most oral products — tablets, capsules, solutions — treat classic allergy symptoms like runny nose, sneezing, it...
- It can, yes — drowsiness is the most commonly reported side effect. Cetirizine is considered less sedating than older antihistamines because it doesn't penetrate the brain as readi...
- You can take oral cetirizine with or without food — it doesn't matter much. Food doesn't reduce the total amount absorbed, though it can delay the peak effect by an hour or two. So...
- Can I take cetirizine with food, or does it need to be on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cetirizine Hydrochloride — tap one for details:
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💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII NVG71ZZ7P0
A salt derived from acetic acid, sodium acetate anhydrous is used in medicines as a buffer to help maintain stable pH levels and sometimes as a preservative or bulking agent in solid formulations.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.023 | $2.74 / 120 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0677 | $8.12 / 120 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.0685 | $8.22 / 120 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cetirizine Hydrochloride 1 mg/mL 00121-0874-04 | PAI | 120 ml | $0.023 | AA | Availability likely | — |
| Cetirizine Hydrochloride 1 mg/mL 16571-0134-12 | Rising | 120 ml | $0.023 | AA | Availability likely | — |
| Cetirizine Hydrochloride 1 mg/mL 45802-0626-26 | Padagis | 1 bottle | $0.023 | AA | Availability likely | — |
| Cetirizine Hydrochloride 1 mg/mLthis 51672-4070-08 | Sun | 1 bottle | $0.023 | AA | Availability likely | — |
| Cetirizine Hydrochloride Oral Solution 5 mg/5mL 62135-0057-41 | Chartwell | 120 ml | $0.023 | AA | Availability likely | — |
| Cetirizine Hydrochloride 1 mg/mL 69452-0426-55 | Bionpharma | 120 ml | $0.023 | AA | Availability likely | — |
| Cetirizine hydrochloride 1 mg/mL 72888-0480-01 | Advagen | 120 ml | $0.023 | AA | Availability likely | — |
| Cetirizine Hydrochloride Oral Solution 1 mg/mL 83745-0185-04 | APOZEAL | 120 ml | $0.023 | AA | Availability likely | — |
| Good Neighbor Pharmacy Childrens All Day Allergy 5 mg/5mL 46122-0203-26 | Amerisource | 1 bottle | $0.035 | — | Availability likely | +54% |
| Cetirizine Hydrochloride 1 mg/mL 57237-0357-12 | Rising | 120 ml | $0.035 | — | Availability likely | +54% |
| Cetirizine Hydrochloride 1 mg/mL 57237-0358-12 | Rising | 120 ml | $0.035 | — | Availability likely | +54% |
| foster and thrive childrens allergy relief 5 mg/5mL 70677-1042-01 | Strategic | 1 bottle | $0.035 | — | Availability likely | +54% |
| Cetirizine Hydrochloride 1 mg/mL 70677-1236-01 | STRATEGIC | 1 bottle | $0.035 | — | Availability likely | +54% |
| Childrens Allergy Relief 1 mg/mL 70677-0149-01 | Strategic | 1 bottle | $0.037 | — | FDA listed | +61% |
| Good Sense Childrens All Day Allergy 5 mg/5mL 00113-0189-26 | L. | 1 bottle | $0.037 | — | Availability likely | +64% |
| Good Sense Childrens All Day Allergy 5 mg/5mL 00113-0503-26 | L. | 1 bottle | $0.037 | — | Availability likely | +64% |
| childrens cetirizine hydrochloride 5 mg/5mL 00904-6765-20 | Major | 1 bottle | $0.037 | — | Availability likely | +64% |
| cetirizine hydrochloride 5 mg/5mL 45802-0974-26 | Padagis | 1 bottle | $0.037 | — | Availability likely | +64% |
| All Day Allergy 5 mg/5mL 46122-0101-26 | Amerisource | 1 bottle | $0.037 | — | Availability likely | +64% |
| Childrens Allergy Relief 1 mg/mL 69230-0316-11 | Camber | 1 bottle | $0.037 | — | Availability likely | +64% |
| Leader Childrens All Day Allergy 5 mg/5mL 70000-0214-01 | Cardinal | 1 bottle | $0.037 | — | Availability likely | +64% |
| Leader Childrens all day allergy 5 mg/5mL 70000-0215-01 | Cardinal | 1 bottle | $0.037 | — | Availability likely | +64% |
| Cetirizine Hydrochloride 1 mg/mL 70752-0104-06 | QUAGEN | 1 bottle | $0.037 | — | Availability likely | +64% |
| Cetrizine Hydrochloride 1 mg/mL 83745-0188-04 | APOZEAL | 1 bottle | $0.037 | — | Availability likely | +64% |
| Dye Free Childrens Cetirizine Hydrocholride 5 mg/5mL 68094-0004-62 | Precision | 10 cups | $0.447 | — | Availability likely | +1861% |
| Wal-Zyr All Day Allergy 5 mg/5mL 00363-2106-01 | WALGREEN | 1 bottle | — | — | FDA listed | — |
| childrens allergy relief 5 mg/5mL 00363-3311-26 | Walgreen | 1 bottle | — | — | FDA listed | — |
| childrens allergy relief 5 mg/5mL 00363-3393-26 | Walgreen | 1 bottle | — | — | FDA listed | — |
| childrens allergy relief 5 mg/5mL 11822-0475-00 | Rite | 1 bottle | — | — | FDA listed | — |
| childrens allergy relief 5 mg/5mL 11822-1189-00 | Rite | 1 bottle | — | — | FDA listed | — |
| Rite Aid childrens allergy relief 1 mg/mL 11822-2106-08 | Rite | 1 bottle | — | — | FDA listed | — |
| childrens cetirizine hydrochloride 5 mg/5mL 17856-6765-01 | ATLANTIC | 72 cups | — | — | FDA listed | — |
| Signature Care Childrens Allergy Relief 5 mg/5mL 21130-0189-34 | Safeway | 1 bottle | — | — | Discontinued | — |
| childrens allergy relief 5 mg/5mL 21130-0465-34 | Safeway | 1 bottle | — | — | FDA listed | — |
| Signature Care Childrens Allergy Relief 5 mg/5mL 21130-0475-26 | Safeway | 1 bottle | — | — | Discontinued | — |
| childrens allergy relief 5 mg/5mL 21130-0653-26 | Safeway | 1 bottle | — | — | FDA listed | — |
| Cetirizine hydrochloride 5 mg/5mL 23155-0929-51 | Heritage | 120 ml | — | AA | FDA listed | — |
| childrens all day allergy 5 mg/5mL 30142-0189-26 | Kroger | 1 bottle | — | — | FDA listed | — |
| Childrens All Day Allergy 5 mg/5mL 30142-0475-26 | Kroger | 1 bottle | — | — | FDA listed | — |
| childrens dye free allergy relief 5 mg/5mL 30142-0643-26 | Kroger | 1 bottle | — | — | FDA listed | — |
| childrens dye free allergy relief 5 mg/5mL 30142-0689-26 | Kroger | 1 bottle | — | — | FDA listed | — |
| Topcare Childrens All Day Allergy 5 mg/5mL 36800-0189-26 | Topco | 1 bottle | — | — | FDA listed | — |
| TopCare Childrens All Day Allergy 5 mg/5mL 36800-0475-00 | Topco | 1 bottle | — | — | FDA listed | — |
| HEB Allergy Relief 5 mg/5mL 37808-0102-08 | H | 1 bottle | — | — | FDA listed | — |
| Allergy Relief 1 mg/mL 37808-0106-08 | H | 1 bottle | — | — | FDA listed | — |
| childrens allergy relief 5 mg/5mL 37808-0671-26 | H | 1 bottle | — | — | Discontinued | — |
| Equaline childrens all day allergy 5 mg/5mL 41163-0475-26 | United | 1 bottle | — | — | FDA listed | — |
| Childrens 24 Hour Allergy 5 mg/5mL 41250-0189-26 | Meijer | 1 bottle | — | — | FDA listed | — |
| Childrens 24 Hour Allergy 5 mg/5mL 41250-0475-26 | Meijer | 1 bottle | — | — | FDA listed | — |
| careone childrens allergy relief 5 mg/5mL 41520-0301-26 | American | 1 bottle | — | — | FDA listed | — |
| careone childrens allergy relief 5 mg/5mL 41520-0902-26 | American | 1 bottle | — | — | FDA listed | — |
| Childrens All Day Allergy 5 mg/5mL 42507-0203-26 | HyVee | 1 bottle | — | — | FDA listed | — |
| childrens all day allergy 5 mg/5mL 42507-0475-26 | HyVee | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy Relief 5 mg/5mL 49035-0106-08 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| Equate Childrens Allergy Relief 5 mg/5mL 49035-0276-01 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 50090-1103-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy Relief 1 mg/mL 50090-4741-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Cetirizine Hydrochloride 1 mg/mL 50090-5220-00 | A-S | 1 bottle | — | AA | FDA listed | — |
| Good Sense Childrens All Day Allergy 5 mg/5mL 50090-7068-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Zyrtec Hives 1 mg/mL 50580-0128-04 | Kenvue | 1 bottle | — | — | FDA listed | — |
| Childrens Zyrtec Allergy 5 mg/5mL 50580-0721-05 | Kenvue | 1 bottle | — | — | FDA listed | — |
| Childrens Zyrtec 5 mg/5mL 50580-0730-01 | Kenvue | 1 bottle | — | — | FDA listed | — |
| Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 51672-2102-01 | Sun | 1 bottle | — | — | FDA listed | — |
| Cetirizine Hydrochloride 1 mg/mL 51672-2106-01 | Sun | 1 bottle | — | — | FDA listed | — |
| Childrens Cetirizine Hydrochloride 1 mg/mL 51672-2147-01 | Sun | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy Relief 1 mg/mL 55315-0354-31 | Fred's, | 1 bottle | — | — | FDA listed | — |
| DG Health Childrens All Day Allergy 5 mg/5mL 55910-0714-26 | Dolgencorp, | 1 bottle | — | — | FDA listed | — |
| childrens allergy 5 mg/5mL 56062-0102-08 | Publix | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy 1 mg/mL 56062-0106-08 | Publix | 1 bottle | — | — | FDA listed | — |
| Childrens Cetirizine Hydrochloride Allergy 1 mg/mL 58602-0028-20 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Childrens Cetirizine Hydrochloride Hives Relief 1 mg/mL 58602-0030-20 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Childrens Cetirizine Hydrochloride Hives Relief 1 mg/mL 58602-0036-15 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy Relief 1 mg/mL 58602-0422-12 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy Relief 5 mg/5mL 59779-0509-26 | CVS | 1 bottle | — | — | FDA listed | — |
| allergy relief childrens 5 mg/5mL 59779-0837-26 | CVS | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Childrens 5 mg/5mL 59779-0884-26 | CVS | 1 bottle | — | — | Discontinued | — |
| Cetirizine Hydrochloride 1 mg/mL 61037-0479-02 | BAJAJ | 120 ml | — | AA | FDA listed | — |
| Cetirizine Hydrochloride 1 mg/mL 61037-0480-22 | BAJAJ | 120 ml | — | — | FDA listed | — |
| Childrens Allergy Relief 1 mg/mL 63868-0865-04 | C.D.M.A., | 1 bottle | — | — | FDA listed | — |
| Kirkland Signature Childrens Aller Tec 5 mg/5mL 63981-0475-43 | Costco | 2 bottles | — | — | FDA listed | — |
| Welby Childrens Allergy Relief 5 mg/5mL 64024-0475-26 | Aldi | 1 bottle | — | — | FDA listed | — |
| Cetirizine Hydrochloride 5 mg/5mL 65162-0003-86 | Amneal | 1 bottle | — | — | FDA listed | — |
| Cetirizine Hydrochloride 5 mg/5mL 65162-0005-86 | Amneal | 1 bottle | — | — | FDA listed | — |
| Cetirizine Hydrochloride 5 mg/5mL 65162-0684-86 | Amneal | 118 ml | — | AA | FDA listed | — |
| Childrens Cetirizine Hydrochloride 5 mg/5mL 68016-0023-43 | Chain | 1 bottle | — | — | FDA listed | — |
| Childrens Cetirzine 5 mg/5mL 68016-0106-08 | Pharmacy | 1 bottle | — | — | FDA listed | — |
| Premier Value Childrens Cetirizine 5 mg/5mL 68016-0165-00 | Pharmacy | 1 bottle | — | — | FDA listed | — |
| SIMPLY RIGHT childrens cetirizine 5 mg/5mL 68196-0102-01 | Sam's | 2 bottles | — | — | Discontinued | — |
| Members Mark Childrens Cetirizine 5 mg/5mL 68196-0475-43 | Sam's | 2 bottles | — | — | FDA listed | — |
| Good Sense Childrens All Day Allergy 5 mg/5mL 68788-4093-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| childrens cetirizine hydrochloride 5 mg/5mL 68788-8188-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| Cetirizine Hydrochloride 1 mg/mL 68788-8282-01 | Preferred | 1 bottle | — | AA | FDA listed | — |
| Cetirizine Hydrochloride 1 mg/mL 68788-8523-01 | Preferred | 1 bottle | — | AA | FDA listed | — |
| Good Sense Childrens All Day Allergy 5 mg/5mL 68788-8803-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| Cetirizine Hydrochloride Oral Solution 1 mg/mL 68788-8890-01 | Preferred | 120 ml | — | AA | FDA listed | — |
| Cetirizine Hydrochloride 1 mg/mL 69206-0990-01 | Aventura | 120 ml | — | AA | FDA listed | — |
| Cetirizine Hydrochloride 1 mg/mL 70752-0103-06 | QUAGEN | 1 bottle | — | — | FDA listed | — |
| Cetirizine Hydrochloride 1 mg/mL 71205-0435-04 | Proficient | 1 bottle | — | AA | FDA listed | — |
| Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 71205-0705-72 | Proficient | 1 bottle | — | — | FDA listed | — |
| childrens cetirizine hydrochloride 5 mg/5mL 71205-0722-04 | Proficient | 1 bottle | — | — | FDA listed | — |
| Cetirizine Hydrochloride 1 mg/mL 72162-2073-02 | Bryant | 1 bottle | — | — | FDA listed | — |
| cetirizine hydrochloride 5 mg/5mL 72162-2339-02 | Bryant | 1 bottle | — | — | FDA listed | — |
| Basic Care Childrens All Day Allergy 5 mg/5mL 72288-0330-34 | Amazon.com | 1 bottle | — | — | FDA listed | — |
| basic care childrens all day allergy 5 mg/5mL 72288-0475-34 | Amazon.com | 1 bottle | — | — | FDA listed | — |
| up and up childrens allergy 5 mg/5mL 82442-0475-26 | Target | 1 bottle | — | — | FDA listed | — |
| up and up childrens allergy 5 mg/5mL 82442-0617-26 | Target | 1 bottle | — | — | FDA listed | — |
| Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 83939-0009-01 | VERITYRX, | 5 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51672-4070-08 You're viewing this | 1 BOTTLE in 1 CARTON (51672-4070-8) / 120 mL in 1 BOTTLE | 2014-05-01 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Perennial Allergic Rhinitis Cetirizine hydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria Cetirizine hydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age.
It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Cetirizine hydrochloride oral solution USP, 1 mg/mL can be taken without regard to food consumption. Children 2 to 5 Years for Chronic Urticaria The recommended initial dose of cetirizine hydrochloride oral solution in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) oral solution once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful oral solution once a day, or one ½ teaspoonful oral solution given every 12 hours.
Children 6 months to <2 years for Perennial Allergic Rhinitis and Chronic Uriticaria The recommended dose of cetirizine hydrochloride oral solution in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.
⛔ Contraindications ▾
CONTRAINDICATIONS Cetirizine hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Pediatric studies were also conducted with cetirizine hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with cetirizine hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks.
Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received cetirizine, the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with cetirizine (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with cetirizine (0.25 mg/kg bid). The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with cetirizine hydrochloride were mild or moderate.
In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of cetirizine hydrochloride was uncommon (0.4% on cetirizine hydrochloride vs. 1% on placebo). Table 1 lists adverse experiences which were reported for cetirizine hydrochloride 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with cetirizine hydrochloride than placebo.
Of these, abdominal pain was considered treatment-related and somnolence appeared to be dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg. The adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in trials with children aged 6 to 11 years. In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences, were similar in the cetirizine and placebo treatment groups in each study.
Somnolence occurred with essentially the same frequency in patients who received cetirizine and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received cetirizine exhibited greater irritability/fussiness than patients on placebo. In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received cetirizine compared to patients who received placebo (9% v.
5.3%). In those patients who received 5 mg or more per day of cetirizine as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v.
1.8%) occurred more frequently. Table 1. Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Cetirizine Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥ 2% in Either the 5-mg or the 10-mg Cetirizine Hydrochloride Group, and More Frequently Than in the Placebo Group Cetirizine hydrochloride Adverse Experiences Placebo (N=309) 5 mg (N=161) 10 mg (N=215) Headache 12.3% 11% 14% Pharyngitis 2.9% 6.2% 2.8% Abdominal pain 1.9% 4.4% 5.6% Coughing 3.9% 4.4% 2.8% Somnolence 1.3% 1.9% 4.2% Diarrhea 1.3% 3.1% 1.9% Epistaxis 2.9% 3.7% 1.9% Bronchospasm 1.9% 3.1% 1.9% Nausea 1.9% 1.9% 2.8% Vomiting 1% 2.5% 2.3% The following events were observed infrequently (less than 2%), in either 3982 adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received cetirizine hydrochloride in U.S. trials, including an open adult study of six months duration.
A causal relationship of these infrequent events with cetirizine hydrochloride administration has not been established. Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention. Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.
Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confus…
🔄 Drug Interactions ▾
Drug-Drug Interactions No clinically significant drug interactions have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. There was a small decrease in the clearance of cetirizine caused by a 400-mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect.
🧒 Pediatric Use ▾
Pediatric Use The safety of cetirizine hydrochloride has been demonstrated in pediatric patients aged 6 months to 5 years. The safety of cetirizine has been demonstrated in 168 patients aged 2 to 5 years in placebo controlled trials of up to 4 weeks duration. On a mg/kg basis, most of the 168 patients received between 0.2 and 0.4 mg/kg of cetirizine hydrochloride.
The safety of cetirizine in 399 patients aged 12 to 24 months has been demonstrated in a placebo-controlled 18-month trial, in which the average dose was 0.25 mg/kg bid, corresponding to a range of 4 to 11 mg/day. The safety of cetirizine hydrochloride oral solution has been demonstrated in 42 patients aged 6 to 11 months in a placebo-controlled 7-day trial. The prescribed dose was 0.25 mg/kg bid, which corresponded to a mean of 4.5 mg/day, with a range of 3.4 to 6.2 mg/day.
The effectiveness of cetirizine hydrochloride for the treatment of allergic rhinitis and chronic idiopathic urticaria in pediatric patients aged 6 months to 5 years is based on an extrapolation of the demonstrated efficacy of cetirizine hydrochloride in adults with these conditions and the likelihood that the disease course, pathophysiology and the drug's effect are substantially similar between these two populations. Efficacy is extrapolated down to 6 months of age for perennial allergic rhinitis because this disease is thought to occur down to these ages in children.
The recommended doses for the pediatric population are based on cross-study comparisons of the pharmacokinetics and pharmacodynamics of cetirizine in adult and pediatric subjects and on the safety profile of cetirizine in both adult and pediatric patients at doses equal to or higher than the recommended doses. The cetirizine AUC and C max in pediatric subjects aged 6 to 23 months who received a mean of 2.3 mg in a single dose and in subjects aged 2 to 5 years who received a single dose of 5 mg of cetirizine oral solution, was estimated to be intermediate between that observed in adults who received a single dose of 10 mg of cetirizine tablets and those who received a single dose of 20 mg of cetirizine tablets.
The safety and effectiveness of cetirizine in pediatric patients under the age of 6 months have not been established.
🆘 Overdosage ▾
OVERDOSAGE Overdosage has been reported with cetirizine hydrochloride. In one adult patient who took 150 mg of cetirizine hydrochloride, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an 18 month old pediatric patient who took an overdose of cetirizine hydrochloride (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness.
Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to cetirizine hydrochloride. Cetirizine hydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.
The acute minimal lethal oral doses were 237 mg/kg in mice (approximately 95 times the maximum recommended daily oral dose in adults on a mg/m 2 basis, or approximately 40 times the maximum recommended daily oral dose in infants on a mg/m 2 basis) and 562 mg/kg in rats (approximately 460 times the maximum recommended daily oral dose in adults on a mg/m 2 basis, or approximately 190 times the maximum recommended daily oral dose in infants on a mg/m 2 basis). In rodents, the target of acute toxicity was the central nervous system, and the target of multiple-dose toxicity was the liver.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Actions Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H 1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity.
In clinical studies, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H 1 receptors. Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain.
Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H 1 receptors. Pharmacokinetics Absorption Cetirizine was rapidly absorbed with a time to maximum concentration (T max ) of approximately 1 hour following oral administration of tablets or oral solution in adults. Comparable bioavailability was found between the tablet and oral solution dosage forms.
When healthy volunteers were administered multiple doses of cetirizine (10 mg tablets once daily for 10 days), a mean peak plasma concentration (C max ) of 311 ng/mL was observed. No accumulation was observed. Cetirizine pharmacokinetics were linear for oral doses ranging from 5 to 60 mg.
Food had no effect on the extent of cetirizine exposure (AUC) but T max was delayed by 1.7 hours and C max was decreased by 23% in the presence of food. Distribution The mean plasma protein binding of cetirizine is 93%, independent of concentration in the range of 25 to 1000 ng/mL, which includes the therapeutic plasma levels observed. Metabolism A mass balance study in 6 healthy male volunteers indicated that 70% of the administered radioactivity was recovered in the urine and 10% in the feces.
Approximately 50% of the radioactivity was identified in the urine as unchanged drug. Most of the rapid increase in peak plasma radioactivity was associated with parent drug, suggesting a low degree of first-pass metabolism. Cetirizine is metabolized to a limited extent by oxidative O-dealkylation to a metabolite with negligible antihistaminic activity.
The enzyme or enzymes responsible for this metabolism have not been identified. Elimination The mean elimination half-life in 146 healthy volunteers across multiple pharmacokinetic studies was 8.3 hours and the apparent total body clearance for cetirizine was approximately 53 mL/min. Interaction Studies Pharmacokinetic interaction studies with cetirizine in adults were conducted with pseudoephedrine, antipyrine, ketoconazole, erythromycin and azithromycin.
No interactions were observed. In a multiple dose study of theophylline (400 mg once daily for 3 days) and cetirizine (20 mg once daily for 3 days), a 16% decrease in the clearance of cetirizine was observed. The disposition of theophylline was not altered by concomitant cetirizine administration.
Special Populations Pediatric Patients In pediatric patients aged 2 to 5 years who received 5 mg of cetirizine, the mean C max was 660 ng/mL. Based on cross-study comparisons, the weight normalized apparent total body clearance was 81 to 111% greater and the elimination half-life was 33 to 41% shorter in this pediatric population than in adults. In pediatric patients aged 6 to 23 months who received a single dose of 0.25 mg/kg cetirizine oral solution (mean dose 2.3 mg), the mean C max was 390 ng/mL.
Based on cross-study comparisons, the weight-normalized, apparent total body clearance was 304% greater and the elimination half-life was 63% shorter in this pediatric population compared to adults. The average AUC( 0-t ) in children 6 months to <2 years of age receiving the maximum dose of cetirizine solution (2.5 mg twice a day) is expected to be two-fold higher than that observed in adults receiving a dose of 10 mg cetirizine tablets o…
🧬 Mechanism of Action ▾
Mechanism of Actions Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H 1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity.
In clinical studies, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H 1 receptors. Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain.
Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H 1 receptors.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cetirizine hydrochloride oral solution USP, 5 mg/5 mL (1 mg/mL) is colorless to slightly yellow with a banana-grape flavor. Each teaspoonful (5 mL) contains 5 mg cetirizine hydrochloride. Cetirizine hydrochloride oral solution is supplied as follows: 120 mL plastic bottles NDC 51672-4070-8 STORAGE Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; or Store refrigerated, 2° to 8°C (36° to 46°F).
📦 Storage and Handling ▾
STORAGE Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; or Store refrigerated, 2° to 8°C (36° to 46°F).
📋 Description ▾
DESCRIPTION Cetirizine hydrochloride is an orally active and selective H 1 -receptor antagonist. The chemical name is (±) - [2- [4- [ (4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C 21 H 25 ClN 2 O 3 ∙2HCl.
The molecular weight is 461.82 and the chemical structure is shown below: Cetirizine hydrochloride is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5.
The inactive ingredients of the oral solution are: artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose. Chemical Structure