Zolase Uses

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What is Zolase?

Zolase is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Zolase is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.

Zolase is also used to treat itching and swelling caused by chronic urticaria (hives).

Zolase may also be used for purposes not listed in this medication guide.

Zolase indications

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Perennial Allergic Rhinitis : Zolase

Oral Solution, USP 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: Zolase

Oral Solution, USP 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.

How should I use Zolase?

Use Zolase orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Zolase orally disintegrating tablets.

Uses of Zolase in details

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Use: Labeled Indications

Oral:

Allergic rhinitis: Relief of symptoms associated with allergic rhinitis.

Urticaria, chronic spontaneous: Treatment of uncomplicated skin manifestations of chronic spontaneous urticaria.

Injection:

Urticaria, acute: Treatment of acute urticaria.

Off Label Uses

Anaphylaxis (adjunct to epinephrine for relief of cutaneous symptoms)

Based on joint guidelines from the American Academy of Allergy, Asthma & Immunology, American College of Allergy, Asthma & Immunology, and Joint Council of Allergy, Asthma and Immunology on the diagnosis and management of anaphylaxis and guidelines from the World Allergy Organization on anaphylaxis, Zolase may be used as adjunctive treatment, although should not be used as monotherapy or as first-line therapy of anaphylaxis.

Angioedema, acute allergic or recurrent idiopathic

Clinical experience suggests the utility of second-generation H receptor antagonists (eg, Zolase) for the treatment of acute allergic or recurrent idiopathic angioedema.

Zolase description

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Zolase HCl is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H1) receptor sites. Zolase HCl is considered a long-acting nonsedating antihistamine and has some mast-cell stabilizing activity.

Zolase dosage

Zolase

Oral Solution, USP can be taken without regard to food consumption.

Children 2 to 5 Years for Chronic Urticaria: The recommended initial dose of Zolase

Oral Solution, USP in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) syrup once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful syrup once a day, or one ½ teaspoonful syrup given every 12 hours.

Children 6 months to < 2 years for Perennial Allergic Rhinitis and Chronic Urticaria: The recommended dose of Zolase

Oral Solution, USP 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.

Zolase interactions

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What other drugs will affect Zolase?

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Theophylline decreases the clearance of Zolase although the disposition of theophylline is not affected.

In common with other antihistamines it is recommended that excessive alcohol consumption be avoided. Concurrent use of Zolase with other CNS depressants should also be avoided as reduction in alertness and impairment of performance may occur.

No evidence of interactions with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, ketoconazole and pseudoephedrine has been reported.

Zolase side effects

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What are the possible side effects of Zolase?

The following clinically significant adverse reaction is described elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Oral Zolase

The following adverse reactions associated with the use of oral Zolase were identified in clinical trials.

In clinical trials in patients 12 years and older the most common adverse reactions to oral Zolase occurring with a 2% or greater incidence and greater than placebo were somnolence (14%), fatigue (6%), dry mouth (5%), pharyngitis (2%), and dizziness (2%). In clinical trials in children 6 to 11 years of age with oral Zolase the most common adverse reactions occurring with a 2% or greater incidence and greater than placebo were headache, pharyngitis, abdominal pain, coughing, somnolence, diarrhea, epistaxis, bronchospasm, nausea, and vomiting. Somnolence appeared to be dose related. Adverse reactions reported in placebo-controlled trials with oral Zolase in pediatric patients 2 to 5 years were qualitatively similar in nature and generally similar in frequency to those reported in trials with children 6 to 11 years of age. In placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences were similar in the oral Zolase and placebo treatment groups in each trial. In a trial of 1 week duration in children 6 to 11 months of age patients who received oral Zolase exhibited greater irritability/fussiness than patients on placebo. In a trial of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received oral Zolase compared to patients who received placebo.

Zolase

The safety data of Zolase was evaluated in a randomized, double-blind, single-dose, non-inferiority study comparing Zolase to intravenous diphenhydramine in 262 adults with acute urticaria.

The adverse reactions with Zolase occurred at an incidence of less than 1% and include: dyspepsia, feeling hot, dysgeusia, headache, paresthesia, presyncope, and hyperhidrosis.

An additional randomized, double-blind, single dose study was conducted in 33 adults which showed similar safety results.

Sedation

Subject-rated sedation scores were assessed at baseline, 1 hr, and/or 2 hrs, and/or "Readiness for Discharge”. Sedation was rated on a 0 to 3 scale (0 = none, to 3 = severe) with lower sedation scores indicating less sedation. Subjects in the Zolase treatment group reported less sedation at all time points compared to subjects treated with diphenhydramine.

Zolase contraindications

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What is the most important information I should know about Zolase?

The use of Zolase is contraindicated in patients with a known hypersensitivity to Zolase or any of its ingredients, levocetirizine, or hydroxyzine.

Active ingredient matches for Zolase:

Cetirizine Hydrochloride

Cetirizine


Unit description / dosage (Manufacturer)Price, USD
Zolase 5mg/5ml SYP / 60ml$ 0.30
Zolase 60 ml Syrup$ 0.03
ZOLASE 5MG SYRUP 1 bottle / 60 ML syrup each (Elder Pharmaceuticals Ltd)$ 0.38
Zolase 5mg Syrup (Elder Pharmaceuticals Ltd)$ 0.38

List of Zolase substitutes (brand and generic names):

ZOLONG 10MG TABLET 1 strip / 10 tablets each (Gujarat Terce)$ 0.22
ZOLONG tab 10 mg x 10's (Gujarat Terce)$ 0.23
Zonatus DMR 100 ml Syrup (Avron Pharma)$ 0.03
Zotacet 10mg TAB / 10 (Zota Healthcare Pvt. Ltd.)$ 0.20
10 mg x 10's (Zota Healthcare Pvt. Ltd.)$ 0.20
Zotacet 10 mg Tablet (Zota Healthcare Pvt. Ltd.)$ 0.02
ZOTACET tab 10 mg x 10's (Zota Healthcare Pvt. Ltd.)$ 0.20
Zotacet MD 10 mg Tablet (Zota Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 0.02
Zotacet-MD 10mg TAB / 10
Zotalase 60 ml Syrup (Elder Pharmaceuticals Pvt Ltd)$ 0.03
Zucet Dec 10+150 Tablet (Glosun Pharmaceuticals (P) Ltd.)$ 0.03
Zucold Nimesulide 100 mg, Phenylephrine hydrochloride 5mg, Cetirizine hydrochloride 5mg. TAB / 10 (Zubit)
10's (Zubit)
ZUCOLD tab 10's (Zubit)
Zurtec D 5+120 Tablet (UCB India Pvt Ltd.)$ 0.01
Zycet 10 mg Tablet (Ascent Corporations (Pvt) Ltd)$ 0.03
ZYCET 10 MG TABLET 1 strip / 10 tablets each (Ascent Corporations (Pvt) Ltd)$ 0.22
Zycet 10mg Tablet (Ascent Corporations (Pvt) Ltd)$ 0.02
Caplets; Oral; Cetirizine Dihydrochloride 10 mg (Dexcel)
Zymed 10 mg x 10 x 10's (Millimed)
Zymed 1 mg/1 mL x 60 mL (Millimed)
Zymed syr 1 mg/mL 60 mL x 1's (Millimed)
Zymed tab 10 mg 10 x 10's (Millimed)
Syrup; Oral; Cetirizine Hydrochloride 5 mg / 5 ml (Unichem Laboratories Ltd.)
Tablet, Film-Coated; Oral; Cetirizine Hydrochloride 10 mg (Unichem Laboratories Ltd.)
ZYNCET Capsule/ Tablet / 10mg / 10 units (Unichem Laboratories Ltd.)$ 0.34
ZYNCET Liquid / 5mg per 5ml / 60ml units (Unichem Laboratories Ltd.)$ 0.31
Zyncet 10mg TAB / 10 (Unichem Laboratories Ltd.)$ 0.34
Zyncet 5mg/5ml SYP / 60ml (Unichem Laboratories Ltd.)$ 0.31
10 mg x 10's (Unichem Laboratories Ltd.)$ 0.42
1 mg x 1 mL x 60ml (Unichem Laboratories Ltd.)$ 0.33
Zyncet 60 ml Syrup (Unichem Laboratories Ltd.)$ 0.03
Zyncet 10 mg Tablet (Unichem Laboratories Ltd.)$ 0.05
ZYNCET 10 MG SYRUP 1 bottle / 30 ML syrup each (Unichem Laboratories Ltd.)$ 0.39
ZYNCET 10 MG TABLET 1 strip / 10 tablets each (Unichem Laboratories Ltd.)$ 0.19
ZYNCET 5 MG/5ML SYRUP 1 bottle / 60 ML syrup each (Unichem Laboratories Ltd.)$ 0.42
ZYNCET film-coated tab 10 mg x 10's (Unichem Laboratories Ltd.)$ 0.46
ZYNCET syr 1 mg x 1 mL x 60ml (Unichem Laboratories Ltd.)$ 0.33
Zyncet 10mg Syrup (Unichem Laboratories Ltd.)$ 0.39
Zyncet 10mg Tablet (Unichem Laboratories Ltd.)$ 0.02
Zyncet 5mg/ml Syrup (Unichem Laboratories Ltd.)$ 0.42

References

  1. DailyMed. "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "cetirizine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "cetirizine". http://www.drugbank.ca/drugs/DB00341 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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