Xero-Sed Uses

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What is Xero-Sed?

Xero-Sed 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.

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

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

Xero-Sed may also be used for purposes not listed in this medication guide.

Xero-Sed indications

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Perennial Allergic Rhinitis : Xero-Sed

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: Xero-Sed

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 Xero-Sed?

Use Xero-Sed 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 Xero-Sed orally disintegrating tablets.

Uses of Xero-Sed 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, Xero-Sed 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, Xero-Sed) for the treatment of acute allergic or recurrent idiopathic angioedema.

Xero-Sed description

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

Xero-Sed dosage

Xero-Sed

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

Children 2 to 5 Years for Chronic Urticaria: The recommended initial dose of Xero-Sed

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 Xero-Sed

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.

Xero-Sed interactions

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What other drugs will affect Xero-Sed?

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Theophylline decreases the clearance of Xero-Sed 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 Xero-Sed 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.

Xero-Sed side effects

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What are the possible side effects of Xero-Sed?

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 Xero-Sed

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

In clinical trials in patients 12 years and older the most common adverse reactions to oral Xero-Sed 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 Xero-Sed 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 Xero-Sed 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 Xero-Sed 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 Xero-Sed 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 Xero-Sed compared to patients who received placebo.

Xero-Sed

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

The adverse reactions with Xero-Sed 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 Xero-Sed treatment group reported less sedation at all time points compared to subjects treated with diphenhydramine.

Xero-Sed contraindications

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What is the most important information I should know about Xero-Sed?

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

Active ingredient matches for Xero-Sed:

Cetirizine Hydrochloride in India.

Cetirizine in India.


Unit description / dosage (Manufacturer)Price, USD
Xero-Sed 10mg TAB / 10$ 0.13
10 mg x 10's$ 0.13
XERO-SED tab 10 mg x 10's (Max)$ 0.13

List of Xero-Sed substitutes (brand and generic names):

Xero SED 10 mg Tablet (Max India Limitd.)$ 0.01
Xpect A 100 ml Syrup (Alkem Laboratories Ltd)$ 0.03
Xpen D 60 ml Syrup (Pentamark Organics)$ 0.04
Xpen D 100 ml Syrup (Pentamark Organics)$ 0.03
Z - CET Capsule/ Tablet / 10mg / 10 units (Centaur Laboratories)$ 0.17
Z Cet 10 mg Tablet (Centaur Drug House Pvt Ltd)$ 0.02
Z-CET 10mg TAB / 10 (Centaur)$ 0.17
10 mg x 10's (Centaur)$ 0.17
Z-CET tab 10 mg x 10's (Centaur)$ 0.17
Zacet 10 mg Tablet (Chemo Drugs)$ 0.01
ZCET 10MG TABLET 1 strip / 10 tablets each (Centaur Pharmaceuticals Pvt Ltd)$ 0.17
Zecoryl Paracetamol 125 mg, Pseudoephedrine 5 mg, Cetirizine 2 mg. SYR / 60ml (Zentis)$ 0.39
60ml (Zentis)$ 0.39
ZECORYL syr 60ml (Zentis)$ 0.39
Zectop 10 mg Tablet (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 0.03
Zeda 0.5 mg x 1's (Verisfield)
Zeda 1 mg x 1's (Verisfield)
Zene 10 mg Tablet (Nectar Pharma)$ 0.02
ZENE 10MG TABLET 1 strip / 10 tablets each (Nectar Pharma)$ 0.23
Zene 10mg Tablet (Nectar Pharma)$ 0.02
ZENRID TABLET 1 strip / 10 tablets each (Kaizen Pharmaceuticals Pvt Ltd)$ 0.24
Zenriz 10 mg x 30's (Pyridam)$ 10.23
Zensil 10 mg x 1 x 10's (Silom Medical)
Zensil 10 mg x 10 x 10's (Silom Medical)

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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