Zyrtec BCNFarma Uses

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What is Zyrtec BCNFarma?

Zyrtec BCNFarma 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.

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

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

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

Zyrtec BCNFarma indications

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Perennial Allergic Rhinitis: Zyrtec BCNFarma hydrochloride syrup 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: Zyrtec BCNFarma hydrochloride syrup 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 Zyrtec BCNFarma?

Use Zyrtec BCNFarma 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 Zyrtec BCNFarma orally disintegrating tablets.

Uses of Zyrtec BCNFarma 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, Zyrtec BCNFarma 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, Zyrtec BCNFarma) for the treatment of acute allergic or recurrent idiopathic angioedema.

Zyrtec BCNFarma description

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

Zyrtec BCNFarma dosage

Zyrtec BCNFarma Dosage

Applies to the following strength(s): 10 mg; 5 mg; 1 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Allergic Rhinitis

5 to 10 mg orally or chewed once a day

Usual Adult Dose for Urticaria

5 to 10 mg orally or chewed once a day

Usual Pediatric Dose for Allergic Rhinitis

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Usual Pediatric Dose for Urticaria

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Renal Dose Adjustments

CrCl less than 30 mL/min: 5 mg orally or chewed once a day.

Use of Zyrtec BCNFarma is not recommended in children under 6 years of age with renal impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Zyrtec BCNFarma in such patients.

Liver Dose Adjustments

5 mg orally or chewed once a day

Use of Zyrtec BCNFarma is not recommended in children under 6 years of age with hepatic impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Zyrtec BCNFarma in such patients.

Precautions

In clinical trials, the occurrence of somnolence has been reported. Due caution should therefore be exercised when driving a car or operating potential dangerous machinery. Concurrent use of alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Dialysis

Zyrtec BCNFarma is not significantly removed by hemodialysis, thus supplementary dosing is not required following hemodialysis. The recommended dosage for patients on hemodialysis is 5 mg orally or chewed once a day.

More about Zyrtec BCNFarma

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Zyrtec BCNFarma interactions

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What other drugs will affect Zyrtec BCNFarma?

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Tablet: Concurrent use with alcohol may potentiate the CNS depressant effects of Zyrtec BCNFarma; maprotiline or tricyclic antidepressants may potentiate the anticholinergic effects of either these medications or Zyrtec BCNFarma.

Monoamine oxidase (MAO) inhibitors are not recommended because the use may prolong and intensify the anticholinergic and CNS depressant effects of Zyrtec BCNFarma.

Concurrent use with ototoxic medications may mask the symptoms of ototoxicity eg, tinnitus, dizziness or vertigo; photosensitizing medications may cause additive photosensitizing effects.

Syrup: No interaction is observed for Zyrtec BCNFarma with pseudoephedrine, cimetidine, ketoconazole, erythromycin and azithromycin. Small decrease in Zyrtec BCNFarma clearance is observed when theophylline (400 mg once daily) is taken with Zyrtec BCNFarma. However, disposition of theophylline was not altered by concomitant Zyrtec BCNFarma administration. Concomitant administration of Zyrtec BCNFarma and macrolides or ketoconazole has never resulted clinically relevant EGG changes. Extent of exposure to Zyrtec BCNFarma was increased by 40% when ritonavir is taken with Zyrtec BCNFarma. Disposition of ritonavir was slightly altered further to concomitant Zyrtec BCNFarma administration.

Zyrtec BCNFarma side effects

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What are the possible side effects of Zyrtec BCNFarma?

Pediatric studies were conducted with Zyrtec BCNFarma hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with Zyrtec BCNFarma 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 Zyrtec BCNFarma, 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 Zyrtec BCNFarma (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 Zyrtec BCNFarma (0.25 mg/kg bid).

The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with Zyrtec BCNFarma 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 Zyrtec BCNFarma hydrochloride was uncommon (0.4% on Zyrtec BCNFarma hydrochloride vs. 1.0% on placebo).

Table 1 lists adverse experiences which were reported for Zyrtec BCNFarma 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 Zyrtec BCNFarma 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 Zyrtec BCNFarma and placebo treatment groups in each study. Somnolence occurred with essentially the same frequency in patients who received Zyrtec BCNFarma hydrochloride and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received Zyrtec BCNFarma 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 Zyrtec BCNFarma compared to patients who received placebo (9.0% v. 5.3%). In those patients who received 5 mg or more per day of Zyrtec BCNFarma 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 Zyrtec BCNFarma Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Zyrtec BCNFarma Hydrochloride Group, and More Frequently Than in the Placebo Group

Adverse Experiences Placebo

(N=309)

Zyrtec BCNFarma Hydrochloride
5 mg

(N=161)

10 mg

(N=215)

Headache 12.3% 11.0% 14.0%
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 1.0% 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 Zyrtec BCNFarma hydrochloride in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Zyrtec BCNFarma 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, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine,

myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.

Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.

Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.

Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.

Reticuloendothelial: lymphadenopathy.

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.

Body as a Whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during Zyrtec BCNFarma therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Zyrtec BCNFarma hydrochloride has been reported.

Post-Marketing Experience

In the post-marketing experience period, the following additional rare, but potentially severe adverse events have been reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide and thrombocytopenia.

Zyrtec BCNFarma contraindications

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What is the most important information I should know about Zyrtec BCNFarma?

Tablet: Zyrtec BCNFarma should not be used except under special circumstances for patients with hepatic and renal function impairment.

The risk-benefit should be considered when medical problems eg, bladder neck obstruction, prostatic hypertrophy, urinary retention and glaucoma exists.

Syrup: Hypersensitivity to Zyrtec BCNFarma dihydrochloride, hydroxyzine, any piperazine derivatives or to any of the excipients of Zyrtec BCNFarma. Patients with severe renal impairment CrCl <10 mL/min. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Zyrtec BCNFarma.

Active ingredient matches for Zyrtec BCNFarma:

Cetirizine in Spain.


List of Zyrtec BCNFarma substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Cetirizine Hydrochloride 10 mg
Tablet; Oral; Cetirizine Hydrochloride 5 mg
Zyrtec Allergy tablet, film coated 10 mg/1 (Johnson & Johnson Consumer Inc., Mc Neil Consumer Healthcare Division (US))
Zyrtec Allergy tablet, orally disintegrating 10 mg/1 (Johnson & Johnson Consumer Inc., Mc Neil Consumer Healthcare Division (US))
Zyrtec D 5+120 Adon Pharma Capsule (Adon Pharmaceuticals)$ 0.01
Zyrtec D 5+120 Capsule (Adon Pharmaceuticals)$ 0.01
ZYRTEC D 5 MG/120 MG CAPSULE 1 strip / 10 capsules each (Adon Pharmaceuticals)$ 0.42
Zyrtec D 5 mg/120 mg Capsule (Adon Pharmaceuticals)$ 0.04
Zyrtec DPS 10 ml Drop (UCB India Ltd.)$ 0.02
Tablet; Oral; Cetirizine Hydrochloride 10 mg
Tablet; Oral; Cetirizine Hydrochloride 5 mg
Drops; Oral; Cetirizine Hydrochloride
Tablet, Film-Coated; Oral; Cetirizine Hydrochloride
Tablet, Film-Coated; Oral; Cetirizine Hydrochloride 10 mg
Tablet, Film-Coated; Oral; Cetirizine Hydrochloride 10 mg
Zytizine 10 mg x 10 x 10's (Asian Pharm)
Zytizine 10 mg x 500's (Asian Pharm)
Zytizine 5 mg/5 mL x 60 mL (Asian Pharm)
Zytizine syr 5 mg/5 mL 60 mL x 1's (Asian Pharm)
Zytizine tab 10 mg 10 x 10's (Asian Pharm)
Zytizine tab 10 mg 500's (Asian Pharm)

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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The results of a survey conducted on ndrugs.com for Zyrtec BCNFarma are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Zyrtec BCNFarma. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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