Betarhin Uses

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What is Betarhin?

Betarhin 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.

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

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

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

Betarhin indications

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Perennial Allergic Rhinitis: Betarhin 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: Betarhin 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 Betarhin?

Use Betarhin 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 Betarhin orally disintegrating tablets.

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

Betarhin description

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

Betarhin dosage

Betarhin 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 Betarhin 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 Betarhin in such patients.

Liver Dose Adjustments

5 mg orally or chewed once a day

Use of Betarhin 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 Betarhin 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

Betarhin 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.

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Betarhin interactions

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What other drugs will affect Betarhin?

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

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

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 Betarhin with pseudoephedrine, cimetidine, ketoconazole, erythromycin and azithromycin. Small decrease in Betarhin clearance is observed when theophylline (400 mg once daily) is taken with Betarhin. However, disposition of theophylline was not altered by concomitant Betarhin administration. Concomitant administration of Betarhin and macrolides or ketoconazole has never resulted clinically relevant EGG changes. Extent of exposure to Betarhin was increased by 40% when ritonavir is taken with Betarhin. Disposition of ritonavir was slightly altered further to concomitant Betarhin administration.

Betarhin side effects

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What are the possible side effects of Betarhin?

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

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

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

Adverse Experiences Placebo

(N=309)

Betarhin
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 Betarhin in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Betarhin 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 Betarhin therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Betarhin 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.

Betarhin contraindications

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

Tablet: Betarhin 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 Betarhin dihydrochloride, hydroxyzine, any piperazine derivatives or to any of the excipients of Betarhin. 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 Betarhin.

Active ingredient matches for Betarhin:

Cetirizine in Indonesia.

Cetirizine diHCl in Indonesia.

Cetirizine hydrochloride in Indonesia.


Unit description / dosage (Manufacturer)Price, USD
Betarhin 10 mg x 20's$ 7.44
Betarhin 60 mL x 1's$ 4.09
Betarhin 30 mL x 1's$ 4.46

List of Betarhin substitutes (brand and generic names):

Tablet; Oral; Cetirizine Hydrochloride 10 mg
BIO ACT Capsule/ Tablet / 10mg / 10 units (Bio-Drug Laboratories Pvt Ltd)$ 0.17
Bio Act 10mg TAB / 10 (Bio-Drug Laboratories Pvt Ltd)$ 0.17
10 mg x 10's (Bio-Drug Laboratories Pvt Ltd)$ 0.17
Bio act 10 mg Tablet (Bio-Drug Laboratories Pvt Ltd)$ 0.02
BIO ACT 10MG TABLET 1 strip / 10 tablets each (Bio-Drug Laboratories Pvt Ltd)$ 0.30
BIO ACT tab 10 mg x 10's (Bio-Drug Laboratories Pvt Ltd)$ 0.17
Bio Act 10mg TAB / 10 (Bio-Drug Laboratories Pvt Ltd)$ 0.17
Bio Act 10mg Tablet (Bio-Drug Laboratories Pvt Ltd)$ 0.03
Biozin 10mg TAB / 10 (Biomedica Life Sciences)$ 0.24
10 mg x 10's (Biomedica Life Sciences)$ 0.24
Biozin 10 mg Tablet (Biomedica Life Sciences)$ 0.02
BIOZIN tab 10 mg x 10's (Biomedica Life Sciences)$ 0.24
Bluetec 10 mg x 10 Blister x 10 Tablet
Bocet-BD 150+5 Tablet (Bioman Pharmaceuticals)$ 0.02
Bogotizin 10 mg x 1 Blister x 10 Tablet
Boie Cetirizine diHCl 10 mg x 100's$ 15.56
Brocet Ambroxol 60 mg, Cetirizine 5mg. TAB / 100 (Captab Biotec)$ 3.86
100's (Captab Biotec)$ 3.86
Brocet 60+5 Tablet (Captab Biotec)$ 0.04
BROCET tab 10's (Captab Biotec)$ 0.39
C Day 10 mg Tablet (Suvik Hitek Pvt. Ltd.)$ 0.01
C DAY 10MG TABLET 1 strip / 10 tablets each (Suvik Hitek Pvt. Ltd.)$ 0.15
C Day 10mg Tablet (Suvik Hitek Pvt. Ltd.)$ 0.01
C Knot 500+25+10 Tablet (Antigen Healthcare P. Ltd.)$ 0.02
C Tec 10 mg Tablet (Perk Pharmaceuticals Ltd.)$ 0.02
C-Triz 10mg Dispertab / 100 (Corona)
10 mg x 100's (Corona)
C-TRIZ dispertab 10 mg x 10's (Corona)
Carcet FC 150+5 Tablet (Burgeon Pharmaceuticals Pvt. Ltd.)$ 0.02

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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