Bepotastine Besilate: Difference between revisions

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{{DrugProjectFormSinglePage
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|authorTag={{RB}}  
|authorTag={{RB}}
|genericName=Bepotastine Besilate
|genericName=Bepotastine Besilate
|aOrAn=a
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|indicationType=treatment
|indicationType=treatment
|indication=itching associated with allergic conjunctivitis
|indication=itching associated with allergic conjunctivitis
|adverseReactions=
|adverseReactions=Disorder of taste, eye irritation, headache, and nasopharyngitis
Disorder of taste, eye irritation, headache, and nasopharyngitis




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The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
|postmarketing=* Hypersensitivity reactions have been reported rarely during the post-marketing use of BEPREVE. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure. The hypersensitivity reactions include itching, body rash, and swelling of lips, tongue and/or throat.
|postmarketing=* Hypersensitivity reactions have been reported rarely during the post-marketing use of BEPREVE. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure. The hypersensitivity reactions include itching, body rash, and swelling of lips, tongue and/or throat.
|drugInteractions=
|drugInteractions=<!--Use in Specific Populations-->
 
<!--Use in Specific Populations-->
|FDAPregCat=C
|FDAPregCat=C
|useInPregnancyFDA=* Teratogenicity studies have been performed in animals. Bepotastine besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day (representing a systemic concentration approximately 3,300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1,000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral doses up to 500 mg/kg/day given during organogenesis and fetal development (>13,000 times the dose in humans on a mg/kg basis). Evidence of infertility was seen in rats given oral bepotastine besilate 1,000 mg/kg/day; however, no evidence of infertility was observed in rats given 200 mg/kg/day (approximately 3,300 times the topical ocular use in humans). The concentration of radio-labeled bepotastine besilate was similar in fetal liver and maternal blood plasma following a single 3 mg/kg oral dose. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.
|useInPregnancyFDA=* Teratogenicity studies have been performed in animals. Bepotastine besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day (representing a systemic concentration approximately 3,300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1,000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral doses up to 500 mg/kg/day given during organogenesis and fetal development (>13,000 times the dose in humans on a mg/kg basis). Evidence of infertility was seen in rats given oral bepotastine besilate 1,000 mg/kg/day; however, no evidence of infertility was observed in rats given 200 mg/kg/day (approximately 3,300 times the topical ocular use in humans). The concentration of radio-labeled bepotastine besilate was similar in fetal liver and maternal blood plasma following a single 3 mg/kg oral dose. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.
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<!--Administration and Monitoring-->
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|administration=* Oral
|administration=* topical ophthalmic
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description


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|overdose====Acute Overdose===
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
<!--Pharmacology-->

Revision as of 14:50, 30 March 2015

Bepotastine Besilate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

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Overview

Bepotastine Besilate is a histamine H1 receptor antagonist that is FDA approved for the treatment of itching associated with allergic conjunctivitis. Common adverse reactions include Disorder of taste, eye irritation, headache, and nasopharyngitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

Dosage

  • Instill one drop of BEPREVE into the affected eye(s) twice a day (BID).

DOSAGE FORMS AND STRENGTHS

  • Topical ophthalmic solution containing bepotastine besilate 1.5%.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bepotastine Besilate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bepotastine Besilate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Bepotastine Besilate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bepotastine Besilate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bepotastine Besilate in pediatric patients.

Contraindications

  • Bepreve is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients

Warnings

Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

5.2 Contact Lens Use Patients should be advised not to wear a contact lens if their eye is red. BEPREVE should not be used to treat contact lens-related irritation.

BEPREVE should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of BEPREVE. The preservative in BEPREVE, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of BEPREVE.

5.3 Topical Ophthalmic Use Only BEPREVE is for topical ophthalmic use only.

Adverse Reactions

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 clinical practice.

The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.

Postmarketing Experience

  • Hypersensitivity reactions have been reported rarely during the post-marketing use of BEPREVE. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure. The hypersensitivity reactions include itching, body rash, and swelling of lips, tongue and/or throat.

Drug Interactions

There is limited information regarding Bepotastine Besilate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Teratogenicity studies have been performed in animals. Bepotastine besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day (representing a systemic concentration approximately 3,300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1,000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral doses up to 500 mg/kg/day given during organogenesis and fetal development (>13,000 times the dose in humans on a mg/kg basis). Evidence of infertility was seen in rats given oral bepotastine besilate 1,000 mg/kg/day; however, no evidence of infertility was observed in rats given 200 mg/kg/day (approximately 3,300 times the topical ocular use in humans). The concentration of radio-labeled bepotastine besilate was similar in fetal liver and maternal blood plasma following a single 3 mg/kg oral dose. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.

An increase in stillborns and decreased growth and development were observed in pups born from rats given oral doses of 1,000 mg/kg/day during perinatal and lactation periods. There were no observed effects in rats treated with 100 mg/kg/day. There are no adequate and well-controlled studies of bepotastine besilate in pregnant women. Because animal reproduction studies are not always predictive of human response, BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bepotastine Besilate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Bepotastine Besilate during labor and delivery.

Nursing Mothers

  • Following a single 3 mg/kg oral dose of radiolabeled bepotastine besilate to nursing rats 11 days after delivery, the maximum concentration of radioactivity in milk was 0.40 mcg-eq/mL 1 hour after administration; at 48 hours after administration the concentration was below detection limits. The milk concentration was higher than the maternal blood plasma concentration at each time of measurement.

It is not known if bepotastine besilate is excreted in human milk. Caution should be exercised when BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is administered to a nursing woman.

Pediatric Use

  • Safety and efficacy of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% have not been established in pediatric patients under 2 years of age. Efficacy in pediatric patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults.

Geriatic Use

  • No overall difference in safety or effectiveness has been observed between elderly and younger patients.

Gender

There is no FDA guidance on the use of Bepotastine Besilate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Bepotastine Besilate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Bepotastine Besilate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Bepotastine Besilate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Bepotastine Besilate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Bepotastine Besilate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • topical ophthalmic

Monitoring

There is limited information regarding Monitoring of Bepotastine Besilate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Bepotastine Besilate in the drug label.

Overdosage

There is limited information regarding Overdose of Bepotastine Besilate in the drug label.

Pharmacology

There is limited information regarding Bepotastine Besilate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Bepotastine Besilate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Bepotastine Besilate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Bepotastine Besilate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Bepotastine Besilate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Bepotastine Besilate in the drug label.

How Supplied

Storage

There is limited information regarding Bepotastine Besilate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Bepotastine Besilate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Bepotastine Besilate in the drug label.

Precautions with Alcohol

  • Alcohol-Bepotastine Besilate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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