bepotastine

bepotastine

(be-poe-tass-teen) ,

Bepreve

(trade name)

Classification

Therapeutic: ocular agents
Pharmacologic: antihistamines
Pregnancy Category: C

Indications

Treatment of itching associated with allergic conjunctivitis.

Action

Acts as a histamine H1 receptor antagonist; also inhibits the release of histamine from mast cells; does not bind to or inactivate histamine.

Therapeutic effects

Decreased ocular itching associated with allergic conjunctivitis.

Pharmacokinetics

Absorption: Some systemic absorption follows ophthalmic administration.
Distribution: Unknown.
Metabolism and Excretion: Minimally metabolized by the liver; 75–90% excreted unchanged in urine.
Half-life: Uknown.

Time/action profile (antihistaminic activity)

ROUTEONSETPEAKDURATION
ophthwithin 15 min1–2 hr†12 hr
†blood levels

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Contact lens use ; Obstetric: Use during pregnancy potential maternal benefit justifies the potential risk to fetus; Lactation: Use cautiously during breastfeeding; Pediatric: Safe and effective use in children <2 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Ear, Eye, Nose, Throat

  • nasopharyngitis

Gastrointestinal

  • taste in mouth following instillation (most frequent)

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Ophthalmic (Adults) One drop in affected eye(s) twice daily.

Availability

Ophthalmic solution: 1.5%

Nursing implications

Nursing assessment

  • Assess signs and symptoms of allergic conjunctivitis (redness, itching, watering) periodically during therapy.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Ophthalmic: Instill 1 drop into affected eyes twice daily. See for administration guidelines.

Patient/Family Teaching

  • Instruct patient to instill bepotastine drops as directed. Do not touch dropper to eye or to any surface.
  • Advise patient to remove contact lens prior to instillation. Do not use bepotastine for treatment of irritation related to contact lens. Do not wear contact lens if eyes are red. Contact lens may be reinserted 10 min following instillation.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Decrease in ocular itching due to allergic conjunctivitis.
References in periodicals archive ?
Bepotastine (Bepreve; C), an antihistamine, and besifloxacin (Besivance; C), a quinolone antibiotic, are new ophthalmic products.
Bepotastine indications: Treatment of itching associated with allergic conjunctivitis
In addition to gaining approvals for BROMDAY and BEPREVE(TM), we initiated our REMURA(TM) (bromfenac ophthalmic solution for dry eye) Phase 3 clinical program, plus released the positive results of our Phase 1/2 bepotastine besilate nasal spray study.
Nasdaq: ISTA), today announced positive preliminary results from a Phase 1/2 clinical study of bepotastine besilate nasal spray conducted in Canada for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies.
In July we launched our Phase 1/2 study of bepotastine nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis.
Nasdaq: ISTA), today announced it has initiated a Phase 1/2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies.
In addition to XiDay, the Company's pipeline includes a bromfenac formulation for dry eye and a bepotastine formulation for nasal allergy.
As we look to 2010 and beyond, Bepreve, Xibrom, XiDay, bepotastine nasal spray, and bromfenac for dry eye stand out as our long-term growth drivers, and we are excited about ISTA's future.
Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co.
In another poster presentation titled "The Safety of the Anti-Histamine Bepotastine Besilate Ophthalmic Solution in a Healthy Pediatric Population from Ten to Seventeen Years of Age", ISTA demonstrated Bepreve 1.
0 million was associated with an upfront payment paid to Mitsubishi Tanabe for the licensing of the nasal dosage form of bepotastine.