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 ?
In "Expansion," the Company launched sales of 7 products with 15 strengths such as Bepotastine Besilate OD Tablets "Nichi-lko" that are more identifiable by different color printing for each strength and Minodronic Acid Tablets 50mg "Nichi-lko" using a sliding card sheet taking into consideration the prevention of accidental ingestion by children in June 2018.
Nichi-Iko Pharmaceutical Co Ltd (Tokyo: 4541)
The pharmacologic agents that are available as ophthalmic solutions, used in the treatment of allergic conjunctivitis belong to diverse classes: (1) Antihistamines - which block H1 receptors, e.g., levocabastine, azelastine, emedastine, bepotastine, and alcaftadine; (2) Mast cell stabilizers - which increase the calcium influx to the mast cell and prevent changes in the membrane permeability resulting in the stability of membrane decreasing degranulation of mast cells, [6] e.g.
Clinical effectiveness of olopatadine therapy in children with allergic conjunctivitis
There are no human eye data for bepotastine (Bepreve), ketotifen (Alaway), and olopatadine (Pataday, Patanol).
Ophthalmic drugs in pregnancy and lactation
According to the trial findings, BEPOSONE (bepotastine besilate/steroid) nasal spray showed highly statistically significant improvements compared to placebo in patients' nasal symptoms following exposure to one of the most potent seasonal allergy triggers, Mountain Cedar pollen.
ISTA Pharmaceuticals Inc announces positive topline results from Phase 2 clinical trial of BEPOSONE nasal spray for seasonal allergic rhinitis
5 January 2012 - ISTA Pharmaceuticals Inc (NASDAQ:ISTA) said on Wednesday that it has launched its Phase II clinical trial of BEPOSONE, a nasal spray combining bepotastine besilate with a steroid for the treatment of symptoms related to seasonal allergic rhinitis.
ISTA plans to enrol some 600 patients in Texas who will be administered either the bepotastine besilate-steroid combination nasal spray, nasal spray containing only one of the active agents, or placebo nasal spray for two weeks.
ISTA launches Phase II allergic rhinitis trial of BEPOSONE
Bepotastine (Bepreve; C), an antihistamine, and besifloxacin (Besivance; C), a quinolone antibiotic, are new ophthalmic products.
Bepotastine, besifloxacin, ecallantide, golimumab, ofatumumab, prasugrel, telavancin, and vigabatrin appear to be compatible with breastfeeding, but there are human data only for vigabatrin.
Drugs approved in 2009
In "Expansion," the Company launched sales of 7 products with 15 strengths such as Bepotastine Besilate OD Tablets "Nichi-Iko" that are more identifiable by different color printing for each strength and Minodronic Acid Tablets 50mg "Nichi-Iko" using a sliding card sheet taking into consideration the prevention of accidental ingestion by children in June 2018.
Nichi-Iko Pharmaceutical Co Ltd (Tokyo: 4541)
M2 PHARMA-October 6, 2010-ISTA reports encouraging preliminary Phase I/II results for bepotastine besilate nasal spray(C)2010 M2 COMMUNICATIONS
6 October 2010 - US ISTA Pharmaceuticals Inc (NASDAQ: ISTA) reported on Wednesday positive preliminary results from a Canadian Phase I/II study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis.
The findings demonstrated two of the three bepotastine besilate concentrations tested were effective in relieving patients' nasal symptoms after exposure to seasonal allergens.
ISTA reports encouraging preliminary Phase I/II results for bepotastine besilate nasal spray
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