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bepotastine (Bepreve)

 

Classes: Antihistamines, Ophthalmic

Dosing and uses of Bepreve (bepotastine)

 

Adult dosage forms and strengths

ophthalmic solution

  • 1.5% (10mL)

 

Allergic Conjunctivitis

Instill 1 gtt into affected eye(s) BId

 

Pediatric dosage forms and strengths

ophthalmic solution

  • 1.5% (10mL)

 

Allergic Conjunctivitis

<2 years old: Safety & efficacy not established

>2 years old: Administer as in adults; instill 1 gtt into affected eye(s) BId

 

Bepreve (bepotastine) adverse (side) effects

>10%

Mild taste disturbance

 

1-10%

Ocular irritation

Headache

Nasopharyngitis

 

Postmarketing Reports

Hypersensitivity reactions, including itching, body rash, and swelling lips, tongue and/or throat

 

Warnings

Contraindications

Hypersensitivity

 

Cautions

Remove contact lenses prior to instillation

Store at room temp; protect from light & excessive heat

To prevent contamination do not touch dropper tip to any surface

Keep bottle tightly closed when not in use

 

Pregnancy and lactation

Pregnancy category: C

Lactation: excretion in milk unknown; use with caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Bepreve (bepotastine)

Cmax: 5.1-7.3 ng/mL

Absorption: Minimal systemic absorption

Protein Bound: 55%

Metabolism: Minimally metabolized by CYP450 isozymes

Excretion: urine (75-90% excreted unchanged)

 

Mechanism of action

Topical H1 receptor antagonist; inhibits histamine release from mast cells