Dosing & Uses
Dosage Forms & Strengths
ophthalmic solution
- 1.5% (10mL)
Allergic Conjunctivitis
Instill 1 gtt into affected eye(s) q12hr
Dosage Forms & Strengths
ophthalmic solution
- 1.5% (10mL)
Allergic Conjunctivitis
<2 years: Safety & efficacy not established
>2 years: Administer as in adults; instill 1 gtt into affected eye(s) q12hr
Adverse Effects
>10%
Mild taste disturbance (25%)
1-10%
Ocular irritation (2-5%)
Headache (2-5%)
Nasopharyngitis (2-5%)
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; benzalkonium chloride may be absorbed by soft contact lenses
To minimize contaminating dropper tip and solution, advise the patient not to touch the eyelids
Store at room temp; protect from light & excessive heat
Keep bottle tightly closed when not in use
Do not wear contact lenses if eye is red
Pregnancy & Lactation
Pregnancy
There are no available human data for use during pregnancy to inform any drug-associated risks; oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures; maternal toxicity was observed in rabbits at lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m² basis)
Lactation
There are no data on human milk, effects on breastfed infant or milk production; developmental and health benefits of breastfeeding should be considered, along with mother’s clinical need for therapy, and any potential adverse effects on breastfed infant
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
Mechanism of Action
Topical H1 receptor antagonist; inhibits histamine release from mast cells
Pharmacokinetics
Cmax: 5.1-7.3 ng/mL
Absorption: Minimal systemic absorption
Protein bound: 55%
Peak serum time: 1-2 hr
Metabolism: Minimally metabolized by CYP450 isozymes
Excretion: Urine (75-90% excreted unchanged)
Images
Patient Handout
Formulary
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