Bepotastine

Bepotastine is a prescription medication indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

• Bepotastine is available under the following different brand names: Bepreve

Common side effects of Bepotastine include:

• an unusual or unpleasant taste in the mouth
• headache
• eye irritation
• stuffy nose
• sore throat

Serious side effects of Bepotastine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat

Rare side effects of Bepotastine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Ophthalmic solution

• 1.5% (10 mL)

Allergic conjunctivitis

Adult dosage

• Instill 1 drop into the affected eye(s) every 12 hours

Pediatric dosage

• Children younger than 2 years: Safety & efficacy not established
• Children older than 2 years: Administer as in adults; instill 1 drop into the affected eye(s) every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Bepotastine has no noted severe interactions with any other drugs.
• Bepotastine has no noted serious interactions with any other drugs.
• Bepotastine has no noted moderate interactions with any other drugs.
• Bepotastine has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bepotastine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bepotastine?”

Cautions

• Remove contact lenses before instillation; soft contact lenses may absorb benzalkonium chloride
• To minimize contaminating the dropper tip and solution, advise patients not to touch their eyelids
• Store at room temperature; protect from light and excessive heat
• Keep the bottle tightly closed when not in use
• Do not wear contact lenses if the eye is red

Pregnancy and Lactation

• There are no available human data on the use of bepotastine during pregnancy to inform any drug-associated risks; oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures; maternal toxicity was observed in rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose on an mg/m² basis)
• Lactation
  • There are no data on the presence of bepotastine in human milk or its effects on breastfed infants, or on milk production; developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant