Generic name: bepotastine ophthalmic
Brand name: Bepreve
Dosage form: ophthalmic solution (1.5%)
Drug class: Ophthalmic antihistamines and decongestants
Medically reviewed by A Ras MD.
What is bepotastine?
Bepotastine is a prescription medicine that is used to treat eye irritation due to allergies.
Bepotastine Besilate Ophthalmic Solution, 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of Bepotastine Besilate Ophthalmic Solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is:
Bepotastine besilate is a white or creamish white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepotastine Besilate Ophthalmic Solution is supplied as a sterile, aqueous 1.5% solution, with a pH of 6.8.
The osmolality of Bepotastine Besilate Ophthalmic Solution, 1.5% is approximately 290 mOsm/kg.
Each mL of Bepotastine Besilate Ophthalmic Solution, 1.5% contains:
Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine)
Preservative: benzalkonium chloride 0.005%
Inactives: sodium chloride, sodium hydroxide to adjust pH, sodium phosphate monobasic dihydrate and water for injection.
Mechanism of Action
Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.
Before taking bepotastine, tell your doctor:
- If you are allergic to bepotastine; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take bepotastine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take bepotastine?
- Tell all of your health care providers that you take bepotastine. This includes your doctors, nurses, pharmacists, and dentists.
- Do not use bepotastine to treat contact lens irritation.
- This medicine may cause harm if swallowed. If bepotastine is swallowed, call a doctor or poison control center right away.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using bepotastine while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is bepotastine best taken?
Use bepotastine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- For the eye only.
- Wash your hands before and after use.
- Take out contact lenses before using bepotastine. Lenses may be put back in 10 minutes after bepotastine is given. Do not put contacts back in if your eyes are irritated or infected.
- Do not wear contact lenses if your eyes are red.
- Do not touch the container tip to the eye, lid, or other skin.
- Tilt your head back and drop drug into the eye.
- After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
What do I do if I miss a dose?
- Use a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not use 2 doses at the same time or extra doses.
What are the side effects of bepotastine that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Change in eyesight, eye pain, or very bad eye irritation.
What are some other side effects of bepotastine?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Eye irritation.
- Bad taste in your mouth.
- Nose and throat irritation.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out bepotastine?
- Store at room temperature.
- Keep lid tightly closed.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
PRINCIPAL DISPLAY PANEL – CARTON LABEL
- Bepotastine Besilate Ophthalmic Solution, 1.5%
- Sterile NDC 60505-6111-1
- For topical ophthalmic use only.
- Rx only
- Apotex Corp.