Drugs Details

Drugs Info of Bepreve
Drugs Details
  • Drugs Type  : Multum
  • Date : 5th Jan 2015 10:57 pm
  • Brand Name : Bepreve
  • Generic Name : bepotastine ophthalmic (Pronunciation: BEP oh TAS teen off THAL mik)
Descriptions

BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of BEPREVE contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is:

 

BEPREVE® (bepotastine besilate) Structural Formula Illustration

Bepotastine besilate is a white or pale yellowish crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. BEPREVE ophthalmic solution is supplied as a sterile, aqueous 1.5% solution, with a pH of 6.8.

The osmolality of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is approximately 290 mOsm/kg.

Each mL of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% contains:

Active: Bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine)

Preservative: benzalkonium chloride 0.005%

Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP.

What are the possible side effects of bepotastine ophthalmic (Bepreve)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using bepotastine ophthalmic and call your doctor at once if you have severe eye irritation when using the eye drops.

Less serious side effects may include:

  • mild eye irritation;
  • stuffy nose, sore throat;
  • headache; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical...

Read All Potential Side Effects and See Pictures of Bepreve »

What are the precautions when taking bepotastine besilate ophthalmic solution 1.5% (Bepreve)?

Before using bepotastine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you develop a new eye...

Read All Potential Precautions of Bepreve »

This monograph has been modified to include the generic and brand name in many instances.

Indications

BEPREVE® (bepotastine besilate) Ophthalmic Solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

Dosage Administration

Instill one drop of BEPREVE into the affected eye(s) twice a day (BID).

How Supplied

Dosage Forms And Strengths

Topical ophthalmic solution containing bepotastine besilate 1.5%

Storage And Handling

BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is supplied in a white low density polyethylene plastic squeeze bottle with a white controlled dropper tip and a white polypropylene cap in the following size:

5 mL (NDC 67425-007-50)
10 mL (NDC 67425-007-75)

Storage

Store at 15° – 25°C (59° – 77°F).

Manufactured for: ISTA Pharmaceuticals®, Inc. Irvine, CA 92618. By: Bausch & Lomb Incorporated Tampa, FL 33637. Revised: 06/2012

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.

Post-Marketing Experience

Hypersensitivity reactions have been reported rarely during the post-marketing use of BEPREVE®. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The hypersensitivity reactions may include itching, body rash, and swelling of lips, tongue and/or throat.

Read the Bepreve (bepotastine besilate ophthalmic solution 1.5%) Side Effects Center for a complete guide to possible side effects

Learn More »
 

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Contamination of Tip and Solution

To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

Contact Lens Use

Patients should be advised not to wear a contact lens if their eye is red. BEPREVE should not be used to treat contact lens-related irritation.

BEPREVE should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of BEPREVE®. The preservative in BEPREVE®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of BEPREVE.

Topical Ophthalmic Use Only

BEPREVE is for topical ophthalmic use only.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Teratogenicity studies have been performed in animals. Bepotastine besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day (representing a systemic concentration approximately 3300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral does up to 500 mg/kg/day given during organogenesis and fetal development ( > 13,000 times the dose in humans on a mg/kg basis). Evidence of infertility was seen in rats given oral bepotastine besilate 1000 mg/kg/day, however, no evidence of infertility was observed in rats given 200 mg/kg/day (approximately 3300 times the topical ocular use in humans). The concentration of radio-labeled bepotastine besilate was similar in fetal liver and maternal blood plasma following a single 3 mg/kg oral dose. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.

An increase in stillborns and decreased growth and development were observed in pups born from rats given oral doses of 1000 mg/kg/day during perinatal and lactation periods. There were no observed effects in rats treated with 100 mg/kg/day.

There are no adequate and well-controlled studies of bepotastine besilate in pregnant women. Because animal reproduction studies are not always predictive of human response, BEPREVE (bepotastine besilate ophthalmic solution) 1.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Following a single 3 mg/kg oral dose of radio-labeled bepotastine besilate to nursing rats 11 days after delivery, the maximum concentration of radioactivity in milk was 0.40 mcg eq/mL 1 hour after administration; at 48 hours after administration the concentration was below detection limits. The milk concentration was higher than the maternal blood plasma concentration at each time of measurement.

It is not known if bepotastine besilate is excreted in human milk. Caution should be exercised when BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is administered to a nursing woman.

Pediatric Use

Safety and efficacy of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% have not been established in pediatric patients under 2 years of age. Efficacy in pediatric patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

BEPREVE is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see ADVERSE REACTIONS].

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.

Pharmacokinetics

Absorption

The extent of systemic exposure to bepotastine following topical ophthalmic administration of bepotastine besilate 1% and 1.5% ophthalmic solutions was evaluated in 12 healthy adults. Following one drop of 1% or 1.5% bepotastine besilate ophthalmic solution to both eyes four time daily (QID) for seven days, bepotastine plasma concentrations peaked at approximately one to two hours post-instillation. Maximum plasma concentrations for the 1% and 1.5% strengths were 5.1 ± 2.5 ng/mL and 7.3 ± 1.9 ng/mL, respectively. Plasma concentrations at 24 hours post-instillation were below the quantifiable limit (2ng/mL) in 11/12 subjects in the two dose groups.

Distribution

The extent of protein binding of bepotastine is approximately 55% and independent of bepotastine concentration.

Metabolism

In vitro metabolism studies with human liver microsomes demonstrated that bepotastine is minimally metabolized by CYP450 isozymes. In vitro studies demonstrated that bepotastine besilate does not inhibit the metabolism of various cytochrome P450 substrates via inhibition of CYP3A4, CYP2C9, and CYP2C19. The effect of bepotastine besilate on the metabolism of substrates of CYP1A2, CYP2C8, CYP2D6 was not studied. Bepotastine besilate has a low potential for drug interaction via inhibition of CYP3A4, CYP2C9, and CYP2C19.

Excretion

The main route of elimination of bepotastine besilate is urinary excretion (with approximately 75-90% excreted unchanged in urine).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term dietary studies in mice and rats were conducted to evaluate the carcinogenic potential of bepotastine besilate. Bepotastine besilate did not significantly induce neoplasms in mice receiving a nominal dose of up to 200 mg/kg/day for 21 months or rats receiving a nominal dose of up to 97 mg/kg/day for 24 months. These dose levels represent systemic exposures approximating 350 and 200 times that achieved with human topical ocular use.

The no observable adverse effect level for bepotastine besilate based on nominal dose levels in carcinogenicity tests were 18.7 to 19.9 mg/kg/day in mice and 9.6 to 9.8 mg/kg/day in rats (representing exposure margins of approximately 60 and 20 times the systemic exposure anticipated for human topical use).

There was no evidence of genotoxicity in the Ames test, in CHO cells (chromosome aberrations), in mouse hepatocytes (unscheduled DNA synthesis), or in the mouse micronucleus test.

When oral bepotastine was administered to male and female rats at doses up to 1,000 mg/kg/day, there was a slight reduction in fertility index and surviving fetuses. Infertility was not seen in rats given 200 mg/kg/day oral bepotastine besilate (approximately 3300 times the systemic concentration anticipated for topical ocular use in humans).

Clinical Studies

Clinical efficacy was evaluated in 2 conjunctival allergen challenge (CAC) studies (237 patients). BEPREVE (bepotastine besilate ophthalmic solution) 1.5% was more effective than its vehicle for relieving ocular itching induced by an ocular allergen challenge, both at CAC 15 minutes post-dosing and a CAC 8 hours post dosing of BEPREVE.

The safety of BEPREVE was evaluated in a randomized clinical study of 861 subjects over a period of 6 weeks.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Topical Ophthalmic Use Only

For topical ophthalmic administration only.

Sterility of Dropper Tip

Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.

Concomitant Use of Contact Lenses

Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that BEPREVE should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of BEPREVE. The preservative in BEPREVE, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of BEPREVE.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

BEPOTASTINE - OPHTHALMIC

 

(BEP-oh-TAS-teen)

 

COMMON BRAND NAME(S): Bepreve

 

USES: This medication is used to treat itching of the eyes due to allergies. Bepotastine is an antihistamine. It works by blocking a certain natural substance (histamine) that causes allergic symptoms.

Do not use this medication to treat red or irritated eyes due to wearing contact lenses. Contact your doctor for further instructions if this occurs.

 

HOW TO USE: Apply this medication in the affected eye(s) usually twice a day or as directed by your doctor.

Wash your hands before each use. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

The preservative in this product may be absorbed by contact lenses. If you wear contact lenses, remove them before using this medication and keep them out of your eyes for at least 10 minutes after each dose.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (for example, other drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

Do not use this product if it becomes contaminated (for example, drops turn a dark color). Use of contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Contact your doctor or pharmacist for more information.

Tell your doctor if your condition does not improve in a few days or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: A mild taste in the mouth, headache, eye irritation, or sore throat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Bepreve (bepotastine besilate ophthalmic solution 1.5%) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using bepotastine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of bepotastine eye drops or start a new bottle.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Ask your doctor about additional ways to reduce your symptoms (such as minimizing your exposure to allergens, using cold compresses and lubricating eye drops).

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Keep the bottle tightly closed and store between 59-77 degrees F (15-25 degrees C) away from moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Bepreve

Generic Name: bepotastine ophthalmic (Pronunciation: BEP oh TAS teen off THAL mik)

  • What is bepotastine ophthalmic (Bepreve)?
  • What are the possible side effects of bepotastine ophthalmic (Bepreve)?
  • What is the most important information I should know about bepotastine ophthalmic (Bepreve)?
  • What should I discuss with my healthcare provider before using bepotastine ophthalmic (Bepreve)?
  • How should I use bepotastine ophthalmic (Bepreve)?
  • What happens if I miss a dose (Bepreve)?
  • What happens if I overdose (Bepreve)?
  • What should I avoid while using bepotastine ophthalmic (Bepreve)?
  • What other drugs will affect bepotastine ophthalmic (Bepreve)?
  • Where can I get more information?

What is bepotastine ophthalmic (Bepreve)?

Bepotastine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of itching or watery eyes.

Bepotastine ophthalmic (for the eye) is used to treat itchy eyes caused by allergies.

Bepotastine ophthalmic should not be used to treat eye discomfort caused by wearing contact lenses.

Bepotastine ophthalmic may also be used for purposes not listed in this medication guide.

What are the possible side effects of bepotastine ophthalmic (Bepreve)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using bepotastine ophthalmic and call your doctor at once if you have severe eye irritation when using the eye drops.

Less serious side effects may include:

  • mild eye irritation;
  • stuffy nose, sore throat;
  • headache; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Bepreve (bepotastine besilate ophthalmic solution 1.5%) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about bepotastine ophthalmic (Bepreve)?

You should not use this medication if you are allergic to bepotastine.

Do not use this medication while wearing contact lenses. Bepotastine ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 10 minutes after using bepotastine before putting in your contact lenses.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Stop using bepotastine ophthalmic and call your doctor at once if you have severe eye irritation when using the eye drops.

Side Effects Centers
  • Bepreve

Patient Detailed How Take

What should I discuss with my healthcare provider before using bepotastine ophthalmic (Bepreve)?

You should not use this medication if you are allergic to bepotastine.

FDA pregnancy category C. It is not known whether bepotastine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether bepotastine ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication in a child younger than 2 years old.

How should I use bepotastine ophthalmic (Bepreve)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before using eye medication.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Side Effects Centers
  • Bepreve

Patient Detailed Avoid Taking

What happens if I miss a dose (Bepreve)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Bepreve)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using bepotastine ophthalmic (Bepreve)?

Do not use this medication while wearing contact lenses. Bepotastine ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 10 minutes after using bepotastine before putting in your contact lenses.

What other drugs will affect bepotastine ophthalmic (Bepreve)?

It is not likely that other drugs you take orally or inject will have an effect on bepotastine used in the eyes. But many drugs can interact with each other. Tell your doctor about all medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about bepotastine ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.01. Revision date: 8/29/2012.

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