Bepreve

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Bepreve uses


1 INDICATIONS AND USAGE

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.

Bepreve ® is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. (1)

2 DOSAGE AND ADMINISTRATION

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

Instill one drop into the affected eye(s) twice a day (BID). (2)

3 DOSAGE FORMS AND STRENGTHS

Topical ophthalmic solution containing Bepreve besilate 1.5%.

Solution containing Bepreve besilate, 1.5%. (3)

4 CONTRAINDICATIONS

Bepreve is contraindicated in patients with a history of hypersensitivity reactions to Bepreve or any of the other ingredients .

Hypersensitivity to any component of this product. (4)

5 WARNINGS AND PRECAUTIONS

  • To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use.
  • Bepreve should not be used to treat contact lens-related irritation. (5.2)
  • Remove contact lenses prior to instillation of Bepreve. (5.2)

5.1 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.

5.2 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.

5.3 Topical Ophthalmic Use Only

Bepreve is for topical ophthalmic use only.

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6 ADVERSE REACTIONS

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

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 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.

6.2 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 include itching, body rash, and swelling of lips, tongue and/or throat.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C: Teratogenicity studies have been performed in animals. Bepreve besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day, but did show some potential for causing skeletal abnormalities at 1,000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral doses 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 Bepreve besilate 1,000 mg/kg/day; however, no evidence of infertility was observed in rats given 200 mg/kg/day (approximately 3,300 times the topical ocular use in humans). The concentration of radio-labeled Bepreve 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 1,000 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 Bepreve 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.

8.3 Nursing Mothers

Following a single 3 mg/kg oral dose of radio-labeled Bepreve 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 Bepreve besilate is excreted in human milk. Caution should be exercised when Bepreve (bepotastine besilate ophthalmic solution) 1.5% is administered to a nursing woman.

8.4 Pediatric Use

Safety and efficacy of Bepreve 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.

8.5 Geriatric Use

No overall difference in safety or effectiveness has been observed between elderly and younger patients.

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11 DESCRIPTION

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

Bepreve besilate is a white or pale yellowish crystalline powder. The molecular weight of Bepreve 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: Bepreve besilate 15 mg (equivalent to 10.7 mg Bepreve)

Preservative: benzalkonium chloride 0.005%

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

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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

12.3 Pharmacokinetics

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

Distribution: The extent of protein binding of Bepreve is approximately 55% and independent of Bepreve concentration.

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

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

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term dietary studies in mice and rats were conducted to evaluate the carcinogenic potential of Bepreve besilate. Bepreve 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 levels for Bepreve 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 topical ocular use in humans).

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 Bepreve 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 Bepreve besilate (approximately 3,300 times the systemic concentration anticipated for topical ocular use in humans).

14 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 a 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.

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16 HOW SUPPLIED/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 24208-629-02)

10 mL (NDC 24208-629-01)

STORAGE

Store at 15° – 25°C (59° – 77°F).

17 PATIENT COUNSELING 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.

Distributed by:

Bausch + Lomb, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Under license from:

Senju Pharmaceutical Co., Ltd.

Osaka, Japan 541-0046

Bepreve is a trademark of Bausch & Lomb

Incorporated or its affiliates.

©Bausch & Lomb Incorporated.

9291001 (flat)

9291101 (folded)

NDC 24208-629-01

Bepreve®

(bepotastine besilate

ophthalmic solution) 1.5%

Sterile 10 mL

Rx only

BAUSCH + LOMB

beprevecarton.jpg

Bepreve pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Bepreve available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Bepreve destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Bepreve Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Bepreve pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Bepreve?

Depending on the reaction of the Bepreve after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Bepreve not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Bepreve addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Bepreve, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Bepreve consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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