BC-Zole Ointment

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BC-Zole Ointment uses

BC-Zole Ointment consists of Beclomethasone, Clotrimazole, Neomycin.

Beclomethasone:


1 INDICATIONS AND USAGE

BC-Zole Ointment Nasal Aerosol is a corticosteroid indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older. ( 1.1 )

1.1 Treatment of Nasal Symptoms of Allergic Rhinitis

BC-Zole Ointment (Beclomethasone)® Nasal Aerosol is indicated for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older.

2 DOSAGE AND ADMINISTRATION

Administer BC-Zole Ointment Nasal Aerosol by the intranasal route only. BC-Zole Ointment (Beclomethasone) Nasal Aerosol must be primed prior to initial use by actuating four times. To do this, remove the protective dust cap from the device, hold the device upright between your thumb and forefinger (index finger) (the canister should be on top, pointing down), and spray 4 times into the air, away from your eyes and face. After the initial priming, the dose counter should read 120 for BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol and BC-Zole Ointment (Beclomethasone) 80 mcg Nasal Aerosol 120-actuation products and 60 for BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol 60-actuation product. If BC-Zole Ointment (Beclomethasone) Nasal Aerosol is not used for 7 consecutive days it should be primed by spraying 2 times. See accompanying illustrated Patient Information and Instructions for Use leaflet for proper use of BC-Zole Ointment (Beclomethasone) Nasal Aerosol.

BC-Zole Ointment (Beclomethasone) Nasal Aerosol is for intranasal use only.

  • The recommended dose of BC-Zole Ointment (Beclomethasone) 80 mcg Nasal Aerosol in patients 12 years and older is 320 mcg per day administered as 2 actuations in each nostril once daily (maximum total daily dose of 4 actuations per day). ( 2.1 )
  • The recommended dose of BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol in children aged 4 to 11 years of age is 80 mcg per day administered as 1 actuation in each nostril once daily (maximum total daily dose of 2 actuations per day). ( 2.1 )

2.1 Allergic Rhinitis

Adults and Adolescents (12 Years of Age and Older): The recommended dose of BC-Zole Ointment (Beclomethasone) Nasal Aerosol is 320 mcg per day administered as 2 actuations in each nostril (QNASL 80 mcg Nasal Aerosol) once daily (maximum total daily dose of 4 actuations per day).

Children (4 to 11 Years of Age): The recommended dose of BC-Zole Ointment (Beclomethasone) Nasal Aerosol is 80 mcg per day administered as 1 actuation in each nostril (QNASL 40 mcg Nasal Aerosol) once daily (maximum total daily dose of 2 actuations per day).

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3 DOSAGE FORMS AND STRENGTHS

BC-Zole Ointment (Beclomethasone) Nasal Aerosol is a nonaqueous nasal spray solution.

Each actuation of BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol delivers 40 mcg of BC-Zole Ointment (Beclomethasone) dipropionate and each actuation of BC-Zole Ointment (Beclomethasone) 80 mcg Nasal Aerosol delivers 80 mcg of BC-Zole Ointment (Beclomethasone) dipropionate. Each strength is supplied in an 8.7 g canister containing 120 actuations; BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol is also supplied in a 4.9 g canister containing 60 actuations.

BC-Zole Ointment (Beclomethasone) Nasal Aerosol is available in two strengths:

  • Each actuation of BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol delivers 40 mcg of BC-Zole Ointment (Beclomethasone) dipropionate. ( 3 )
  • Each actuation of BC-Zole Ointment (Beclomethasone) 80 mcg Nasal Aerosol delivers 80 mcg of BC-Zole Ointment (Beclomethasone) dipropionate. ( 3 )
  • Each strength is supplied in an 8.7 g canister containing 120 actuations; BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol is also supplied in a 4.9 g canister containing 60 actuations. ( 3 )

4 CONTRAINDICATIONS

BC-Zole Ointment (Beclomethasone) Nasal Aerosol is contraindicated in patients with a history of hypersensitivity to BC-Zole Ointment (Beclomethasone) dipropionate and/or any other BC-Zole Ointment (Beclomethasone) Nasal Aerosol ingredients .

Patients with a history of hypersensitivity to BC-Zole Ointment (Beclomethasone) dipropionate and/or any other BC-Zole Ointment (Beclomethasone) Nasal Aerosol ingredients. ( 4 )

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5 WARNINGS AND PRECAUTIONS

  • Nasal discomfort, epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
  • Eye Disorders. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts. ( 5.2 )
  • Hypersensitivity, rash, and urticaria may occur after administration of BC-Zole Ointment (Beclomethasone) Nasal Aerosol. ( 5.3 )
  • Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. ( 5.4 )
  • Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue BC-Zole Ointment (Beclomethasone) Nasal Aerosol slowly. ( 5.5 )
  • Potential reduction in growth velocity in pediatric patients. Monitor growth routinely in pediatric patients receiving BC-Zole Ointment (Beclomethasone) Nasal Aerosol. ( 5.6, 8.4 )

5.1 Local Nasal Effects

Nasal Discomfort, Epistaxis, and Nasal Ulceration: In clinical trials of 2 to 52 weeks duration, epistaxis and nasal ulcerations were observed more frequently and some epistaxis events were more severe in patients treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol than those who received placebo. In the 52-week safety trial in patients with perennial allergic rhinitis, nasal erosions were identified in 4 of 415 patients and a nasal ulceration was identified in 1 of 415 patients treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol. No nasal erosions or ulcerations were reported for patients who received placebo. In clinical trials conducted in pediatric patients ages 4 to 11 years, the local nasal effect was similar to those reported in patients 12 years of age and older. Patients using BC-Zole Ointment (Beclomethasone) Nasal Aerosol over several months or longer should be examined periodically for possible changes in the nasal mucosa. If an adverse reaction (e.g., erosion, ulceration) is noted, discontinue BC-Zole Ointment (Beclomethasone) Nasal Aerosol .

Candida Infection: In previous clinical trials with an aqueous formulation of BC-Zole Ointment (Beclomethasone) dipropionate administered intranasally, localized infections of the nose and pharynx with Candida albicans had been reported. There were no instances of similar infections observed in clinical trials with BC-Zole Ointment (Beclomethasone) Nasal Aerosol. If such an infection develops, it may require treatment with appropriate local therapy and discontinuation of BC-Zole Ointment (Beclomethasone) Nasal Aerosol treatment. Thus, patients using BC-Zole Ointment (Beclomethasone) Nasal Aerosol over several months or longer should be examined periodically for evidence of Candida infection.

Nasal Septal Perforation: Instances of nasal septal perforation have been reported in patients following the intranasal application of BC-Zole Ointment (Beclomethasone) dipropionate. There were no nasal septal perforations reported during clinical trials in the indicated dose of BC-Zole Ointment (Beclomethasone) 80 mcg Nasal Aerosol administered as 320 mcg once daily in adults and adolescents. There was one report of nasal septal perforation observed in the dose-ranging pediatric clinical trial.

Impaired Wound Healing: Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use BC-Zole Ointment (Beclomethasone) Nasal Aerosol until healing has occurred.

5.2 Eye Disorders

Use of intranasal and inhaled corticosteroids may result in the development of increased intraocular pressure, blurred vision, glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts.

Glaucoma and cataract formation was evaluated with ocular assessments that included intraocular pressure measurements and slit lamp examinations in 245 adolescent and adult patients with perennial allergic rhinitis who were treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol 320 mcg daily (N=197) or placebo (N=48) for up to 52 weeks. In 94% of patients, intraocular pressure (IOP) remained within the normal range (<21 mmHg) during the treatment portion of the trial. There were 10 patients (5%) treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol and 1 patient (2%) treated with placebo that had intraocular pressure that increased above normal levels (≥21 mmHg) and greater than baseline during the treatment portion of the trial. Two of these occurrences in patients treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol were reported as adverse reactions, one serious. No instances of cataract formation or other clinically significant ocular incidents were reported in this 52-week safety trial .

5.3 Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following administration of BC-Zole Ointment (Beclomethasone) dipropionate nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of BC-Zole Ointment (Beclomethasone) Nasal Aerosol. Discontinue BC-Zole Ointment (Beclomethasone) Nasal Aerosol if any such reactions occur .

5.4 Immunosuppression

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chickenpox or measles develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.

5.5 Hypothalamic-Pituitary-Adrenal Axis Effect

When intranasal steroids are used at higher-than-recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of BC-Zole Ointment (Beclomethasone) Nasal Aerosol should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, and depression). Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

5.6 Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving BC-Zole Ointment (Beclomethasone) Nasal Aerosol .

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6 ADVERSE REACTIONS

Systemic and local corticosteroid use may result in the following:

  • Epistaxis, nasal discomfort, nasal ulcerations, Candida albicans infection, and impaired wound healing
  • Eye Disorders
  • Hypercorticism, adrenal suppression, and growth reduction [see Warnings and Precautions (5.5) (5.6) , Use in Specific Populations (8.4)]
  • Immunosuppression

The most common adverse reactions (≥ 1% and greater than placebo) in patients 12 years of age and older include nasal discomfort, epistaxis, and headache. ( 6.1 )

The most common adverse reactions (≥ 2% and greater than placebo) in children 4 to 11 years of age include headache, pyrexia, upper respiratory tract infection, and nasopharyngitis. ( 6.1 )

To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-482-9522 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 Years of Age and Older:

The safety data described below for adults and adolescents 12 years of age and older with seasonal or perennial allergic rhinitis are based on 4 placebo-controlled clinical trials of 2 to 6 weeks duration evaluating doses of BC-Zole Ointment (Beclomethasone) nasal aerosol from 80 to 320 mcg once daily. These short-term trials included a total of 1394 patients with either seasonal or perennial allergic rhinitis. Of these, 575 (378 female and 197 male) received at least one dose of BC-Zole Ointment (Beclomethasone) Nasal Aerosol, 320 mcg once daily and 578 (360 female and 218 male) received placebo. Patient ages ranged from 12 to 82 years and the racial distribution of patients was 81% white, 16% black, and 4% other.

Short-Term (2–6 Weeks) Trials: Less than 2% of patients in the clinical trials discontinued treatment because of adverse reactions with the rate of withdrawal among patients who received BC-Zole Ointment (Beclomethasone) Nasal Aerosol similar to or lower than the rate among patients who received placebo. Table 1 displays the common adverse reactions (≥ 1% and greater than placebo-treated patients).

  • Table 1. Adverse Events With ≥ 1% Incidence and Greater than Placebo in BC-Zole Ointment (Beclomethasone)
  • Nasal Aerosol-Treated Adult and Adolescent Patients with Seasonal or
  • Perennial Allergic Rhinitis in Controlled Clinical Trials of 2 to 6 Weeks
  • Duration (Safety Population)

Adult and Adolescent Patients 12 Years of Age and Older


BC-Zole Ointment (Beclomethasone) Nasal Aerosol

320 mcg

(N = 575)

n (%)


Placebo

(N = 578)

n (%)


Nasal Discomfort


30 (5.2)


28 (4.8)


Epistaxis


11 (1.9)


7 (1.2)


Headache


13 (2.3)


9 (1.6)


Nasal ulcerations occurred in 2 patients treated with placebo and in 1 patient treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol. There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not have sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

Long-Term 52-Week Safety Trial: In a 52-week placebo-controlled long-term safety trial in patients with PAR, 415 patients (128 males and 287 females, aged 12 to 74 years) were treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol at a dose of 320 mcg once daily and 111 patients (44 males and 67 females, aged 12 to 67 years) were treated with placebo. Of the 415 patients treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol, 219 patients were treated for 52 weeks and 196 patients were treated for 30 weeks. While most adverse events were similar in type and rate between the treatment groups, epistaxis occurred more frequently in patients who received BC-Zole Ointment (Beclomethasone) Nasal Aerosol (45 out of 415, 11%) than in patients who received placebo (2 out of 111, 2%). Epistaxis also tended to be more severe in patients treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol. In 45 reports of epistaxis in patients who received BC-Zole Ointment (Beclomethasone) Nasal Aerosol, 27, 13, and 5 cases were of mild, moderate, and severe intensity, respectively, while the reports of epistaxis in patients who received placebo were of mild (1) and moderate (1) intensity. Seventeen patients treated with BC-Zole Ointment (Beclomethasone) Nasal Aerosol experienced adverse reactions that led to withdrawal from the trial compared to 3 patients treated with placebo. There were 4 nasal erosions and 1 nasal septum ulceration which occurred in patients who received BC-Zole Ointment (Beclomethasone) Nasal Aerosol, and no erosions or ulcerations noted in patients who received placebo. No patient experienced a nasal septum perforation during the trial.

Pediatric Patients Aged 4 to 11 Years:

The safety data described below for pediatric patients 4 to 11 years of age with seasonal or perennial allergic rhinitis are based on 3 placebo-controlled clinical trials. These trials were 2 to 12 weeks in duration, evaluated doses of BC-Zole Ointment (Beclomethasone) nasal aerosol 80 mcg to 160 mcg once daily and included a total of 1360 patients with either seasonal or perennial allergic rhinitis. Of these, 668 (312 female and 356 male) received at least one dose of BC-Zole Ointment (Beclomethasone) Nasal Aerosol, 80 mcg once daily, 241 (116 female and 125 male) received BC-Zole Ointment (Beclomethasone) Nasal Aerosol 160 mcg once daily, and 451 (203 female and 248 male) received placebo. The racial distribution of patients was 73% white, 20% black, and 6% other. Based on the results from the dose ranging trial, 80 mcg once daily was chosen as the dose in pediatric patients.

Less than 1.5% of patients in the clinical trials discontinued treatment because of adverse reactions with the rate of withdrawal among patients who received BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg once daily similar to or lower than the rate among patients who received placebo. Table 2 displays the common adverse reactions (≥ 2% and greater than placebo-treated patients). Additionally, epistaxis was reported at a rate of 4% for both BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg once daily and placebo treated patients.


Table 2. Adverse Events With ≥ 2% Incidence and Greater than Placebo in BC-Zole Ointment (Beclomethasone) Nasal

  • Aerosol-Treated Pediatric Patients with Seasonal or Perennial Allergic Rhinitis in
  • Controlled Clinical Trials of 2 to 12 weeks Duration (Safety Population)

Pediatric Patients 4 to 11 Years of Age


BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg

(N=668)

n (%)


Placebo (N=451)

n (%)


Headache


23 (3.4)


15 (3.3)


Pyrexia


19 (2.8)


7 (1.6)


Upper respiratory tract infection


17 (2.5)


8 (1.8)


Nasopharyngitis


15 (2.2)


6 (1.3)

6.2 Postmarketing Experience

In addition to adverse reactions reported from clinical trials for BC-Zole Ointment (Beclomethasone) Nasal Aerosol, the following adverse events have been reported during postmarketing use of BC-Zole Ointment (Beclomethasone) Nasal Aerosol or other intranasal and inhaled formulations of BC-Zole Ointment (Beclomethasone) dipropionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to BC-Zole Ointment (Beclomethasone) dipropionate or a combination of these factors.

BC-Zole Ointment (Beclomethasone) Nasal Aerosol: sneezing, burning sensation

Intranasal BC-Zole Ointment (Beclomethasone) dipropionate: Nasal septal perforation, blurred vision, glaucoma, cataracts, central serous chorioretinopathy (CSC), loss of taste and smell, and hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported following intranasal administration of BC-Zole Ointment (Beclomethasone) dipropionate.

Inhaled BC-Zole Ointment (Beclomethasone) dipropionate: Hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, and bronchospasm have been reported following the oral inhalation of BC-Zole Ointment (Beclomethasone) dipropionate.

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7 DRUG INTERACTIONS

No drug interaction studies have been performed with BC-Zole Ointment (Beclomethasone) Nasal Aerosol.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled clinical trials in pregnant women treated with BC-Zole Ointment Nasal Aerosol. BC-Zole Ointment (Beclomethasone) dipropionate was teratogenic and embryocidal in the mouse and rabbit although these effects were not observed in rats. BC-Zole Ointment (Beclomethasone) Nasal Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.

BC-Zole Ointment (Beclomethasone) dipropionate administered subcutaneously was teratogenic and embryocidal in the mouse and rabbit at doses approximately twice the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m2 basis at maternal doses of 0.1 and 0.025 mg/kg/day in mice and rabbits, respectively). No teratogenicity or embryocidal effects were seen in rats at approximately 460 times MRHDID (in adults on a mg/m2 basis at a maternal inhalation dose of 15 mg/kg/day).

Non-teratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

8.3 Nursing Mothers

It is not known whether BC-Zole Ointment (Beclomethasone) dipropionate is excreted in human breast milk. However, other corticosteroids have been detected in human breast milk and thus caution should be exercised when BC-Zole Ointment (Beclomethasone) Nasal Aerosol is administered to a nursing mother.

8.4 Pediatric Use

The safety and effectiveness of BC-Zole Ointment Nasal Aerosol in children 4 years and older have been established . The safety and effectiveness of BC-Zole Ointment (Beclomethasone) Nasal Aerosol in children younger than 4 years of age have not been established. Controlled pediatric clinical trials with BC-Zole Ointment (Beclomethasone) Nasal Aerosol included 909 children 4 to 11 years of age and 188 adolescent patients 12 to 17 years of age .

Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effects of reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including BC-Zole Ointment (Beclomethasone) Nasal Aerosol, should be monitored routinely (e.g., via stadiometry).

A 12-month, randomized, controlled clinical trial evaluated the effects of QVAR®, an orally inhaled HFA BC-Zole Ointment (Beclomethasone) dipropionate product, without spacer versus chlorofluorocarbon-propelled (CFC) BC-Zole Ointment (Beclomethasone) dipropionate with large volume spacer on growth in children with asthma ages 5 to 11 years. A total of 520 patients were enrolled, of whom 394 received HFA-beclomethasone dipropionate (100 to 400 mcg/day ex-valve) and 126 received CFC-beclomethasone dipropionate (200 to 800 mcg/day ex-valve). When comparing results at month 12 to baseline, the mean growth velocity in children treated with HFA-beclomethasone dipropionate was approximately 0.5 cm/year less than that noted with children treated with CFC-beclomethasone dipropionate via large volume spacer. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives.

The potential for BC-Zole Ointment (Beclomethasone) Nasal Aerosol to cause reduction in growth velocity in susceptible patients or when given at higher than recommended dosages cannot be ruled out.

8.5 Geriatric Use

Clinical trials of BC-Zole Ointment (Beclomethasone) Nasal Aerosol did not include sufficient numbers of subjects aged 65 years and older to determine whether they responded differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, administration to elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

10 OVERDOSAGE

Chronic overdosage may result in signs/symptoms of hypercorticism . There are no data available on the effects of acute or chronic overdosage with BC-Zole Ointment (Beclomethasone) Nasal Aerosol.

11 DESCRIPTION

BC-Zole Ointment (Beclomethasone) dipropionate USP, the active component of BC-Zole Ointment (Beclomethasone) Nasal Aerosol, is an anti-inflammatory steroid having the chemical name 9-chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17, 21-dipropionate and the following chemical structure:

BC-Zole Ointment (Beclomethasone) dipropionate, a di-ester of BC-Zole Ointment (Beclomethasone) (a synthetic corticosteroid chemically related to dexamethasone), is a white to almost white, odorless powder with a molecular formula of C28H37ClO7 and a molecular weight of 521.1. It is practically insoluble in water, very soluble in chloroform, and soluble in acetone and in dehydrated alcohol.

BC-Zole Ointment (Beclomethasone) Nasal Aerosol is a pressurized, nonaqueous solution in a metered-dose aerosol device intended ONLY for intranasal use. It contains a solution of BC-Zole Ointment (Beclomethasone) dipropionate in propellant HFA-134a (1,1,1,2-tetrafluoroethane) and dehydrated ethanol. BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol delivers 40 mcg of BC-Zole Ointment (Beclomethasone) dipropionate from the nasal actuator and 50 mcg from the valve. BC-Zole Ointment (Beclomethasone) 80 mcg Nasal Aerosol delivers 80 mcg of BC-Zole Ointment (Beclomethasone) dipropionate from the nasal actuator and 100 mcg from the valve. Each strength delivers 59 mg of solution from the valve with each actuation. Each canister of BC-Zole Ointment (Beclomethasone) 40 mcg or 80 mcg Nasal Aerosol, contains 8.7 g of drug and excipients and each provides 120 actuations after priming. Additionally, BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol contains 4.9 g of drug and excipients and provides 60 actuations after priming.

Chemical structure.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

BC-Zole Ointment dipropionate is a prodrug that is extensively converted to the active metabolite, beclomethasone-17-monopropionate. The precise mechanism through which BC-Zole Ointment (Beclomethasone) dipropionate affects rhinitis symptoms is unknown. Corticosteroids have been shown to have multiple anti-inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and the release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines).

Beclomethasone-17-monopropionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 13 times that of dexamethasone, 6 times that of triamcinolone acetonide, 1.5 times that of budesonide and 25 times that of BC-Zole Ointment (Beclomethasone) dipropionate. The clinical significance of these findings is unknown.

12.2 Pharmacodynamics

Adrenal Function: The effects of BC-Zole Ointment (Beclomethasone) Nasal Aerosol on the HPA axis were evaluated in two 6-week, randomized, double-blind, parallel-group perennial allergic rhinitis trials – one in adult and adolescent patients 12 to 45 years of age and another in children 6 to 11 years of age. In the first study with adolescent and adult patients aged 12 to 45, BC-Zole Ointment (Beclomethasone) Nasal Aerosol 320 mcg, once daily, was compared with both placebo nasal aerosol and a positive control (a placebo/prednisone group that received prednisone 10 mg orally once daily for the final 7 days of the treatment period). In the second study with pediatric patients aged 6 to 11, BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg once daily was compared to placebo nasal aerosol. HPA-axis function was assessed by 24-hour serial serum cortisol levels prior to the first dose and after 6 weeks of treatment. Patients were domiciled for the 24-hour serum cortisol assessments. The change from baseline in the 24-hour serum cortisol weighted mean for BC-Zole Ointment (Beclomethasone) Nasal Aerosol and placebo after 6 weeks of treatment were compared.

In the HPA–axis study in patients 12 to 45 years of age, baseline geometric mean serum cortisol weighted mean values were similar in the BC-Zole Ointment (Beclomethasone) Nasal Aerosol 320 mcg/day and placebo treatment groups (9.04 and 8.45 mcg/dL, respectively). After 6 weeks of treatment, the geometric mean values were 8.18 and 8.01 mcg/dL, respectively, with a change from baseline in 24-hour serum cortisol weighted mean for the BC-Zole Ointment (Beclomethasone) Nasal Aerosol and placebo groups of 0.86 and 0.44, resulting in a difference of 0.42. The geometric mean ratio for BC-Zole Ointment (Beclomethasone) Nasal Aerosol 320 mcg/day to placebo was 0.96 (95% CI: 0.87, 1.06). For comparison, in the positive-control (prednisone) treatment group, the geometric mean ratio for placebo to placebo/prednisone 10 mg/day was 3.17 (95% CI: 2.68, 3.74).

In the HPA-axis study in patients 6 to 11 years of age, baseline geometric mean serum cortisol weighted mean values were similar in the BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg/day and placebo treatment groups (5.97 and 6.47 mcg/dL, respectively). After 6 weeks of treatment the geometric mean values were 6.19 and 7.13 mcg/dL, respectively with no decrease from baseline values in both treatment groups. The geometric mean ratio for BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg/day to placebo was 0.91 (95% CI; 0.81, 1.03).

12.3 Pharmacokinetics

Absorption

Following intranasal administration, most of the BC-Zole Ointment (Beclomethasone) dipropionate undergoes extensive conversion to its active metabolite, beclomethasone-17-monopropionate, during absorption. Plasma concentrations of BC-Zole Ointment (Beclomethasone) dipropionate and beclomethasone-17-monopropionate have been measured with BC-Zole Ointment (Beclomethasone) Nasal Aerosol in 2 adult and/or adolescent clinical trials and 1 pediatric clinical trial.

The single-dose pharmacokinetics of BC-Zole Ointment (Beclomethasone) Nasal Aerosol were evaluated in a randomized, open-label, 3-period, crossover trial in healthy adult volunteers. Systemic levels of beclomethasone-17-monopropionate and BC-Zole Ointment (Beclomethasone) dipropionate after single-dose intranasal administration of BC-Zole Ointment (Beclomethasone) dipropionate at doses of 80 and 320 mcg were compared with the systemic levels of beclomethasone-17-monopropionate and BC-Zole Ointment (Beclomethasone) dipropionate after administration of orally inhaled BC-Zole Ointment (Beclomethasone) dipropionate HFA at a dose of 320 mcg (QVAR® Inhalation Aerosol). The results of this trial demonstrated that the systemic bioavailability of BC-Zole Ointment (Beclomethasone) Nasal Aerosol 320 mcg was approximately 27.5% (approximately 4-fold lower) of that of orally inhaled BC-Zole Ointment (Beclomethasone) dipropionate HFA 320 mcg/day based on the plasma concentrations of beclomethasone-17-monopropionate (AUClast: 1139.7 vs 4140.3 hr*pg/mL; GMR: 0.275; 90% CI for the GMR: 0.214, 0.354). The peak exposure to BC-Zole Ointment (Beclomethasone) Nasal Aerosol 320 mcg/day was approximately 19.5% (approximately 5-fold lower) of that of orally inhaled BC-Zole Ointment (Beclomethasone) dipropionate HFA 320 mcg/day as measured by beclomethasone-17-monopropionate (Cmax: 262.7 vs 1343.7 pg/mL; GMR: 0.195; 90% CI for the GMR: 0.158, 0.241).

Following repeated once-daily administration of BC-Zole Ointment (Beclomethasone) Nasal Aerosol, there was no accumulation or increase in plasma exposure to beclomethasone-17-monopropionate or BC-Zole Ointment (Beclomethasone) dipropionate, most likely due to the short plasma half-life relative to the dosing frequency.

Distribution

The in vitro protein binding for beclomethasone-17-monopropionate was reported to be 94% to 96% over the concentration range of 1000 to 5000 pg/mL. The volume of distribution at steady state for BC-Zole Ointment (Beclomethasone) dipropionate is moderate (20 L) but more extensive for beclomethasone-17-monopropionate (424 L).

Metabolism

BC-Zole Ointment (Beclomethasone) dipropionate undergoes extensive first-pass metabolism, forming three metabolites via CYP3A4, beclomethasone-17-monopropionate, beclomethasone-21-monopropionate, and BC-Zole Ointment (Beclomethasone). Beclomethasone-17-monopropionate is the major and most active metabolite.

Elimination

The major route of elimination of inhaled BC-Zole Ointment (Beclomethasone) dipropionate appears to be via metabolism. More than 90% of inhaled BC-Zole Ointment (Beclomethasone) dipropionate is found as beclomethasone-17-monopropionate in the systemic circulation. The mean elimination half-life of beclomethasone-17-monopropionate is 2.8 hours. The terminal elimination half-lives of BC-Zole Ointment (Beclomethasone) dipropionate and beclomethasone-17-monopropionate following intranasal dosing with BC-Zole Ointment (Beclomethasone) Nasal Aerosol (320 mcg) were approximately 0.3 hours and 4.5 hours, respectively. Irrespective of the route of administration (injection, oral, or inhalation), BC-Zole Ointment (Beclomethasone) dipropionate and its metabolites are mainly excreted in the feces. Less than 10% of the drug and its metabolites are excreted in the urine. It is likely that intranasal BC-Zole Ointment (Beclomethasone) dipropionate follows a similar elimination pathway.

Special Populations

Formal pharmacokinetic studies using BC-Zole Ointment (Beclomethasone) Nasal Aerosol were not conducted in any special populations.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenicity of BC-Zole Ointment (Beclomethasone) dipropionate was evaluated in rats that were exposed for a total of 95 weeks: 13 weeks at inhalation doses up to 0.4 mg/kg and the remaining 82 weeks at combined oral and inhalation doses up to 2.4 mg/kg. In this trial, there was no evidence of carcinogenicity at the highest dose: approximately 70 and 120 times the maximum recommended human daily intranasal dose (MRHDID) in adults and children, respectively, on a mg/m2 basis.

BC-Zole Ointment (Beclomethasone) dipropionate did not induce gene mutation in bacterial cells or mammalian Chinese hamster ovary (CHO) cells in vitro. No significant clastogenic effect was seen in cultured CHO cells in vitro or in the mouse micronucleus test in vivo.

In rats, BC-Zole Ointment (Beclomethasone) dipropionate caused decreased conception rates at an oral dose of 16 mg/kg (approximately 490 times the MRHDID in adults on a mg/m2 basis). There was no significant effect of BC-Zole Ointment (Beclomethasone) dipropionate on fertility in rats at oral doses of 1.6 mg/kg (approximately 50 times the MRHDID in adults on a mg/m2 basis). Inhibition of the estrous cycle in dogs was observed following oral doses of 0.5 mg/kg (approximately 50 times the MRHDID in adults on a mg/m2 basis). No inhibition of the estrous cycle in dogs was seen following 12 months of exposure at an estimated inhalation dose of 0.33 mg/kg (approximately 35 times the MRHDID in adults on a mg/m2 basis).

14 CLINICAL STUDIES

14.1 Seasonal and Perennial Allergic Rhinitis

Adult and Adolescent Patients Aged 12 Years and Older: The efficacy and safety of BC-Zole Ointment (Beclomethasone) Nasal Aerosol have been evaluated in 3 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials of 2 to 6 weeks duration in adult and adolescent patients 12 years and older with symptoms of seasonal or perennial allergic rhinitis. The 3 clinical trials included one 2-week dose-ranging trial in patients with seasonal allergic rhinitis, one 2-week efficacy trial in patients with seasonal allergic rhinitis, and one 6-week efficacy trial in patients with perennial allergic rhinitis. The trials included a total of 1049 patients (366 males and 683 females). About 81% of patients were Caucasian and 17% African American, the mean age was approximately 38 years. Of these patients 521 received BC-Zole Ointment (Beclomethasone) Nasal Aerosol 320 mcg once daily administered as 2 actuations in each nostril.

Assessment of efficacy was based on the total nasal symptom score (TNSS). TNSS is calculated as the sum of the patients' scoring of the 4 individual nasal symptoms (rhinorrhea, sneezing, nasal congestion, and nasal itching) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) as reflective (rTNSS) or instantaneous (iTNSS). rTNSS required the patients to record symptom severity over the previous 12 hours; iTNSS required the patients to record symptom severity over the previous 10 minutes. Morning and evening TNSS scores were averaged over the treatment period and the difference from placebo in the change from baseline rTNSS was the primary efficacy endpoint. The morning iTNSS reflects the TNSS at the end of the 24-hour dosing interval and is an indication of whether the effect was maintained over the 24-hour dosing interval.

Dose-Ranging Trial: The dose-ranging trial was a 2-week trial that evaluated the efficacy of 3 doses of BC-Zole Ointment (Beclomethasone) dipropionate nasal aerosol (80, 160, and 320 mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, only treatment with BC-Zole Ointment (Beclomethasone) dipropionate nasal aerosol at the dose of 320 mcg/day resulted in statistically significant improvements compared with placebo in the primary efficacy endpoint, rTNSS ( Table 3 ).

Table 3. Mean Changes from Baseline in Reflective Total Nasal Symptom Score Over 2

Weeks in Adult and Adolescent Patients with Seasonal Allergic Rhinitis (ITT

Population)

Treatment N Baseline

(SD)

LS Mean (SE)

Change from

Baseline

Difference From Placebo
LS Mean 95% CI

BC-Zole Ointment (Beclomethasone) dipropionate

320 mcg/day


122


9.17 (1.66)


-2.22 (0.18)


-0.63


-1.13, 0.13


BC-Zole Ointment (Beclomethasone) dipropionate

160 mcg/day


123


9.24 (1.57)


-1.87 (0.18)


-0.29


-0.78, 0.21


BC-Zole Ointment (Beclomethasone) dipropionate

80 mcg/day


118


9.33 (1.72)


-1.88 (0.18)


-0.29


-0.80, 0.21


Placebo


123


8.98 (1.47)


-1.59 (0.18)


The 320 mcg dose also demonstrated a statistically significant decrease in morning iTNSS than placebo, indicating that the effect was maintained over the 24-hour dosing interval.

Seasonal and Perennial Allergic Rhinitis Trials: In 2 randomized, double-blind, parallel-group, multicenter, placebo-controlled efficacy trials, once-daily treatment with BC-Zole Ointment (Beclomethasone) Nasal Aerosol for 2 weeks in patients with seasonal allergic rhinitis and for 6 weeks in patients with perennial allergic rhinitis resulted in statistically significant greater decreases from baseline in the rTNSS and morning iTNSS than placebo ( Table 4 ).

Table 4. Mean Changes From Baseline in Reflective and Instantaneous Total Nasal

Symptom Scores in Adult and Adolescent Patients with Seasonal or Perennial

Allergic Rhinitis (ITT Population)

Treatment N Baseline

(SD)

LS Mean (SE)

Change from

Baseline

Difference From Placebo
LS Mean 95% CI

Seasonal Allergic Rhinitis


Reflective Total Nasal Symptom Scores (rTNSS)


BC-Zole Ointment (Beclomethasone) dipropionate

320 mcg/day


167


9.6 (1.51)


-2.0 (0.16)


-0.91


-1.3, -0.5


Placebo


171


9.5 (1.54)


-1.0 (0.15)


Instantaneous Total Nasal Symptom Scores (iTNSS)


BC-Zole Ointment (Beclomethasone) dipropionate

320 mcg/day


167


9.0 (1.74)


-1.7 (0.15)


-0.92


-1.3, -0.5


Placebo


171


8.7 (1.81)


-0.8 (0.15)


Perennial Allergic Rhinitis


Reflective Total Nasal Symptom Scores (rTNSS)


BC-Zole Ointment (Beclomethasone) dipropionate

320 mcg/day


232


8.9 (1.70)


-2.5 (0.14)


-0.84


-1.2, -0.5


Placebo


234


9.0 (1.73)


-1.6 (0.14)


Instantaneous Total Nasal Symptom Scores (iTNSS)


BC-Zole Ointment (Beclomethasone) dipropionate

320 mcg/day


232


8.1 (1.98)


-2.1 (0.13)


-0.78


-1.1, -0.4


Placebo


234


8.3 (1.96)


-1.4 (0.13)


Pediatric Patients 4 to 11 Years of Age: The efficacy and safety of BC-Zole Ointment (Beclomethasone) Nasal Aerosol have been evaluated in 2 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials of 2 to 12 weeks duration in pediatric patients 4 to 11 years of age with symptoms of seasonal or perennial allergic rhinitis. The 2 clinical trials included one 2-week dose-ranging trial in patients with seasonal allergic rhinitis (6 - 11 years of age), and one 12-week efficacy trial in patients with perennial allergic rhinitis (4 - 11 years of age). The trials included a total of 1255 patients (680 males and 575 females). About 73% of patients were Caucasian and 20% African American, the mean age was approximately 8 years for one study and 9 years for the second study. Of these patients 596 received BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg once daily administered as 1 actuation of BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol in each nostril.

Assessment of efficacy was based on the total nasal symptom score (TNSS) as described in adult and adolescents efficacy studies.

Dose-Ranging Seasonal Allergic Rhinitis Trial: The dose-ranging trial was a 2-week trial that evaluated the efficacy of 2 doses of BC-Zole Ointment (Beclomethasone) dipropionate nasal aerosol (80 and 160mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, treatment with BC-Zole Ointment (Beclomethasone) dipropionate nasal aerosol at the dose of 80 mcg/day resulted in statistically significant improvements compared with placebo in the primary efficacy endpoint, rTNSS ( Table 5 ).


Table 5. Mean Changes from Baseline in Reflective and Instantaneous Total Nasal

  • Symptom Scores Over 2 Weeks in Pediatric Patients with Seasonal Allergic
  • Rhinitis (ITT Population)

Treatment


N


Baseline

(SD)


LS Mean (SE)

Change

from Baseline


Difference From Placebo


LS Mean


95% CI


Reflective Total Nasal Symptom Scores (rTNSS)


BC-Zole Ointment (Beclomethasone) dipropionate 80 mcg/day


239


8.9 (1.62)


-1.9 (0.14)


-0.71


-1.1, -0.3


BC-Zole Ointment (Beclomethasone) dipropionate 160 mcg/day


241


9.0 (1.71)


-2.0 (0.14)


-0.76


-1.1, -0.4


Placebo


234


9.0 (1.70)


-1.2 (0.14)


-


-


Instantaneous Total Nasal Symptom Scores (iTNSS)


BC-Zole Ointment (Beclomethasone) dipropionate 80 mcg/day


238


8.1 (1.99)


-1.6 (0.13)


-0.63


-1.0, -0.3


BC-Zole Ointment (Beclomethasone) dipropionate 160 mcg/day


241


8.1 (2.13)


-1.7 (0.13)


-0.73


-1.1, -0.4


Placebo


234


8.2 (2.10)


-1.0 (0.13)


-


-


The 80 mcg daily dose also demonstrated a statistically significant decrease in morning iTNSS than placebo, indicating that the effect was maintained over the 24-hour dosing interval. Based on the results from the dose ranging trial, 80 mcg once daily was chosen as the dose for pediatric patients 4-11 years of age.

Perennial Allergic Rhinitis Trial: In a randomized, double-blind, parallel-group, multicenter, placebo-controlled efficacy trial, treatment with BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg once daily in patients with perennial allergic rhinitis resulted in statistically significant greater decreases from baseline in the rTNSS (the primary endpoint) and iTNSS than placebo over the first six weeks of treatment ( Table 6 ).


Table 6. Mean Changes from Baseline in Reflective Total Nasal Symptom Score Over 6 Weeks in

  • Pediatric Patients 6 to 11 Years of Age with Perennial Allergic Rhinitis (FAS)

Treatment


N


Baseline

(SD)


LS Mean (SE)

Change from

Baseline


Difference From Placebo


LS Mean


95% CI


Reflective Total Nasal Symptom Scores (rTNSS)


BC-Zole Ointment (Beclomethasone) dipropionate 80 mcg/day


296


8.6 (1.56)


-2.26 (0.12)


-0.66


-1.08, -0.24


Placebo


153


8.6 (1.60)


-1.60 (0.17)


-


-


Instantaneous Total Nasal Symptom Scores (iTNSS)


BC-Zole Ointment (Beclomethasone) dipropionate 80 mcg/day


296


7.9 (2.05)


-1.98 (0.12)


-0.58


-0.99, -0.18


Placebo


153


7.8 (2.12)


-1.39 (0.17)


-


-


FAS=full analysis set

For pediatric patients 4-11 years of age, improvements in average patient-reported rTNSS and iTNSS were also significantly greater in BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg per day treated patients compared with placebo.

16 HOW SUPPLIED/STORAGE AND HANDLING

BC-Zole Ointment (Beclomethasone) Nasal Aerosol is supplied in 2 strengths and supplied as a pressurized aluminum canister inserted into a blue and white plastic nasal actuator with a built-in dose counter and white dust cap, as follows:

BC-Zole Ointment (Beclomethasone) 40 mcg Nasal Aerosol contains 8.7 g of drug and excipients and provides 120 actuations (NDC 59310-206-12) and for the 60-actuation product, 4.9 g of drug and excipients (NDC 59310-206-06). Each actuation delivers 40 mcg of BC-Zole Ointment (Beclomethasone) dipropionate from the nasal actuator and 50 mcg from the valve.

BC-Zole Ointment (Beclomethasone) 80 mcg Nasal Aerosol contains 8.7 g of drug and excipients and provides 120 actuations (NDC 59310-210-12). Each actuation delivers 80 mcg of BC-Zole Ointment (Beclomethasone) dipropionate from the nasal actuator and 100 mcg from the valve.

Each canister of BC-Zole Ointment (Beclomethasone) Nasal Aerosol has a built-in spray counter, which starts at 124 and counts down each time a spray is released for the 120 actuation product and 64 for the 60 actuation product. After the 4 initial priming sprays, the spray counter should read 120 sprays or 60 sprays for the respective products. The correct amount of medication in each intranasal dose cannot be ensured after the counter reads 0; therefore, the device should be discarded when the counter reads 0.

Do not remove the BC-Zole Ointment (Beclomethasone) Nasal Aerosol canister from the actuator. The BC-Zole Ointment (Beclomethasone) Nasal Aerosol canister should only be used with the BC-Zole Ointment (Beclomethasone) Nasal Aerosol actuator and the actuator should not be used with any other drug product.

CONTENTS UNDER PRESSURE

Do not puncture. Do not store near heat or open flame. Do not expose to temperatures higher than 49°C (120°F) as this may cause bursting of the canister. Never throw the device into a fire or an incinerator.

Store at 25°C (77°F); excursions are permitted between 15° and 30°C (59° and 86°F).

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

17.1 Local Nasal Effects

Inform patients that treatment with BC-Zole Ointment Nasal Aerosol may lead to adverse reactions, including epistaxis, nasal ulceration, and nasal discomfort. Candida infection may also occur with treatment with BC-Zole Ointment (Beclomethasone) Nasal Aerosol. In addition, nasal BC-Zole Ointment (Beclomethasone) dipropionate products are known to be associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use BC-Zole Ointment (Beclomethasone) Nasal Aerosol until healing has occurred .

17.2 Eye Disorders

Inform patients that blurred vision, glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Patients should inform their health care providers if a change in vision is noted while using BC-Zole Ointment (Beclomethasone) Nasal Aerosol .

17.3 Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following administration of BC-Zole Ointment dipropionate nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of BC-Zole Ointment (Beclomethasone) Nasal Aerosol. If any such reactions occur, patients should discontinue use of BC-Zole Ointment (Beclomethasone) Nasal Aerosol .

17.4 Immunosuppression

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex .

17.5 Use Daily for Best Effect

Patients should use BC-Zole Ointment Nasal Aerosol on a regular, once-daily basis since its effectiveness depends on its regular use. BC-Zole Ointment (Beclomethasone) Nasal Aerosol may not have an immediate effect on rhinitis symptoms. The patient should not increase the prescribed dosage but should contact their physician if symptoms do not improve or if the condition worsens.

17.6 Keep Spray Out of Eyes or Mouth

Patients should be informed to avoid spraying BC-Zole Ointment (Beclomethasone) Nasal Aerosol in their eyes or mouth.

Teva Respiratory, LLC

Frazer, PA 19355 USA

©2017, Teva Respiratory, LLC. All rights reserved.

BC-Zole Ointment (Beclomethasone)® is a registered trademark of Teva Respiratory, LLC.

Manufactured for Teva Respiratory, LLC

Frazer, PA 19355

By: 3M Drug Delivery Systems

Northridge, CA 91324

United States Patent Nos. 7,780,038

PE3533 Rev. 07/2017

Teva Respiratory logo


PATIENT INFORMATION

BC-Zole Ointment (Beclomethasone) (kyoo nay' zel)

(beclomethasone dipropionate)

Nasal Aerosol

  • BC-Zole Ointment (Beclomethasone) Nasal Aerosol is available in 2 different strengths:
    • BC-Zole Ointment (Beclomethasone) Nasal Aerosol 40 mcg is only for use in children 4 years to 11 years of age and should be given under the supervision of a parent, guardian or caregiver.
  • BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg is only for use in adolescents and adults 12 years of age and older.

What is BC-Zole Ointment (Beclomethasone) Nasal Aerosol?

BC-Zole Ointment (Beclomethasone) Nasal Aerosol is a prescription medicine that treats seasonal nasal and year-round nasal allergy symptoms in children 4 years of age and older and adults.

BC-Zole Ointment (Beclomethasone) Nasal Aerosol contains BC-Zole Ointment (Beclomethasone) dipropionate, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When BC-Zole Ointment (Beclomethasone) Nasal Aerosol is sprayed into the nose, it may help reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, itching, and sneezing.

It is not known if BC-Zole Ointment (Beclomethasone) Nasal Aerosol is safe and effective in children under 4 years of age.


Who should not use BC-Zole Ointment (Beclomethasone) Nasal Aerosol?

Do not use BC-Zole Ointment (Beclomethasone) Nasal Aerosol if you or your child is allergic to BC-Zole Ointment (Beclomethasone) dipropionate or any of the ingredients in BC-Zole Ointment (Beclomethasone) Nasal Aerosol. See the end of this leaflet for a complete list of ingredients in BC-Zole Ointment (Beclomethasone) Nasal Aerosol.


What should you tell your or your child’s healthcare provider before using BC-Zole Ointment (Beclomethasone) Nasal Aerosol?

Before using BC-Zole Ointment (Beclomethasone) Nasal Aerosol, tell the healthcare provider about all of your medical conditions, including if you or your

Child:

  • has had recent nose problems such as nasal sores, nasal surgery, or a nasal injury.
  • has or have had eye problems, such as blurred vision, increased pressure in their eye (glaucoma) or cataracts.
  • has tuberculosis or any untreated fungal, bacterial, or viral infections, or eye infections caused by herpes.
  • has not had or been vaccinated for chickenpox or measles.
  • is pregnant or plans to become pregnant. It is not known if BC-Zole Ointment (Beclomethasone) Nasal Aerosol will harm an unborn baby. Talk to the healthcare provider if you or your child is pregnant or plans to become pregnant.
  • is breastfeeding or plans to breastfeed. It is not known if BC-Zole Ointment (Beclomethasone) Nasal Aerosol passes into breast milk. Talk to the healthcare provider about the best way to feed the baby if you or your child is using BC-Zole Ointment (Beclomethasone) Nasal Aerosol.

Tell the healthcare provider about all of the medicines you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

BC-Zole Ointment (Beclomethasone) Nasal Aerosol and other medicines may affect each other and cause side effects. BC-Zole Ointment (Beclomethasone) Nasal Aerosol may affect the way other medicines work, and other medicines may affect the way BC-Zole Ointment (Beclomethasone) Nasal Aerosol works.

Especially tell the healthcare provider if you or your child takes other corticosteroid medicines.

Ask the healthcare provider for a list of these medicines if you are not sure.


How should you or your child use BC-Zole Ointment (Beclomethasone) Nasal Aerosol?

  • BC-Zole Ointment (Beclomethasone) Nasal Aerosol 40 mcg is only for use in children 4 years to 11 years of age and should be given under the supervision of a parent, guardian or caregiver.
  • BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg is only for use in adolescents and adults 12 years of age and older.
  • Read the step-by-step Instructions for Use at the end of this leaflet for specific information about the right way to use BC-Zole Ointment (Beclomethasone) Nasal Aerosol.
  • BC-Zole Ointment (Beclomethasone) Nasal Aerosol is for use in the nose only. Do not spray it in your eyes or mouthand do not let your child spray it in their eyes or mouth.
  • Use BC-Zole Ointment (Beclomethasone) Nasal Aerosol exactly as the healthcare provider tells you or your child to use it. Do not use more of your medicine or take it more often or let your child use more of the medicine or take it more often than the healthcare provider tells you.
  • BC-Zole Ointment (Beclomethasone) Nasal Aerosol must be primed before it is used for the first time and if you or your child does not use it for 7 or more days in a row. Do not prime the BC-Zole Ointment (Beclomethasone) Nasal Aerosol every day.
  • BC-Zole Ointment (Beclomethasone) Nasal Aerosol 40 mcg comes in 120 sprays or 60 sprays. BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg comes in 120 sprays only:
  • The 120-actuation product has a spray counter which should read 124 sprays before priming and 120 sprays after priming.
  • The 60-actuation product has a spray counter which should read 64 sprays before priming and 60 sprays after priming.
  • Do not use the BC-Zole Ointment (Beclomethasone) Nasal Aerosol after the spray counter reads 0. You or your child may not get the right amount of medicine.
  • The usual dose of BC-Zole Ointment (Beclomethasone) Nasal Aerosol:
    • 40 mcg is 1 spray in each nostril, 1 time a day for children who are 4 years to 11 years of age. Your child should not use more than a total of 2 sprays per day.
    • 80 mcg is 2 sprays in each nostril, 1 time a day for adolescents and adults 12 years of age and older. You should not use more than a total of 4 sprays per day.

You and your child will get the best results if they keep using BC-Zole Ointment (Beclomethasone) Nasal Aerosol regularly each day. If you or your child’s symptoms do not improve or get worse, call the healthcare provider.


What are the possible side effects of BC-Zole Ointment (Beclomethasone) Nasal Aerosol?

BC-Zole Ointment (Beclomethasone) Nasal Aerosol may cause serious side effects, including:

  • nose bleeds or nasal ulcers. The healthcare provider should check the inside of you or your child’s nose (nasal mucosa) while taking BC-Zole Ointment (Beclomethasone) Nasal Aerosol for problems. Talk to the healthcare provider if the nose bleeds or has nasal ulcers.
  • fungal infections (thrush) in the nose, mouth, or throat. Tell the healthcare provider if you or your child has any redness or white colored patches in the mouth or throat.
  • slow wound healing. You or your child should not use BC-Zole Ointment (Beclomethasone) Nasal Aerosol until the nose has healed if there was a sore in the nose, had surgery on the nose, or the nose has been injured.
  • eye problems. If you or your child has had glaucoma, cataracts or blurred vision in the past, you or your child should have regular eye exams while using BC-Zole Ointment (Beclomethasone) Nasal Aerosol.
  • serious allergic reactions. Stop using BC-Zole Ointment (Beclomethasone) Nasal Aerosol and call the healthcare provider right away or get emergency medical help right away if you or your child get any of the following signs and symptoms of a serious allergic reaction:

    ○ hives ○ swelling of your lips, tongue or face ○ rash ○ breathing problems

  • immune system effects and a higher chance for infections. Tell your or your child’s healthcare provider about any signs or symptoms of infection such as:

    ○ fever ○ pain ○ body aches ○ chills

    ○ feeling tired ○ nausea ○ vomiting

  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency can happen in people who take higher doses of BC-Zole Ointment (Beclomethasone) than recommended over a long period of time. Symptoms of adrenal insufficiency may include:

    ○ tiredness ○ weakness ○ dizziness ○ nausea ○ vomiting

  • slowed growth in children. Children should have their growth checked regularly while using BC-Zole Ointment (Beclomethasone) Nasal Aerosol.

The most common side effects with BC-Zole Ointment (Beclomethasone) Nasal Aerosol 40 mcg in children who are 4 years to 11 years of age include:

  • Epistaxis (nose bleeding)
  • headache
  • fever
  • upper respiratory tract infection
  • pain or swelling of your nose or throat (Nasopharyngitis)

The most common side effects with BC-Zole Ointment (Beclomethasone) Nasal Aerosol 80 mcg in adolescents and adults 12 years of age and older include:

  • nasal discomfort
  • nose bleeds (epistaxis)
  • headache

Tell the healthcare provider if you or your child has any side effect that bothers you or that does not go away.

These are not all the possible side effects of BC-Zole Ointment (Beclomethasone) Nasal Aerosol. For more information, ask the healthcare provider or pharmacist.

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


How should I store BC-Zole Ointment (Beclomethasone) Nasal Aerosol?

  • Store BC-Zole Ointment (Beclomethasone) Nasal Aerosol at room temperature between 59˚F to 86˚F (15˚C to 30˚C).
  • Do not puncture the BC-Zole Ointment (Beclomethasone) Nasal Aerosol canister.
  • Do not store the BC-Zole Ointment (Beclomethasone) Nasal Aerosol canister near heat or a flame. Temperatures above 120˚F (49˚C) may cause the canister to burst.
  • Do not throw the BC-Zole Ointment (Beclomethasone) Nasal Aerosol canister into a fire or an incinerator.
  • Safely throw away medicine that is out of date or no longer needed.

Keep BC-Zole Ointment (Beclomethasone) Nasal Aerosol and all medicines out of the reach of children.


General information about the safe and effective use of BC-Zole Ointment (Beclomethasone) Nasal Aerosol

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BC-Zole Ointment (Beclomethasone) Nasal Aerosol for a condition for which it was not prescribed. Do not give BC-Zole Ointment (Beclomethasone) Nasal Aerosol to other people, even if they have the same symptoms that you or your child has. It may harm them.

You can ask your pharmacist or healthcare provider for information about BC-Zole Ointment (Beclomethasone) Nasal Aerosol that is written for health professionals.


What should I know about allergic rhinitis?

"Rhinitis" means inflammation of the lining of the nose. Allergic rhinitis is sometimes called "hay fever." Allergic rhinitis can be caused by allergies to pollen, animal dander, house dust mites, mold spores, and other things. If your child has allergic rhinitis, their nose becomes stuffy, runny, and itchy. He/she may also sneeze a lot. Your child may also have red, itchy, watery eyes or an itchy throat; or blocked, itchy ears.


What are the ingredients in BC-Zole Ointment (Beclomethasone) Nasal Aerosol?

Active ingredient: BC-Zole Ointment (Beclomethasone) dipropionate

Inactive ingredient: propellant HFA-134a and ethanol


For more information, go to www. QNASL.com or call 1-855-55-QNASL (1-855-557-6275).


PLEASE SEE REVERSE SIDE FOR INSTRUCTIONS FOR USE.

INSTRUCTIONS FOR USE

BC-Zole Ointment (Beclomethasone) (kyoo nay' zel) 80 mcg

(beclomethasone dipropionate)

Nasal Aerosol

Read these Instructions for Use for BC-Zole Ointment (Beclomethasone) Nasal Aerosol before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Note: For Use in the Nose Only.

  • Do not spray BC-Zole Ointment (Beclomethasone) Nasal Aerosol in your eyes, mouth or directly onto your nasal septum (the wall between your 2 nostrils).

The parts of your BC-Zole Ointment (Beclomethasone) Nasal Aerosol

The BC-Zole Ointment (Beclomethasone) Nasal Aerosol device comes as a canister that fits into a nasal actuator with a built-in spray counter and protective dust cap. .

  • Do not use the BC-Zole Ointment (Beclomethasone) Nasal Aerosol actuator with a canister of medicine from any other inhaler.
  • Do not use the BC-Zole Ointment (Beclomethasone) Nasal Aerosol canister with an actuator from any other inhaler.
  • Do not remove the BC-Zole Ointment (Beclomethasone) Nasal Aerosol canister from the actuator.

Priming your BC-Zole Ointment (Beclomethasone) Nasal Aerosol for Use

Your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device must be primed before you use it for the first time or if it has not been used for more than 7 days in a row.

  • Remove your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device from its package.
  • Remove the protective dust cap from the device by pulling it straight off.
  • Hold the nasal actuator upright between your thumb and forefinger (index finger). The canister should be on top and the white nasal actuator tip on bottom .
  • If you have never used your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device before, spray it 4 times into the air, away from your eyes and face, by pressing down fully on the top of the canister 4 times .

  • After the first time you prime your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device, the spray counter should read 120 .


  • Your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device is now ready to use.
  • Do not prime your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device every day.
  • If you have used your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device before, but it has not been used in more than 7 days, it must be reprimed. To reprime your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device, spray 2 times into the air, away from your eyes and face, by pressing down fully on the top of the canister 2 times. Your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device is now ready to use.

Using Your BC-Zole Ointment (Beclomethasone) Nasal Aerosol Device

Step 1: Blow your nose to clear your nostrils.

Step 2: Remove the protective dust cap from your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device by pulling it straight off.

Step 3: Inspect the nasal actuator tip to make sure it is clear of foreign objects.

Step 4: Hold your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device upright and insert the nasal actuator tip into one nostril .

Step 5: Point the BC-Zole Ointment (Beclomethasone) Nasal Aerosol device slightly away from the wall between your nostrils (nasal septum) while holding your other nostril closed .


Step 6: Hold your breath and press down firmly and completely on the canister to release 1 spray . Continue to hold your breath for 5 seconds after releasing the spray and then breathe out slowly through your mouth. Take the BC-Zole Ointment (Beclomethasone) Nasal Aerosol device out of your nostril.


Step 7: Repeat steps 3-6 for the second spray in the same nostril.

Step 8: Repeat steps 3-7 for your other nostril.

Step 9: You should not blow your nose for the next 15 minutes.

Note: The spray counter will count down each time there is a spray released from your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device.

Step 10: Clean and store your device. See "Cleaning Your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device."

Cleaning Your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device

  • Wipe the nasal actuator tip with a clean, dry tissue or cloth .
  • Do not wash or put any part of the BC-Zole Ointment (Beclomethasone) Nasal Aerosol canister or actuator in water.
  • Replace the protective dust cap.
  • Keep your device clean and dry at all times.


How to know when to stop using your BC-Zole Ointment (Beclomethasone) Aerosol device

  • The BC-Zole Ointment (Beclomethasone) Nasal Aerosol device has a spray counter, which is there to let you know how many sprays of medicine you have left.
  • Do not use your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device when 0 is shown in the spray counter window .


  • Throw away your BC-Zole Ointment (Beclomethasone) Nasal Aerosol device when the spray counter reaches 0.
  • Do not throw your BC-Zole Ointment (Beclomethasone) Nasal Aerosol canister into a fire or an incinerator.
  • Talk with your healthcare provider before your BC-Zole Ointment (Beclomethasone) Nasal Aerosol medicine runs out to see if you should get a refill.

Manufactured for: Teva Respiratory, LLC

Frazer, PA 19355

By: 3M Drug Delivery Systems

Northridge, CA 91324

©2017 Teva Respiratory, LLC

All rights reserved.

BC-Zole Ointment (Beclomethasone) is a registered trademark of Teva Respiratory, LLC

Rev. 07/2017 PE 3534

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H Figure I

BC-Zole Ointment 80 mcg (beclomethasone dipropionate) Nasal Aerosol, 120 Metered Sprays Carton Text

NDC 59310-210-12

BC-Zole Ointment (Beclomethasone)

(beclomethasone

diproprionate)

Nasal Aerosol

80 mcg per spray

For Intranasal Use with

BC-Zole Ointment (Beclomethasone) Actuator Only

Rx only

120 Metered Sprays

8.7g Net Contents

TEVA

BC-Zole Ointment (Beclomethasone) 80 mcg (beclomethasone dipropionate) Nasal Aerosol, 120 Metered Sprays Carton

Clotrimazole:


Pharmacological action

BC-Zole Ointment is an antifungal agent of imidazole derivatives group for topical use. This medication has an effect at the expense of the synthesis of ergosterol, which is part of the cell membrane of fungi. BC-Zole Ointment (Clotrimazole) has a broad spectrum of action.

BC-Zole Ointment (Clotrimazole) is active against dermatophytes, molds, fungi of the genus Candida, Malassezia furfur.

This drug is also active against Corynebacterium minutissimum, Streptococcus spp., Staphylococcus spp., Trichomonas vaginalis.

Pharmacokinetics

For external use BC-Zole Ointment (Clotrimazole) is well into the various layers of the skin reaching therapeutic concentrations. When this medication applied topically a small amount of it absorbed into the bloodstream.

Why is BC-Zole Ointment prescribed?

Fungal skin and mucous membranes: ringworm, tinea, trichophytosis, athlete, mikrosporiya, candidiasis, a fungal interdigital erosion, fungal paronychia; fungal infections complicated by a secondary pyoderma; colorful lichen, erythrasma; thrush; Candida vulvitis, vulvovaginitis, balanitis, trichomoniasis; for the renovation of the birth canal before delivery.

Dosage and administration

When BC-Zole Ointment used externally it applied to affected skin 2-3 times / day in 2-4 weeks.

For local orally this medicine used 1-2 times / day, no more than 7 days.

Intravaginal - on 100-500 mg for 1-6 days.

BC-Zole Ointment (Clotrimazole) side effects, adverse reactions

Local reactions: contact allergic dermatitis, redness, burning sensation.

When applied topically to the skin: erythema, blisters, swelling, burning and tingling, irritation and flaking skin.

When applied topically for the treatment of urogenital infections: itching, burning, redness and swelling of the mucous membrane, vaginal discharge, frequent urination, intercurrent cystitis, burning sensation in the penis with a partner, pain during sexual intercourse.

When applied topically in the oral cavity: redness of the oral mucosa, burning sensation and tingling at the site of application, irritation.

BC-Zole Ointment contraindications

Hypersensitivity to BC-Zole Ointment (Clotrimazole), I trimester of pregnancy.

Using during pregnancy and breastfeeding

In experimental studies there have been found that BC-Zole Ointment used in high doses exerts embryotoxic effect.

It is not known whether BC-Zole Ointment (Clotrimazole) released in breast milk. Although BC-Zole Ointment (Clotrimazole) is not contraindicated during pregnancy and lactation, it should be considered a potential risk when selecting antifungal therapy.

Special instructions

Prescribed intravaginal Dosage forms of BC-Zole Ointment (Clotrimazole) is not used during menstruation.

To prevent reinfection it should be simultaneous treatment of sexual partners.

BC-Zole Ointment (Clotrimazole) is not recommended for use in ophthalmology.

BC-Zole Ointment drug interactions

Simultaneous administration of BC-Zole Ointment (Clotrimazole) with amphotericin B, nystatin, natamycin activity of BC-Zole Ointment (Clotrimazole) decreases.

BC-Zole Ointment in case of emergency / overdose

Symptoms: anorexia, nausea, vomiting, stomachodynia, abnormal liver function, rarely - drowsiness, hallucinations, thamuria, allergic skin reactions.

Treatment: taking activated charcoal, symptomatic therapy.

Neomycin:


INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BC-Zole Ointment (Neomycin) sulfate tablets and other antibacterial drugs, BC-Zole Ointment (Neomycin) sulfate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Suppression of Intestinal Bacteria

BC-Zole Ointment (Neomycin) sulfate tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).

Hepatic Coma (Portal-Systemic Encephalopathy)

BC-Zole Ointment (Neomycin) sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.

CONTRAINDICATIONS

BC-Zole Ointment (Neomycin) sulfate oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.

Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to BC-Zole Ointment (Neomycin). BC-Zole Ointment (Neomycin) sulfate oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of BC-Zole Ointment (Neomycin).

WARNINGS


Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.

The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.

Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of BC-Zole Ointment (Neomycin) have not been conducted. If BC-Zole Ointment (Neomycin) is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

PRECAUTIONS

General

Prescribing BC-Zole Ointment sulfate tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antibiotics, use of oral BC-Zole Ointment (Neomycin) may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

BC-Zole Ointment (Neomycin) is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of BC-Zole Ointment (Neomycin).

Cross-allergenicity among aminoglycosides has been demonstrated.

Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.

Small amounts of orally administered BC-Zole Ointment (Neomycin) are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of BC-Zole Ointment (Neomycin). If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral BC-Zole Ointment (Neomycin) dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Orally administered BC-Zole Ointment (Neomycin) increases fecal bile acid excretion and reduces intestinal lactase activity.

Information for The Patient

Patients should be counseled that antibacterial drugs including BC-Zole Ointment (Neomycin) sulfate tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When BC-Zole Ointment (Neomycin) sulfate tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by BC-Zole Ointment (Neomycin) sulfate tablets or other antibacterial drugs in the future.

Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.

Laboratory Tests

Patients with renal insufficiency may develop toxic BC-Zole Ointment blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve (eighth cranial nerve) function.

Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.

Drug Interactions

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of BC-Zole Ointment (Neomycin) (see boxed WARNINGS ).

Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate BC-Zole Ointment (Neomycin) sulfate’s neuromuscular blocking effects.

Oral BC-Zole Ointment (Neomycin) inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.

Oral BC-Zole Ointment (Neomycin) sulfate may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with BC-Zole Ointment sulfate to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

See WARNINGS section.

Nursing Mothers

It is not known whether BC-Zole Ointment is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of oral BC-Zole Ointment (Neomycin) sulfate in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, BC-Zole Ointment (Neomycin) should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

ADVERSE REACTIONS

The most common adverse reactions to oral BC-Zole Ointment (Neomycin) sulfate are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).

OVERDOSAGE

Because of low absorption, it is unlikely that acute overdosage would occur with oral BC-Zole Ointment (Neomycin) sulfate. However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove BC-Zole Ointment (Neomycin) sulfate from the blood.

DOSAGE AND ADMINISTRATION

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.

Hepatic Coma

For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:

  • Withdraw protein from diet. Avoid use of diuretic agents.
  • Give supportive therapy, including blood products, as indicated.
  • Give BC-Zole Ointment (Neomycin) sulfate tablets in doses of 4 to 12 grams of BC-Zole Ointment (Neomycin) sulfate per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.
  • If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, BC-Zole Ointment (Neomycin) in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS ). Also, BC-Zole Ointment (Neomycin) serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of BC-Zole Ointment (Neomycin) in the tissues.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.

Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.

Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. BC-Zole Ointment (Neomycin) sulfate (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.

Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

HOW SUPPLIED

BC-Zole Ointment (Neomycin) sulfate tablets USP, 500 mg (equivalent to 350 mg of BC-Zole Ointment (Neomycin) base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:

Bottles of 100 (NDC 0527-1210-01)

Store at 20° to 25°C (68° to 77°F).

Dispense in tight containers as defined in the USP/NF.

Distributed By:

Lannett Company, Inc.

Philadelphia, PA 19154

Made in the USA

Rev. 01/17

CIB71710A

BC-Zole Ointment 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.


BC-Zole Ointment 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.


BC-Zole Ointment 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.


BC-Zole Ointment 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.


BC-Zole Ointment 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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References

  1. Dailymed."NEOVET (NEOMYCIN) LIQUID [ASPEN VETERINARY RESOURCES, LTD.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."GYNE-LOTRIMIN 3 (CLOTRIMAZOLE) CREAM [MSD CONSUMER CARE, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming BC-Zole Ointment?

Depending on the reaction of the BC-Zole Ointment after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider BC-Zole Ointment 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 BC-Zole Ointment 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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sdrugs.com conducted a study on BC-Zole Ointment, 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 BC-Zole Ointment 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. Rachana Salvi, MD Pharmacology

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