DRUGS & SUPPLEMENTS

Beclomet Compositum

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Beclomet Compositum uses

Beclomet Compositum consists of Albuterol, Beclomethasone Dipropionate.

Albuterol:


Pharmacological action

Beclomet Compositum is a beta adrenoagonists with a predominant effect on beta2-adrenergic receptors (localized, particularly in the bronchi, myometrium, blood vessels).

This medication prevents and reduces or eliminates bronchospasm, reduces the resistance in the airways, increases the vital capacity. It prevents the release of histamine, slow reacting substance from mast cells and factors chemotaxis of neutrophils. Compared with other drugs of this group has a less pronounced positive chrono-and inotropic effect on myocardium. It widen of coronary arteries, practically does not reduce blood pressure. Has tocolytic effect, lowering the tone and the contractile activity of the myometrium.

Pharmacokinetics

When using an aerosol there is a rapid absorption of Beclomet Compositum (Albuterol) (salbutamol) in the blood, but its concentration in plasma when used in recommended doses are very low or below detection limit.

After oral administration Beclomet Compositum (Albuterol) is well absorbed from the gastrointestinal tract. Plasma protein binding is 10%. Metabolised with "first pass" through the liver and possibly in the wall of the intestine, the main metabolite - inactive sulfate conjugate. salbutamol is not metabolised in the lungs, thus its ultimate metabolism and excretion following inhalation depends on the method of application, which defines the relationship between inhaled salbutamol and unintentionally swallowed.

T1/2 from plasma is 2-7 hours. Beclomet Compositum (Albuterol) (salbutamol) is rapidly excreted in the urine as metabolites and unchanged substance, in small amounts excreted in the feces.

Why is Beclomet Compositum prescribed?

The prevention and relief of bronchospasm in all forms of bronchial asthma. Reversible airway obstruction in chronic bronchitis and emphysema, bronchial obstruction in children.

Threatening preterm labor with uterine contractions; birth to 37-38 weeks of pregnancy; isthmic-cervical insufficiency, decrease in fetal heart rate, depending on uterine contractions during opening of the cervix and expulsion. As a preventive measure during surgery on the pregnant uterus (the imposition of a circular suture with the lack of internal os of the uterus).

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Dosage and administration

Beclomet Compositum for oral use as a means of extending the broncho adults and children over 12 years - 2.4 mg 3-4 times / day; if necessary, the dose may be increased to 8 mg 4 times / day. Children aged 6-12 years - 2 mg 3-4 times / day; children 2-6 years - 1-2 mg 3 times / day.

Beclomet Compositum (Albuterol) for inhalation use dose depends on the applied dosage form, frequency of use depends on the testimony and the clinical situation.

As a tocolytic agent used as IV infusion in dose of 1-2 mg.

Beclomet Compositum (Albuterol) side effects, adverse reactions

Cardiovascular system: a transient expansion of peripheral blood vessels, a moderate tachycardia.

Central nervous system: headache, dizziness, nausea, vomiting.

Metabolic: hypokalaemia.

Allergic reactions: in a few cases - angioedema, allergic reactions in the form of skin rashes, urticaria, hypotension, collapse.

Other: Tremor of hands, inner trembling, tension, rarely - paradoxical bronchoconstriction, muscle cramps.

Contraindications

The threat of miscarriage in I and II trimesters of pregnancy, premature placental abruption, bleeding or toxemia in the III trimester of pregnancy, infancy to 2 years; hypersensitivity to salbutamol.

Using during pregnancy and breastfeeding

Category of the fetus by FDA - C.

Beclomet Compositum is contraindicated in threatened miscarriage in I and II trimesters of pregnancy, premature detachment of the placenta, bleeding, or toxicosis in the III trimester of pregnancy. If necessary, the use of salbutamol during pregnancy should be related to the expected benefits of treatment for the mother and the potential risk to the fetus. Currently is insufficient data on the safety of salbutamol in early pregnancy. salbutamol is excreted in breast milk, so if you need to use during lactation should also assess the potential benefits of treatment for the mother and the potential risk to the child.

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Special instructions

With caution used Beclomet Compositum (Albuterol) when tachyarrhythmia and other cardiac arrhythmias, arterial hypertension, myocarditis, heart defects, aortic stenosis, diabetes, thyrotoxicosis, glaucoma, acute heart failure (with careful medical supervision).

Increase doses or frequency of receiving Beclomet Compositum (Albuterol) (salbutamol) should be under the supervision of a doctor. Reducing the interval may be only in exceptional cases and should be strictly justified.

In the application of salbutamol there was a risk of hypokalemia, so the period of treatment in patients with severe asthma should monitor the flow levels of potassium in the blood. The risk of hypokalemia increases with hypoxia.

Precautionary measures

To increase the effectiveness of therapy the patient should be trained in the proper use of inhalers and the beginning of treatment to use an inhaler under the supervision of medical personnel. Receiving high doses of salbutamol in patients with acute asthma leads to the fact that each subsequent attack of breathlessness becomes more intense the previous syndrome. In severe asthma interval between inhalations should be at least 20 minutes. In the absence of the minimal effect of inhalation or the appearance of pronounced tremor, tachycardia, cardiac arrhythmias continued uncontrolled use of the inhaler is contraindicated, and should appeal to the doctor. The risk of complications increases as in the long duration of treatment, and at a sharp lifting of the drug.

Beclomet Compositum (Albuterol) drug interactions

With simultaneous use of Beclomet Compositum (Albuterol) (salbutamol) with not cardioselective beta-blockers may suppress mutual therapeutic effects; with theophylline - increases the risk of tachycardia and arrhythmia, in particular, supraventricular extrasystoles.

With simultaneous use of salbutamol and xanthine derivatives, SCS or diuretics increases the risk of hypokalemia.

Beclomet Compositum in case of emergency / overdose

Symptoms: tachycardia (heart rate to 200 bpm), ventricular flutter, reducing blood pressure, increased cardiac output, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremors, headache, agitation, hallucinations, convulsions.

Treatment: removal of preparation and holding of symptomatic therapy of beta-blockers (selective) in patients with bronchial asthma requires extreme caution because of the risk of severe bronchospasm reaction.

Beclomethasone Dipropionate:


1 INDICATIONS AND USAGE

Beclomet Compositum 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

Beclomet Compositum (Beclomethasone Dipropionate)® 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 Beclomet Compositum Nasal Aerosol by the intranasal route only. Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 40 mcg Nasal Aerosol and Beclomet Compositum (Beclomethasone Dipropionate) 80 mcg Nasal Aerosol 120-actuation products and 60 for Beclomet Compositum (Beclomethasone Dipropionate) 40 mcg Nasal Aerosol 60-actuation product. If Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol.

Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol is for intranasal use only.

  • The recommended dose of Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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

Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol is a nonaqueous nasal spray solution.

Each actuation of Beclomet Compositum (Beclomethasone Dipropionate) 40 mcg Nasal Aerosol delivers 40 mcg of Beclomet Compositum (Beclomethasone Dipropionate) and each actuation of Beclomet Compositum (Beclomethasone Dipropionate) 80 mcg Nasal Aerosol delivers 80 mcg of Beclomet Compositum (Beclomethasone Dipropionate). Each strength is supplied in an 8.7 g canister containing 120 actuations; Beclomet Compositum (Beclomethasone Dipropionate) 40 mcg Nasal Aerosol is also supplied in a 4.9 g canister containing 60 actuations.

Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol is available in two strengths:

  • Each actuation of Beclomet Compositum (Beclomethasone Dipropionate) 40 mcg Nasal Aerosol delivers 40 mcg of Beclomet Compositum (Beclomethasone Dipropionate). ( 3 )
  • Each actuation of Beclomet Compositum (Beclomethasone Dipropionate) 80 mcg Nasal Aerosol delivers 80 mcg of Beclomet Compositum (Beclomethasone Dipropionate). ( 3 )
  • Each strength is supplied in an 8.7 g canister containing 120 actuations; Beclomet Compositum (Beclomethasone Dipropionate) 40 mcg Nasal Aerosol is also supplied in a 4.9 g canister containing 60 actuations. ( 3 )

4 CONTRAINDICATIONS

Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol is contraindicated in patients with a history of hypersensitivity to Beclomet Compositum (Beclomethasone Dipropionate) and/or any other Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol ingredients .

Patients with a history of hypersensitivity to Beclomet Compositum (Beclomethasone Dipropionate) and/or any other Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol slowly. ( 5.5 )
  • Potential reduction in growth velocity in pediatric patients. Monitor growth routinely in pediatric patients receiving Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol .

Candida Infection: In previous clinical trials with an aqueous formulation of Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol. If such an infection develops, it may require treatment with appropriate local therapy and discontinuation of Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol treatment. Thus, patients using Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate). There were no nasal septal perforations reported during clinical trials in the indicated dose of Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol. Discontinue Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol .

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 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate)
  • 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


Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol. In 45 reports of epistaxis in patients who received Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol, 80 mcg once daily, 241 (116 female and 125 male) received Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol 80 mcg once daily and placebo treated patients.


Table 2. Adverse Events With ≥ 2% Incidence and Greater than Placebo in Beclomet Compositum (Beclomethasone Dipropionate) 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


Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol, the following adverse events have been reported during postmarketing use of Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol or other intranasal and inhaled formulations of Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) or a combination of these factors.

Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol: sneezing, burning sensation

Intranasal Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate).

Inhaled Beclomet Compositum (Beclomethasone Dipropionate): Hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, and bronchospasm have been reported following the oral inhalation of Beclomet Compositum (Beclomethasone Dipropionate).

7 DRUG INTERACTIONS

No drug interaction studies have been performed with Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum Nasal Aerosol. Beclomet Compositum (Beclomethasone Dipropionate) was teratogenic and embryocidal in the mouse and rabbit although these effects were not observed in rats. Beclomet Compositum (Beclomethasone Dipropionate) 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.

Beclomet Compositum (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 Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol is administered to a nursing mother.

8.4 Pediatric Use

The safety and effectiveness of Beclomet Compositum Nasal Aerosol in children 4 years and older have been established . The safety and effectiveness of Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol in children younger than 4 years of age have not been established. Controlled pediatric clinical trials with Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) product, without spacer versus chlorofluorocarbon-propelled (CFC) Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol.

11 DESCRIPTION

Beclomet Compositum (Beclomethasone Dipropionate) USP, the active component of Beclomet Compositum (Beclomethasone Dipropionate) 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:

Beclomet Compositum (Beclomethasone Dipropionate), a di-ester of 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.

Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol is a pressurized, nonaqueous solution in a metered-dose aerosol device intended ONLY for intranasal use. It contains a solution of Beclomet Compositum (Beclomethasone Dipropionate) in propellant HFA-134a (1,1,1,2-tetrafluoroethane) and dehydrated ethanol. Beclomet Compositum (Beclomethasone Dipropionate) 40 mcg Nasal Aerosol delivers 40 mcg of Beclomet Compositum (Beclomethasone Dipropionate) from the nasal actuator and 50 mcg from the valve. Beclomet Compositum (Beclomethasone Dipropionate) 80 mcg Nasal Aerosol delivers 80 mcg of Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) 40 mcg or 80 mcg Nasal Aerosol, contains 8.7 g of drug and excipients and each provides 120 actuations after priming. Additionally, Beclomet Compositum (Beclomethasone Dipropionate) 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

Beclomet Compositum is a prodrug that is extensively converted to the active metabolite, beclomethasone-17-monopropionate. The precise mechanism through which Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate). The clinical significance of these findings is unknown.

12.2 Pharmacodynamics

Adrenal Function: The effects of Beclomet Compositum (Beclomethasone Dipropionate) 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, Beclomet Compositum (Beclomethasone Dipropionate) 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, Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol and placebo groups of 0.86 and 0.44, resulting in a difference of 0.42. The geometric mean ratio for Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) undergoes extensive conversion to its active metabolite, beclomethasone-17-monopropionate, during absorption. Plasma concentrations of Beclomet Compositum (Beclomethasone Dipropionate) and beclomethasone-17-monopropionate have been measured with Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol in 2 adult and/or adolescent clinical trials and 1 pediatric clinical trial.

The single-dose pharmacokinetics of Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol were evaluated in a randomized, open-label, 3-period, crossover trial in healthy adult volunteers. Systemic levels of beclomethasone-17-monopropionate and Beclomet Compositum (Beclomethasone Dipropionate) after single-dose intranasal administration of Beclomet Compositum (Beclomethasone Dipropionate) at doses of 80 and 320 mcg were compared with the systemic levels of beclomethasone-17-monopropionate and Beclomet Compositum (Beclomethasone Dipropionate) after administration of orally inhaled Beclomet Compositum (Beclomethasone Dipropionate) HFA at a dose of 320 mcg (QVAR® Inhalation Aerosol). The results of this trial demonstrated that the systemic bioavailability of Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol 320 mcg was approximately 27.5% (approximately 4-fold lower) of that of orally inhaled Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol 320 mcg/day was approximately 19.5% (approximately 5-fold lower) of that of orally inhaled Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol, there was no accumulation or increase in plasma exposure to beclomethasone-17-monopropionate or Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) is moderate (20 L) but more extensive for beclomethasone-17-monopropionate (424 L).

Metabolism

Beclomet Compositum (Beclomethasone Dipropionate) undergoes extensive first-pass metabolism, forming three metabolites via CYP3A4, beclomethasone-17-monopropionate, beclomethasone-21-monopropionate, and beclomethasone. Beclomethasone-17-monopropionate is the major and most active metabolite.

Elimination

The major route of elimination of inhaled Beclomet Compositum (Beclomethasone Dipropionate) appears to be via metabolism. More than 90% of inhaled Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) and beclomethasone-17-monopropionate following intranasal dosing with Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol (320 mcg) were approximately 0.3 hours and 4.5 hours, respectively. Irrespective of the route of administration (injection, oral, or inhalation), Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) follows a similar elimination pathway.

Special Populations

Formal pharmacokinetic studies using Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol were not conducted in any special populations.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenicity of Beclomet Compositum (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.

Beclomet Compositum (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, Beclomet Compositum (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 Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) nasal aerosol (80, 160, and 320 mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, only treatment with Beclomet Compositum (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

Beclomet Compositum (Beclomethasone Dipropionate)

320 mcg/day


122


9.17 (1.66)


-2.22 (0.18)


-0.63


-1.13, 0.13


Beclomet Compositum (Beclomethasone Dipropionate)

160 mcg/day


123


9.24 (1.57)


-1.87 (0.18)


-0.29


-0.78, 0.21


Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) 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)


Beclomet Compositum (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)


Beclomet Compositum (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)


Beclomet Compositum (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)


Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol 80 mcg once daily administered as 1 actuation of Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) nasal aerosol (80 and 160mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, treatment with Beclomet Compositum (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)


Beclomet Compositum (Beclomethasone Dipropionate) 80 mcg/day


239


8.9 (1.62)


-1.9 (0.14)


-0.71


-1.1, -0.3


Beclomet Compositum (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)


Beclomet Compositum (Beclomethasone Dipropionate) 80 mcg/day


238


8.1 (1.99)


-1.6 (0.13)


-0.63


-1.0, -0.3


Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) 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)


Beclomet Compositum (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)


Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol 80 mcg per day treated patients compared with placebo.

16 HOW SUPPLIED/STORAGE AND HANDLING

Beclomet Compositum (Beclomethasone Dipropionate) 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:

Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) from the nasal actuator and 50 mcg from the valve.

Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) from the nasal actuator and 100 mcg from the valve.

Each canister of Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol canister from the actuator. The Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol canister should only be used with the Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum Nasal Aerosol may lead to adverse reactions, including epistaxis, nasal ulceration, and nasal discomfort. Candida infection may also occur with treatment with Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol. In addition, nasal Beclomet Compositum (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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol .

17.3 Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following administration of Beclomet Compositum nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol. If any such reactions occur, patients should discontinue use of Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum Nasal Aerosol on a regular, once-daily basis since its effectiveness depends on its regular use. Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol in their eyes or mouth.

Teva Respiratory, LLC

Frazer, PA 19355 USA

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

Beclomet Compositum (Beclomethasone Dipropionate)® 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

Beclomet Compositum (Beclomethasone Dipropionate) (kyoo nay' zel)

(beclomethasone dipropionate)

Nasal Aerosol

  • Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol is available in 2 different strengths:
    • Beclomet Compositum (Beclomethasone Dipropionate) 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.
  • Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol 80 mcg is only for use in adolescents and adults 12 years of age and older.

What is Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol?

Beclomet Compositum (Beclomethasone Dipropionate) 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.

Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol contains Beclomet Compositum (Beclomethasone Dipropionate), which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol is safe and effective in children under 4 years of age.


Who should not use Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol?

Do not use Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol if you or your child is allergic to Beclomet Compositum (Beclomethasone Dipropionate) or any of the ingredients in Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol. See the end of this leaflet for a complete list of ingredients in Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol.


What should you tell your or your child’s healthcare provider before using Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol?

Before using Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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.

Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol and other medicines may affect each other and cause side effects. Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol may affect the way other medicines work, and other medicines may affect the way Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol?

  • Beclomet Compositum (Beclomethasone Dipropionate) 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.
  • Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol.
  • Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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.
  • Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol every day.
  • Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol 40 mcg comes in 120 sprays or 60 sprays. Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol after the spray counter reads 0. You or your child may not get the right amount of medicine.
  • The usual dose of Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol?

Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol.
  • serious allergic reactions. Stop using Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol.

The most common side effects with Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol?

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

Keep Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol and all medicines out of the reach of children.


General information about the safe and effective use of Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol for a condition for which it was not prescribed. Do not give Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol?

Active ingredient: Beclomet Compositum (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

Beclomet Compositum (Beclomethasone Dipropionate) (kyoo nay' zel) 80 mcg

(beclomethasone dipropionate)

Nasal Aerosol

Read these Instructions for Use for Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol in your eyes, mouth or directly onto your nasal septum (the wall between your 2 nostrils).

The parts of your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol

The Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol actuator with a canister of medicine from any other inhaler.
  • Do not use the Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol canister with an actuator from any other inhaler.
  • Do not remove the Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol canister from the actuator.

Priming your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol for Use

Your Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device, the spray counter should read 120 .


  • Your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device is now ready to use.
  • Do not prime your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device every day.
  • If you have used your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device before, but it has not been used in more than 7 days, it must be reprimed. To reprime your Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device is now ready to use.

Using Your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol Device

Step 1: Blow your nose to clear your nostrils.

Step 2: Remove the protective dust cap from your Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device upright and insert the nasal actuator tip into one nostril .

Step 5: Point the Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device.

Step 10: Clean and store your device. See "Cleaning Your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device."

Cleaning Your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device

  • Wipe the nasal actuator tip with a clean, dry tissue or cloth .
  • Do not wash or put any part of the Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Aerosol device

  • The Beclomet Compositum (Beclomethasone Dipropionate) 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 Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device when 0 is shown in the spray counter window .


  • Throw away your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol device when the spray counter reaches 0.
  • Do not throw your Beclomet Compositum (Beclomethasone Dipropionate) Nasal Aerosol canister into a fire or an incinerator.
  • Talk with your healthcare provider before your Beclomet Compositum (Beclomethasone Dipropionate) 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.

Beclomet Compositum (Beclomethasone Dipropionate) 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

Beclomet Compositum 80 mcg (beclomethasone dipropionate) Nasal Aerosol, 120 Metered Sprays Carton Text

NDC 59310-210-12

Beclomet Compositum (Beclomethasone Dipropionate)

(beclomethasone

diproprionate)

Nasal Aerosol

80 mcg per spray

For Intranasal Use with

Beclomet Compositum (Beclomethasone Dipropionate) Actuator Only

Rx only

120 Metered Sprays

8.7g Net Contents

TEVA

Beclomet Compositum (Beclomethasone Dipropionate) 80 mcg (beclomethasone dipropionate) Nasal Aerosol, 120 Metered Sprays Carton

Beclomet Compositum pharmaceutical active ingredients containing related brand and generic drugs:

infoActive 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.


Beclomet Compositum available forms, composition, doses:

infoForm 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.


Beclomet Compositum destination | category:

infoDestination 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.


Beclomet Compositum Anatomical Therapeutic Chemical codes:

infoA 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.


Beclomet Compositum pharmaceutical companies:

infoPharmaceutical 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."QNASL (BECLOMETHASONE DIPROPIONATE) AEROSOL, METERED [TEVA RESPIRATORY, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."BECLOMETHASONE DIPROPIONATE MONOHYDRATE: 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).
  3. "BECLOMETHASONE DIPROPIONATE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Beclomet Compositum?

Depending on the reaction of the Beclomet Compositum after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Beclomet Compositum 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 Beclomet Compositum 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 Beclomet Compositum, 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 Beclomet Compositum 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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