BECONASE AQ (Page 3 of 4)

Geriatric Use:

Clinical studies of BECONASE AQ Nasal Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

In general, side effects in clinical studies have been primarily associated with irritation of the nasal mucous membranes.

Adverse reactions reported in controlled clinical trials and open studies in patients treated with BECONASE AQ Nasal Spray are described below.

Mild nasopharyngeal irritation following the use of beclomethasone aqueous nasal spray has been reported in up to 24% of patients treated, including occasional sneezing attacks (about 4%) occurring immediately following use of the spray. In patients experiencing these symptoms, none had to discontinue treatment. The incidence of transient irritation and sneezing was approximately the same in the group of patients who received placebo in these studies, implying that these complaints may be related to vehicle components of the formulation.

Fewer than 5 per 100 patients reported headache, nausea, or lightheadedness following the use of BECONASE AQ Nasal Spray. Fewer than 3 per 100 patients reported nasal stuffiness, nosebleeds, rhinorrhea, or tearing eyes.

Rare cases of ulceration of the nasal mucosa and instances of nasal septum perforation have been spontaneously reported (see PRECAUTIONS).

Reports of dryness and irritation of the nose and throat and unpleasant taste and smell have been received. There are rare reports of loss of taste and smell.

Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the use of intranasal beclomethasone dipropionate (see PRECAUTIONS).

Rare cases of immediate and delayed hypersensitivity reactions, including anaphylactoid/anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasone dipropionate.

Cases of growth suppression have been reported for intranasal corticosteroids, including BECONASE AQ (see PRECAUTIONS: Pediatric Use).

OVERDOSAGE

When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, BECONASE AQ Nasal Spray should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy. No deaths occurred when beclomethasone dipropionate was given as single oral doses of 3,000 mg/kg to mice (approximately 36,000 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis, or approximately 21,000 times the maximum recommended daily intranasal dose in children on a mg/m2 basis) and 2,000 mg/kg to rats (approximately 48,000 times the maximum recommended daily intranasal dose in adults or approximately 29,000 times the maximum recommended daily intranasal dose in children on a mg/m2 basis). One bottle of BECONASE AQ Nasal Spray contains beclomethasone dipropionate, monohydrate equivalent to 10.5 mg of beclomethasone dipropionate; therefore, acute overdosage is unlikely.

DOSAGE AND ADMINISTRATION

Adults and Children 12 Years of Age and Older:

The usual dosage is 1 or 2 nasal inhalations (42 to 84 mcg) in each nostril twice a day (total dose, 168 to 336 mcg/day).

Children 6 to 12 Years of Age:

Patients should be started with 1 nasal inhalation in each nostril twice daily; patients not adequately responding to 168 mcg or those with more severe symptoms may use 336 mcg (2 inhalations in each nostril). Once adequate control is achieved, the dosage should be decreased to 84 mcg (1 spray in each nostril) twice daily. BECONASE AQ Nasal Spray is not recommended for children below 6 years of age.

The maximum total daily dosage should not exceed 2 sprays in each nostril twice daily (336 mcg/day).

In patients who respond to BECONASE AQ Nasal Spray, an improvement of the symptoms of seasonal or perennial rhinitis usually becomes apparent within a few days after the start of therapy with BECONASE AQ Nasal Spray. However, symptomatic relief may not occur in some patients for as long as 2 weeks. BECONASE AQ Nasal Spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement.

The therapeutic effects of corticosteroids, unlike those of decongestants, are not immediate. This should be explained to the patient in advance in order to ensure cooperation and continuation of treatment with the prescribed dosage regimen.

In the presence of excessive nasal mucous secretion or edema of the nasal mucosa, the drug may fail to reach the site of intended action. In such cases it is advisable to use a nasal vasoconstrictor during the first 2 to 3 days of therapy with BECONASE AQ Nasal Spray.

Directions for Use:

Illustrated Patient’s Instructions for Use accompany each package of BECONASE AQ Nasal Spray.

HOW SUPPLIED

BECONASE AQ Nasal Spray, 42 mcg is supplied in an amber glass bottle fitted with a metering atomizing pump and nasal adapter in a box of 1 (NDC 0173-0388-79) with patient’s instructions for use. Each bottle contains 25 g of suspension and will provide 180 metered sprays.

The correct amount of medication in each spray cannot be assured after 180 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used.

Store between 15° and 30°C (59° and 86°F).

Distributed by:

GlaxoSmithKline

Research Triangle Park, NC 27709

Trademarks are owned by or licensed to the GSK group of companies.

©2021 GSK group of companies or its licensor.

February 2021

BCN:3PI

PHARMACISTDETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

BECONASE AQ

(beclomethasone dipropionate,

monohydrate)

Nasal Spray, 42 mcg

For Intranasal Use Only. SHAKE WELL BEFORE USE.

Patient’s Instructions for Use

Shake the suspension spray bottle well before using it. Read complete instructions carefully and use only as directed.

To Use:

1. Remove the safety clip and the plastic dust cap from the nasal applicator (Figure 1).

Figure 1

Figure 1

2. The very first time the spray is used, prime the pump into the air by pressing downward on the white collar, using your forefinger and middle finger while supporting the base of the bottle with your thumb. When you prime the pump for the first time, press down and release the pump 6 times or until a fine spray appears (Figure 2).

The pump is now ready for use. If the pump is not used for 7 days, prime until a fine spray appears.

Figure 2

Figure 2

3. Gently blow your nose to clear your nostrils. Close 1 nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril (Figure 3).

Figure 3

Figure 3

4. For each spray, press firmly downward once on the white collar, using your forefinger and middle finger while supporting the base of the bottle with your thumb. Avoid spraying in eyes. Breathe gently inward through the nostril.

5. Breathe out through your mouth.

6. Repeat steps 5 through 7 in the other nostril.

7. Replace the plastic dust cap and safety clip.

8. DISCARD THE BOTTLE AFTER the date calculated by your doctor or pharmacist. The correct amount of medication in each spray cannot be assured after 180 sprays even though the bottle is not completely empty. Discard the bottle after 180 sprays. Before the discard date you should consult your doctor to see if a refill is needed. Do not take extra doses or stop taking BECONASE AQ Nasal Spray without consulting your doctor.

Cleansing: To clean the nasal applicator, remove the plastic dust cap and safety clip and then press gently upward on the white collar to free the nasal applicator. Wash the applicator and dust cap with cold water. Dry and replace with the plastic dust cap and safety clip back in position.

If the nasal applicator becomes blocked, remove the dust cap, unscrew the complete pump mechanism, and soak the pump in warm water for a few minutes. Rinse with cold water, dry, refit to bottle, and reprime the pump.

Caution: BECONASE AQ Nasal Spray is not intended to give rapid relief of your nasal symptoms. BECONASE AQ Nasal Spray controls the underlying disorders responsible for your attacks, so it is important that you use it regularly at the times recommended by your doctor. The full benefit of BECONASE AQ Nasal Spray may take a few days to develop.

Storage: Store between 15° and 30°C (59° and 86°F).

Distributed by:

GlaxoSmithKline

Research Triangle Park, NC 27709

Trademarks are owned by or licensed to the GSK group of companies.

©2021 GSK group of companies or its licensor.

February 2021

BCN:3PIL

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