INTRODUCTION

BUDENASE AQ contains Budesonide which belongs to the group of medicines called Corticosteroids. It is used to treat or prevent the signs and symptoms of allergic rhinitis and nasal polyps. Allergic rhinitis (also known as hay fever) is an allergic response caused due to sensitivity of an individual against various allergens such as pollens, dusts, moulds, or flakes of skin from certain animals. It can occur seasonally or year-round and often characterized by inflammation of the inner lining of the nose accompanied with nasal congestion, repeated sneezing, and red, watery, or itchy eyes. Nasal polyps are non-cancerous growth of tissues on the linings of the nasal passage. It is caused due to chronic inflammation or infection in the nasal tract, allergic reactions or due to certain immune disorders. It is often characterized by loss of smell, nasal pain, runny nose, repeated sneezing, nasal congestion, changes in taste, headache, abnormal sounds while breathing (snoring) or inability to breathe via nose which may lead to breathing from mouth.

Budesonide is a steroid medication. It works by blocking the release of certain chemicals that causes allergic reactions in the nasal tract. As a result, it controls the symptoms of allergic rhinitis and nasal polyps in the affected patients. During therapy with BUDENASE AQ, your doctor would regularly monitor your child’s growth and reduce the dose of budesonide if there is any delay in your child’s growth.

Before using BUDENASE AQ, inform your doctor if you have any liver problems or problems with your pituitary or adrenal glands. It is not advisable to use BUDENASE AQ if you already have ulcerations or infections in the nasal tract. It is important to tell your doctor about the list of steroidal medicines that you have used in the past as a precaution. BUDENASE AQ should be used in pregnant or breastfeeding women only if it is considered necessary by your doctor. It is generally not recommended for use in children aged below 6 years. The most common side effects of using BUDENASE AQ are nasal irritation, nasal bleeds or and repeated sneezing. Consult your doctor if any of the symptom worsens.

USES OF BUDENASE AQ

• Treats or prevents the signs and symptoms of allergic rhinitis and nasal polyps

HOW BUDENASE AQ WORKS

BUDENASE AQ controls the symptoms of allergic rhinitis and nasal polyps, where budesonide blocks the release of certain chemicals that triggers allergic response in the nasal tract. As a result, it reduces the onset of allergic symptoms and relieves unpleasant symptoms associated with allergic rhinitis and nasal polyps (such as repeated sneezing, nasal congestion, eye redness with itching, loss of smell or snoring).

DIRECTIONS FOR USE

Use BUDENASE AQ as directed by your physician. It is for intranasal use only. Keep the tip of the nozzle gently inside your nose and gently spray the medicine. It is not necessary to inhale the medicine while spraying. Your doctor will decide the correct dose, number of sprays and duration of therapy for you depending up on your age, body weight and disease condition. Avoid contact of BUDENASE AQ with your eyes, ears, or mouth. If contact happens accidentally, rinse it off with water immediately.

SIDE EFFECTS OF BUDENASE AQ

HOW TO MANAGE SIDE EFFECTS

Skin rash:

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing while going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom worsens.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before using BUDENASE AQ, inform your doctor if you are using any of the following medicines such as:

• medicines used to treat fungal infections (Ex. ketoconazole or itraconazole)
• medicines containing estrogens such as hormone replacement therapy (Ex. ethinyl estradiol)
• birth control pills

Overdosage:

If you or anyone else accidentally used more of BUDENASE AQ, contact your doctor immediately or go to the nearest hospital straight away.

SYNOPSIS

MORE INFORMATION

• Keep BUDENASE AQ out of reach from children
• Store at room temperature

FAQs ABOUT BUDENASE AQ

How long will it take for BUDENASE AQ to show the results?

The effect of BUDENASE AQ are noticeable only after a few days of therapy and it should be used before getting exposed to any allergens to ensure complete protection from allergic responses. Consult your doctor if you do not see any improvement in your disease condition even after using this medicine for a prolonged period.

Is BUDENASE AQ safe for long-term use?

BUDENASE AQ is generally safe to use with lesser side effects. However, long term use can cause anxiety, depression, eye problems or growth retardation in young children. Research suggests that long-term use of BUDENASE AQ can also cause Cushingoid syndrome. Check with your doctor if you experience any abnormal symptoms if you are instructed to use BUDENASE AQ for a prolonged period.

Can BUDENASE AQ cause blurred vision?

Yes. BUDENASE AQ can cause blurred vision in some individuals. Consult your ophthalmologist if you experience blurred vision, as it could be due to any eye damage, formation of cataracts or glaucoma in the eye after using BUDENASE AQ.

Can BUDENASE AQ stop growth in children?

Yes. BUDENASE AQ can cause growth retardation in children. To avoid this, your doctor will carefully monitor your child's growth on a regular basis. To lessen the effect of BUDENASE AQ on growth, your doctor may reduce the dose as well.

How long should I use BUDENASE AQ?

Use BUDENASE AQ as prescribed by your doctor. The effect of BUDENASE AQ are noticeable only after a few days of therapy and it should be used before getting exposed to any allergens to ensure complete protection from allergic responses. Continue to use BUDENASE AQ as instructed by your doctor, even if you don’t have any symptoms. Do not stop using BUDENASE AQ without consulting your doctor as it may cause the symptoms to reappear.

Can I stop using BUDENASE AQ once my symptoms subside?

No. Always use BUDENASE AQ as advised by your physician. Continue to use BUDENASE AQ as long as your doctor prescribes it to you. Do not stop using this medicine or reduce the dose suddenly without consulting your doctor as it may make it less effective.

What can I do if I forget to use BUDENASE AQ?

If you forget to use BUDENASE AQ, take it as soon as you remember. However, if it is time to take your next dose, skip the missed dose and take the next dose. Do not use a double dose to compensate the missed dose.

Can BUDENASE AQ be used in children?

BUDENASE AQ is not recommended for use in children aged below 6 years. It should be used in children aged above 6 years only if prescribed by the physician. While using [GBNKEYWOD], careful monitoring is required as it may delay the growth in young children.

What are the common side effects caused by [GBNKKEYWORD]?

Nasal irritation, repeated sneezing, and bleeding from the nose are common while using BUDENASE AQ. Consult your doctor if you experience them.

How to use [GBNKKEYWORD]?

Gently place the nozzle of BUDENASE AQ in the nostril (nose) and spray the medicine. You don't have to breathe in and out at the same moment while spraying. If you are still doubtful regarding the use of BUDENASE AQ, Consult your doctor for advice.

REFERENCES

1. K.D. Tripathi. Drugs for cough and bronchial asthma. Essentials of medical pharmacology. 8th Edition. 2019. Page – 250-251.

2. J Day, T Carrillo. Comparison of the efficacy of budesonide and fluticasone propionate aqueous nasal spray for once daily treatment of perennial allergic rhinitis. NIH. National Library of Medicine. National Centre of Biotechnology Information. PubMed.gov. December 1998. [Accessed on 2nd June 2022] https://pubmed.ncbi.nlm.nih.gov/9847429/

3. Wytske J Fokkens, Endre Cserháti, José Manuel Lopes dos Santos, Fatima Praca, Marinus van Zanten, Alexander Schade, György Simon. Budesonide aqueous nasal spray is an effective treatment in children with perennial allergic rhinitis, with an onset of action within 12 hours. NIH. National Library of Medicine. National Centre of Biotechnology Information. PubMed.gov. September 2002. [Accessed on 2nd June 2022] https://pubmed.ncbi.nlm.nih.gov/12269648/

4. McNeil Products Limited. Electronic Medicines Compendium (EMC). [Revised in March 2021]. [Accessed on 2nd June 2022]. https://www.medicines.org.uk/emc/files/pil.10205.pdf

5. Mylan Pharmaceuticals ULC. Budesonide Aqueous Nasal Spray 100 mcg per metered dose. [Revised in December 2015] [Accessed on 30th May 2022] https://pdf.hres.ca/dpd_pm/00033190.PDF

6. Gerard Laboratories. Budesonide Mylan 100 micrograms/dose nasal spray, suspension. [Revised in August 2012] [Accessed on 30th May 2022] https://docetp.mpa.se/LMF/Budesonid%20Mylan%20100%20microg-dose%20nasal%20spray,%20susp%20ENG%20PL_09001bee807a2267.pdf

7. Cipla Inc. Budenase AQ Nasal Spray (Budesonide). [Revised in September 2013] [Accessed on 30th May 2022] https://www.ciplamed.com/print-product-pdf/23759

USEFUL DIAGNOSTIC TESTS

• Absolute Eosinophil Count
• Complete Blood Count