Generic Name: Budesonide 0.1% Nasal Spray
Manufacturer/Distributor: Opsonin Pharma Limited.
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Indications of Pulmicort 100 Nasal Spray
Seasonal and perennial allergic rhinitis prophylaxis and treatment
Vasomotor rhinitis prophylaxis and therapy
Nasal polyposis symptom alleviation.
Prevention of nasal polyps following polypectomy.
Pharmacology of Pulmicort 100 Nasal Spray
Budesonide is a synthetic corticosteroid with high glucocorticoid activity but low mineralocorticoid activity. It possesses a 200-fold greater affinity for the glucocorticoid receptor and a 1000-fold higher anti-inflammatory efficacy on the skin than cortisol. Corticosteroids have been demonstrated to have a broad spectrum of inhibitory effects against a variety of cell types (e.g., mast cell, eosinophil, neutrophil, macrophage, and lymphocyte) and mediators (e.g., histamine, eicosanoids, leukotriene, and cytokine) involved in allergy induced inflammation.
Dosage of Pulmicort 100 Nasal Spray
Adults and children 6 years of age and older: 100 mcg per day administered as one spray per nostril once daily.
Adults (12 years of age and older): The maximum recommended dose is 400 mcg per day administered as four sprays per nostril once daily.
Pediatric Use: Safety and effectiveness in pediatric patients below 6 years of age have not been established.
Administration of Pulmicort 100 Nasal Spray
How to use the Nasal Spray-
Shake the bottle gently and remove the dust cover.
Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
Gently blow the nose to clear the nostrils.
Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
Breathe out through your mouth.
Repeat the above steps in the same/ other nostril for consecutive doses.
Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
Remove the dust cover.
Gently pull off the nasal applicator.
Wash the applicator and dust cover in warm water.
Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
Gently push the applicator back on the top of the bottle and re-fix the dust cover.
Interaction of Pulmicort 100 Nasal Spray
There have been no reports of major medication interactions.
Contraindications
No information provided.
Side Effects of Pulmicort 100 Nasal Spray
Adverse local responses to budesonide are generally moderate and transitory. During clinical trials of budesonide nasal formulations, no systemic adverse effects were observed. Sneezing, headache, sore throat, dry mouth, nausea, and other typical side effects have been observed.
Pregnancy & Lactation
Pregnancy: The FDA has classified inhaled budesonide as pregnancy category B. When administered in large dosages via inhalation, budesonide has not been demonstrated to be teratogenic in animals. Despite the animal studies, it appears that fetal damage is unlikely if the inhalation medication is used during pregnancy. However, because human studies cannot rule out the risk of damage, inhaled budesonide should be used during pregnancy only if absolutely necessary.
Lactation: The quantities of budesonide excreted into breastmilk from breathed budesonide are minute, therefore baby exposure is minimal. Inhaled corticosteroids are appropriate for use during nursing, according to reviewers and an expert panel. Budesonide is only approximately 9% bioavailable when taken orally; bioavailability in the baby is expected to be equally low for any budesonide that enters breastfeeding.
Precautions & Warnings
In patients with current or dormant tuberculosis, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex infection, budesonide nasal spray should be used with care. Patients who have recently experienced nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid.
Storage Conditions
Keep below 30°C and away from light and moisture. Keep out of children's reach.
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