Azelastine Hydrochloride BP 140 mcg
Fluticasone Propionate BP 50 mcg
Composition:
Azelastine Hydrochloride BP 0.14% w/v
Fluticasone Propionate BP 0.05% w/v
Preservatives: Benzalkonium Chloride Solution BP 0.02% w/v
Phenylethyl Alcohol USP 0.25% w/v
Excipients q.s
Azeflumark nasal spray is indicated for the management of symptoms of allergic rhinitis, once the need for an antihistamine and corticosteroid has
been established. It is recommended for the treatment of moderate to severe persistent symptoms in adults and adolescents above 12 years of age. It can be used for treating non- allergic vasomotor rhinitis in adults and adolescents, 12 years of age and older. For children aged 5-12 years, recommended for severe symptoms of allergic rhinitis.
The most likely side effects with the combination of azelastine hydrochloride and fluticasone propionate are headache, somnolence, pharyngitis, epistaxis, nasal burning/ irritation, nausea, vomiting, cough, and taste disturbances. The combination may produce a bitter taste which may lead to occasional nausea. This hitter taste usually disappears after sometime.
Mometasone Furoate Monohydrate
Equivalent to Mometasone Furoate USP 50 mcg
Composition:
Mometasone Furoate Monohydrate
Equivalent to Mometasone Furoate USP 0.05% w/v
Preservative
Benzalkonium Chloride Solution BP 0.02% w/v
Phenyl Ethyl Alcohol USP 0.25% w/v
Mometasone Furoate Nasal Spray is indicated for use in adults and children 12 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.
Mometasone Furoate Nasal Spray is indicated for the treatment of nasal polyps in adults 18 years of age and older.
Mometasone Furoate Nasal Spray is also indicated or use in children 6 to 11 years of age to treat the symptoms of seasonal allergic or perennial allergic rhinitis.
In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with Mometasone Furoate Nasal Spray may be initiated up to four weeks prior to the anticipated start of the pollen season.
Treatment-related adverse events reported in clinical studies for allergic rhinitis in adult and adolescent patients are shown below (Table 1).
| Table I Allergic Rhinitis-Treatment Related Undesirable Effects for Mometasone Furoate Nasal Spray
Very common (>1/10), common (> 1 /100, < 1/10); uncommon (>1/1000, < 1/100); rare (> I/10,000, < 1/1000); very rare (<1/10,000)
|
|
| Respiratory, thoracic and mediastinal disorders
Common: |
Epistaxis, Pharyngitis, nasal burning, nasal irritation, nasal ulceration |
| General disorders and administration site conditions
Common: |
Headache |
Epistaxis was generally self-limiting and mild in severity and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studied (up to 15%). The incidence of all other effects was comparable with that of placebo.
In the pediatric population, the incidence of adverse events, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
In patients treated for nasal polyposis, the overall incidence of adverse events was comparable to placebo and similar to that observed for patients with allergic rhinitis.
Treatment-related adverse events reported in ≥1% of patients in clinical studies for polyposis are shown below (Table 2)
| Table 2: Polyposis-Treatment Related Undesirable Effects = 1% for Mometasone Furoate Nasal Spray
Very common (>1/10), common (> 1 /100, < 1/10); uncommon (>1/1000, < 1/100); rare (> 1/10,000, < 1/1000); very rare (<1/10,000)
|
||
| 200 mcg once a day | 200 mcg twice a day | |
| Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection Epistaxis
|
Common Common |
Uncommon Very common |
| Gastrointestinal disorders
Throat irritation |
—– |
Common |
| General disorders and administration site conditions
Headache |
Common |
Common |
In patients treated for acute rhinosinusitis, the incidence of epistaxis for Mometasone Furoate was 3.3% vs. 2.6% for placebo and similar to that observed for patients treated with allergic rhinitis.
Rarely. immediate hypersensitivity reactions, including bronchospasm and dyspnea may occur after intranasal administration of Mometasone Furoate Monohydrate. Very rarely, anaphylaxis and angioedema have been reported.
Disturbances of taste and smell have been reported very rarely.
As with other intranasal corticosteroids rare cases of nasal septum perforation have been reported.
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.
Rare cases of glaucoma, increased intraocular pressure and/or cataracts have been reported with the use of intranasal corticosteroids
Levocetirizine Dihydrochloride 5 mg
Excipients q.s.
Levocetirizine is indicated for:
– the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
– the relief of symptoms of chronic idiopathic urticaria.
Somnolence, Dizziness, Headache, Pharyngitis, Rhinitis, Abdominal pain, Dry mouth, nausea, Fatigue. Uncommon: Agitation, Paraesthesia, Diarrhoea, Pruritus, Rash, Asthenia, Malaise.
