Thông tin thuốc của Azelastine

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Thông tin thuốc gốc

Chỉ định và Liều dùng

Nasal
Seasonal allergic rhinitis

Adult: As 0.1% (140 mcg/actuation) nasal spray: 1 spray (140 mcg) into each nostril bid (total dose of 560 mcg). As 0.1% (137 mcg/actuation) nasal spray: 1 or 2 sprays (137 mcg or 274 mcg) in each nostril bid. As 0.15% (205.5 mcg/actuation) nasal spray: 1 or 2 sprays (205.5 mcg or 411 mcg) in each nostril bid, or 2 sprays (411 mcg) into each nostril once daily. Dosage recommendations and treatment guidelines may vary among individual products or between countries. Refer to specific product information.
Child: As 0.1% (140 mcg/actuation) nasal spray: ≥6 years Same as adult dose. As 0.1% (137 mcg/actuation) nasal spray: 5-11 years 1 spray (137 mcg) in each nostril bid; ≥12 years Same as adult dose. As 0.15% (205.5 mcg/actuation) nasal spray: 6-11 years 1 spray (205.5 mcg) in each nostril bid; ≥12 years Same as adult dose. Dosage recommendations and treatment guidelines may vary among individual products or between countries. Refer to specific product information.

Nasal
Perennial allergic rhinitis

Adult: As 0.1% (140 mcg/actuation) nasal spray: 1 spray (140 mcg) into each nostril bid (total dose: 560 mcg). As 0.15% (205.5 mcg/actuation) nasal spray: 2 sprays (411 mcg) in each nostril bid. Dosage recommendations and treatment guidelines may vary among individual products or between countries. Refer to specific product information.
Child: As 0.1% (140 mcg/actuation) nasal spray: ≥6 years Same as adult dose. As 0.15% (205.5 mcg/actuation) nasal spray: 6-11 years 1 spray (205.5 mcg) into each nostril bid; ≥12 years Same as adult dose. Dosage recommendations and treatment guidelines may vary among individual products or between countries. Refer to specific product information.

Nasal
Vasomotor rhinitis

Adult: As 0.1% (137 mcg/actuation) nasal spray: 2 sprays (274 mcg) into each nostril bid. Dosage recommendations may vary among individual products or between countries. Refer to specific product guidelines.
Child: As 0.1% (137 mcg/actuation) nasal spray: ≥12 years Same as adult dose. Dosage recommendations and treatment guidelines may vary among individual products or between countries. Refer to specific product information.

Ophthalmic
Seasonal allergic conjunctivitis

Adult: As 0.05% ophthalmic solution: Instil 1 drop into the affected eye(s) bid, may be increased to 4 times daily if necessary.
Child: ≥4 years Same as adult dose.

Ophthalmic
Perennial allergic conjunctivitis

Adult: As 0.05% ophthalmic solution: Instil 1 drop into affected eye(s) bid, may be increased to 4 times daily if necessary. Max treatment duration: 6 weeks.
Child: ≥12 years Same as adult dose.

Thận trọng

Not intended to treat eye infections (ophthalmic). Children. Pregnancy and lactation.

Tác dụng không mong muốn

Eye disorders: Mild transient eye irritation (e.g. burning or stinging sensation), transient blurred vision, eye pain.
Gastrointestinal disorders: Bitter taste, dry mouth, nausea, dysgeusia, vomiting.
General disorders and administration site conditions: Fatigue.
Immune system disorders: Very rarely, hypersensitivity reactions (e.g. rash, pruritus, urticaria).
Nervous system disorders: Headache, dizziness, dysaesthesia.
Psychiatric disorders: Somnolence.
Respiratory, thoracic and mediastinal disorders: Mild transient irritation of the inflamed nasal mucosa (e.g. stinging, itching, sneezing, epistaxis), nasal discomfort, cough, pharyngitis, sinusitis, asthma.

Phân loại thai kỳ (US FDA)

Inhalation/Respiratory/Nasal/Ophth: C

Thông tin tư vấn bệnh nhân

This drug may cause somnolence (nasal) or transient effects on vision (ophthalmic); if affected, do not drive or operate machinery. Ophthalmic: Do not wear contact lenses if the eyes are red. Remove soft contact lenses prior to instillation of eye drops and wait for at least 15 minutes before reinsertion.

Tương tác

Nasal: Concurrent use with CNS depressants may lead to reduced alertness and impaired CNS function.

Tương tác với thức ăn

Nasal: Alertness and CNS function may be reduced or impaired with alcohol.

Tác dụng

Description:
Mechanism of Action: Azelastine is a phthalazinone derivative long-acting antihistamine that competes with histamine for H₁-receptors on effector cells, thereby inhibiting the release of histamine and other chemical mediators involved in allergic responses such as leukotriene, platelet activation factor (PAF), and serotonin. Additionally, it decreases hyperactivity of the airways and increases bronchial epithelial cilia motility, thus improving mucociliary transport when given intranasally.
Onset: 3 minutes (ophthalmic); 15-30 minutes (nasal).
Duration: 8 hours (ophthalmic); 12 hours (nasal).
Pharmacokinetics:
Absorption: Ocular absorption is low. Bioavailability: Approx 40% (nasal). Time to peak plasma concentration: 2-3 hours (0.1% nasal spray); 4 hours (0.15% nasal spray).
Metabolism: Metabolised in the liver via oxidation by CYP450 enzyme system to the major active metabolite, N-desmethylazelastine.
Excretion: Mainly via faeces (approx 75%, <10% as unchanged drug). Elimination half-life: As 0.15% nasal spray: 25 hours (azelastine); 57 hours (N-desmethylazelastine).

Đặc tính

Chemical Structure Image — **Azelastine**

Bảo quản

Ophthalmic solution/drops: Store between 2-25°C. Nasal spray: Store between 20-25°C. Do not refrigerate or freeze. Storage recommendations may vary among individual products or between countries. Refer to specific product guidelines.

Phân loại MIMS

Thuốc chống sung huyết mũi & các chế phẩm khác dùng cho mũi / Thuốc giảm sung huyết, gây tê, kháng viêm trong Nhãn khoa

Phân loại ATC

R01AC03 - azelastine ; Belongs to the class of topical antiallergic preparations, excluding corticosteroids. Used as antiallergic agents.
S01GX07 - azelastine ; Belongs to the class of other ophthalmologic antiallergics.

Tài liệu tham khảo

Anon. Azelastine (Nasal). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/10/2022.

Anon. Azelastine (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/10/2022.

Anon. Azelastine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 11/10/2022.

Azelastine HCl Nasal Spray (Padagis Israel Pharmaceuticals Ltd). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/10/2022.

Azelastine Hydrochloride 0.5 mg/mL Eye Drops, Solution (Brown & Burk UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 11/10/2022.

Azelastine Hydrochloride Ophthalmic Solution 0.05% Solution/Drops (Alembic Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/10/2022.

Azelastine Hydrochloride Spray, Metered (Amneal Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/10/2022.

Azelastine-Comod (Konimex). MIMS Indonesia. http://www.mims.com/indonesia. Accessed 09/11/2022.

Buckingham R (ed). Azelastine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/10/2022.

Joint Formulary Committee. Azelastine Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/10/2022.

Rhinolast Nasal Spray (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 11/10/2022.

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