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Brusonex

Brusonex

mometasone

Nhà sản xuất:

Farmea

Nhà phân phối:

Nafarma
Thông tin kê toa chi tiết tiếng Anh
Contents
Mometasone furoate.
Description
Each 100 g contains: Mometasone furoate monohydrate 0.05173 g equivalent to 50 µg of mometasone furoate.
Excipients/Inactive Ingredients: Benzalkonium chloride, Glycerol sodium chloride, Polysorbate 80, Microcrystalline cellulose, sodium carmellose, Citric acid monohydrate, sodium citrate.
Action
Pharmacology: Pharmacodynamics: Mometasone furoate is a synthetic glucocorticoid with anti-inflammatory activity. Corticosteroids inhibit many types of cells (eutrophic cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (histamine, eicosanoids, leukotriene, and cytokines) that are involved in inflammation and asthma. White blood cells and macrophages facilitate the initiation of these substance-mediated responses. Mometasone furoate inhibits the adhesion of leukocytes to the damaged vessel wall, which then prevents the inflammatory cells from migrating to the damaged area, constricting the vessels and reducing the permeability of blood vessels, resulting in the inflammatory cells not reaching the site of damage.
Pharmacokinetics: Mometasone furoate nasal spray has negligible systemic bioavailability (<=0.1%) and is generally undetectable in plasma, despite the use of a sensitive quantification with a low defined limit of 50 pg/ml; therefore, there are no corresponding pharmacokinetic data for this dosage form. Mometasone furoate suspension is very poorly absorbed by the gastrointestinal tract and a small amount can be swallowed and absorbed undergoing an extensive initial metabolism before being excreted in urine and bile.
Indications/Uses
Indicated for adults and children over 3 years old.
Brusonex (nasal spray) is used to treat and prevent the symptoms of seasonal allergic or perennial allergic rhinitis (runny nose, sneezing, and itchy nose). Mometasone nasal spray is a topical steroid drug. It works by reducing inflammation (swelling) in the nasal passages.
Dosage/Direction for Use
After initial priming of the Brusonex nasal spray pump (usually 6 to 7 times until the spray is uniform), each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate. If the pump is not used for 14 days or longer, reprime the pump with 2 actuations until a uniform spray is observed, before next use.
Shake container well before each use.
Adults (including older patients) and children 12 years of age and older: The usual recommended dose is two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms). Once symptoms are controlled, dose reduction to one actuation in each nostril (total dose 100 micrograms) may be effective for maintenance. Dose reduction is recommended following control of symptoms.
Children between the ages of 3 and 11 years: The usual recommended dose is one actuation (50 micrograms/actuation) in each nostril once daily (total dose 100 micrograms).
The time to onset of clinically significant effects occurs 12 hours after the first dose.
Overdosage
Because of the negligible ≤ (0.1%) systemic bioavailability of Brusonex, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage.
Contraindications
Hypersensitivity to the active substance or to any of the excipient ingredients.
Patients with the presence of an infection of the nasal mucosa, e.g. herpes simplex.
Patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Special Precautions
Corticosteroids can cause hyperadrenal cortical hyperplasia or inhibition of the hypothalamic-pituitary-adrenal axis (HPA), especially in young children or patients who take high doses over a prolonged period of time. Inhibition of the HPA axis can lead to adrenal insufficiency.
Adrenal suppression may occur in some patients treated with high doses of mometasone furoate spray for prolonged treatment of asthma. Systemic absorption may occur after nasal spray, especially after high doses or prolonged periods of time.
Mometasone furoate spray can aggravate pre-existing diseases such as tuberculosis, bacterial infections, superbugs, fungi or parasites, or eye herpes. Chickenpox or measles can progress more severely or even cause death in susceptible patients.
Avoid nasal corticosteroids in patients who have recently had nasal wall ulcers, or who have recently had rhinoplasty or nasal injury.
Corticosteroids sprayed through the mouth and nasal spray for a long time can cause a decrease in the mineral density of bones and cause a large rate decrease in pediatric patients. These therapies can also cause glaucoma and/or subcapsular cataracts. To minimize the systemic effects of oral or nasal corticosteroids, each patient should be titrated to the lowest effective dose. Monitor the severity of the pediatric patient as usual. Generally, taking the smallest dose is effective and in the shortest time to minimize unwanted effects.
Effects on Ability to Drive and Use Machines: Does not affect the ability to drive and operate the machines.
Use In Pregnancy & Lactation
There are no well-controlled or adequate studies on pregnant women. After spraying the maximum clinically recommended dose for the patient, the plasma mometasone concentration was not measured, so the fetal exposure to the drug was considered negligible and the possibility of reproductive toxicity was very low.
As with other nasal corticosteroid preparations, Brusonex should only be given to pregnant, lactating women of reproductive age when the benefits may outweigh the potential risks to the mother, fetus and young child. Children whose mothers take corticosteroids during pregnancy must be closely monitored for adrenal insufficiency.
Adverse Reactions
Common, ADR >1/100: Nervous system disorders: Headache, fatigue, depression, pain.
Nerves - muscles and bones disorders: Muscle - bone pain, joint pain, back pain, muscle pain.
Respiratory disorders: Rhinitis, upper respiratory tract infections, pharyngitis, cough, nosebleeds.
Cardiovascular disorders: Chest pain.
Gastrointestinal disorders: Abdominal pain, loss of appetite, dry throat, diarrhea, indigestion, flatulence, gastroenteritis, nausea, vomiting.
Genitalia - Urine disorders: Menstrual pain.
Eye disorders: Conjunctivitis.
Ear disorders: Earache, otitis media.
Other: Viral infections, oral candidiasis, influenza-like syndrome.
Uncommon, ADR <1/100 (limited to critical or life-threatening ADRs): Anaphylaxis, angioedema, growth retardation, nasal candidiasis, burning sensation and nasal irritation, perforation of the nasal wall, nasal ulcers, fungal diseases.
Oral candidiasis.
Rare, ADR <1/1000: Olfactory disorders, taste disorders.
Inform the doctor of any undesirable effects the patient may experience when taking the drug.
View ADR Reporting Link
Drug Interactions
The semi-liquid drug for Brusonex nasal spray was administered concomitantly with loratadine with no apparent effect on the concentration of loratadine or its main metabolites in the plasma. Mometasone furoate plasma concentrations are undetectable. Coordinated treatment is well tolerated.
Storage
Store in sealed packaging at a temperature below 30°C, away from heat, light and moisture.
Shelf Life: 2 years from the date of manufacture.
MIMS Class
Nasal Decongestants & Other Nasal Preparations
ATC Classification
R01AD09 - mometasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Presentation/Packing
Dạng
Brusonex Hỗn dịch xịt mũi 50 mcg/dose
Trình bày/Đóng gói
140 dose x 1's
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