Basic information: Flovent inhaler is intended for preventing asthma in patients that take it regularly at the right dose
- Brand Name: Flohale / Flixotide
- Generic Name: Fluticasone propionate
- Preparation: Inhalers: Inhalers: 125mcg; 50mcg
- Available: Generic for Fluticasone propionate
Instruction for Use
Main component of Flovent Inhaler is Fluticasone.
Pharmaceutical Form, Composition and Packing
It is released metered spray as a suspension in white or almost white.
1 dose contains fluticasone propionate (micronised) 50 mcg.
Additive agents: benzalkonium chloride – 10 g, phenyl ethanol – 250 mcg, polysorbate 80 – 100 g, Avicel RC-591 – 1250 mg, dextrose anhydrous – 5000 g, purified water – 0.1 ml.
It is produced as glucocorticosteroids (GCS), tri – fluorate synthetic compound with high affinity for glucocorticoid receptor. It has anti-inflammatory, antiallergic, antipruritic effect by intranasal, inhaled, external application. At therapeutic doses, Flovent inhaler for asthma has practically no effect on hypothalamic-pituitary-adrenal axis.
Indications for Use
For inhalation use: a basic anti-inflammatory asthma, COPD treatment (including chronic bronchitis and emphysema).
For intranasal use: allergic rhinitis prevention and treatment.
For external use: eczema (including atopic, children, discoid), nodular prurigo, psoriasis (excluding widespread plaque), lichen planus, contact dermatitis, discoid lupus erythematosus, generalized erythroderma (as additional means), red prickly heat, seborrheic dermatitis.
It can be used only orally.
To achieve full therapeutic effect, drug must be used regularly. The maximum therapeutic effect may be achieved after 3-4 days of asthma treatment.
Flovent inhaler for asthma is applied as inhalation. Initial dose is determined based on a dose of fluticasone which is recommended for this disease severity treatment. Then, starting dose should be gradually reduced to minimum effective dose.
Adults and adolescents aged 12 years and older:
- 2 inhalations (25 micrograms of salmeterol and 50 micrograms fluticasone);
- 2 times a day, or 2 inhalation (25 mcg salmeterol and 125 mcg fluticasone);
- 2 times a day, or 2 inhalations (25 micrograms of salmeterol and 250 micrograms fluticasone);
- 2 times a day, or 1 inhalation (50 micrograms salmeterol and 100 micrograms fluticasone);
- 2 times a day, or one inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone);
- 2 times a day, or 1 inhalation (50 micrograms salmeterol and 500 micrograms fluticasone);
- 2 times a day.
Children from age 4 to 12: 2 inhalations (25 to 50 mcg of salmeterol and fluticasone g), 2 times a day, or 1 inhalation (50 mcg of salmeterol and fluticasone 100), 2 times a day.
If abnormal liver and kidney function is present it is not required to lower the dose. The same picture is with elderly people.
Inhalation application may cause oral cavity and throat candidiasis, hoarseness, paradoxical bronchospasm; long-term use at high doses, or concomitant use of corticosteroids prior to ingestion there rarely observed decrease in adrenocortical function, osteoporosis, growth retardation in children, cataract, glaucoma.
Intranasal application: very rare – dryness and irritation of nose and throat, unpleasant taste and smell; in rare cases – nasal septum perforation, especially in surgical interventions in nasal cavity in history.
For external use: possible burning and itching at site of application; long-term use may provoke atrophic changes of skin – thinning, striae, dilation of superficial blood vessels, hypertrichosis, hypopigmentation; allergic contact dermatitis, secondary infection, especially when using occlusive dressings and applied to area of skin folds; long-term use at high doses can cause systemic absorption of drug to development of symptomatic Cushing disease.
For intranasal and inhalation application: hypersensitivity to fluticasone.
For external use:
- acne rosacea;
- acne vulgaris;
- perioral dermatitis;
- primary viral skin infections (herpes simplex, chicken pox);
- perianal and genital itching;
- primary skin lesions of bacterial and fungal etiology;
- children up to 6 months (in case fluticasone application in form of cream);
- children up to 1 year (in case of fluticasone application in form of ointments); hypersensitivity to fluticasone.
Pregnancy and Lactation
The safety of fluticasone during pregnancy is not currently installed.
Application during pregnancy and lactation is possible in cases where expected benefit to mother outweighs potential risk to fetus or child.
It is believed that fluticasone penetration in breast milk is impossible.
Simultaneous use of fluticasone by inhalation and inhibitors of enzyme CYP3A4 (including ketoconazole, ritonavir) may increase fluticasone systemic action.
At intranasal application: use with caution after systemic administration of corticosteroids.
Fluticasone inhalation application is not intended for asthma attack relief. To be used with caution in case of concomitant pulmonary tuberculosis, as well as in conjunction with inhibitors of CYP3A4 isoenzyme. Transfering patient with oral corticosteroids to inhaled fluticasone application should be made with caution, under control of adrenal cortex function. Fluticasone treatment should be stopped gradually. It is necessary to regularly monitor dynamics of children growth receiving inhaled corticosteroids for a long time.
For external use: Avoid contact with eyes; systemic absorption is more likely in infants.
Regardless of mode of administration, long-term use is possible because suppression of adrenocortical function can be found.
Effects on Ability to Drive Vehicles and Management Mechanisms
Effect of fluticasone on ability to drive and use machines is not observed.