Flohale Rotacaps
Fluticasone Propionate Inhalation
0.5mg
Cipla Ltd.
| Pack size | 1 |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 86.14 NPR |
Indications
Flohale Rotacaps is used for:
Asthma prophylaxis
Adult Dose
Inhalation
Asthma prophylaxis
Adult: As fluticasone propionate powd or aerosol inhaler: 100 mcg bid in mild asthma, up to 500-1,000 mcg bid in severe cases.
Child: 4-16 yr As fluticasone propionate powd or aerosol inhaler: 50-100 mcg bid, increased to 200 mcg bid if necessary.
Child Dose
Inhalation
Asthma prophylaxis
Child: 4-16 yr As fluticasone propionate powd or aerosol inhaler: 50-100 mcg bid, increased to 200 mcg bid if necessary.
<4 years: Safety and efficacy not established
Renal Dose
Administration
Prime inhaler (4 actuations into air) before first use and after prolonged (>7 days) idleness
Valve holding chamber and face mask may be used for younger patients
Contra Indications
Hypersensitivity to drug, components or milk proteins, which may result in anaphylaxis, angioedema, rash, and urticaria.
Primary treatment of status asthmaticus, acute bronchospasm.
Precautions
Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex; care must be taken to avoid exposure
Nasal septum perforation, epistaxis, wheezing
Cataracts, glaucoma, increased intraocular pressure may occur; monitor for glaucoma and cataracts
Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure
Hypercorticism and adrenal suppression may occur with high dosages or at regular dosage in susceptible individuals; if such changes occur, taper withdrawal gradually
May decrease growth velocity in children; monitor growth of pediatric patients
Assess for decrease in bone mineral density initially and periodically thereafter
Use with caution in immunocompromised patients
Prolonged use of corticosteroids may increase incidence of secondary infection
Risk of infections of nose and pharynx, including Candida albicans; must rinse mouth after inhalation to reduce risk
Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress
During periods of stress or severe status asthmaticus, supplementary systemic corticosteroids may be immediately required; patient should carry warning card indicating possible need for supplementary systemic steroids in such emergencies
Lactation: Fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low; concentrations in human breast milk are likely to be correspondingly low; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or from underlying maternal condition
Pregnancy-Lactation
Interactions
Adverse Effects
Side effects of Fluticasone Propionate Inhalation :
>10%
Oral candidiasis (<31%),Throat irritation (3-22%),Upper respiratory tract infection (16-18%),Fatigue or malaise (16%),Nasal congestion (16%),Rhinitis (<13%),Musculoskeletal pain (2-12%),Headache (5-11%)
1-10%
Nasal congestion (8%),Sinusitis or sinus infection (4-7%),Cough (4-6%),Bronchitis (2-6%),Hoarseness or dysphonia (2-6%),Allergic rhinitis (5%),Nasal discharge (5%),Upper respiratory inflammation (2-5%),Muscle injury (<5%),Gastrointestinal (GI) discomfort or pain (1-4%)
Frequency Not Defined
Hypersensitivity reactions (including anaphylaxis, angioedema, rash, urticaria)
Respiratory: Rhinitis, rhinorrhea or postnasal drip, nasal sinus disorders, laryngitis
GI: Diarrhea, loss of taste, viral infections, dyspeptic symptoms, discomfort, pain, hyposalivation
Muscular: Musculoskeletal pain, stiffness, tightness, rigidity, injuries, soreness
Other: Dizziness, migraine, fever, viral infection, pain, chest symptoms, viral skin infections, soft tissue injuries, urinary infections
Mechanism of Action
Fluticasone utilises a fluorocarbothioate ester linkage at the 17 carbon position. It has potent vasoconstrictive and anti-inflammatory activity, but weak hypothalamic-pituitary-adrenal (HPA) inhibitory effect when applied topically. Fluticasone shown to exhibit anti-inflammatory effect on neutrophils, eosinophils, macrophages, mast cells, lymphocytes, and mediators (histamine, leukotrienes, cytokines, eicosanoids)
Note
Flohale 0.5mg Rotacaps manufactured by Cipla Ltd.. Its generic name is Fluticasone Propionate Inhalation. Flohale is availble in Nepal.
Farmaco Nepal drug index information on Flohale Rotacaps is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.