M inhaler is indicated for the regular maintenance treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting ?2-agonist) is appropriate. This includes patients not adequately controlled with inhaled corticosteroids and inhaled short-acting ?2-agonist on an ?as required? basis.
This inhaler (a pressurised inhalation, suspension) which contains two active ingredients:
Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs.
Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta 2 agonists. Long-acting beta 2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe.
Together these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your doctor or asthma nurse.
This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack i.e. you are already breathless and wheezing. You will need to use a fast acting ‘reliever’ medicine such as salbutamol if this happens.
it inhaler is for administration by the inhaled route in patients with asthma from the age of 12 years and older. it inhaler is delivered by a press-and-breathe pressurised metered dose inhaler (pMDI) which also contains an integrated dose indicator. Each inhaler will provide at least 120 actuations (60 doses).The long-term efficacy of the highest dose of 500/20 micrograms (2 actuations of 250/10 micrograms) twice daily has not been evaluated.Recommended dose for adults and children aged 12 years and above Two inhalations of it inhaler 50/5 micrograms or it inhaler 125/5 micrograms twice daily. If the patient?s asthma remains poorly controlled on it inhaler 50/5 it ? PRESSURISED METERED DOSE INHALER Page 3 of 27 micrograms, the total daily dose of the inhaled corticosteroid can be increased by administering the next highest strength combination product, i.e. it inhaler 125/5 micrograms, two puffs twice daily. Recommended dose for adults only Two inhalations of it inhaler 250/10 micrograms twice daily. If the patient?s asthma remains poorly controlled on it inhaler 125/5 micrograms, the total daily dose can be increased by administering the next highest strength combination product, i.e. it inhaler 250/10 micrograms, two puffs twice daily. Children Under 12 Years it inhaler is not recommended for children under 12 years Patients currently receiving medium to high doses of inhaled corticosteroids For patients who are currently receiving medium to high doses of inhaled corticosteroid therapy, and whose disease severity clearly warrants treatment with two maintenance therapies, the recommended starting dose is two inhalations twice daily of it inhaler 125/5 micrograms.
No formal drug interaction studies have been performed with this inhaler. Fluticasone Propionate, an individual component of this inhaler, is a substrate of CYP 3A4. The effects of short-term co-administration of strong CYP 3A4 inhibitors (e.g. Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Ketoconazole, Telithromycin) together with this inhaler is of minor clinical relevance, but caution needs to be taken in long-term treatment and co-administration with such drugs should be avoided if possible.
This inhaler is contraindicated in patients with hypersensitivity to any of the active substances or to the excipients.
Hyperglycemia,headache,tremor,dizziness,dysgeusia,palpitation,dysphonia,,throat irritation,dry mouth,peripheral oedema
Pregnancy Category B3 There are no adequate and well-controlled studies with it inhaler in pregnant or breastfeeding women. There are only limited data in pregnant women on the use of it inhaler, and on the use of fluticasone propionate inhaler and eformoterol fumarate inhaler, administered alone or together. Studies in animals have shown reproductive toxicity. In pregnant rabbits, treatment with fluticasone propionate and eformoterol fumarate in combination by inhalation during the period of organogenesis (doses of 2/0.2 to 40/4 micrograms/kg/day fluticasone propionate/eformoterol fumarate) caused serious adverse effects on embryofetal development including increased post-implantation loss and malformations (cleft palate). These occurred in the absence of maternotoxicity and at doses yielding exposure to the two drugs (plasma and AUC) less than that expected in patients at MRHD. Decreased fetal weight and increased incidences of fetal skeletal variations and retarded ossification were observed in a corresponding study in rats in which treatment (doses up to 160/16 micrograms/kg/day fluticasone propionate/eformoterol fumarate) yielded drug exposure up to four times (fluticasone propionate) or six times (eformoterol fumarate) the clinical AUC at the MRHD. These findings are compatible with those of previous studies conducted with the individual drugs. Corticosteroids are known to induce fetotoxicity and teratogenicity in animals, but these results may not be relevant to human therapy. Administration of it inhaler is not recommended during pregnancy, and should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Because of the potential for beta-agonist interference with uterine contractility, use of it inhaler for the management of asthma during labour should be restricted to those patients in whom the benefit outweighs the risks, and the lowest effective dose to maintain adequate asthma control should be used. Use in lactation It is not known whether fluticasone propionate or eformoterol fumarate, or their metabolites, are excreted in human breast milk. Such excretion has been demonstrated for both drugs in lactating rats. In addition, growth and survival of pups were found to be decreased when lactating rats were given eformoterol fumarate at oral doses greater than 1 mg/kg/day. A risk to the suckling child cannot be excluded. Therefore, the administration of it to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
There are no data available from clinical trials on overdose with this inhaler, however, data on overdose with both single drugs are given below:
Formoterol Fumarate: An overdose of Formoterol would likely lead to an exaggeration of effects that are typical for ß2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.
Fluticasone Propionate: Acute overdose with Fluticasone Propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.
Store in a cool and dry place, protected from light.
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