Flutide Inhaler (250mcg+10mcg)/Puff

Product Information

FLUTIDE HFA

Flutide® HFA

Fluticasone Propionate & Formoterol Fumarate Dihydrate

Presentation

Flutide 125/5 HFA: Each metered dose actuation delivers Fluticasone Propionate BP 125 micrograms and Formoterol Fumarate Dihydrate

BP 5 micrograms.

Flutide 250/10 HFA: Each metered dose actuation delivers Fluticasone Propionate BP 250 micrograms and FormoterolFumarateDihydrate

BP 10 micrograms.

Indications

Asthma: This fixed-dose combination of Fluticasone Propionate and FormoterolFumarate (Flutide inhaler) is indicated in the regular

treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting ß2 agonist) is

appropriate:

* For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting ß2 agonist. Or,

* For patients already adequately controlled on both an inhaled corticosteroid and a long-acting ß2 agonist.

Flutide 125 microgram /5 microgram inhaler are indicated in adults and adolescents aged 12 years and above.

COPD: Flutide is recommended when a long-acting ß2 agonist/Inhaled corticosteroid is indicated & patients are unable to use other

long-acting ß2 agonist/Inhaled corticosteroid.

Flutide 250 microgram /10 microgram inhaler is indicated in adults only.

Dosage and administration

Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that

the strength of Flutide inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be

titrated to the lowest dose at which effective control of symptoms is maintained.

Patients should be given the strength of Flutide inhaler containing the appropriate Fluticasone Propionate dosage for the severity

of their disease.

Asthma: Flutide 125 microgram/5 microgram inhaler – only

Recommended dose for adults and adolescents aged 12 years and above: Flutide 125 microgram/5 microgram inhaler – two inhalations

(puffs) twice daily normally taken in the morning and in the evening.

For adults only: The total daily dose can be further increased if asthma still remains poorly controlled by administering the

highest strength of this combination product – i.e. Flutide 250 microgram/10 microgram inhaler – two inhalations (puffs) twice

daily. This highest strength is for use in adults only; it should not be used in adolescents aged 12 years and above.

Children under 12 years: No data are available for this strength of Flutide inhaler in children.

Flutide inhaler in any strength is not recommended for use in children less than 12 years of age.

Flutide 250 microgram/10 microgram inhaler – only

Recommended dose for adults: Flutide 250 microgram/10 microgram inhaler – two inhalations (puffs) twice daily normally taken in

the morning and in the evening.

Adolescents under 18 years and children: No data are available for this strength of Flutide inhaler in children or adolescents.

Flutide inhaler in any strength is not recommended for use in children less than 12 years of age.

Flutide inhaler 250 microgram/10 microgram per actuation should not be used in adolescents.

COPD: Flutide 250 microgram/10 microgram inhaler

Flutide 250 microgram/10 microgram, two inhalations (puffs) twice daily normally taken in the morning and in the evening.

Flutide inhaler – all strengths

Special patient groups: There is no need to adjust the dose in elderly patients.

There are no data available for use of Flutide inhaler in patients with hepatic or renal impairment.

Contra-indications, warnings, etc.

Contra-indications: Flutide inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting

bronchodilator is required. Patients should be advised to have their medicine to be used for relief in an acute asthma attack

available at all times.

The prophylactic use of Flutide inhaler in exercise-induced asthma has not been studied. For such use, a separate rapid-acting

bronchodilator should be considered. Patients should be reminded to take their Flutide inhaler maintenance dose as prescribed,

even when asymptomatic. Patients should not be initiated on Flutide inhaler during an exacerbation, or if they have significantly

worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with

Flutide inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled

or worsen after initiation on Flutide inhaler.

Flutide inhaler should not be used as the first treatment for asthma.

Flutide inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients

with fungal, viral or other infections of the airway. Flutide inhaler should be used with caution in patients with thyrotoxicosis,

phaeochromocytoma, diabetes mellitus, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium,

hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe

cardiovascular disorders, such as ischaemic heart disease, cardiac arrhythmias or severe heart failure. Caution must be observed

when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc

interval.

As for all ß2 agonists, additional blood sugar controls should be considered in diabetic patients. As with other inhalation

therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Flutide

inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects

are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid

features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract glaucoma

and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety,

depression or aggression (particularly in children). It is important, therefore, that the patient is reviewed regularly and the

dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

Paediatric population: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is

regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid,

if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to

referring the patient to a paediatric respiratory specialist.

Only limited data are available in respect of the use of Flutide inhaler in children under 12 years of age. Flutide inhaler is not

recommended for use in children under 12 years of age until further data become available.

Drug interaction: No formal drug interaction studies have been performed with Flutide inhaler. Fluticasone Propionate, an

individual component of Flutide 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 Flutide 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.

The ECG changes and/or hypokalaemia that may result from the administration of non-potassium sparing diuretics (such as loop or

thiazide diuretics) can be acutely worsened by ß agonists, especially when the recommended dose of the ß agonist is exceeded.

Although the clinical significance of these effects is not known, caution is advised in the co-administration of a ß agonist with

non-potassium sparing diuretics. Xanthine derivates and glucocorticosteroids may add to a possible hypokalaemic effect of the ß

agonists. In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards ß2 sympathomimetics.

Concomitant treatment with monoamine oxidase inhibitors, including agents with similar properties such as Furazolidone and

Procarbazine, may precipitate hypertensive reactions. FormoterolFumarate, as with other ß2 agonists, should be administered with

caution to patients being treated with tricyclic antidepressants or monoamine oxidase inhibitors, and during the immediate two

week period following their discontinuation, or other drugs known to prolong the QTc interval such as antipsychotics (including

Phenothiazines), Quinidine, Disopyramide, Procainamide, and antihistamines. Drugs that are known to prolong the QTc interval can

increase the risk of ventricular arrhythmias.

Beta adrenergic receptor antagonists (ß blockers) and FormoterolFumarate may inhibit the effect of each other when administered

concurrently. Beta blockers may also produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not

normally be treated with ß blockers and this includes ß blockers used as eye drops for treatment of glaucoma. However, under

certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of ß

blockers in patients with asthma. In this setting, cardioselective ß blockers could be considered, although they should be

administered with caution.

Fertility, pregnancy and lactation: Pregnancy: There are limited data on the use of Fluticasone Propionate and FormoterolFumarate,

either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination,

Flutide inhaler in pregnant women. Studies in animals have shown reproductive toxicity. Administration of Flutide inhaler is not

recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to

the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used.

Breastfeeding: It is not known whether Fluticasone Propionate or FormoterolFumarateare excreted in human breast milk. Therefore, a

decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Flutide inhaler therapy taking into

account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility: There are no data available on effects on fertility following administration of Flutide inhaler. In animal studies, no

effects on fertility have been seen following administration of the individual active substances at clinically relevant doses.

Undesirable effects: Undesirable effects which have been associated with Flutide inhaler during clinical development are given in

the table below, listed by system organ class. The following frequency categories form the basis for classification of the

undesirable effects as: very common (=1/10), common (=1/100 and <1/10), uncommon (=1/1,000 and <1/100), rare (=1/10,000 <

1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping,

undesirable effects are presented in order of decreasing seriousness.

Flutide Box [https://unimedunihealth.com/wp-content/uploads/2017/05/Flutide-Box-123x300.jpg]

[https://unimedunihealth.com/wp-content/uploads/2017/05/Flutide-Box.jpg]

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of

breath after dosing. Since Flutide inhaler contains both Fluticasone Propionate and FormoterolFumarate, the same pattern of

undesirable effects as reported for these substances may occur. In the unlikely event of a hypersensitivity reaction to Flutide

inhaler, treatment should be initiated in accordance with standard treatment for any other hypersensitivity reaction, which may

include the use of antihistamines and other treatment as required. Flutide inhaler may need to be discontinued immediately and an

alternative asthma therapy may need to be initiated if necessary. Dysphonia and candidiasis may be relieved by gargling or rinsing

the mouth with water or brushing the teeth after using the product. Symptomatic candidiasis can be treated with topical

anti-fungal therapy whilst continuing the treatment with Flutide inhaler.

Overdose: There are no data available from clinical trials on overdose with Flutideinhaler, however, data on overdose with both

single drugs are given below:

FormoterolFumarate: 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.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Flutide 125/5 HFA: Each canister contains 120 metered dose.

Flutide  250/10 HFA: Each canister contains 120 metered dose.

Manufactured by

UniMed&UniHealth Manufacturers Ltd.

B K Bari, Gazipur, Bangladesh

® Registered Trademark