Flutiform Dosage/Direction for Use

Posology: 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 Flutiform 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. Once control of asthma is achieved with the lowest strength of Flutiform inhaler administered twice daily treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. As a general principle the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Regular review of patients as treatment is stepped down is extremely important.
There are no data available for use of Flutiform inhaler in patients with COPD. Flutiform inhaler should not be used in patients with COPD.
Patients should be given the strength of Flutiform inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease. Note: Flutiform 50 microgram/5 microgram per actuation, strength is not appropriate in adults and adolescents with severe asthma. Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily dose (in micrograms). If an individual patient should require doses outside the recommended dose regimens, appropriate doses of the β₂ agonist and the inhaled corticosteroid in separate inhalers, or appropriate doses of the inhaled corticosteroid alone, should be prescribed.
Flutiform 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).
Flutiform 50 microgram/5 microgram inhaler - only: Recommended dose for adults, adolescents and children aged 5 years and above: Flutiform 50 microgram/5 microgram inhaler - two inhalations (puffs) twice daily normally taken in the morning and in the evening.
For adults and adolescents: If the patient's asthma remains poorly controlled the total daily dose of the inhaled corticosteroid can be increased by administering a higher strength of this combination product - i.e. Flutiform 125 microgram/5 microgram inhaler - two inhalations (puffs) twice daily. This strength should not be used in children under the age of 12 years.
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. Flutiform 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 and children.
Children under 5 years: Experience in children under the age of 5 years is limited (see Use in Children under Precautions, Paediatric population under Adverse Reactions, Pharmacology: Pharmacodynamics: Paediatric population under Actions, Pharmacology: Toxicology: Preclinical safety data under Actions). Flutiform inhaler in any strength is not recommended for use in children less than 5 years of age; Flutiform inhaler should not be used in this young age group.
Flutiform 125 microgram/5 microgram inhaler - only: Recommended dose for adults and adolescents aged 12 years and above: Flutiform 125 microgram/5 microgram inhaler - two inhalations (puffs) twice daily normally taken in the morning and in the evening.
Patients may be transferred to the lowest strength of this combination product i.e. Flutiform 50 microgram/5 microgram inhaler if their asthma is adequately controlled. A patient's dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
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. Flutiform 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 Flutiform inhaler in children. Experience in children under the age of 12 years is limited to the lowest strength (50microgram/5 microgram) (see Use in Children under Precautions, Paediatric population under Adverse Reactions, Pharmacology: Pharmacodynamics: Paediatric population under Actions, Pharmacology: Toxicology: Preclinical safety data under Actions). Flutiform inhaler in this strength (125microgram/5 microgram) is not recommended for use in children less than 12 years of age; Flutiform inhaler 125 microgram/5 microgram per actuation should not be used in this young age group.
Flutiform 250 microgram/10 microgram inhaler - only: Recommended dose for adults: Flutiform 250 microgram /10 microgram inhaler - two inhalations (puffs) twice daily normally taken in the morning and in the evening.
Patients may be transferred to a lower strength of this combination product i.e. Flutiform 125 microgram/5 microgram inhaler or ultimately Flutiform 50 microgram/5 microgram inhaler if their asthma is adequately controlled. A patient's dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Adolescents under 18 years and children: No data are available for this strength of Flutiform inhaler in children or adolescents. Experience in children is limited to the lowest strength (50 microgram/5 microgram) (see Use in Children under Precautions, Paediatric population under Adverse Reactions, Pharmacology: Pharmacodynamics: Paediatric population under Actions, Pharmacology: Toxicology: Preclinical safety data under Actions). Flutiform inhaler in this strength (250 microgram/10 microgram) is not recommended for use in adolescents or children; Flutiform inhaler 250 microgram/10 microgram per actuation should not be used in this young age group.
Flutiform inhaler 250 microgram/10 microgram per actuation should not be used in adolescents or children. However there are lower strengths available i.e. 50 microgram/5 microgram per actuation which may be used in children or adolescents or 125 microgram/5 microgram per actuation which may be used in adolescents.
Flutiform 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 Flutiform inhaler in patients with hepatic or renal impairment (see Pharmacology: Pharmacokinetics under Actions). These patients should be regularly monitored by a physician to ensure titration to the lowest dose at which effective control of symptoms is maintained. As the fractions of fluticasone and formoterol which reach systemic circulation are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe hepatic impairment.
General information: Inhaled corticosteroids alone are the first line of treatment for most patients. Flutiform inhaler is not intended for the initial treatment of mild asthma. For patients with severe asthma the inhaled corticosteroid therapy should be established before prescribing a fixed-dose combination product.
Patients should be made aware that Flutiform inhaler must be used daily for optimum benefit, even when asymptomatic.
Patients using Flutiform inhaler should not use additional long-acting β₂ agonists for any reason. If asthma symptoms arise in the period between doses, an inhaled, short-acting β₂ agonist should be taken for immediate relief.
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 Flutiform 125 microgram/5 microgram inhaler.
Use of a spacer device with Flutiform inhaler is recommended in patients who find it difficult to synchronise aerosol actuation with inspiration of breath. The AeroChamber Plus Flow-Vu is the recommended spacer device.
Patients should be instructed in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs.
Re-titration to the lowest effective dose should always follow the introduction of a spacer device.
Method of administration: For inhalation use.