Neumoterol Dosage/Direction for Use

Route of administration: For inhalation use.
Dosage: Budesonide + Formoterol (Neumoterol) is not intended for the initial management of asthma. The dosage of the components of Budesonide + Formoterol (Neumoterol) is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β₂ adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Patients should be regularly reassessed by their prescriber/health care provider so that the dosage of Budesonide + Formoterol (Neumoterol) remains optimal. When long-term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
For Budesonide + Formoterol (Neumoterol) there are two treatment approaches: Budesonide + Formoterol (Neumoterol) maintenance therapy: Budesonide + Formoterol (Neumoterol) is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue.
Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Recommended doses: Adults (18 years and older): 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily.
Adolescents (12-17 years): 1-2 inhalations twice daily.
In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include Neumoterol given once daily, when in the opinion of the prescriber, a long-acting bronchodilator would be required to maintain control.
Increasing use of a separate rapid acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Children under 12 years: As only limited data are available, Budesonide + Formoterol (Neumoterol) is not recommended for children younger than 12 years.
Budesonide + Formoterol (Neumoterol) maintenance and reliever therapy: Budesonide + Formoterol (Neumoterol) is taken as regular maintenance treatment and as needed in response to symptoms.
Patients take a daily maintenance dose of Budesonide + Formoterol (Neumoterol) and in addition take Budesonide + Formoterol (Neumoterol) as needed in response to symptoms. Patients should be advised to always have Budesonide + Formoterol (Neumoterol) available for rescue use.
Budesonide + Formoterol (Neumoterol) maintenance and reliever therapy should especially be considered for patients with: inadequate asthma control and in frequent need of reliever medication; asthma exacerbations in the past requiring medical intervention.
Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Budesonide + Formoterol (Neumoterol) as-needed inhalations.
Recommended doses: Adults (18 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion.
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered.
Children and adolescents under 18 years: Budesonide + Formoterol (Neumoterol) maintenance and reliever therapy is not recommended for children and adolescents.
General Information: Special patient groups: There are no special dosing requirements for elderly patients. There are no data available for use of Budesonide + Formoterol (Neumoterol) in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.
Method of administration: Instructions for correct use of Budesonide + Formoterol (Neumoterol): Patients should be instructed to use Budesonide + Formoterol (Neumoterol) even when they are asymptomatic in order to get the maximum benefit from therapy.
Follow the instructions under Patient Counselling Information to learn how to use Budesonide + Formoterol (Neumoterol) with the inhaler. The budesonide and formoterol capsules must be used only with the inhaler provided in the package. This inhaler was created especially for use with the budesonide and formoterol capsules.
The capsules should only be removed from the bottle and handled immediately prior to use, so that they do not suffer any effects of moisture from hands or the environment.
Make sure that the hands are completely dry so that the capsule does not get wet.
Warning: Do not swallow the capsules. Use the powder of the capsule only for inhalation.