Asthma: 1-2 puffs every 4-6 hours as needed. Maximum: 12 inhalations/day.
Prophylaxis of exercise-induced bronchospasm:
MDI: 2 puffs 5-30 minutes prior to exercise.
Nebulized 2.5 mg 3-4 times daily.
Tablets: 2-4 mg orally 3-4 times daily.
Sustained release tablets: 4-8 mg q12h (Maximum dose: 32 mg/day).
Acute treatment of bronchospasm:
MDI (90 mcg/puff): 4-8 puffs every 20 minutes for up to 4 hours, then every 1-4 hours as needed.
Nebulization: 2.5 mg (3ml) 3-4 times/day over 5-15 minutes.
Bronchospasm in ICU patients (acute): Nebulization: 2.5-5 mg every 20 minutes for 3 doses, then 2.5-10 mg every 1-4 hours as needed, or 10-15 mg/hour continuously.
Bronchospasm, acute: MDI 2 puffs separated by 1-3 minutes, follow with third as needed.
Bronchospasm, prevention: MDI, 2 puffs q8h, Maximum of 3 puffs q6h or 2 puffs q4h.
Bronchospasm, prevention: (intermittent flow nebulizer) 0.5-1 ml (1-2 mg) 3-4 times per day (Maximum of 8 mg/day). (continuous flow nebulizer) 1.25 ml (2.5 mg) 3-4 times/day. (Maximum of 14 mg/day).
Supplied [0.8% aerosol. 0.2% (2 mg/ml) inhalation Soln].
Bronchospasm: MDI: Aerosol: 1-2 puffs every 4-6 hours.
Nebulization: 0.63 mg 3 times/day at intervals of 6-8 hours. Dosage may be increased to 1.25 mg 3 times/day with close monitoring for adverse effects. Most patients gain optimal benefit from regular use.
|Levalbuterol (R-enantiomer of albuterol) has approximately 2-fold greater binding affinity compared to racemic albuterol, and approximately 100-fold greater binding affinity than S-albuterol. (Bronchodilatory effects of racemic albuterol are due to R-albuterol).|
Asthma, bronchospasm: 20 mg orally 3-4 times/day.
Oral aerosol inhalation: 2-3 puffs q3-4 hours (Max of 12 puffs/day).
Nebulizer: 0.3 ml (5%) in 2.5 ml NS q4-6 hours prn.
INDICATIONS AND USAGE
Maintenance Treatment of COPD
BROVANA (arformoterol tartrate) Inhalation Solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA Inhalation Solution is for use by nebulization only.
Important Limitations of Use
BROVANA Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2)].
BROVANA Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of BROVANA Inhalation Solution in asthma have not been established.
DOSAGE AND ADMINISTRATION
The recommended dose of BROVANA (arformoterol tartrate) Inhalation Solution is one 15 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose of greater than 30 mcg (15 mcg twice daily) is not recommended.
BROVANA Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor (see the accompanying Medication Guide). BROVANA Inhalation Solution should not be swallowed. BROVANA Inhalation Solution should be stored refrigerated in foil pouches. After opening the pouch, unused unit-dose vials should be returned to, and stored in, the pouch. An opened unit-dose vial should be used right away.
If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be reevaluated and additional therapeutic options should be considered.
No dose adjustment is required for patients with renal or hepatic impairment. However, since the clearance of BROVANA Inhalation Solution is prolonged in patients with hepatic impairment, they should be monitored closely.
The drug compatibility (physical and chemical), efficacy, and safety of BROVANA Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
The safety and efficacy of BROVANA Inhalation Solution have been established in clinical trials when administered using the PARI LC® Plus nebulizer (with a face mask or mouthpiece) and the PARI DURA NEB™ 3000 compressor. The safety and efficacy of BROVANA Inhalation Solution delivered from non-compressor based nebulizer systems have not been established.
DOSAGE FORMS AND STRENGTHS
BROVANA (arformoterol tartrate) Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each 2 mL vial contains 15 mcg of arformoterol equivalent to 22 mcg of arformoterol tartrate.
(Long-acting Beta-2 agonist):
Asthma (maintenance therapy): Oral inhalation – 12 mcg (1 capsule) q12h via aerolizer inhaler. (Maximum of 24 mcg/day).
COPD: Oral inhalation 12 mcg (1 capsule) q12h via aerolizer inhaler.
Exercise-induced bronchospasm (EIB): 12 mcg (1 capsule) at least 15 min before exercise as needed.
Supplied: [12 mcg capsule]
ARCAPTA NEOHALER consists of a dry powder formulation of indacaterol maleate for oral inhalation only with the NEOHALER inhaler. The inhalation powder is packaged in clear gelatin capsules.
Each clear, hard gelatin capsule contains a dry powder blend of 75 mcg of indacaterol (equivalent to 97 mcg of indacaterol maleate) with approximately 25 mg of lactose monohydrate (which contains trace levels of milk protein) as the carrier.
The active component of ARCAPTA NEOHALER is indacaterol maleate, a (R) enantiomer. Indacaterol maleate is a selective beta2-adrenergic agonist.
INDICATIONS AND USAGE
ARCAPTA NEOHALER is a long-acting beta2-adrenergic agonist indicated for:
The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
-ARCAPTA NEOHALER is NOT indicated to treat acute deteriorations of chronic obstructive pulmonary disease.
-ARCAPTA NEOHALER is NOT indicated for asthma.
DOSAGE AND ADMINISTRATION
DO NOT SWALLOW ARCAPTA CAPSULES
FOR USE WITH NEOHALER DEVICE ONLY
FOR ORAL INHALATION ONLY
ARCAPTA capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of ARCAPTA capsules are only for oral inhalation and should only be used with the NEOHALER device.
The recommended dosage of ARCAPTA NEOHALER is the once-daily inhalation of the contents of one 75 mcg ARCAPTA capsule using the NEOHALER inhaler.
ARCAPTA NEOHALER should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use ARCAPTA NEOHALER more than one time every 24 hours.
ARCAPTA capsules must always be stored in the blister, and only removed IMMEDIATELY BEFORE USE.
No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data is available for subjects with severe hepatic impairment
75 mcg ARCAPTA NEOHALER contains ARCAPTA (indacaterol inhalation powder) capsules packaged in aluminum blister cards, one NEOHALER inhaler, and an FDA approved Medication Guide.
Unit Dose (blister pack), Box of 30 (5 blister cards with 6 capsules each) NDC 0078-0619-15
The NEOHALER inhaler consists of a white protective cap and a base with mouthpiece, capsule chamber and two translucent red push buttons.
Storage and Handling
Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature].
75 mcg: Protect capsule from light and moisture.
ARCAPTA capsules should be used with the NEOHALER inhaler only. The NEOHALER inhaler should not be used with any other capsules.
Capsules should always be stored in the blister and only removed from the blister immediately before use.
Always use the new NEOHALER inhaler provided with each new prescription.
Initial U.S. Approval: 2014
Mechanism of Action: Olodaterol is a long-acting beta2-adrenergic agonist (LABA). The compound exerts its pharmacological effects by binding and activation of beta2-adrenoceptors after topical administration by inhalation. Activation of these receptors in the airways results in a stimulation of intracellular adenyl cyclase, an enzyme that mediates the synthesis of cyclic-3’, 5’ adenosine monophosphate (cAMP). Elevated levels of cAMP induce bronchodilation by relaxation of airway smooth muscle cells. In vitro studies have shown that olodaterol has 241-fold greater agonist activity at beta2-adrenoceptors compared to beta1-adrenoceptors and 2,299-fold greater agonist activity compared to beta3-adrenoceptors. The clinical significance of these findings is unknown.
Beta-adrenoceptors are divided into three subtypes: beta1-adrenoceptors predominantly expressed on cardiac smooth muscle, beta2-adrenoceptors predominantly expressed on airway smooth muscle, and beta3-adrenoceptors predominantly expressed on adipose tissue. Beta2-agonists cause bronchodilation. Although the beta2-adrenoceptor is the predominant adrenergic receptor in the airway smooth muscle, it is also present on the surface of a variety of other cells, including lung epithelial and endothelial cells and in the heart. The precise function of beta2-receptors in the heart is not known, but their presence raises the possibility that even highly selective beta2-agonists may have cardiac effects.
INDICATIONS AND USAGE:
1.1 Maintenance Treatment of COPD
STRIVERDI RESPIMAT is a long-acting beta2-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
1.2 Important Limitations of Use
STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD [see Warnings and Precautions (5.2)].
STRIVERDI RESPIMAT is not indicated to treat asthma. The safety and effectiveness of STRIVERDI RESPIMAT in asthma have not been established.
HOW SUPPLIED: STRIVERDI RESPIMAT consists of a STRIVERDI RESPIMAT inhaler and an aluminum cylinder (STRIVERDI RESPIMAT cartridge) containing olodaterol (as the hydrochloride). The STRIVERDI RESPIMAT cartridge is intended for use with the STRIVERDI RESPIMAT inhaler only.
Each actuation from the STRIVERDI RESPIMAT inhaler delivers 2.7 mcg olodaterol hydrochloride, equivalent to 2.5 mcg olodaterol. Two actuations equal one dose.
Asthma: usual dosage for adults and children 4 years of age and older is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart). If symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief.
COPD: usual dosage for adults is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart).
Prevention of Exercise-Induced Bronchospasm (EIB): One inhalation at least 30 minutes before exercise. Additional doses should not be used for 12 hours after the administration of this drug. If regular, twice-daily dosing is not effective in preventing EIB, other appropriate therapy for EIB should be considered.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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