Formoterol fumarate dihydrate

Formoterol Fumarate Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1 ) Important limitations of use: Formoterol Fumarate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) Formoterol Fumarate Inhalation Solution is not indicated to treat asthma. …

• The recommended dose of Formoterol Fumarate Inhalation Solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization
• A total daily dose greater than 40 mcg is not recommended
• Formoterol Fumarate Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor
• The safety and efficacy of Formoterol Fumarate Inhalation Solution have been established in clinical trials when administered using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) and the PRONEB® Ultra compressor
• The safety and efficacy of Formoterol Fumarate Inhalation Solution delivered from non-compressor based nebulizer systems have not been established
• Formoterol Fumarate Inhalation Solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE
• Contents of any partially used container should be discarded
• 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 re-evaluated and additional therapeutic options should be considered
• The drug compatibility (physical and chemical), efficacy, and safety of Formoterol Fumarate Inhalation Solution when mixed with other drugs in a nebulizer have not been established
• For oral inhalation only
• One 20 mcg/2 mL vial every 12 hours For use with a standard jet nebulizer (with a facemask or mouthpiece) connected to an air compressor

Formoterol Fumarate Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each vial contains formoterol fumarate dihydrate, USP equivalent to 20 mcg/2 mL of formoterol fumarate. Inhalation Solution (unit dose vial for nebulization); 20 mcg/2 mL solution ( 3 )

• Formoterol Fumarate Inhalation Solution is not indicated for use in children
• The safety and effectiveness of Formoterol Fumarate Inhalation Solution
• In pediatric patients have not been established
• The pharmacokinetics of formoterol fumarate has not been studied
• In pediatric patients

Of the 586 subjects who received Formoterol Fumarate Inhalation Solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. Of the 123 subjects who received Formoterol Fumarate Inhalation Solution in the 12-week safety and efficacy trial, 48 (39%) were 65 years of age or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Serious Asthma-Related Events Inform patients that long-acting beta agonist, such as Formoterol Fumarate Inhalation Solution, when used as monotherapy [without an inhaled corticosteroid], increase the risk of serious asthma-related events, including asthma-related death
• Formoterol Fumarate Inhalation Solution is not indicated
• For the treatment of asthma
• Acute Exacerbations or Deteriorations Formoterol Fumarate Inhalation Solution is not indicated for relief of acute symptoms, and extra doses should not be used for that purpose. …

• Use of a LABA, including Formoterol Fumarate Inhalation Solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS ]
• Formoterol Fumarate Inhalation Solution is not indicated
• For the treatment of asthma
• Use of a LABA, including Formoterol Fumarate Inhalation Solution, without an inhaled corticosteroid is contraindicated in patients with asthma

Other adrenergic drugs may potentiate effect. Use with caution. ( 5.3 , 7.1 ) Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 5.7 , 7.2 , 7.3 ) MAO inhibitors, tricyclic antidepressants and drugs that prolong QTc interval may potentiate effect on the cardiovascular system. Use with extreme caution. ( 7.4 ) Beta-blockers may decrease effectiveness. Use with caution and only when medically necessary. …

LABA as monotherapy (without inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) Do not initiate Formoterol Fumarate Inhalation Solution in acutely deteriorating patients. ( 5.2 ) Do not use for relief of acute symptoms. Concomitant short-acting beta 2 -agonists can be used as needed for acute relief. ( 5.2 ) Do not exceed the recommended dose. Excessive use of Formoterol Fumarate Inhalation Solution or use in conjunction with other medications containing long-acting beta 2 -agonists, can result in clinically significant cardiovascular effects, and may be fatal. ( 5.3 , 5.5 ) Life-threatening paradoxical bronchospasm can occur. …

Long-acting beta 2 -adrenergic agonists, such as Formoterol Fumarate Inhalation Solution, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events. Formoterol Fumarate Inhalation Solution is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS (5.1) ] . Most common adverse reactions ( > 2% and more common than placebo) are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Ritedose Pharmaceuticals, LLC at 1-855-806-3300 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary There are limited available data with Formoterol Fumarate Inhalation Solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Beta-agonists may interfere with uterine contractility (see Clinical Considerations ) . …

The expected signs and symptoms with overdosage of Formoterol Fumarate Inhalation Solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under ADVERSE REACTIONS . Signs and symptoms may include angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, and metabolic acidosis. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.