Olodaterol

What is Olodaterol?

• Olodaterol (STRIVERDI RESPIMAT) Inhalation Spray is a long-acting beta2-adrenergic agonist (LABA) used for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

What are the uses of this medicine?

This medicine is 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.

Limitation of Use

• STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD.
• STRIVERDI RESPIMAT is not indicated to treat asthma. The safety and effectiveness of STRIVERDI RESPIMAT in asthma have not been established.

How does this medicine work?

• 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.
• ABA medicines such as STRIVERDI RESPIMAT help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.

Who Should Not Use this medicine ?

• Use of a LABA, including STRIVERDI RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma.
• STRIVERDI RESPIMAT is not indicated for the treatment of asthma.

What drug interactions can this medicine cause?

• Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of STRIVERDI RESPIMAT.
• Caution is advised in the co-administration of beta-agonists with non-potassium-sparing diuretics.
• STRIVERDI RESPIMAT, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval.
• Beta-adrenergic receptor antagonists (beta-blockers) and STRIVERDI RESPIMAT may interfere with the effect of each other when administered concurrently.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage:

• The recommended dose of STRIVERDI RESPIMAT is two inhalations once-daily at the same time of the day. Do not use STRIVERDI RESPIMAT more than two inhalations every 24 hours.

Administration

• Do not use STRIVERDI RESPIMAT unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. Ask your healthcare provider or pharmacist if you have any questions.
• The STRIVERDI RESPIMAT inhaler has a slow moving mist that helps you inhale the medicine.
• Use STRIVERDI RESPIMAT exactly as your healthcare provider tells you to use it. Do not use STRIVERDI RESPIMAT more often than prescribed.
• Use 1 dose (2 puffs) of STRIVERDI RESPIMAT, 1 time each day, at the same time of the day.
• If you miss a dose of STRIVERDI RESPIMAT, take it as soon as you remember. Do not take more than 1 dose (2 puffs) in 24 hours.
• If you take too much STRIVERDI RESPIMAT, call your healthcare provider or go to the nearest hospital emergency room right away.
• Do not spray STRIVERDI RESPIMAT in your eyes.
• STRIVERDI RESPIMAT Inhalation Spray should only be given using the STRIVERDI RESPIMAT inhaler. The STRIVERDI RESPIMAT inhaler should not be used to give other medicines.
• Always use the new STRIVERDI RESPIMAT inhaler that is provided with each new prescription.
• STRIVERDI RESPIMAT does not relieve sudden symptoms of COPD. You should not take extra doses of STRIVERDI RESPIMAT to relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have one prescribed for you.
• Do not stop using STRIVERDI RESPIMAT or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
• If your COPD symptoms worsen over time do not increase your dose of STRIVERDI RESPIMAT, instead call your healthcare provider.
• Do not use STRIVERDI RESPIMAT:
• more often than prescribed for you,
• at a higher dose than prescribed for you, or
• with other LABA medicines. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Inhalation spray: Each actuation from the mouthpiece delivers 2.5 mcg olodaterol, equivalent to 2.7 mcg olodaterol hydrochloride. Two actuations equal one dose.

This medicine is available in fallowing brand namesː

• STRIVERDI RESPIMAT

What side effects can this medication cause?

The most common side effects of this medicine include:

• runny nose
• sore throat
• upper respiratory infection
• bronchitis
• urinary tract infection
• cough
• dizziness
• rash
• diarrhea
• back pain
• joint pain

STRIVERDI RESPIMAT can cause serious side effects, including:

• serious problems from asthma
• COPD symptoms can get worse over time
• sudden shortness of breath can happen immediately after using STRIVERDI RESPIMAT
• effects on your heart
• changes in laboratory blood levels including high blood sugar (hyperglycemia) and low levels of potassium (hypokalemia)
• serious allergic reactions including rash, hives, itching, swelling of the face, lips, tongue, throat, difficulties in breathing or swallowing

What special precautions should I follow?

LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. Do not initiate STRIVERDI RESPIMAT in acutely deteriorating COPD patients. Do not use for relief of acute symptoms. Concomitant short-acting beta2-agonists can be used as needed for acute relief. Do not exceed the recommended dose. Excessive use of STRIVERDI RESPIMAT, or use in conjunction with other medications containing LABA can result in clinically significant cardiovascular effects and may be fatal. Life-threatening paradoxical bronchospasm can occur. Discontinue STRIVERDI RESPIMAT immediately. Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis or sensitivity to sympathomimetic drugs.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: myocardial ischemia, angina pectoris, hypertension or hypotension, tachycardia, arrhythmias, palpitations, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis. cardiac arrest and even death may be associated with an overdose of STRIVERDI RESPIMAT.

Management of overdosage:

• Treatment of overdosage consists of discontinuation of STRIVERDI RESPIMAT together with institution of appropriate symptomatic and supportive therapy.
• The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm.
• There is insufficient evidence to determine if dialysis is beneficial for overdosage of STRIVERDI RESPIMAT.
• Cardiac monitoring is recommended in cases of overdosage.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled clinical studies with STRIVERDI RESPIMAT in pregnant women to inform of drug-associated risk of adverse pregnancy-related outcomes.

Can this medicine be used in children?

• STRIVERDI RESPIMAT is not indicated for use in children. The safety and effectiveness of STRIVERDI RESPIMAT in the pediatric population have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: olodaterol
• Inactive ingredients: water for injection, benzalkonium chloride, edetate disodium, and anhydrous citric acid

Who manufactures and distributes this medicine?

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

What should I know about storage and disposal of this medication?

• Store STRIVERDI RESPIMAT at room temperature, between 68°F to 77°F (20°C to 25°C).
• Do not freeze your STRIVERDI cartridge or RESPIMAT inhaler.
• Keep STRIVERDI RESPIMAT inhaler, cartridge, and all medicines out of the reach of children.

• Dailymed label info on Olodaterol
• FDA Olodaterol

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