Striverdi Respimat

Striverdi Respimat is a prescription medication used for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Striverdi Respimat belongs to a group of drugs called long-acting beta2-adrenergic agonists. These work by relaxing the airways.

This medication is available as a spray for inhalation and is taken once daily.

Common side effects of Striverdi Respimat include upper respiratory tract infections, inflammation of the nasal passages and throat, bronchitis, urinary tract infections, cough, rash, diarrhea, back pain, and joint pain.

Striverdi Respimat can also cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Striverdi Respimat is a prescription medication used for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not used to treat asthma or acute exacerbations or deteriorations of COPD.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Boehringer Ingelheim Pharmaceuticals, Inc.

Serious side effects have been reported with Striverdi Respimat. See the “Striverdi Respimat Precautions” section.

Common side effects of Striverdi Respimat  include

• upper respiratory tract infections
• inflammation of the nasal passages and throat
• bronchitis
• urinary tract infections
• cough
• rash
• diarrhea
• back pain
• joint pain

Striverdi Respimat can also cause dizziness. Do not drive or operate heavy machinery until you know how Striverdi Respimat affects you.

This is not a complete list of Striverdi Respimat side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other beta2-adrenergic agonists such as formoterol (Foradil, in Symbicort) and salmeterol (Serevent, in Advair)
• diuretics such as hydrochlorothiazide (Microzide), furosemide (Lasix), and torsemide (Demadex)
• steroids such as hydrocortisone (Cortef), prednisone (Prednisone Intensol), prednisolone (Orapred, Prelone), and methylprednisolone (Medrol, Depo-Medrol)
• monoamine oxidase inhibitors such as phenelzine (Nardil, Nardelzine), tranylcypromine (Parnate), and selegiline (Deprenyl, Eldepryl)
• beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), metoprolol (Lopressor), and propranolol (Inderal)

This is not a complete list of Striverdi Respimat drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Striverdi Respimat including the following:

Common side effects of Striverdi Respimat include

• upper respiratory tract infections
• inflammation of the nasal passages and throat
• bronchitis
• urinary tract infections
• cough
• rash
• diarrhea
• back pain
• joint pain

Striverdi Respimat  can also cause dizziness. Do not drive or operate heavy machinery until you know how Striverdi Respimat affects you.

Do not take Striverdi Respimat if you:

• are allergic to Striverdi Respimat or to any of its ingredients
• have asthma

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Striverdi Respimat, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Striverdi Respimat, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Striverdi Respimat or to any of its ingredients
• have heart problems
• have kidney problems
• have liver problems
• have diabetes mellitus
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Striverdi Respimat falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Striverdi Respimat crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medicaStriverdi Respimat tion. Your doctor and you will decide if the benefits outweigh the risk of using Striverdi Respimat.

Take Striverdi Respimat exactly as prescribed.

This medication is available as a spray for inhalation and is taken once daily a day.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Striverdi Respimat at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the condition being treated.

The recommended dose/dose range of Striverdi Respimat for the maintenance treatment of airway obstruction in chronic obstructive pulmonary disease is 2 inhalations once daily, at the same time each day. The dose is equivalent to 5 micrograms of Striverdi Respimat.

If you take too much Striverdi Respimat, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Striverdi Respimat at room temperature.

Keep this and all medicines out of the reach of children.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large, placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including olodaterol, the active ingredient in Striverdi Respimat. The safety and efficacy of Striverdi Respimat in patients with asthma have not been established. Striverdi Respimat is not indicated for the treatment of asthma.