spiriva respimat

Do not use SPIRIVA RESPIMAT if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines.

SPIRIVA RESPIMAT is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA RESPIMAT can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and get immediate medical care.

SPIRIVA RESPIMAT can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA RESPIMAT, and call your doctor right away or seek emergency medical care.

SPIRIVA RESPIMAT can increase the pressure in your eyes (acute narrow-angle glaucoma), which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

Dizziness and blurred vision may occur with it. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or other machines.

it can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

The most common side effects reported with it in patients with COPD include sore throat, cough, dry mouth, and sinus infection.

The most common side effects with it in adult patients with asthma were sore throat, headache, bronchitis, and sinus infection. The side effect profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

Do not spray it into your eyes, as this may cause blurring of vision and pupil dilation.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with it can increase side effects.

INDICATIONS

SPIRIVA RESPIMAT, 2.5 mcg, is a long-term, once-daily, prescription medicine used to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema. it also reduces the likelihood of COPD flare-ups (COPD exacerbations).

SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older.

it is not a treatment for sudden symptoms of asthma or COPD.

Chronic Obstructive Pulmonary Disease

Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD); reduction of COPD exacerbations

Spiriva Handihaler: 2 PO inhalations of 1 capsule (18 mcg) qDay via HandiHaler inhalation device

Spiriva Respimat: 5 mcg (2 actuations; 2.5 mcg/actuation) inhaled PO qDay

Asthma

Indicated for long-term, once-daily, maintenance treatment of asthma in patients aged ≥12 yr

Spiriva Respimat: 2.5 mcg (2 actuations; 1.25 mcg/actuation) inhaled PO qDay

Dosage Modifications

CrCl <50 mL/min: Use only if benefit outweighs potential risk

Cystic Fibrosis (Orphan)

Improvement of pulmonary function in conjunction with standard therapy in management of patients with cystic fibrosis

Orphan indication sponsor

• Boehringer Ingelheim Pharmaceuticals, Inc, PO Box 368, 900 Ridgebury Road, Ridgefield, CT 06877