Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
TIOTROPIUM BROMIDE MONOHYDRATE (UNII: L64SXO195N) (TIOTROPIUM - UNII:0EB439235F), OLODATEROL HYDROCHLORIDE (UNII: 65R445W3V9) (OLODATEROL - UNII:VD2YSN1AFD)
Boehringer Ingelheim Pharmaceuticals Inc.
TIOTROPIUM BROMIDE MONOHYDRATE
TIOTROPIUM 3.124 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
STIOLTO RESPIMAT is a combination of tiotropium and olodaterol indicated for long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Important Limitations of Use - STIOLTO RESPIMAT is not indicated to treat acute deteriorations of COPD [see Warnings and Precautions (5.2)]. - STIOLTO RESPIMAT is not indicated to treat asthma. The safety and effectiveness of STIOLTO RESPIMAT in asthma have not been established. Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1)] . STIOLTO RESPIMAT is not indicated for the treatment of asthma. STIOLTO RESPIMAT is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product [see Warnings and Precautions (5.4)] . In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, inc
STIOLTO RESPIMAT Inhalation Spray is supplied in a labeled carton containing one STIOLTO RESPIMAT cartridge and one STIOLTO RESPIMAT inhaler. The STIOLTO RESPIMAT cartridge is provided as an aluminum cylinder with a tamper protection seal on the cap. The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler and should not be interchanged with any other RESPIMAT device delivered product. The STIOLTO RESPIMAT inhaler is a cylindrical shaped plastic inhalation device with a gray colored body and a clear base. The clear base is removed to insert the cartridge. The inhaler contains a dose indicator. The light green-colored cap and the written information on the label of the gray inhaler body indicate that it is labeled for use with the STIOLTO RESPIMAT cartridge. STIOLTO RESPIMAT Inhalation Spray is available as: The STIOLTO RESPIMAT cartridge has a net fill weight of at least 4 grams and when used with the STIOLTO RESPIMAT inhaler, is designed to deliver the labeled number of metered actuations after preparation for use. When the labeled number of actuations has been dispensed from the inhaler, the RESPIMAT locking mechanism will be engaged and no more actuations can be dispensed. After assembly, the STIOLTO RESPIMAT inhaler should be discarded at the latest 3 months after first use or when the locking mechanism is engaged, whichever comes first. Keep out of reach of children. Do not spray into eyes. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid freezing.
New Drug Application
Boehringer Ingelheim Pharmaceuticals Inc. ---------- MEDICATION GUIDE STIOLTO® RESPIMAT® (sti-OL-to– RES peh mat) (tiotropium bromide and olodaterol) inhalation spray, for oral inhalation use Read the Medication Guide that comes with STIOLTO RESPIMAT before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about STIOLTO RESPIMAT? STIOLTO RESPIMAT has been approved for chronic obstructive pulmonary disease (COPD) only. STIOLTO RESPIMAT is not to be used in asthma. STIOLTO RESPIMAT can cause serious side effects, including: • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as olodaterol (one of the medicines in STIOLTO RESPIMAT), have an increased risk of death from asthma problems. • It is not known if LABA medicines, such as olodaterol (one of the medicines in STIOLTO RESPIMAT), increase the risk of death in people with COPD. • Get emergency medical care if: • breathing problems worsen quickly • you use your rescue inhaler medicine, but it does not relieve your breathing problems What is STIOLTO RESPIMAT? STIOLTO RESPIMAT contains the anticholinergic tiotropium, and the long-acting beta2-adrenergic agonist (LABA), olodaterol. STIOLTO RESPIMAT is used long term, 2 puffs once each day, in controlling symptoms of COPD in adults with COPD). Anticholinergic and LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. STIOLTO RESPIMAT is not for use to treat sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you. It is not known if STIOLTO RESPIMAT is safe and effective in people with asthma. STIOLTO RESPIMAT should n Preberite celoten dokument
STIOLTO RESPIMAT- TIOTROPIUM BROMIDE AND OLODATEROL SPRAY, METERED BOEHRINGER INGELHEIM PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE STIOLTO RESPIMAT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STIOLTO RESPIMAT. STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL INHALATION SPRAY), FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 2015 INDICATIONS AND USAGE STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta - adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1) Important limitations: STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. (1.1) STIOLTO RESPIMAT is NOT indicated to treat asthma. (1.1) DOSAGE AND ADMINISTRATION For oral inhalation only. Two inhalations of STIOLTO RESPIMAT once-daily at the same time of day. (2) DOSAGE FORMS AND STRENGTHS Inhalation spray: Each actuation from the mouthpiece delivers 2.5 mcg tiotropium (equivalent to 3.124 mcg tiotropium bromide monohydrate), and 2.5 mcg olodaterol (equivalent to 2.736 mcg olodaterol hydrochloride). Two actuations equal one dose. (3) CONTRAINDICATIONS Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma. (4) Hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product. (4) WARNINGS AND PRECAUTIONS LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. (5.1) Do not initiate STIOLTO RESPIMAT in acutely deteriorating COPD patients. (5.2) Do not use for relief of acute symptoms. Concomitant short-acting beta -agonists can be used as needed for acute relief. (5.2) Do not exceed the recommended dose. Excessive use of STIOLTO RESPIMAT, or use in conjunction with other medications containing LABA can result in clinically signifi Preberite celoten dokument