Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)
GlaxoSmithKline LLC
SALMETEROL XINAFOATE
SALMETEROL 50 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
SEREVENT DISKUS is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with an ICS in patients aged 4 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma. LABA, such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death [see Warnings and Precautions (5.1)] . Use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an ICS is contraindicated [see Contraindications (4)] . Use SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low- or medium-dose ICS. Pediatric and Adolescent Patients Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent pati
SEREVENT DISKUS is supplied as a disposable teal green plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0521-00). Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children. SEREVENT DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard SEREVENT DISKUS 6 weeks after opening the foil pouch or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
New Drug Application
GlaxoSmithKline LLC ---------- MEDICATION GUIDE SEREVENT DISKUS (SER uh vent DISK us) (salmeterol xinafoate inhalation powder) for oral inhalation use What is the most important information I should know about SEREVENT DISKUS? SEREVENT DISKUS can cause serious side effects, including: • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (the medicine in SEREVENT DISKUS), have an increased risk of death from asthma problems if they use SEREVENT DISKUS without also using a medicine called an inhaled corticosteroid (ICS). • Call your healthcare provider if breathing problems worsen over time while using SEREVENT DISKUS. You may need different treatment. • Get emergency medical care if: • your breathing problems worsen quickly. • you use your rescue inhaler, but it does not relieve your breathing problems. • Do not use SEREVENT DISKUS as your only asthma medicine. SEREVENT DISKUS must only be used with an ICS. • SEREVENT DISKUS should be used only if your healthcare provider decides that your asthma is not well controlled with an ICS. • Children and adolescents who take LABA medicines as their only asthma medicine may have an increased risk of being hospitalized for asthma problems. What is SEREVENT DISKUS? • SEREVENT DISKUS is a prescription inhaled LABA medicine. LABA medicines such as salmeterol 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. • SEREVENT DISKUS is not used to relieve sudden breathing problems and will not replace a rescue inhaler. • It is not known if SEREVENT DISKUS is safe and effective in children younger than 4 years. • SEREVENT DISKUS is used for asthma, exercise-induced bronchospasm (EIB), and chronic obstructive pulmonary disease (COPD) as follows: Asthma: • SEREVENT DISKUS is a prescription medicine used to contro Preberite celoten dokument
SEREVENT DISKUS- SALMETEROL XINAFOATE POWDER, METERED GLAXOSMITHKLINE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SEREVENT DISKUS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEREVENT DISKUS. SEREVENT DISKUS (SALMETEROL XINAFOATE INHALATION POWDER), FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 1994 WARNING: ASTHMA-RELATED DEATH _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • INDICATIONS AND USAGE SEREVENT DISKUS is a LABA indicated for: • • • Important limitation of use: Not indicated for relief of acute bronchospasm. (1.1, 1.3) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Inhalation powder: Inhaler containing salmeterol (50 mcg) as a powder formulation for oral inhalation. (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • LONG-ACTING BETA -ADRENERGIC AGONISTS (LABA), SUCH AS SALMETEROL, THE ACTIVE INGREDIENT IN SEREVENT DISKUS, AS MONOTHERAPY (WITHOUT INHALED CORTICOSTEROIDS [ICS]) INCREASE THE RISK OF ASTHMA-RELATED DEATH. A U.S. TRIAL SHOWED AN INCREASE IN ASTHMA-RELATED DEATHS IN SUBJECTS RECEIVING SALMETEROL (13 DEATHS OUT OF 13,176 SUBJECTS TREATED FOR 28 WEEKS ON SALMETEROL VERSUS 3 OUT OF 13,179 SUBJECTS ON PLACEBO). WHEN LABA ARE USED IN FIXED-DOSE COMBINATION WITH ICS, DATA FROM LARGE CLINICAL TRIALS DO NOT SHOW A SIGNIFICANT INCREASE IN THE RISK OF SERIOUS ASTHMA- RELATED EVENTS (HOSPITALIZATIONS, INTUBATIONS, DEATH) COMPARED WITH ICS ALONE. (5.1) 2 PRESCRIBE SEREVENT DISKUS ONLY AS ADDITIONAL THERAPY FOR PATIENTS WITH ASTHMA WHO ARE CURRENTLY TAKING BUT ARE INADEQUATELY CONTROLLED ON AN ICS. DO NOT USE SEREVENT DISKUS FOR PATIENTS WHOSE ASTHMA IS ADEQUATELY CONTROLLED ON LOW- OR MEDIUM-DOSE ICS. (1.1, 5.1) AVAILABLE DATA FROM CONTROLLED CLINICAL TRIALS SUGGEST THAT LABA AS MONOTHERAPY INCREASE THE RISK OF ASTHMA-RELATED HOSPITALIZATION IN PEDIATRIC AND ADOLESCENT PATIENTS. (5.1) Treatment of asthma in patients aged 4 years and older with an Preberite celoten dokument