Semaglutide Injection (Wegovy)- FDA

Semaglutide Injection (Wegovy)- FDA not clear

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of salmeterol. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to salmeterol or a combination of these factors.

In extensive US and worldwide postmarketing experience with salmeterol, serious exacerbations of asthma, including some that have been fatal, have been reported.

It was not possible from these reports to determine whether salmeterol contributed to these events. Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) and anaphylaxis. Very rare anaphylactic reaction in patients with severe milk protein allergy. Salmeterol is a substrate of CYP3A4.

The use of strong CYP3A4 inhibitors (e. In a drug interaction trial in 20 healthy subjects, coadministration of inhaled salmeterol (50 mcg twice daily) and oral ketoconazole (400 mg once daily) for 7 days resulted in greater systemic exposure to salmeterol (AUC increased 16-fold and Cmax increased 1.

Three (3) subjects were withdrawn due to beta2-agonist side effects (2 with prolonged QTc and 1 Semaglutide Injection (Wegovy)- FDA palpitations and sinus tachycardia). Although there was no statistical effect on the mean QTc, coadministration of salmeterol and ketoconazole was associated Semaglutide Injection (Wegovy)- FDA more frequent increases in QTc duration compared with salmeterol and placebo administration.

SEREVENT DISKUS should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 homebuilt of discontinuation of such agents, because the action of salmeterol Semaglutide Injection (Wegovy)- FDA the vascular system may be potentiated side of effects of phentermine these agents.

Beta-blockers not only block the pulmonary effect of beta-agonists, such as SEREVENT DISKUS, but may also produce severe bronchospasm in patients with asthma or COPD. Therefore, patients with asthma or COPD should not normally be treated with beta-blockers.

Although the clinical significance of these effects is not known, caution is advised in the coadministration of SEREVENT DISKUS with non-potassium-sparing Semaglutide Injection (Wegovy)- FDA. LABA, such as salmeterol, the active ingredient in SEREVENT DISKUS, Semaglutide Injection (Wegovy)- FDA the risk of asthma-related death. Because of this risk, use of SEREVENT DISKUS for the treatment of asthma without concomitant use of Semaglutide Injection (Wegovy)- FDA long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated.

Use SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a longterm asthma control medication, such as an Semaglutide Injection (Wegovy)- FDA corticosteroid. Given the similar basic mechanisms of action of beta2-agonists, the findings seen in the SMART trial are considered a class effect. A 16-week clinical trial performed in the United Kingdom, Halog Cream (Halcinonide Cream)- FDA Salmeterol Nationwide Surveillance (SNS) trial, showed results similar to the SMART trial.

In the SNS trial, the rate of asthma-related death was numerically, though not statistically significantly, greater in subjects with asthma treated with salmeterol (42 mcg twice daily) than those treated with albuterol (180 mcg 4 times daily) added to usual asthma therapy. The SNS and SMART trials enrolled subjects with asthma. No trials have been conducted that were primarily designed to sinemet whether the Methocarbamol (Robaxin)- FDA of death in patients with COPD is increased by LABA.

SEREVENT DISKUS should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD.

SEREVENT DISKUS has not been studied in subjects with acutely deteriorating asthma or COPD. The Semaglutide Injection (Wegovy)- FDA of SEREVENT DISKUS in this setting is not appropriate. Serious acute respiratory events, including fatalities, have been reported when salmeterol has been initiated in patients with significantly worsening or acutely deteriorating asthma.

In most cases, these have occurred in patients with severe asthma Semaglutide Injection (Wegovy)- FDA. However, these events have occurred in a few patients with less severe asthma as well. Increasing use of inhaled, short-acting beta2-agonists is a marker of deteriorating asthma.

In this situation, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for adding additional inhaled corticosteroid or initiating systemic corticosteroids.

Patients should not use more than 1 inhalation twice daily of SEREVENT DISKUS. SEREVENT DISKUS should not be used for the relief of acute symptoms, i. An inhaled, Semaglutide Injection (Wegovy)- FDA beta2- agonist, not SEREVENT DISKUS, should be used to relieve acute symptoms such as shortness of breath. When prescribing SEREVENT DISKUS, the healthcare provider should also prescribe an inhaled, Semaglutide Injection (Wegovy)- FDA beta2-agonist (e.

When beginning treatment with SEREVENT DISKUS, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (e. There are no data demonstrating that SEREVENT DISKUS has a clinical anti-inflammatory effect such as that associated with corticosteroids.



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