Serevent

Name: Serevent

Other uses for this medicine

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

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Is salmeterol safe to take if I'm pregnant or breastfeeding?

Adequate studies of salmeterol during pregnancy have not been done. In some, but not all, pregnant animal models exposure to very high doses of oral salmeterol has led to offspring with birth defects. The concentrations of salmeterol in the blood after these very high doses, however, were much higher than the concentrations observed after inhalation. Salmeterol inhalation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In rats, salmeterol is excreted in milk. Therefore, caution should be exercised when salmeterol is administered to nursing women.

Side Effects of Serevent

Serevent can cause serious side effects, including:

  • See “Serevent Precautions”
  • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of the face, mouth, and tongue
    • breathing problems
  • sudden breathing problems immediately after inhaling your medicine
  • effects on heart
    • increased blood pressure
    • a fast or irregular heartbeat
    • chest pain
  • effects on nervous system
    • tremor
    • nervousness
  • changes in blood (sugar, potassium)
 

Common side effects of Serevent include:

Asthma in adults and children:

  • headache
  • nasal congestion
  • bronchitis
  • throat irritation
  • runny nose
  • flu

Chronic obstructive pulmonary disease:

  • headache
  • musculoskeletal pain
  • throat irritation
  • cough
  • respiratory infection

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with Serevent. Ask your healthcare provider or pharmacist for more information.

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

Serevent Precautions

Serevent can cause serious side effects, including:

1. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as Serevent have an increased risk of death from asthma problems. Call your healthcare provider if breathing problems worsen over time while using Serevent. You may need a different treatment.

Get emergency treatment

  • breathing problems worsen quickly
  • you use your rescue inhaler medicine, but it does not relieve your breathing problems

Do not take Serevent:

  • to treat your asthma without an asthma medicine known as an inhaled corticosteroid
  • if you are allergic to Serevent or any of the ingredients in Serevent 
  • breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems

2. Do not use Serevent as your only asthma medicine. Serevent must only be used with a long-term asthma-control medicine, such as an inhaled corticosteroid.

3. When your asthma is well controlled, your healthcare provider may tell you to stop taking Serevent. Your healthcare provider will decide if you can stop Serevent without loss of asthma control. You will continue taking your long-term asthma-control medicine, such as an inhaled corticosteroid.

4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

Before Using Serevent

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of salmeterol in children above 4 years of age. Safety and efficacy have not been established in children younger than 4 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of salmeterol in the elderly. However, elderly patients with heart problems may require special caution when receiving salmeterol.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Fluconazole
  • Posaconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfuzosin
  • Amiodarone
  • Amprenavir
  • Apomorphine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Boceprevir
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Darunavir
  • Dasabuvir
  • Dasatinib
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Fingolimod
  • Flecainide
  • Fosamprenavir
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lapatinib
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Mifepristone
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Ombitasvir
  • Ondansetron
  • Paliperidone
  • Paritaprevir
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Quinidine
  • Quinine
  • Ranolazine
  • Ritonavir
  • Saquinavir
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sunitinib
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tipranavir
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Vardenafil
  • Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Erythromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma attack, acute or
  • Bronchospasm (difficulty with breathing), acute or
  • COPD flare-up—Should not be used in patients with these conditions.
  • Diabetes or
  • Heart or blood vessel disease or
  • Heart rhythm problems (e.g., arrhythmia, QT prolongation) or
  • Hypertension (high blood pressure) or
  • Hyperthyroidism (overactive thyroid) or
  • Hypokalemia (low potassium in the blood) or
  • Ketoacidosis (high ketones in the blood) or
  • Seizures, history of—Use with caution. May make these conditions worse.

Warnings

DATA FROM A LARGE PLACEBO-CONTROLLED SAFETY STUDY THAT WAS STOPPED EARLY SUGGEST THAT SALMETEROL MAY BE ASSOCIATED WITH RARE SERIOUS ASTHMA EPISODES OR ASTHMA-RELATED DEATHS. Data from this study, called the Salmeterol Multi-center Asthma Research Trial (SMART), further suggest that the risk might be greater in African American patients. These results led to stopping the study prematurely (see CLINICAL TRIALS: Asthma: Salmeterol Multi-center Asthma Research Trial). The data from the SMART study are not adequate to determine whether concurrent use of inhaled corticosteroids provides protection from this risk. Given the similar basic mechanisms of action of beta2-agonists, it is possible that the findings seen in the SMART study may be consistent with a class effect.

Findings similar to the SMART study findings were reported in a prior 16-week clinical study performed in the United Kingdom, the Salmeterol Nationwide Surveillance (SNS) study. In the SNS study, the incidence of asthma-related death was numerically, though not statistically, greater in patients with asthma treated with salmeterol (42 mcg twice daily) versus albuterol (180 mcg 4 times daily) added to usual asthma therapy.

Serevent INHALATION AEROSOL SHOULD NOT BE INITIATED IN PATIENTS WITH SIGNIFICANTLY WORSENING OR ACUTELY DETERIORATING ASTHMA, WHICH MAY BE A LIFE-THREATENING CONDITION. Serious acute respiratory events, including fatalities, have been reported, both in the United States and worldwide, when Serevent Inhalation Aerosol has been initiated in this situation.

Although it is not possible from these reports to determine whether Serevent Inhalation Aerosol contributed to these adverse events or simply failed to relieve the deteriorating asthma, the use of Serevent Inhalation Aerosol in this setting is inappropriate.

Serevent INHALATION AEROSOL SHOULD NOT BE USED TO TREAT ACUTE SYMPTOMS. It is crucial to inform patients of this and prescribe an inhaled, short-acting beta2-agonist for this purpose as well as warn them that increasing inhaled beta2-agonist use is a signal of deteriorating asthma.

Serevent INHALATION AEROSOL IS NOT A SUBSTITUTE FOR INHALED OR ORAL CORTICOSTEROIDS. Corticosteroids should not be stopped or reduced when Serevent Inhalation Aerosol is initiated.

(See PRECAUTIONS: Information for Patients and the PATIENT'S INSTRUCTIONS FOR USE accompanying the product.)

1. Do Not Introduce Serevent Inhalation Aerosol as a Treatment for Acutely Deteriorating Asthma: Serevent Inhalation Aerosol is intended for the maintenance treatment of asthma (see INDICATIONS AND USAGE) and should not be introduced in acutely deteriorating asthma, which is a potentially life-threatening condition. There are no data demonstrating that Serevent Inhalation Aerosol provides greater efficacy than or additional efficacy to inhaled, short-acting beta2-agonists in patients with worsening asthma. Serious acute respiratory events, including fatalities, have been reported both in the United States and worldwide in patients receiving Serevent Inhalation Aerosol. In most cases, these have occurred in patients with severe asthma (e.g., patients with a history of corticosteroid dependence, low pulmonary function, intubation, mechanical ventilation, frequent hospitalizations, or previous life­threatening acute asthma exacerbations) and/or in some patients in whom asthma has been acutely deteriorating (e.g., unresponsive to usual medications; increasing need for inhaled, short­acting beta2-agonists; increasing need for systemic corticosteroids; significant increase in symptoms; recent emergency room visits; sudden or progressive deterioration in pulmonary function). However, they have occurred in a few patients with less severe asthma as well. It was not possible from these reports to determine whether Serevent Inhalation Aerosol contributed to these events or simply failed to relieve the deteriorating asthma.

2. Do Not Use Serevent Inhalation Aerosol to Treat Acute Symptoms: An inhaled, short-acting beta2-agonist, not Serevent Inhalation Aerosol, should be used to relieve acute asthma or COPD symptoms. When prescribing Serevent Inhalation Aerosol, the physician must also provide the patient with an inhaled, short-acting beta2-agonist (e.g., albuterol) for treatment of symptoms that occur acutely, despite regular twice-daily (morning and evening) use of Serevent Inhalation Aerosol.

When beginning treatment with Serevent Inhalation Aerosol, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute asthma or COPD symptoms (see PRECAUTIONS: Information for Patients).

3. Watch for Increasing Use of Inhaled, Short-Acting Beta2-Agonists, Which Is a Marker of Deteriorating Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient’s inhaled, short-acting beta2-agonist becomes less effective or the patient needs more inhalations than usual, this may be a marker of destabilization of asthma. In this setting, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for corticosteroids. If the patient uses 4 or more inhalations per day of an inhaled, short-acting beta2-agonist for 2 or more consecutive days, or if more than 1 canister (200 inhalations per canister) of inhaled, short-acting beta2-agonist is used in an 8-week period in conjunction with Serevent Inhalation Aerosol, then the patient should consult the physician for reevaluation. Increasing the daily dosage of Serevent Inhalation Aerosol in this situation is not appropriate. Serevent Inhalation Aerosol should not be used more frequently than twice daily (morning and evening) at the recommended dose of 2 inhalations.

4. Do Not Use Serevent Inhalation Aerosol as a Substitute for Oral or Inhaled Corticosteroids: The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids. There are no data demonstrating that Serevent Inhalation Aerosol has a clinical anti-inflammatory effect and could be expected to take the place of corticosteroids. Patients who already require oral or inhaled corticosteroids for treatment of asthma should be continued on this type of treatment even if they feel better as a result of initiating Serevent Inhalation Aerosol. Any change in corticosteroid dosage should be made ONLY after clinical evaluation (see PRECAUTIONS: Information for Patients).

5. Do Not Exceed Recommended Dosage: As with other inhaled beta2-adrenergic drugs, Serevent Inhalation Aerosol should not be used more often or at higher doses than recommended. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Large doses of inhaled or oral salmeterol (12 to 20 times the recommended dose) have been associated with clinically significant prolongation of the QTc interval, which has the potential for producing ventricular arrhythmias.

6. Paradoxical Bronchospasm: Serevent Inhalation Aerosol can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Serevent Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

7. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of Serevent Inhalation Aerosol, as demonstrated by rare cases of urticaria, angioedema, rash, and bronchospasm.

8. Upper Airway Symptoms: Symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported rarely in patients receiving Serevent Inhalation Aerosol.

Serevent Inhalation Aerosol, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Serevent Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Serevent Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Overdosage

The expected signs and symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Overdosage with Serevent Inhalation Aerosol may be expected to result in exaggeration of the pharmacologic adverse effects associated with beta-adrenoceptor agonists, including tachycardia and/or arrhythmia, tremor, headache, and muscle cramps. Overdosage with Serevent Inhalation Aerosol can lead to clinically significant prolongation of the QTc interval, which can produce ventricular arrhythmias. Other signs of overdosage may include hypokalemia and hyperglycemia.

As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of Serevent Inhalation Aerosol.

Treatment consists of discontinuation of Serevent Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Serevent Inhalation Aerosol. Cardiac monitoring is recommended in cases of overdosage.

No deaths were seen in rats at inhalation doses of 2.9 mg/kg (approximately 240 times the maximum recommended human daily inhalation dose on a mg/m2 basis) and in dogs at 0.7 mg/kg (approximately 190 times the maximum recommended human daily inhalation dose on a mg/m2 basis). By the oral route, no deaths occurred in mice at 150 mg/kg (approximately 6,100 times the maximum recommended human daily inhalation dose on a mg/m2 basis) and in rats at 1,000 mg/kg (approximately 81,000 times the maximum recommended human daily inhalation dose on a mg/m2 basis).

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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