Salmeterol

Salmeterol is a prescription medicine used for the treatment and prevention of asthma symptoms and COPD maintenance.

• Salmeterol is available under the following different brand names: Serevent Diskus

Adult and pediatric dosage

Powder

• 50mcg/inhalation

Asthma Prevention and Maintenance

Adult dosage

• 1 inhalation (50 mcg) twice daily; not to exceed twice-daily administration

Pediatric dosage

• Children below 4 years: Safety and efficacy not established
• Children above 4 years: 1 inhalation (50 mcg) twice daily; not to exceed twice-daily administration

COPD Maintenance

Adult dosage

• 1 inhalation (50 mcg) twice daily; not to exceed twice-daily administration

Prevention of Exercise-Induced Asthma

Adult dosage

• 1 inhalation 30 minutes before exercise; a second dose not to be administered for another 12 hours; not for use in individuals receiving twice-daily therapy of salmeterol

Pediatric dosage

• Children below 4 years: Safety and efficacy not established
• Children above 4 years: 1 inhalation (50 mcg) twice daily; not to exceed twice-daily administration

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Salmeterol include:

• headache,
• flu symptoms,
• joint or muscle pain,
• throat irritation,
• cough, and
• stuffy or runny nose.

Serious side effects of Salmeterol include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• worsening asthma symptoms,
• other breathing problems,
• severe headache,
• blurred vision,
• pounding in  neck or ears,
• chest pain,
• fast or irregular heartbeats,
• tremors,
• nervousness,
• increased thirst,
• increased urination,
• dry mouth,
• fruity breath odor,
• leg cramps,
• constipation,
• fluttering in the chest,
• numbness or tingling,
• muscle weakness, and
• limp feeling.

Rare side effects of Salmeterol include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Salmeterol has severe interactions with the following drugs:
  • darunavir
  • fosamprenavir
  • indinavir
  • lefamulin
  • lopinavir
  • nelfinavir
  • ritonavir
• Salmeterol has serious interactions with at least 38 other drugs.
• Salmeterol has moderate interactions with at least 268 other drugs.
• Salmeterol has minor interactions with at least 16 other drugs:

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to drug or excipients
• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required
• Treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Salmeterol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Salmeterol?”

Cautions

• Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; therapy 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 salmeterol at recommended doses, if they occur, the drug may need to be discontinued
• The drug should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs; patients should not use another medicine containing a LABA (e.g., formoterol fumarate, arformoterol tartrate, indacaterol) for any reason
• Use caution in diabetes mellitus and ketoacidosis; clinically significant and dose-related changes in blood glucose and/or serum potassium are seen infrequently during clinical trials at recommended doses
• Not for acute asthma; for acute asthma exacerbations, use short-acting beta-agonists (eg, albuterol)
• Not for acute episodes of COPD
• May increase risk of severe, potentially fatal asthma attacks; small but significant increase in asthma-related deaths for patients using salmeterol vs placebo, with greater risk in African-Americans
• Therapy may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects; a decrease in serum potassium is usually transient, not requiring supplementation
• Use caution in patients with hypokalemia, hepatic impairment, seizure disorders, and hyperthyroidism
• Paradoxical bronchospasm may occur with therapy; if it occurs it should be treated immediately with an inhaled, short-acting bronchodilator; treatment should be discontinued immediately and alternative therapy instituted; upper airway symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported in patients receiving therapy
• When initiating and throughout treatment in patients receiving oral or ICS for treatment of asthma, patients must continue taking a suitable dosage of corticosteroids to maintain clinical stability even if they feel better as a result of initiating salmeterol; any change in corticosteroid dosage should be made only after clinical evaluation
• Use Serevent Diskus only as an 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
• Immediate hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur with therapy; anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose reported
• Use only for the shortest duration of time
• Deterioration of disease
  • Not for use in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD, including patients with significantly increased symptoms
  • Worsening or acutely deteriorating asthma is associated with an increase in the need for inhaled, short-acting beta2-agonists; decreasing response to usual medications; increasing need for systemic corticosteroids; recent emergency room visits; deteriorating lung function
  • 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 ICS or initiating systemic corticosteroids; patients should not use the drug more than 1 inhalation twice daily
• Drug interaction overview
  • Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) is not recommended because increased cardiovascular adverse effects may occur

Pregnancy and Lactation

• Available data from published epidemiological studies and case reports in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Beta-agonists may interfere with uterine contractility
• There are clinical considerations in pregnant women with asthma
• In women with poorly or moderately controlled asthma, there is an increased risk of pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate
• Severe asthma during pregnancy has been associated with maternal mortality, fetal mortality, or both
• Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control
• Labor and delivery
  • There are no adequate and well-controlled human studies that have evaluated the effects of therapy during labor and delivery; because of the potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those patients in whom the benefits outweigh the risks
• Lactation
  • There is no information regarding the presence of salmeterol in human milk, effects on the breastfed child, or milk production
  • The drug is detected in rat milk; drug concentrations in human plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be low
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from treatment or underlying maternal condition