salmeterol

REMS

As concomitant therapy for the treatment of asthma and the prevention of bronchospasm in patients who are currently taking but are inadequately controlled on a long-term asthma-control medication (e.g., inhaled corticosteroid).
Prevention of exercise-induced bronchospasm.
Maintenance treatment to prevent bronchospasm in chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Produces accumulation of cyclic adenosine monophosphate (cAMP) at beta₂-adrenergic receptors.
Relatively specific for beta (pulmonary) receptors.

Therapeutic Effects:

Bronchodilation.

Absorption: Minimal systemic absorption follows inhalation.

Distribution: Action is primarily local.

Metabolism/Excretion: Unknown.

Half-life: 3–4 hr.

Contraindicated in:

Hypersensitivity to salmeterol or milk proteins
Acute attack of asthma (onset of action is delayed)
Patients not receiving a long-term asthma-control medication (e.g., inhaled corticosteroid) (↑ risk of asthma-related death)
Patients whose asthma is currently controlled on low- or medium-dose inhaled corticosteroid therapy.

Use Cautiously in:

Cardiovascular disease (including angina and hypertension)
Seizure disorders
Diabetes
Glaucoma
Hyperthyroidism
Pheochromocytoma
Excessive use (may lead to tolerance and paradoxical bronchospasm)
OB: Use only if potential maternal benefit justifies potential fetal risk; may inhibit contractions during labor
Lactation: Use while breast feeding only if potential maternal benefit justifies potential risk to infant
Pedi: Children <4 yr (safety not established); a fixed-dose combination product containing salmeterol and an inhaled corticosteroid should be strongly considered to ensure adherence.

CV: palpitations, tachycardia.

GI: abdominal pain, diarrhea, nausea.

MS: muscle cramps/soreness.

Neuro: trembling , headache, nervousness.

Resp: paradoxical bronchospasm, cough.

Drug-Drug:

Beta blockers may ↓ therapeutic effects.
MAO inhibitors and tricyclic antidepressants potentiate cardiovascular effects.
↑levels and ↑ risk of cardiovascular effects when used with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, or saquinavir); concurrent use is not recommended.

Drug-Natural Products:

Use with caffeine-containing herbs (cola nut, guarana, mate, tea, coffee) ↑ stimulant effect.

Asthma

Inhaln (Adults and Children 4 yr): 50 mcg (1 inhalation) twice daily (approximately 12 hr apart).

Prevention of Exercise-Induced Bronchospasm

Inhaln (Adults and Children 4 yr): 50 mcg (1 inhalation) 30 min before exercise; additional doses should not be used for 12 hr.

COPD

Inhaln (Adults): 50 mcg (1 inhalation) twice daily (approximately 12 hr apart).

Salmeterol should be used along with an inhaled corticosteroid, not as monotherapy. Patients taking salmeterol twice daily should not use additional doses for exercise-induced bronchospasm.
Inhaln: Serevent Diskus: Once removed from foil overwrap, discard diskus when every blister has been used or 6 wk have passed, whichever comes first.

Therapeutic Classification: bronchodilators

Pharmacologic Classification: adrenergics

Powder for oral inhalation (Serevent Diskus): 50 mcg/blister;
In combination with: fluticasone (Advair Diskus, Advair HFA, AirDuo RespiClick, Wixhela Inhub). See Appendix [not included in this PDA edition].

(bronchodilation)

ROUTE	ONSET	PEAK	DURATION
Inhaln	10–25 min	3–4 hr	12 hr†

†9 hr in adolescents.

Assess lung sounds, pulse, and BP before administration and periodically during therapy.
Monitor pulmonary function tests before initiating therapy and periodically during therapy.
Observe for paradoxical bronchospasm (wheezing, dyspnea, tightness in chest) and hypersensitivity reaction (rash; urticaria; swelling of the face, lips, or eyelids). Frequently occurs with first use of new canister or vial. If condition occurs, withhold medication and notify physician or other health care professional immediately.

Lab Test Considerations:

May cause ↑ serum glucose concentrations; occurs rarely with recommended doses and is more pronounced with frequent use of high doses.
- May cause ↓ serum potassium concentrations, which are usually transient and dose related; rarely occurs at recommended doses and is more pronounced with frequent use of high doses.

Toxicity and Overdose:

Symptoms of overdose include persistent agitation, chest pain or discomfort, decreased BP, dizziness, hyperglycemia, hypokalemia, seizures, tachyarrhythmias, persistent trembling, and vomiting.
- Treatment includes discontinuing salmeterol and other beta-adrenergic agonists and providing symptomatic, supportive therapy. Cardioselective beta blockers are used cautiously because they may induce bronchospasm.

Ineffective airway clearance (Indications).

Advise patient to take salmeterol as directed. Do not use more than the prescribed dose. If a regularly scheduled dose is missed, use as soon as possible and resume regular schedule. Do not double doses. If symptoms occur before next dose is due, use a rapid-acting inhaled bronchodilator.
Instruct patient using powder for inhalation never to exhale into diskus device and always to hold device in a level horizontal position. Mouthpiece should be kept dry; never wash.
Caution patient not to use salmeterol to treat acute symptoms. A rapid-acting inhaled beta-adrenergic bronchodilator should be used for relief of acute asthma attacks.
Advise patients on chronic therapy not to use additional salmeterol to prevent exercise-induced bronchospasm. Patients using salmeterol for prevention of exercise-induced bronchospasm should not use additional doses of salmeterol for 12 hr after prophylactic administration.
Advise patient to notify health care professional immediately if difficulty in breathing persists after use of salmeterol, if condition worsens, if more inhalations of rapid-acting bronchodilator than usual are needed to relieve an acute attack, or if using 4 or more inhalations of a rapid-acting bronchodilator for 2 or more consecutive days or more than 1 canister in an 8-wk period.
Salmeterol is often used with inhaled corticosteroids and is not a substitute for corticosteroids or adrenergic bronchodilators. Advise patients using inhalation or systemic corticosteroids to consult health care professional before stopping or reducing therapy.
Advise patient to notify health care professional if pregnancy is planned or suspected, or if breast feeding.
Emphasize the importance of regular follow-up exams to determine progress during therapy.

Prevention of bronchospasm or reduction of frequency of acute asthma attacks in patients with chronic asthma. Improvement in asthma control can occur within 15 min of starting therapy, but full benefit may take 1 wk or longer. Time to onset and degree of symptom relief will vary with individual.
Prevention of exercise-induced asthma.

NDC Code^*

0173- GlaxoSmithKline LLC
0173-0520- SEREVENT DISKUS
0173-0520-00- 1 INHALER in 1 CARTON (0173-0520-00) > 28 POWDER, METERED in 1 INHALER

0173- GlaxoSmithKline LLC
0173-0521- SEREVENT DISKUS
0173-0521-00- 1 INHALER in 1 CARTON (0173-0521-00) > 60 POWDER, METERED in 1 INHALER

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Pronunciation ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Implementation ⬆ ⬇

US Brand Names ⬆ ⬇

Classifications ⬆ ⬇

Availability ⬆ ⬇

Time/Action Profile ⬆ ⬇

Assessment ⬆ ⬇

Pot. Nursing Diagnoses ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

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