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 an inhaled corticosteroid.
Prevention of exercise-induced bronchospasm.
Maintenance treatment to prevent bronchospasm in COPD.

Contraindicated in:

Hypersensitivity to salmeterol or milk proteins
Acute attack of asthma (onset of action is delayed)
Patients not receiving a 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 during pregnancy only if potential maternal benefit justifies potential fetal risk; may inhibit contractions during labor
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
Pedi: Children <4 yr (safety and effectiveness not established).

CV: palpitations, tachycardia.

GI: abdominal pain, diarrhea, nausea.

MS: muscle cramps/soreness.

Neuro: headache, nervousness, tremor.

Resp: cough, paradoxical bronchospasm.

Drug-Drug:

Beta blockers may ↓ therapeutic effects.
MAO inhibitors and tricyclic antidepressants may potentiate cardiovascular effects.
Strong CYP3A4 inhibitors, including ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, nefazodone, or nelfinavir, may ↑ levels and the risk of toxicity; concurrent use not recommended.

Drug-Natural Products:

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

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

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).

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

Therapeutic Effects:

Bronchodilation.

Therapeutic Classification: bronchodilators

Pharmacologic Classification: adrenergics

Absorption: Minimal systemic absorption follows inhalation.

Distribution: Action is primarily local.

Metabolism/Excretion: Metabolized in the liver via the CYP3A4 isoenzyme; 60% excreted in feces, 25% excreted in urine.

Half-life: 3–4 hr.

(bronchodilation)

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

†9 hr in adolescents.

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 should be 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.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Emphasize the importance of regular follow-up exams to determine progress during therapy.

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

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆