Ambrisentan Tablets and Salmeterol Xinafoate

• Generic Name: ambrisentan
• Dosage Forms: tablet, film coated
• Other Brand Names: Letairis

Ambrisentan lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Ambrisentan is used to treat pulmonary arterial hypertension (PAH) in adults. It improves your ability to exercise and prevents your condition from getting worse. Ambrisentan is sometimes used with a medicine called tadalafil (Adcirca).

For women, ambrisentan is available only from a certified pharmacy under a special program. You must be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing.

Ambrisentan may also be used for purposes not listed in this medication guide.

• Generic Name: salmeterol
• Dosage Forms: n.a.
• Other Brand Names: Serevent Diskus, Serevent

Salmeterol is used only concomitantly with long-term asthma controller therapy (e.g., inhaled corticosteroids) for treatment of asthma and prevention of bronchospasm in patients with reversible obstructive airway disease, including symptoms of nocturnal asthma.

Monotherapy with long-acting β2-adrenergic agonists (e.g., salmeterol) increases the risk of asthma-related death and may increase risk of asthma-related hospitalization in children and adolescents. Use of salmeterol for treatment of asthma without concomitant use of long-term asthma controller therapy (e.g., inhaled corticosteroids) is contraindicated. (See Boxed Warning and also Asthma-related Death and Life-threatening Events under Cautions.)

Salmeterol is used only as additional therapy in patients with asthma currently receiving long-term asthma controller therapy (e.g., inhaled corticosteroids) but whose disease is inadequately controlled with such therapy.

Salmeterol in fixed combination with fluticasone is used only in patients with asthma not responding adequately to long-term asthma controller therapy (e.g., inhaled corticosteroids) or whose disease severity warrants initiation of treatment with both an inhaled corticosteroid and a long-acting β2-adrenergic agonist.

Once asthma control achieved and maintained, assess patient at regular intervals and step down therapy (e.g., discontinue salmeterol) if possible without loss of asthma control, and maintain patient on long-term asthma controller therapy (e.g., inhaled corticosteroids).

Salmeterol is not a substitute for corticosteroids; corticosteroid therapy should not be stopped or reduced in dosage when salmeterol is initiated. (See Concomitant Anti-inflammatory Therapy under Cautions.)

Do not use salmeterol alone or in fixed combination with fluticasone in patients with asthma adequately controlled on low or medium dosage of inhaled corticosteroids.

In children and adolescents with asthma requiring addition of a long-acting β2-adrenergic agonist to an inhaled corticosteroid, generally use a fixed-combination preparation containing both an inhaled corticosteroid and a long-acting β2-adrenergic agonist to ensure compliance with both drugs.

When separate administration of long-term asthma controller therapy (e.g., inhaled corticosteroids) and a long-acting β2-adrenergic agonist is clinically indicated, take appropriate steps to ensure compliance with both drugs. If compliance cannot be ensured, a fixed-combination preparation containing both an inhaled corticosteroid and a long-acting β2-adrenergic agonist is recommended.

Salmeterol alone or in fixed combination with fluticasone not indicated for relief of acute bronchospasm. (See Deterioration of Disease and Acute Episodes under Cautions.)

Prevention of exercise-induced bronchospasm.

Use as a single agent for prevention of exercise-induced bronchospasm may be clinically indicated in patients without persistent asthma.

Use for prevention of exercise-induced bronchospasm may be clinically indicated in patients with persistent asthma; however, treatment of asthma should include long-term asthma controller therapy (e.g., inhaled corticosteroids).

Long-term symptomatic treatment of reversible bronchospasm associated with moderate to severe COPD (e.g., FEV1 less than 80% of predicted), including chronic bronchitis and emphysema.

Fixed combination with fluticasone as the inhalation powder (Advair Diskus) is used for maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema; also used to reduce COPD exacerbations in patients with a history of exacerbations.

Not indicated for relief of acute bronchospasm. Use a short-acting inhaled β2-agonist intermittently (as needed) for acute symptoms of COPD. (See Deterioration of Disease and Acute Episodes under Cautions.)