Montelukast Sodium and Xtampza ER

• Generic Name: montelukast
• Dosage Forms: n.a.
• Other Brand Names: Singulair

Prevention and long-term symptomatic management of asthma. Efficacy for this indication demonstrated when the drug was administered in the evening.

In patients with mild persistent asthma, low-dose orally inhaled corticosteroids considered first-line agents for long-term control. Alternative agents, including certain leukotriene modifiers (i.e., montelukast, zafirlukast), may be used but are less effective than inhaled corticosteroids and are not preferred as initial therapy.

In patients with moderate persistent asthma, low-dose inhaled corticosteroids with a long-acting inhaled β2-agonist bronchodilator (e.g., salmeterol, formoterol) or monotherapy with medium-dose inhaled corticosteroids preferred. However, the National Asthma Education and Prevention Program (NAEPP) recommends that beneficial effects of long-acting inhaled β2-agonists be weighed carefully against increased risk of severe asthma exacerbations and asthma-related deaths associated with daily use of such agents.

Alternative agents, including certain leukotriene modifiers (i.e., montelukast, zafirlukast), can be added to a low dosage of inhaled corticosteroid for treatment of moderate persistent asthma, but these options are less effective. Considerations favoring combination with orally inhaled corticosteroids include intolerance to long-acting β2-adrenergic agonists, marked preference for oral therapy, and demonstration of superior responsiveness to these leukotriene modifiers.

In adults and children ≥5 years of age with severe persistent asthma, NAEPP and the Global Initiative for Asthma (GINA) state that maintenance therapy with inhaled corticosteroids at medium to high dosages and adjunctive therapy with a long-acting inhaled β2-agonist is preferred. Alternatives to a long-acting inhaled β2-agonist in such patients receiving medium-dose inhaled corticosteroids include certain leukotriene modifiers (i.e., montelukast, zafirlukast), but these agents are generally not preferred.

In infants and children ≤4 years of age, NAEPP states that an inhaled corticosteroid at medium or high dosages and adjunctive therapy with either a long-acting inhaled β2-agonist or montelukast is the only preferred treatment.

Maintenance therapy with montelukast may be considered in patients who are unable or unwilling to comply with therapy using inhaled corticosteroids (e.g., young children).

Not recommended for relief of acute bronchospasm; however, may continue therapy during acute asthma exacerbations. (See Acute Asthma under Cautions.)

Prevention of exercise-induced bronchospasm.

Leukotriene modifiers not included as first-line agents or as alternative agents to orally inhaled β2-adrenergic agonists in current guidelines; addition of montelukast may provide additional measure of control in patients currently maintained on long-term controller therapy.

Manufacturer states that patients who experience exacerbations of asthma after exercise should have a short-acting orally inhaled β2-adrenergic agonist available for rescue. Not established that daily administration of montelukast for chronic treatment of asthma prevents acute episodes of exercise-induced bronchospasm.

Symptomatic management of seasonal or perennial allergic rhinitis. Efficacy for this indication demonstrated when the drug was administered in the morning or evening.

Has been used successfully in patients with chronic idiopathic urticaria; beneficial when added to existing therapy.

• Generic Name: oxycodone
• Dosage Forms: capsule, extended release
• Other Brand Names: Oxaydo, Oxycontin, Oxyfast, Roxicodone, Xtampza ER, Oxecta, Oxycontin, Roxybond, Xtampza ER; oxycodone is also present in the following combination drugs: Combunox, Endocet, Endodan, Moxduo, Oxycodan, Percocet, Percodan, Primlev, Roxicet, Xartemis XR, and others, OxyIR, Roxybond

Xtampza ER is an opioid pain medication used to treat moderate to severe pain.

The extended-release form of oxycodone is for around-the-clock treatment of pain and should not be used on an as-needed basis for pain.

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