roflumilast 500 ug
1 INDICATIONS AND USAGE Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use: Roflumilast tablets are not a bronchodilator and are not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. Roflumilast tablets are a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. ( 1 , 14 ) Limitations of Use: • Roflumilast tablets are not a bronchodilator and are not indicated for the relief of acute bronchospasm. ( 1 , 14 ) • Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. ( 2 , 14 )
mylan pharmaceuticals inc.
ROUND WHITE M RF
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
ROFLUMILAST Tablets are available containing 500 mcg of
ROFLUMILAST. The 500 mcg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and RF on the other side. They are available as follows: NDC 0378-1905-93 bottles of 30 tablets NDC 0378-1905-77 bottles of 90 tablets NDC 0378-1905-05 bottles of 500 tablets 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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