roflumilast 500 ug

1 INDICATIONS AND USAGE Roflumilast tablet is 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 tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roﬂumilast 250 mcg is a starting dose, for the ﬁrst 4 weeks of treatment only and is not the effective (therapeutic) dose. Roflumilast tablet is 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 tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. (1 , 14) • Roﬂumilast tablet 250 mcg is a starting dose, for the ﬁrst 4 weeks of treatment only and is not the effective (therapeutic) dose. ( 2 , 14 )

Camber Pharmaceuticals, Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] off label use` `[5] nausea` `[6] headache` `[7] diarrhoea` `[8] dyspnoea` `[9] arthralgia` `[10] vomiting`

6 months ago

ROUND WHITE H I

6 months ago

H I ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

ROFLUMILAST Tablets 250 mcg are supplied as white to off white, round, flat bevel edged tablets, debossed with 'H' on one side and 'T' on the other side. The 250 mcg tablets are available as: Carton of 20 (2 x 10) Unit-dose Tablets NDC 31722-676-32 Carton of 28 (1 x 28) Unit-dose Tablets NDC 31722-676-36

ROFLUMILAST Tablets 500 mcg are supplied as white to off white, round, flat bevel edged tablets, debossed with 'H' on one side and 'I' on the other side. The 500 mcg tablets are available as: Bottles of 30 Tablets NDC 31722-623-30 Bottles of 90 Tablets NDC 31722-623-90 Carton of 100 (10 x 10) Unit-dose Tablets NDC 31722-623-32 16.2 Storage and Handling Store

ROFLUMILAST tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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roflumilast 500 ug

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] pain [4] off label use [5] nausea [6] headache [7] diarrhoea [8] dyspnoea [9] arthralgia [10] vomiting

ROUND WHITE H I

H I ROUND WHITE

More pills like ROUND H I

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] off label use` `[5] nausea` `[6] headache` `[7] diarrhoea` `[8] dyspnoea` `[9] arthralgia` `[10] vomiting`