ROFLUMILAST

Other

Brand names: Roflumilast

Oral

Mechanism of Action

12.1 Mechanism of Action Roflumilast and its active metabolite (roflumilast N-oxide) are selective inhibitors of phosphodiesterase 4 (PDE4). Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic-3',5'-adenosine monophosphate (cyclic AMP)-metabolizing enzyme in lung tissue) activity leads to accumulation of intracellular cyclic AMP. While the specific mechanism(s) by which roflumilast tablets exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells.

Indications

14 ) Limitations of Use: Roflumilast tablets is not a bronchodilator and is 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 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Acute Bronchospasm: Do not use for the relief of acute bronchospasm
Carefully weigh the risks and benefits of treatment with roflumilast tablets in patients with a history of depression and/or suicidal thoughts or behavior
Before using roflumilast tablets in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with roflumilast tablets in such patients
Prescribers should carefully evaluate the risks and benefits of continuing treatment with roflumilast tablets if such events occur

Known Side Effects

10 documented side effects by frequency

Shortness of Breath

>10%

Diarrhea

1-10%

Nausea

1-10%

Weight Loss

1-10%

Headache

1-10%

Drug Not Working

1-10%

Cough

0.1-1%

Insomnia

0.1-1%

Dizziness

0.1-1%

Decreased Appetite

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral