罗氟司特片说明书

Instructions:

The EU approved the marketing of roflumilast tablets in July 2010 for the treatment of chronic obstructive pulmonary disease (COPD). Roflumilast tablets, a selective phosphodiesterase 4 (PDE4) inhibitor, are the first new class of COPD treatment drugs approved by the EU in more than a decade.

【Indications】

Roflumilast tablets Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor and a new treatment drug for chronic obstructive pulmonary disease COPD. Roflumilast tablets are used to treat bronchitis-related cough and mucus excess in patients with severe chronic obstructive pulmonary disease (COPD). Roflumilast is not intended for the treatment of COPD patients with concurrent primary emphysema.

【Usage and Dosage】

The recommended dose of roflumilast for patients with COPD is 500 mcg once daily, with or without food.

  【Adverse reactions】

The most common adverse reactions of roflumilast tablets (≥2%): diarrhea/weight loss/nausea/headache/back pain/flu/insomnia/dizziness/loss of appetite, etc.

【Notes】

Acute bronchospasm: Do not use roflumilast film tablets to relieve acute bronchospasm.

Treatment with roflumilast film tablets may result in psychiatric events including suicidal behavior: Advise patients, their caregivers, and families to be alert to the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and to contact their healthcare provider if such changes occur. Carefully weigh the risks and benefits of treatment with roflumilast film tablets in patients with a history of depression and/or suicidal thoughts or behaviors.

Treatment with roflumilast film tablets may result in weight loss: monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuing use.

Be aware of drug interactions during treatment with roflumilast: it is not recommended to use roflumilast film tablet with strong inducers of cytochrome P450 enzymes (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin).

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

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