通用名称为DALIRESP
罗氟司特500mcg;片。

法律分类：
RX

药理类为DALIRESP
选择性磷酸二酯酶4（PDE4）抑制剂。

对DALIRESP制造商
森林实验室
主治为DALIRESP
COPD加重慢性支气管炎和严重的慢性阻塞性肺病患者病情加重的历史，以减少风险。不为缓解急性支气管痉挛。

成人剂量为DALIRESP
500mcg，每天一次。

儿童剂量为DALIRESP
不推荐使用。

禁忌的DALIRESP
中度至重度肝损害（Child-Pugh分级B级或C）。

为DALIRESP警告/注意事项
抑郁症。自杀意念。轻度肝损害（Child-Pugh分级A级）。失眠，焦虑，抑郁，自杀意念，其他情绪变化的监测，重新评估，如果出现。定期监测体重;考虑停止，如果出现原因不明或显着的减肥。怀孕（部件）。劳动和分娩，哺乳母亲：不推荐。

为DALIRESP的相互作用
伴随强劲的CYP450诱导剂（如利福平，苯巴比妥，卡马西平，苯妥英）：不推荐。 Potentiated CYP3A4和CYP1A2的抑制剂（如红霉素，酮康唑，氟伏沙明，依诺沙星，西咪替丁），口服避孕药含孕二烯酮+炔雌醇（可能增加的不利影响）。

为DALIRESP不良反应
胃肠不适，体重下降，头痛，背痛，流感，头晕，食欲下降，精神的影响（例如，失眠，焦虑，抑郁）。

DALIRESP如何提供？
标签-30

相关疾病：

慢性阻塞性肺病

DALIRESP

Generic Name for DALIRESP

Roflumilast 500mcg; tablets.

Legal Classification:

Rx

Pharmacological Class for DALIRESP

Selective phosphodiesterase 4 (PDE4) inhibitor.

Manufacturer of DALIRESP

Forest Laboratories

Indications for DALIRESP

To reduce risk of COPD exacerbations in severe COPD patients with chronic bronchitis and a history of exacerbations. Not for the relief of acute bronchospasm.

Adult dose for DALIRESP

500mcg once daily.

Children's dosing for DALIRESP

Not recommended.

Contraindications for DALIRESP

Moderate-to-severe liver impairment (Child-Pugh Class B or C).

Warnings/Precautions for DALIRESP

Depression. Suicidal ideation. Mild liver impairment (Child-Pugh Class A). Monitor for insomnia, anxiety, depression, suicidal ideation, other mood changes; reevaluate if occurs. Monitor weight regularly; consider discontinuing if unexplained or significant weight loss occurs. Pregnancy (Cat. C). Labor & delivery, nursing mothers: not recommended.

Interactions for DALIRESP

Concomitant strong CYP450 inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin): not recommended. Potentiated by CYP3A4 and CYP1A2 inhibitors (eg, erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine), and by oral contraceptives containing gestodene + ethinyl estradiol (possible increased adverse effects).

Adverse Reactions for DALIRESP

GI upset, weight decrease, headache, back pain, influenza, dizziness, decreased appetite; psychiatric effects (eg, insomnia, anxiety, depression).

How is DALIRESP supplied?

Tabs—30

Daliresp Description
Roflumilast is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis). It should be used along with other medications (bronchodilators such as salmeterol, ipratropium) to treat COPD. It works by reducing the irritation and swelling of the airways. Controlling symptoms of breathing problems can decrease time lost from work or school.
This medication must be used regularly to be effective. It does not work immediately and should not be used to relieve sudden shortness of breath or wheezing. If sudden breathing problems occur, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

Daliresp Directions
Read the Medication Guide and, if available, the Patient Information Leaflet from your pharmacist before you start taking roflumilast and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily.
Use this medication regularly in order to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same time each day. Do not increase your dose, use this medication more frequently, or stop using it without first consulting your doctor.
Tell your doctor if your condition does not improve or if it worsens.

Daliresp Cautions
Before taking roflumilast, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, cancer, heart disease (such as heart failure), current/past infections (such as tuberculosis, herpes), mental/mood disorders (depression, thoughts of suicide), unexplained/extreme weight loss, immune system disorders (such as lupus, HIV).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Daliresp Side Effects
Diarrhea, weight loss, stomach/abdominal pain, nausea, loss of appetite, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Check your weight regularly while taking this medication. Tell your doctor right away of any unusual or extreme weight loss.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as nervousness, depression, thoughts of suicide), trouble sleeping, shaking (tremors), fast/irregular heartbeat.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Daliresp Active Ingredients

FDA批准慢性支气管炎新药

2011年3月1日，美国食品药品管理局(FDA)宣布已批准口服药Daliresp(罗氟司特)用于减少重度慢性阻塞性肺疾病(COPD)症状加重或恶化的发生频率。

罗氟司特是一种磷酸二酯酶-4抑制剂，适用于重度COPD患者，治疗支气管炎引起的咳嗽和黏液分泌过多等症状，但不适用于治疗气肿型COPD。

罗氟司特的安全性和疗效在两项Ⅲ期临床试验中得到了证实，这两项试验纳入了逾1,500例年龄≥40岁且接受罗氟司特治疗的患者。这些受试者都有COPD病史且伴有慢性支气管炎，并在开始治疗前的12个月内都有病情加重的情况发生。

罗氟司特不宜用于治疗急性支气管痉挛，也不推荐用于18岁以下的患者。罗氟司特使用者报告的最常见的不良反应包括腹泻、恶心、头痛、失眠、背痛、食欲减退和眩晕。