Roflumilast tablets (Roflumilast)-DALIRESP instructions

1. Common name: Roflumilast

Product name: DALIRESP, Daxas, Dikaisu (Hong Kong version)

Other names: Roflumilast tablets

2. Indications:

Roflumilast tablets (Roflumilast) can be used to reduce the risk of COPD exacerbations in patients with severe chronic obstructive pulmonary disease (COPD; chronic obstructive pulmonary disease) who have chronic bronchitis and a history of exacerbations.

Restrictions on use: Roflumilast tablets are not bronchodilators and are not suitable for relieving acute bronchospasm; Roflumilast tablets250mcg is the starting dose, which is only used in the first 4 weeks of treatment and is not an effective (therapeutic) dose.

3. Usage and dosage:

The maintenance dose of roflumilast tablets is 500 micrograms (mcg) per day, with or without food. Starting treatment with 250 mcg of roflumilast once daily for 4 weeks, followed by increasing to 500 mcg of roflumilast once daily, may reduce treatment discontinuation rates in some patients. However, 250mcg per day is not an effective (therapeutic) dose.

4. Adverse reactions:

In clinical studies of roflumilast tablets, more common adverse reactions may include diarrhea, abdominal pain, nausea, vomiting, decreased appetite, weight loss, headache, dizziness, insomnia, and back and joint pain. Rare but potentially serious adverse reactions include depression, suicidality, allergic reactions (including angioedema, urticaria, and rash), and gynecomastia.

5. Supply and storage:

Roflumilast tablets are available in 250mcg and 500mcg and can be stored at 20-25°C (68-77°F); excursions allowed to 15-30°C (59°-86°F).

6. Taboo:

Roflumilast tablets are contraindicated in the following conditions: Moderate to severe hepatic impairment (Child-Pugh Class B or C).

7. Mechanism of action:

Roflumilast and its active metabolite (roflumilastN-oxide) are selective inhibitors of phosphodiesterase 4 (PDE4) . Roflumilast and roflumilastN-oxide inhibit the activity of PDE4 (the major cyclic-3′, 5′-adenosine monophosphate [cyclicAMP] metabolic enzyme in lung tissue), leading to the accumulation of intracellular cyclicAMP. Although the specific mechanism by which roflumilast exerts its therapeutic effect in COPD patients has not been fully determined, it is thought to be related to an increase in intracellular cyclic adenosine monophosphate in lung cells.

8. Special groups:

1. Pregnancy and breastfeeding: If the patient is pregnant or breastfeeding, or thinks that she may be pregnant or is planning to have a baby, please consult your doctor or pharmacist before taking this medicine. Patients should not become pregnant during treatment with this drug and should use an effective method of contraception during treatment as roflumilast may be harmful to an unborn baby.

2. Children and adolescents: Do not give roflumilast tablets to children and adolescents under the age of 18.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9a1d0a8-581f-4f91-a2b8-f419192d0ebf