Rofaday 500 Mcg (10 Tab)

ROFADAY 500 MCG Tablet by LUPIN LTD

Name

• Common Name: Roflumilast
• Brand Name: Rofaday 500 mcg Tablet

Composition

ROFADAY 500 MCG Tablet contains Roflumilast 500 mcg as its active ingredient. It belongs to a class of medications known as phosphodiesterase-4 (PDE4) inhibitors.

Uses

ROFADAY 500 MCG Tablet is primarily used for the maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients who experience frequent flare-ups. This medication helps to:

• Reduce the risk of COPD exacerbations.
• Control airway inflammation in the lungs.
• Improve lung function and facilitate easier breathing by relaxing the muscles in the airways.
• Support bronchodilator therapy in COPD.

It is important to note that ROFADAY is not intended for the immediate relief of sudden breathlessness or acute bronchospasm; a rescue inhaler should be used for such emergencies.

Dosage and Administration

The usual dosage for adults is 500 micrograms (one tablet) once daily. The tablet should be swallowed whole with a glass of water, and it should not be chewed, crushed, or broken. ROFADAY can be taken with or without food, but it is recommended to take it at the same time each day to maximize its effectiveness and establish a routine. Always follow your doctor's prescribed dose and duration of treatment. If a dose is missed, take it as soon as you remember, or skip it if it is almost time for the next dose; do not take a double dose.

Side Effects

Common Side Effects:

• Diarrhea, nausea, stomach pain, decreased appetite, weight loss.
• Headache, insomnia (difficulty sleeping), dizziness, back pain.
• Trembling, rapid or irregular heartbeat, vomiting, indigestion, rash, muscle pain, fatigue, anxiety.

Serious Side Effects:

• Psychiatric events, including anxiety, depression, and suicidal thoughts.
• Allergic reactions with symptoms such as swelling and breathing difficulties.

Consult your doctor if any side effects persist or worsen, or if you experience any serious side effects.

Precautions

• ROFADAY is not recommended for individuals with moderate to severe liver impairment or acute liver failure. Liver function may require monitoring during treatment.
• Use with caution in patients with a history of depression, as roflumilast may worsen symptoms or trigger mood changes. There is an increased risk of psychiatric events, including suicidal thoughts.
• This medicine is not recommended for use in children under 18 years of age.
• Caution is advised during pregnancy. Patients should use an effective method of contraception during treatment, as it may cause harm to the unborn baby.
• If you are breastfeeding, consult your doctor before taking this medicine.
• Patients should regularly monitor their weight, and any unexplained and significant weight loss should be reported to a doctor.
• Avoid consuming alcohol while taking ROFADAY, as it may increase the risk of side effects such as stomach problems or headaches.
• Inform your doctor about any pre-existing health conditions (e.g., cancer, heart disease, kidney problems) and all other medications you are currently taking, including herbal supplements, to avoid potential drug interactions.
• Smoking can alter the blood levels of roflumilast and may affect dosing.

Storage

Store ROFADAY 500 MCG Tablets below 30°C. Keep at room temperature and avoid direct sunlight.

What is ROFADAY 500 MCG used for?

ROFADAY 500 MCG is primarily used for the long-term, maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) in adults who have chronic bronchitis and experience frequent flare-ups. It helps to reduce the frequency of COPD exacerbations. It is important to note that ROFADAY is not for immediate relief of sudden breathing problems or acute bronchospasm; a rescue inhaler should be used for such emergencies.

How does ROFADAY 500 MCG work?

ROFADAY 500 MCG contains the active ingredient Roflumilast, which belongs to a class of medications called phosphodiesterase-4 (PDE4) inhibitors. It works by selectively blocking the PDE4 enzyme, which normally breaks down cyclic adenosine monophosphate (cAMP) in the lungs. By preventing the breakdown of cAMP, Roflumilast increases its levels in lung tissues. This process helps to control inflammation, relax the muscles around your airways, and ultimately improve airflow, making breathing easier for individuals with severe COPD.

What is the usual dosage of ROFADAY 500 MCG?

The usual dosage for adults is 500 micrograms (mcg) taken once daily. It is recommended to take the tablet at the same time each day, consistently. It can be taken with or without food. Always follow your doctor's specific instructions regarding dosage, as it may vary based on your individual condition and response to treatment.

What are the possible side effects of ROFADAY 500 MCG?

Common side effects may include diarrhea, nausea, stomach pain, decreased appetite, weight loss, headache, and insomnia (difficulty sleeping). Some individuals might also experience dizziness, trembling, or back pain. In rare cases, more serious side effects such as anxiety, depression, or suicidal thoughts have been reported. Most common side effects are usually temporary and resolve over time. However, if any side effects persist, worsen, or if you experience serious symptoms like suicidal thoughts, it is crucial to consult your doctor immediately.

Is ROFADAY 500 MCG safe during pregnancy or breastfeeding?

Pregnancy: Caution is advised when taking ROFADAY 500 MCG during pregnancy. It is generally not recommended unless absolutely necessary, and the potential risks and benefits should be thoroughly discussed with your doctor. Animal studies have indicated a potential for harm to the developing baby.

Breastfeeding: ROFADAY 500 MCG is not recommended during breastfeeding. Limited data suggests potential harm to the infant through breastmilk transfer. If treatment is considered essential, your doctor should be consulted, and the infant should be closely monitored for any undesirable effects.

Can ROFADAY 500 MCG be taken with other medications?

ROFADAY 500 MCG can interact with other medications. It is important to inform your doctor about all medicines you are currently taking, including over-the-counter drugs, herbal supplements, and vitamins. Specifically, Roflumilast levels can be affected by:

• CYP3A4 inhibitors: Strong inhibitors like ketoconazole, itraconazole, and ritonavir may increase the concentration of Roflumilast in your blood, potentially increasing the risk of side effects.
• CYP3A4 inducers: Medicines such as rifampicin, phenobarbital, and carbamazepine can reduce the effectiveness of Roflumilast by decreasing its concentration in the body.
• Other medications like theophylline, oral corticosteroids, methotrexate, enoxacin, or cimetidine may also interact.

What precautions should be taken while using ROFADAY 500 MCG?

Several precautions should be observed when taking ROFADAY 500 MCG:

• It is not for acute breathing problems; always have a rescue inhaler for emergencies.
• Inform your doctor if you have a history of depression, psychiatric issues, or suicidal thoughts, as Roflumilast may worsen these conditions.
• This medicine is not recommended for individuals with moderate to severe liver impairment or acute liver failure. Your doctor may need to monitor your liver function.
• Monitor your weight regularly, as decreased appetite and weight loss are possible side effects. Report any unexplained or significant weight loss to your doctor.
• Exercise caution with alcohol consumption, as it might increase the risk of certain side effects like stomach problems or headaches.
• If you experience dizziness or blurred vision, avoid driving or operating heavy machinery.
• ROFADAY 500 MCG is not recommended for use in children under 18 years of age.
• Smoking can alter the blood levels of Roflumilast, potentially affecting its dosing and efficacy.

What happens if a dose of ROFADAY 500 MCG is missed?

If you miss a dose of ROFADAY 500 MCG, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should ROFADAY 500 MCG be stored?

ROFADAY 500 MCG tablets should be stored below 30°C. Keep them at room temperature and protect them from direct sunlight.