Daxas Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Daxas Tablet contains roflumilast, a Phosphodiesterase 4 (PDE4) inhibitor. It is a prescription anti-inflammatory tablet used alongside other inhaled treatments to help manage severe COPD in adults. Daxas helps reduce COPD exacerbations and improves lung function when used together with bronchodilator therapy. It is not a rescue medicine for sudden breathing attacks.

What is Daxas Tablet

Daxas is a prescription tablet containing roflumilast, an anti-inflammatory medicine used alongside other inhaled treatments to help manage severe COPD in adults.

Daxas Tablet uses

• Reduces COPD exacerbations
• Treats severe COPD associated with chronic bronchitis
• Provides long-term anti-inflammatory treatment
• Used alongside bronchodilator therapy

Benefits of Daxas Tablet

• Improves lung function (FEV1) compared with placebo
• Reduces the rate of moderate or severe COPD flare-ups (exacerbations)
• Effects were seen on top of other COPD treatments patients were already taking

How Daxas Tablet works

Daxas works by blocking an enzyme called PDE4, which is involved in causing inflammation in the lungs. By reducing this inflammation, it helps stop the airways from narrowing and eases breathing problems in COPD.

Daxas Tablet dosage

Swallow the tablet with water and take it at the same time every day. The tablet can be taken with or without food. Daxas is not for treating a sudden attack of breathlessness; you need a separate rescue medicine for that. It is used in addition to bronchodilator treatment, not on its own. Continue taking it as prescribed even if you have no symptoms, in order to maintain control of your lung function. You may need to take Daxas for several weeks before you notice its full effect.

If you forget a dose, take it as soon as you remember; if a whole day is missed, just continue the next day with the next tablet as usual; do not take a double dose. Daxas is not recommended for children and adolescents under 18 years of age. No dose adjustment is needed for elderly patients.

Available forms and strengths

• Film-coated tablet (500 micrograms)

Side effects of Daxas Tablet

Common

• Weight decrease
• Decreased appetite
• Sleeplessness (insomnia)
• Headache
• Diarrhoea
• Nausea
• Stomach ache (abdominal pain)

Serious

• Hypersensitivity reactions (generalised allergic reaction affecting skin, mouth and tongue, possibly leading to difficulty breathing and/or a drop in blood pressure and fast heartbeat)
• Feeling anxious, nervous, or depressed
• Suicidal thinking and behaviour, including completed suicide
• Trembling, dizziness, vertigo
• Palpitations (rapid or irregular heartbeat)
• Gastritis, vomiting, acid reflux, indigestion
• Rash, hives (urticaria)
• Muscle pain or cramps, back pain
• Male breast enlargement (gynaecomastia)
• Respiratory tract infections
• Bloody stools, constipation
• Elevated liver or muscle enzymes seen in blood tests

Warnings and precautions

• Daxas can increase the risk of psychiatric problems such as trouble sleeping, anxiety, nervousness, and depression. There have been rare reports of suicidal thoughts, behavior, and completed suicide. Tell your doctor right away about any changes in mood or behavior, or any suicidal thoughts. Daxas is not recommended for people with a history of depression linked to suicidal thoughts or behavior.
• Some patients lose weight while taking Daxas. You should weigh yourself regularly, and tell your doctor about any unexplained or concerning weight loss, as treatment may need to be stopped.
• Daxas should not be started, or should be stopped, in people with severe immune system diseases, severe acute infections, or cancer (other than basal cell skin cancer), and in those taking certain immune-suppressing medicines, because there isn't enough experience using it in these situations.
• Daxas has not been studied in people with certain serious heart failure conditions, so it is not recommended for them.
• Daxas is not a rescue medicine for sudden breathing attacks. You still need another medicine on hand at all times for that purpose.
• This medicine contains lactose. People with certain rare hereditary sugar intolerance conditions should not take it.
• Combining Daxas with theophylline is not recommended because there isn't data to support it.
• Daxas should not be used during pregnancy or by women who could become pregnant unless they are using effective contraception, because of limited safety data. Daxas should not be used while breastfeeding because it may pass into breast milk and a risk to the baby cannot be ruled out.
• No dose change is needed for people with kidney problems, including severe kidney impairment. People with moderate or severe liver problems should not take Daxas. Those with mild liver impairment should use it with caution since there isn't enough data to confirm the right dose.
• No major direct interaction with alcohol is established, but excessive alcohol can worsen liver or general health problems.
• Daxas does not affect your ability to drive or use machines.

Storage

• Keep out of the reach and sight of children
• Do not use after the expiry date, which refers to the last day of that month
• This medicine does not require any special storage conditions
• Medicines should not be disposed of via wastewater or household waste; ask your pharmacist how to dispose of medicines no longer required

When to see a doctor

• If you have a severe allergic reaction—such as swelling of the face, lips, mouth, tongue or throat causing trouble swallowing or breathing, hives, severe dizziness with a very fast heartbeat, and heavy sweating—stop taking Daxas and get emergency medical help right away.
• Tell your doctor immediately if you have any suicidal thoughts. If you take more Daxas than you should, contact your doctor or pharmacist right away and bring your medicine and leaflet with you.

Alternatives

• Tiotropium
• Umeclidinium
• Glycopyrronium
• Budesonide