Aprezo 20 Mg Tablet (4 Tab)

APREZO 20 MG TABLET

APREZO 20 MG TABLET, manufactured by Glenmark Pharmaceuticals Ltd., is a medication used to treat certain inflammatory conditions.

• Name:

  • Brand Name: APREZO 20 MG TABLET
  • Common Name: Apremilast (also known by the brand name Otezla)

• Composition:

  • Each film-coated tablet contains Apremilast 20 mg.

• Uses: APREZO 20 MG TABLET is prescribed for adults to treat:

  • Active psoriatic arthritis, a form of arthritis associated with psoriasis.
  • Moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.
  • Oral ulcers associated with Behçet's disease. Apremilast works by blocking the action of certain natural substances in the body that cause inflammation.

• Dosage and Administration: APREZO 20 MG TABLET is taken orally, with or without food, and tablets should be swallowed whole; they should not be crushed, split, or chewed. Treatment typically begins with a 5-day titration schedule to minimize gastrointestinal side effects, gradually increasing the dose until the recommended maintenance dose is reached.

  • Initial Titration Schedule:
    • Day 1: 10 mg once daily (morning).
    • Day 2: 10 mg twice daily (morning and evening).
    • Day 3: 10 mg in the morning and 20 mg in the evening.
    • Day 4: 20 mg twice daily (morning and evening).
    • Day 5: 20 mg in the morning and 30 mg in the evening.
  • Maintenance Dose: From Day 6 onwards, the recommended dose is 30 mg twice daily (approximately 12 hours apart).
  • Renal Impairment: For patients with severe renal impairment (creatinine clearance less than 30 mL/minute), the recommended maintenance dose is 30 mg once daily in the morning, with a modified titration schedule.

• Side Effects: Common side effects often occur within the first few weeks of therapy and may include:

  • Diarrhea, nausea, vomiting, stomach pain.
  • Headache (including tension headache), fatigue.
  • Upper respiratory tract infection, nasopharyngitis, cough.
  • Decreased appetite, leading to weight loss. Serious side effects, though rare, can include:
  • Mood changes, depression, or suicidal thoughts.
  • Significant or unexplained weight loss.

• Precautions:

  • Patients should be monitored for severe diarrhea, nausea, or vomiting, especially elderly patients, and dose adjustment or discontinuation may be necessary.
  • Patients with a history of depression or suicidal thoughts should use this medicine with caution, and any worsening psychiatric symptoms should be reported to a doctor immediately.
  • Regular weight monitoring is recommended due to the potential for weight loss.
  • Apremilast is generally not recommended during pregnancy or breastfeeding, and women of childbearing potential should use effective contraception.
  • Inform your doctor about all other medications you are taking, including over-the-counter or herbal medicines, as drug interactions can occur, particularly with strong CYP3A4 inducers.

• Storage: Store APREZO 20 MG TABLET in a dry place where the temperature stays below 30°C (86°F). Keep the medicine out of reach of children.

APREZO 20 MG TABLET contains apremilast as its active ingredient. It is a phosphodiesterase 4 (PDE4) inhibitor, which helps reduce inflammation in the body.

What is APREZO 20 MG TABLET used for?

APREZO 20 MG TABLET is used to treat active psoriatic arthritis, moderate to severe plaque psoriasis, and oral ulcers associated with Behçet's disease in adults. Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis, causing inflammation in the joints. Plaque psoriasis is a skin condition characterized by red, scaly, itchy, and sometimes painful patches on the skin.

How does APREZO 20 MG TABLET work?

APREZO 20 MG TABLET works by inhibiting an enzyme called phosphodiesterase 4 (PDE4). By blocking PDE4, it helps to regulate the overactive immune response and reduce inflammation in the body, thereby alleviating the symptoms of psoriatic arthritis, plaque psoriasis, and oral ulcers.

What is the usual dosage for APREZO 20 MG TABLET?

The dosage for APREZO typically involves an initial titration schedule to reduce gastrointestinal symptoms. For adults, it usually starts with a low dose and gradually increases over 5 days until a maintenance dose is reached. A common titration schedule is:

• Day 1: 10 mg in the morning.
• Day 2: 10 mg in the morning and 10 mg in the evening.
• Day 3: 10 mg in the morning and 20 mg in the evening.
• Day 4: 20 mg in the morning and 20 mg in the evening.
• Day 5: 20 mg in the morning and 30 mg in the evening.
• Day 6 onwards (maintenance): 30 mg twice daily (approximately 12 hours apart). The tablets can be taken with or without food. For patients with severe kidney impairment (creatinine clearance less than 30 mL/minute), the recommended maintenance dose is usually 30 mg once daily, and the initial titration should only follow the morning schedule.

What are the possible side effects of APREZO 20 MG TABLET?

Common side effects include diarrhea, nausea, headache, upper respiratory tract infection (such as sore throat, cough, sneezing, runny nose, and nasal congestion), and vomiting. Some patients may also experience stomach pain, loss of appetite, and weight loss. More serious, though rare, side effects can include severe allergic reactions (like anaphylaxis or angioedema) and mood changes, including depression or suicidal thoughts.

Is APREZO 20 MG TABLET safe during pregnancy or breastfeeding?

APREZO (apremilast) is generally not recommended during pregnancy. There are limited studies in pregnant women, and animal studies have shown potential risks. Women who could become pregnant should use effective contraception during treatment. It is also contraindicated during breastfeeding, as it is not known whether apremilast or its metabolites are excreted in human milk, although it has been detected in the milk of lactating mice. It is recommended to consult your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding.

Can APREZO 20 MG TABLET be taken with other medications?

APREZO can interact with certain other medications. It is not recommended to take it with strong inducers of the CYP450 enzyme, such as rifampicin (used for tuberculosis), and certain medications for seizures like phenytoin, phenobarbital, and carbamazepine. These interactions can reduce the effectiveness of apremilast. Always inform your doctor about all prescription, non-prescription, herbal products, and dietary supplements you are taking to avoid potential interactions.

What precautions should be taken with APREZO 20 MG TABLET?

Before taking APREZO, inform your doctor if you have a history of depression or suicidal thoughts, kidney problems (especially severe impairment), or are underweight. Regular monitoring of weight is recommended, and unexplained or significant weight loss should be reported to your doctor. Patients should also be monitored for severe gastrointestinal symptoms like diarrhea, nausea, and vomiting, especially during the first few weeks of treatment, as these can sometimes lead to complications, particularly in elderly patients or those taking medications that cause volume depletion or hypotension.

What happens if a dose is missed?

If you miss a dose of APREZO, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double doses to make up for a missed one. If you miss more than one dose, consult your healthcare team for guidance.

How should APREZO 20 MG TABLET be stored?

APREZO should be stored in a closed container at room temperature, away from heat, moisture, and direct light. Keep it out of the reach of children. Do not keep outdated medicine or medicine no longer needed. It should generally be stored below 30ºC (86ºF).