Aprezo 10 Mg Tablet (4 Tab)

APREZO 10 MG TABLET (4 TAB) by GLENMARK PHARMACEUTICALS LTD.

• Name:

  • Brand Name: Aprezo 10 Tablet
  • Common Name: Apremilast

• Composition:

  • Each tablet contains 10 mg of Apremilast as the active ingredient.

• Uses: Aprezo 10 Tablet is a phosphodiesterase 4 (PDE4) inhibitor used to treat various inflammatory conditions. It is prescribed for:

  • Moderate to severe plaque psoriasis (a chronic inflammatory skin disease).
  • Active psoriatic arthritis (inflammation in the joints for people with psoriasis).
  • Oral ulcers associated with Behçet's disease (an uncommon inflammatory illness).

• Dosage and Administration: Aprezo 10 Tablet is taken orally, with or without food. The typical dosage involves a gradual titration over five days, starting with 10 mg once daily on Day 1 and increasing to a recommended maintenance dose of 30 mg twice daily by Day 6. Tablets should be swallowed whole and not crushed, chewed, or broken.

• Side Effects:

  • Common: Diarrhea, nausea, vomiting, headache, upper respiratory tract infection, stomach pain, loss of appetite, and back pain.
  • Serious: Depression with suicidal thoughts, significant unexplained weight loss, and changes in behavior or mood.

• Precautions: Do not take Aprezo 10 Tablet if you are allergic to Apremilast or its components. It is not recommended for individuals with severe diarrhea, nausea, vomiting, or a history of depression with suicidal thoughts. Use with caution in patients with severe kidney problems, as a dosage adjustment may be necessary. Consult a doctor if you are pregnant or breastfeeding. Inform your doctor about all other medications you are taking, including herbal remedies like St. John's Wort, as interactions can occur.

• Storage: Store Aprezo 10 Tablet below 30°C in a cool and dry place, protected from moisture, sunlight, and heat. Keep out of sight and reach of children.

APREZO 10 MG TABLET contains the active ingredient Apremilast, which is used to treat certain inflammatory conditions. It is manufactured by Glenmark Pharmaceuticals Ltd.

Here are some frequently asked questions about APREZO 10 MG TABLET:

What is APREZO 10 MG TABLET used for?

APREZO 10 MG TABLET is primarily used to treat active psoriatic arthritis, moderate to severe plaque psoriasis, and oral ulcers associated with Behçet's disease in adults.

How does APREZO 10 MG TABLET work?

APREZO 10 MG TABLET works by inhibiting phosphodiesterase 4 (PDE4), an enzyme involved in the inflammatory process. By doing so, it increases levels of cyclic adenosine monophosphate (cAMP) inside cells, which helps to reduce the production of various inflammatory mediators and increase anti-inflammatory mediators, thereby decreasing inflammation.

What is the usual dosage for APREZO 10 MG TABLET?

The recommended adult dosage of apremilast is typically 30 mg twice daily, but treatment usually begins with a lower dose that is gradually increased over the first 5 to 6 days to minimize gastrointestinal side effects. For example, a common titration schedule starts with 10 mg once daily on Day 1, increasing gradually to 30 mg twice daily by Day 6. If you have severe kidney problems, your doctor may recommend a reduced maintenance dose, often 30 mg once daily.

What are the possible side effects of APREZO 10 MG TABLET?

Common side effects include diarrhea, nausea, headache, upper respiratory tract infection, vomiting, and decreased appetite with potential weight loss. More serious, but less common, side effects can include severe diarrhea, nausea, and vomiting, as well as mood changes, including depression or suicidal thoughts. If you experience any severe or persistent side effects, especially mood changes, contact your doctor immediately.

Is APREZO 10 MG TABLET safe during pregnancy or breastfeeding?

APREZO 10 MG TABLET is generally not recommended during pregnancy or breastfeeding. There are limited human studies on its use during pregnancy, and animal studies have shown potential risks. Apremilast has been detected in the milk of lactating mice, and it is unknown if it passes into human breast milk. Therefore, it is advised to avoid this medication if you are pregnant, planning to become pregnant, or breastfeeding.

Can APREZO 10 MG TABLET be taken with other medications?

APREZO 10 MG TABLET can interact with certain medications. It is not recommended to take it with strong inducers of the CYP450 enzyme system, such as rifampin (an antibiotic), carbamazepine, phenobarbital, or phenytoin (used for seizures), and St. John's Wort (an herbal supplement), as these can decrease the effectiveness of apremilast. Always inform your doctor and pharmacist about all prescription, over-the-counter, herbal, and vitamin supplements you are taking.

What precautions should be taken while taking APREZO 10 MG TABLET?

It is important to monitor your progress regularly with your doctor. Your doctor may check your weight, as apremilast can cause weight loss, and consider discontinuation if significant unexplained weight loss occurs. Be sure to inform your doctor if you have a history of depression or suicidal thoughts, as this medication can worsen psychiatric symptoms. Use with caution in elderly patients, who may be at higher risk for complications from severe gastrointestinal issues like diarrhea, nausea, or vomiting. Dosage adjustment is necessary for patients with severe renal impairment (creatinine clearance less than 30 mL/minute).

What happens if a dose of APREZO 10 MG TABLET is missed?

If you miss a dose of APREZO 10 MG TABLET, 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 the missed one.

How should APREZO 10 MG TABLET be stored?

Store APREZO 10 MG TABLET in a closed container at room temperature, away from excessive heat, moisture, and direct light. Do not freeze the medicine. Keep all medications out of the reach of children and pets.