Pirfenex 801 Mg Tab

PIRFENEX 801 MG TABLET

• Name:

  • Brand Name: Pirfenex 801 mg Tablet
  • Common Name: Pirfenidone (active ingredient)

• Composition:

  • Each film-coated tablet contains Pirfenidone 801 mg.

• Uses: Pirfenex 801 mg Tablet is primarily prescribed for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults. This medication helps to:

  • Manage mild to moderate IPF.
  • Slow down the progression of the disease by reducing scarring and swelling in the lungs.

• Dosage and Administration:

  • Pirfenex 801 mg Tablet should be taken orally with food, as prescribed by your doctor.
  • It is generally recommended to take it at the same time each day.
  • A typical dosage titration for adults begins with lower doses, gradually increasing to a maintenance dose. For instance, on Day 15 and thereafter, the maintenance dose is often 801 mg, three times a day, not exceeding 2403 mg per day. Do not alter the dosage or discontinue without consulting your doctor.

• Side Effects:

  • Common Side Effects: Nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dizziness, loss of appetite, indigestion, photosensitivity (increased sensitivity to sunlight), and vomiting.
  • Serious Side Effects: Symptoms of serious liver problems such as pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin may occur.

• Precautions:

  • Allergies: Do not use if allergic to pirfenidone or any of its components.
  • Photosensitivity: Pirfenidone can increase sensitivity to sunlight. Patients should use sunscreen (SPF 50 or higher), wear protective clothing, and avoid direct sun exposure.
  • Liver/Kidney Impairment: Use with caution in patients with mild to moderate liver or kidney impairment. It is contraindicated in severe liver impairment or end-stage kidney disease requiring dialysis. Regular liver function monitoring is advised.
  • Smoking: Smoking can reduce the effectiveness of the medication; it is essential to quit smoking during treatment.
  • Pregnancy and Breastfeeding: Not recommended during pregnancy as it may harm an unborn baby. Consult a doctor if breastfeeding.
  • Alcohol: Avoid consuming alcohol as it may increase dizziness.
  • Driving: May cause dizziness or sleepiness; avoid driving or operating machinery until you know how it affects you.
  • Drug Interactions: Inform your doctor about all medications you are taking, especially fluvoxamine (an antidepressant), which can increase pirfenidone levels. Other drugs like rifampin may decrease pirfenidone levels.

• Storage:

  • Store below 30°C.
  • Protect from light and moisture.
  • Keep out of reach and sight of children.

PIRFENEX 801 MG Tablet, containing pirfenidone, is a medication primarily used to treat Idiopathic Pulmonary Fibrosis (IPF), a chronic and progressive lung disease. It works by reducing scarring and inflammation in the lungs, thereby helping to slow the decline of lung function.

Here are some frequently asked questions about PIRFENEX 801 MG Tablet:

What is PIRFENEX 801 MG Tablet used for?

PIRFENEX 801 MG Tablet is used to treat Idiopathic Pulmonary Fibrosis (IPF) in adults. IPF is a condition where lung tissues become scarred and thickened over time, making it difficult to breathe. The medication helps to reduce fibrosis (scarring) and inflammation in the lungs, aiming to slow down the progression of the disease and improve lung function.

How does PIRFENEX 801 MG Tablet work?

While the exact mechanism is not fully understood, pirfenidone is believed to have antifibrotic, anti-inflammatory, and antioxidant properties. It works by interfering with the ability of cells to create scar tissue and by attenuating the production of transforming growth factor-beta 1 (TGF-β1), a key protein involved in the fibrotic process and inflammation.

What is the usual dosage for PIRFENEX 801 MG Tablet?

The typical daily maintenance dosage is 801 mg three times a day, for a total of 2403 mg/day. Treatment usually begins with a dose titration period over 14 days to improve tolerability:

• Days 1-7: 267 mg three times daily (total 801 mg/day).
• Days 8-14: 534 mg three times daily (total 1602 mg/day).
• Day 15 onwards: 801 mg three times daily (total 2403 mg/day). It is important to take the medicine with food at the same time each day.

What are the possible side effects of PIRFENEX 801 MG Tablet?

Common side effects include nausea, rash, abdominal pain, diarrhea, fatigue, headache, upset stomach, dizziness, vomiting, loss of appetite, heartburn (acid reflux), weight loss, joint pain, stuffy nose, sneezing, sore throat, and sleep problems (insomnia).

Serious side effects, though less common, can include severe ongoing stomach pain, signs of liver injury (yellowing of the skin or eyes, dark urine, pale stools, unusual bleeding or bruising, severe tiredness, or pain in the upper right side of the stomach), or severe allergic reactions (hives, difficulty breathing, swelling of the face, lips, tongue, or throat). If you experience any serious side effects, seek immediate medical attention.

Is PIRFENEX 801 MG Tablet safe during pregnancy or breastfeeding?

PIRFENEX is generally not recommended during pregnancy or breastfeeding. There is insufficient data on its use in pregnant women, and it is unknown if pirfenidone or its metabolites pass into human milk, with a potential for accumulation. Your doctor will weigh the potential benefits against the potential risks to decide if the medication is appropriate.

Can PIRFENEX 801 MG Tablet be taken with other medications?

PIRFENEX can interact with other medications, particularly those metabolized by the CYP1A2 enzyme. Strong CYP1A2 inhibitors (like fluvoxamine or enoxacin) can significantly increase pirfenidone levels and should generally be avoided or require a dose reduction of pirfenidone. Moderate CYP1A2 inhibitors (such as ciprofloxacin) may also necessitate a dose adjustment. Strong CYP1A2 inducers (like rifampin, carbamazepine, phenobarbital, or primidone) can decrease the effectiveness of pirfenidone and should be avoided. It's important to inform your doctor about all medications, vitamins, and herbal supplements you are taking. Avoid consuming grapefruit or grapefruit juice, as it can increase the concentration of pirfenidone in your blood.

What precautions should be taken while on PIRFENEX 801 MG Tablet?

Take PIRFENEX with food to help reduce gastrointestinal side effects. The medication can cause photosensitivity, making your skin more sensitive to sunlight. It is crucial to avoid or minimize exposure to direct sunlight and sunlamps, use a high SPF (50 or higher) sunblock daily, and wear protective clothing when outdoors. Regular liver function tests are necessary before and during treatment, usually monthly for the first 6 months and then every 3 months. Pirfenidone is not recommended for patients with severe liver impairment or end-stage renal disease. Smoking can lower the blood levels of pirfenidone, reducing its effectiveness, so quitting smoking is strongly advised.

What happens if a dose of PIRFENEX 801 MG Tablet is missed?

If you miss a dose, take it as soon as you remember with food. 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 two doses at the same time to make up for a missed dose. If you miss 14 consecutive days or more of treatment, contact your doctor, as you may need to restart the medication with the initial 2-week titration regimen.

How should PIRFENEX 801 MG Tablet be stored?

PIRFENEX 801 MG Tablets should be stored at room temperature, ideally at 25°C (77°F), with excursions permitted between 15-30°C (59-86°F). Keep the bottle tightly closed and protect the tablets from moisture and light. Safely dispose of any outdated or no longer needed medication. Keep out of reach of children.