Pirfenidone Tablets 200mg Tablet

What is Pirfenidone Tablets 200mg Tablet?

Pirfenidone Tablets 200 mg contain pirfenidone, an oral antifibrotic medicine used in the management of idiopathic pulmonary fibrosis (IPF). Pirfenidone is a pyridone compound that may help reduce processes associated with pulmonary fibrosis. The 200 mg tablet provides pirfenidone for oral administration.

Uses / Indications

Pirfenidone tablets are used for the treatment of:

• Idiopathic pulmonary fibrosis (IPF)
• Progressive fibrotic lung disease where pirfenidone is an approved treatment, subject to applicable product information and local regulatory requirements

Pirfenidone is specifically indicated for idiopathic pulmonary fibrosis in established prescribing information.

Benefits

• Provides an oral formulation of pirfenidone for antifibrotic therapy.
• Used in the management of idiopathic pulmonary fibrosis.
• Supports treatment regimens intended to address the progression of pulmonary fibrosis.
• Available as a 200 mg tablet for oral administration.
• May be incorporated into a healthcare professional-directed treatment regimen.

Side Effects

Common Side Effects

Possible adverse effects may include:

• Nausea
• Diarrhoea
• Dyspepsia
• Vomiting
• Abdominal discomfort
• Dizziness
• Fatigue
• Decreased appetite
• Skin rash
• Photosensitivity reactions

Gastrointestinal effects and photosensitivity reactions are recognised adverse effects associated with pirfenidone treatment.

Less Common or Serious Side Effects

Clinically important reactions may include:

• Liver function abnormalities
• Significant photosensitivity reactions
• Severe skin reactions
• Serious hypersensitivity reactions
• Persistent or severe gastrointestinal symptoms

Liver function testing is recommended before initiating treatment, and clinically significant skin reactions require prompt medical assessment.

How Does It Work?

Pirfenidone

Pirfenidone is an antifibrotic medicine whose pharmacological activity involves modulation of processes associated with fibrosis and inflammation. Its precise mechanism of action is not completely established.

By influencing pathways involved in fibrotic activity, pirfenidone is used to help manage idiopathic pulmonary fibrosis. The clinical use and treatment response should be assessed by a qualified healthcare professional.

Dosage Guidelines

The appropriate dosage of pirfenidone depends on the indication, treatment stage, tolerability, liver function, renal status, smoking status and other patient-specific factors.

For IPF, established prescribing information uses a gradual dose escalation before reaching the maintenance regimen, and pirfenidone is taken with food. The specific regimen for a 200 mg formulation should follow the approved product information for that formulation and market.

The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.

For oral tablets:

• Take exactly as prescribed.
• Take with food where specified by the approved product information.
• Follow the prescribed treatment schedule.
• Do not alter or discontinue treatment without professional advice.
• Liver function should be assessed as clinically appropriate.

When Not to Use

Pirfenidone should not be used in patients with a known hypersensitivity to pirfenidone or any component of the formulation.

Particular medical assessment may be required in patients with:

• Liver impairment
• Significant renal impairment
• A history of serious photosensitivity reactions
• Conditions associated with increased risk of adverse skin reactions

The approved product information should be consulted for specific contraindications and dose modifications.

Drug / Product Interactions

Clinically relevant interactions may occur because pirfenidone metabolism can be affected by other medicines and smoking.

Particular attention may be required with:

• Strong or moderate CYP1A2 inhibitors
• Medicines that may affect hepatic metabolism
• Other medicines associated with liver injury
• Smoking, which can reduce pirfenidone exposure

Patients should inform their healthcare professional about all prescription medicines, over-the-counter medicines, vitamins and herbal products they use.

Safety Advice

Overdose

If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

Missed Dose

Take the missed dose according to the approved product information and prescribed schedule. Do not take two doses at the same time to compensate for a missed dose unless specifically instructed by a healthcare professional.

Pregnancy

Pirfenidone should be used during pregnancy only following appropriate medical assessment. Patients who are pregnant or planning pregnancy should discuss treatment with their healthcare professional.

Breastfeeding

It is not established whether pirfenidone passes into human breast milk. A healthcare professional should assess the potential benefits and risks before use during breastfeeding.

Children

The safety and effectiveness of pirfenidone in children have not been established in the cited prescribing information.

Elderly Patients

Older patients should use pirfenidone according to professional medical advice, with consideration of liver, kidney and other relevant clinical factors.

Renal Impairment

Patients with renal impairment may require particular assessment before and during treatment. The appropriate use and dose should follow the approved product information.

Liver Function

Liver function tests should be conducted before initiating pirfenidone, with further monitoring as clinically appropriate.

Smoking

Smoking may reduce exposure to pirfenidone. Patients should discuss smoking cessation with their healthcare professional.

General Instructions

• Take the medicine according to the prescribed schedule.
• Take with food where directed by the approved product information.
• Follow the prescribed treatment and dose-escalation schedule where applicable.
• Do not alter the dose without professional advice.
• Report persistent gastrointestinal symptoms or significant skin reactions.
• Follow recommended liver-function monitoring.
• Keep the medicine in its original packaging where appropriate.
• Do not share prescription medicines.

Special Dietary / Lifestyle Tips

Pirfenidone should be taken with food according to established prescribing information, which may help reduce nausea and dizziness.

Patients should avoid smoking during treatment where possible because smoking can affect pirfenidone exposure.

Comparison with Other Treatments

Pirfenidone is an antifibrotic medicine used in the management of idiopathic pulmonary fibrosis. Other treatments for fibrotic lung disease may have different mechanisms, indications, dosing schedules and safety considerations.

Treatment selection depends on the specific diagnosis, disease characteristics, concomitant medicines, organ function, tolerability and applicable prescribing guidance.

Precautions & Warnings

• Liver function should be assessed before starting treatment.
• Monitor for signs of liver-related adverse effects where clinically appropriate.
• Protect skin from excessive sunlight and monitor for photosensitivity reactions.
• Seek medical advice if severe rash or other significant skin reactions develop.
• Persistent nausea, diarrhoea, vomiting or abdominal symptoms should be reported.
• Inform the healthcare professional about all other medicines being taken.
• Smoking may reduce pirfenidone exposure.
• Use during pregnancy or breastfeeding should follow appropriate professional assessment.
• Patients with renal or hepatic impairment may require additional assessment.

Pirfenidone prescribing information specifically highlights liver monitoring, photosensitivity, severe cutaneous reactions and gastrointestinal adverse effects.

Can I Use It With Other Medicines?

Generally Compatible With

Pirfenidone may be used with other medicines when clinically appropriate following assessment of the patient’s complete medication profile.

Use With Caution / Avoid

Professional advice is particularly important when pirfenidone is used with:

• CYP1A2 inhibitors or other medicines that may alter pirfenidone exposure
• Medicines associated with liver injury
• Other medicines metabolised through pathways that may affect pirfenidone concentrations
• Regular smoking or tobacco exposure

Do not start, stop or change other medicines without appropriate medical advice.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

• Keep properly closed.
• Protect from excessive heat.
• Protect from moisture.
• Keep out of reach of children.
• Do not use after the expiry date.
• Keep in the original packaging where appropriate.

Frequently Asked Questions

1. What is Pirfenidone Tablets 200 mg used for?

Pirfenidone is an antifibrotic medicine indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

2. What is the active ingredient in Pirfenidone 200 mg Tablets?

The active ingredient is pirfenidone 200 mg per tablet.

3. How does Pirfenidone work?

Pirfenidone has antifibrotic and anti-inflammatory pharmacological effects. Its precise mechanism is not completely established, but it is used to help manage fibrotic processes associated with idiopathic pulmonary fibrosis.

4. Should Pirfenidone be taken with food?

Established prescribing information recommends taking pirfenidone with food, which may also help reduce nausea and dizziness.

5. Does Pirfenidone require liver monitoring?

Yes. Liver function tests should be performed before initiating treatment, with further monitoring according to clinical requirements and approved prescribing information.

6. Can Pirfenidone cause skin reactions?

Pirfenidone can cause photosensitivity and skin reactions. Patients should take appropriate precautions against excessive sun exposure and seek medical advice for significant skin reactions.

7. What should I do if I miss a dose?

Follow the approved product instructions and prescribed schedule. Do not take two doses at the same time to make up for a missed dose.

8. How should Pirfenidone 200 mg tablets be stored?

Store the product according to the conditions stated on the approved product label and package insert, and keep it out of reach of children.