Pirfenidon Cipla (Pirfenidone 267 mg)

What Is Pirfenidon Cipla and What Is It Used For?

Pirfenidon Cipla is a generic antifibrotic medicine prescribed for the treatment of idiopathic pulmonary fibrosis (IPF) in adults. It contains 267 mg of pirfenidone per tablet and helps slow the scarring process in the lungs, preserving breathing capacity and slowing disease progression.

Pirfenidon Cipla contains the active substance pirfenidone, which belongs to a class of medications known as antifibrotic agents. Pirfenidone was first approved by the European Medicines Agency (EMA) in 2011 and by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of idiopathic pulmonary fibrosis, making it one of the first medicines specifically developed for this rare, life-limiting disease. Following patent expiry, generic versions such as Pirfenidon Cipla became available, broadening access to antifibrotic therapy worldwide.

Idiopathic pulmonary fibrosis is a chronic, progressive disease in which the lung tissue gradually becomes thickened, stiff, and scarred (fibrotic). The term "idiopathic" means the cause of the fibrosis is unknown. As the scarring worsens, the lungs lose elasticity and become less efficient at transferring oxygen from inhaled air into the bloodstream. Patients typically experience a progressively worsening dry cough, breathlessness on exertion, fatigue, and characteristic finger clubbing. IPF primarily affects adults over the age of 50 and is more common in men than in women, with a median survival of 3 to 5 years after diagnosis without treatment.

While pirfenidone does not cure IPF or reverse established lung damage, pivotal clinical trials have demonstrated that it can significantly slow the rate of decline in lung function. The landmark ASCEND trial (Assessment of Pirfenidone to Confirm Efficacy and Safety in IPF) and the earlier CAPACITY trials showed that pirfenidone reduces the decline in forced vital capacity (FVC) – the key objective measure of lung function in IPF – and may improve progression-free survival compared with placebo. A pooled analysis published in the European Respiratory Journal also suggested a survival benefit for patients treated long-term.

The exact mechanism by which pirfenidone works is not fully understood, but research suggests it has three complementary properties: anti-fibrotic (reduces the proliferation of fibroblasts and formation of scar tissue), anti-inflammatory (reduces lung inflammation driven by cytokines such as TNF-alpha and TGF-beta), and antioxidant (protects cells from damage caused by reactive oxygen species). Together, these actions help slow the progressive scarring that characterises IPF at a cellular level.

Who Typically Receives Pirfenidon Cipla?

Pirfenidon Cipla is prescribed for adults with a confirmed diagnosis of idiopathic pulmonary fibrosis. Diagnosis is typically made by a multidisciplinary team including a pulmonologist, radiologist, and pathologist, using a combination of high-resolution CT (HRCT) imaging showing a typical usual interstitial pneumonia (UIP) pattern, clinical assessment, and pulmonary function tests. Some national guidelines also permit pirfenidone to be used in other forms of progressive pulmonary fibrosis, though approved indications vary between countries.

Patients starting Pirfenidon Cipla typically have mild to moderate IPF (FVC of 50–90% predicted and DLCO of 30–79% predicted), though real-world experience has expanded use to patients with more severe disease. Treatment is long-term and is typically continued indefinitely as long as the patient is deriving benefit and tolerating the medicine.

What Should You Know Before Taking Pirfenidon Cipla?

Before starting Pirfenidon Cipla, your doctor must evaluate your liver and kidney function, review all your current medications, assess your smoking status, and discuss the risks of sun sensitivity. Several medical conditions and drug interactions can make Pirfenidon Cipla unsafe or require dose adjustments.

It is essential that your prescribing physician has a complete picture of your medical history, current medications, and lifestyle before initiating treatment with Pirfenidon Cipla. Certain conditions absolutely prevent the use of this medicine, while others require careful monitoring, lifestyle modifications, and possible dose adjustments. Baseline investigations usually include liver function tests (ALT, AST, ALP, bilirubin), kidney function (creatinine, eGFR), full blood count, and a review of concomitant medicines for potential interactions.

Contraindications

You must not take Pirfenidon Cipla in the following situations:

• Hypersensitivity (allergy) to pirfenidone or any of the other ingredients in the tablet, including excipients such as microcrystalline cellulose, croscarmellose sodium, povidone, colloidal anhydrous silica, magnesium stearate, and film-coating components
• History of angioedema with pirfenidone – symptoms include swelling of the face, lips, and/or tongue, which may be accompanied by difficulty breathing or wheezing and represent a life-threatening reaction
• Concurrent use of fluvoxamine – this antidepressant (used for depression and obsessive-compulsive disorder) is a potent CYP1A2 inhibitor that dramatically increases pirfenidone blood levels, creating a high risk of serious toxicity
• Severe liver impairment or end-stage liver disease (Child-Pugh class C) – the liver is responsible for metabolising pirfenidone, and significantly impaired liver function can lead to dangerous drug accumulation
• Severe kidney disease or end-stage kidney disease requiring dialysis – impaired renal clearance affects drug elimination, and clinical data in this population are limited

Warnings and Precautions

Discuss the following with your doctor before and during treatment with Pirfenidon Cipla:

Photosensitivity (sun sensitivity): Pirfenidone significantly increases the skin's sensitivity to ultraviolet (UV) radiation. You may develop severe sunburn, blisters, or rashes even after brief sun exposure. Daily use of broad-spectrum sunscreen with SPF 50 or higher is essential, along with protective clothing covering the arms, legs, neck, and head. Wear a wide-brim hat and UV-blocking sunglasses outdoors, avoid direct sunlight between 10 a.m. and 4 p.m., and never use sunlamps or tanning beds during treatment. Do not combine Pirfenidon Cipla with tetracycline antibiotics (such as doxycycline or minocycline), since these further increase photosensitivity.

Liver function: Pirfenidone can cause elevations of liver enzymes, and rare cases of serious liver injury – some life-threatening – have been reported post-marketing. Baseline liver function tests are required before starting treatment, monthly for the first six months, and every three months thereafter for the duration of treatment. If liver enzyme levels rise significantly, your doctor will either reduce the dose temporarily, interrupt treatment, or discontinue it altogether. Patients should report any new symptoms of liver problems (yellowing of the skin or eyes, dark urine, right upper quadrant pain, easy bruising, unusual fatigue) immediately.

Severe skin reactions: Although rare, pirfenidone has been associated with Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking Pirfenidon Cipla and seek immediate medical attention if you develop widespread skin rashes, blisters, mouth sores, or skin peeling, especially if accompanied by fever. These conditions are medical emergencies.

Kidney problems: If you have mild to moderate kidney impairment, tell your doctor. While dose adjustment is not typically required based on age or mild renal dysfunction alone, more frequent monitoring may be necessary and the drug should be used with caution.

Smoking: Cigarette smoking induces CYP1A2 enzymes, which can substantially reduce blood levels of pirfenidone and decrease its effectiveness. Patients should stop smoking before starting Pirfenidon Cipla and remain abstinent throughout treatment. Smoking cessation also independently improves outcomes in IPF.

Dizziness and fatigue: Pirfenidon Cipla can cause dizziness and tiredness, especially during the dose titration phase. Exercise caution when driving, operating machinery, or performing any activity that requires alertness, balance, and coordination until you know how the medicine affects you.

Weight loss and decreased appetite: Pirfenidone may cause loss of appetite and weight loss, which can be particularly concerning in patients with advanced IPF who may already be losing weight. Your doctor will monitor your weight throughout treatment and may refer you to a dietitian if weight loss becomes clinically significant.

Gastrointestinal tolerability: Taking Pirfenidon Cipla with food is essential to minimise nausea and dizziness. A substantial meal is preferred over a snack.

Pregnancy and Breastfeeding

As a precautionary measure, it is advisable to avoid using Pirfenidon Cipla if you are pregnant, planning to become pregnant, or think you may be pregnant, as the risks to the unborn child are unknown. There are no adequate clinical studies of pirfenidone in pregnant women. Animal reproductive studies have not conclusively demonstrated either safety or teratogenic risk, and therefore a potential risk cannot be excluded. Women of childbearing potential should use effective contraception during treatment.

It is not known whether pirfenidone passes into human breast milk. Because of the potential for serious adverse reactions in a breastfed infant, and because of the importance of the drug to the mother, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother. Discuss the risks and benefits with your doctor before breastfeeding while taking Pirfenidon Cipla.

Children and Adolescents

Pirfenidon Cipla should not be given to children and adolescents under 18 years of age. The safety and efficacy of pirfenidone in paediatric patients have not been established. Idiopathic pulmonary fibrosis is almost exclusively an adult disease, and the use of antifibrotics in children is limited to highly specialised centres for very rare paediatric interstitial lung diseases, typically within clinical trials.

Elderly Patients

No dose adjustment is generally required in elderly patients based on age alone, which is particularly relevant given that the IPF population is predominantly older adults. However, elderly patients may be more susceptible to side effects, especially gastrointestinal symptoms, dizziness, and weight loss. Comorbidities and polypharmacy also increase the risk of clinically relevant drug interactions, so close monitoring is recommended.

Excipients and Sodium Content

Pirfenidon Cipla contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "sodium-free" and is unlikely to affect patients following a sodium-restricted diet. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine if the formulation contains lactose – please check the local product information supplied with the pack.

How Does Pirfenidon Cipla Interact with Other Drugs?

Pirfenidon Cipla (pirfenidone) is primarily metabolised by the CYP1A2 enzyme system in the liver. Drugs that inhibit CYP1A2 can increase pirfenidone levels and the risk of side effects, while CYP1A2 inducers can reduce its effectiveness. Several common medications, foods, and lifestyle factors produce clinically significant interactions.

Pirfenidone is metabolised mainly by the cytochrome P450 enzyme CYP1A2, with minor contributions from CYP2C9, CYP2C19, CYP2D6, and CYP2E1. Any medication, food, or habit that significantly affects CYP1A2 activity can alter pirfenidone blood levels, potentially leading to increased toxicity or reduced efficacy. Always provide your doctor and pharmacist with a complete list of medications you are taking, including over-the-counter drugs, dietary supplements, herbal remedies, and recreational substances. Reviewing medication lists annually and whenever a new drug is added is good practice.

Major Interactions (Avoid or Use with Extreme Caution)

Interactions That May Reduce Effectiveness

Food, Beverage, and Lifestyle Interactions

Grapefruit juice: You should not drink grapefruit juice while taking Pirfenidon Cipla. Grapefruit (and related citrus fruits such as Seville orange, pomelo, and bitter orange) contains furanocoumarins that inhibit CYP enzymes involved in pirfenidone metabolism, potentially leading to increased drug levels and a higher risk of side effects.

Tetracycline antibiotics (e.g., doxycycline, minocycline): While not a direct pharmacokinetic interaction, tetracyclines also cause photosensitivity. Taking them alongside pirfenidone can significantly increase the risk and severity of sun-related skin reactions. If a tetracycline is absolutely necessary, extra sun protection and careful monitoring are required.

Caffeine: Caffeine is metabolised by CYP1A2 and theoretically competes with pirfenidone. Moderate caffeine intake is not prohibited, but very high intake (more than 500 mg per day, roughly five or more cups of brewed coffee) may theoretically affect drug levels. Consistent, moderate caffeine intake is preferable to fluctuating high doses.

Alcohol: No direct pharmacological interaction between pirfenidone and alcohol is established, but alcohol can worsen dizziness and fatigue and may place additional stress on the liver. Most specialists advise limiting or avoiding alcohol during pirfenidone treatment, particularly during the dose titration phase.

What Is the Correct Dosage of Pirfenidon Cipla?

Pirfenidon Cipla is gradually titrated over a 14-day period to minimise side effects. The target maintenance dose is 801 mg (three 267 mg tablets) taken three times daily with food, for a total of 2,403 mg per day (9 tablets per day).

Treatment with Pirfenidon Cipla must be initiated and supervised by a specialist physician experienced in the diagnosis and management of idiopathic pulmonary fibrosis. Because Pirfenidon Cipla is supplied only as a 267 mg tablet, all doses at every stage of titration and maintenance are achieved by increasing the number of tablets taken at each administration. The dose is gradually increased over two weeks to allow the body to adjust to the medicine and to reduce the likelihood of gastrointestinal side effects such as nausea, vomiting, and diarrhoea.

Adults – Standard Dose Titration (267 mg Tablets)

Swallow the tablets whole with a glass of water, during or immediately after a meal. Taking Pirfenidon Cipla with food is important because it reduces the risk of nausea, dizziness, and other gastrointestinal symptoms, and a consistent meal pattern helps stabilise exposure. Spacing the three daily doses evenly (for example, with breakfast, lunch, and dinner) supports consistent drug levels and adherence. Using a pill organiser or setting phone alarms can be helpful, given the nine-tablet daily burden at maintenance.

Dose Reduction for Side Effects

Your doctor may reduce the dose if you experience tolerability problems such as bothersome gastrointestinal symptoms (nausea, vomiting, diarrhoea), severe skin reactions from sun exposure, or significant rises in liver enzyme levels on blood tests. Typical modifications include reducing from 3 tablets to 2 tablets three times daily (1,602 mg/day) or from 2 tablets to 1 tablet three times daily (801 mg/day) until symptoms resolve, after which the dose may be gradually re-escalated. Most patients tolerate the full maintenance dose once their body has adapted to the medicine.

Children

Pirfenidon Cipla is not approved for use in children or adolescents under 18 years of age. IPF does not typically occur in the paediatric population, and safety and efficacy data in children are not available. Paediatric interstitial lung diseases are managed in highly specialised centres, often within the context of clinical trials.

Elderly Patients

No dose adjustment is generally required in elderly patients based on age alone. However, elderly patients may be more susceptible to side effects, particularly gastrointestinal symptoms, dizziness, and weight loss. Close clinical monitoring is recommended, and dose adjustments should be made based on tolerability, liver function, and kidney function.

Special Populations

Mild to moderate liver impairment (Child-Pugh A and B): Use with close monitoring. Dose reduction may be required if liver enzymes rise. Pirfenidone is contraindicated in severe liver impairment (Child-Pugh C).

Mild to moderate kidney impairment (creatinine clearance 30–80 mL/min): No specific dose adjustment is recommended, but use with caution and closer monitoring. Pirfenidone is contraindicated in severe kidney impairment (creatinine clearance below 30 mL/min) and in patients requiring dialysis.

Ethnicity and body weight: No specific dose adjustment is required, though some pharmacokinetic differences have been observed between populations.

Missed Dose

If you forget a dose, take it as soon as you remember. However, do not take a double dose to make up for a missed one. There should be at least 3 hours between each dose. Never take more tablets in a single day than your prescribed daily dose. If you miss multiple doses or stop for more than 14 consecutive days, contact your doctor before restarting, as re-titration may be needed.

Overdose

If you (or anyone else) takes too many tablets, contact your doctor, pharmacist, emergency services, or the nearest emergency department immediately, and bring the medication carton and remaining tablets with you. Overdose symptoms may include an intensification of the known side effects, particularly gastrointestinal distress, dizziness, drowsiness, and elevated liver enzymes. There is no specific antidote for pirfenidone; treatment is supportive and may include close monitoring of liver enzymes, fluids, and management of any specific symptoms.

What Are the Side Effects of Pirfenidon Cipla?

Like all medicines, Pirfenidon Cipla can cause side effects, although not everyone gets them. The most common side effects include nausea, fatigue, diarrhoea, dizziness, and skin reactions from sun exposure. Serious but rare side effects include liver damage, severe allergic reactions, and serious skin conditions such as Stevens-Johnson syndrome.

Side effects with pirfenidone tend to be most prominent during the initial dose titration period and often improve as the body adjusts to the medicine. Taking Pirfenidon Cipla with food significantly reduces the incidence and severity of gastrointestinal side effects, and splitting doses evenly across the day can also help. If side effects are bothersome or persistent, your doctor can temporarily lower the dose, introduce supportive therapy (for example, antiemetics for nausea, topical treatments for rash), or use slower titration. Most patients ultimately tolerate the full maintenance dose.

Managing Common Side Effects

Nausea, vomiting, and indigestion: Take Pirfenidon Cipla during or immediately after a substantial meal. Try smaller, more frequent meals, stay well hydrated, avoid lying down for 30 minutes after each dose, and consider bland foods during flare-ups. Over-the-counter antiemetics or a short course of metoclopramide or ondansetron may be prescribed.

Diarrhoea: Maintain hydration with oral rehydration fluids. Loperamide may help if diarrhoea is persistent and non-infectious.

Photosensitivity: Apply SPF 50+ broad-spectrum sunscreen every morning, reapply every 2 hours outdoors, wear long sleeves, trousers, a wide-brim hat, and UV-blocking sunglasses, and avoid peak sun hours. Even on cloudy days, UV exposure can trigger reactions.

Fatigue: Prioritise sleep, pace activities throughout the day, engage in gentle regular exercise, and discuss options with your doctor if fatigue is severe. Pulmonary rehabilitation programmes often help.

If you experience any side effects, including those not listed here, talk to your doctor or pharmacist. Reporting side effects helps regulatory authorities continuously monitor the benefit-risk profile of medications. In the United States, report side effects to the FDA MedWatch program; in the European Union, contact your national medicines agency; in the United Kingdom, use the MHRA Yellow Card scheme; in Australia, use the TGA Database of Adverse Event Notifications.

How Should You Store Pirfenidon Cipla?

Store Pirfenidon Cipla at room temperature (below 30 °C), out of reach of children, in the original packaging to protect from moisture and light. Use before the expiry date printed on the carton and blister. No refrigeration is required.

Keep this medicine out of the sight and reach of children. Store Pirfenidon Cipla at room temperature, typically below 30 °C (86 °F). Keep the tablets in the original blister pack or bottle to protect them from moisture and light until you are ready to take them. No special refrigeration or freezing is required, and the medicine should not be exposed to extreme heat, direct sunlight, or humidity (for example, avoid the bathroom cabinet).

Do not use this medicine after the expiry date printed on the bottle label, blister pack, and carton after "EXP." The expiry date refers to the last day of that month. Discard any tablets that appear discoloured, broken, or otherwise compromised, even if they are within the expiry date.

Do not dispose of medicines via wastewater or household waste. Return unused or expired medicines to your pharmacy for safe disposal; many pharmacies operate take-back schemes. These measures help protect the environment and prevent accidental exposure or misuse.

Travel Considerations

When travelling, carry Pirfenidon Cipla in your hand luggage in its original packaging, along with your prescription and a letter from your doctor (particularly useful for international travel). Avoid leaving the medicine in a hot car or in checked luggage where it may be exposed to extreme temperatures. For long trips across time zones, ask your pharmacist in advance about adjusting the dosing schedule so doses remain roughly 8 hours apart without unintended double-dosing.

What Does Pirfenidon Cipla Contain?

Pirfenidon Cipla film-coated tablets contain pirfenidone 267 mg as the active ingredient, together with standard pharmaceutical excipients and a film coat. The tablets are oval or round, film-coated, and available in blister packs or bottles.

Each Pirfenidon Cipla film-coated tablet contains 267 mg of pirfenidone as the active substance. The other ingredients (excipients) are typical of film-coated tablets and include:

Tablet core excipients (typical): Microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, and magnesium stearate. These excipients ensure the tablet holds its shape, disintegrates in the stomach, and releases the active drug predictably.

Film coating (typical): Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, and iron oxide pigments (E172) for colour. The coating protects the tablet and helps with swallowing. The exact composition and colour of Pirfenidon Cipla 267 mg may vary; please refer to the patient information leaflet supplied with your specific pack for definitive excipient information and visual description.

Pirfenidon Cipla 267 mg is typically supplied in blister packs or in bottles, in pack sizes that support the starting, titration, and maintenance phases of treatment. Not all pack sizes may be marketed in all countries. The packaging usually includes markings or reminders to take the dose three times daily, especially important given the nine-tablet daily regimen at maintenance.

Bioequivalence to the Originator

As a generic medicine, Pirfenidon Cipla has been authorised on the basis of bioequivalence studies demonstrating that its rate and extent of absorption are comparable to the reference medicinal product (Esbriet). Generic medicines contain the same active ingredient in the same strength and dosage form, are manufactured to the same pharmaceutical quality standards, and must meet the same regulatory requirements for safety, efficacy, and quality as their originator counterparts. Excipients may differ, which is relevant only for patients with specific allergies or intolerances.