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Drug information on Pirfenex (200mg) (Pirfenidone) from Cipla Limited

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Pirfenex (200mg)   Film coated tablet Cipla Limited Generic : Pirfenidone	160.00 200mg 10

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Asthma

Bronchiectasis

Chronic Obstructive Pulmonary Disease

Whooping Cough

Pirfenidone is a novel drug with anti-inflammatory and antifibrotic properties which improves lung function in idiopathic pulmonary fibrosis(IPF).

•  Gastrointestinal: Nausea, vomiting, gastritis, GERD (gastro oesophageal reflux disease), loss of appetite, indigestion, abdominal pain, abdominal distension

•  Skin: Photosensitivity, rash, itching and dry skin

•  Central Nervous System: Dizziness, insomnia, and fatigue

•  Respiratory: Sinusitis and upper respiratory infections

•  Others: Increased liver enzymes, joint pain, weight loss

• The recommended daily maintenance dosage for adults is 801mg (3 capsules of 267mg each) three times a day to be taken with food.
• The maximum daily dosage should not exceed 2403mg.

In treating idiopathic pulmonary fibrosis, the dosage can be started as per the following schedule:

From day 1 to 7 - 1 capsule per day
From day 7 to 14 - 2 capsules per day
From day 15 - 3 capsules per day

• Patients who miss pirfenidone for 14 days or more should restart the treatment with initial 2 week schedule to reach the full maintenance dosage schedule that starts from day 15.
• Patients who miss less than 14 days, the dosage before the interruption can be continued. They should not take two doses at the same time and more than three doses per day.

• Pirfenidone comes as a capsule to be taken by mouth.
• It is usually taken with food to avoid gastric discomfort.
• The capsules to be taken at the same time every day.

Pirfenidone is not recommended in patients with:

• End stage renal disease who require dialysis.
• Severe liver impairment or damage.

It is also contraindicated in patients taking fluvoxamine treatment.

• Liver enzymes could increase during pirfenidone therapy. The levels to be monitored for either temporary dosage adjustment or discontinuation of the therapy.
• Rashes and sensitivity to sunlight, tanning beds and other fluorescent lamps can occur. Avoid direct sun exposure by using sunscreen (SPF- sun protection factor- 50 or even higher), protective clothing and sun glasses.
• The safety of pirfenidone in children is not known.

• Cigarette smoking during the therapy should be stopped as smoking causes increased clearance of drug from the body leading to decreased effectiveness of the drug.
• Increased calorie intake may be required in patients with excessive weight loss due to pirfenidone.

Increase in the toxicity of pirfenidone may occur with the following drugs and hence their combined use with pirfenidone should be avoided.

• Anti depressants such as fluvoxamine, fluoxetine and paroxetine
• Antibiotics such as ciprofloxacin and chloramphenicol

Decrease in the circulating plasma levels of pirfenidone could occur with drugs such as omeprazole.

• Store in a tightly closed container.
• Discard the medicine safely if the medicine is out of date or damaged.