Generic Pirfenidone Tablets (Pirfenex by Cipla) is an antifibrotic agent which is used to treat mild to moderate forms of a certain lung disease called Idiopathic Pulmonary Fibrosis (IPF). This disease causes the lungs to get scarred and become stiff, making it difficult to breathe.

1. Generic Pirfenidone Tablets
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Generic Pirfenidone Tablets (Pirfenex by Cipla) is
an antifibrotic agent which is used to treat mild to
moderate forms of a certain lung disease called
Idiopathic Pulmonary Fibrosis (IPF). This disease
causes the lungs to get scarred and become stiff,
making it difficult to breathe.

2. Pirfenex Tablets
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Pirfenex Tablets are manufactured
by Cipla Limited, India.
(Website: www.cipla.com)

3. Pirfenidone Tablets – Brand Names
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Pirfenidone tablets are available as
Esbriet, Pirfenex, Etuary, KitosCell LP
and Pirespa.

4. Active Ingredient
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The active ingredient contained in Pirfenex
Tablets is Pirfenidone. Each film-coated
tablet contains 200 mg of Pirfenidone.

5. Chemical Structure
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The structure of Pirfenidone is given below:

6. Uses of Pirfenex Tablets
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Pirfenex tablets manufactured by Cipla
Limited, India are indicated for the treatment
of Idiopathic Pulmonary Fibrosis (IPF), a
medical condition wherein a scar tissue
forms deep within the lungs. The scar tissue
thickens and becomes stiff or thick over time,
which can make it harder for the lungs to
work.

7. Pirfenex Dosage
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➢The starting dose of Generic Pirfenidone
Tablets (Pirfenex) for adults is 200 mg, three
times a day (600 mg/day), after a meal.
➢ Gradually increase the dose to 600 mg, three
times a day (1,800 mg/day), under
observation .
➢Furthermore, appropriately increase or
decrease the dose from time to time depending
upon the symptoms.
The dosage of Pirfenex tablets (Generic
Pirfenidone) is given below:

8. Generic Pirfenidone Dosage
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➢The treatment has to be started with 200 mg tablets
given three times a day (600 mg/day). After 2 weeks,
the dose has to be gradually increased by 200 mg at a
time. It is desirable to maintain or achieve a final dose
of 600 mg at a time (1,800 mg/day).
➢Patients who miss their dose for 14 consecutive days
or more of Pirfenidone treatment should re-initiate
therapy by undergoing the initial dose titration regimen
up to the recommended daily dose.
➢In case the treatment interruption is less than 14
consecutive days, the dose can be resumed at the
previous recommended daily dose without titration.
The dosage of Generic Pirfenidone tablets
(Pirfenex by Cipla) is given below:

9. Storage Instructions
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Generic Pirfenidone Tablets (Pirfenex by
Cipla) have to be stored at controlled
room temperature i.e. from 20°C to 25°C
(68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Store in a cool dry place.
Keep this as well as all other medicines
away from children and pets.

10. Warnings
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Elevated liver enzymes: ALT, AST, and bilirubin
elevations have occurred with Generic Pirfenidone
tablets (Pirfenex). Monitor ALT, AST, and bilirubin
before and during treatment. Temporary dosage
reductions or discontinuations may be necessary.
Gastrointestinal Disorders: Nausea, vomiting,
diarrhea, dyspepsia, gastro-esophageal reflux
disease, and abdominal pain have occurred with
Generic Pirfenidone tablets. Temporary dosage
reductions or discontinuations may be necessary.
Before using this medication, tell your doctor or
pharmacist your medical history, especially of: liver
disease, kidney disease (such as dialysis).

11. Warnings
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Photosensitivity and Rash: Photosensitivity and
rash have been observed with Pirfenex
tablets. Avoid exposure to sunlight and
sunlamps.
This medication may make the patients more
sensitive to the sun. They must limit their time in
the sun and avoid tanning booths and
sunlamps. They must use sunscreen and wear
protective clothing when outdoors.
Patients must tell their doctor right away if they
get sunburned or have skin blisters/redness.
Temporary dosage reductions or
discontinuations may be required.

12. Warnings
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This medicine may make patients dizzy or
tired or drowsy. Patients must not drive, use
machinery, or do any activity that requires
alertness until they are sure that they can
perform such activities safely.
Limit alcoholic beverages.
Before having surgery, patients must inform
their doctor or dentist about all the medicines
or supplements that they use (including
prescription drugs, nonprescription drugs, and
herbal products).

13. Pirfenex Tablets
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Contraindications
Pirfenex is contraindicated in patients with a
hypersensitivity to Pirfenidone or any other
component of this medication.
They are also contraindicated in patients with a
history of angioedema with Pirfenidone,
concomitant use of Fluvoxamine, severe hepatic
impairment or end stage liver disease and Severe
renal impairment (CrCl <30 ml/min) or end stage
renal disease requiring dialysis

14. Generic Pirfenidone Side Effects
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➢The most common Generic Pirfenidone
Tablets (Pirfenex by Cipla) side effects with an
incidence rate of 10% or more are nausea,
rash, abdominal pain, upper respiratory tract
infection, diarrhea, fatigue, headache,
dyspepsia, dizziness, vomiting, anorexia, gastro-
esophageal reflux disease, sinusitis, insomnia,
weight decreased, and arthralgia.
➢Get medical help immediately in case the
patient has any symptoms of liver damage,
including: persistent nausea/vomiting, loss of
appetite, stomach/abdominal pain, yellowing
eyes/skin, dark urine.

15. Generic Pirfenidone Overdose
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Multiple doses of Pirfenidone up to a dose
of 4806 mg/day were administered as six
267 mg capsules three times daily to
healthy adult volunteers over a 12-day
dose escalation period. Adverse reactions
were mild, transient, and consistent with
the most frequently reported adverse
reactions for Pirfenidone.

16. Generic Pirfenidone Overdose
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In cases of a suspected Generic
Pirfenidone Tablets (Pirfenex by Cipla)
overdose, supportive medical care must be
provided including monitoring of vital signs
and close observation of the clinical status
of the patient.

17. Pirfenidone Tablets During Pregnancy
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Pirfenidone Tablets (Pirfenex by Cipla) has
been classified by the US FDA as
Pregnancy Category C.
Animal reproduction studies have shown
an adverse effect on the fetus and there
are no adequate and well-controlled
studies in humans, but potential benefits
may warrant use of the medication in
pregnant women inspite of the potential
risks.

18. Pirfenex Tablets
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Pirfenex Tablets click here
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Pirfenex (Generic Pirfenidone tablets) by
Cipla Limited, India.