FIBRODONE 400 Tablet 10's

Idiopathic Pulmonary Fibrosis Rx required

Best Price* ₹ 296.00 MRP ₹ 370.00
(Inclusive of all taxes) *10 Tablet(s) in a Strip * Mkt: Lupin Ltd * Country of Origin: India * Delivery charges if applicable will be applied at checkout

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INTRODUCTION

FIBRODONE 400 contains Pirfenidone which belongs to the group of medicines called Anti-fibrotics or Anti-inflammatory agents. It is used in the treatment of mild to moderate Idiopathic pulmonary fibrosis in adults. Idiopathic pulmonary fibrosis is a condition in which the tissues in the lungs (alveoli) become swollen and scarred over time and making it difficult to breathe. This makes it hard for the lungs to work properly.

FIBRODONE 400 is not recommended for use in patients with severe or end-stage liver or kidney disease. Before taking FIBRODONE 400 inform your doctor if you have mild to moderate liver disease, kidney problems or photosensitivity reactions. FIBRODONE 400 is not recommended for use in pregnant women unless advised by your doctor. It is not known whether FIBRODONE 400 passes into breast milk, hence consult your doctor before taking this medicine.

FIBRODONE 400 is not recommended for use in children and adolescents below 18 years of age. FIBRODONE 400 should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking this medicine. Avoid smoking while using FIBRODONE 400 as it reduces the effect of this medicine. Also, avoid drinking grapefruit juice as it may lead to unwanted effects.

The most common side effects of taking FIBRODONE 400 are nausea, stomach problems such as acid reflux, vomiting, constipation, diarrhoea, indigestion or stomach upset, weight loss, decreased appetitetiredness, dizziness, headache. Consult your doctor if any of the above side effects worsen.

USES OF FIBRODONE 400

  • Treats idiopathic pulmonary fibrosis

HOW FIBRODONE 400 WORKS

FIBRODONE 400 works by exhibiting anti-inflammatory, antioxidant and antifibrotic properties that suppress the factors (transforming growth factor -β (TGF-β)) causing scarring and swelling of the tissues. As a result, it treats and controls the fibrosis of the tissues resulting in improving lung function.

DIRECTIONS FOR USE

Take FIBRODONE 400 as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF FIBRODONE 400

COMMON

  • infections of the throat or the airways and sinusitis, influenza and/or common cold
  • nausea
  • stomach problems such as acid reflux, vomiting, constipation, diarrhoea, indigestion or stomach upset
  • weight loss
  • decreased appetite
  • difficulty sleeping
  • tiredness, dizziness, headache
  • shortness of breath
  • joint pain
  • bladder infections
  • feeling sleepy
  • change in taste sensation
  • hot flushes
  • bloating, abdominal pain and discomfort, heartburn, and flatulence
  • elevated liver enzymes
  • sunburn or skin reactions due to exposure in the sun or to sun lamps
  • skin problems such as rashes, itchy skin, redness, dry skin
  • muscle pain
  • weakness or feeling low in energy
  • chest pain

UNCOMMON

  • headache, dizziness, confusion, weakness, muscle cramps or nausea and vomiting (due to low levels of sodium in the blood)

Stop taking FIBRODONE 400 and contact your doctor immediately if you experience any of the following side effects:

  • signs of angioedema or serious allergic reactions or anaphylaxis such as urticaria, itching, swelling of the face, lips, tongue or throat causing difficulty in breathing or feeling faint
  • signs of abnormal liver function such as yellowish discolouration of skin and white of the eye, dark urine, itching of the skin, pain on the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily and tiredness
  • signs and symptoms of stevens-johnson syndrome or toxic epidermal necrolysis such as fever and flu-like symptoms followed by reddish or circular patches on the trunk, often with central blisters, peeling of the skin, ulcers on mouth, throat, eyes, nose and genitals

HOW TO MANAGE SIDE EFFECTS

Headache:

Drink ample amount of water. Get adequate rest. Try to be relaxed and stress free. Apply a pain-relieving balm on the forehead if necessary. Contact your doctor if the symptom does not improve.

Nausea and Vomiting:

Take the FIBRODONE 400, with or just after a meal. Stick to simple meals. Avoid eating oily, fried or spicy foods. Contact your doctor if the symptom does not improve.

Diarrhoea:

Drink lot of fluids, such as water or fruit juices to keep yourself hydrated. Do not take any medicine on your own to treat diarrhoea. Contact your doctor if the symptom does not improve.

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. Contact your doctor if the symptom does not improve.

Decreased appetite:

Eat when you feel hungry. Eat smaller meals frequently than usual. Snack only when you're hungry. Eat a nutritious snack which is rich in calories and protein, such as dried fruit and nuts. Contact your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

PREGNANCY

FIBRODONE 400 is not recommended for use if you are pregnant, planning to become pregnant or think you might be pregnant as the potential risks to the unborn child are unknown. Consult your doctor before taking FIBRODONE 400.

BREASTFEEDING

It is not known whether FIBRODONE 400 pass through the breast milk, hence, consult your doctor before taking FIBRODONE 400.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel dizzy or tired after taking FIBRODONE 400.

KIDNEY

FIBRODONE 400 is not recommended for use in patients with severe or end-stage kidney disease (requiring dialysis). It should be used with caution in patients with mild to moderate kidney problems. Consult your doctor before taking FIBRODONE 400.

LIVER

FIBRODONE 400 is not recommended for use in patients with severe or end-stage liver disease. It should be used with caution in patients with mild to moderate liver disease. Consult your doctor before taking FIBRODONE 400.

ALLERGY

Do not take FIBRODONE 400 if you are allergic to Pirfenidone.

OTHERS

Before taking FIBRODONE 400, inform your doctor if you:

  • have photosensitive reactions (more sensitive) to sunlight
  • are a smoker

Use in pediatrics:

FIBRODONE 400 is not recommended for use in children and adolescents under 18 years of age. Contact child’s doctor for advice.

Use in geriatrics:

FIBRODONE 400 should be taken with caution in elderly patients (above 65 years of age) Your doctor will decide the dose, duration of the treatment and its frequency for you depending on the severity of your existing condition and other comorbid diseases.

INTERACTIONS

A. Drug-Drug Interaction:

Before taking FIBRODONE 400, inform your doctor if you are taking any of the following medicines:

  • fluvoxamine (used to treat depression and obsessive-compulsive disorder)
  • chloramphenicol, enoxacin, ciprofloxacin, doxycycline (used to treat bacterial infections)
  • amiodarone, propafenone, mexiletine, quinidine (used to treat heart rhythm disorders)
  • omeprazole, esomeprazole (used to treat indigestion or acid reflux)
  • rifampicin, rifampin (used to treat tuberculosis).
  • methoxsalen (used to treat skin diseases like psoriasis and vitiligo)
  • oral contraceptives such as ethinyl estradiol or norethindrone (used to prevent pregnancy)
  • miconazole, fluconazole, voriconazole, terbinafine (used to treat fungal infections)
  • moclobemide, fluoxetine, duloxetine, paroxetine (used to treat depression)
  • bupropion (helps to stop smoking)
  • cinacalcet (used to treat hyperparathyroidism)
  • phenytoin, carbamazepine (used to treat fits)

B. Drug - Food interaction:

Avoid drinking grapefruit juice while taking FIBRODONE 400 as it may lead to unwanted effects. Consult your doctor before taking FIBRODONE 400.

Overdosage:

If you or anyone else accidentally take too much of FIBRODONE 400, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

Drug :   Pirfenidone
Pharmacological Category :   Anti-fibrotics or Anti-inflammatory agents
Therapeutic Indication :   Mild to moderate Idiopathic Pulmonary Fibrosis
Dosage Forms :   Tablet

MORE INFORMATION

  • Keep FIBRODONE 400 out of reach of children
  • Store at room temperature

FAQs ABOUT FIBRODONE 400

Can FIBRODONE 400 be used for treating lung disease?

Yes, FIBRODONE 400 is used to treat mild to moderate idiopathic pulmonary fibrosis (condition in which the lungs become scarred and breathing becomes increasingly difficult) in adults above 18 years of age. Consult your doctor before taking FIBRODONE 400.

Does FIBRODONE 400 cause liver damage?

Yes, FIBRODONE 400 may cause liver damage. Stop taking FIBRODONE 400 and contact your doctor if you experience any unusual symptoms like yellowish discolouration of skin and white of the eyes, dark urine, itching of the skin, pain on the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily and tiredness. Consult your doctor before taking FIBRODONE 400.

Does FIBRODONE 400 cause dizziness?

Yes, FIBRODONE 400 may cause dizziness. To manage this effect, try to rest and relax and get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Do not consume alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom does not improve.

Is FIBRODONE 400 a steroid medicine?

No, FIBRODONE 400 is not a steroid medication. It is used to treat mild to moderate idiopathic pulmonary fibrosis (IPF) in adults. It causes scarring and swelling of the lung tissue resulting in breathing difficulties. This medicine helps to reduce the symptoms of the disease and make you breathe better.

Is FIBRODONE 400 safe to use during pregnancy?

FIBRODONE 400 is not recommended for use if you are pregnant, planning to become pregnant or think you might be pregnant as the potential risks to the unborn child are unknown. Consult your doctor before taking FIBRODONE 400.

REFERENCES

1. Laurance Brunton. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. Chemotherapy of neoplastic diseases 12th Edition, 2011. Page - 1718.

2. Genentech, Inc. Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) (ASCEND). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in April 2017] [Accessed on 18th June 2022] https://clinicaltrials.gov/ct2/show/NCT01366209

3. Paul W. Noble, Carlo Albera, Williamson Z. Bradford, Ulrich Costabel, Roland M. du Bois, Elizabeth A. Fagan, Robert S. Fishman, Ian Glaspole, Marilyn K. Glassberg, Lisa Lancaster, David J. Lederer, Jonathan A. Leff, Steven D. Nathan, Carlos A. Pereira, Jeffrey J. Swigris, Dominique Valeyre, and Talmadge E. King, Jr. Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials. NIH. National Library of Medicine, National center for biotechnology information. January 2016. [Accessed on 18th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697914/

4. Roche Products Limited. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on 18th June 2022] https://www.medicines.org.uk/emc/files/pil.2731.pdf

5. InterMune, Inc. U.S. Food & Drug Administration. [Revised in October 2014] [Accessed on 18th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022535s000lbl.pdf

6. Roche Pharma AG. European Medical Agency (EMA). [Revised in September 2015] [Accessed on 18th June 2022] https://www.ema.europa.eu/en/documents/product-information/esbriet-epar-product-information_en.pdf

7. Hoffmann-La Roche Limited. Pirfenidone. [Revised in August 2021] [Accessed on 18th June 2022] https://www.rochecanada.com/PMs/Esbriet/Esbriet_PM_E.pdf

USEFUL DIAGNOSTIC TESTS

  • Liver function tests

VIDEOS

Pirfenidone Tablet - Drug Information

Pirfenidone Tablet : Therapeutic Uses, Warning and Precautions, Interactions, Directions for Use, Side Effects and Storage

PRODUCT DETAILS

    Country Of Origin
    India
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ALTERNATE BRANDS
PRIFEDON 400 Tablet 15's
Prescription Idiopathic Pulmonary Fibrosis Rx required
Rs.615.00
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FIBRODONE 400 Tablet 10's

FIBRODONE 400 Tablet 10's Mkt: Lupin Ltd

M.R.P.: Rs.370.00
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