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Other brands with the same active ingredient
These brands contain the same active ingredient (Pirfenidone). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Pulbo is used in adults to treat mild to moderate idiopathic pulmonary fibrosis (IPF), a condition in which scar tissue builds up in the lungs for no known cause.
Pharmacology
Pirfenidone is a newer medicine that works by calming inflammation, fighting cell damage from oxidative stress, and slowing the scarring process in the lungs. In people with idiopathic pulmonary fibrosis (IPF), it may help preserve lung function and cut down on flare-ups of the disease. Exactly how it does this at the molecular level is still not fully understood, but researchers have identified some likely pathways. One important one is that it holds back TGF-β1 (transforming growth factor-β1), a signalling protein that drives scar tissue formation and the buildup of fibrous material in the lungs. It also appears to tone down other strong inflammation-promoting substances, such as TNF-α, interleukin-1, and interferon-gamma. In animal studies, pirfenidone reduced both the movement of inflammatory cells into lung tissue and the increase in blood vessel leakiness that bleomycin exposure normally causes.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Pirfenidone is taken by mouth with food. Adults: When treatment begins, the dose is increased gradually over 14 days until it reaches the recommended daily dose of nine 267 mg tablets or three 801 mg tablets per day, as follows. On days 1 to 7, one 267 mg tablet is taken three times a day (801 mg per day). On days 8 to 14, two 267 mg tablets are taken three times a day (1602 mg per day). From day 15 onward, three 267 mg tablets or one 801 mg tablet are taken three times a day (2403 mg per day). The recommended daily dose of Pirfenidone for patients with IPF is three 267 mg tablets or one 801 mg tablet three times a day with food, giving a total of 2403 mg per day. Doses above 2403 mg per day are not recommended for any patient. Patients who miss 14 or more consecutive days of Pirfenidone treatment should restart therapy by repeating the initial 2-week step-up schedule up to the recommended daily dose. If treatment is interrupted for fewer than 14 consecutive days, the previous recommended daily dose can be resumed without stepping up again. Dose adjustments and other points for safe use: Gastrointestinal events: Patients who cannot tolerate therapy because of gastrointestinal side effects should be reminded to take the medicine with food. If symptoms persist, Pirfenidone may be reduced to 1 to 2 tablets (267 mg to 534 mg) 2 to 3 times a day with food, and then increased again to the recommended daily dose as tolerated. If symptoms continue, patients may be told to stop treatment for 1 to 2 weeks so that the symptoms can settle. Photosensitivity reaction or rash: Patients who develop a mild to moderate photosensitivity reaction or rash should be reminded to apply a sunblock every day and to avoid sun exposure. The dose of Pirfenidone may be reduced to three 267 mg tablets per day (one 267 mg tablet three times a day). If the rash is still present after 7 days, Pirfenidone should be stopped for 15 days and then increased again to the recommended daily dose in the same way as during the initial step-up period. Patients who develop a severe photosensitivity reaction or rash should be told to stop taking the medicine and to seek medical advice. Once the rash has cleared, Pirfenidone may be restarted and increased again up to the recommended daily dose at the physician's discretion. Hepatic function: If there is a significant rise in alanine and/or aspartate aminotransferases (ALT/AST), with or without a rise in bilirubin, the dose of Pirfenidone should be adjusted or treatment stopped according to the guidelines.
Side Effects
Common side effects include nausea, rash, abdominal pain, upper respiratory tract infection, diarrhoea, tiredness, headache, indigestion, dizziness, vomiting, loss of appetite (anorexia), gastro-oesophageal reflux disease, sinusitis, difficulty sleeping, weight loss, and joint pain. Rare side effects include photosensitivity reaction (increased sensitivity of the skin to sunlight), decreased appetite, itching, weakness, altered sense of taste, and non-cardiac chest pain.
Cautions & Contraindications
Warnings & Precautions
Elevated liver enzymes: Raised ALT, AST, and bilirubin levels have been reported with Pulbo. Check ALT, AST, and bilirubin before starting treatment and at intervals during it. The dose may need to be lowered or the medicine stopped for a time. Photosensitivity and rash: Skin sensitivity to light and rash have been reported with Pulbo. Avoid direct sunlight and sunlamps. Apply sunscreen and wear protective clothing every day. The dose may need to be lowered or the medicine stopped for a time. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, indigestion, gastro-oesophageal reflux disease, and abdominal pain have been reported with Pulbo. The dose may need to be lowered or the medicine stopped for a time.
Contraindications
Do not use pirfenidone if you are allergic to it or any of its other ingredients, if you are taking fluvoxamine, if you have severe liver impairment or end-stage liver disease, or if you have severe kidney impairment (CrCl below 30 ml/min) or end-stage kidney disease requiring dialysis.
Pregnancy & Breastfeeding
Pregnancy: No data exist on the use of Pirfenidone in pregnant women. In animal studies, pirfenidone and/or its metabolites cross the placenta and can accumulate in the amniotic fluid. At a high dose of 1000 mg/kg/day, rats showed a longer gestation period and reduced fetal viability. As a precaution, it is best to avoid Pirfenidone during pregnancy.
Lactation: It is not known whether pirfenidone or its metabolites pass into human breast milk. Animal pharmacokinetic studies have shown that pirfenidone and/or its metabolites are excreted in milk and may accumulate there, so a risk to the breastfeeding infant cannot be ruled out. A decision should be made to either stop breastfeeding or stop Pirfenidone treatment, weighing the benefit of breastfeeding for the child against the benefit of the therapy for the mother.
Fertility: Pirfenidone did not affect fertility or reproductive performance in rats at doses up to 1000 mg/kg/day, roughly 3 times the maximum recommended daily dose (MRDD) in adults on an mg/m2 basis.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Use in Children & Adolescents: It is not known if Pulmofib is safe and effective in children & adolescents.Hepatic Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of Pulmofib as needed. Pulmofib is not recommended for use in patients with severe hepatic impairment.Renal Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of Pulmofib as needed. Pulmofib is not recommended for use in patients with end-stage renal disease on dialysis.Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of Pulmofib.
Overdose
There is limited clinical experience with overdose. Multiple doses of Pulmofib up to a dose of 4806 mg/day were administered as six 267 mg tablets 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 Pulmofib.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store in a cool & dry place. Protect from light & moisture. Keep all medicine out of reach of children.
Drug Interactions
Common questions about Pulfibro 801 mg 801 mg
What is Pulfibro 801 mg 801 mg Tablet?
Pulfibro 801 mg 801 mg Tablet is a medicine that contains Pirfenidone. It is made by Unimed Unihealth Pharmaceuticals Ltd. It belongs to the Immunosuppressant group of medicines.
What is Pulfibro 801 mg used for?
Pulbo is used in adults to treat mild to moderate idiopathic pulmonary fibrosis (IPF), a condition in which scar tissue builds up in the lungs for no known cause.
What are the side effects of Pulfibro 801 mg?
Common side effects include nausea, rash, abdominal pain, upper respiratory tract infection, diarrhoea, tiredness, headache, indigestion, dizziness, vomiting, loss of appetite (anorexia), gastro-oesophageal reflux disease, sinusitis, difficulty sleeping, weight loss, and joint pain. Rare side effects include photosensitivity reaction (increased sensitivity of the skin to sunlight), decreased appetite, itching, weakness, altered sense of taste, and non-cardiac chest pain.
Can I take Pulfibro 801 mg during pregnancy or while breastfeeding?
Pregnancy: No data exist on the use of Pirfenidone in pregnant women. In animal studies, pirfenidone and/or its metabolites cross the placenta and can accumulate in the amniotic fluid. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Pulfibro 801 mg?
There is limited clinical experience with overdose. Multiple doses of Pulmofib up to a dose of 4806 mg/day were administered as six 267 mg tablets three times daily to healthy adult volunteers over a 12-day dose escalation period. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Pulfibro 801 mg?
Store in a cool & dry place. Protect from light & moisture.
Can I take other medicines with Pulfibro 801 mg?
Some medicines can interact with Pirfenidone, for example: Ciprofloxacin, Fluvoxamine Maleate. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Pulfibro 801 mg?
Pulfibro 801 mg is a prescription (Rx) medicine. Take it as your doctor advises.