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Pulfibro 801
Unimed Unihealth Pharmaceuticals Ltd.
Generic: Pirfenidone
Safety Advices
বাংলা
English
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Pulfibro 801. Please consult your doctor.
CONSULT YOUR DOCTOR
Pulfibro 801 may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Information regarding the use of Pulfibro 801 during breastfeeding is not available. Please consult your doctor.
UNSAFE
Pulfibro 801 may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
CAUTION
Pulfibro 801 should be used with caution in patients with kidney disease. Dose adjustment of Pulfibro 801 may be needed. Please consult your doctor.
Use of Pulfibro 801 is not recommended with severe kidney disease and dialysis patients.
CAUTION
Pulfibro 801 should be used with caution in patients with liver disease. Dose adjustment of Pulfibro 801 may be needed. Please consult your doctor.
Use of Pulfibro 801 is not recommended in patients with severe liver disease.
Medicine Overview of Pulfibro 801mg Tablet
Introduction
Pulfibro 801 is a prescription medicine used in the treatment of idiopathic pulmonary fibrosis. It reduces scarring and swelling in the lungs and helps to breathe better. It may be taken with food. But, It is better to take it at the same time every day to get the most benefits. The dose and how often you take it depends on what you are taking it for. Your doctor will decide how much you need to improve your symptoms. You should take this medicine for as long as it is prescribed for you. The most common side effects of this...
... Show moreUses of Pulfibro 801
- Idiopathic pulmonary fibrosis
Side effects of Pulfibro 801
Common
- Insomnia (difficulty in sleeping)
- Headache
- Dizziness
- Tiredness
- Sinus inflammation
- Loss of appetite
- Upper respiratory tract infection
- Weight loss
How to use Pulfibro 801
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Pulfibro 801 is to be taken with food.
How Pulfibro 801 works
Pulfibro 801 is an antifibrotic medication. It works by reducing fibrosis (scarring) and swelling in the lungs. This makes breathing easier.
Quick Tips
- Pulfibro 801 reduces scarring and swelling in the lungs, and helps you breathe better.
- It is best to take this medicine with food and at the same time each day.
- This medication may make you more sensitive to sun. Use sunscreen and wear protective clothing when outdoors.
- Stop smoking during treatment with Pulfibro 801 as it can reduce the effect of the treatment.
- It may cause dizziness or sleepiness. Do not drive or do anything requiring concentration until you know how it affects you.
- It may cause weight loss. Monitor your weight regularly.
- Your doctor may check your liver function regularly. Inform your doctor if you develop abdominal pain, loss of appetite, darkened urine or yellowing of the eyes or skin (jaundice).
Brief Description
Indication
Idiopathic pulmonary fibrosis (IPF)
Administration
Should be taken with food: Take w/ food to reduce the possibility of nausea & dizziness. Swallow whole w/ water. Take doses at same time each day.
Adult Dose
Idiopathic Pulmonary Fibrosis
Initial dose titration
Days 1-7: 267 mg (1 capsule) PO TID
Days 8-14: 534 mg (2 capsules) PO TID
Day 15 and thereafter: 801 mg (3 capsules) PO TID
Maintenance dose
801 mg (3 capsules) PO TID with food
Not to exceed 2403 mg/day (9 capsules/day)
Hepatic impairment
Mild-to-moderate (Child Pugh A or B): Use caution; monitor and consider dosage modification or discontinuation as needed
Severe (Child Pugh C): Not recommended (not studied)
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Mild, moderate, or severe: Use caution; monitor and consider dosage modification or discontinuation as needed
ESRD requiring dialysis: No recommended (not studied)
Contraindication
Hypersensitivity. History of angioedema. Severe hepatic & renal impairment or end stage liver & renal disease. Concomitant use w/ fluvoxamine.
Mode of Action
Precise mechanism by which pirfenidone may work in pulmonary fibrosis has not been established
Inhibits transforming growth factor (TGF)-beta, a chemical mediator that controls many cell functions including proliferation and differentiation
Also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation
Precaution
Hepatic function abnormalities, hepatic impairment, photosensitivity reaction or rash, angioedema, dizziness, fatigue & wt loss. May affect ability to drive or operate machinery. Avoid use in pregnancy & lactation.
Side Effect
>10%
Nausea (36%),Rash (30%),Upper respiratory tract infection (27%),Diarrhea (26%),Abdominal pain (24%),Headache (22%),Dyspepsia (19%),Dizziness (18%),Vomiting (13%),GERD (11%),Sinusitis (11%)
1-10%
Insomnia (10%),Weight decreased (10%),Arthralgia (10%),Photosensitivity (9%),Decreased appetite (8%),Pruritus (8%),Asthenia (6%),Dysgeusia (6%),Noncardiac chest pain (5%),AST/ALT ≥3 x ULN (3.7%)
<1%
AST/ALT ≥10 x ULN (0.3%)
Pregnancy Category Note
Data in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage.
Interaction
Inhibition of CYP1A2 w/ concomitant grapefruit juice. Increased exposure w/ fluvoxamine & other strong & selective CYP1A2 inhibitors, ciprofloxacin, amiodarone, propafenone. Potential to induce hepatic enzyme production by smoking. Lowered plasma levels w/ omeprazole, rifampicin.
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