Introduction
Pulbo 534 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 medicine include insomnia, headache, and dizziness. To overcome dizziness, avoid driving or attention-seeking activity. Some people may experience weight loss, hence monitor your weight regularly or ask for doctor consultation. Some side effects, which means you must inform your doctor include abdominal pain, loss of appetite, darkened urine or yellowing of the eyes. Your doctor may perform a liver function test while on treatment. Before taking this medicine, let your doctor know if you have liver or kidney disease. Your doctor should also know about all other medicines you are taking as many of these may make this medicine less effective or change the way it works. It makes your skin sun-sensitive, wear protective clothing or apply sunscreen while in direct contact with sun. Inform your doctor if you are pregnant or breastfeeding.
Uses of Pulbo 534
- Idiopathic pulmonary fibrosis
Side effects of Pulbo 534
Common
- Insomnia (difficulty in sleeping)
- Headache
- Dizziness
- Tiredness
- Sinus inflammation
- Loss of appetite
- Upper respiratory tract infection
- Weight loss
How to use Pulbo 534
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. Pulbo 534 is to be taken with food.
How Pulbo 534 works
Pulbo 534 is an antifibrotic medication. It works by reducing fibrosis (scarring) and swelling in the lungs. This makes breathing easier.
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.