Pulmova Tablet

Introduction

Pulmova Tablet 801 mg is a drug used in the treatment of idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis (IPF) is a progressive and fatal lung disease characterized by a thickening and scarring of the walls of the lungs leading to difficulty breathing and decreased air flow. By reducing inflammation and fibrosis, pirfenidone can help improve symptoms related to IPF.

Uses

Pulmova Tablet 801 mg is used to treat mild to moderate idiopathic pulmonary fibrosis (IPF) in adults. It may slow the progression of lung damage or improve lung function. It is not a cure, but it can help.

Brand Name	Pulmova
Type	Tablet
Weight	801 mg
Generic	Pirfenidone
Manufacturer	NIPRO JMI Pharma Ltd.
Available in	English বাংলা

Mechanism of Action

Pulmova Tablet 801 mg blocks the production of chemical messengers called cytokines, which are responsible for causing inflammation in the lungs and other tissues. It also inhibits the protein kinase signalling pathway, which drives inflammation in the body. By blocking the actions of these cytokines and the protein kinase signalling pathway, pirfenidone helps to reduce inflammation and fibrosis in the lungs.

How Long Does It Take To Work?

Pulmova Tablet 801 mg may take several weeks or months to take full effect. The medication must be taken regularly as prescribed to be as effective as possible.

Absorption

Pulmova Tablet 801 mg is absorbed rapidly in the gastrointestinal tract. The maximum serum concentration of pirfenidone is usually reached within 1 to 3 hours after oral administration.

Route of Elimination

Pulmova Tablet 801 mg is mainly metabolised in the liver and then eliminated mainly via the kidneys. The primary metabolites are glucuronide conjugates, which are excreted in the urine.

Dosage

Route of administration: Pirfenidone is administered orally with food.

Adults: Upon initiating treatment, the dose should be titrated to the recommended daily dose of nine 267 mg tablets or three 801 mg tablet per day over a 14-days period as follows:

Days 1 to 7: One 267 mg tablet administered three times a day (801 mg/day)
Days 8 to 14: Two 267 mg tablets administered three times a day (1602 mg/day)
Day 15 onward: Three 267 mg tablets or one 801 mg tablet administered three times a day (2403 mg/day)

The recommended daily dose of Pirfenidone for patients with IPF is three 267 mg tablets or one 801 mg three times a day with food for a total of 2403 mg/day. Doses above 2403 mg/day are not recommended for any patient. Patients who miss 14 consecutive days or more of Pirfenidone treatment should re-initiate therapy by undergoing the initial 2-week titration regimen up to the recommended daily dose. For treatment interruption of less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration.

Dose adjustments and other considerations for safe use: Gastrointestinal events: In patients who experience intolerance to therapy due to gastrointestinal side effects, patients should be reminded to take the medicinal product with food. If symptoms persist Pirfenidone may be reduced to 1-2 tablets (267 mg-534 mg) 2-3 times/day with food with re-escalation to the recommended daily dose as tolerated. If symptoms continue, patients may be instructed to interrupt treatment for 1 to 2 weeks to allow symptoms to resolve.

Photosensitivity reaction or rash: Patients who experience a mild to moderate photosensitivity reaction or rash should be reminded of the instruction to use a sunblock daily and to avoid sun exposure. The dose of Pirfenidone may be reduced to three 267 mg tablets/day (one 267 mg tablet three times a day). If the rash persists after 7 days, Pirfenidone should be discontinued for 15 days, with re-escalation to the recommended daily dose in the same manner as the dose escalation period. Patients who experience severe photosensitivity reaction or rash should be instructed to interrupt the dose and to seek medical advice. Once the rash has resolved, Pirfenidone may be re-introduced and re-escalated up to the recommended daily dose at the discretion of the physician.

Hepatic function: In the event of significant elevation of alanine and/or aspartate aminotransferases (ALT/AST) with or without bilirubin elevation, the dose of Pirfenidone should be adjusted or treatment discontinued according to the guidelines.

The recommended adult dose of pirfenidone is 2403 mg taken orally three times per day. For patients who cannot tolerate the full dose, the dose can be gradually increased over two weeks to the maximum recommended dose.

Administration

Pulmova Tablet 801 mg should be taken orally, at least one hour before or two hours after meals. It is important to drink plenty of fluids throughout the day to reduce the risk of serious side effects.

Side Effects

Common side effects of pirfenidone include nausea, vomiting, indigestion, stomach pain, diarrhea, loss of appetite, dizziness, and fatigue. Other side effects may include dry skin and/or nails, difficulty sleeping, nightmares, low blood pressure, and rash. Serious side effects such as allergic reactions and liver damage may occur but are rare.

Toxicity

Pulmova Tablet 801 mg is generally well tolerated, and no major toxicity has been observed at the recommended dose. There is a potential for drug interactions, so it is important to discuss all medications and supplements you are taking with your doctor.

Precaution

Patients should inform their doctor of any changes in their health or any medications they are taking before taking pirfenidone. Patients should not drive or operate heavy machinery while taking pirfenidone as it may impair mental and physical abilities.

Interaction

Pulmova Tablet 801 mg may interact with other medications or supplements, such as antacids, antibiotics, or anti-fungal medications. It is important to discuss all medications and supplements with your doctor to avoid drug interactions.

Disease Interaction

Patients with kidney or liver disease, low blood pressure, or a history of seizures should be monitored closely by their doctor while taking pirfenidone.

Drug Interaction

Pulmova Tablet 801 mg may interact with other drugs such as antibiotics, anti-fungal medications, or antacids. Patients should inform their doctor of any and all medications that they are taking to avoid drug interactions. Medications that may interact with pirfenidone include omeprazole, itraconazole, and cimetidine.

Food Interactions

Pulmova Tablet 801 mg should be taken either 1 hour before or 2 hours after meals. There are no known food interactions with this medication.

Pregnancy Use

Pulmova Tablet 801 mg should not be used during pregnancy. Consult your doctor about the risks and benefits of taking pirfenidone if you are pregnant.

Lactation Use

Pulmova Tablet 801 mg has not been studied in lactating women and its safety is not known. Women who are breastfeeding should not take pirfenidone.

Acute Overdose

In case of overdose, call 911 for emergency medical attention. Symptoms of overdose may include nausea, vomiting, diarrhea, headache, and dizziness.

Contraindication

Patients who have had an allergic reaction to pirfenidone should not use this medication. It should also not be used by pregnant or lactating women. Patients with liver or kidney disease, a history of seizures, or low blood pressure should consult their doctor before taking.

Use Direction

Pulmova Tablet 801 mg should be taken at least one hour before or two hours after meals, typically 3 times per day.Patients should not miss doses and should take the medication as prescribed to receive the full benefit. The medication should be taken with a full glass of water and patients should drink plenty of fluids throughout the day.

Storage Condition

Pulmova Tablet 801 mg should be stored at room temperature away from direct sunlight and heat. It should be kept in a safe place out of the reach of children and pets.