Indications
Pulmobi Tablet is used for:
Idiopathic pulmonary fibrosis (IPF)
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)
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.
Contra Indications
Hypersensitivity. History of angioedema. Severe hepatic & renal impairment or end stage liver & renal disease. Concomitant use w/ fluvoxamine.
Precautions
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.
Pregnancy-Lactation
Pregnancy: Data in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage
Lactation: No information is available on presence of pirfenidone in human milk, effects of drug on breastfed infant, or effects of drug on milk production; lack of clinical data during lactation precludes clear determination of risk of pirfenidone to infant during lactation; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and potential adverse effects on breastfed child from pirfenidone or from underlying maternal condition
Interactions
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.
Side Effects
Side effects of Pirfenidone :
>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%)
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
Note
Pulmobi 801 mg Tablet generic name is Pirfenidone. Pulmobi 801 mg Tablet is manufactured by Bio Pharma Laboratories Ltd.Pulmobi is availble in all over Bangladesh.
Mes BD drug index information on Pulmobi Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.