Pirfenidone Tablets

Pirfenex (Generic Pirfenidone tablets) - Product Information

Generic Pirfenidone tablets (Pirfenex) is used to treat Idiopathic Pulmonary Fibrosis (IPF). Pirfenex helps to reduce the scarring and swelling in the lungs, and helps you breathe better.
The safety and effectiveness of Pirfenidone in pediatric patients have not been established.
Pirfenex, manufactured by Cipla Limited, India, is available in the strength of 200 mg.
We also have in stock Albuterol Inhaler (Asthalin 100 mcg Inhaler) which is also used as oral inhalation therapy for patients diagnosed with various bronchospasm conditions such as bronchitis, emphysema, or COPD (chronic obstructive pulmonary disease).

Name of the Drug

Pirfenex tablets.

Manufacturer of Pirfenex Tablets

Cipla Limited, India  
Website: www.cipla.com

Active Pharmaceutical Ingredient

The active ingredient present in Pirfenex tablets is Pirfenidone. Each film-coated tablet contains 200 mg of Pirfenidone.

Uses of Pirfenidone Tablets (Pirfenex)

Pirfenex (Generic Pirfenidone tablets)is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

Pirfenex (Generic Pirfenidone tablets) - Dosage

Generic Pirfenidone tablets should be administered exactly as suggested by your doctor. Your doctor may recommend a dosage of Pirfenex tablets depending on your age, medical requirement, body weight, other medical conditions, and current medications. Treatment with Pirfenex should be initiated and supervised by specialist physicians experienced inthe diagnosis and treatment of IPF.
The initial dose for adults is 200 mg, three times a day (600 mg/day), after a meal. Gradually increase the dose to 600 mg, three times a day (1,800 mg/day), under observation. Furthermore, appropriately increase or decrease the dose from time to time depending upon the symptoms. Recommendations for Dosage Adjustment:
• Start with 200 mg tablets given three times a day (600 mg/day). After 2 weeks, gradually increase the dose by 200 mg at a time. It is desirable to maintain or achieve a final dose of 600 mg at a time (1,800 mg/day).
• Patients who miss 14 consecutive days or more of pirfenidone treatment should re-initiate therapy by undergoing the initial dose titration regimen (see Recommendations for Dose Adjustment above) 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.
Pirfenex tablets work effectively if the amount of Pirfenidone is maintained at a constant level in the body. You should be systematic about the daily schedule for the medication such that you take tablets at about the same time every day, to get the maximum benefit of the medication. Continue taking Pirfenex tablets without missing any doses for the recommended treatment period and do not stop the treatment suddenly even if you feel better.

Please consult your doctor for exact dosing instructions. Pirfenex tablets (Generic Pirfenidone tablets) should be administered in the dose prescribed by the doctor and for the duration recommended by the doctor.

Missed Dose

If you forget to take your regular Pirfenidone tablet dose on time, take it whenever you remember.
If you remember the next day, skip the missed dose and take your scheduled dose. Do not take a double dose to compensate the missed dose.

Pirfenidone Tablets Mechanism of Action

Pirfenidone works by targeting multiple fibrotic and inflammatory pathways, primarily by inhibiting the Transforming Growth Factor-beta (TGF-ß) pathway to reduce fibroblast proliferation, differentiation into myofibroblasts, and extracellular matrix production.
It also reduces pro-fibrotic growth factors such as platelet-derived growth factor (PDGF) and basic fibroblast growth factor (bFGF), upregulates matrix metalloproteinases (MMPs) to break down existing fibrosis, and possesses antioxidant properties to combat oxidative stress. Additionally, it has anti-inflammatory effects, which include decreasing pro-inflammatory cytokines like TNF-a, and modulates the immune system.

Storage Instructions for Pirfenex (Generic Pirfenidone tablets)

Store Pirfenex tablets at controlled room temperature (20°C to 25°C),protected from heat, moisture, and sunlight. Excursions are permitted from 15°C to 30°C.
Retain the original packing of the medication and do not consume Generic Pirfenidone tablets past its expiration date printed on the blister pack. Keep the pack of away from the reach of children and pets. Do not dispose Pirfenex tablets along with domestic waste or sewage. Consult your doctor or pharmacist about the correct method of disposal.

Contraindications

Pirfenex tablets are contraindicated in patients with a hypersensitivity to Pirfenidone or any inactive ingredient present in Pirfenex tablets. Pirfenex tablets are contraindicated in the following cases:

• history of angioedema with Pirfenidone
• concomitant use of Fluvoxamine
• severe hepatic impairment or end stage liver disease
• severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis

Overdose

There is limited clinical experience with overdose. Multiple doses of pirfenidone up to a dose of 4806 mg/day were administered as six 267 mg capsules 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 Pirfenidone.
In the event of a suspected overdose, supportive medical care should be provided including monitoring of vital signs and close observation of the clinical status of the patient.

Warnings and Precautions

Elevated liver enzymes and drug-induced liver injury:
ALT, AST, and bilirubin elevations have occurred with Pirfenidone tablets including cases of drug-induced liver injury. In the postmarketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required.
Photosensitivity and Rash:
Photosensitivity and rash have been noted with Pirfenidone tablets. Avoid exposure to sunlight and sunlamps. Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required.
Severe Cutaneous Adverse Reactions (SCAR):
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reactions with eosinophilia and systemic symptoms (DRESS) have been reported in association with the use of Pirfenidone tablets in the postmarketing setting. Interrupt Pirfenidone tablets in case of signs or symptoms of SCAR. Permanently discontinue Pirfenex if a SCAR is confirmed.
Gastrointestinal disorders:
Nausea, vomiting, diarrhea, dyspepsia, gastro-esophageal reflux disease, and abdominal pain have occurred with Pirfenidone tablets. Temporary dosage reductions or discontinuations may be required.

Effects On Ability To Drive And Use Machines

Pirfenidone may cause dizziness and fatigue, which could influence the ability to drive or use machines.

Side Effects of Pirfenidone (Pirfenex Tablets)

The most commonly reported adverse reactions during clinical study experience with Pirfenidone at a dose of 2403 mg/day compared to placebo, respectively, were nausea (32.4% versus 12.2%), rash (26.2% versus 7.7%), diarrhoea (18.8% versus 14.4%), fatigue (18.5% versus 10.4%), dyspepsia (16.1% versus 5.0%), anorexia (11.4% versus 3.5%), headache (10.1% versus 7.7%), and photosensitivity reaction (9.3% versus 1.1%).
Serious side effects were recorded at similar frequencies among patients treated with 2403 mg/day of pirfenidone and placebo in clinical studies.

Pirfenidone (Pirfenex Tablets) During Pregnancy

has been classified by the US FDA as Pregnancy Category C.
There are no data from the use of Pirfenidone in pregnant women. In animals placental transfer of Pirfenidone and/or its metabolites occurs with the potential for accumulation of pirfenidone and/or its metabolites in amniotic fluid. At high doses (1000 mg/kg/day or greater) rats exhibited prolongation of gestation and reduction in foetal viability.
As a precautionary measure, it is preferable to avoid the use of Pirfenex (Generic Pirfenidone) during pregnancy.
Do not use this medicine without your doctor's consent in case you are pregnant. Stop using this medication and inform your doctor immediately if you become pregnant during treatment.

Nursing Considerations

It is unknown whether Pirfenidone or its metabolites are excreted in human milk. Available pharmacokinetic data in animals have shown excretion of pirfenidone and/or its metabolites in milk with the potential for accumulation of pirfenidone and/or its metabolites in milk. A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue from Pirfenidone therapy, taking into account the benefit of breast-feeding for the child and the benefit of Pirfenidone therapy for the mother.
Do not use this medication without telling your doctor if you are breast-feeding a baby.

Buy Generic Pirfenidone 200 mg Pills Online From Only $0.95 per Pill

You can buy Generic Pirfenidone tablets online from Everest Online Pharmacy at a cheap price. Pirfenex 200 mg tablets, manufactured by Cipla Limited, India are supplied in a blister strip of 10 tablets. The 200 mg tablets cost only $0.95 per unit when you place an order for 600 tablets.

Disclaimer

The above information is provided to the best of our knowledge and in good faith. It is without a warrant of any kind, expressed or implied.

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