Pefla Tablet

Introduction

Pefla Tablet 400 mg is a synthetic broad-spectrum fluoroquinolone antibiotic used to treat a variety of bacterial infections. It is effective against both gram-negative and gram-positive bacteria and is often used in the treatment of urinary tract infections, respiratory infections, gastrointestinal infections, and skin infections.

Uses

Pefla Tablet 400 mg is indicated for the treatment of:

Urinary tract infections (UTIs)
Lower respiratory tract infections
Gastrointestinal infections (e.g., bacterial diarrhea)
Skin and soft tissue infections
Bone and joint infections
Gynecological infections

It is also used as a prophylactic treatment in certain surgeries and as part of combination therapy for some multi-drug resistant infections.

Brand Name	Pefla
Type	Tablet
Weight	400 mg
Generic	Pefloxacin
Manufacturer	Sonear Laboratories Ltd.
Available in	English বাংলা

Mechanism of Action

Pefla Tablet 400 mg works by inhibiting bacterial DNA gyrase and topoisomerase IV, which are enzymes essential for DNA replication, transcription, and repair. By preventing these processes, Pefla Tablet 400 mg disrupts bacterial growth and leads to the death of the bacterial cells. It is bactericidal in nature, meaning it kills bacteria directly.

How Long Does It Take to Work?

Pefla Tablet 400 mg starts working within a few hours of administration. Symptom improvement is typically observed within 2 to 3 days for most infections. However, for full resolution of the infection, it is important to complete the prescribed course of the antibiotic, even if symptoms subside earlier.

Absorption

Pefla Tablet 400 mg is well absorbed from the gastrointestinal tract after oral administration, with bioavailability close to 100%. Peak plasma concentrations are reached 1 to 2 hours after dosing. The drug is also available in intravenous form for use in severe infections.

Route of Elimination

Pefla Tablet 400 mg is primarily metabolized by the liver, with about 60% of the drug being converted into active metabolites. It is excreted through the urine and bile, with a significant portion of the drug eliminated unchanged in the urine. It has a relatively long elimination half-life, which allows for twice-daily dosing.

Dosage

The typical dosage of Pefla Tablet 400 mg is:

400 mg twice daily for most infections.
In severe infections, the dose may be increased to 800 mg twice daily.

The duration of therapy depends on the type and severity of the infection but typically ranges from 5 to 14 days. In cases of renal or hepatic impairment, dosage adjustments may be necessary.

Administration

Pefla Tablet 400 mg is available in oral and intravenous formulations. The oral tablets should be taken with a full glass of water and can be taken with or without food. Intravenous administration is used for patients with severe infections or those who cannot take oral medications.

Side Effects

Common side effects of Pefla Tablet 400 mg include:

Nausea and vomiting
Diarrhea
Headache
Dizziness
Abdominal pain

Serious side effects include:

Tendinitis and tendon rupture
QT prolongation (abnormal heart rhythm)
Severe hypersensitivity reactions
Clostridioides difficile-associated diarrhea (C. difficile)
Neurological effects, including seizures and hallucinations

Toxicity

Pefla Tablet 400 mg can cause significant toxicity, particularly in the tendons (tendinitis and tendon rupture), nervous system (seizures, neuropathy), and cardiovascular system (QT prolongation). It can also cause hepatotoxicity (liver damage) and should be used with caution in patients with existing liver disease. Overdose may lead to severe neurological and cardiovascular effects.

Precautions

Precautions include:

Monitoring for signs of tendon damage, especially in older patients and those on corticosteroids.
Avoiding the use in patients with a history of seizures or other neurological conditions.
Regular monitoring of liver function tests in patients with hepatic impairment.
Careful ECG monitoring in patients with cardiovascular disease, due to the risk of QT prolongation.

Interaction

Pefla Tablet 400 mg has several drug interactions, including:

Antacids containing magnesium, aluminum, or calcium, which can reduce the absorption of Pefla Tablet 400 mg.
Corticosteroids, which may increase the risk of tendon rupture.
Drugs that prolong the QT interval (e.g., antiarrhythmic agents) should be avoided to minimize the risk of cardiac arrhythmias.

Disease Interaction

Pefla Tablet 400 mg should be used cautiously in patients with:

Liver disease, as it is primarily metabolized by the liver.
Renal impairment, as dosage adjustments may be required.
Seizure disorders, as Pefla Tablet 400 mg can lower the seizure threshold.
Cardiovascular disease, particularly those with a history of QT prolongation or arrhythmias.

Drug Interaction

Pefla Tablet 400 mg interacts with several drugs, including:

Anticoagulants like warfarin, which may increase the risk of bleeding.
Nonsteroidal anti-inflammatory drugs (NSAIDs), which can increase the risk of CNS toxicity and seizures.
Drugs that affect heart rhythm (e.g., amiodarone, sotalol) should be used cautiously due to the risk of QT prolongation.

Food Interactions

Pefla Tablet 400 mg can be taken with or without food. However, it should not be taken with dairy products, as calcium in dairy can interfere with its absorption. It is recommended to take Pefla Tablet 400 mg at least 2 hours before or after consuming any dairy products or supplements containing calcium, magnesium, or aluminum.

Pregnancy Use

Pefla Tablet 400 mg is not recommended for use during pregnancy due to the risk of fetal harm, particularly in developing bones and joints. It should only be used in pregnant women if the potential benefits outweigh the risks.

Lactation Use

Pefla Tablet 400 mg is excreted in breast milk and may cause harm to the nursing infant, particularly by affecting bone and joint development. Breastfeeding should be avoided while taking Pefla Tablet 400 mg.

Acute Overdose

In the case of an overdose, symptoms may include confusion, seizures, dizziness, and arrhythmias. Supportive care should be provided, and gastric lavage may be used in cases of recent ingestion. There is no specific antidote for Pefla Tablet 400 mg overdose.

Contraindication

Pefla Tablet 400 mg is contraindicated in:

Patients with a history of hypersensitivity to Pefla Tablet 400 mg or other fluoroquinolones.
Patients with a history of tendon disorders related to fluoroquinolone use.
Patients with myasthenia gravis, as fluoroquinolones can exacerbate muscle weakness.

Use Direction

Pefla Tablet 400 mg should be taken as directed by the healthcare provider, usually 400 mg twice daily. The full course of the antibiotic should be completed, even if symptoms resolve before the end of the course, to prevent antibiotic resistance and ensure the complete eradication of the infection.

Storage Conditions

Pefla Tablet 400 mg should be stored at room temperature, between 20°C to 25°C (68°F to 77°F). It should be kept in its original packaging, away from light and moisture. The medication should be kept out of reach of children.

Volume of Distribution

The volume of distribution (Vd) for Pefla Tablet 400 mg is approximately 2.7 L/kg, indicating good tissue penetration, including into the lungs, skin, and bone.

Half Life

The half-life of Pefla Tablet 400 mg is approximately 10 to 13 hours, allowing for twice-daily dosing. In patients with hepatic impairment, the half-life may be prolonged.

Clearance

Pefla Tablet 400 mg is cleared primarily via hepatic metabolism and biliary excretion. The clearance is reduced in patients with liver dysfunction, necessitating dose adjustments. Renal clearance accounts for a smaller proportion of the drug's elimination.

See in details version Pefla Tablet 400 mg also Pefla Tablet 400 mg in bangla