RENOVA 320mg TAB

Description

Generic Name: Gemifloxacin
Brand Name: RENOVA
Strength: 320mg per tablet
Form: Oral tablet
Pack Size: 10 tablets per pack
Pharmacological Class: Fluoroquinolone Antibiotic
Prescription Status: Prescription-only (Rx)

Overview:

RENOVA 320mg Tablet contains Gemifloxacin, a broad-spectrum fluoroquinolone antibiotic, effective against a wide range of bacterial infections. Gemifloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes crucial for DNA replication and transcription. This leads to bacterial cell death and helps eliminate infections.

Gemifloxacin is primarily used for the treatment of respiratory tract infections, such as community-acquired pneumonia (CAP) and acute bacterial exacerbations of chronic bronchitis (ABECB). It can also be used for the treatment of urinary tract infections (UTIs) and other soft tissue infections caused by susceptible organisms.

Mechanism of Action:

Gemifloxacin belongs to the fluoroquinolone class of antibiotics, which exert their effect by inhibiting the bacterial enzymes DNA gyrase and topoisomerase IV. These enzymes are critical for the supercoiling and unwinding of bacterial DNA, processes essential for replication and cell division. By disrupting these processes, Gemifloxacin prevents the bacteria from multiplying, effectively killing them.

Indications:

RENOVA 320mg Tablet is indicated for the treatment of infections caused by susceptible bacteria, including:

• Community-Acquired Pneumonia (CAP)
• Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
• Uncomplicated Urinary Tract Infections (UTIs)
• Skin and Soft Tissue Infections
• Acute Sinusitis (bacterial origin)

Dosage and Administration:

• Typical Adult Dose:
  • Community-Acquired Pneumonia (CAP): 320mg once daily for 5 to 7 days.
  • Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB): 320mg once daily for 5 days.
  • Urinary Tract Infections (UTIs): 320mg once daily for 3 to 5 days, depending on the severity.
• Renal Impairment: Dose adjustments may be necessary for patients with renal insufficiency.
• Hepatic Impairment: No dose adjustment is typically required, but caution is advised.

Always follow the prescribed dosage and complete the full course of treatment to prevent bacterial resistance.

Side Effects:

Common:

• Nausea
• Diarrhea
• Headache
• Dizziness
• Insomnia
• Rash

Less common but serious:

• Tendon rupture or tendinitis (especially in elderly patients)
• QT prolongation (leading to irregular heartbeats)
• Severe allergic reactions (e.g., anaphylaxis, hives)
• Clostridium difficile-associated diarrhea
• Liver enzyme elevations
• Nerve damage (peripheral neuropathy)

Precautions:

• Tendon Rupture: Fluoroquinolones, including Gemifloxacin, have been associated with an increased risk of tendon rupture, especially in older adults and those using corticosteroids. Discontinue the medication immediately if tendon pain or inflammation occurs.
• QT Interval Prolongation: Gemifloxacin may cause QT interval prolongation, especially in patients with electrolyte imbalances or those on antiarrhythmic drugs.
• Pregnancy and Lactation: Gemifloxacin should be used during pregnancy only if the benefit outweighs the potential risk to the fetus. It is not recommended during breastfeeding.
• Renal and Hepatic Impairment: Caution is advised in patients with kidney or liver disease. Regular monitoring may be necessary.

Drug Interactions:

• Antacids or mineral supplements (containing calcium, magnesium, aluminum, iron): These may reduce the absorption of Gemifloxacin.
• Antiarrhythmic drugs (e.g., amiodarone, sotalol): Increased risk of QT interval prolongation and arrhythmias.
• Warfarin: Fluoroquinolones may enhance the effects of warfarin, increasing the risk of bleeding.
• Corticosteroids: Combined use may increase the risk of tendon rupture.

Storage Instructions:

• Store at room temperature (15°C to 25°C).
• Protect from moisture and light.
• Keep out of reach of children.

Packaging:

• Supplied as 10 tablets per bottle, each containing 320mg of Gemifloxacin.

Key Benefits:

• Broad-spectrum activity against a wide range of Gram-positive and Gram-negative bacteria, including respiratory pathogens.
• Effective in treating common respiratory infections like pneumonia and chronic bronchitis exacerbations.
• Convenient once-daily dosing helps improve patient compliance.
• Rapid action in alleviating symptoms associated with bacterial infections, aiding quicker recovery.