ALEVO 500 (Levofloxacin) 500 mg, 10 tablets

What is ALEVO 500?

ALEVO 500 is an oral antibiotic containing 500 mg of Levofloxacin, a fluoroquinolone antibacterial agent. It is designed to treat various bacterial infections, including respiratory tract infections, urinary tract infections, skin infections, and prostatitis.

ALEVO 500 is effective against a wide range of gram-positive and gram-negative bacteria, offering a broad spectrum of antimicrobial activity.

Each package of ALEVO 500 contains 10 tablets, which are light peach-colored and film-coated for ease of swallowing.

What are the ingredients in ALEVO 500?

Each tablet of ALEVO 500 contains:

• Active Ingredient:
  • Levofloxacin hemihydrate: 500 mg
• Inactive Ingredients:
  • Microcrystalline cellulose
  • Starch
  • Colloidal silicon dioxide
  • Talc
  • Sodium starch glycolate
  • Magnesium stearate
  • Instacoat Aqua III (IA-III 40521)

What does ALEVO 500 look like?

ALEVO 500 tablets are light peach-colored, barrel-shaped, film-coated, with a score line on one side.

How does ALEVO 500 work?

Pharmacokinetics

Levofloxacin is rapidly and almost completely absorbed after oral administration, with peak plasma concentrations reached within 1 to 2 hours. The absolute bioavailability is approximately 99%. The half-life of levofloxacin is about 6-8 hours, and it is primarily excreted through the kidneys.

Pharmacodynamics

Levofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication, transcription, repair, and recombination. It is effective against a wide range of gram-positive and gram-negative bacteria, anaerobic bacteria, and other pathogens.

What infections can ALEVO 500 treat?

ALEVO 500 is used to treat various infections caused by susceptible bacteria, including:

• Acute bacterial sinusitis
• Exacerbation of chronic bronchitis
• Nosocomial pneumonia
• Complicated urinary tract infections, including acute pyelonephritis
• Skin and soft tissue infections
• Uncomplicated urinary tract infections
• Prostatitis

How should you take ALEVO 500?

ALEVO 500 tablets are taken orally once or twice daily, with or without food. The dosage depends on the type and severity of the infection, as well as the patient's renal function. Here are some general guidelines:

• Chronic bronchitis exacerbation: 250-500 mg once daily for 7-10 days
• Pneumonia: 500 mg once daily for 7-14 days
• Sinusitis: 500 mg once daily for 10-14 days
• Uncomplicated urinary tract infections: 250 mg once daily for 3 days
• Complicated urinary tract infections: 250 mg once daily for 7-10 days
• Prostatitis: 500 mg once daily for 28 days
• Acute pyelonephritis: 250 mg once daily for 7-10 days
• Skin and soft tissue infections: 250-500 mg 1-2 times daily for 7-10 days

Tablets should be swallowed whole with a glass of water.

What are the possible side effects of ALEVO 500?

Common:

• Candidiasis
• Headache, dizziness, insomnia, irritability
• Shortness of breath, bronchospasm
• Nausea, diarrhea, constipation, abdominal pain, vomiting, dyspepsia, flatulence
• Rash, itching
• Vaginitis
• Chest pain, back pain, limb pain

Rare:

• Anemia, thrombocytopenia, pancytopenia, neutropenia
• Hyperglycemia, hypoglycemia, hyperkalemia
• Excitement, confusion, depression, hallucinations, sleep disturbances, anorexia, tremor, agitation, psychotic states
• Seizures, paresthesia, hypertension, drowsiness, fainting, general weakness
• Palpitations, tachycardia, arrhythmia, QT interval prolongation, vascular collapse
• Gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous colitis, bloody diarrhea
• Elevated liver enzymes, increased bile phosphatase, jaundice
• Tendinitis, arthralgia, myalgia, skeletal pain, tendon rupture, rhabdomyolysis
• Renal dysfunction, acute renal failure, interstitial nephritis
• Stevens-Johnson syndrome, Lyell's syndrome, pseudomembranous colitis, vasculitis, toxic epidermal necrolysis, erythema multiforme, hyperhidrosis
• Extrapyramidal symptoms and other coordination disorders
• Agranulocytosis

Very Rare:

• Angioedema, anaphylactic shock, anaphylactoid reactions, photosensitivity, allergic pneumonitis, fever
• Hypoglycemia, especially in diabetic patients
• Visual and hearing disturbances
• Taste disturbance
• Smell disturbances up to loss of smell
• Hepatitis, liver necrosis, acute liver failure
• Sensory and sensorimotor peripheral neuropathy
• Mental reactions with auto-aggressive behavior, including suicidal thoughts and actions

Who should not use ALEVO 500?

Do not use ALEVO 500 if:

• You are allergic to levofloxacin or other quinolones, or any of the tablet's components
• You have had tendon disorders related to quinolone use
• You have epilepsy
• You are under 18 years of age
• You are pregnant or breastfeeding

How should you store ALEVO 500?

Store ALEVO 500 in a dry, light-protected place at temperatures not exceeding 30°C (86°F). Keep out of reach of children. The shelf life is three years. Do not use after the expiration date.