Olecin

Description

About Olecin Tablet (Levofloxacin)

Olecin Tablet, containing levofloxacin, is a fluoroquinolone antibiotic used to treat various bacterial infections. It works by inhibiting essential bacterial enzymes (topoisomerase IV and DNA gyrase) required for DNA replication and repair, thereby killing the bacteria. It is active against a wide range of gram-negative and gram-positive microorganisms.

Important Note on Fluoroquinolones: Fluoroquinolones like levofloxacin should be reserved for patients who do not have other available treatment options for certain conditions like acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections due to the risk of serious side effects.

What Olecin Tablet Treats

Olecin Tablet is prescribed for a range of bacterial infections in adults, including:

• Respiratory Tract Infections:
  • Community-acquired pneumonia
  • Nosocomial (hospital-acquired) pneumonia
  • Acute bacterial sinusitis (use only if other treatment options are not available)
  • Acute bacterial exacerbation of chronic bronchitis (use only if other treatment options are not available)
• Skin and Skin Structure Infections:
  • Uncomplicated skin and skin structure infections
  • Complicated skin and skin structure infections
• Urinary Tract Infections:
  • Complicated urinary tract infections
  • Acute pyelonephritis (kidney infection)
  • Uncomplicated urinary tract infections (use only if other treatment options are not available)
• Other Infections:
  • Anthrax (post-exposure therapy)
  • Chronic bacterial prostatitis
  • Plague (treatment and prophylaxis, including pneumonic and septicemic plague, caused by Yersinia pestis)

Dosing Information

Adult Dosing

• Community-Acquired Pneumonia: 500 mg orally or intravenously once daily for 7-14 days OR 750 mg orally or intravenously once daily for 5 days.
• Nosocomial Pneumonia: 750 mg orally or intravenously once daily for 7-14 days.
• Acute Bacterial Sinusitis: 500 mg orally or intravenously once daily for 10-14 days OR 750 mg orally or intravenously once daily for 5 days.
• Acute Bacterial Exacerbation of Chronic Bronchitis: 500 mg orally or intravenously once daily for ≥7 days.
• Inhalational Anthrax (Post-exposure therapy): 500 mg orally once daily for 60 days, starting as soon as possible after exposure.
• Skin/Skin Structure Infections:
  • Uncomplicated: 500 mg orally or intravenously once daily for 7-10 days.
  • Complicated: 750 mg orally or intravenously once daily for 7-14 days.
• Chronic Bacterial Prostatitis: 500 mg orally or intravenously once daily for 28 days.
• Complicated Urinary Tract Infections & Acute Pyelonephritis: 250 mg orally or intravenously once daily for 10 days OR 750 mg orally or intravenously once daily for 5 days.
• Uncomplicated Urinary Tract Infections: 250 mg orally or intravenously once daily for 3 days.
• Plague: 500 mg orally or intravenously once daily for 10-14 days.

Child Dosing (for pediatric patients aged 6 months or older for Plague)

• General (PO, IV): 16 mg/kg/day divided every 12 hours up to 50 kg body weight, then 500 mg once daily for post-exposure anthrax prophylaxis every 12 hours.
• For Respiratory Infections:
  • Under 5 years: 20 mg/kg/day every 12 hours.
  • Over 5 years: 10 mg/kg/day every 24 hours.

Renal Dosing

Dosage adjustments are necessary for patients with impaired kidney function:

• Creatinine Clearance (CrCl) 20-49 mL/min:
  • Initially, 500 mg daily, then 250 mg every 24 hours.
  • Alternatively: Initially, 750 mg daily, then 750 mg every 48 hours.
• Creatinine Clearance (CrCl) 10-19 mL/min:
  • Initially, 500 mg daily, then 250 mg every 48 hours.
  • Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours.
• Hemodialysis/Continuous Ambulatory Peritoneal Dialysis (CAPD):
  • Initially, 500 mg daily, then 250 mg every 48 hours.
  • Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours.

Administration

• Oral Solution: Should be taken on an empty stomach (1 hour before or 2 hours after meals). Ensure adequate fluid intake.
• Tablet: May be taken with or without food. Ensure adequate fluid intake.
• Intravenous (IV) Preparation:
  • Single-use vials: Dilute in 50-100 mL of Dextrose 5% in Water (D5W), Normal Saline (NS), or D5/NS solution for injection to achieve a concentration of 5 mg/mL. Other suitable solutions include sodium lactate, Plasma-Lyte, D5/lactated Ringer, and D5/NS with potassium chloride.
• Intravenous (IV) Administration:
  • Administer by IV infusion only, not as a rapid injection (bolus). Rapid or bolus administration can cause a sudden drop in blood pressure and must be avoided.
  • Infuse 250-500 mg over 60 minutes.
  • Infuse 750 mg over 90 minutes.

Important Considerations

Do Not Use If You Have:

• Hypersensitivity: An allergy to levofloxacin or any other quinolone antibiotic.
• Children under 18 years: Generally contraindicated, except for specific indications like plague in children aged 6 months or older.

Precautions:

• CNS Disorders: Use with caution in patients with known or suspected central nervous system (CNS) disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures.
• Sunlight Exposure: Avoid unnecessary exposure to direct sunlight or artificial UV light, as levofloxacin can increase sensitivity to light.
• Cardiac Conditions: Use with caution in patients with a history of prolonged QT interval or uncorrected electrolyte disturbances (e.g., low potassium or magnesium), as it can affect heart rhythm.
• Diabetes Mellitus (DM): Carefully monitor blood glucose levels in diabetic patients, as levofloxacin can cause changes in blood sugar.
• Monitoring: Your doctor may periodically monitor your kidney function, liver function, and blood cell counts during treatment.
• Pregnancy and Lactation: Generally not recommended during pregnancy or lactation. The drug is excreted in breast milk.
• Elderly: Use with caution in elderly patients.
• Driving/Operating Machinery: May impair your ability to drive or operate machinery due to potential side effects like dizziness.

Potential Drug Interactions:

Tell your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements, as some can interact with levofloxacin:

• QT Interval-Prolonging Drugs: Additive effects on QT interval prolongation with class IA antiarrhythmics (e.g., quinidine, procainamide) or class III antiarrhythmics (e.g., amiodarone, sotalol), fluoxetine, or imipramine.
• Antacids, Sucralfate, Didanosine, Mineral Supplements: Reduced absorption of levofloxacin when taken with sucralfate, didanosine, antacids containing magnesium or aluminum, or dietary supplements containing zinc, calcium, magnesium, or iron. Take levofloxacin at least 2 hours before or 2 hours after these products.
• Antidiabetic Agents (e.g., Insulin, Glibenclamide): Altered blood glucose levels may occur. Monitor blood sugar carefully.
• Corticosteroids: Increased risk of severe tendon disorders (e.g., tendon rupture).
• NSAIDs (Nonsteroidal Anti-inflammatory Drugs): Increased risk of CNS stimulation and seizures.
• Warfarin: Increased prothrombin time (a measure of blood clotting), increasing the risk of bleeding.

Possible Side Effects

Like all medicines, Olecin Tablet can cause side effects. If you experience any severe or persistent side effects, contact your doctor immediately.

Common Side Effects (1-10%):

• Nausea (7%)
• Headache (6%)
• Diarrhea (5%)
• Insomnia (4%)
• Constipation (3%)
• Dizziness (3%)
• Dyspepsia (indigestion) (2%)
• Rash (2%)
• Vomiting (2%)
• Chest pain (1%)
• Dyspnea (shortness of breath) (1%)
• Edema (swelling) (1%)
• Fatigue (1%)
• Injection-site reaction (1%)
• Moniliasis (yeast infection) (1%)
• Pain (1%)
• Pruritus (itching) (1%)
• Vaginitis (1%)

Less Common Side Effects (<1%):

• Cardiac: Cardiac arrest, palpitations, ventricular tachycardia, arrhythmia (irregular heartbeat).
• Nervous system: Tremor, convulsions (seizures), paresthesia (numbness/tingling), vertigo (spinning sensation), hypertonia (increased muscle tone), hyperkinesias (involuntary movements), abnormal gait, somnolence (drowsiness), syncope (fainting).
• Metabolic: Hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), hyperkalemia (high potassium).
• Blood/Lymphatic System: Anemia, thrombocytopenia (low platelet count), granulocytopenia (low granulocyte count).
• Musculoskeletal/Connective Tissue: Arthralgia (joint pain), tendonitis (tendon inflammation), myalgia (muscle pain), skeletal pain.
• Gastrointestinal (GI): Gastritis, stomatitis (mouth inflammation), pancreatitis (pancreas inflammation), esophagitis, gastroenteritis, glossitis (tongue inflammation), pseudomembranous/ C. difficile colitis (severe bowel inflammation).
• Hepatobiliary: Abnormal hepatic function, increased hepatic enzymes, increased alkaline phosphatase (liver function abnormalities).
• Psychiatric: Anxiety, agitation, confusion, depression, hallucinations, nightmares, sleep disorder, anorexia, abnormal dreaming.
• Other: Immune hypersensitivity reaction, acute renal failure, urticaria (hives), phlebitis (vein inflammation), epistaxis (nosebleed).

Potentially Fatal Side Effects (Seek immediate medical attention):

• Anaphylaxis: A severe, life-threatening allergic reaction.

How it Works

Levofloxacin exerts its antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase. These enzymes are crucial for bacterial DNA replication, transcription, repair, and recombination. By blocking these enzymes, levofloxacin prevents bacteria from growing and multiplying, leading to their death. It has in vitro activity against a wide range of gram-negative and gram-positive microorganisms.

Disclaimer: This information about Olecin Tablet is for general knowledge only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider for any health concerns or before making any decisions related to your health or treatment.