Mega Flox 200 mg (Tablet)

Indications

• Treatment of community-acquired pneumonia (CAP)
• Treatment of acute bacterial exacerbations of chronic bronchitis (ABECB)
• Treatment of Chronic Obstructive Pulmonary Disease (COPD)
• Treatment of Acute Maxillary Sinusitis (AMS)
• Treatment of urinary tract infections
• Treatment of bacterial prostatitis
• Treatment of bacterial diarrhea
• Treatment of osteomyelitis
• Combination treatment for tuberculosis
• Combination treatment for leprosy

Pharmacology

• Inhibition of DNA gyrase
• Inhibition of topoisomerase IV
• Broad-spectrum antibacterial agent
• Effective against gram positive organisms
• Effective against Mycobacteria and Chlamydia spp
• Well absorbed following oral administration
• High plasma concentration
• Unaffected by administration with milk or food
• Reduced bioavailability with antacids
• Well distributed into body fluids and tissues
• Metabolized by the liver
• Excreted in feces and urine

Dosage & Administration

• Loading dose of two 200 mg tablets
• Subsequent daily single tablet of 200 mg
• Varied dosage for patients with renal impairment

Interaction

• Chelation complexes with aluminium and magnesium cations
• Potential interaction with medications affecting QTc interval
• No interaction with theophylline, caffeine, warfarin, or cimetidine
• No alteration by probenecid

Contraindications

• Hypersensitivity to any ingredient
• Pregnancy and lactation
• Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
• History of Achilles tendinitis following fluoroquinolones use

Side Effects

• Mild to moderate in severity
• Transient in nature
• Includes photosensitivity reaction, diarrhea, nausea, headache, dizziness, insomnia, abdominal pain, pruritus, taste perversion, vomiting, flatulence, vasodilatation

Pregnancy & Lactation

• No adequate and well-controlled studies in pregnant women
• Use only if potential benefit justifies potential risk to the fetus

Precautions & Warnings

• Discontinue therapy at signs of phototoxicity reaction
• Safety and effectiveness not established for children, adolescents, pregnant women, and lactating women
• Adequate hydration to prevent concentrated urine formation
• Administer with caution in renal insufficiency
• Avoid concomitant prescription of medications prolonging QTc interval
• Avoid excessive exposure to sunlight

Use in Special Populations

• Unaltered pharmacokinetics in the elderly with normal renal function
• Pharmacokinetics not studied in pediatric subjects
• No gender differences in pharmacokinetics
• Plasma concentrations doubled in varying degrees of renal impairment
• Pharmacokinetics not altered in mild or moderate hepatic impairment without cholestasis

Therapeutic Class

• 4-Quinolone preparations

Storage Conditions

• Keep out of reach of children
• Store away from heat and direct light
• Store below 30°C

Related Brands

• Floxipar 200 mg (Tablet) - acme-laboratories-ltd
• Aciflox 200 mg (Tablet) - aci-limited