Composition : Each AZGOFLOX 400 mg film coated tablet contains 436.8 mg moxifloxacin hydrochloride, equivalent to 400 mg moxifloxacin.Therapeutic Category : Antibiotic, Quinolone.
Pregnancy : Should not be used during pregnancy.
Lactation : Excretion in breast milk unknown/ not recommended
Indications
- Treatment of mild to moderate community-acquired pneumonia, including penicillin-resistant Streptococcus pneumonia (PRSP).
- Acute bacterial exacerbation of chronic bronchitis.
- Acute bacterial sinusitis.
AZGOFLOX 400MG 5 F.C. TABS.
Contraindications
Hypersensitivity to moxifloxacin or other quinolone antibiotics or any component of the formulation.
Pregnant women, breastfeeding mothers. children and growing adolescents less than or equal18 years.
Warnings/Precautions
Use with caution in patients with significant bradycardia, significant heart failure with reduced left ventricular ejection fraction (weak heart), history of symptomatic cardiac arrhythmias or acute myocardial ischemia. moxifloxacin causes a dose-dependent QT prolongation.
Coadministration of moxifloxacin with other drugs that also prolong the QT interval or induce bradycardia should be avoided.
Use with caution in individuals at risk of seizures (CNS disorders or concurrent therapy with medications which may lower seizure threshold).
Discontinue in patients who experience significant CNS adverse effects (dizziness, hallucinations, suicidal ideation or actions).
Not recommended in patients with moderate to severe hepatic insufficiency.
Use with caution in diabetes: glucose regulation may be altered.
Tendon inflammation and/or rupture have been reported with quinolone antibiotics. Risk may be increased with concurrent corticosteroids. particularly in the elderly. Discontinue at first signs or symptoms of tendon pain.
Severe hypersensitivity reactions. including anaphylaxis, have occurred with quinolone therapy. If an allergic reaction occurs (itching, urticaria, dyspnea or facial edema, loss of consciousness. tingling. cardiovascular collapse) discontinue drug immediately.
Prolonged use may result in super infection: pseudomembranous colitis may occur and should be considered in all patients who present with diarrhea.
Quinolones may exacerbate myasthenia grains.
Avoid UV radiation and not expose to excessive strong sunlight.
Adverse Reactions
Dizziness.
Gastrointestinal : Nausea (7%), Diarrhea (6%).
anaphylactic reaction, anaphylactic shock, anxiety, confusion.
Convulsions.
ECG abnormalities, hallucinations, hepatitis. hyperglycemia. hypertension, hypotension,peripheral edema, prothrombin time increased/ decreased, pseudomembranous colitis.psychotic reaction.
QT prolongation.
Stevens-Johnson syndrome.
Tachycardia.
Tendon rupture.
Tongue discoloration.
Tremor.
Vertigo.
Vision abnormalities.
Ventricular tachycardia.
Torsade de pointes and cardiac arrest have been reported (very rarely), usually in patients with concurrent severe proarrhythmic conditions.
AZGOFLOX Dosage
Adults Dosage in Acute bacterial sinusitis
One film coated tablet AZGOFLOX 400 mg every 24 hours for 7 days.
Adults Dosage in Chronic bronchitis, acute bacterial exacerbation
One film coated tablet AZGOFLOX 400 mg every 24 hours for 5 to 10 days.
Adults Dosage in Community-acquired pneumonia
One film coated tablet AZGOFLOX 400 mg every 24 hours for 10 days.
Elderly Dosage
No dosage adjustments are required based on age or patients with low body weight.
Dosage adjustment in renal impairment patients
No dosage adjustment is required, in patients with slight to severely impaired kidney function including dialysis patients.
Dosage adjustment in hepatic impairment patients
There is no experience in patients with impaired liver function.
Patient Information
May be taken with or without food.
Take 4 hours before or 8 hours after multiple vitamins, antacids. or other products containing magnesium, aluminum, iron or zinc.
Drink plenty of fluids.
Contact your prescriber immediately if signs of allergy occur or if signs of tendon inflammation or pain occur.
Do not discontinue therapy until your course has been completed.
Take a missed dose as soon as possible. Unless it is almost time for your next dose.
Storage: Store below 30 degrees celsius.
Presentation
AZGOFLOX 400 mg tablets- Packs of 5 film coated tablets.
AZGOFLOX 400- Arabic Information
AZGOFLOX- Arabic Information
Categories and tags: Moxifloxacin, Fluoroquinolones, QUINOLONE ANTIBACTERIALS, ANTIBACTERIALS FOR SYSTEMIC USE, ANTIINFECTIVES FOR SYSTEMIC USE.
English Alternatives
Alternatives: Delmoxa, Azgoflox, Advancrib, Actimoxiflox, Shamsomox, Rowamoxiflox, Rightiflox, Raspelocin, Quinomoxin, Quinofloxachem, Primoxizar, Moxitrix, Moxiflox, Moxifl, Moxavidex, Moxacin, Mograflox, Moflox, Meramerix, Kinomoxi, Idelox, Gastamoxacine, Dolabactin.
