Binozyt

Binozyt

azithromycin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Azithromycin dihydrate
Indications/Uses
Adequately diagnosed acute bacterial otitis media & acute exacerbation of chronic bronchitis; URTI including sinusitis & pharyngitis/tonsillitis; mild to moderately severe community acquired pneumonia (CAP); skin & soft tissue, & odontostomatological infections; uncomplicated genital infections due to Chlamydia trachomatis in STD in men & women, & due to non-multiresistant Neisseria gonorrheae; chancroid due to Haemophilus ducreyi; disseminated Mycobacterium avium complex (DMAC) infections in patients w/ advanced HIV infection. Prophylaxis against Mycobacterium avium complex (MAC) infections in patients infected w/ HIV.
Dosage/Direction for Use
Adult 500 mg daily for 3 consecutive days (total dose: 1,500 mg). STD caused by Chlamydia trachomatis, Haemophilus ducreyi, or susceptible Neisseria gonorrheae 1,000 mg as single oral dose. CAP Following IV therapy, 500 mg as single daily dose to complete 7-10 day course of therapy. DMAC infection 600 mg once daily. Prophylaxis against MAC infection 1,200 mg as single dose once a wk.
Administration
Should be taken on an empty stomach: Swallow whole w/ sufficient fluid, do not chew.
Contraindications
Hypersensitivity to azithromycin dihydrate, erythromycin, any macrolide or ketolide antibiotic.
Special Precautions
Discontinue use if allergic reaction occurs; if liver dysfunction has emerged; if signs & symptoms of hepatitis occur. Not intended for suitable severe infections where fast high blood conc of antibiotic have to be achieved. Serious allergic reactions, including angioneurotic oedema & anaphylaxis, & dermatologic reactions including acute generalised exanthematous pustulosis, SJS, TEN, & DRESS. Fulminant hepatitis potentially leading to life-threatening liver failure; abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis & failure. Pseudomembranous colitis. Clostridium difficile associated diarrhea. Prolonged cardiac repolarization & QT interval imparting risk of developing cardiac arrhythmia & Torsades de Pointes. Exacerbations of myasthenia gravis symptoms & new onset of myasthenia syndrome. Patients w/ congenital or documented QT prolongation; currently receiving treatment w/ other active substances known to prolong QT interval eg, class IA (quinidine & procainamide) & class III (dofetilide, amiodarone & sotalol) antiarrhythmics, cisapride & terfenadine, antipsychotic agents eg, pimozide, antidepressants eg, citalopram, & fluoroquinolones eg, moxifloxacin & levofloxacin; electrolyte disturbance, particularly hypokalaemia & hypomagnesemia; clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency; neurological & psychiatric disorder. Long-term use. Perform LFTs/investigations in case of signs & symptoms of liver dysfunction eg, rapid developing asthenia associated w/ jaundice, dark urine, bleeding tendency or hepatic encephalopathy. Observe for signs of superinfection w/ non-susceptible organisms. Not to be co-administered w/ ergot derivatives. Not recommended in erythromycin-resistant gm +ve strains & most strains of methicillin resistant staphylococci. May affect ability to drive or operate machinery. Severe renal impairment (GFR <10 mL/min). Significant hepatic disease. Pregnancy & lactation. Neonates (risk of infantile hypertrophic pyloric stenosis). Childn (prevention or treatment of MAC). Elderly.
Adverse Reactions
Diarrhea. Headache; vomiting, abdominal pain, nausea; decreased lymphocyte count & blood bicarbonate, increased eosinophil count, basophils, monocytes & neutrophils. MAC: Flatulence, abdominal discomfort, loose stools. Anorexia; dizziness, paraesthesia, dysgeusia; visual impairment; deafness; rash, pruritus; arthralgia; fatigue. SJS.
Drug Interactions
Reduced peak serum conc w/ antacid. Increased serum levels of P-gp substrate eg, digoxin & colchicine. Concomitant use w/ ergot derivatives; rifabutin; QT interval-prolonging medicinal products. Increased conc of phosphorylated zidovudine. Cases of rhabdomyolysis w/ statins. Potentiated anticoagulation w/ coumarin-type oral anticoagulants. Elevated cyclosporine Cmax & AUC0-5. Increased conc w/ nelfinavir. Possible co-resistance w/ macrolide antibiotics (eg, erythromycin), lincomycin & clindamycin.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Binozyt cap 250 mg
Packing/Price
6's
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