Zenith Suspension/Zenith OD Suspension

Zenith Suspension Infections caused by microorganisms sensitive to azithromycin eg, URTI including sinusitis, pharyngitis, tonsillitis; lower resp tract infections including bronchitis & pneumonia; acute otitis media; skin & soft tissue infections; uncomplicated genital infections caused by Chlamydia trachomatis or Neisseria gonorrhoeae (non-multi-resistant strains). Zenith OD Suspension Mild to moderate infections eg, lower resp tract infections eg, acute bacterial bronchitis, community-acquired pneumonia in patients suitable for outpatient oral treatment; URTI eg, acute bacterial sinusitis, acute otitis media, acute streptococcal pharyngitis or tonsillitis (as 2nd-line treatment); uncomplicated skin & skin structure infections; Chlamydia trachomatis conjunctivitis & trachoma.

Zenith Suspension Adult & adolescent >45 kg Total dose: 1,500 mg taken either according to 3- or 5-day therapy schedule. 3-day therapy schedule: 12.5 mL once daily for 3 days. 5-day therapy schedule: Day 1: 12.5 mL all at once. Days 2-5: 6.25 mL daily. Uncomplicated genital infection from Chlamydia trachomatis or sensitive Neisseria gonorrhoeae 25 mL. Childn & adolescent up to 45 kg 3-day therapy schedule: Days 1-3: Body wt >45 kg 12.5 mL daily, 36-45 kg 10 mL daily, 26-35 kg 7.5 mL daily, 17-25 kg 5 mL daily, 16 kg 4 mL daily, 14 kg 3.5 mL daily, 12 kg 3 mL daily, 10 kg 2.5 mL daily. 5-day therapy schedule: Body wt >45 kg Day 1: 12.5 mL daily. Days 2-5: 6.25 mL daily, 36-45 kg Day 1: 10 mL daily. Days 2-5: 5 mL daily, 26-35 kg Day 1: 7.5 mL daily. Days 2-5: 3.75 mL daily, 17-25 kg Day 1: 5 mL daily. Days 2-5: 2.5 mL daily, 16 kg Day 1: 4 mL daily. Days 2-5: 2 mL daily, 14 kg Day 1: 3.5 mL daily. Days 2-5: 1.75 mL daily, 12 kg Day 1: 3 mL daily. Days 2-5: 1.5 mL daily, 10 kg Day 1: 2.5 mL daily. Days 2-5: 1.25 mL daily. Acute otitis media Total dose: 30 mg/kg taken either as single dose or according to 3- or 5-day therapy schedule. Streptococcal pharyngitis 10 mg/kg or 20 mg/kg daily for 3 days. Max daily dose: 500 mg. Zenith OD Suspension Ped 3-day regimen: Days 1-3: Body wt >45 kg Adult dose, 36-45 kg 10 mL once daily, 26-35 kg 7.5 mL once daily, 15-25 kg 5 mL once daily, <15 kg 10 mg/kg once daily. 5-day regimen: Body wt >45 kg Day 1: Adult dose. Days 2-5: Adult dose. 36-45 kg Day 1: 10 mL once daily. Days 2-5: 5 mL once daily, 26-35 kg Day 1: 7.5 mL once daily. Days 2-5: 3.75 mL once daily, 15-25 kg Day 1: 5 mL once daily. Days 2-5: 2.5 mL once daily, <15 kg Day 1: 10 mg/kg once daily. Days 2-5: 5 mg/kg once daily. Pharyngitis/tonsillitis 12 mg/kg once daily for 5 days. Childn ≥12 mth Conjunctivitis & trachoma 20 mg/kg either as single dose or once wkly for up to 3 wk.

May be taken with or without food.

Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. Zenith OD Suspension Patients w/ history of cholestatic jaundice/hepatic dysfunction associated w/ prior use of azithromycin.

Reports of rare serious allergic reactions, including angioneurotic oedema & anaphylaxis (rarely fatal), & dermatologic reactions including acute generalized exanthematous pustulosis, SJS, TEN, & DRESS; discontinue use if an allergic reaction occurs. Perform LFTs/investigations immediately in cases where signs & symptoms of liver impairment occur; discontinue use if signs & symptoms of hepatitis occur. Reports of Clostridium difficile-associated diarrhoea; prolonged cardiac repolarization & QT interval, imparting a risk of developing cardiac arrhythmia & torsades de pointes; exacerbations of symptoms of myasthenia gravis & new onset of myasthenia syndrome. Observe for signs of superinfection w/ non-susceptible organisms including fungi. Not intended to treat severe infections where fast high blood conc of antibiotic has to be achieved. Caution in patients w/ neurological & psychiatric disorders. Not to be co-administered w/ ergot derivatives. May affect ability to drive or operate machinery. Increased systemic exposure in patients w/ severe renal impairment (GFR <10 mL/min). Use during pregnancy only if benefit outweighs risk. Reports of infantile hypertrophic pyloric stenosis following use in neonates (treatment up to 42 days of life). Safety & efficacy for the prevention or treatment of Mycobacterium avium complex in childn have not been established. Zenith Suspension Reports of pseudomembranous colitis. Not recommended for use against erythromycin-resistant gram +ve strains & most strains of methicillin-resistant staphylococci. No experience on safety & effectiveness of long-term use. Caution in patients w/ significant hepatic disease. Decision needs to be made whether breast-feeding should be interrupted or whether treatment should be dispensed or interrupted. Zenith OD Suspension Not to be given to patients w/ pneumonia who are judged to be inappropriate for oral treatment due to moderate or severe illness or risk factors. Efficacy & safety have not been studied in patients w/ severe neutropenia (WBC <1,000/mm³). Not indicated for treatment of infected burn wounds. Perform serologic test for syphilis at time of diagnosis. Not recommended in patients w/ lysosomal lipid storage diseases eg, Tay-Sachs disease, Nieman-Pick disease. Caution in diabetic patients. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Caution in patients w/ severe renal impairment &/or significant liver disease. Discard milk during treatment & up to 2 days after discontinuation of treatment. Elderly may be more susceptible to development of torsades de pointes arrhythmias than younger patients. Safety & efficacy for treatment of CAP, acute otitis media or acute bacterial sinusitis in childn <6 mth old, or for treatment of pharyngitis & tonsillitis in childn <2 yr have not been established.

Nausea, vomiting, diarrhea/loose stools, abdominal discomfort (pain, cramps), & headache. Zenith Suspension Decreased lymphocyte count & blood bicarbonate, increased eosinophil count, basophils, monocytes & neutrophils. Possibly or probably related to Mycobacterium avium complex prophylaxis & treatment: Diarrhoea, abdominal pain, nausea, flatulence, abdominal discomfort, loose stools. Anorexia; dizziness, headache, paraesthesia, dysgeusia; visual impairment; deafness; rash, pruritus; arthralgia; fatigue. Zenith OD Suspension Rash.

Reduced peak serum conc w/ antacids. Elevated C_max & AUC of ciclosporin. Increased serum levels of P-gp substrates eg, digoxin & colchicine. May potentiate anticoagulant effect of coumarin-type oral anticoagulants. Ergotism w/ ergot derivatives eg, ergotamine or dihydroergotamine. Reports of rhabdomyolysis w/ statins. Reports of neutropenia w/ rifabutin. Increased conc of active metabolite (phosphorylated zidovudine) of zidovudine in the peripheral blood. Zenith Suspension Possible co-resistance w/ macrolide antibiotics, lincomycin, clindamycin. Not to be co-administered w/ medicinal products known to prolong QT interval. Zenith OD Suspension In vitro evidence of additive to synergistic effects w/ chloroquine & quinine against Plasmodium falciparum including multi-drug resistant strains. Potentially enhanced risk of cardiotoxicity of astemizole; significant inhibition of alfentanil clearance. Increased conc of cisapride, phenytoin & hexobarbital. May increase pharmacological effects of disopyramide. Increased conc w/ nelfinavir. May inhibit metabolism of pimozide. Possible interaction w/ terfenadine. Increased serum conc of theophylline.

Macrolides

J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.

Rx