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Ruzit

Ruzit

azithromycin

Manufacturer:

Sandoz S.R.L.

Distributor:

Natrapharm
Concise Prescribing Info
Contents
Azithromycin monohydrate
Indications/Uses
Infections caused by susceptible organisms in upper resp (including sinusitis & pharyngitis/tonsillitis) & lower resp (including bronchitis & pneumonia) tract, skin & soft tissue. Acute otitis media. Uncomplicated genital infections due to Chlamydia trachomatis or non-multi-resistant Neisseria gonorrhoeae.
Dosage/Direction for Use
Adult & adolescent >45 kg Usually 1,500 mg total dose, taken either according to 3-day or 5-day therapy schedule. 3-day schedule: 500 mg once daily for 3 days. 5-day therapy: 500 mg once daily on day 1, then 250 mg once daily on days 2-5. Uncomplicated genital infection from Chlamydia trachomatis or sensitive Neisseria gonorrhoeae 1,000 mg as a single dose. Childn & adolescent up to 45 kg 3-day regimen: 10 mg/kg once daily for 3 days. 5-day regimen: 10 mg/kg on day 1, then 5 mg/kg on days 2-5. Max total dose: 1,500 mg. Acute otitis media Total dose: 30 mg/kg given as a single dose, or 3-day or 5-day therapy. Streptococcal pharyngitis 10 mg/kg or 20 mg/kg daily for 3 days. Max daily dose: 500 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic.
Special Precautions
Rare serious allergic reactions, including angioneurotic oedema & anaphylaxis, & dermatologic reactions including acute generalized exanthematous pustulosis, SJS, TEN, DRESS. Stop administration if liver dysfunction has emerged. Discontinue immediately if signs & symptoms of hepatitis occur. Not recommended for use against erythromycin-resistant gram +ve strains & most strains of methicillin resistant staphylococci. Not intended to treat severe infections where fast high blood conc of antibiotic have to be achieved. Patients w/ significant hepatic disease; severe renal impairment (GFR <10 mL/min); neurological & psychiatric disorders. Consider C. difficile-associated diarrhoea or pseudomembranous colitis in patients presenting diarrhoea following antibiotic use. Theoretical possibility of ergotism w/ ergot derivatives. Observe for signs of superinfection including fungi. Risk of developing cardiac arrhythmia & torsades de pointes. Exacerbations of symptoms of myasthenia gravis. No experience on safety & effectiveness of long-term use. Visual impairment & blurred vision may have an effect on ability to drive & operate machinery. Use during pregnancy only if benefit outweighs the risk. Decision needs to be made whether breast-feeding or treatment should be interrupted. 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.
Adverse Reactions
Diarrhoea. Headache; vomiting, abdominal pain, nausea; 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.
Drug Interactions
Reduced peak serum conc w/ antacids. Increased serum levels of P-gp substrates eg, digoxin & colchicine. Possibility of interaction w/ ergot derivatives. Increased conc of phosphorylated zidovudine. Reports of rhabdomyolysis w/ statins. Reports of potentiated anticoagulation of coumarin-type oral anticoagulants. Elevated Cmax & AUC of ciclosporin. Reports of neutropenia w/ rifabutin. Possible co-resistance between macrolide antibiotics, lincomycin, clindamycin; concomitant use is not recommended. Not to be co-administered w/ medicinal products known to prolong QT interval.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Ruzit powd for susp 200 mg/5 mL
Packing/Price
20 mL x 1's (P365/box)
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