Axcel Azithromycin

Axcel Azithromycin



Kotra Pharma


Kotra Pharma
Concise Prescribing Info
Azithromycin dihydrate
Infections caused by susceptible organisms: Lower resp tract infections eg, bronchitis & pneumonia; skin & soft tissue infections; acute otitis media; URTI eg, sinusitis & pharyngitis/tonsillitis. Streptococci eradication in oropharynx. STD: Uncomplicated genital infections due to Chlamydia trachomatis; chancroid due to Haemophilus ducreyi; uncomplicated genital infections due to non-multiresistant Neisseria gonorrhoea excluding concurrent infection w/ Treponema pallidum.
Dosage/Direction for Use
Adult & elderly STD caused by Chlamydia trachomatis & Haemophilus ducreyi 1,000 mg as single dose. STD caused by susceptible Neisseria gonorrhoea 1,000-2,000 mg in combination w/ ceftriaxone 250-500 mg. Other indications Total dosage: 1,500 mg, may be given as 500 mg daily for 3 days or 500 mg on day 1, then 250 mg daily on days 2-5. Childn >45 kg Adult dose. Max total dose: 1,500 mg.
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotics.
Special Precautions
Discontinue use if severe cutaneous ARs occur. Not as 1st choice for pharyngitis & tonsillitis caused by Streptococcus pyogenes; sinusitis; acute otitis media. Not indicated for infected burn wounds. Superinfection; Clostridium difficile-associated diarrhoea; congenital or documented QT prolongation; electrolyte disturbance; clinically relevant bradycardia, cardiac arrhythmia or insufficiency; myasthenia gravis; infantile hypertrophic pyloric stenosis; neurological or psychiatric disorders. Ensure susceptibility testing prior to treatment of skin & soft tissue infection. Not to be co-administered w/ ergot derivatives. Concomitant use w/ drugs prolonging QT interval eg, class IA & III antiarrhythmics; cisapride, terfenadine; antipsychotics; antidepressants; fluoroquinolones; hepatotoxic drugs. May affect ability to drive & use machines. Significant hepatic disease; fulminant hepatitis, preexisting hepatic disease; severe renal impairment (GFR <10 mL/min). Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Diarrhoea. Headache; vomiting, abdominal pain, nausea; decreased lymphocyte count & blood bicarbonate, increased eosinophil count, basophils, monocytes & neutrophils.
Drug Interactions
Reduced peak serum conc w/ antacids. Increased serum levels of P-gp substrates eg, digoxin, colchicine. Increased conc of phosphorylated zidovudine. Ergotism w/ ergot derivatives. Rhabdomyolysis w/ atorvastatin. Potentiated anticoagulation w/ coumarin-type oral anticoagulants. Elevated cyclosporin Cmax & AUC. Increased conc w/ nelfinavir. Neutropenia w/ rifabutin. Rise in theophylline levels. QT interval prolongation, ventricular arrhythmias & Torsade de pointes w/ cisapride. Enhanced effects w/ astemizole, alfentanil.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Axcel Azithromycin tab 500 mg
1 × 3's
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