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Axcel Azithromycin

Axcel Azithromycin

azithromycin

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Concise Prescribing Info
Contents
Azithromycin dihydrate
Indications/Uses
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.
Administration
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotics.
Special Precautions
Discontinue use if severe cutaneous adverse reactions 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. Raised theophylline levels. QT interval prolongation, ventricular arrhythmias & Torsade de pointes w/ cisapride. Enhanced effects w/ astemizole, alfentanil.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Axcel Azithromycin tab 500 mg
Packing/Price
1 × 3's
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