AZOMYCIN
Capsules and Powder for Oral Suspension
Broad Spectrum Antibiotic
Composition :
Each capsule contains:
Azithromycin dihydrate equivalent to 250 mg azithromycin base.
Each 5 ml of oral suspension contains:
Azithromycin dihydrate equivalent to 200 mg azithromycin base.
Properties :
AZOMYCIN contains azithromycin which belongs to a new subclass of macrolide tibiotics with broaderspactrurn.ot activity Sllstained tisslleantlniotic.Ieve’s and expanded therapeutic range. AZOMYCIN is active against Gram-positive bacteria with more potency than other macrolides against Gram-negative bacteria especially H. influenzae. AZOMYCIN is also active against atypical intracellular
organisms such as Mycoplasma pneumoniae and Chlamydia trachomatis. AZOMYCIN binds specifically to 50S ribosomal subunit of susceptible microorganisms and inhibits protein synthesis through dissociation of RNA from ribosomes. Clinically, AZOMYCIN therapy exerts high cure rate and offers the advantages of once daily dosing, short course of therapy and excellent patient
compliance. AZOMYCIN is well tolerated and safely used in patients (adults and children) allergic to penicillin with rare incidence of the GI side effects commonly encountered with administration of most other macrolides.
Pharmacokinetics :
Azithromycin is rapidly absorbed from the GIT after oral administration. The dose should preferably be taken on empty stomach as absorption is affected by the presence of food. Peak plasma concentrations are achieved within 2 – 3 hours and the drug is widely distributed into body tissues and fluids. Less than 50%
of the drug is bound to plasma proteins with higher concentrations achieved in tissues than in plasma. Only a small amount of the oral dose is metabolized in the liver. Azithromycin is mainly excreted in the bile as unchanged drug and metabolites and about 6% is excreted in the urine. Azithromycin has extended half-life ranging from 40 – 60 hours. It is still not clear whether the drug is excreted
in breast milk or crosses the placenta.
Antimicrobial Spectrum :
– Gram-positive aerobic bacteria:
Staphylococcus aureus, Staph. epidermidis, Streptococcus pyogenes, Strep. viridans, Strep. agalactiae, Strep. pneumoniae and other Streptococcus spp.
– Gram-negative aerobic bacteria:
Haemophilus influenzae, H. ducreyi , Moraxella catarrhalis, Neisseria gonorrhoeae , Legionella pneumophila, Bordetella pertussis, Shigella spp., Escherichia coli, Salmonella and Aeromonas spp.
– Anaerobic bacteria:
Bacteroides fragilis and other Bacteroides spp., Clostridium perfringens and Peptostreptococcus spp.
– Other microorganisms:
Chlamydia trachomatis, Chlamydia pneumoniae, Treponema pallidum, Borrelia burgdorferi, Toxoplasma gondii, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum and Mycobacterium avium.
Indications :
AZOMYCIN is indicated for treatment of infections caused by susceptible microorganisms:
– Upper respiratory tract infections: otitis media, sinusitis, pharyngitis and tonsillitis.
– Lower respiratory tract infections: acute exacerbation of chronic bronchitis, community acquired pneumonia and exacerbations of chronic obstructive pulmonary disease.
– Skin and soft tissue infections: cellulitis, abscesses, frunculosis , pyoderma and infected traumatic and post-operative wounds.
– Venereal diseases: gonorrhea, chancroid and genital ulcer diseases.
– Genit ourinary infections: cervicitis, urethritis, pelvic inflammatory disease, prostatitis, epididymitis and epididymo-orchitis.
– HIV ( human immunodeficiency virus) infection: as prophylaxis against Mycobacterium avium complex
– Infective endocarditis prophylaxis: before oral, dental, respiratory or other procedures.
Dosage and administration :
1- Preparation of the suspension: Shake the bottle to loosen the powder Then, add the provided solvent gradually with shaking. The resultant suspension will provide 200 mg azithromycin activity per teaspoonful (5 ml). Once reconstituted, the suspension is stable for 5 days at temperature (15 – 25°C)
2- AZOMYCIN should be administered as a single daily dose one hour before or two hours after meals. Shake the suspension well before use.
3- Dosage:
Adults: 2 Azomycin capsules ( 500 mg ) as a single dose once daily for 3 days.
Alternatively, 2 Azomycin capsules ( 500 mg ) as a single dose on first day followed by only one Azomycin capsule daily for the next 4 days. In non-gonococcal urethritis or cervicitis, genital chlamydial infections and chancroid: 4 Azomycin capsules ( 1 g ) as a single dose therapy.
Children: 10 mg/kg as a single dose daily for 3 days or 10 mglkg on first day followed by 5 mg/kg daily for the next 4 days.
Contraindications :
Hypersensitivity to macrolide antibiotics.
Precautions :
Azithromycin should be used with caution in patients with impaired hepatic function.
Side effects :
Azithromycin is safe and well tolerated. Rarely, gastrointestinal disturbances such as nausea, diarrhea and abdominal discomfort may occur.
Pregnancy and lactation :
No teratogenic or harmful fetal effects have been reported. However, azithromycin should be used cautiously during pregnancy and lactation and only if clearly indicated.
Drug interactions :
Azithromycin is free of the drug interactions common with many other macrolides. Concurrent use of antacids containing aluminium and magnesium with azithromycin decreases its peak serum concentration but does not affect the extent of absorption.
Interference with laboratory tests :
None reported.
Overdosage and treatment :
Accidental ingestion of very high doses may result in nausea, vomiting, epigastric distress and diarrhea Treatment Includes supportive measures
Packing :
A box containing 6 capsules in a blister
A bottle containing powder of azithromycin dihydrate equivalent to 600 mg azithromycin base + Solvent.
Storage :
Keep at temperature not exceeding 25° C, away from moisture.
Keep out of the reach of children.
Prduced by :
Pharco pharmaceuticals alexandria
