- Each 5 ml of Zisrocin suspension contains Azithromycin dihydrate equivalent to 100 mg Azithromycin base.

Zisrocln is indicated for infections caused by organisms sensitive to Azithromycin, like infections of the:

• Upper respiratory tract infections including sinusitis and pharyngitis J tonsillitis. Azthromycin is effective in the eradication of Streptococci from the oropharynx.

• Lower respiratory tract infections including bronchitis and pneumonia .

• Otitis media.

• Skin and soft tissue infections.

• S.T.Ds, Zisrocin is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis. Also Zisrocin is indicated in the treatment of uncomplicated genital infections due to non - multiresistant Neisseria gonontioea. Concurrent infection with Treponema pallidum should be excluded.

Zisrocin should be administered as a SINGLE daily dose, and each dose of the capsule form should be taken at least 2 hours before or after meals, because the presence of food in stomach reduces the bioavailability at least 50%. Zlsrocln powder for oral suspension form can be taken with food.

- Doses for adults & Elderty:

- For treatment of STD caused by Chlamydia trachomatis or susceptible Neisseria gonon'hoea, the dose is 1 gm as a SINGLE oral dose.

- For all other indications, the dose is ONE Capsule (500 mg) daily for 3 days.

- oases for patients with Renal Impairment:

The same dosage as in patients with normal renal function may be used in patients with mild renal impairment (creatinine clearance> 40 ml J min.). There is no data with regards to

Zisrocin usage in patients with more severe renal impairment.

- Doses for patients with Hepatic

Impairment:

The same dosage as in patients with normal hepatic function may be used in patients with mild to moderate hepatic impairment.

- oases for children:

- For children with normal weights,

Zisrocin suspension is given as a SINGLE daily dose of 10 mg I Kg body weight for 3 days ( The total dose is 30 mg I Kg B.W.)

- For children weighing less than 15 Kg., Zisrocin suspension should be precisely measured.

- For children weighing 15 Kg or more, Zisrocin suspension should be administered according to the following tab le:

N.B. Zisrocin Capsule form can be only administered to children weighing more than 45 Kg

• Capsules should be swallowed whole.

• P.O.S.:1 - Add distelled water up to the mark, to get 30 ml of suspension.

2- Shake well prior each use.

- As with other macrolides, rare serious allergic reactions e.g. angioedema and anaphylaxis have been reported.

- Caution should be exercised before prescribing Zisrocin to patients with severe renal impairment, as there are no enough data regarding Azithromycin usage in such cases.

- Also, caution should be exercised before prescribing Zisrocin to patients with significant hepatic disease, as liver is the principle elimination route for Azithromycin.

- Azithromycin and ergot derivatives should not be coadministered, because there is a theoretical possibility of ergotism. 

lnspite of studies have demonstrated that Azithromycin crosses placanta, but have revealed no evidence of harm to the fetus,

Zisrocin should only be used in pregnant or lactating women where adequate alternatives are not available, because safety of use in human pregnancy & lactation has not been established.

Due to the possibility of drug - drug interaction between Zisrocin and other medicaments, caution should be exercised with patients receiving Zisrocin concomitantly with Antacids, Cylclosporine, Digoxin, Ergot derivatives (see warning & precautions).

On the other hand, pharmacokinetic studies revealed that there is no evidence of interaction between Azithromycin and Cimetidine, Methylprednisolone, Theophylline, Terfenadine, Zidovudine. With Warfarin, Zisrocin may be co-administered, but monitoring of the prothrombin time should be continued as routinely perfonned.

Zisrocin is well tolerated with low incidence of side effects. The

majority of side effects observed were mild to moderate in severity.

The majority of side effects were gastrointestinal in origin, with diarrhea and loose stools, abdominal discomfort ( pain/ cramps) nausea, vomiting and flatulence. In clinical trials, reversible elevations in liver transaminases have been observed with frequency similar to the comparative macrolides and penicillins used. Rarely, cases of cholestatic jundice have been observed.

Allergic reactions including rash, photosensitivity, angioedema and anaphylaxis have occurred (see warning & precautions)

- Pharmacodynamics

Azithromycin is the first of a class of antibiotic designated chemically as azalides. Chemically it is derived by insertion of a nitrogen atom into the lactone ring of erythromycin A. The mode of action of azithromycin is inhibition of protein synthesis in bacteria and preventing translocation of peptides. In vitro, Azithromycin demonstrates activity against a wide range of bacteria including:·

Gram positive aerobic bacteria: Staphylococcus aureus,Streptococcus pyogenes (group A beta - haemolytic streptococci), Streptococcus pneumoniae, alpha - haemolytic Streptococci (Viridans group) and other Streptococci, and Corynebacterium diphtheriae. Azithromycin demonstrates cross resistance with erythromycin resistant Gram - positive strains, induding Streptococcus faecalis (enterococcus) and most strains of methicillin - resistant Staphylococci.

•Gram - negative aerobic bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Acinetobacter species, Yersinia species, Vibrio cholera Parahaemolyticus, Plesiomonas Shigelloides, Legionella pneumophila, Bordetella pertussis, Bordetella parapertussis, Shigella species, Pasteurella species. Azithromycin activities are variable against E.coli Salmonella enteritidis,Salmonella typhi, Enterobacter species, Aaeromonas hydrophila and Klebsiella species, and suscepti bility tests should be performed. There are some species which are usually resistant to Azithromycin e.g. proteus species, Serratia species, Morganella species and PseudOOlOnas aeruginosa

•Anaerobic bacteria: Bacteroides fragilis, Bacteroid species, Clostridium perfringens, Peptococcus species and Peptostreptococcus species, Fusobacterium necrophorum and Propionibacterium acnes.

•Organisms of S.T.Ds: Azithromycin is active against Chlamydia trachomatis and also shows good activity against Treponema pallidum, Neisseria gonorrhoeae and Haemophilus ducreyi, Borrelia burgdorferi(lyme disease agent), Chlamydia pneumoniae, Toxoplasma gondii, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, pneumocystis carinii, Mycobacterium avium - intracellulare, Campylobacter species and Listeria monocytogenes.

Following oral administration in human, Azithromycin is widely distributed throughout the body, bioavailabi lity is approximately 37%. Administration following a substantial meal reduces bioavailability of capsules, but not the powder for oral suspension, by at least 50%. The time taken to peak plasma levels is 2 – 3 hours. Plasma terminal elimination half - life closely reflects the tissue depletion half - life of 2 -4 days. Pharmacokinetic studies have shown markedly higher Azithromycin levels in tissue thanin plasma (up to 50 times the maximum observed concentrationin plasma) indicating that the drug is heavily tissue bound.

Concentration in target tissues, such as lung, tonsil and prostate exceed the ( Mic 90) for likely pathogens after a single dose of 500 mg.

In animal studies, high Azithromy~n concentration have been observed in phagocytes. In expenmental models, higher concentrations of Azithromycin are released during active phagocytosis than from nonstimulated phagocytes. In animal models this results in high concentrations of Azithromycin being delivered to the site of infection.

- Zisrocin 500 mg capsules: box of 3 capsules in a blister

- Zisrocin Suspension: bottle oontaining 600 mg Azithromycin

powder for oral suspension 100 mg / 5 ml.

Store below 25"C, protect from light. Keep out of reach of children