MACROMAX 500 Tablet

For infections caused by susceptible organisms; in lower respiratory tract infection including bronchitis and pneumonia, skin and soft tissue infections, otitis media and in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis.

MACROMAX may be also be used as a component of regimen in the treatment of Mycobacterium avium complex (MAC) infection and may be used as an alternative to rifabutin for prophylaxis. It has been tired in protozoal infections including toxoplasmosis. MACROMAX is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis.

METHOD OF APPLICATION & DOSAGE

MACROMAX should be given as a single daily dose with or without food. MACROMAX should be taken whole.

ADULTS: For treatment of sexually transmitted diseases caused by Chlamydia trachomatis, the dose is 1g given as a single dose.

For most other indication, the dose is 1.5g, which should be given 500mg daily for 3 days.

IN THE ELDERLY: The same dose range as in younger patients may be used in the elderly.

IN CHILDREN: Reduction in dose is necessary. It is not recommended in children below age of six months.

In patients with a known hypersensitivity to Azithromycin or any of the macrolide antibiotics. Because of the theoretical possibility of ergotism, Azithromycin and ergot derivatives should not be co-administered.

MACROMAX is well tolerated with a low incidence of side effects. Most side effects observed are mild to moderate in severity.

The majority of side effects were gastrointestinal in origin with nausea, abdominal discomfort (pain/cramps), vomiting, flatulence, diarrhoea and loose stools being occasionally observed.

Allergic reactions such as rash r photosensitivity have occurred and there have also been rare reports of serious hypersensitivity reactions.

Reversible elevations in liver transaminases have been observed with a frequency similar to the comparative macrolides and penicillins used in clinical trials. Rarely, cases f cholestatic jaundice have been found.

Transient mild reductions is neutrophil counts have occasionally been observed in clinical trials, although a casual relationship to Azithromycin has not been established.

Hearing impairment: In investigational studies where higher doses were used for prolonged periods of time, reversible hearing impairment was seen in some patients.

The following drug interactions have been observed with MACROMAX.

(See the package insert about the details below.)

- antacids

- cyclosporin

- digoxin

- ergot derivatives

- theophylline

- warfarin

- terfenadine

Azithromycin is nitrogen containing macrolide or azalide with actions and uses similar to those of erythromycin. Though it is less active than erythromycin against streptococci and staphylococci, it has greater activity than erythromycin in vitro against some Gram-negative pathogens such as Haemophilus influenza and Moraxella (Branhamella) catarrhalis. Azithromycin is also active against some of the Enterobacteriaceae such as Escherichia coli and Salmonella and Shigella spp. Azithromycin is also more active than erythromycin against Chlamydia trachomatis and some opportunistic mycobacteria including Mycobacterium avium complex. It has activity against the protozoa Toxoplasma gondii and Plasmodium falciparum.

It is given by mouth as the dehydrate, in tablet or suspension form. Dosage is calculated in terms of the base.