Azithromycin

Azithromycin


PHARMACEUTICAL FORM AND FORMULATION:

Each TABLET contains: 
Azithromycin dihydrate equivalent to .......................... 500 mg of azithromycin base.
Excipient, c.b.p. 1 tablet

INDICATIONS:

AZITROMYCIN is indicated in infections caused by susceptible organisms.

In sexually transmitted infections, AZITHROMYCIN is indicated in both men and women in the treatment of uncomplicated genital infections due to Chlamydia trachomatis. It is also indicated for the treatment of chancroid due to Haemophilus ducreyi, as well as in the treatment of uncomplicated genital infections due to Neisseria gonorrhoeae that is not multiresistant.

The concomitant infection with Treponema pallidum should be excluded.



CONTRAINDICATIONS: It is contraindicated in patients with a history of allergic reactions to AZITHROMYCIN or any of the macrolide antibiotics.



PRECAUTIONS: As with erythromycin and other macrolides, cases of severe allergic reactions, including angioedema and anaphylaxis (rarely fatal), have been reported rarely.

Some of these reactions with AZITROMYCIN have resulted in recurrent symptoms, requiring longer periods of observation and treatment.

Because the liver is the main route of elimination of AZITROMYCIN, it should be used with caution in patients with significant liver pathology.

In patients who are given ergot derivatives, ergot has been precipitated when administered simultaneously with some macrolide antibiotics. No information is available regarding the possibility of interactions between ergot and AZITROMYCIN. However, due to the theoretical possibility of ergotism, AZITROMYCIN and ergot derivatives should not be administered simultaneously.

As with any antibiotic, signs of superinfection with non-susceptible organisms, including fungi, should be monitored.

In patients with severe renal insufficiency (IFG <10 ml / min), a 33% increase in systemic exposure to AZITROMYCIN was observed.

In the treatment with other macrolides it has been observed that prolonged cardiac repolarization and the QT interval cause a risk of developing cardiac arrhythmia and torsades de pointes. A similar effect with AZITHROMYCIN can not be completely excluded in patients with a high risk of prolonged cardiac repolarization. (See Secondary and adverse reactions).




RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION:

Studies of animal reproduction have shown that AZITROMYCIN crosses the placenta, but did not reveal evidence of damage to the fetus. There are no data about secretion in milk. Safety has not been established for use during pregnancy and lactation. AZITROMYCIN should only be used in pregnant or lactating women when adequate alternatives are not available.




SECONDARY AND ADVERSE REACTIONS: 

AZITHROMYCIN is well tolerated with a low frequency of side effects. In clinical studies, the following adverse reactions were reported:

Disorders of the blood and lymphatic system: In clinical studies, transient episodes of mild neutropenia have occasionally been observed, although a causal relationship with AZITHROMYCIN has not been established.

Ear and labyrinth disorders: Auditory deterioration, including hearing loss, deafness and / or tinnitus has been reported in some patients receiving AZITHROMYCIN. Many of these have been associated with prolonged use of high doses in research studies.

In such cases, when follow-up information was available, most events were reversible.




DRUG INTERACTIONS AND OTHER GENDER:

Antacids: In a pharmacokinetic study investigating the effects of the simultaneous administration of antacids with AZITROMYCIN, no effect on bioavailability as such was observed, although the maximum serum concentration was reduced by approximately 25%. Patients who receive both AZITHROMYCIN and antacids should not take these medications simultaneously.

Cetirizine: In healthy volunteers, the administration of AZITROMYCIN for 5 days with cetirizine 20 mg did not produce pharmacological interactions or significant changes in the QT interval.

Didanosine: The simultaneous administration of daily doses of 1,200 mg / day of AZITROMYCIN with 400 mg / day of didanosine in 6 patients with HIV, did not affect the pharmacokinetics of didanosine, compared with placebo.

Digoxin: It has been reported that some macrolide antibiotics alter the microbial metabolism of digoxin in the intestine in certain patients. The possibility that digoxin reaches high concentrations in patients receiving AZITROMYCIN (an azalide antibiotic related to macrolides) and digoxin should be kept in mind.




PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility: No have carried out long-term animal studies to evaluate the potential carcinogenesis.

AZITHROMYCIN has not shown mutagenic potential in routine laboratory tests, lymphoma test in mouse, clastogenic test in human lymphocytes and clastogenic test in mouse bone marrow.




DOSAGE AND ROUTE OF ADMINISTRATION: 

Oral.

AZITHROMYCIN should be administered as the only daily dose. The treatment time is established according to the degree of infection. AZITHROMYCIN tablets can be taken with or without food.

Adults: For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus ducreyi, or susceptible strains of Neisseria gonorrhoeae, the dose of AZITROMYCIN is 1,000 mg as a single dose.

Elderly: The same dose is used as in adults.

Patients with renal insufficiency: In patients with mild to moderate renal impairment (IFG 10-80 ml / min) or severe (IFG <10 ml / min) dose adjustment is not necessary.

Patients with hepatic impairment: The same dosage may be administered as in patients with mild to moderate hepatic impairment than in patients with normal hepatic function.



RECOMMENDATIONS ON STORAGE: Keep at room temperature to no more than 30 ° C and in a dry place.