Azirex is an azalide antibiotic, a subclass of macrolide antibiotic. It acts by binding to the 50s ribosomal subunit of susceptible microorganisms and thus interfering with microbial protein synthesis. Azirex has been shown to be active against most strains in the following microorganisms, both In vitro and in clinical infections:
Gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Escherichia coli.
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Bacteroides fragilis, Legionella pneumophila, oxoplasma gondii.
Azirex is used for infections caused by susceptible organisms in-
Upper respiratory tract infections including sinusitis, pharyngitis and tonsillitis
Lower respiratory tract infections including bronchitis, acute bacterial exacerbations of chronic obstructive pulmonary
Skin and soft tissue infections including cellulitis, pyoderma, erysipelas, wound infections
Sexually transmitted diseases, especially in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid)
Mild or moderate typhoid due to multiple-antibacterial resistant organisms
Prophylaxis against a-hemolytic (viridans group) streptococcal bacterial endocarditis
Other infections including odontogenic infections, bartonella infections, toxoplasmosis, babesiosis
Azirex is also used to associated treatment for these conditions: Acute Bacterial Sinusitis (ABS), Acute Otitis Media, Acute bacterial exacerbation of COPD caused by Haemophilus Influenza Infections, Moraxella Catarrhalis Infection, Streptococcus Pneumoniae Infections, Bacterial Conjunctivitis, Bacterial Sinusitis, Cervicitis, Chancroid, Community Acquired Pneumonia (CAP), Genital Ulcer Disease (GUD), Pelvic Inflammatory Disease (PID), Pharyngitis, Streptococcal Pharyngitis, Streptococcal tonsillitis, Tonsillitis bacterial, Traveler's Diarrhea, Uncomplicated Skin and Skin Structure Infections, Urethritis
|Other Names||Azithromycin, Azithromycine, Azithromycinum, Azitromicina|
The serum protein binding of azithromycin varies in humans, decreasing from 51% at 0.02 g/mL to 7% at 2 g/mL .
|Manufacturer||Theo Pharma Pvt Ltd, Belsen Pharmaceuticals Ltd|
|Available Country||India, Bangladesh|
|Last Updated:||June 23, 2021 at 9:00 am|
Table Of contents
Azirex tablet can be taken with or without food. Azirex suspension should be taken at least 1 hour before or 2 hours after meal.
For respiratory tract infections, otitis media and skin & soft tissue infections: 500 mg once daily for 3 days or an alternative to this as 500 mg once on day 1, followed by 250 mg once daily for next 4 days. For sexually transmitted diseases like genital ulcer, non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis : a single 1 gm (1000 mg) dose. For the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae : a single 2 gm (2000 mg) dose. In typhoid, 500 mg once daily for 7 days. In Cholera, a single 1 gm (1000 mg) dose. In Shigellosis, 500 mg once on day 1, followed by 250 mg once daily for next 4 days.
Azirex can be taken with or without food.
To reconstitute Azirex 15 ml powder for suspension: Add 10 ml or 2 tea spoonfuls of just boiled and cooled water to the content of the bottle and shake well to mix uniformly.
To reconstitute Azirex 30 ml powder for suspension: Add 20 ml or 4 tea spoonfuls of just boiled and cooled water to the content of the bottle and shake well to mix uniformly.
To reconstitute Azirex 50 ml powder for suspension: Add 35 ml or 7 tea spoonfuls of just boiled and cooled water to the content of the bottle and shake well to mix uniformly.
Azirex is well tolerated with a low incidence of side efects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy. Reversible elevations in liver transaminases have been observed occasionally. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although causal relationship to Azirex has not been established.
As with any antibiotic, observation for signs of super infection with non-susceptable organisms, including fungi, is recommended. Precaution should be taken in patients with more severe renal impairment.
Antacids: Peak serum levels but not the total extent of absorption are reduced by aluminium and magnesium containing antacids in the stomach. Azirex should therefore be taken at least 1 hour before or 2 hours after taking these antacids.
Ergot Derivatives: Because of the theoretical possibility of ergotism, concomitant administration of ergot derivatives and Azirex should be avoided. Digoxin & Cyclosporin: Macrolides have been known to increase the plasma concentration of Digoxin & Cyclosporin and so caution should be exercised while co-administration is necessary.
Anti-Histamines: A potentially life threatening interaction between erythromycin and terfenadine or astemizole have been reported. Although such an interaction with Azirex is not established yet, it is wise to avoid concomitant use of Azirex and terfenadine or astemizole.
- Take on an empty stomach. Take at least 1 hour before or 2 hours after meals.
Volume of Distribution
After oral administration, azithromycin is widely distributed in tissues with an apparent steady-state volume of distribution of 31.1 L/kg . Significantly greater azithromycin concentrations have been measured in the tissues rather than in plasma or serum , . The lung, tonsils and prostate are organs have shown a particularly high rate of azithromycin uptake .
This drug is concentrated within macrophages and polymorphonucleocytes, allowing for effective activity against Chlamydia trachomatis . In addition, azithromycin is found to be concentrated in phagocytes and fibroblasts, shown by in vitro incubation techniques. In vivo studies demonstrate that concentration in phagocytes may contribute to azithromycin distribution to inflamed tissues .
Terminal elimination half-life: 68 hours
Mean apparent plasma cl=630 mL/min (following single 500 mg oral and i.v. dose)
Pregnancy & Breastfeeding use
Pregnancy: US FDA pregnancy category B. In the animal studies, no evidence of harm to the fetus due to Azirex was found. Because animal reproduction studies are not always predictive of human response, Azirex should be used during pregnancy only if clearly needed.
Lactation: It is not known whether Azirex is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azirex is administered to nursing mother.
Azirex is contraindicated in patients hypersensitive to Azirex or any other macrolide antibiotic. Co-administration of ergot derivatives and Azirex is contraindicated. Azirex is contraindicated in patients with hepatic diseases.
Pediatric Use: Azirex oral dosage forms can be administered to pediatric patients from 6 months of age. Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
There are no data available on overdose with Azirex. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
Interaction with other Medicine
Peak serum levels but not the total extent of absorption were reduced by the presence of magnesium and aluminum-containing antacids. Azirex should be taken at least 1 hr before or 2 hrs after these antacids. In patients receiving ergot alkaloids, Azirex should be avoided concurrently because of the possibilty of ergotism result in from interaction of Azirex with the cytochrome P-450 system However, no cases of such interaction have been reported. Macrolides have been known to increase the plasma concentration of digoxin and cyclosporine. Therefore, if co-administration is necessary caution should be exercised and serum levels of digoxin and cyclosporine should be checked. There have been no pharmacokinetic drug interactions between Azirex and warfarin, theophylline, carbamazepine, methylprednisolone and cimetidine.
Azirex IV infusion: When diluted according to the instructions, azithromycin for injection is stable for 24 hours at or below room temperature 30° C, or for 7 days if stored under refrigeration 5° C.
Azirex capsule, tablet and dry powder for suspension: should be stored at room temperature (below 30° C). Any unused portion of reconstituted Azirex suspension should be discarded after 5 days.
Azirex eye drops: Store unopened bottle under refrigeration at 2°C to 8°C. Once the bottle is opened, store at 2°C to 25°C for up to 14 days. Discard after the 14 days.