AZITHROCINE
(Azithromycin)

PROPERTIES
AZITHROCINE is an azalide, derived from the macrolide class of antibiotics.

ACTION
Following oral administration in humans, AZITHROCINE is wildly distributed throughout the body, bioavailability is approximately 37 %. 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 to 4 days.
Kinetic studies have shown markedly higher AZITHROCINE levels in tissue than in plasma (up to 50 times the maximum observed concentration in plasma) indicating that the drug is highly tissue bound. Concentration in target tissues such as lung, tonsil and prostate exceed the MIC90 for likely pathogens after a single dose of 500 mg.
AZITHROCINE demonstrates activity against a wide range of Gram-positive and Gram-negative bacteria including: staphylococcus aureus, strepto¬coccus pneumoniae, streptococcus pyogenes (Group A) and other strepto¬coccal species, haemophilus influenzae and parainfluenzae, moraxella catarrhalis, anaeorobes including bacteroides fragilis, E. coli, bordetella parapertussis, borrelia burgdorferi, haemophilus ducreyi, neisseria gonor¬rhea and chlamydia trachomatis.
AZITHROCINE also demonstrates activity against legionella pneumophila, mycoplasma pneumoniae and hominis, campylobacter sp., toxoplasma gondii and treponema pallidum.
 

INDICATIONS
AZITHROCINE is indicated for infections caused by susceptible organisms, in lower respiratory tract infections including: bronchitis and pneumonia, skin and soft tissue infections, otitis media and in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis.
In sexually transmitted diseases in men and women, AZITHROCINE is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachmoatis.
 

CONTRAINDICATIONS
AZITHROCINE is contraindicated in patients with known hypersensitivity to Azithromycin or any of the macrolide antibiotics. AZITHROCINE and ergot derivatives should not be co-administrated. AZITHROCINE should not be used in hepatic disease.
 

PRECAUTIONS AND WARNINGS
As with other erythromycin and other macrolide, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis have been reported.
As with any antibiotic, observation for signs of superinfection with non¬susceptible organisms, including fungi is recommended.
Use in renal impairment: No dose adjustment is needed in patients with mild renal impairment (creatinine clearance > 40 ml / min). Caution should be exercised in severe renal impairment.
Use in hepatic impairment: AZITHROCINE should not be used in patients with hepatic disease.

PREGNANCY AND LACTATION
AZITHROCINE should be used during pregnancy only if adequate alter¬natives are not available.
DRUG INERACTIONS
Antacids: AZITHROCINE should be taken at least one hour before or 2 hours after the antacids.
Cyclosporin: Cyclosporin levels should be monitored and dose adjusted accordingly.
Digoxin: No interactions have been reported, any way raised digoxin levels should be borne in mind.
Ergot derivatives: AZITHROCINE and ergot derivatives should not be co-administered.
No interaction with the following drugs were reported when used conco¬mitantly with: Carbamazepine, Cimetidine, Methyl prednisolone, Theophylline and Wafarin.
 

SIDE EFFECTS
AZITHROCINE is well tolerated. Most side effects observed were mild to moderate in severity.
The majority of side effects were gastrointestinal in origin with nausea, abdominal discomfort (pain/cramps), vomiting, flatulence, diarrhea and loose stools being occasionally observed.
Allergic reactions such as rash have occurred and there have also been rare reports of serious hypersensitivity reactions.
Reversible elevations in liver transaminases have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials.
Transient mild reductions in neutrophil counts have occasionally been observed.

DOSAGE AND ADMINISTRATION
AZITHROCINE should be administered as a single dose daily and in common with many other antibiotics should be taken at least 1 hour before or 2 hours after food.
Adults and Elderly: For sexually transmitted diseases caused by Chlamydia trachomatis the dose is 1 gr. given as a single dose.
For all other indications, the total dose is 1.5 gr. which should be given as 500 mg daily for 3 days.
Children: AZITHROCINE powder for oral suspension should be used for children under 45 kg.
There is no information on children under six months of age.
The dose in children is 10 mg/kg as a single daily dose for 3 days.
AZITHROCINE suspension should be administered using the spoon provided according to the following guidance:

OVERDOSAGE
Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhea. Gastric lavage and general supportive measures are indicated.
 

PACKAGES AND COMPOSITION
AZITHROCINE 250: 1 x 6 Capsules,
Each capsule contains: Azithromycin 250 mg.
AZITHROCINE 500: 1 x 3 Capsules,
Each capsule contains: Azithromycin 500 mg.
AZITHAOCINE 200: bottle of 15 ml containing dry powder ready for reconstitution.
Each 5 ml of reconstituted suspension contain: Azithromycin 200 mg.
 

STORAGE
Store below 30°C.
Keep out of the reach of children.
 

RECONSTITUTION:
Add a little water and shake well, then slowly add more water up to the line on the label.