DOSAGE & ADMINISTRATION:
Adults:
- In uncomplicated Chlamydia trachomatis urethritis and cervicitis, the dose is 1,000 mg in one single oral dose.
- For all other indications, the dose is 1,500 mg, to be administered as 500 mg per day for three consecutive days. Alternatively, the same total dose (1,500 mg) can also be given over a period of 5 days with 500 mg on the first day and then 250 mg on days 2 to 5.
- Other pharmaceutical forms are also available to treat these patients.
Elderly people:
- The same dose as in adult patients is used in the older people. Since older patients can be at risk of developing cardiac arrhythmia and torsades de pointes (see section 4.4), caution is advised.
Children and adolescents (<18 years):
- The total dose in children aged 1 year and older is 30 mg/kg, administered as 10 mg/kg once daily for three days or over a period of five days starting with a single dose of 10 mg/kg on the first day, followed by doses of 5 mg/kg per day for the following 4 days, according to the tables shown below. Limited data are available for use in children younger than 1 year.
| Weight (kg) | 3-day therapy | 5-day therapy | |
| Day 1–3
10 mg/kg/day |
Day 1
10 mg/kg/day |
Day 2–5
5 mg/kg/day |
|
| 10 kg | 100 mg | 100 mg | 50 mg |
| 12 kg | 120 mg | 120 mg | 60 mg |
| 14 kg | 140 mg | 140 mg | 70 mg |
| 16 kg | 160 mg | 160 mg | 80 mg |
| 17–25 kg | 200 mg | 200 mg | 100 mg |
| 26–35 kg | 300 mg | 300 mg | 150 mg |
| 36–45 kg | 400 mg | 400 mg | 200 mg |
| > 45 kg | 500 mg | 500 mg | 250 mg |
The dose for the treatment of pharyngitis caused by Streptococcus pyogenes is an exception: In the treatment of pharyngitis caused by Streptococcus pyogenes, Azithromycin has proved to be effective when it is administered to children as a single dose of 10 mg/kg or 20 mg/kg for 3 days with a maximum daily dose of 500 mg. At these two doses, a comparable clinical effect was observed, even if the eradication of the bacteria was more significant at a daily dose of 20 mg/kg.
Penicillin is, however, the drug of first choice in the treatment of pharyngitis caused by Streptococcus pyogenes and the prevention of subsequent rheumatic fever.
Patients with renal impairment:
No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10-80 ml/min).
Patients with hepatic impairment:
A dose adjustment is not necessary for patients with mild to moderately impaired liver function.
Method of administration:
- Use the attached measuring cup to add 30 ml distilled water into the bottle for reconstitution. Shake until the powder is mixed well into a homogeneous oral suspension.
- Take the drug following the prescribed/recommended dosage, using the measuring cup for each time usage.
- After taking the suspension, a bitter after-taste can be avoided by drinking fruit juice directly after swallowing. Azithromycin powder for oral suspension should be given in a single daily dose. The suspension may be taken together with food.
CONTRA-INDICATION:
- History of hypersensitivity to any of the Macrolide antibiotics.
CAUTION:
- Because Azithromycin is principally eliminated via the liver, caution should be exercised when administered to patients with impaired hepatic function or renal function impairment.
- The use of the drug is not recommended in children under 6 months.
DRUG INTERACTION:
- Aluminum and Magnesium-containing antacids reduce the peak serum level of Azithromycin but not extend Azithromycin absorption.
- Azithromycin should not be coadministered with warfarin (increased anticoagulant effects) or with Digoxin or Ergotamine.
- With Cyclosporine A (increased Cyclosporine level) or food, this medication should be taken at a distance from meals, as food decreases the absorption of Azithromycin.
USE FOR PREGNANCY & LACTATION:
Pregnancy:
- Use during pregnancy only if clearly needed.
Lactation:
- It is not known whether Azithromycin is excreted in breast milk. Exercise caution when administering to a nursing woman.
DRUG EFFECT TO DRIVER & MACHINE WORKER:
- The drug doesn’t cause drowsiness, so it is usable for people who are operating vehicles and machines.
ADVERSE DRUG REACTION (ADR):
- Most side effects are mild to moderate in severity and are reversible upon discontinuation of the drug.
- The common adverse effects have been referable to disorders of the gastrointestinal tract, such as vomiting, diarrhea, abdominal pain.
- Rare occurrences include: vaginitis, nephritis, central nervous system symptoms like dizziness, vertigo, fatigue, skin reactions such as rash, photosensitivity, angioedema.
Note: Inform the doctor about adverse drug reactions.
OVERDOSE & TREATMENT:
- Not found any documents saying about overdose of drug.
PHARMACODYNAMIC:
Azithromycin is an antibiotic drug in the macrolide group, called azalid, having wide effects. The drug has good anti-bacterial effects by the way it combines with the ribosome of bacteria to prevent them from synthesizing protein.
- Although, Azithromycin has cross-resistance with Erythromycin, so caution when using Azithromycin if bacterial drug-resistance is detected.
- Azithromycin has strong effects against Gram-positive bacteria such as Streptococcus, Pneumococcus, Staphylococcus aureus. Some other species of bacteria include Corynebacterium diphtheria, Clostridium perfringens, Peptostreptococcus, Propionibacterium acnes.
- Azithromycin also shows strong effects against Gram-negative bacteria such as Haemophilus influenza, Moraxella catarrhalis, Acinetobacter, Yersinia, Legionella pneumophila, etc.
- Azithromycin has effects on Listeria monocytogenes, Mycobacterium avium, Mycoplasma pneumoniae, and some intracellular bacteria like Chlamydia trachomatis, Toxoplasma gondii.
PHARMACOKINETICS:
- Azithromycin is widely distributed into the body; bioavailability is 40%. Food reduces 50% of absorption.
- The maximum concentration in blood plasma reaches after 2–3 hours. The drug is mainly distributed into tissues such as lung, tonsil, prostate, and granulocyte macrophages, many times higher than in blood.
- A small amount of Azithromycin is reduced methyl in the liver and excreted via bile in its original form and an amount in transformed form. About 6% of the dose is excreted via urine within 72 hours in its original form.
