Generic Name বাংলায় দেখুন
Azithromycin Dihydrate
Therapeutic Group: Anti Bacterial (Macrolides)
Indications :
Azithromycin is indicated 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
- Disease (COPD)
- Otitis media
- Skin and soft tissue infections including cellulitis, pyoderma, erysipelas, wound infections
- Diarrhea, Shigellosis
- 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
Azithromycin 250 Tablet: Each tablet contains Azithromycin Dihydrate USP 262.015 mg equivalent to Azithromycin 250 mg.
Azithromycin 500 Tablet: Each tablet contains Azithromycin Dihydrate USP 524.03 mg equivalent to Azithromycin 500 mg.
Azithromycin 15 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.
Azithromycin 30 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.
Azithromycin 35 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.
Azithromycin 50 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.
Azithromycin IV Infusion: Each vial contains lyophilized powder of Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg and each normal saline bottle contains 250 ml 0.9% Sodium Chloride solution. After reconstitution with 250 ml 0.9% Sodium Chloride solution according to direction, each ml contains Azithromycin Dihydrate USP equivalent to Azithromycin 2 mg.
Pharmacology :
Azithromycin is acid-stable and can therefore be taken orally with no need for protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. The time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and high lipid solubility.Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half-life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drugs from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as an unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus Influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma Pneumoniae , Betalactamase production should have no effect on azithromycin activity.
- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C, F, G), Viridans group streptococci
- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella Pneumophila
- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia.
Dosage & Administration :
Oral-Adult:
- 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 the 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 the next 4 days.
* Take the medicine as advised by your doctor or pharmacist *
Children:
- 10 mg/kg weight once daily for 3 days for a child over 6 months
- 200 mg (1 teaspoonful) for 3 days if weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if weight is 36-45 kg.
- In typhoid, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with the clinical response.
- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with the clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
- The safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
Administration :
Reconstitution procedure of suspension-
Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the watermark of the bottle label.
Step 03: Shake until powder is totally mixed with water.
Azithromycin should be taken a minimum of 1 hour before or 2 hours after the meal.
Interaction :
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids, Azithromycin should be avoided due to the likelihood of ergotism resulting from the interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There are no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone, or Cimetidine.
Contraindications :
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or the other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
Side Effects :
Azithromycin is well tolerated with a coffee incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
Pregnancy & Lactation :
The pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are not any adequate and well-controlled studies on pregnant women. Since animal reproduction studies aren't always predictive of human response, azithromycin should be used during pregnancy as long as adequate alternatives aren't available. it's not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is run to nursing women.
Precautions & Warnings :
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is suggested. No dose adjustment is required in patients with renal impairment.
Overdose Effects :
There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include deafness, severe nausea, vomiting, and diarrhea. lavage and general supportive measures are indicated.
Storage :
Keep in a dry place far away from light and warmth. exclude the reach of children.
Brand Names
Brand Name | Company | Strength |
| Aprocin | Aristopharma Ltd. | 250 mg+500 mg |
| Azithrocin | Beximco Pharmaceuticals Ltd. | 250 mg+500 mg |
| Tridosil | Incepta Pharmaceuticals Ltd. | 250 mg+500 mg |
| Zimax | Square Pharmaceuticals Ltd. | 250 mg+500 mg |
| Azicin | Opsonin Pharma Ltd. | 250 mg+500 mg |
| Zibac | Popular Pharmaceuticals Ltd. | 250 mg+500 mg |