Azalid Suspension (35ml)

Indications of Azalid 35 ml Powder For Solution

Azalid 35 ml Powder For Solution is used to treat infections in the lower respiratory tract, such as bronchitis and pneumonia, as well as infections in the upper respiratory tract, such as sinusitis and pharyngitis/tonsillitis, otitis media, and skin and soft tissue infections. Azalid 35 ml Powder For Solution is used to treat non-gonococcal urethritis and cervicitis caused by Chlamydia trachomatis in both men and women with sexually transmitted infections.

Pharmacology of Azalid 35 ml Powder For Solution

Azithromycin is stable to acid, so it can be taken orally without protecting stomach acid. Easily absorbed; greater absorption on an empty stomach. For oral dosage forms, the time for adults to reach maximum concentration is 2.1 to 3.2 hours. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, high concentrations of azithromycin are released. The concentration of azithromycin in tissues can be 50 times higher than in plasma. This is due to ion trapping and high fat solubility. The half-life of

Azithromycin allows a single high-dose administration, but it can still maintain the antibacterial level in the infected tissue for several days. After a single administration of 500 mg, the plasma concentration of azithromycin showed a multiphasic decline, the average apparent plasma clearance rate was 630 ml/min, and the terminal elimination half-life was 68 hours. The extended terminal half-life is believed to be due to the massive absorption and subsequent release of the drug from the tissue. The bile excretion of azithromycin (mainly unchanged) is the main route of elimination. Over the course of a week, approximately 6% of the administered dose appeared as the parent drug in the urine.

Microbiology: Azithromycin works by binding to the 50S ribosomal subunit of susceptible microorganisms, which interferes with the synthesis of microbial proteins. Nucleic acid synthesis is not affected. In vitro and in clinical infections, azithromycin has been shown to be active against most isolates of the following microorganisms:

• facultative gram-positive and aerobic microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Pyogenic Streptococcus
• facultative aerobic microorganisms, and
• facultative Haemophilic negative microorganisms: , Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
• Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, β-lactamase production Has no effect on azithromycin activity.
• Facultative gram-positive and aerobic microorganisms: Streptococcus (group C, F, G), Streptococcus viridans
• Facultative gram-negative and aerobic microorganisms: Bordetella pertussis, Legionella pneumophila
• Anaerobic microorganisms: Distreptococcus, Peptostreptococcus

Azalid 35 ml Powder For Solution Dosage & Administration

Oral-

Adult:

• 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days.
• For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

• 10 mg/kg body weight once daily for 3 days for child over 6 months
• 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
• 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
• In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

• 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 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 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.
• Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

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 completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Interaction of Azalid 35 ml Powder For Solution

In the presence of food or an antacid, azithromycin absorption is reduced. Because of the risk of ergotism from Azithromycin's interaction with the cytochrome P-450 system, it should be avoided in patients receiving ergot alkaloids. Because macrolides raise digoxin and cyclosporin plasma concentrations, caution should be used while taking them together. Azithromycin has not been found to interact with Warfarin, Theophylline, Carbamazepine, Methylprednisolone, or Cimetidine.

Contraindications of Azalid 35 ml Powder For Solution

Patients who are hypersensitive to Azalid 35 ml Powder For Solution or any other macrolide antibiotic should avoid taking it. Ergot derivatives and azithromycin should not be taken together. Patients with hepatic disorders should avoid Azalid 35 ml Powder For Solution.

Azalid 35 ml Powder For Solution Side Effects

Azalid 35 ml Powder For Solution is a well-tolerated antibiotic with few adverse effects. Nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes are among the side effects, which are reversible as the medication is stopped.

Pregnancy & Lactation

Azithromycin falls into the B pregnancy category. Azithromycin has been shown in animal reproductive tests to cause no harm to the fetus. In pregnant women, there are no sufficient and well-controlled trials. Because animal reproduction studies do not always reflect human response, Azalid 35 ml Powder For Solution should only be administered during pregnancy if there are no other options. Azithromycin is not known to be secreted in breast milk. As a result, when Azithromycin is given to a nursing woman, vigilance should be observed.

Precautions & Warnings

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

Therapeutic Class of Azalid 35 ml Powder For Solution

Macrolides

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.