Zimax 500

Indications

Zimax 500 is used to treat infections (produced by susceptible organisms) in the lower respiratory tract, such as bronchitis and pneumonia, the upper respiratory tract, such as sinusitis and pharyngitis/tonsillitis, otitis media, and skin and soft tissue infections. Azithromycin is used to treat non-gonococcal urethritis and cervicitis caused by Chlamydia trachomatis in both men and women with sexually transmitted infections.

 

Pharmacology

Because azithromycin is acid-stable, it can be given orally without the requirement for stomach acid protection. It is easily absorbed, and its absorption is enhanced when taken on an empty stomach. For oral dose formulations, the time to peak concentration in adults ranges from 2.1 to 3.2 hours. Azithromycin is aggressively delivered to the site of infection due to its high concentration in phagocytes. Large amounts of azithromycin are released during vigorous phagocytosis. Azithromycin concentrations in tissues can be more than 50 times greater than in plasma. Because of ion trapping and the high lipid solubility, this is the case.

Because of the long half-life of azithromycin, a large single dosage can be given while still maintaining bacteriostatic levels in infected tissue for several days. Following a single 500 mg dosage, azithromycin plasma concentrations decreased in a polyphasic fashion, with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The extended terminal half-life is considered to be caused by substantial drug absorption and subsequent release from tissues. A primary route of elimination for azithromycin is biliary excretion, which is mostly unaltered. Approximately 6% of the given dosage shows as unaltered medication in urine over the course of a week.

 

Dosage

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 the next 2 days may also be given.

Children:

• 10 mg/kg body weight once daily for 3 days for a child over 6 months
• 200 mg (1 teaspoonful) for 3 days if bodyweight is 15-25 kg
• 300 mg (1½ teaspoonfuls) for 3 days if bodyweight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if bodyweight 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 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 water mark of the bottle label.
• Step 03: Shake until powder is completely mixed with water.

Zimax 500 should be taken at least 1 hour before or 2 hours after a meal.

 

Interaction

In the presence of food and an antacid, azithromycin absorption is decreased. Azithromycin should be avoided in patients taking ergot alkaloids due to the risk of ergotism caused by Azithromycin's interaction with the cytochrome P-450 system. Because macrolides raise the plasma concentrations of digoxin and cyclosporin, they should be used with care. Azithromycin has not been shown to interact with Warfarin, Theophylline, Carbamazepine, Methylprednisolone, or Cimetidine.

 

Contraindications

Zimax 500 is not recommended for people who are allergic to it or any other macrolide antibiotic. Ergot derivatives and Azithromycin should not be used together. Azithromycin is not recommended for those who have a hepatic illnesses.

 

Side Effects

Zimax 500 is well tolerated and has a low risk of adverse effects. The adverse effects are reversible with the termination of treatment and include nausea, vomiting, stomach discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes.

 

Pregnancy & Lactation

Azithromycin's pregnancy category is B. Animal reproduction studies have shown that Azithromycin does no damage to the fetus. In pregnant women, there are no appropriate and well-controlled trials. Because animal reproduction studies are not necessarily indicative of human response, Azithromycin should only be taken during pregnancy if no other options are available. Azithromycin is not known to be secreted in breast milk. As a result, while administering Azithromycin to nursing mothers, extreme caution should be taken.

 

Precautions & Warnings

As with any antibiotic, it is important to keep an eye out for symptoms of superinfection with non-susceptible organisms, particularly fungus. In individuals with renal impairment, no dosage modification is required.

 

Therapeutic Class

Macrolides

 

Storage Conditions

Keep away from light and heat in a dry area. Keep out of children's reach.

 

Pharmaceutical Name

Square Pharmaceuticals Ltd.      

 

Generic

Azithromycin

 

Related Products

• Zithrox 500
• Azithrocin 500
• Azyth 500