What is the importance of azithromycin (Intravenous)?

From the Guidelines

Azithromycin IV is a crucial antibiotic therapy for the treatment of severe infections, including community-acquired pneumonia.

Importance of Azithromycin IV

The recommended dose is 500mg administered intravenously once daily for 1-5 days, depending on the specific infection being treated 1.

• In cases of community-acquired pneumonia, azithromycin IV is typically administered for 2-5 days, followed by oral azithromycin to complete a 7-10 day course of therapy.
• The use of azithromycin IV provides high tissue penetration and rapid achievement of therapeutic drug levels, making it an effective treatment option for severe infections 1.

Clinical Guidelines

According to clinical guidelines, azithromycin IV can be considered for carefully selected patients with CAP with nonsevere disease and no risk factors for infection with DRSP or gram-negative pathogens 1.

• Initial therapy should be given intravenously for most admitted patients, but some without risk factors for severe pneumonia could receive oral therapy, especially with highly bioavailable agents such as fluoroquinolones.
• The emergence of high rates of macrolide resistance in many areas suggests that this therapy cannot be routinely recommended 1.

Duration of Treatment

The optimal duration of therapy for CAP is still being studied, but short treatment courses may be possible with azithromycin due to its long serum or tissue half-life 1.

• Trials comparing oral azithromycin for 5 d with erythromycin and with cefaclor for 10 d in the treatment of pneumonia due to “atypical pathogens” and bacterial pathogens, respectively, suggest that shorter courses with this agent may be used 1.

From the FDA Drug Label

Co-administration with efavirenz or fluconazole had a modest effect on the pharmacokinetics of azithromycin. No dosage adjustment of either drug is recommended when azithromycin is co-administered with any of these agents Interactions with the drugs listed below have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interaction. Nonetheless, they have been observed with macrolide products Until further data are developed regarding drug interactions when azithromycin and these drugs are used concomitantly, careful monitoring of patients is advised: Digoxin - elevated digoxin concentrations. Ergotamine or dihydroergotamine - acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia. Terfenadine, cyclosporine, hexobarbital, and phenytoin-elevated concentrations Laboratory Test Interactions There are no reported laboratory test interactions. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Azithromycin has shown no mutagenic potential in standard laboratory tests: mouse lymphoma assay, human lymphoma clastogenic assay, and mouse bone marrow clastogenic assay No evidence of impaired fertility due to azithromycin was found. Pregnancy Teratogenic Effects. Pregnancy Category B Reproduction studies have been performed in rats and mice at doses up to moderately maternally toxic dose concentrations (i.e., 200 mg/kg/day by the oral route). These doses, based on a mg/m 2 basis, are estimated to be 4 and 2 times, respectively, the human daily dose of 500 mg by the oral route. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman Pediatric Use Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established. In controlled clinical studies, azithromycin has been administered to pediatric patients (age 6 months to 16 years) by the oral route For information regarding the use of azithromycin for oral suspension in the treatment of pediatric patients, refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles. Geriatric Use Pharmacokinetic studies with intravenous azithromycin have not been performed in older volunteers Pharmacokinetics of azithromycin following oral administration in older volunteers (65 to 85 years old) were similar to those in younger volunteers (18 to 40 years old) for the 5 day therapeutic regimen In multiple-dose clinical trials of intravenous azithromycin in the treatment of community-acquired pneumonia, 45% of patients (188/414) were at least 65 years of age and 22% of patients (91/414) were at least 75 years of age. No overall differences in safety were observed between these subjects and younger subjects in terms of adverse events, laboratory abnormalities, and discontinuations Similar decreases in clinical response were noted in azithromycin- and comparator-treated patients with increasing age. Elderly patients may be more susceptible to development of torsades de pointes arrhythmia than younger patients (see WARNINGS). Azithromycin for Injection contains 114 mg (4.96 mEq) of sodium per vial. At the usual recommended doses, patients would receive 114 mg (4. 96 mEq) of sodium. The geriatric population may respond with a blunted natriuresis to salt loading. The total sodium content from dietary and non-dietary sources may be clinically important with regard to such diseases as congestive heart failure.

The importance of azithromycin (Intravenous) is not explicitly stated in the provided text. Key points include:

• Contraindications and warnings: careful monitoring of patients is advised when co-administering azithromycin with certain drugs, such as digoxin, ergotamine, and terfenadine.
• Pregnancy and lactation: azithromycin should be used during pregnancy only if clearly needed, and caution should be exercised when administering to a nursing woman.
• Pediatric and geriatric use: safety and effectiveness in children under 16 years have not been established, and elderly patients may be more susceptible to certain adverse effects. However, the provided text does not directly address the question of the importance of azithromycin (Intravenous) 2.

From the Research

Importance of Azithromycin (Intravenous)

The importance of azithromycin (intravenous) can be understood from its efficacy and safety in treating various infections. Some key points include:

• Azithromycin is effective in treating community-acquired pneumonia (CAP) caused by Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus (methicillin-sensitive), and Streptococcus pneumoniae 3, 4.
• It is also used to treat pelvic inflammatory disease (PID) caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma hominis 4, 5.
• Azithromycin has a unique pharmacokinetic profile, allowing for once-daily dosing and high tissue penetration, making it an effective monotherapy for many cases 4, 6.
• Clinical and bacteriologic response rates have been similar to or better than comparative agents, with fewer side effects 3, 7, 5.

Efficacy and Safety

Some key findings on the efficacy and safety of azithromycin (intravenous) include:

• A study found that intravenous azithromycin followed by oral azithromycin was associated with fewer side effects and equal efficacy to a regimen of cefuroxime plus erythromycin for hospitalized patients with CAP 3.
• Another study demonstrated that azithromycin had a satisfactory therapeutic outcome similar to amoxicillin/clavulanate or erythromycin for the treatment of community-acquired pneumonia in children, with significantly fewer side effects 7.
• A review of published data indicated that azithromycin may exert anti-inflammatory/immunomodulatory effects, making it useful in the treatment of acute and chronic airway diseases 6.
• A multicenter, unblinded, non-comparative phase 3 trial found that intravenous azithromycin followed by oral azithromycin was effective and well-tolerated in the treatment of acute PID and perihepatitis in Japanese women, with a clinical success rate of 94.1% 5.