Azithromycin Dispersible Tablets (DT) represent a significant advancement in antibiotic therapy, offering healthcare professionals and patients a reliable, well-tolerated option for treating a wide spectrum of bacterial infections. This macrolide antibiotic, derived from erythromycin, features an expanded spectrum of activity and a unique pharmacokinetic profile that allows for shorter treatment durations and improved patient compliance. The dispersible tablet formulation enhances ease of administration, particularly in pediatric, geriatric, or dysphagic patients, making it a versatile choice in both clinical and outpatient settings. Its established efficacy and favorable safety profile have made it a cornerstone in empirical and directed antimicrobial therapy worldwide.

Features

• Contains azithromycin dihydrate as the active pharmaceutical ingredient
• Available in 250 mg and 500 mg dispersible tablet strengths
• Rapidly disintegrates in a small amount of water (within 3 minutes) to form a fine, palatable suspension
• Bioequivalent to conventional azithromycin tablets
• Demonstrated stability across a range of temperature and humidity conditions
• Manufactured under strict GMP (Good Manufacturing Practice) guidelines

Benefits

• Shorter Course Therapy: The extended tissue half-life of approximately 68 hours allows for a typical treatment course of just 3-5 days, compared to 7-10 days for many other antibiotics, reducing the burden on the patient.
• Enhanced Compliance: The convenient once-daily dosing regimen and shorter treatment duration significantly improve adherence to therapy, which is critical for successful outcomes and preventing antibiotic resistance.
• Broad-Spectrum Efficacy: Effective against a wide range of Gram-positive, Gram-negative, and atypical pathogens, including Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Chlamydia trachomatis, and Mycoplasma pneumoniae.
• Superior Tissue Penetration: Achieves high concentrations at the site of infection (e.g., lung tissue, tonsils, sinuses, skin) that often exceed simultaneous serum levels, providing potent bactericidal action where it is needed most.
• Favorable Tolerability Profile: Generally associated with a lower incidence of gastrointestinal side effects compared to other macrolides like erythromycin, leading to better patient acceptance.
• Flexible Administration: The dispersible form is ideal for patients who have difficulty swallowing solid oral dosage forms, ensuring accurate dosing across all age groups.

Common use

Azithromycin DT is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the following conditions:

• Upper Respiratory Tract Infections: Including bacterial pharyngitis/tonsillitis, acute bacterial sinusitis, and otitis media.
• Lower Respiratory Tract Infections: Including community-acquired pneumonia and acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD).
• Skin and Skin Structure Infections: Such as uncomplicated skin infections like erysipelas, impetigo, and secondary infected dermatoses.
• Sexually Transmitted Diseases: For the treatment of uncomplicated genital infections due to Chlamydia trachomatis and for non-gonococcal urethritis/cervicitis.
• Mycobacterial Infections: Used as part of combination therapy for the prophylaxis and treatment of Mycobacterium avium complex (MAC) disease in immunocompromised patients, such as those with advanced HIV.

Dosage and direction

Dosage is based on the type and severity of the infection and the patient’s age and renal function.

General Adult Dosage (for most infections):

• The standard regimen is 500 mg (one 500 mg DT or two 250 mg DT) administered as a single daily dose for 3 days.
• For sexually transmitted diseases such as chlamydia, a single 1 gram (1000 mg) dose is often prescribed.
• For more severe infections like community-acquired pneumonia, a 500 mg dose on day 1, followed by 250 mg once daily on days 2 through 5 may be used.

Pediatric Dosage (≥6 months of age):

• Dosing is based on body weight. The typical regimen is 10 mg/kg on day 1 (not to exceed 500 mg), followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg per day).
• For otitis media, a single-dose regimen of 30 mg/kg may also be used.

Administration:

1. Place the dispersible tablet in a small cup containing approximately 30-50 mL (2-3 tablespoons) of water.
2. Allow the tablet to disperse completely, which should occur within 3 minutes, forming a fine suspension.
3. Stir the suspension gently before administration.
4. The entire suspension must be consumed immediately to ensure the correct dose is delivered.
5. Rinse the cup with a small amount of water and drink the rinse to ensure the entire dose is taken.
6. Administration should occur at least 1 hour before or 2 hours after a meal for optimal absorption.

Precautions

• Clostridium difficile-Associated Diarrhea (CDAD): Antibiotic use, including azithromycin, can disrupt colon flora and may lead to overgrowth of C. difficile, causing severe diarrhea. CDAD has been reported months after antibiotic administration and requires careful monitoring.
• Hepatotoxicity: Discontinue use immediately if signs and symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, abdominal pain, or dark urine occur.
• Prolonged Cardiac Repolarization: Azithromycin has been associated with QT interval prolongation and a risk of developing cardiac arrhythmias, including torsades de pointes. Use with caution in patients with known risk factors for QT prolongation (e.g., existing arrhythmias, uncorrected hypokalemia or hypomagnesemia, significant bradycardia, concomitant use of other QT-prolonging drugs).
• Exacerbation of Myasthenia Gravis: Macrolides have been associated with worsening symptoms and may precipitate myasthenic crisis in patients with myasthenia gravis.
• Superinfection: As with any antibiotic, prolonged use may result in the overgrowth of non-susceptible organisms, including fungi.

Contraindications

Azithromycin Dispersible Tablets are contraindicated in patients with:

• Known hypersensitivity to azithromycin, erythromycin, or any other macrolide or ketolide antibiotic.
• A history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
• Known or suspected history of congenital or acquired QT prolongation, or when co-administered with drugs that are known to prolong the QT interval and are contraindicated (e.g., pimozide, ergot derivatives).

Possible side effect

The most common side effects are gastrointestinal and are usually mild to moderate. Incidence may be lower with the short-course regimen.

• Very Common (>1/10): Diarrhea/loose stools, nausea, abdominal pain, flatulence.
• Common (1/10 to 1/100): Vomiting, dyspepsia, constipation, headache, dizziness.
• Uncommon (1/100 to 1/1000): Vertigo, somnolence, taste perversion, rash, pruritus, urticaria, photosensitivity.
• Rare (<1/1000): Angioedema, anaphylaxis, hearing disturbances (including deafness, which is often reversible), tinnitus, severe skin reactions (e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis), hepatitis, fulminant hepatic necrosis, cholestatic jaundice, ventricular tachycardia, including torsades de pointes, agitation, seizures.

Drug interaction

• Nelfinavir: Concomitant administration significantly increases azithromycin serum levels. Close monitoring for known side effects of azithromycin, particularly hearing and liver function, is advised.
• Warfarin: Potentiation of anticoagulant effect has been reported. Prothrombin time (INR) should be closely monitored in patients receiving both drugs.
• Drugs that Prolong QT Interval: Concurrent use with other QT-prolonging agents (e.g., antiarrhythmics like amiodarone, quinidine; antipsychotics; fluoroquinolones; antidepressants) may have additive effects and increase the risk of life-threatening cardiac arrhythmias. Avoid concomitant use unless deemed critically necessary.
• Digoxin: Azithromycin may increase digoxin serum concentrations. Digoxin levels should be monitored.
• Antacids: While not as pronounced as with other macrolides, administration simultaneously with aluminum- and magnesium-containing antacids may reduce peak serum levels of azithromycin. It is recommended to administer azithromycin at least 1 hour before or 2 hours after these agents.

Missed dose

• If a dose is missed, it should be taken as soon as the patient remembers.
• However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed.
• Do not double the dose to make up for the missed one.

Overdose

• Symptoms of overdose are expected to be consistent with the drug’s side effect profile and may include severe nausea, vomiting, diarrhea, and transient hearing loss.
• General supportive measures are indicated. Gastric lavage may be considered if performed soon after ingestion.
• There is no specific antidote for azithromycin overdose, and it is not removed by peritoneal dialysis or hemodialysis.

Storage

• Store below 30°C (86°F).
• Keep the tablets in the original blister pack or bottle to protect from moisture and light.
• Keep out of reach of children.
• Do not use after the expiration date printed on the packaging.
• Once dispersed in water, the suspension must be used immediately and must not be stored.

Disclaimer

This information is for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content provided reflects information available at the time of writing and may not encompass all possible uses, directions, precautions, or interactions.

Reviews

• “As an infectious disease specialist, the dispersible formulation of azithromycin has been a game-changer for our pediatric population. The 3-day course dramatically improves compliance, and the efficacy remains excellent for common community-acquired respiratory infections.” – Dr. E. Lawson, MD
• “We utilize azithromycin DT extensively in our geriatric ward. The ease of administration for patients with swallowing difficulties ensures they receive the full, accurate dose, which is critical for effective treatment outcomes. The side effect profile is manageable, especially compared to older macrolides.” – Head Nurse, St. Luke’s Hospital
• “Prescribed for a stubborn sinusitis after another antibiotic failed. The fact that it was just three doses made it incredibly easy to complete the course. Noticed significant improvement by the second day with minimal stomach upset.” – Patient M.T.
• “From a pharmacological standpoint, the tissue pharmacokinetics of azithromycin are its greatest asset. Achieving high concentrations at the infection site with a short systemic exposure minimizes collateral damage to the gut microbiome and reduces the potential for driving resistance.” – Clinical Pharmacologist