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PRO-AZITHROMYCINE is a brand name for Azithromycin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PRO-AZITHROMYCINE for Oral Administration PRO-AZITHROMYCINE (azithromycin dihydrate tablets) for oral administration is indicated for treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the following diseases and specific conditions. As recommended dosages,…
Verbatim from this product's HC label. Tap a section to expand.
for specific dosing recommendations. Because some strains are resistant to azithromycin, when applicable, appropriate culture and susceptibility tests should be initiated before treatment to determine the causative organism and its susceptibility to azithromycin.
Therapy with PRO-AZITHROMYCINE may be initiated before results of these tests are known; once the results become available, antibiotic treatment should be adjusted accordingly.
Adults Pharyngitis and tonsillitis:
Pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci) occurring in individuals who cannot use first line therapy.
NOTE:
Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin dihydrate is often effective in the eradication of susceptible strains of streptococci from the oropharynx.
However, data establishing the efficacy of azithromycin dihydrate in the subsequent prevention of rheumatic fever are not available at present.
Acute bacterial exacerbations of chronic obstructive pulmonary disease:
Acute bacterial exacerbations of chronic obstructive pulmonary diseases caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Community-acquired pneumonia:
Community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Chlamydia pneumoniae in patients for whom oral therapy is appropriate. Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomial acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
Uncomplicated skin and skin structure infections:
). Prescribers should consider the risk of QT prolongation which can lead to fatal events when weighing the risks and benefits of azithromycin. Risk factors for torsade de pointes include patients: • With a history of torsade de pointes • With congenital or documented QT prolongation • Currently receiving treatment with other active substances known to prolong QT interval such as antiarrhythmics of classes IA and III; antipsychotic agents; antidepressants; and fluoroquinolones.
g. receiving intravenous azithromycin, hepatobiliary impaired) There is information that 'QT Related Adverse Events' may occur in some patients receiving azithromycin. 5 Post-Market Adverse Reactions). These include but are not limited to: one AIDS patient dosed at 750 mg to 1 g daily experienced prolonged QT interval and torsade de pointes; a patient with previous history of arrhythmias who experienced torsade de pointes and subsequent myocardial infarction following a course of azithromycin therapy; and a pediatric case report of prolonged QT interval experienced at a therapeutic dose of azithromycin which reversed to normal upon discontinuation (see 10 CLINICAL PHARMACOLOGY, Cardiac Electrophysiology).
, Tay-Sachs disease, Niemann-Pick disease) the use of PRO-AZITHROMYCINE in these patients is not recommended. 9 Saccharide Intolerance • Due to the lactose content in the tablet coating, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take the tablet formulation.
Gastrointestinal A higher incidence of gastrointestinal adverse events (8 of 19 subjects) was observed when Azithromycin was administered to a limited number of subjects with GFR<10 mL/min. Clostridioides difficile associated disease Clostridioides difficile associated disease (CDAD) has been reported with use of many antibacterial agents including azithromycin.
1 Pregnant Women 11/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ........................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS............................................................................................................ 2 Geriatrics ................................................................................................................
5 2 CONTRAINDICATIONS .............................................................................................. 5 4 DOSAGE AND ADMINISTRATION............................................................................... 1 Dosing Considerations ............................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................... 5 Missed Dose ........................................................................................................... 6 5 OVERDOSAGE ..........................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING................................ 7 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations ................................................................................................
1 Pregnant Women............................................................................................. 2 Breast-feeding ................................................................................................. 4 Geriatrics .........................................................................................................
PRO-AZITHROMYCINE is contraindicated: • in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin • in those with a hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibacterial agent, or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Uncomplicated skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae. 5 Genitourinary tract infections: Urethritis and cervicitis due to Neisseria gonorrhoeae or Chlamydia trachomatis.
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. Patients should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis.
Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.
Prevention of Disseminated Mycobacterium Avium Complex (MAC) Disease:
PRO-AZITHROMYCINE, taken at a dose of 1200 mg weekly, alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in persons with advanced HIV infections (see 14 CLINICAL TRIALS).
2 Geriatrics Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness. However, elderly patients may be more susceptible to development of torsade de pointes arrhythmias.
4 Geriatrics; 10 CLINICAL PHARMACOLOGY). 2 CONTRAINDICATIONS PRO-AZITHROMYCINE is contraindicated: • in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin • in those with a hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibacterial agent, or to any ingredient in the formulation or component of the container.
For a complete listing, see
CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agents.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridioides difficile. Clostridioides difficile produces toxins A and B which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridioides difficile.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridioides difficile. Surgical evaluation should be instituted as clinically indicated, as surgical intervention may be required in certain severe cases (see 8 ADVERSE REACTIONS).
Hematologic Severe neutropenia (WBC < 1000/mm3) may adversely affect the distribution of azithromycin and its transport to the site of infection. Antibacterials with proven efficacy in this population should be used, as outlined by the relevant guidelines for treatment of patients with severe neutropenia.
Efficacy and safety of azithromycin have not been studied in patients with severe neutropenia. Hepatic/Biliary/Pancreatic Since the liver is the principal route of elimination for azithromycin, the use of oral PRO- AZITHROMYCINE preparations should be undertaken with caution in patients with impaired hepatic function.
Azithromycin has not been studied in patients with severe hepatic impairment (see 10 CLINICAL PHARMACOLOGY). Hepatotoxicity Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death.
Rare cases of acute hepatic necrosis requiring liver 10 transplant or causing death have been reported in patients following treatment with oral azithromycin. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur (see 8 ADVERSE REACTIONS).
Immune Allergic reactions may occur during and soon after treatment with azithromycin dihydrate. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure.
These patients required prolonged periods of observation and symptomatic treatment. If an allergic reaction occurs, the drug should be discontinued, and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Monitoring and Laboratory Tests Monitoring of QT/QTc intervals during treatment with PRO-AZITHROMYCINE may be considered by the physician as appropriate. Musculoskeletal Exacerbations of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
The use […]
11 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview .................................................................................. 2 Clinical Trial Adverse Reactions .............................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................ 5 Post-Market Adverse Reactions ............................................................................
17 9 DRUG INTERACTIONS ............................................................................................. 2 Drug Interactions Overview .................................................................................. 4 Drug-Drug Interactions .........................................................................................
5 Drug-Food Interactions ......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions ........................................................................
24 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics .........................................................................................
3 Pharmacokinetics ............................................................................................ 25 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 26 12 SPECIAL HANDLING INSTRUCTIONS.........................................................................
26 PART II: SCIENTIFIC INFORMATION .................................................................................... 27 13 PHARMACEUTICAL INFORMATION ......................................................................... 27 14 CLINICAL TRIALS .....................................................................................................
2 Comparative Bioavailability Studies .................................................................... 27 15 MICROBIOLOGY ...................................................................................................... 34 16 NON-CLINICAL TOXICOLOGY ...................................................................................
…59 PATIENT MEDICATION INFORMATION ............................................................................................................ 60 4 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS PRO-AZITHROMYCINE for Oral Administration PRO-AZITHROMYCINE (azithromycin dihydrate tablets) for oral administration is indicated for treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the following diseases and specific conditions.
As recommended dosages, durations of therapy and applicable patient populations vary among these infections, see 4 DOSAGE AND ADMINISTRATION for specific dosing recommendations. Because some strains are resistant to azithromycin, when applicable, appropriate culture and susceptibility tests should be initiated before treatment to determine the causative organism and its susceptibility to azithromycin.
Therapy with PRO-AZITHROMYCINE may be initiated before results of these tests are known; once the results […]