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TEVA-AZITHROMYCIN 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: TEVA-AZITHROMYCIN (azithromycin monohydrate hemiethanolate) 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…
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 TEVA-AZITHROMYCIN may be initiated before results of these tests are known; once the results become available, antibiotic treatmen t 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 is often effective in the eradication of susceptible strains of streptococci from the oropharynx.
However, data establishing the efficacy of azithromycin 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).
TEVA-AZITHROMYCIN (Azithromycin tablets) Page 5 of 67 Uncomplicated skin and skin structure infections: Uncomplicated skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae.
). 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 antiarrhythmic of classes IA and III; antipsychotic agents; antidepressants; and fluoroquinolones.
• With electrolyte disturbance, particularly in cases of hypokalaemia and hypomagnesemia. TEVA-AZITHROMYCIN (Azithromycin tablets) Page 9 of 67 • With clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency. • Elderly may be more susceptible to drug-associated effects on the QT interval.
g. receiving intravenous azithromycin, hepatobiliary impaired). There is information that 'QT Related Adverse Events' may occur in some patients receiving azithromycin. These include but are not limited to: one AIDS patient dosed at 750 mg to 1 g daily e xperienced 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 TEVA- AZITHROMYCIN in these patients is not recommended. 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. CDAD may range in severity from mild diarrhea to fatal colitis.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................ 5 Post-Market Adverse Reactions ..............................................................................
15 9 DRUG INTERACTIONS .................................................................................................. 2 Drug Interactions Overview ....................................................................................
4 Drug-Drug Interactions........................................................................................... 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions .......................................................................... 23 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action ...........................................................................................
2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics................................................................................................. 23 11 STORAGE, STABILITY AND DISPOSAL ...........................................................................
25 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 25 PART II: SCIENTIFIC INFORMATION.........................................................................................
26 13 PHARMACEUTICAL INFORMATION.............................................................................. 26 14 CLINICAL TRIALS..........................................................................................................
TEVA-AZITHROMYCIN 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 TEVA-AZITHROMYCIN (Azithromycin tablets) Page 6 of 67 PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Azithromycin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEVA- AZITHROMYCIN and other antibacterial drugs, TEVA-AZITHROMYCIN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. 1 Pediatrics Based on the data submitted and reviewed by Health Canada, the safety and efficacy of TEVA- AZITHROMYCIN in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
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 TEVA-AZITHROMYCIN 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
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 TEVA-AZITHROMYCIN (Azithromycin tablets) Page 10 of 67 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 TEVA- AZITHROMYCIN 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 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 TEVA-AZITHROMYCIN. 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 TEVA-AZITHROMYCIN 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 of azithromycin in patients TEVA-AZITHROMYCIN (Azithromycin tablets) Page 11 of 67 with a known history of myasthenia gravis is not recommended. Renal The safety, […]
… 28 15 MICROBIOLOGY .......................................................................................................... 28 16 NON CLINICAL TOXICOLOGY .......................................................................................
31 17 SUPPORTING PRODUCT MONOGRAPHS...................................................................... 62 PATIENT MEDICATION INFORMATION.................................................................................... 63 TEVA-AZITHROMYCIN (Azithromycin tablets) Page 4 of 67 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TEVA-AZITHROMYCIN (azithromycin monohydrate hemiethanolate) 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 TEVA-AZITHROMYCIN may be initiated before results of these tests are known; once the results become available, antibiotic treatmen t 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 is often effective in the eradication of susceptible strains of streptococci from the oropharynx.
However, data establishing the efficacy of azithromycin 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).
TEVA-AZITHROMYCIN (Azithromycin tablets) Page 5 of 67 Uncomplicated skin and skin structure infections: Uncomplicated skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae.
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. […]