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NRA-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: AND CLINICAL USE ............................................................................................ 3 CONTRAINDICATIONS.................................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General Serious allergic reactions, including angioedema, anaphylaxis, and dermatological reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermolysis, toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic symptoms (DRESS) have been reported rarely (with rare reports of fatalities), in patients on azithromycin dihydrate therapy (see CONTRAINDICATIONS).
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.
The use of azithromycin with other drugs may lead to drug-drug interactions. For established or potential drug interactions, see DRUG INTERACTIONS section of the product monograph. , Tay-Sachs disease, Niemann-Pick disease) the use of azithromycin dihydrate in these patients is not recommended.
Azithromycin and ergot derivatives should not be co-administered due to the possibility that ergot toxicity may be precipitated by macrolide antibiotics. Acute ergot toxicity is characterized by severe peripheral vasospasm, including ischemia of the extremities, along with dysesthesia and possible central nervous system effects.
As with any antibacterial preparation, observation for signs of superinfection with nonsusceptible organisms, including fungi is recommended. 87 g of sucrose. 87 g / 5 ml of reconstituted oral suspension), the oral suspension formulation is not indicated for persons with fructose intolerance (hereditary fructose intolerance), glucose-galactose malabsorption or saccharase-isomaltase deficiency.
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. Intramuscular use of azithromycin is not recommended; extravasation of drug into the tissues may cause tissue injury.
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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Carcinogenesis and Mutagenesis Long term studies in animals have not been performed to evaluate carcinogenic potential. Azithromycin has shown no genotoxic or mutagenic potential in standard laboratory tests (see TOXICOLOGY). NRA-AZITHROMYCIN Product Monograph Page 6 of 64 Cardiovascular Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac arrhythmia and torsade de pointes, have been seen in treatment with macrolides including azithromycin (see ADVERSE REACTIONS).
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. There have been spontaneous reports from post-marketing experience of prolonged QT interval and torsade de pointes (see ADVERSE REACTIONS - Post marketing Experience).
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 ACTION AND CLINICAL PHARMACOLOGY, Cardiac Electrophysiology).
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. Clostridium difficile-associated disease Clostridium 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. 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 Clostridium difficile. Clostridium 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. NRA-AZITHROMYCIN Product Monograph Page 7 of 64 If the diagnosis of CDAD is suspected or confirmed, appropriate […]