What is ZITHROMAX used for?
They arise from the antibacterial activity and pharmacokinetic characteristics of azithromycin. They take into account both the clinical studies that this drug has led to and its place in the range of antibacterial products currently available.
They are limited to infections caused by germs defined as sensitive:
Angina documented with beta-hemolytic streptococcus A, as an alternative to treatment with beta-lactams, particularly when it cannot be used,
Superinfections of acute bronchitis,
Exacerbations of chronic bronchitis,
Stomatological infections.
Official recommendations on the proper use of antibacterials should be taken into account.
Conditions for which this medicine may be prescribed
- Beta-hemolytic strep throat
- Bacterial superinfection of acute bronchitis.
- Exacerbation of chronic bronchitis.
- Stomatological infection
Method of administration and dosage of the drug ZITHROMAX
Dose
Adult
Angina, stomatological infections: 500 mg (2 tablets) per day for 3 days.
This dose, with a short duration of administration of 3 days, is explained by the particular pharmacokinetic properties of azithromycin and the maintenance of activity, in these indications, several days after the last dose.
Superinfections of acute bronchitis, exacerbations of chronic bronchitis: 500 mg (2 tablets) the first day and then 250 mg (1 tablet) the following 4 days. The duration of the treatment will be 5 days.
Old subject
The recommended dose is the same as in the adult patient. As elderly patients may present with proarrhythmogenic conditions, caution is recommended due to the risk of cardiac arrhythmia and torsade de pointes (see section 4.4).
Liver failure
Same dose in patients with moderate to moderate hepatic impairment (see section 4.4).
Administration form
The tablets can be taken with or without food, in a single daily intake.
Possible side effects of the drug ZITHROMAX
- Candidiasis
- Vaginal infection
- Pneumonia
- Fungal infection
- Bacterial infection
- Pharyngitis
- Stomach flu
- Respiratory disorder
- Rhinitis
- Oral yeast infection
- Pseudomembranous colitis
- Leukopenia
- Neutropenia
- Eosinophilia
- Thrombocytopenia
- Hemolytic anemia
- Angioedema
- Hypersensitivity
- Anaphylactic reaction
- Anorexy
- Nervousness
- Insomnia
- Agitation
- Aggressiveness
- Anxiety
- Delirium
- Hallucination
- Headache
- Feeling dizzy
- Drowsiness
- Dysgeusia
- Paresthesia
- Syncope
- Seizures
- Hypoesthesia
- Psychomotor hyperactivity
- Anosmia
- Ageusia
- Parosmia
- Myasthenia
- Visual disturbance
- Hearing impairment
- Ear disorder
- Vertigo maze
- Deafness
- Tinnitus
- Palpitation
- Torsades de pointes
- Arrhythmia
- Ventricular tachycardia
- QT extension
- Hot flushes
- Hypotension
- Dyspnoea
- Epistaxis
- Diarrhea
- Vomiting
- Abdominal pain
- Sickness
- Constipation
- Flatulence
- Dyspepsia
- Gastritis
- Dysphagia
- Abdominal distension
- Dry mouth
- Belching
- Ulceration of the mouth
- Hypersalivation
- Pancreatitis
- Discoloration of the tongue.
- Liver function disorder
- Cholestatic jaundice
- Liver failure
- Fulminant hepatitis
- Liver necrosis
- Acne
- Skin itching
- Hives
- Dermatitis
- Dry Skin
- Hyperhidrosis
- Photosensitivity
- Generalized acute exanthematous pustulosis
- Dress syndrome
- Stevens-Johnson syndrome
- Lyell syndrome
- Erythema multiforme
- Osteoarthritis
- Myalgia
- Back pain
- Neck Pain
- Arthralgia
- Dysuria
- Kidney pain
- Acute kidney failure
- Interstitial nephritis
- Metrorrhagia
- Testicular disorder
- Edema
- Asthenia
- Discomfort
- Tired
- Facial edema
- Chest pain
- Fever
- Pain
- Peripheral edema
- Decreased lymphocyte count
- Increased amount of eosinophils.
- Decreased bicarbonate blood levels.
- Increased basophils.
- Monocyte increase
- Neutrophil increase.
- Aspartate aminotransferase increased
- Alanine aminotransferase increased
- Increased bilirubinemia.
- Increased uremia
- Increased serum creatinine.
- Abnormal serum potassium concentration
- Increased alkaline phosphatase.
- Chloride increase
- Increased glucose
- Platelets increased
- Decreased hematocrit
- Increased bicarbonates.
- Abnormal sodium level
- Post-procedure complication
Show more The table below shows the side effects identified during clinical trials and after marketing on the organ system and the frequency. Group frequencies are defined according to the following convention: very frequent (³ 1/10); frequent (³ 1/100 to at least 1/10); uncommon (³ 1/1000 to at least 1/100); rare (³ 1 / 10,000 to at least 1 / 1,000); very rare (less than 1 / 10,000); and indefinite (cannot be estimated from the available data). Within each group frequency, the undesirable effects are presented in descending order of severity.
Possible or likely side effects related to azithromycin based on clinical trial experience and post-marketing surveillance:
Very common (≥ 1/10) | Common (≥ 1/100 to minus 1/10) | Rare (≥ 1/10000 to minus 1/1000) | Very rare (less than 1 / 10,000) | Frequency not known | |
Infections and infestations. | Candidiasis Vaginal infection Pneumonia Fungal infection Bacterial infection Pharyngitis Gastroenteritis Respiratory disorder Rhinitis Oral candidiasis | Pseudomembranous colitis (see section 4.4) | |||
Blood and lymphatic system disorders. | Leukopenia Neutropenia Eosinophilia | Thrombocytopenia Hemolytic anemia | |||
Immune system disorders. | Angioedema Hypersensitivity | Anaphylactic reaction (see section 4.4) | |||
Metabolism and nutrition disorders. | Anorexy | ||||
Psychiatric disorders | Nervousness Insomnia | Agitation | Aggression Anxiety Delusion Hallucination | ||
Nervous system disorders | Headache | Dizziness Feeling drowsy Dysgeusia Paresthesia | Syncope, Seizure Hypoaesthesia Psychomotor hyperactivity Anosmia Ageusia Parosmia Myasthenia (see section Warnings and precautions for use) | ||
Eye conditions | Visual disturbances | ||||
Ear and labyrinth disorders. | Ear disorders Dizziness | Hearing impairment, including deafness and / or tinnitus. | |||
Heart conditions | Palpitations | Torsades de pointes Arrhythmia including ventricular tachycardia QT interval lengthening (see section Warnings and precautions for use) | |||
Vascular disorders | Hot flushes | Hypotension | |||
Respiratory, thoracic and mediastinal disorders. | Dyspnea epistaxis | ||||
Gastrointestinal disorders. | Diarrhea, Vomiting abdominal pain nausea | Constipation Flatulence Dyspepsia Gastritis Dysphagia Abdominal bloating Dry mouth Burping Oral ulceration Ptalism | Pancreatitis Discoloration of the tongue | ||
Hepatobiliary disorders. | Liver function abnormality Cholestatic jaundice | Hepatic impairment (rarely causing death) Fulminant hepatitis Hepatic necrosis (see section 4.4) | |||
Skin and subcutaneous tissue disorders. | Rash Pruritus Urticaria Dermatitis Dry skin Hyperhidrosis | Photosensitivity reaction Generalized exanthematous pustulosis * DRESS syndrome * (drug hypersensitivity syndrome with eosinophilia and systemic symptoms) | Stevens-Johnson syndrome Toxic epidermal necrolysis Erythema multiforme | ||
Musculoskeletal and connective tissue disorders. | Osteoarthritis Myalgia Back pain Neck pain | Arthralgia | |||
Kidney and urinary tract disorders. | Dysuria, kidney pain | Acute kidney failure Interstitial nephritis | |||
Reproductive system and breast disorders. | Metrorrhagia Testicular disorder | ||||
General disorders and administration site conditions. | Edema Asthenia Malaise Fatigue Facial edema Chest pain Fever Pain Peripheral edema | ||||
Research | Decreased lymphocyte count Increased eosinophil count Decreased blood bicarbonate concentration Increased basophils Increased monocytes Increased neutrophils | Increase of aspartate amino - transferase Increase of alanine amino - transferase Increase of bilirubinemia Increase of uremia Increase of serum creatinine Abnormal concentration of potassium in blood Increase of alkaline phosphatase in blood Increase of glucose Increase of platelets Decrease of hematocrit Increase of bicarbonates | |||
Injuries and poisonings. | Post-procedure complication |
* Adverse reaction reported after marketing.
Contraindications: when not to use this medicine?
- Azithromycin hypersensitivity
- Erythromycin hypersensitivity
- Macrolide hypersensitivity
- Severe liver failure
- Breastfeeding
- Severe cholestasis
- Lactase deficiency
- Galactose malabsorption syndrome
- Glucose malabsorption syndrome
- Galactose intolerance
- First trimester pregnancy
See more This medicine should NEVER BE USED if:
Hypersensitivity to azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients listed in the Composition section,
· Combination with ergot alkaloids: dihydroergotamine, ergotamine (see sections 4.4 and 4.4),
Combination with cisapride (see section Interactions with other medicinal products and other forms of interaction),
Combination with colchicine (see section Interactions with other medicinal products and other forms of interaction),
Severe hepatic impairment (see section 4.4).
Presentation of this medicine
6 tablets in blister (PVC / aluminum)
Appearance and shape
Compressed film.
ZITHROMAX: its other forms
- ZITHROMAX 500 mg Infusion box of 1 bottle of 500 mg.
- ZITHROMAX 250 mg film-coated tablet, box of 6
Composition of the drug ZITHROMAX
Active principle | Compressed film |
Azithromycin | 250 mg * |
* per unit dose Active ingredients: Azithromycin Excipients with known effects? : Opadry white II (Y-30-18037): lactose Other excipients: pregelatinized starch, anhydrous calcium phosphate anhydrous, croscarmellose sodium, magnesium stearate, sodium lauryl sulfate, hypromellose, titanium dioxide and triacetin Effects on ability to drive and use machines
There is no data to suggest that azithromycin may affect patients' ability to drive or use machines. However, patients should be warned that they may experience side effects such as dizziness, drowsiness, certain visual or hearing disorders during treatment with azithromycin. Therefore, caution is advised when driving a vehicle or operating machinery.
Warnings and precautions for use
- Reserved for adults
- QT prolongation interval
- Hypokalemia
- Hypomagnesemia
- Bradycardia
- Cardiac arrhythmia
- Severe heart failure
- Woman
- Old subject
- Hypersensitivity reaction
- Skin reaction
- Liver failure
- Diarrhea due to antibiotic treatment.
- Myasthenia
- Superinfection
- Severe kidney failure (Clcr minus 40 ml / min)
Show more QT interval extension
Cases of prolonged cardiac repolarization and QT prolongation, involving a risk of cardiac arrhythmia and torsades de pointes, have been observed during treatment with macrolides, including azithromycin (see section, Undesirable Effects). Since the following situations may lead to an increased risk of ventricular arrhythmia (including torsades de pointes) which can lead to death, caution should be exercised when treating patients with azithromycin:
· Have a prolonged congenital or documented QT interval.
You are currently receiving treatment with other active substances known to prolong the QT interval (see section Interactions with other medicinal products and other forms of interaction).
Having an electrolyte disorder, especially in cases of hypokalemia and hypomagnesemia.
· Have clinically significant bradycardia, cardiac arrhythmia, or severe heart failure.
Women and elderly patients may also be more sensitive to treatments that prolong the QT interval.
Hypersensitivity
As with erythromycin and other macrolides, rare serious allergic reactions such as angioedema and anaphylactic (rarely fatal) reactions have been reported. The possibility of recurrence of symptoms after discontinuation of symptomatic treatment requires prolonged monitoring and possibly treatment.
Skin reactions
Additionally, serious life-threatening skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome (drug hypersensitivity syndrome with eosinophilia and systemic symptoms) and generalized acute exanthematous pustuosis (PEAG)) have been reported. Patients should be advised to observe the effects on the skin, as well as the suggestive signs and symptoms that generally appear within the first few weeks of treatment. If symptoms are suggestive (eg, progressive rash often associated with lesions or blisters on mucous membranes), azithromycin should be discontinued immediately. It is recommended not to restart the treatment.
Hepatotoxicity
Since the liver is the main route of elimination of azithromycin, the prescription of azithromycin is not recommended in patients with severe hepatic impairment or in patients with severe cholestasis.
Fulminant hepatitis that can lead to life-threatening liver failure has been reported with azithromycin (see section 4.8). Some patients may have had pre-existing liver disease or have taken other hepatotoxic drugs.
Liver function tests should be performed immediately if there are signs or symptoms of liver failure, such as the rapid onset of jaundice associated with jaundice, dark urine, a tendency to bleed, or hepatic encephalopathy. The use of azithromycin should be discontinued immediately if liver dysfunction develops.
Clostridium difficile-associated diarrhea
Clostridium difficile-associated diarrhea (DACD) has been reported with the use of virtually all antibiotics, including azithromycin. Its severity can range from mild diarrhea to life-threatening pseudomembranous colitis. Antibiotic treatment changes the flora of the colon, leading to an overgrowth of C. difficile.
C. difficile produces toxins A and B, which contribute to the development of DACD. These toxin-producing strains increase morbidity and mortality, since infections can be refractory to antibiotic treatment and require a colectomy. The presence of DACD should be considered in all patients who develop diarrhea after the use of antibiotics. It is important that this diagnosis is made in patients who have diarrhea during or after taking an antibiotic, since cases have been observed up to 2 months after stopping treatment.
Myasthenia
Exacerbations of myasthenia gravis symptoms and new outbreaks of myasthenic syndrome have been reported in patients taking azithromycin (see section 4.8).
Superinfection
As with all antibiotics, it is recommended to monitor for signs of secondary infection with non-susceptible organisms, including fungi.
Derived from ergot
When treated with ergot ergot derivatives, certain concomitantly administered macrolide antibiotics precipitate ergotism. There is no data on a possible interaction between ergot and azithromycin. However, taking into account the theoretical risk of ergotism, ergot derivatives and azithromycin should not be administered together (see sections Contraindications and interactions with other medicinal products and other forms of interaction).
Hypertrophic pyloric stenosis in infants.
Cases of hypertrophic pyloric stenosis in infants have been reported with the use of azithromycin in newborns (treatment up to 42 days of age). Parents and caregivers should be encouraged to contact the doctor if vomiting or food hyperreactivity occurs.
Renal insufficiency
In severe renal impairment (glomerular filtration rate minus 10 ml / min), a 33% increase in systemic exposure to azithromycin has been observed.
No dose adjustment is useful in patients with mild renal impairment (creatinine clearance greater than 40 ml / min). In patients with creatinine clearance less than 40 ml / min, the prescription of azithomycin should be used with caution.
Related to excipients
This medicine contains lactose. It is not recommended for use in patients with galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption (rare inherited disease).
Mechanism of action: how does it work?
Pharmacotherapeutic group: ANTIBACTERIALS FOR SYSTEMIC USE, ATC code: J01FA10 (J: Antiinfectives)
Familial macrolide antibiotic.
Azithromycin is the first molecule in the class of azalide antibiotics (macrolide family).
Azithromycin works by inhibiting bacterial protein synthesis by binding to the 50 S part of the ribosome and preventing translocation of peptides.
Spectrum of antibacterial activity
Critical concentrations separate the sensitive strains from the intermediate and the last resistant strains:
S minus 0.5 mg / l and R plus 4 mg / l
The prevalence of acquired resistance may vary depending on geography and time for some species. Therefore, it is useful to have information on the prevalence of local resistance, especially for the treatment of serious infections. These data can only provide guidance on the probabilities of the sensitivity of a bacterial strain to this antibiotic.
When the variability in the prevalence of resistance in Australia is known for a bacterial species, it is indicated in the table below:
Categories | Frequency of resistance acquired in Australia (plus 10%) (extreme values) |
SENSITIVE SPECIES | |
Gram positive aerobes | |
Bacillus cereus | |
Corynebacterium diphtheriae | |
Enterococci | 50 - 70% |
Rhodococcus equi | |
Staphylococcus meti-S | |
Staphylococcus meti-R * | 70 - 80% |
Streptococcus B | |
Non-grouping streptococcus | 30 - 40% |
Streptococcus pneumoniae | 35 - 70% |
Streptococcus pyogenes | 16 - 31% |
Gram negative aerobes | |
Bordetella pertussis | |
Branhamella catarrhalis | |
Campylobacter | |
Legionella Moraxella | |
Anaerobes | |
Actinomyces | |
Bacteroides | 30 - 60% |
Eubacterium | |
Mobiluncus | |
Peptostreptococcus | 30 - 40% |
Porphyromonas | |
Pre-bottle | |
Propionibacterium acnes | |
Others | |
Borrelia burgdorferi | |
Chlamydia | |
Coxiella | |
Leptospires | |
Mycoplasma pneumoniae | |
Treponema pallidum |
Categories | Frequency of resistance acquired in Australia (plus 10%) (extreme values) |
MODERATELY SENSITIVE SPECIES (in vitro intermediate sensitivity) | |
Gram-negative aerobes Haemophilus Neisseria gonorrhoeae | |
Anaerobes Clostridium perfringens | |
Other Ureaplasma urealyticum | |
RESISTANT SPECIES | |
Corynebacterium jeikeium aerobic Gram-positive Asteroids Nocardia | |
Aerobic Gram-Negative Acinetobacter Enterobacteriaceae Pseudomonas | |
Ferobacterium Anaerobes | |
Other Mycoplasma hominis |
* The frequency of methicillin resistance is approximately 30 to 50% of all staphylococci and is found mainly in hospitals
Cardiac electrophysiology:
QTc prolongation was studied in a randomized, placebo-controlled, parallel group study of 116 healthy volunteers who received chloroquine (1000 mg) alone or in combination with azithromycin (500 mg, 1,000 mg, and 1,500 mg once daily). Concomitant administration of azithromycin resulted in dose- and concentration-dependent QTc prolongation. When comparing the results observed between healthy volunteers who received chloroquine combined with azithromycin and those who received chloroquine alone, it was observed that the maximum mean (upper limit of the 95% confidence interval) QTcF intervals increased by 5 (10) ms, 7 (12) ms and 9 (14) ms, respectively, with azithromycin doses of 500 mg, 1000 mg and 1500 mg.
Pediatric population
Following evaluation of studies in children, the use of azithromycin is not recommended for the treatment of malaria, either as monotherapy or in combination with chloroquine or artemisinin-based medicinal products. , since non-inferiority to the recommended antimalarial drugs in the treatment of uncomplicated malaria has not been established.
Interactions: do not take this medicine with ..
Contraindicated associations
+ Cisapride
Increased risk of ventricular rhythm disturbances, especially torsade de pointes.
+ Colchicine
Increased colchicine side effects with potentially fatal consequences.
+ Dihydroergotamine (see section Warnings and precautions for use)
Ergotism with the possibility of necrosis of the extremities (inhibition of hepatic elimination of ergot alkaloids).
+ Ergotamine (see section Warnings and precautions for use)
Ergotism with the possibility of necrosis of the extremities (decreased hepatic elimination of ergotamine alkaloids).
Associations not recommended
+ Dopaminergic ergot alkaloids
(Bromocriptine, cabergoline, lisuride, pergolide)
Increased plasma concentrations of dopaminergic agents with possible increase in their activity or appearance of signs of overdose.
Associations subject to precautions for use.
+ Atorvastatin
Increased risk of unwanted (concentration-dependent) effects such as rhabdomyolysis, due to decreased liver metabolism to lower cholesterol.
Use lower doses of cholesterol or other statins unaffected by this type of interaction.
+ Cyclosporine
Risk of increased blood concentrations of cyclosporine and serum creatinine.
Determination of cyclosporine blood concentrations, control of renal function and dose adjustment during the combination and after discontinuation of the macrolide.
+ Digoxin
Elevation of digoxemia due to increased absorption of digoxin.
Clinical monitoring and possibly digoxinemia during azithromycin treatment and after discontinuation.
+ Drugs that can give torsades de pointes, in particular class IA antiarrhythmics (ex: quinidine), class III (ex: amiodarone, sotalol), antipsychotics (ex: phenothiazines, pimozide), tricyclic antidepressants (ex: citalopram), some fluoroquinolones (ex: moxifloxacin, levofloxacin). Hypokalemia (hypokalemic drugs) is a favorable factor, as is bradycardia (bradycardiating drugs) or a pre-existing congenital or acquired QT interval prolongation (see Warnings and Precautions for Use section).
Increased risk of ventricular rhythm disturbances, especially torsade de pointes.
Clinical and electrocardiographic monitoring during the association.
+ Simvastatin
Increased risk of unwanted (concentration-dependent) effects such as rhabdomyolysis, due to decreased liver metabolism to lower cholesterol.
Use lower doses of cholesterol or other statins unaffected by this type of interaction.
+ Antivitamins K
Greater effect of antivitamin K and the risk of bleeding.
More frequent INR monitoring. Possible dose adjustment of anti-vitamin K during treatment with macrolides and after discontinuation.
Special INR imbalance problems
Many cases of increased oral anticoagulant activity have been reported in patients receiving antibiotics. The marked infectious or inflammatory context, the age and the general condition of the patient seem to be risk factors. Under these circumstances, it seems difficult to draw a line between infectious disease and its treatment in the event of INR imbalance. However, certain classes of antibiotics are more involved: these include fluoroquinolones, macrolides, cyclins, cotrimoxazole, and certain cephalosporins.
Incompatibilities
Aimlessly.
How to react in case of overdose?
The side effects observed with doses higher than the recommended doses were similar to those observed with the recommended doses.
What to do in case of overdose: gastric lavage and symptomatic treatment.
ZITHROMAX: pregnancy, lactation and fertility
Pregnancy
1st trimester:
As a precaution, it is best not to use azithromycin during the first trimester of pregnancy. In fact, although animal data on rodents do not show any malformation effects, clinical data is insufficient.
From the second quarter:
Due to the expected benefit, the use of azithromycin can be considered from the second trimester of pregnancy if necessary. In fact, although limited, the clinical data are reassuring when used beyond the first trimester.
Breastfeeding
Azithromycin is excreted in breast milk. A risk for newborns / infants cannot be excluded. A decision must be made to stop breastfeeding or to stop or refrain from treatment taking into account the benefit of breastfeeding for the child compared to the benefit of treatment for the woman.
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Package | Price |
---|---|
100 mg 270 pills | AUD 162.39 |
100 mg 180 pills | AUD 119.09 |
100 mg 120 pills | AUD 88.41 |
100 mg 90 pills | AUD 73.08 |
100 mg 60 pills | AUD 61.35 |
250 mg 360 pills | AUD 276.07 |
250 mg 270 pills | AUD 231.41 |
250 mg 180 pills | AUD 170.51 |
250 mg 120 pills | AUD 126.31 |
250 mg 90 pills | AUD 105.56 |
250 mg 60 pills | AUD 88.41 |
500 mg 360 pills | AUD 568.38 |
500 mg 270 pills | AUD 475.00 |
500 mg 180 pills | AUD 351.85 |
500 mg 120 pills | AUD 259.83 |
500 mg 90 pills | AUD 216.53 |
500 mg 60 pills | AUD 160.59 |
500 mg 30 pills | AUD 100.14 |