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ZARAXIN is a brand name for Azithromycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Zaraxin 500 mg film-coated tablets is indicated for the treatment of the following infections, when caused by microorganisms sensitive to azithromycin: - infections of the lower respiratory tract such as acute bronchitis and mild to moderately severe community-acquired pneumonia. Clinical efficacy against respiratory…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology:
This medicine should be taken in a single daily dose. The duration of treatment for the different types of infection are mentioned below. Adults The dosage for treatment of sexually transmitted diseases caused by chlamydia trachomatis is 1000 mg taken in a single oral dose.
The usual dosage for prophylaxis of MAC infections in patients with HIV (CD4 count ≤100/mm3) is 1200 mg once a week. For all other indications, the total dosage is 1500 mg, to be administered as a single daily dose of 500 mg for three days.
Alternatively, the same total dosage (1500 mg) can be given over a period of 5 days, starting with 500 mg on day 1 and 250 mg on day 2 to 5. Paediatric population Zaraxin tablets should only be given to children with a body weight above 45 kg when normal adult dose should be used.
g. suspensions, may be used. Elderly Elderly patients receive the recommended dosage for adults. 4). Method of administration The tablets should be swallowed whole and may be taken with or without food.
The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency.
The frequency grouping is defined using the following convention:
Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1 000 to <1/100); Rare (≥ 1/10 000 to <1/1 000); Very Rare (< 1/10 000); and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1. 4), which has rarely resulted in death Hepatitis fulminant Hepatic necrosis Skin and subcutaneous tissue disorders Rash Pruritis Urticaria Dermatitis Dry skin Hyperhidrosis Stevens-Johnson syndrome, Photosensitivity reaction Acute Generalized Exanthematous Pustulosis (AGEP), Drug Rash with eosinophilia and systemic Symptoms (DRESS) Toxic epidermal necrolysis, Erythema multiforme Musculoskeletal and connective tissue disorders Arthralgia Osteoarthritis Myalgia Back pain Neck pain Renal and urinary disorders Dysuria Renal pain Acute renal failure Interstitial nephritis Gynaecological and breast diseases very common common uncommon rare very rare not known Metrorrhagia, Testicular disorders General disorders and administration site conditions Fatigue Oedema Asthenia Malaise Face oedema Chest pain Pyrexia Pain Peripheral edema Investigations Lymphocyte count decreased, Eosinophil count increased, Blood bicarbonate decreased, Basophil, monocytes and neutrophil count increased Aspartate aminotransferase increased, Alanine aminotransferase increased, Blood bilirubin increased Blood urea increased Blood creatinine increased Blood potassium abnormal Blood alkaline phosphatase increased, Chloride increased, Glucose increased, Platelets increased, Hematocrit decreased, Bicarbonate increased, Abnormal sodium Injury and poisoning Post procedural complication Table 2.
As with erythromycin and other macrolides, rare serious allergic reactions, including angioedema and anaphylaxis (rarely fatal), dermatologic reactions including acute generalized exanthematous pustulosis (AGEP), Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (rarely fatal) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.
Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and 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. Since the liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease.
8). Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products. In cases of signs and symptoms of liver dysfunction such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver function tests/investigations should be performed immediately.
Azithromycin administration should be stopped if liver dysfunction has emerged. Liver function disorders, hepatitis, cholestatic jaundice, liver necrosis and hepatic failure have been reported and have been fatal in a number of cases.
Discontinue the use of azithromycin immediately if signs and symptoms of hepatitis occur. In patients receiving ergot derivatives, ergotism has been precipitated by coadministration of some macrolide antibiotics. There are no data concerning the possibility of an interaction between ergot and azithromycin.
However, because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be co-administered. 8). As the following situations may lead to an increased risk for ventricular arrhythmias (including torsade de pointes) which can lead to cardiac arrest, azithromycin should be used with caution in patients with on-going proarrhythmic conditions (especially women and elderly patients) such as: - Patients with congenital or documented QT prolongation.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Adverse effects caused possibly or very likely by the prophylaxis or treatment of Mycobacterium avium-infection. The data originate from clinical studies or surveys after market introduction. These side effects are different by nature or frequency from the side effects reported for a drug with an immediate or retarded release.
Very common Common Rare Metabolism and nutrition disorders Anorexia Nervous system disorders Dizziness, Headache, Paraesthesia, Dysgeusia Hypoesthesia Eye disorders Visual impairment Ear and labyrinth disorders Deafness Hearing impairment, Tinnitus Cardiac disorders Palpitations Gastrointestinal disorders Diarrhea, Abdominal pain, Nausea, Flatulence, Abdominal condition, Soft defecation Hepatobiliary disorders Hepatitis Skin and subcutaneous tissue disorders Rash, Pruritis Stevens-Johnson syndrome, Photosensitivity reaction Musculoskeletal and connective tissue disorders Arthralgia General disorders and administration site conditions Fatigue Malaise, Asthenia Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
- Patients currently receiving treatment with other active substances known to prolong QT interval such as antiarrhythmics of classes IA (quinidine and procainamide) and III (dofetilide, sotalol and amiodarone), cisapride and terfenadine, antipsychotic agents such as pimozide; antidepressants such as citalopram; and fluoroquinolones such as moxifloxacin and levofloxacin.
- Patients with electrolyte disturbance, particularly in cases of hypokalaemia and hypomagnesemia. - Patients with clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency. 5). 8). g. fungal infections) is recommended.
Clostridioides difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.
difficile. Strains of C. difficile produces toxins A and B which contribute to the development of CDAD. Certain hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea during or subsequent to the administration of any antibiotic. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
No dosage adjustment is required in patients with mild or moderate renal function impairment (creatinine clearance > 40 mL/min). 2). After the use of macrolide antibiotics, cases of pseudomembranous colitis have been reported. This diagnosis should therefore be considered for patients who suffer from diarrhea after start of the treatment with azithromycin.
There is no experience regarding the safety and efficacy of long-term use of azithromycin for the mentioned indications except for prophylaxis against MAC infections. In case of rapid recurrent infections, treatment with another antibiotic should be considered.
After the use of Azithromycin in neonates (treatment in the first 42 days after birth), cases of hypertrophic pyloric stenosis in infants (IHPS) were reported. The parents and the nursing staff are prompted to contact their doctor if any vomiting or irritation would occur at feeding.
Safety and efficacy of Azithromycin for the prevention or treatment of Mycobacterium Avium Complex (MAC) in children have not been established. Excipients Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose […]