Zithrotel

Zithrotel

azithromycin

Manufacturer:

Anfarm-Hellas

Distributor:

DCH Auriga

Marketer:

TTN
Full Prescribing Info
Contents
Azithromycin dihydrate.
Description
Each vial contains 500 mg of azithromycin dihydrate, which after reconstitution results in a 100 mg/ml azithromycin solution.
Indications/Uses
Treatment of community-acquired pneumonia due to the indicated susceptible microorganisms. Treatment of pelvic inflammatory disease (PID) due to the indicated susceptible microorganisms.
Dosage/Direction for Use
Adults and adolescents (>12 years of age): The recommended dose for the treatment of community-acquired pneumonia due to the indicated susceptible microorganisms is of 500 mg administered as a single intravenous daily dose for at least two consecutive days. The intravenous therapy should be followed by the oral administration of azithromycin in a single daily dose of 500 mg up to 7 to 10 days of treatment.
Transition to oral therapy should be carried out when indicated by the doctor and according to the clinical response.
The recommended dose for the treatment of pelvic inflammatory disease (PID) due to the indicated susceptible microorganisms is of 500 mg administered as a single intravenous daily dose for one or two days. The intravenous therapy should be followed by the oral administration of azithromycin in a single daily dose of 250 mg up to 7 days of treatment. Transition to oral therapy should be carried out when indicated by the doctor and according to the clinical response. Once the patient has been responded clinically the intravenous therapy should be displaced by the oral administration of azithromycin.
Children: The efficacy and safety of azithromycin as powder for solution for infusion for the treatment of infections in children and adolescents has not been established.
Use in the elderly: No dose adjustment is required in elderly patients that require therapy with azithromycin.
Use in patients with renal impairment: No dose adjustment is recommended in patients with mild to moderate renal impairment (GFR 10-80 ml/min). Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR < 10 ml/min) (see Precautions).
Use in patients with hepatic impairment: Dose adjustment is not required for patients with mild to moderate hepatic dysfunction but the medicinal product should be used with caution in patients with significant hepatic disease (Precautions).
Mode of Administration: Once the product is reconstituted and diluted, is intended to be administered by intravenous infusion. It should not be administered as an intravenous bolus or an intramuscular injection (see Precautions and Cautions for Usage).
The concentration of the solution for infusion and the infusion rate of azithromycin as powder for solution for infusion should be 1 mg/ml for 3 hours or 2 mg/ml for 1 hour. Concentration > 2 mg/ml should be avoided.
Preparation of the solution for intravenous administration is as follows: Reconstitution: The initial solution of azithromycin is prepared by adding 4.8 ml of sterile water for injections to the 500 mg vial and shaking the vial until all the drug is dissolved. It is recommended that a standard 5 ml (non-automated) syringe be used to ensure that the exact volume of 4.8 ml of sterile water for injections is dispensed. Each ml of reconstituted solution contains azithromycin dihydrate equivalent to 100 mg azithromycin (100 mg/ml).
Parenteral administration drugs should be inspected visually for particulate in suspension prior to administration. If particulate in suspension is evident in reconstituted solution, the drug solution should be discarded.
The reconstituted solution must be further diluted prior to administration as instructed as follows.
Dilution: To provide azithromycin over a concentration range of 1.0 – 2.0 mg/ml, transfer 5 ml of the 100 mg/ml azithromycin solution to the appropriate amount of any of the diluents listed in Cautions for Usage.
(See Table.)

Click on icon to see table/diagram/image

It is recommended that a 500 mg dose of azithromycin as powder for solution for infusion, diluted according to the instructions above, be administered as an intravenous infusion over at least 60 minutes.
Overdosage
Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. In the event of overdose, general symptomatic treatment and supportive measures are indicated as required.
Contraindications
The use of the product is contraindicated in patients with a known hypersensitivity to azithromycin, erythromycin or any of the macrolide or ketolide antibiotics or to any excipients listed in Description.
Co-administration of macrolides with cisapride is contraindicated.
Special Precautions
As with erythromycin and other macrolide antibiotics, rare severe allergic reactions including angioedema and anaphylaxis (rarely fatal), have been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms when symptomatic therapy was discontinued and required a longer period of observation and treatment.
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. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin.
In case 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.
In patients treated with ergotamine derivatives, ergotism has been precipitated by co-administration of some macrolide antibiotics. There are no data concerning the possibility of an interaction between ergotamine and azithromycin. However, because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be co-administrated. As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms including fungi is recommended.
Clostridium difficile associated diarrhoea (Pseudomembranous colitis-CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibiotics alters the normal flora of the colon allowing an overgrowth of C. difficile. Strains of C. difficile producing hypertoxin A and B contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. Therefore, CDAD must be considered in patients who present with diarrhoea during or subsequent to the administration of any antibiotics.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents Discontinuation of therapy with azithromycin and the administration of specific treatment for C. difficile should be considered.
Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
In patients with severe renal impairment (GFR <10 ml/min) a 33% increase in systemic exposure to azithromycin was observed.
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides. A similar effect with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization; therefore caution is required when treating patients: With congenital or documented QT prolongation.
Currently receiving treatment with other active substance known to prolong QT interval such as antiarrhytmics of classes IA and III, cisapride and terfenadine.
With electrolyte disturbance, particularly in case of hypokalaemia and hypomagnesemia.
With clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency.
Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving azithromycin therapy.
Intravenous use: Azithromycin powder for solution for infusion should be reconstituted and diluted according to the instructions and should be administered as an intravenous infusion over at least 60 minutes.
It should not be administered as an intravenous bolus or an intramuscular injection (see Mode of Administration under Dosage & Administration and Cautions for Usage).
Use in Children: The efficacy and safety of azithromycin as powder for solution for infusion for the treatment of infections in children and adolescents has not been established.
Use In Pregnancy & Lactation
Reproduction studies have been performed in animals at doses up to moderately maternally toxic dose concentrations. In these animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.
It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, azithromycin should not be used during breast-feeding unless the doctor decides the potential benefit justifies the potential risk to the foetus.
Caution For Usage
Azithromycin as powder for solution for infusion is supplied in single dose vials.
The initial solution of azithromycin is prepared by adding 4.8 ml of sterile water for injections to the 500 mg vial and shaking the vial until all the drug is dissolved. Each ml of reconstituted solution contains azithromycin dihydrate equivalent to 100 mg azithromycin (100 mg/ml).
Concentration >2mg/ml should be avoided.
Parenteral administration drugs should be inspected visually for particulate in suspension prior to administration. If particulate in suspension is evident in reconstituted solution, the drug solution should be discarded.
To provide azithromycin over a concentration range of 1.0-2.0 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed as follows: Normal Saline (0.9% sodium chloride).
½ Normal Saline (0.45 sodium chloride).
5% Dextrose Lactated Ringer’s Solution.
5% Dextrose in ½ Normal Saline (0.45 sodium chloride) with 20 mEq KCl.
5% Dextrose in Lactated Ringer’s Solution.
5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride).
5% Dextrose in ½ Normal Saline (0.45 sodium chloride).
It is recommended that a 500 mg dose of azithromycin as powder for solution for infusion, diluted according to the instructions above, be administered as an intravenous infusion over at least 60 minutes.
Azithromycin should not be administered as an intravenous bolus or an intramuscular injection.
Storage
Store below 30°C.
Shelf-Life: 2 years.
Concentrated solution after reconstitution (according to the instructions): Azithromycin as powder for solution for infusion is chemically and physically stable during 24 hours, when stored below 30°C.
Diluted solutions, prepared according to the instructions, are chemically and physically stable for 24 hours at or below 30°C, or for 7 days if stored under refrigeration (2-8°C).
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the reconstitution/dilution has taken place in controlled and validated aseptic conditions.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Powd for infusion (vial) 500 mg (white to off-white lyophilised powder) x 1's.
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