Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
Azithromycin as powder for solution for infusion is indicated for the treatment of community-acquired pneumonia due to susceptible microorganisms, (see Section 5.1) in adult patients where initial intravenous therapy is required.
Azithromycin as powder for solution for infusion is indicated for the treatment of pelvic inflammatory disease (PID) due to susceptible microorganisms (see Section 5.1), in patients where initial intravenous therapy is required.
Consideration should be given to official guidance regarding the appropriate use of antibacterial agents.
The recommended dose of Azithromycin (azithromycin as powder for solution for infusion) for the treatment of adult patients with 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 of Azithromycin (azithromycin as powder for solution for infusion) for the treatment of adult patients with 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.
No dose adjustment is required in elderly patients that require therapy with azithromycin.
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 Section 4.4 and Section 5.2).
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 diseases (see Section 4.4).
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.
Once Azithromycin (azithromycin as powder for solution for infusion) 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.
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.
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 below.
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 Section 6.6 Special precautions for disposal and other handling.
| Final infusion solution concentration (mg/ml) | Amount of diluent (ml) |
|---|---|
| 1.0 mg/ml | 500 ml |
| 2.0 mg/ml | 250 ml |
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.
Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. The typical symptoms of an overdose with macrolide antibiotics include reversible loss of hearing, severe nausea, vomiting and diarrhoea. In the event of overdose, general symptomatic treatment and supportive measures are indicated as required.
3 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 25°C.
Diluted solutions, prepared according to the instructions, are chemically and physically stable for 24 hours at or below 25°C, or for 72 hours if stored at 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.
This medicinal product does not require any special storage conditions prior to reconstitution.
For storage conditions after reconstitution and dilution of the medicinal product, see Section 6.3.
Azithromycin is packed in 12 ml glass (type I) vials with bromobutyl rubber stopper and sealed with aluminium/plastic flip-off cap.
Pack sizes of 1 vial with powder for solution for infusion.
Azithromycin as powder for solution for infusion is supplied in single dose vials.
The initial reconstituted solution is prepared by adding 4.8 ml of sterile water for injections to the 12 ml vial initial content using a standard 5 ml syringe (non-automated) and shaking the vial until all the drug is dissolved. Each ml reconstituted solution contains azithromycin dihydrate equivalent to 100 mg azithromycin (100 mg/ml).
The reconstituted medicinal product is chemically and physically stable during 24 hours, when stored below 25°C. Diluted solutions, prepared according to the instructions, are chemically and physically stable for 24 hours at or below 25°C, or for 72 hours if stored at 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.
The reconstituted solution must be further diluted prior to administration.
To provide azithromycin at a concentration of 1.0 or 2.0 mg/ml, transfer 5 ml of the 100 mg/ml azithromycin solution to the appropriate amount of any of the diluents listed below.
| Final infusion solution concentration (mg/ml) | Amount of diluent (ml) |
|---|---|
| 1.0 mg/ml | 500 ml |
| 2.0 mg/ml | 250 ml |
The reconstituted solution can be diluted with:
0.9% sodium chloride
0.45% sodium chloride
5% dextrose in water
Lactated Ringer’s solution
5% dextrose in 0.3% sodium chloride
5% dextrose in 0.45% sodium chloride
Parenteral administration drugs should be inspected visually for particulate in suspension prior to administration. If particulate in suspension is evident in the reconstituted solution, it should be discarded.
It is recommended that the 500 mg dose of azithromycin as powder for solution for infusion, diluted as described 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.
Any unused product or waste material should be disposed of in accordance with local requirements.
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