Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Moxilen is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):
Moxilen is also indicated for the prophylaxis of endocarditis.
Moxilen is also indicated for the treatment and prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The dose of Moxilen that is selected to treat an individual infection should take into account:
The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment (see section 4.4 regarding prolonged therapy).
| Indication* | Dose* |
|---|---|
| Acute bacterial sinusitis Asymptomatic bacteriuria in pregnancy Acute pyelonephritis Dental abscess with spreading cellulitis Acute cystitis | 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours Acute cystitis may be treated with 3 g twice daily for one day |
| Acute otitis media Acute streptococcal tonsillitis and pharyngitis Acute exacerbations of chronic bronchitis | 500 mg every 8 hours, 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours for 10 days |
| Community acquired pneumonia | 500 mg to 1 g every 8 hours |
| Typhoid and paratyphoid fever | 500 mg to 2 g every 8 hours |
| Prosthetic joint infections | 500 mg to 1 g every 8 hours |
| Prophylaxis of endocarditis | 2 g orally, single dose 30 to 60 minutes before procedure |
| Helicobacter pylori eradication | 750 mg to 1 g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. clarithromycin, metronidazole) for 7 days |
| Lyme disease (see section 4.4) | Early stage: 500 mg to 1 g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days) Late stage (systemic involvement): 500 mg to 2 g every 8 hours up to a maximum of 6 g/day in divided doses for 10 to 30 days |
* Consideration should be given to the official treatment guidelines for each indication
Children may be treated with Moxilen capsules or powder for oral suspension.
Moxilen powder for oral suspension is recommended for children under six months of age.
Children weighing 40 kg or more should be prescribed the adult dosage.
| Indication+ | Dose+ |
|---|---|
| Acute bacterial sinusitis Acute otitis media Community acquired pneumonia Acute cystitis Acute pyelonephritis Dental abscess with spreading cellulitis | 20 to 90 mg/kg/day in divided doses* |
| Acute streptococcal tonsillitis and pharyngitis | 40 to 90 mg/kg/day in divided doses* |
| Typhoid and paratyphoid fever | 100 mg/kg/day in three divided doses |
| Prophylaxis of endocarditis | 50 mg/kg orally, single dose 30 to 60 minutes before procedure |
| Lyme disease (see section 4.4) | Early stage: 25 to 50 mg/kg/day in three divided doses for 10 to 21 days Late stage (systemic involvement): 100 mg/kg/day in three divided doses for 10 to 30 days |
+ Consideration should be given to the official treatment guidelines for each indication.
* Twice daily dosing regimens should only be considered when the dose is in the upper range.
No dose adjustment is considered necessary.
| GFR (ml/min) | Adults and children ≥40 kg | Children <40 kg# |
|---|---|---|
| greater than 30 | no adjustment necessary | no adjustment necessary |
| 10 to 30 | maximum 500 mg twice daily | 15 mg/kg given twice daily (maximum 500 mg twice daily) |
| less than 10 | maximum 500 mg/day | 15 mg/kg given as a single daily dose (maximum 500 mg) |
# In the majority of cases, parenteral therapy is preferred.
Amoxicillin may be removed from the circulation by haemodialysis.
| Haemodialysis | |
|---|---|
| Adults and children ≥40 kg | 15 mg/kg/day given as a single daily dose. Prior to haemodialysis one additional dose of 15 mg/kg should be administered. In order to restore circulating drug levels, another dose of 15 mg/kg should be administered after haemodialysis. |
Amoxicillin maximum 500 mg/day.
Dose with caution and monitor hepatic function at regular intervals (see sections 4.4 and 4.8).
| Indication* | Dose* |
|---|---|
| Severe infections of the ear, nose and throat (such as mastoiditis peritonsillar infections, epiglottis and sinusitis when accompanied by severe systemic signs and symptoms Acute exacerbations of chronic bronchitis Community acquired pneumonia Acute cystitis Acute pyelonephritis Severe dental abscess with spreading cellulitis | 750 mg to 2 g every 8 hours, or 2 g every 12 hours, maximum of 12 g/day |
| Prosthetic joint infections | 750 mg to 2 g every 8 hours, or 2 g every 12 hours, maximum of 12 g/day |
| Prophylaxis of endocarditis | 2 g single dose 30 to 60 minutes before procedure |
| Treatment of endocarditis | 1 g to 2 g every 4 to 6 hours, maximum of 12 g/day |
| Bacterial meningitis | 1 g to 2g every 4 to 6 hours, maximum of 12 g/day |
| Lyme disease (see section 4.4) | Late stage (systemic involvement): 2 g every 8 hours |
| Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed in section 4.1 | 1 g to 2 g every 4, 6 or 8 hours, maximum of 12 g/day |
* Consideration should be given to the official treatment guidelines for each indication
Maximum daily dosage: 4 g/day.
Maximum single dose: 1 g.
| Infants and toddlers >3 months and children <40 kg Indication* | Dose* |
|---|---|
| Severe infections of the ear, nose and throat (such as mastoiditis peritonsillar infections, epiglottis and sinusitis when accompanied by severe systemic signs and symptoms Community acquired pneumonia Acute cystitis Acute pyelonephritis Severe dental abscess with spreading cellulitis | 20 to 200 mg/kg/day given in 2 to 4 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg |
| Prophylaxis of endocarditis | 50 mg/kg single dose 30 to 60 minutes before procedure |
| Treatment of endocarditis | 200 mg/kg/day in 3 to 4 equally divided does of up to 25 mg/kg or infusions of up to 50 mg/kg |
| Bacterial meningitis | 100 to 200 mg/kg/day in 3 to 4 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg |
| Lyme disease (see section 4.4) | Early stage: 25 to 50 mg/kg/day in three divided doses for 10 days (range 10 to 21 days) Late stage (systemic involvement): 50 mg/kg/day in three divided doses |
| Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed in section 4.1 | 50 to 150 mg/kg/day given in 3 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg |
* Consideration should be given to the official treatment guidelines for each indication.
| Neonates ≥4kg and infants up to 3 months Indication* | Dose* |
|---|---|
| Most infections | Usual daily dose of 20 to 150 mg/kg/day given in 3 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg |
| Treatment of endocarditis | 150 mg/kg/day given in 3 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg |
| Bacterial meningitis | 150 mg/kg/day given in three divided doses |
| Lyme disease (see section 4.4) | Early stage: 25 to 50 mg/kg/day in three divided doses for 10 days (range 10 to 21 days) Late stage (systemic involvement): 50 mg/kg/day in three divided doses |
| Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed in section 4.1 | Usual daily dose of 50 to 150 mg/kg/day given in 3 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg |
* Consideration should be given to the official treatment guidelines for each indication.
| Premature Neonates <4kg Indication* | Dose* |
|---|---|
| Most infections | Usual daily dose of 20 to 100 mg/kg/day given in 2 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg |
| Treatment of endocarditis | 100 mg/kg/day given in two divided doses |
| Bacterial meningitis | 100 mg/kg/day given in two divided doses |
| Lyme disease (see section 4.4) | Early stage: 25 to 50 mg/kg/day in two divided doses for 10 days (range 10 to 21 days) Late stage (systemic involvement): 50 mg/kg/day in two divided doses |
| Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed in section 4.1 | Usual daily dose of 50 to 100 mg/kg/day given in 2 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg |
* Consideration should be given to the official treatment guidelines for each indication.
Maximum daily dosage: 120 mg/kg/day as 2 to 6 equally divided doses.
No adjustment needed; as for adults.
| Adults and children ≥40 kg | Children <40 kg | |||
|---|---|---|---|---|
| GFR (ml/min) | Intravenous | Intramuscular | Intravenous | Intramuscular |
| greater than 30 | No adjustment | No adjustment | No adjustment | No adjustment |
| 10 to 30 | 1g stat, then 500 mg to 1 g twice day | 500 mg every 12 hours | 25 mg/kg twice daily | 15 mg/kg every 12 hours |
| less than 10 | 1 g stat, then 500 mg/day | 500 mg/day given as a single dose | 25 mg/kg/day given as a single dose | 15 mg/kg/day given as a single dose |
In patients receiving haemodialysis and peritoneal dialysis.
Amoxicillin may be removed from the circulation by haemodialysis.
| Haemodialysis | Peritoneal dialysis | |||
|---|---|---|---|---|
| Intravenous | Intramuscular | Intravenous | Intramuscular | |
| Adults and children ≥40 kg | 1 g at the end of dialysis, then 500 mg every 24 hours | 500 mg during dialysis, 500 mg at the end, then 500 mg every 24 hours | 1 g stat, then 500 mg/day | 500 mg/day given as a single dose |
| Children <40 kg | 25 mg/kg stat and 12.5 mg/kg at the end of the dialysis, then 25 mg/kg/day | 15 mg/kg during and at the end of dialysis, then 15 mg/kg every 24 hours | 25 mg/kg/day given as a single dose | 15 mg/kg/day given as a single dose |
Moxilen is for oral use.
Absorption of amoxicillin is unimpaired by food.
Therapy can be started parenterally according to the dosing recommendations of the intravenous formulation and continued with an oral preparation.
Capsules: Swallow with water without opening capsule.
Powder for oral suspension (bottles): For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Intravenous: Moxilen may be administered either by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or via a drip tube or by infusion over 20 to 30 minutes.
Intramuscular: Do not inject more than 1 g of amoxicillin at one time in adults.
Do not inject more than 60 mg/kg at one time in children.
Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed. Convulsions may occur in patients with impaired renal function or in those receiving high doses (see sections 4.4 and 4.8).
Amoxicillin has been reported to precipitate in bladder catheters, predominantly after intravenous administration of large doses. A regular check of patency should be maintained (see section 4.4).
Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.
Amoxicillin may be removed from the circulation by haemodialysis.
Moxilen hard capsules: 36 months.
Moxilen and Moxilen Forte powder for oral suspension: 36 months.
Following reconstitution, they have a shelf life of 15 days if kept in a refrigerator (2°C-8°C) or of 7 days if kept at a temperature below 25°C.
Moxilen powder for solution for injection or infusion vials: 24 months.
On reconstitution for intra muscular or intravenous administration (injection or infusion), they should be used immediately.
Moxilen hard capsules should be stored below 25°C in the original package, in order to protect from moisture.
Moxilen and Moxilen Forte powder for oral suspension should be stored below 25°C.
Moxilen powder for solution for injection or infusion vials should be stored below 30°C, in the original package, in order to protect from light.
For storage conditions after reconstitution, dilution or first opening of the medicinal product (powder for oral suspension and powder for solution for injection or infusion) - see section 6.3.
Moxilen hard capsules 250 mg and 500 mg are packed in polyvinylchloride film-aluminium foil blisters with a leaflet, in cartons. Cartons containing 16, 20, 100, 250, 500 or 1000 capsules are available.
Moxilen and Moxilen Forte powder for oral suspension are presented in amber (type III) glass bottles sealed with aluminium pilfer proof caps with an inert PVC liner.
Bottles containing powder to give 60 ml and 100 ml of suspension following reconstitution are available.
Moxilen powder for solution for injection or infusion is presented in clear 8 ml type III glass vials, sealed with a rubber stopper of 20 mm diameter and an aluminium overcap, with a leaflet, in card cartons.
Cartons containing 1, 10, 50 or 100 vials are available.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Check cap seal is intact before use.
Invert and shake bottle to loosen powder.
Fill the bottle with water to just below the mark on the bottle label.
Invert and shake well, then top up with water to the mark. Invert and shake again.
Shake well before taking each dose.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
500 mg, 1 g powder for solution for injection or infusion
| Vial | Diluent (ml) |
|---|---|
| 500mg | 10 |
| 1g | 20 |
Water for injections is the normal diluent.
A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless or a pale straw colour. All solutions should be shaken vigorously before injection.
Preparation of intravenous infusions and stability: add without delay the reconstituted solution of 500 mg (as prepared above – these are minimum volumes) to 50 ml of infusion fluid.
Preparation of intravenous infusions and stability: add without delay the reconstituted solution of 1 g (as prepared above – these are minimum volumes) to 100 ml infusion fluid (e.g. using a mini bag or in-line burette).
Intravenous amoxicillin may be given in a range of different intravenous fluids.
Intravenous solution:
Water for injection
NaCl
Ringer NaCl
Sodium lactate
Ringer sodium lactate
Dextrose
NaCl – dextrose
Amoxicillin is less stable in infusions containing carbohydrate. Reconstituted solutions of amoxicillin may be injected into the drip tubing over a period of 0.5 to 1 hour.
h3, Intramuscular administration
| Vial | Diluent |
|---|---|
| 500mg | 2.5 ml water for injections or 5.1 ml benzyl alcohol solution |
| 1g | 2.5 ml lidocaine hydrochloride solution |
All solutions should be shaken vigorously before injection and administered within 30 minutes of reconstitution.
Any residual antibiotic solution should be discarded.
For single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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