Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Codal-Synto Ltd, 21 Constantinoupoleos, 3011 Limassol, Cyprus
Syntoclav has a broad spectrum of activity against bacterial pathogens that are common in both hospital and general practice, including organisms that are insensitive to amoxicillin alone due to beta-lactamase production. A more detailed list of sensitive species is given under “Pharmacodynamics”.
Syntoclav is indicated for the short term therapy of bacterial infections believed to be caused by beta-lactamase producing organisms resistant to amoxicillin alone.
Infections of the upper respiratory tract, such as otitis media, sinusitis and recurrent tonsillitis. Common causative organisms include Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Streptococcus pneumoniae and Streptococcus pyogenes.
Infections of the lower respiratory tract such as bronchopneumonia and severe acute exacerbation in chronic bronchitis. Common causative organisms include Haemophilus influenzae, Moraxella (Branhamella) catarrhalis and Streptococcus pneumoniae.
Infection of skin and soft tissue, such as severe dental abscess with spreading cellulitis, animal bites and cellulitis. Common causative organisms include Bacteroides sp., Staphylococcus aureus and Streptococcus pyogenes.
Infections of the abdomen and the genital-urinary tract, such as cystitis (especially recurrent or complicated cystitis, excluding prostatitis), intra-abdominal sepsis, pelvic sepsis, pueperal sepsis and septic abortion. Common causative organisms include the Enterobacteriaceae, mainly Escherichia coli, Enterococcus sp. and Staphylococcus saprophyticus.
Prophylaxis of wound infection associated with surgical procedures in particular gastrointestinal, pelvic, major head and neck surgery and after limb amputation for infection.
Mixed infections caused by amoxicillin-susceptible organisms in conjunction with Syntoclav-susceptible β-lactamase-producing organisms may be treated with Syntoclav. These infections should not require the addition of another antibiotic resistant to β-lactamases.
Adults and children over 12 years: Usually 1.2 g three times a day. In more serious infections, increase frequency to four times a day.
Children 3 months-12 years: Usually 30 mg/kg Syntoclav three times a day. In more serious infections, increase frequency to four times a day.
Children 0-3 months: 30 mg/kg Syntoclav every 12 hours in premature infants and in full-term infants during the perinatal period, increasing to eight hours thereafter.
Each 30 mg of Syntoclav provides 25mg of amoxicillin and 5mg of clavulanic acid.
The usual dose is 1.2 g Syntoclav given intravenously at the induction of anaesthesia. Operations where there is a high risk of infection, e.g. colorectal surgery, may require three, and up to four, doses of 1.2 g Syntoclav in a 24-hour period. These doses are usually given at 0, 8, 16 (and 24) hours. This regimen can be continued for several days if the procedure has a significantly increased risk of infection.
Clear clinical signs of infection at operation will require a normal course of intravenous or oral Syntoclav therapy post-operatively.
| Mild impairment (creatinine clearance >30 ml/min) | Moderate impairment (creatinine clearance 10-30 ml/min) | Severe impairment (creatinine clearance <10 ml/min) |
|---|---|---|
| No change in dosage. | 1.2 g IV stat., followed by 600 mg IV 12 hourly. | 1.2 g IV stat., followed by 600 mg IV 24 hourly. Dialysis decreases serum concentrations of Syntoclav and an additional 600 mg IV dose may need to be given during dialysis and at the end of dialysis. |
Similar reductions in dosage should be made for children.
In the case of hepatic impairment dose with caution; the hepatic function should be monitored at regular intervals.
There are, as yet, insufficient data on which to base a dosage recommendation.
Each 1.2 g vial of Syntoclav contains approximately 1.0 mmol of potassium and 2.7 mmol of sodium.
Syntoclav may be administered either by intravenous injection or by intermittent infusion (see Section 6.6). It is not suitable for intramuscular administration.
Duration of therapy should be appropriate to the indication and should not exceed 14 days without review.
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).
Convulsions may occur in patients with impaired renal function or in those receiving high doses.
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/clavulanic acid can be removed from the circulation by haemodialysis.
24 months.
Store below 25°C.
20ml Glass vials Type II; packs of 1, 5, 10, 25, 50 and 100 vials are available.
Not all pack sizes may be marketed.
To reconstitute dissolve in 20 ml Water for Injections.
Syntoclav should be given by slow intravenous injection over a period of three to four minutes and used within 20 minutes of reconstitution. It may be injected directly into a vein or via a drip tube.
Alternatively, Syntoclav may be infused in Water for Injections, Sodium Chloride 0.9% Intravenous Injection or Lactated Ringer’s Injection Intravenous Infusion. Add, without delay, 1.2 g reconstituted solution to 100 ml infusion fluid (e.g. using a minibag or in-line burette). Infuse over 30-40 minutes and complete within 4 hours of reconstitution if Water for Injection is used or within 3 hours if Sodium Chloride Intravenous Injection (0.9% w/v) or Lactated Ringer’s Injection Intravenous Infusion are used. Any residual antibiotic solutions should be discarded.
Syntoclav is less stable in infusions containing glucose, dextran or bicarbonate. Reconstituted solution should, therefore, not be added to such infusions but may be injected into the drip tubing over a period of three to four minutes.
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