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Amoclav

Amoxicillin + Clavulanic acid




Brand Name, Dosage Format and Strength
Amoclav  1000 mg/200 mg  Powder for Injection

Therapeutic Category
Anti-infectives (Systemic)

Sub Therapeutic
Antibacterial, Antifungal, Antituberculosis, Antivirals

Class
Aminoglycoside, Cephalosporin, Chloramphenicol, Lincosamide, Macrolide, Penicillin, Penicillin + Beta lactamase Inhibitor , Penicillinase-resistant isoxazolylpenicillin, Penicillin; Beta-lactam + Beta-lactamase Inhibitor, Quinolone, Sulfonamide + Folate Inhibitor, Tetracycline, Triazole Antibiotic, Immunostimulant, Neuraminidase Inhibitor

Marketing Division





DOSAGE AND ADMINISTRATION

  •  Co-amoxiclav may be administered either by IV injection or by intermittent infusion. It is NOT suitable for IM administration.
  • Co-amoxiclav should be given by slow IV injection over a period of 3 to 4 mins and within 20 mins of reconstitution. It may be injected directly into the vein or via a drip tube.
  • Treatment should not exceed 14 days without re-evaluation of the patient.
Usual Recommended IV Co-amoxiclav Dose:
Adults and Children
12 yrs and older (> 40 kg)
1.2 g (Amoxicillin 1000 mg + Clavulanic acid 200 mg) every 6 to 8 hrs, depending on the severity of infection
Children 3 mos to
12 yrs old
30 mg (Amoxicillin 25 mg + Clavulanic acid 5 mg) per kg BW 6 to 8 hrs, depending on the severity of infection.
Children 0 to 3 mos
(> 4 kg)
30 mg (Amoxicillin 25 mg + Clavulanic acid 5 mg) per kg BW every 8 hrs
Children 0 to 3 mos
(< 4 kg)
30 mg/kg(Amoxicillin 25 mg + Clavulanic acid 5 mg) per kg BW every 12 hrs
Or, as prescribed by a physician.
Dosage for Surgical Prophylaxis: Surgical prophylaxis with Co-amoxiclav should aim to protect the patient for the period of risk of infection.
  • In adults, procedures lasting less than one (1) hr are successfully covered by IV Co-amoxiclav 1.2 g (Amoxicillin 1000 mg + Clavulanic acid 200 mg) administered at induction of anesthesia.
  • Longer operations or when there is a high risk of infection (e.g., colorectal surgery) may require subsequent doses of IV Co-amoxiclav 1.2 g (Amoxicillin 1000 mg + Clavulanic acid 200 mg) [up to 4 doses in 24 hrs], and this regimen can be continued for several days if the procedure has significantly increased the risk of infection.
  • Clear clinical signs of infection at operation will require a normal course of IV or oral Co-amoxiclav therapy post-operatively.
Dosage in Elderly Patients: No dosage adjustment necessary. However, if there is evidence of renal impairment, dose should be adjusted as for renally- impaired adults.
 
Dosage in Patients with Renal Impairment: Dosing adjustments are based on the maximum recommended level of amoxicillin.
 
Renal Impairment
Recommended IV
Co-amoxiclav Dose in Renal Impairment
Adults
Children
Mild Impairment
(CLCR >30 mL/min)
No dosage adjustment necessary
No dosage adjustment necessary
 
Moderate Impairment
(CLCR 10 to 30 mL/min
1.2 g* (Amoxicillin 1000 mg + Clavulanic acid   200 mg) IV stat followed by 600 mg (Amoxicillin 500 mg + Clavulanic acid 100 mg) IV every 12 hrs
 30 mg (Amoxicillin 25 mg + Clavulanic acid 5 mg) per kg body weight every 12 hrs
 
 
 
Severe Impairment
(CLCR <10 mL/min)
·      1.2 g*(Amoxicillin 1000 mg + Clavulanic acid 200 mg) IV stat followed by 600 mg (Amoxicillin 500 mg + Clavulanic acid 100 mg) IV every 24 hrs.
·      An additional 600 mg (Amoxicillin 500 mg + Clavulanic acid 100 mg) IV dose may need to be supplemented at the end of dialysis.**
·    30 mg (Amoxicillin 25 mg + Clavulanic acid 5 mg) per kg BW every 24 hrs
·    An additional 15 mg (Amoxicillin 12.5 mg + Clavulanic acid 2.5 mg) per kg BW may need to be supplemented at the end of dialysis.**

*Each 1.2 g vial of Co-amoxiclav contains about 1 mmol potassium and 3.1 mmol sodium

**Dialysis decreases serum concentrations of Co-amoxiclav.

Dosage in Patients with Hepatic Impairment: Dose with caution; monitor hepatic function at regular intervals for both adults and children. Data on where to base the dosage recommendation have not been established.
 
Directions for Use
 
Directions for Reconstitution: To reconstitute, dissolve IV Co-amoxiclav powder in the required amount of diluent (Water for Injection is the usual diluent). Reconstituted solutions are normally clear and colorless and free from foreign particles.
Co-amoxiclav Vial
Volume of Diluent
(mL)
600 mg (500 mg/100 mg)
10
1.2 g (1000 mg/200 mg)
20
There are two ways of administering IV Co-amoxiclav:
  • Slow IV Injection for 3 to 4 mins after reconstitution.
  • IV Infusion over 30 to 40 mins (should be further diluted after reconstitution).
Preparation of IV Infusion and Stability: 
  • Add without delay (i.e., Solutions should be made up to full infusion volume immediately after reconstitution) Co-amoxiclav 600 mg (500 mg/100 mg) reconstituted solution to 50 mL infusion fluid OR 1.2 g (1000 mg/200 mg) reconstituted solution to 100 mL infusion fluid (preferably using a mini-bag or in-line burette). Infuse over 30 to 40 mins and complete within the time stated.
  • Satisfactory antibiotic concentrations are retained at 5°C and at room temperature (25°C) in the recommended volumes of the following infusion fluids. If reconstituted and maintained at room temperature, infusions should be completed within the time stated. 
IV Infusion Fluids
Stability Period
 at 25°C
Water for Injection
4 hrs
Sodium Chloride IV Infusion (0.9% w/v)
4 hrs
Sodium Lactate IV Infusion (one sixth molar)
4 hrs
Compound Sodium Chloride Injection
(Ringer’s Solution)
3 hrs
Compound Sodium Lactate IV Infusion (Ringer’s Lactate Solution; Hartmann’s Solution)
3 hrs
Potassium Chloride and Sodium Chloride IV Infusion
3 hrs
  • Reconstituted solution should not be frozen.
  • For storage at 5°C, the reconstituted solution should be added to pre-refrigerated infusion bags which may be stored for up to 8 hrs. Thereafter, the infusion should be administered immediately after reaching room temperature.
IV Infusion Fluids
Stability Period
at 5°C
Water for Injection
8 hrs
Sodium Chloride IV Infusion
8 hrs
  •  Co-amoxiclav vials are not suitable for multi-dose use.Any unused antibiotic solution should be disposed properly.
  • Co-amoxiclav IV is less stable in infusions containing glucose, dextran or bicarbonate. Therefore, reconstituted solution should not be added to such infusions but may be injected into the drip tubing over a period of 3 to 4 mins.
Incompatibilities
 
Co-amoxiclav IV should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates or with IV lipid emulsions. If Co-amoxiclav injection is prescribed concomitantly with an aminoglycoside, the antibiotics should not be mixed in the syringe, IV fluid container or giving set because of loss of activity of the aminoglycoside under these conditions.

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