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National Drug Formulary

MOXICLAV POWDER FOR SOLUTION FOR INJECTION/ INFUSION 1.2G/VIAL [SIN17446P]

Active ingredients: MOXICLAV POWDER FOR SOLUTION FOR INJECTION/ INFUSION 1.2G/VIAL

View product's general information
Last updated 24 April 2026

Product Info

MOXICLAV POWDER FOR SOLUTION FOR INJECTION/ INFUSION 1.2G/VIAL

[SIN17446P]

Product information

Active Ingredient and Strength

AMOXICILLIN SODIUM EQV. TO AMOXICILLIN - 1,000 MG/VIAL
POTASSIUM CLAVULANATE EQV. TO CLAVULANIC ACID - 200 MG/VIAL

Dosage Form

INJECTION, POWDER, FOR SOLUTION

Manufacturer and Country

MEDOCHEMIE LTD (FACTORY B -INJECTABLE FACILITY) - CYPRUS
ZHUHAI UNITED LABORATORIES CO, LTD. (INTERMEDIATE 5:1 MIXTURE) - CHINA

Registration Number

SIN17446P

Licence Holder

MEDOCHEMIE SINGAPORE PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J01CR02

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

4.1 Therapeutic indications

Moxiclav 1.2g powder for solution for injection/infusion may be administered for the short-term treatment of primarily serious infections due to micro-organisms that are resistant to amoxicillin and other B-lactam antibiotics as a result of the formation of a clavulanic acid-susceptible ß-lactamase, such as:

  • Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.

  • Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia.

  • Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.

  • Skin and soft tissue infections e.g. boils, abscesses, cellulites, wound infections.

  • Bone and joint infections e.g. osteomyelitis.

  • Other infections e.g. intra-abdominal sepsis.

Moxiclav 1.2g powder for solution for injection/infusion can be used for prophylaxis against infections in major surgery such as gastrointestinal, pelvic, head and neck, cardiac, renal, joint replacement and biliary tract.

Dosing

4.2 Posology and method of administration

Dosage

The duration of treatment is dependent on the indication and the severity of the infection. Moxiclav 1.2g powder for solution for injection/infusion may not be used for more than 14 days without monitoring of the patient’s liver function.

Adults and children over 12 years
Normal renal function
Non-serious infections: Amoxicillin/Clavulanic acid 1000/200 mg 8 hourly by intravenous injection. In more serious infections, increase frequency to six hourly intervals, If possible, preference should be given to the oral form of Amoxicillin/Clavulanic acid.

Table caption

Children (3 months – 12 years)

- Serious infections

Usually 25/5 mg/kg per slow intravenous injection or infusion (infusion time at least 30 minutes) every six hours.

- Non-serious infections

Up to a maximum 25/5 mg/kg per slow intravenous injection or infusion (infusion time at least 30 minutes), every eight hours. If possible the oral form of Amoxicillin/Clavulanic acid is preferable.

Children (0 – 3 months)

25/5 mg/kg per infusion every 12 hours in premature infants and full term infants during the perinatal period, increasing to eight hours thereafter.

Dosage in the case of renal impairment
Elimination of clavulanic acid and amoxicillin via the kidneys is delayed in patients with renal impairment. Depending on the degree of renal impairment, the total daily dose of Moxiclav 1.2g powder for solution for injection/infusion (expressed in quantities of amoxicillin) should not exceed that indicated in following table.

Moxiclav Dosage Table 1



Similar reduction in dosage should be made for children.

Adult dose for surgical prophylaxis
Amoxicillin/Clavulanic acid 1000/200 mg Powder for solution for injection/infusion at the induction of anaesthesia. Operations where there is an increased risk of infection, e.g. colorectal surgery, may require 3 up to 4 doses in a 24-hour period 8 hourly.

Contraindications

4.3 Contraindications

  • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information or to any penicillin antibiotic.

  • History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

  • History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).