Photo Gallery
Large Photo
Thumbnail 1 Thumbnail 2 Thumbnail 3 Thumbnail 4
Photo Gallery

Amoxicillin/ Acid clavulanic 250 mg/ 31,25 mg

Manufacturer

Branch of Imexpharm Corporation - Vinh Loc Hi-Tech Pharmacetical Antibiotic Plant

Applicant company

Imexpharm Pharmaceutical Joint Stock Company

Active ingredient

Acid clavulanic (as Kali clavulanat - Syloid (1:1)); Amoxicilin (as Amoxicilin trihydrat powder)

Content

250 mg / 31,25 mg

Shelf life

24 months

Dosage Form

Powder for oral suspension

Package

Box of 1 bag x 12 sachets x 1 g

Visa Number

893110271824

Issuing Date

06/05/2024

Therapeutic area

Antibiotics

Indication

Amoxicillin/Clavulanic Acid 250 mg/31.25 mg should be used in accordance with antibiotic prescribing guidelines and local bacterial sensitivity data.
Amoxicillin/Clavulanic Acid 250 mg/31.25 mg is indicated for the short-term treatment of infections caused by amoxicillin/clavulanic acid-sensitive bacteria at the following sites:
- Upper respiratory tract infections (including ENT infections) such as recurrent tonsillitis, sinusitis, otitis media, typically caused by Streptococcus pneumoniae, Haemophilus influenzae¹, Moraxella catarrhalis¹, and Streptococcus pyogenes.
- Lower respiratory tract infections such as acute exacerbations of chronic bronchitis, lobar pneumonia, and bronchopneumonia, typically caused by Streptococcus pneumoniae, Haemophilus influenzae¹, and Moraxella catarrhalis¹.
- Genitourinary tract infections such as cystitis, urethritis, pyelonephritis, and female genital tract infections, typically caused by Enterobacteriaceae¹ (mainly Escherichia coli¹), Staphylococcus saprophyticus, Enterococcus spp., and gonorrhea caused by Neisseria gonorrhoeae¹.
- Skin and soft tissue infections, typically caused by Staphylococcus aureus¹, Streptococcus pyogenes, and Bacteroides spp¹.
- Bone and joint infections, such as osteomyelitis, typically caused by Staphylococcus aureus¹, usually requiring prolonged treatment.
- Other infections, such as infected miscarriage, postpartum infections, and intra-abdominal infections.
¹Some bacterial strains of these species produce beta-lactamase enzymes, rendering them resistant to amoxicillin when used alone (see section on Pharmacodynamic Properties).
Bacterial susceptibility to Amoxicillin/Clavulanic Acid 250 mg / 31.25 mg may vary according to geographical location and over time. Local epidemiological data on antimicrobial susceptibility should be consulted where available, and susceptibility testing should be performed when clinically indicated.
Mixed infections caused by amoxicillin-susceptible strains in conjunction with beta-lactamase-producing organisms susceptible to amoxicillin/clavulanic acid may be appropriately treated with this formulation.

Dosage

Dosage is adjusted according to severity of infection, age, weight and renal function of the patient.
Doses are expressed in terms of amoxicillin/clavulanic acid unless otherwise stated in terms of individual components.
Duration of treatment should be adjusted according to patient response. Some infections (e.g. osteomyelitis) require longer durations of treatment. Treatment should not be continued beyond 14 days without reassessment of the patient's condition.
Adults:

Infection Dosage
Mild to moderate infections 1000 mg amoxicilin/ 125 mg acid clavulanic/ time x 2 time per day (equivalent to 4 sachets/ time x 2 times/ day)
Severe infections (including recurrent and chronic urinary tract infections, lower respiratory tract infections) 1000 mg amoxicilin/ 125 mg acid clavulanic/ time x 3 times per day (equivalent to 4 sachets/ time x 3 times/ day)
Children:
- Children weighing 40 kg or more: Use the same dosage as adults.
- Children under 12 years of age and/or weighing less than 40 kg:
+ Recommended dose: 40 mg amoxicillin/5 mg clavulanic acid/kg/day to 80 mg amoxicillin/10 mg clavulanic acid/kg/day (not to exceed 3000 mg amoxicillin/375 mg clavulanic acid/day), divided into 3 times/day, depending on the severity of the infection.
+ Or the recommended dose is calculated by sachet:
Weighing Dosage per sachet
10 kg to under 20 kg 1 sachet/ time x 3 times/ day
20 kg to under 30 kg 2 sachets/ time x 3 times/ day
30 kg to under 40 kg 2-3 sachets/ time x 3 times/ day
- Premature infants: There is no recommended dose for premature infants.
Elderly:
No dosage adjustment is required. Use the same dosage as for adults. If there are signs of renal impairment, the dosage should be adjusted according to creatinine clearance (CrCl)
Patients with renal impairment:
Creatinine clearance (CrCl) Dosage
≥ 30 mL/min No dosage adjustment is required.
< 30 mL/min The combination of amoxicillin/clavulanic acid at a ratio of 8/1 is not recommended because there is no dosage adjustment recommendation.
Patients requiring hemodialysis: Only use this drug for patients with creatinine clearance (CrCl) of 30 mL/min or more.
Patients with hepatic impairment: Use with caution and periodically check liver function during the use of the drug.

Contact

Product Grid
TOP