Mechanism of action

Product Detail
Mechanism of action
Anqi is an oral antibacterial combination consisting of the semisynthetic antibiotic
amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of
clavulanic acid). Amoxicillin is an analog of ampicillin.
Clavulanic acid is a β-lactam structurally related to the penicillins and possesses the
ability to inactivate a wide variety of β-lactamases by blocking the active sites of these
enzymes. Combination of amoxicillin and clavulanate potassium may prevent amoxicillin
from hydrolyzed by β-lactamase.
Anqi has similar but broader antimicrobial spectrum with that of amoxicillin.
It exhibits good antimicrobial activity against Staphylococcus aureus (β-lactamase
producing), Staphylococcus epidermidis , Staphylococcus saprophyticus , enterococci,
Enterobacter species (β-lactamase and non–β-lactamase–producing), Haemophilus
influenzae, Moraxella catarrhalis, Bacteroides species(including Bacteroides fragilis).
Anqi is not active against MRSA, P auruginosa and Enterobacter species
(plasmid-mediated β-lactamases producing ).
Pharmacokinetics
Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract
after oral administration. Dosing in the fasted or fed state has minimal effect on the
pharmacokinetics of amoxicillin.
Following 375mg anqi was administered oral,(amoxicillin 250mg, clavulanate potassium
125mg), peak plasma concentration of amoxicillin ( 5.6mg/L) is achieved at 1.5 hr (Cmax),
(t1/2β) is 1hr. 50%~78% of amoxicillin is excreted in urine within 8 hr. peak plasma
concentration of clavulanate potassiumis (3.4mg/L) is achieved at 1 hr. Protein binding is
22%~30%. t1/2β is 0.76~1.4 hr, 46% of clavulanate potassiumis excreted bia urine within
8 hrs. Bioavailability is 97% and 75% respectively.
Clinical application
This product can be used for the following infection due to susceptible microorganism:
respiratory infection, urinary tract infection and skin and soft tissue infection.
Indication
This product indicated for:
lower respiratory tract infections, otitis media, sinusitis due to the influenzae producing
haemophilus and Moraxella catarrhalis bacteria; the respiratory tract, urinary tract and
skin and soft tissue infections caused by Staphylococcus aureus and Enterobacteriaceae
producing bacteria such as E. coli, Klebsiella; mild to moderate infections due to the
Enterococci infection
The product is also indicated for above infections caused by non-enzyme-producing
bacteria.
Adverse effects
1、gastrointestinal symptoms: diarrhea, nausea and vomiting.
2、Skin rash, especially due to infectious mononucleosis.
3、reare case of allergy shock, drug fever and asthma. 4、rear case of moderate rise of transaminase, eosinophilia , leukopenia and super-infection due to Candida. Precaution
1. Caution should be exercised to patients with history of allergy to cephalosporin, asthma,
exzema, hay fever, urticaria and other hypersensitivity、patients with severely impaired
hepatic function.
2、Cefaclor has cross allergic response with PCs or cephamycin, so patient who is allergic
to patient who is allergic to PCs, penicillin derivate, bellacillin, and other cephalomycin
should take it with caution.
3、Cefaclor has cross allergic response with ampicillin, so patient who is allergic to patient
who is allergic to PCs, penicillin derivate should take it with caution.
4、The patients with impaired renal function may require dose adjustment based on serum
creatine clearance.
Hemodialysis may have impact the serum concentration of amoxicillin. One additional
dose of this product is required upon completion of hemodialysis.
5、For suspected patient of gonorrhea, dark vision fildes test is required before taking this
product.
6、Patients with severely impaired hepatic function should take this product with caution.
Hepatic, renal and hematologic system function test should e conducted st regular basis.
7、Laboratory Test Interactions: (1) High urine concentrations of amocixillin may result
in false-positive reactions when testing for the presence of glucose in urine using
CLINITEST®, Benedict's Solution, or Fehling's Solution. (2) May cause elevation of test
value of AST/ALT.
Pregnant and Nursing Mothers : (1) Ampicillin-class antibiotics can penetrate through
placenta. Therefore, taking Anqi is contraindicated by pregnant women.
2、Small amount of Amoxicillin may be excreted into mother’s milk. Amoxicillin used by
nursing mother may lead to sensitization of infants.Therefore, caution should be exercised
to nursing women when takingthis product.
Dosage and administration
This product should be orally.
For ault with medium to severe infection: 625mg once, given 3 times per day. Once cycle
lasts for 7~10 days.
For pediatric use:
New born or Infants within 3 months: Amoxicillin 15mg/kg each time, twice a day.
Children with body weight ≤40kg: a) General Infection: Amoxicillin 15mg/kg each time,
twice a day; or Amocixillin 20mg/kg, 3 times a day. One cycle lasts 7~10 days. b) Other
infectious situation: half dose of above schedule.
Children with body weight above 40kg could use adult dosage.
For Patients with insufficient renal function: patients with CrCl >30ml/min need not to
reduce dose; patients with CrCl between 10 to 30ml/min use 250~500mg(Amoxicillin) oral
dosage every 12 hrs; patients with CrCl <10ml/min take the product by 250~500mg
(Amoxicillin) daily dose.
For patients with hemodialysis: oral administration of 250~500mg (Amoxicillin) every 24 hrs referring to individual situation; additional doses are required during and after hemadialysis. Properties and appearance
The Granules is white to yellowish and sweet.
Specification
This product is is an antibacterial combination consisting of the amoxicillin and
clavulanate potassium.
Each Granules contains 0.125g of amocixillin and 31.25 mg of clavulanate potassium.
Package
Double composite membrane packaging, 6 bags / box
Price
20 RMB/box

Source: http://www.simcere.com/simcere/productpic/enpro_8_1_200759164592.pdf