Amoxicillin/ Clavulanate Potassium (4: 1) Tablets

Amoxicillin and Clavulanate Potassium Tablets
 

Generic name: Amoxicillin and Clavulanate Potassium Tablets(4:1)
Brand name: Anqi
Composition:
Amoxicillin :(2S,5,R,6,R)-6-[(,R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate
Clavulanate Potassium:
(Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate

Chemical structure:

Molecular formula: C16H19N3O5S•3H2O,C8H8KNO5
Molecular weight:419.45,237.25
Strength:156.25mg(4:1)

Description: This product is a film coat, and the coat is white to yellowish after the coating is removed.
Indications:
This product is indicated  for the treatment of infections caused by sensitive bacteria, such as:
1  Upper Respiratory Tract Infection: sinusitis, tonsillitis, pharyngitis ,etc.
2  Lower Respiratory Tract infection: acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia,
lung abscess and complicated bronchial infection.
3 Urinary Tract Infections: cystitis, urethritis, pyelonephritis, prostatitis, pelvic inflammatory disease, urinary
tract infections caused by Neisseria gonorrhoeae and soft chancre.
4  Skin and Soft Tissue Infections: boils, abscesses, cellulitis, wound infection, intra-abdominal sepsis etc.
5  Other Infections: otitis media, osteomyelitis, septicemia, peritonitis and postoperative infection etc.

Dosage and Administration:

Taken orally.For adults and children more than 12 years old, 2 packets each time, 3 times daily; and for
children between 7 to 12 years old,1.5 packets each time, 3 times daily; and for children between 1 to 7 years
old, 1 packet each time, 3 times daily; and for children between 3 months to 1 years old, 0.5 packet each time
,3 times daily; In the case of  serious infection, the dose can be doubled or be followed the doctor's advice.
Without re-examination, consecutive treatment period should be no more than 14 days.

Pharmacology and toxicology:
Mechanism of action:
Adco-Amoclav is a combination of amoxicillin and potassium clavulanate. The amoxicillin component of the
formulation exerts a bactericidal action against many strains of Gram positive and Gram-negative organisms.
The clavulanic acid component has little or no antimicrobial action. It does, however, by inactivation of
susceptible beta-lactamase protect amoxicillin from degradation by beta-lactamase enzymes produced by
penicillin resistant strains of organisms.
Antibacterial Activity 
Clavulanic acid is an irreversible inhibitor  beta-lactamases produced by Staphylococcus aureus, Escherichia
coli, Klebsiella pneumoniae, Proteus mirabilis and Proteus vulgaris , H. influenzae, N. gonorrhoeae and B.
fragilis( In-vitroactivity does not necessarily imply in-vivo efficacy). Potassium clavulanate does not inactivate
the chromosomally mediated (Sykes Type 1 Cephalosporinase) beta-lactamases produced by Acinetobacter
speciesCitrobacter species,Enterobacter,indole positive Proteus,Providencia species and Serratia marcescen.
Pharmacokinetics:
The pharmacokinetics of amoxicillin and clavulanic acid are closely allied and neither are adversely affected
by the presence of food in the stomach, and are stable in the presence of gastric acid. The oral bioavailability
of amoxicillin and potassium clavulante is approximately 90% and 75% respectively.
Peak serum levels of both occur about 1-2 hour after oral administration. Clavulanic acid has about the same
plasma elimination half-life (1 hour) as that of amoxicillin (1,3 hours). Adco-Amoclav Suspension is eliminated
primarily unchanged through the renal route (glomerularfiltration and tubular secretion). Approximately
50-78% of amoxicillin and 25-40% of clavulanic acid are excreted unchanged in urine within the first 6 hrs
after administration.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects 
Amoxicillin
Sensitivity reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity
to penicillins and in those with a history of allergy, asthma, hay fever or urticaria.The hypersensitivity reactions
reported are erythematous maculopapular rashes, urticaria, fever and joint pains. Anaphylactic shock may
occur.
Gastrointestinal 
Nausea, heartburn, vomiting and diarrhoea.Pseudomembranous colitis has been
reported.
Liver
Hepatotoxicity, hepatitis, cholestatic jaundice may occur. A moderate rise in serum glutamic oxalacetic
transaminase (SGOT) has been noted, but the significance of this finding is unknown.
Hemic and Lymphatic Systems 
Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and granulocytopenia
have been reported during therapy with Adco-Amoclav. These reactions are usually reversible on
discontinuation of therapy and are believed to be hypersensitivity phenomena.
Central Nervous System
Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioural changes, and/or dizziness have
also been reported. Depression, seizures, or hallucinations.Other A sore mouth or tongue and a black hairy
tongue have been reported.Allergic reactions which may include exfoliative dermatitis, other skin rashes,
interstitial nephritis and vasculitis, may occur. Erythema multiforme (including Stevens Johnson syndrome),
toxic episodes of necrolysis.

Storage:Store below 25°C, protected from moisture.
After reconstitution the product must be stored at 2-8°C in a refrigerator. In order to maintain stability, the
prepared suspension must under no circumstances be stored outside the fridge. The prepared suspension
should be consumed within 7 days of preparation.
Packs:Package material: 12 tablet /blist/Box
Shelf-life:24 months