| Generic Name |
Amoxicillin-Clavulanic Acid Oral Suspension |
| Strength |
228.5mg/5ml; 457mg/5ml |
| Packing |
1 bottle/box |
| Origin |
China |
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Product name:
Amoxicillin-Clavulanic Acid Oral Suspension
Character:
This product is a white powder. It can be prepared with water as an oral, sugar-free suspension with strawberry flavor.
Indications:
Amoxicillin potassium clavulanate dry suspension, indicated for the short-term treatment of infection suspected to be caused by β-lactamase-producing amoxicillin-resistant bacteria. Amoxicillin alone should be considered in other cases. Upper respiratory tract infections (including ear, nose and throat) : sinusitis, otitis media, recurrent tonsillitis. These infections are usually caused by Streptococcus pneumoniae, Haemophilus influenzae *. Caused by Moraxella catarrhal * and Streptococcus pyogenes. Lower respiratory tract infection: acute onset of chronic bronchitis (especially severe bronchitis), bronchopneumonia. These infections are usually caused by Streptococcus pneumoniae, Haemophilus influenzae *, and Moraxella kataxella *. Urinary infections: cystitis (especially recurrent or complex infections, but not prostatitis). These infections are usually caused by Enterobacteriaceae *(mainly Escherichia coli *), Staphylococcus saprophyticus, and Enterococcus *. Skin and soft tissue infections: cellulitis, animal bites, severe gum abscess with maxillofacial cellulitis. These infections are usually caused by Staphylococcus aureus *, Streptococcus pyogenes *, and Bacteroides *. * Some strains of these genera produce beta-lactamase and are therefore not sensitive to amoxicillin alone. This product can be used for the treatment of amoxicillin sensitive bacteria and β-lactamase sensitive bacteria caused by mixed infections. These infections are treated without the addition of other anti-beta-lactamase antibiotics.
Adverse reactions:
Data from large-scale clinical studies have been used to determine the frequency of adverse events ranging from very common to rare. The incidence of all other adverse events (e.g., incidence < 1 in 10,000 adverse events) are based on post-marketing data and are usually reported rates rather than actual incidence.
Incidence is defined as:
Very common 1/10),
Common (> 1/100 and < 1/10),
Not common (> 1/1000 and < 1/100),
Rare (> 1/10,000 and < 1/1000),
Very rare 1/10,000).
Infections and invasive diseases
Common: mucocutaneous candidiasis.
Blood and lymphatic system disorders
Rare: reversible leukopenia (including neutropenia) and thrombocytopenia.
Very rare: reversible agranulocytosis and hemolytic anemia, prolonged bleeding time and prothrombin time (see Precautions).
Immune system disorder
Very rare: angioedema, anaphylaxis. Seropathic syndrome, allergic vasculitis.
Nervous system disorder
Less common: dizziness, headache.
Very rare: reversible excitement and convulsions. Convulsions can occur in patients with impaired kidney function or in those using high doses.
Gastrointestinal reaction
Grown man
Very common: diarrhea.
Common: nausea, vomiting.
Children
Common: Diarrhea, nausea, vomiting.
All patients
Nausea is more common at higher doses. If gastrointestinal adverse reactions occur orally, this product can be taken with meals to reduce symptoms.
Less common: indigestion.
Very rare: Antibiotic associated colitis (including pseudomembranous colitis and hemorrhagic colitis).
Black hairy tongue
Discoloration of the tooth surface is very rare in children. Good oral hygiene can prevent discoloration and brushing can remove discoloration of the tooth surface.
Hepatobiliary abnormality
Uncommon: Patients may have moderate AST and/or ALT changes on beta-lactam antibiotics, the significance of which has not been determined.
Very rare: hepatitis and cholestatic jaundice. However, it has also been reported in patients taking other penicillins or cephalosporins.
Hepatic adverse events occur more often in men or elderly patients and may be related to prolonged medication. These liver adverse reactions are rare in children.
Signs and symptoms of adverse reactions may appear during or shortly after the end of treatment, but sometimes several weeks after discontinuation. Changes in liver function are usually reversible. Liver adverse events can be more serious but rarely cause death in patients who already have a serious underlying condition or are taking medications that affect liver function.
Skin and subcutaneous tissue disorders
Less common: rash, itching, and hives.
Rare: Polytypic erythema.
Very rare: Stevens-Johnson syndrome, toxic epidermal melt necrosis, bulloid exfoliative dermatitis, and acute generalized exfoliative impetigo (AGEP).
At the onset of any of the above symptoms, the drug should be stopped immediately.
Kidney and urinary tract abnormalities
Very rare: interstitial nephritis, crystalluria (see Drug overdose).
Vaginal itching, pain and abnormal discharge may occur.
Pharmacology and toxicology:
Bacterial resistance is mainly due to the production of beta-lactamase enzymes, which destroy antibiotics before they can be used on pathogenic bacteria.
Amoxicillin is a semi-synthetic broad-spectrum antibiotic that acts on many gram-positive and gram-negative bacteria. However, beta-lactamase reduces the effect of amoxicillin, so the bacteria producing beta-lactamase are not included in the bacterial spectrum in which amoxicillin acts alone.
Clavulanic acid is a β-lactam, similar in structure to penicillin, and has an inhibitory effect on penicillin-resistant and cephalosporin common β-lactam enzymes present in microorganisms. In particular, clavulanic acid has a strong inhibitory effect on β-lactamase, which is clinically important and mediated by plasmids and can cause cross-resistance. However, the inhibitory effect on chromosome mediated β-lactamase type 1 was weak.
The presence of clavulanic acid can protect amoxicillin from β-lactamase degradation, thus expanding the antibacterial spectrum of amoxicillin. These include many bacteria that are normally resistant to amoxicillin and other penicillins and cephalosporins. Therefore, this product has significant broad-spectrum antibacterial action, and is also a β-lactamase inhibitor.
This product has effects on the following bacteria:
Gram-positive bacteria:
Aerobic bacteria: , Corynebacterium, Enterococcus faecalis *, Enterococcus faecium *, Listeria monocytogenes, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus virescens, Staphylococcus aureus *, coagulase negative Staphylococcus *.
Anaerobic bacteria: Clostridium, peptococcus, peptostreptococcus.
Gram-negative bacteria:
Aerobic bacteria: Bordetella pertussis, Brucella, Escherichia Coli *, Haemophilus influenzae *, Klebsiella *, Moraxella catarrata *(Catarrhamia), Neisseria gonorrhoea *, Neisseria meningitidis *, Pasteurella haematoseptica, Proteus mirabilis *, Proteus vulgaris *, Salmonella *, Shigella *, Pasteurella multocida.
Anaerobic bacteria: Bacteroides *(including Bacteroides fragilis).
* : Some strains of this genus produce beta-lactamase and are therefore not sensitive to amoxicillin alone.
Storage:
Store in a dry place below 25ºC, sealed.
Once the product is prepared, it should be refrigerated in the refrigerator (2 ~ 8ºC). The prepared product should be taken within 7 days. If there is any remaining, please discard it.
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