What is Augmentin 500 mg/125 mg?
Amoxicillin (Augmentin 500 mg/125 mg) is an antibiotic in a group of drugs called penicillins. Amoxicillin (Augmentin 500 mg/125 mg) fights bacteria in the body.
Clavulanate potassium is a form of Clavulanic Acid (Augmentin 500 mg/125 mg), which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.
The combination of Amoxicillin (Augmentin 500 mg/125 mg) and clavulanate potassium is used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.
Amoxicillin (Augmentin 500 mg/125 mg) and clavulanate potassium may also be used for purposes not listed in this medication guide.
Augmentin 500 mg/125 mg indications
Augmentin 500 mg/125 mg-600 is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors:
- antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
- age ≤ 2 years
- daycare attendance
NOTE: Acute otitis media due to S. pneumoniae alone can be treated with Amoxicillin (Augmentin 500 mg/125 mg). Augmentin 500 mg/125 mg-600 is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL.
Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤ 2 mcg/mL) and the β-lactamase–producing organisms listed above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Augmentin 500 mg/125 mg-600 and other antibacterial drugs, Augmentin 500 mg/125 mg-600 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Augmentin 500 mg/125 mg description
Each film-coated tablet contains Amoxicillin (Augmentin 500 mg/125 mg) trihydrate equivalent to Amoxicillin (Augmentin 500 mg/125 mg) 500 mg, and potassium clavulanate equivalent to Clavulanic Acid (Augmentin 500 mg/125 mg) 125 mg, respectively.
Each vial contains Amoxicillin (Augmentin 500 mg/125 mg) sodium equivalent to Amoxicillin (Augmentin 500 mg/125 mg) 1000 mg and clavulanate potassium equivalent to Clavulanic Acid (Augmentin 500 mg/125 mg) 200 mg, respectively.
Augmentin 500 mg/125 mg tablets also contains the following excipients: Microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, povidone (K30), eudragit E 100, isopropyl alcohol, magnesium stearate, white opadryl 03B58965, PEG400, methylene chloride.
Augmentin 500 mg/125 mg is an antibacterial combination consisting of the semi-synthetic antibiotic Amoxicillin (Augmentin 500 mg/125 mg) and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of Clavulanic Acid (Augmentin 500 mg/125 mg)). Amoxicillin (Augmentin 500 mg/125 mg) is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Its molecular formula is C16H19N305S3H20 and the molecular weight is 419.46. Chemically, Amoxicillin (Augmentin 500 mg/125 mg) is (2S, 5R, 6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl) acetamido]-3, 3-dimethyl-7-oxo-4-1-azabicyclo[3.2.1] heptane-2-carboxylic acid trihydrate.
Amoxicillin (Augmentin 500 mg/125 mg): Clavulanic Acid (Augmentin 500 mg/125 mg) is produced by the fermentation of Streptomyces clavuligerus. It 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. Clavulanic Acid (Augmentin 500 mg/125 mg) is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KN05 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R, 5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate.
Augmentin 500 mg/125 mg dosage
Tablet: Tablets should be taken immediately before a meal.
General Information: For infections caused by Amoxicillin (Augmentin 500 mg/125 mg)-sensitive organisms, the dosage is that approved for Amoxicillin (Augmentin 500 mg/125 mg) as the Clavulanic Acid (Augmentin 500 mg/125 mg) component does not contribute to the therapeutic effect.
Adults: 1 or 2 Augmentin 500 mg/125 mg 375 mg tab 8 hourly or 1 Augmentin 500 mg/125 mg 625 mg tab 8 hourly for more severe infections and infections of the respiratory tract.
For Amoxicillin (Augmentin 500 mg/125 mg)-resistant organisms, the dosage of Augmentin 500 mg/125 mg tablets are as follows:
Since both Augmentin 500 mg/125 mg 375 mg and 625 mg contain the same amount of Clavulanic Acid (Augmentin 500 mg/125 mg) (125 mg, as the potassium salt), 2 Augmentin 500 mg/125 mg 375 mg are not equivalent to 1 Augmentin 500 mg/125 mg 625 mg. Therefore, 2 Augmentin 500 mg/125 mg 375 mg should not be substituted for 1 Augmentin 500 mg/125 mg 625 mg for treatment of more severe infections.
Renal Failure: Both Amoxicillin (Augmentin 500 mg/125 mg) and Clavulanic Acid (Augmentin 500 mg/125 mg) are excreted by the kidneys and the serum t½ of each increases in patients with renal failure. Therefore, the dose may need to be reduced or the interval extended. The following schedule in the dosage is proposed:
Haemodialysis decreases serum concentrations of both Amoxicillin (Augmentin 500 mg/125 mg) and Clavulanic Acid (Augmentin 500 mg/125 mg) and an additional dose should be administered at the end of dialysis.
Oral Suspension:
Suspensions should be taken immediately before a meal.Reconstitution: For reconstitution to 30 mL, add water till the mark, invert the bottle and shake well until all the powder is dispersed.
Children: 25-50 mg/kg/day of the 4 parts Amoxicillin (Augmentin 500 mg/125 mg), 1 part Clavulanic Acid (Augmentin 500 mg/125 mg) preparations (which corresponds to a daily dosage of the equivalent of Amoxicillin (Augmentin 500 mg/125 mg) 20-40 mg/kg and Clavulanic Acid (Augmentin 500 mg/125 mg) 5-10 mg/kg) to be taken in divided doses every 8 hrs at the start of a meal.
Dosage Guide:
To correspond to a dosage of 25-50 mg/kg/day.
To correspond to a dosage of 50 mg/kg/day.
IV/IM: Augmentin 500 mg/125 mg may be administered by the IV routes.
Augmentin 500 mg/125 mg is administered by IM or slow IV injection in doses of 500 mg every 8 hrs.
Severe Infections: 1 g every 6 hrs by slow IV injection over 3-4 min or by infusion over 30-60 min.
Children ≤10 years: 50-100 mg/kg body weight daily by injection in divided doses.
Augmentin 500 mg/125 mg interactions
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What other drugs will affect Augmentin 500 mg/125 mg?
Probenecid decreases the renal excretion of Amoxicillin (Augmentin 500 mg/125 mg). Concurrent use with Augmentin 500 mg/125 mg may result in increased and prolonged blood levels of Amoxicillin (Augmentin 500 mg/125 mg).
The concurrent administration of allopurinol and ampicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. But it is not known whether this potentiation of ampicillin rash is due to allopurinol or the hyperuricemia present in these patients.
Augmentin 500 mg/125 mg should not be co-administrated with disulfiram.
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Augmentin 500 mg/125 mg. Thus, Augmentin 500 mg/125 mg should be used with care in patients on anticoagulation therapy.
Augmentin 500 mg/125 mg may reduce the effect of oral contraceptives and the caution should be given to patients.
Laboratory Test Interactions: Augmentin 500 mg/125 mg results in high urine concentration. High urine concentration of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest, Benedict or Fehling's solution.
Augmentin 500 mg/125 mg side effects
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What are the possible side effects of Augmentin 500 mg/125 mg?
The most frequently reported adverse effects were diarrhoea, nausea, vomiting, abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness and hot flushes. The incidence and severity of adverse effects, particularly nausea and diarrhoea, increased with the higher recommended dose and can be minimised by administering the agent at the start of a meal. In addition, as these symptoms are especially related to the potassium clavulanate component, where these GI symptoms occur and a higher concentration of Amoxicillin (Augmentin 500 mg/125 mg) is required, consideration should be given to administering the additional Amoxicillin (Augmentin 500 mg/125 mg) separately.
Hepatitis and cholestatic jaundice have been reported with the combination of Amoxicillin (Augmentin 500 mg/125 mg) and Clavulanic Acid (Augmentin 500 mg/125 mg); the Clavulanic Acid (Augmentin 500 mg/125 mg) component has been implicated. The events associated with Augmentin 500 mg/125 mg may be severe and occur predominantly in adult or elderly patients. Signs and symptoms usually occur during or shortly after treatment, but in some cases may not become apparent until several weeks after treatment has ceased. The hepatic events are usually reversible. However, in extremely rare circumstances, death has been reported. These have almost always been cases associated with serious underlying disease or concomitant medication.
A moderate rise in aspartate transaminase and/or alanine transaminase has been noted in patients treated with Augmentin 500 mg/125 mg, the significance of these findings is unknown.
The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Augmentin 500 mg/125 mg.
Gastrointestinal: Gastritis, stomatitis, glossitis, black hairy tongue, enterocolitis and pseudomembranous colitis. If GI reactions are evident, they may be reduced by taking Augmentin 500 mg/125 mg at the start of a meal.
Amoxicillin (Augmentin 500 mg/125 mg) causes hypersensitivity reactions similar to those induced by penicillin G and ampicillin, including rashes and fever. The incidence of these reaction is probably no higher than with other penicillins. 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 uticaria. Hypersensitivity reactions include skin rashes, urticaria, erythema multiforme, rare cases of Stevens-Johnson syndrome and less frequently exfoliative dermatitis and toxic epidermal necrolysis have been reported. Whenever such reactions occur, Augmentin 500 mg/125 mg should be discontinued. Serious and occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema can occur with oral penicillin.
Haematopoietic and Lymphatic: Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in patients treated with Augmentin 500 mg/125 mg. Prolongation of bleeding time and prothrombin time have also been reported less frequently.
Amoxicillin (Augmentin 500 mg/125 mg) alone or in combination with Clavulanic Acid (Augmentin 500 mg/125 mg) has been associated with acute hepatic dysfunction. The incidence rate (95% confidence intervals) were 1.7 (1.1-2.7) (Amoxicillin (Augmentin 500 mg/125 mg)-Clavulanic Acid (Augmentin 500 mg/125 mg)) and 0.3 (0.2-0.5)/10,000 prescriptions (Amoxicillin (Augmentin 500 mg/125 mg) alone). Risks were increased in patients receiving >1 course and in older recipients.
Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioural changes and/or dizziness have also been reported. Depression, seizures or hallucinations.
Augmentin 500 mg/125 mg contraindications
Hypersensitivity to the Amoxicillin (Augmentin 500 mg/125 mg)/clavulanate potassium to any of the penicillins or to any of the excipients of Augmentin 500 mg/125 mg.
History of a severe immediate hypersensitivity reaction (eg, anaphylaxis) to another β-lactam agent (eg, a cephalosporin, carbapenem or monobactam).
History of cholestatic jaundice/hepatic dysfunction due to Augmentin 500 mg/125 mg.
Active ingredient matches for Augmentin 500 mg/125 mg:
Amoxicillin/Clavulanic Acid in Austria, Bulgaria, Hungary.
List of Augmentin 500 mg/125 mg substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Augmentin-Extra (Hungary) | |
| Augmentine (Iceland, Spain) | |
| Injectable; Injection; Amoxicillin Trihydrate 1000 mg; Clavulanate Potassium 200 mg (Gsk) | |
| Injectable; Injection; Amoxicillin Trihydrate 500 mg; Clavulanate Potassium 100 mg (Gsk) | |
| Tablet, Chewable; Oral; Amoxicillin Trihydrate 125 mg; Clavulanate Potassium 31.25 mg (Gsk) | |
| Tablet, Chewable; Oral; Amoxicillin Trihydrate 200 mg; Clavulanate Potassium 28.5 mg (Gsk) | |
| Tablet, Chewable; Oral; Amoxicillin Trihydrate 250 mg; Clavulanate Potassium 62.5 mg (Gsk) | |
| Tablet, Chewable; Oral; Amoxicillin Trihydrate 400 mg; Clavulanate Potassium 57 mg (Gsk) | |
| Tablet; Oral; Amoxicillin Trihydrate 250 mg; Clavulanate Potassium 125 mg (Gsk) | |
| Tablet; Oral; Amoxicillin Trihydrate 500 mg; Clavulanate Potassium 125 mg (Gsk) | |
| Tablet; Oral; Amoxicillin Trihydrate 875 mg; Clavulanate Potassium 125 mg (Gsk) | |
| Augmentine D.A.C. (Iceland) | |
| Augmentine Plus (Spain) | |
| Tablet, Prolonged Release; Oral; Amoxicillin Trihydrate 1000 mg; Clavulanic Acid / Clavulanate Potassium 62.5 mg | |
| AugmentinMR Bid (Costa Rica, El Salvador, Guatemala, Honduras, Panama) | |
| Augmex (Myanmar, Peru, Vietnam) | |
| Augmex 625 (Vietnam) | |
| Augmex Duo (Vietnam) | |
| Augmexx (India) | |
| Augmexx Amoxicillin + Clavulanic Acid150mg VIAL / 1 (VHB (Critical Care)) | $ 0.43 |
| Augmexx Amoxicillin + ClavulanicAcid300mg VIAL / 1 (VHB (Critical Care)) | $ 0.72 |
| Augmexx Amoxicillin + ClavulanicAcid600mg VIAL / 1 (VHB (Critical Care)) | $ 1.12 |
| Augmexx Amoxicillin + ClavulanicAcid1200mg VIAL / 1 (VHB (Critical Care)) | $ 2.17 |
| 1's (VHB (Critical Care)) | $ 2.17 |
| Augmexx Amoxicillin + Clavulanic Acid 150mg VIAL / 1 (VHB (Critical Care)) | $ 0.43 |
| Augmexx Amoxicillin + ClavulanicAcid 300mg VIAL / 1 (VHB (Critical Care)) | $ 0.72 |
| Augmexx Amoxicillin + ClavulanicAcid 600mg VIAL / 1 (VHB (Critical Care)) | $ 1.12 |
| Augmexx Amoxicillin + ClavulanicAcid 1200mg VIAL / 1 (VHB (Critical Care)) | $ 2.17 |
| AUGMEXX 1000MG/200MG INJECTION 1 vial / 1 injection each (VHB (Critical Care)) | $ 1.64 |
| AUGMEXX 125MG/25MG INJECTION 1 vial / 1 injection each (VHB (Critical Care)) | $ 0.48 |
| AUGMEXX 250MG/50MG INJECTION 1 vial / 1 injection each (VHB (Critical Care)) | $ 0.83 |
| AUGMEXX 500MG/100MG INJECTION 1 vial / 1 injection each (VHB (Critical Care)) | $ 1.19 |
| Augmexx 1000 mg/200 mg Injection (VHB (Critical Care)) | $ 1.64 |
| Augmexx 125 mg/25 mg Injection (VHB (Critical Care)) | $ 0.48 |
| Augmexx 250 mg/50 mg Injection (VHB (Critical Care)) | $ 0.83 |
| Augmexx 500 mg/100 mg Injection (VHB (Critical Care)) | $ 1.19 |
| Augmoks (Bahrain, Oman) | |
| AUGNIC (India) | |
| 100's (Siomond) | $ 4.82 |
| 30ml (Siomond) | $ 0.92 |
| Augnic Amoxicillin 250 mg, Clavulanicacid 125 mg. DT-TAB / 100 (Siomond) | $ 3.61 |
| Augnic Amoxicillin 500 mg, Clavulanicacid 125 mg. TAB / 100 (Siomond) | $ 4.82 |
| Augnic Amoxicillin 200 mg, Clavulanicacid 28.5 mg/5 mL. SUSP / 30ml (Siomond) | $ 0.92 |
| AUGNIC 200MG/28.5MG DRY SYRUP 1 bottle / 30 ML dry syrup each (Siomond) | $ 0.92 |
| AUGNIC dispertab 10's (Siomond) | $ 3.61 |
| AUGNIC tab 10's (Siomond) | $ 4.82 |
See 7042 substitutes for Augmentin 500 mg/125 mg | |
References
- DailyMed. "AMOXICILLIN; CLAVULANATE POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "CLAVULANIC ACID". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- PubChem. "amoxicillin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
