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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 10.03.2022
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Augmentin 625-600 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 625). Augmentin 625-600 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 625-600 and other antibacterial drugs, Augmentin 625-600 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.
Amoxicillin (Augmentin 625) is an antibiotic in a group of drugs called penicillins. Amoxicillin (Augmentin 625) fights bacteria in the body.
Clavulanate potassium is a form of Clavulanic acid (Augmentin 625), which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.
The combination of Amoxicillin (Augmentin 625) 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 625) and clavulanate potassium may also be used for purposes not listed in this medication guide.
Augmentin 625-600, 600 mg/5 mL, does not contain the same amount of Clavulanic acid (Augmentin 625) (as the potassium salt) as any of the other suspensions of AUGMENTIN. Augmentin 625-600 contains 42.9 mg of Clavulanic acid (Augmentin 625) per 5 mL, whereas the 200 mg/5 mL suspension of AUGMENTIN contains 28.5 mg of Clavulanic acid (Augmentin 625) per 5 mL and the 400 mg/5 mL suspension contains 57 mg of Clavulanic acid (Augmentin 625) per 5 mL. Therefore, the 200 mg/5 mL and 400 mg/5 mL suspensions of AUGMENTIN should not be substituted for Augmentin 625-600, as they are not interchangeable.
Dosage
Pediatric patients 3 months and older: Based on the Amoxicillin (Augmentin 625) component (600 mg/5 mL), the recommended dose of Augmentin 625-600 is 90 mg/kg/day divided every 12 hours, administered for 10 days.
| Body Weight (kg) | Volume of Augmentin 625-600 providing 90 mg/kg/day |
| 8 | 3.0 mL twice daily |
| 12 | 4.5 mL twice daily |
| 16 | 6.0 mL twice daily |
| 20 | 7.5 mL twice daily |
| 24 | 9.0 mL twice daily |
| 28 | 10.5 mL twice daily |
| 32 | 12.0 mL twice daily |
| 36 | 13.5 mL twice daily |
Pediatric patients weighing 40 kg and more: Experience with Augmentin 625-600 (600 mg/5 mL formulation) in this group is not available.
Adults: Experience with Augmentin 625-600 (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Augmentin 625-600 (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of AUGMENTIN.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.
Directions for Mixing
Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Augmentin 625-600 (600 mg/5 mL Suspension)
| Bottle Size | Amount of Water Required for Reconstitution |
| 75 mL | 70 mL |
| 125 mL | 110 mL |
| 200 mL | 180 mL |
Each teaspoonful (5 mL) will contain 600 mg Amoxicillin (Augmentin 625) as the trihydrate and 42.9 mg of Clavulanic acid (Augmentin 625) as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist: For patients who wish to alter the taste of Augmentin 625-600, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of Augmentin 625-600. The resulting suspension is stable for 10 days under refrigeration. Other than the 5 flavors listed above, GlaxoSmithKline has not evaluated the stability of Augmentin 625-600 when mixed with other flavors distributed by FLAVORx.
Administration: To minimize the potential for gastrointestinal intolerance, Augmentin 625-600 should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Augmentin 625-600 is administered at the start of a meal.
How supplied
Augmentin 625-600, 600 mg/5 mL, for
Oral Suspension:
NDC 43598-003-69
Hypersensitivity to the Amoxicillin (Augmentin 625)/clavulanate potassium to any of the penicillins or to any of the excipients of Augmentin 625.
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 625 (Augmentin 625).
See also:
What other drugs will affect Augmentin 625?
Administration of probenecid prior to dosing results in marked increase in the mean serum concentrations of Amoxicillin (Augmentin 625). Probenecid decreases the renal tubular secretion of Amoxicillin (Augmentin 625), but does not affect Clavulanic acid (Augmentin 625) excretion. Concurrent use with Augmentin 625 may result in increased and prolonged blood levels of Amoxicillin (Augmentin 625) but not of Clavulanic acid (Augmentin 625).
When Amoxicillin (Augmentin 625) and warfarin are taken concomitantly, the INR can be altered.
Interaction of Augmentin 625 with coumarin or indandione-derivative anticoagulants, heparin, NSAIDs especially aspirin, other platelet aggregation inhibitors or thrombolytic agents may be clinically significant.
Augmentin 625 may decrease the efficacy of oestrogen-containing oral contraceptives. Patients should be warned accordingly. The simultaneous use of Amoxicillin (Augmentin 625) and an oral contraceptive might be expected to cause breakthrough bleeding or pregnancy on rare occasions because of reduced absorption owing to diarrhea, on the basis of experience with ampicillin.
The concurrent administration of allopurinol and ampicillin substantially increases the incidence of rashes in patients receiving both agents as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. There are no data on Amoxicillin (Augmentin 625)/clavulanate combination and allopurinol administered concurrently.
No information is available about the concurrent use of Augmentin 625 and alcohol. However, the ingestion of alcohol whilst being treated with some other β-lactam antibiotics has precipitated a disulfiram (Antabuse)-like reaction in some patients. Therefore, the ingestion of alcohol should be avoided during and for several days after treatment with Augmentin 625.
Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugate oestriol, oestrio-glucuronide, conjugated oestrone and oestradiol has been noted. This effect may also occur with Amoxicillin (Augmentin 625) and therefore, Augmentin 625.
The use of this antibiotic may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy.
See also:
What are the possible side effects of Augmentin 625?
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 625) is required, consideration should be given to administering the additional Amoxicillin (Augmentin 625) separately.
Hepatitis and cholestatic jaundice have been reported with the combination of Amoxicillin (Augmentin 625) and Clavulanic acid (Augmentin 625); the Clavulanic acid (Augmentin 625) component has been implicated. The events associated with Augmentin 625 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 625, the significance of these findings is unknown.
The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Augmentin 625.
Gastrointestinal: Gastritis, stomatitis, glossitis, black hairy tongue, enterocolitis and pseudomembranous colitis. If GI reactions are evident, they may be reduced by taking Augmentin 625 at the start of a meal.
Amoxicillin (Augmentin 625) 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 625 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 625. Prolongation of bleeding time and prothrombin time have also been reported less frequently.
Amoxicillin (Augmentin 625) alone or in combination with Clavulanic acid (Augmentin 625) has been associated with acute hepatic dysfunction. The incidence rate (95% confidence intervals) were 1.7 (1.1-2.7) (Amoxicillin (Augmentin 625)-Clavulanic acid (Augmentin 625)) and 0.3 (0.2-0.5)/10,000 prescriptions (Amoxicillin (Augmentin 625) 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.
Each film-coated tablet contains Amoxicillin (Augmentin 625) trihydrate equivalent to Amoxicillin (Augmentin 625) 500 mg, and potassium clavulanate equivalent to Clavulanic acid (Augmentin 625) 125 mg, respectively.
Each vial contains Amoxicillin (Augmentin 625) sodium equivalent to Amoxicillin (Augmentin 625) 1000 mg and clavulanate potassium equivalent to Clavulanic acid (Augmentin 625) 200 mg, respectively.
Augmentin 625 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 625 is an antibacterial combination consisting of the semi-synthetic antibiotic Amoxicillin (Augmentin 625) and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of Clavulanic acid (Augmentin 625)). Amoxicillin (Augmentin 625) 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 625) 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 625): Clavulanic acid (Augmentin 625) 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 625) 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.