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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 21.03.2022
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Amoxi Plus-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 (Amoxi Plus). Amoxi Plus-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 Amoxi Plus-600 and other antibacterial drugs, Amoxi Plus-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 (Amoxi Plus) is an antibiotic in a group of drugs called penicillins. Amoxicillin (Amoxi Plus) fights bacteria in the body.
Clavulanate potassium is a form of Clavulanic Acid (Amoxi Plus), which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.
The combination of Amoxicillin (Amoxi Plus) 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 (Amoxi Plus) and clavulanate potassium may also be used for purposes not listed in this medication guide.
Amoxi Plus-600, 600 mg/5 mL, does not contain the same amount of Clavulanic Acid (Amoxi Plus) (as the potassium salt) as any of the other suspensions of AUGMENTIN. Amoxi Plus-600 contains 42.9 mg of Clavulanic Acid (Amoxi Plus) per 5 mL, whereas the 200 mg/5 mL suspension of AUGMENTIN contains 28.5 mg of Clavulanic Acid (Amoxi Plus) per 5 mL and the 400 mg/5 mL suspension contains 57 mg of Clavulanic Acid (Amoxi Plus) per 5 mL. Therefore, the 200 mg/5 mL and 400 mg/5 mL suspensions of AUGMENTIN should not be substituted for Amoxi Plus-600, as they are not interchangeable.
Dosage
Pediatric patients 3 months and older: Based on the Amoxicillin (Amoxi Plus) component (600 mg/5 mL), the recommended dose of Amoxi Plus-600 is 90 mg/kg/day divided every 12 hours, administered for 10 days.
Body Weight (kg) | Volume of Amoxi Plus-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 Amoxi Plus-600 (600 mg/5 mL formulation) in this group is not available.
Adults: Experience with Amoxi Plus-600 (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Amoxi Plus-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.
Amoxi Plus-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 (Amoxi Plus) as the trihydrate and 42.9 mg of Clavulanic Acid (Amoxi Plus) as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist: For patients who wish to alter the taste of Amoxi Plus-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 Amoxi Plus-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 Amoxi Plus-600 when mixed with other flavors distributed by FLAVORx.
Administration: To minimize the potential for gastrointestinal intolerance, Amoxi Plus-600 should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxi Plus-600 is administered at the start of a meal.
How supplied
Amoxi Plus-600, 600 mg/5 mL, for
Oral Suspension:
NDC 43598-003-69
Hypersensitivity to the Amoxicillin (Amoxi Plus)/clavulanate potassium to any of the penicillins or to any of the excipients of Amoxi Plus.
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 Amoxi Plus.
See also:
What other drugs will affect Amoxi Plus?
Administration of probenecid prior to dosing results in marked increase in the mean serum concentrations of Amoxicillin (Amoxi Plus). Probenecid decreases the renal tubular secretion of Amoxicillin (Amoxi Plus), but does not affect Clavulanic Acid (Amoxi Plus) excretion. Concurrent use with Amoxi Plus may result in increased and prolonged blood levels of Amoxicillin (Amoxi Plus) but not of Clavulanic Acid (Amoxi Plus).
When Amoxicillin (Amoxi Plus) and warfarin are taken concomitantly, the INR can be altered.
Interaction of Amoxi Plus with coumarin or indandione-derivative anticoagulants, heparin, NSAIDs especially aspirin, other platelet aggregation inhibitors or thrombolytic agents may be clinically significant.
Amoxi Plus may decrease the efficacy of oestrogen-containing oral contraceptives. Patients should be warned accordingly. The simultaneous use of Amoxicillin (Amoxi Plus) 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 (Amoxi Plus)/clavulanate combination and allopurinol administered concurrently.
No information is available about the concurrent use of Amoxi Plus 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 Amoxi Plus.
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 (Amoxi Plus) and therefore, Amoxi Plus.
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 Amoxi Plus?
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 (Amoxi Plus) is required, consideration should be given to administering the additional Amoxicillin (Amoxi Plus) separately.
Hepatitis and cholestatic jaundice have been reported with the combination of Amoxicillin (Amoxi Plus) and Clavulanic Acid (Amoxi Plus); the Clavulanic Acid (Amoxi Plus) component has been implicated. The events associated with Amoxi Plus 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 Amoxi Plus, the significance of these findings is unknown.
The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Amoxi Plus.
Gastrointestinal: Gastritis, stomatitis, glossitis, black hairy tongue, enterocolitis and pseudomembranous colitis. If GI reactions are evident, they may be reduced by taking Amoxi Plus at the start of a meal.
Amoxicillin (Amoxi Plus) 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, Amoxi Plus 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 Amoxi Plus. Prolongation of bleeding time and prothrombin time have also been reported less frequently.
Amoxicillin (Amoxi Plus) alone or in combination with Clavulanic Acid (Amoxi Plus) has been associated with acute hepatic dysfunction. The incidence rate (95% confidence intervals) were 1.7 (1.1-2.7) (Amoxicillin (Amoxi Plus)-Clavulanic Acid (Amoxi Plus)) and 0.3 (0.2-0.5)/10,000 prescriptions (Amoxicillin (Amoxi Plus) 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 (Amoxi Plus) trihydrate equivalent to Amoxicillin (Amoxi Plus) 500 mg, and potassium clavulanate equivalent to Clavulanic Acid (Amoxi Plus) 125 mg, respectively.
Each vial contains Amoxicillin (Amoxi Plus) sodium equivalent to Amoxicillin (Amoxi Plus) 1000 mg and clavulanate potassium equivalent to Clavulanic Acid (Amoxi Plus) 200 mg, respectively.
Amoxi Plus 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.
Amoxi Plus is an antibacterial combination consisting of the semi-synthetic antibiotic Amoxicillin (Amoxi Plus) and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of Clavulanic Acid (Amoxi Plus)). Amoxicillin (Amoxi Plus) 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 (Amoxi Plus) 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 (Amoxi Plus): Clavulanic Acid (Amoxi Plus) 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 (Amoxi Plus) 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.