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Composition: HibioticN®600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the ß-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Each 5 mL of reconstituted 600 mg/42.9 mg per 5 mL oral suspension of HibioticN®600 contains 0.23 mEq potassium. Inactive ingredient : Sodium citrate tribasic anhydrous, citric acid anhydrous , colloidal silicon dioxide , microcrystalline cellulose , dimethicone 350 , lemon flavor , sucrose .

Indications And Usage: HibioticN®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 ß-lactamase–producing strains), or M. catarrhalis (including ß-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. HibioticN®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 ß-lactamase–producing organisms listed above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of HibioticN®600 and other antibacterial drugs, HibioticN®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.

Contraindications: HibioticN®600 is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Hibiotic®

Adverse Reactions: ADVERSE REACTIONS HibioticN®600 is generally well tolerated. The majority of side effects observed in pediatric clinical trials of acute otitis media were either mild or moderate, and transient in nature; 4.4% of patients discontinued therapy because of drug-related side effects. The most commonly reported side effects with probable or suspected relationship to HibioticN®600 were contact dermatitis, i.e., diaper rash (3.5%), diarrhea (2.9%), vomiting (2.2%), moniliasis (1.4%), and rash (1.1%). The most common adverse experiences leading to withdrawal that were of probable or suspected relationship to HibioticN®600 were diarrhea (2.5%) and vomiting (1.4%). The following adverse reactions have been reported for ampicillin-class antibiotics: Gastrointestinal: Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. Hypersensitivity Reactions: Skin rashes, pruritus, urticaria, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme (rarely Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin. Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibiotics, but the significance of these findings is unknown. Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been infrequently reported with Hibiotic . It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications. Renal: Interstitial nephritis and hematuria have been reported rarely. Crystalluria has also been reported . Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, 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 less than 1% of the patients treated with Hibiotic . There have been reports of increased prothrombin time in patients receiving Hibiotic and anticoagulant therapy concomitantly. Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely. Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Dosage & Administration: HibioticN®600 Powder for Oral Suspension, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of Hibiotic. HibioticN®600 Powder for Oral Suspension contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of Hibiotic contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of Hibiotic should not be substituted for HibioticN®600 Powder for Oral Suspension as they are not interchangeable. Dosage: Pediatric patients 3 months and older: Based on the amoxicillin component (600 mg/5 mL), the recommended dose of HibioticN®600 is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).Body Weight (kg)Volume of HibioticN®600 providing 90 mg/kg/day83.0 mL twice daily124.5 mL twice daily166.0 mL twice daily207.5 mL twice daily249.0 mL twice daily2810.5 mL twice daily3212.0 mL twice daily3613.5 mL twice dailyPediatric patients weighing 40 kg and more: Experience with HibioticN®600 (600 mg/5 mL formulation) in this group is not available. Adults: Experience with HibioticN®600 (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given HibioticN®600 (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of Hibiotic. Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. Administration: To minimize the potential for gastrointestinal intolerance, HibioticN®600 Powder for Oral Suspension should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when HibioticN®600 Powder for Oral Suspension is administered at the start of a meal. Note: SHAKE ORAL SUSPENSION WELL BEFORE USING.

Drug Interactions: Drug Interactions : Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with HibioticN®600 Powder for Oral Suspension may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid cannot be recommended. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with HibioticN®600 Powder for Oral Suspension and allopurinol administered concurrently. In common with other broad-spectrum antibiotics, amoxicillin/clavulanate may reduce the efficacy of oral contraceptives. Drug/Laboratory Test Interactions: Oral administration of Hibiotic will result in high urine concentrations of amoxicillin. High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin and therefore HibioticN®600 Powder for Oral Suspension, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX®) be used. Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with amoxicillin and therefore HibioticN®600 Powder for Oral Suspension.

How Supplied: HibioticN®600 mg Powder for oral suspension : bottle of 80 ml after reconstitution with distilled water

Clinical Pharmacology In Adults: The pharmacokinetics of amoxicillin and clavulanate were determined in pediatric patients, 8 months to 11 years, given HibioticN®600 Powder for Oral Suspension at an amoxicillin dose of 45 mg/kg q12h with a snack or meal. The mean plasma amoxicillin and clavulanate pharmacokinetic parameter values are listed in the following table. Table 1. Mean (±SD) Plasma Amoxicillin and Clavulanate Pharmacokinetic Parameter Values Following Administration of 45 mg/kg of HibioticN®600 Powder for Oral Suspension Every 12 Hours to Pediatric PatientsPARAMETER*AMOXICILLIN Arithmetic mean ± standard deviation, except Tmax values which are medians (ranges).CLAVULANATE*Cmax (mcg/mL)15.7 ± 7.71.7 ± 0.9Tmax (hr)2.0 (1.0 - 4.0)1.1 (1.0 - 4.0)AUC0-t (mcg⋅hr/mL)59.8 ± 20.04.0 ± 1.9T1/2 (hr)1.4 ± 0.31.1 ± 0.3CL/F (L/hr/kg)0.9 ± 0.41.1 ± 1.1The effect of food on the oral absorption of HibioticN®600 Powder for Oral Suspension has not been studied. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of 10 mL of 250 mg/5 mL suspension of Hibiotic. Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid. Neither component in HibioticN®600 Powder for Oral Suspension is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. Oral administration of a single dose of HibioticN®600 Powder for Oral Suspension at 45 mg/kg (based on the amoxicillin component) to pediatric patients, 9 months to 8 years, yielded the following pharmacokinetic data for amoxicillin in plasma and middle ear fluid (MEF). Table 2. Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Administration of 45 mg/kg of HibioticN®600 Powder for Oral Suspension to Pediatric PatientsTimepointAmoxicillin concentration in plasma (mcg/mL)Amoxicillin concentration in MEF (mcg/mL)1 hourmean   median range7.7 9.3 1.5 - 14.0 (n = 5)3.2 3.5 0.2 - 5.5 (n = 4)2 hourmean  median range15.7 13.0 11.0 - 25.0 ( n= 7)3.3 2.4 1.9 - 6 (n = 5)3 hourmean median range13.0 12.0 5.5 - 21.0 (n = 5)5.8 6.5 3.9 - 7.4 (n = 5)Dose administered immediately prior to eating. Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues. Microbiology Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by ß-lactamases, and therefore, its spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a ß-lactam, structurally related to penicillin, which possesses the ability to inactivate a wide range of ß-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid-mediated ß-lactamases frequently found responsible for transferred drug resistance. The clavulanic acid component of HibioticN®600 Powder for Oral Suspension protects amoxicillin from degradation by ß-lactamase enzymes and effectively extends the antibiotic spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other ß-lactam antibiotics. Thus, HibioticN®600 Powder for Oral Suspension possesses the distinctive properties of a broad-spectrum antibiotic and a ß-lactamase inhibitor. Amoxicillin/clavulanic acid has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Aerobic Gram-Positive Microorganisms: Streptococcus pneumoniae (including isolates with penicillin MICs ≤ 2 mcg/mL) Aerobic Gram-Negative Microorganisms: Haemophilus influenzae (including ß-lactamase–producing isolates) Moraxella catarrhalis (including ß-lactamase–producing isolates) The following in vitro data are available, but their clinical significance is unknown. At least 90% of the following microorganisms exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the susceptible breakpoint for amoxicillin/clavulanic acid. However, the safety and efficacy of amoxicillin/clavulanic acid in treating infections due to these microorganisms have not been establi