Antibacterial Drugs

  • Chemical Composition

    Amoxicillin (As trihydate) 600 mg - Clavulanic Acid (as potassium ) 42.9 / 5 ml

  • Packing

    60ml-75ml-125ml /Oral Suspension

  • Medical Id


  • License Number


  • License date


Excipients Aerosil ( Colloidal silicon dioxide ) Silicon dioxide , Sodium carboxymethylcellulose , Aspartame , Xanthan gum ,Strawberry cream flavor .
Mechanism Of Action This drug is an oral antibacterial combination consisting of amoxicillin and the beta lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is a semisynthetic antibiotic with in vitro bactericidal activity against Gram-positive and Gram-negative bacteria. Clavulanic acid is a beta-lactam, structurally related to the penicillins, which possesses the ability to inactivate some beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins.
INDICATIONS For ES-600 only: • it is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae, 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 • Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. The strength ES-600 is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC (Minimum Inhibitory Concentration) ≥ 4 mcg/mL. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy, to prevent increasing the risk of the development of drug resistant bacteria. When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, this drug should not be used.
CONTRAINDICATIONS • In patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens - Johnson syndrome) to amoxicillin, clavulanate or to other beta lactam antibacterial drugs (e.g., penicillins and cephalosporins). • In patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with this drug.
Side EFFECTS For ES-600: The most commonly reported side effects were contact dermatitis (diaper rash), diarrhea, vomiting, moniliasis and rash. The most common adverse experiences leading to withdrawal that were of probable or suspected relationship to the drug were diarrhea and vomiting.
WARNINGS • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including this drug. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, it should be discontinued and appropriate therapy instituted. • Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of this drug. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment. • Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including this drug, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. These infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis. • A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, it should not be administered to these patients. • The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfection occurs, the drug should be discontinued and appropriate therapy instituted. • The chewable tablets and the Powder for Oral suspension should not be taken by patients with Phenylketonuria because both contain aspartame which contains phenylalanine. Pediatric Use: The safety and effectiveness of the Powder for Oral Suspension and chewable tablets have been established in pediatric patients. Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of this drug should be modified in pediatric patients aged <12 weeks (<3 months). Geriatric Use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Information For Patients • Patients should be counseled that antibacterial drugs, including this drug, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). • Patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: decrease the effectiveness of the treatment, and increase the likelihood that bacteria will develop resistance and will not be treatable by this drug or other antibacterial drugs in the future. • Patients should be counseled that diarrhea is a common problem caused by anti-bacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with anti-bacterials, patients can develop watery and bloody stools even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact the physician.
DRUG INTERACTIONS Probenecid: Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use may result in increased and prolonged blood concentrations of amoxicillin. Coadministration of probenecid is not recommended. Oral Anticoagulants: Abnormal prolongation of prothrombin time (increased [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with this drug. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. Allopurinol: The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. Oral Contraceptives: This drug may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. Effects on Laboratory Tests: High urine concentrations of amoxicillin 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 this drug, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
Pregnancy And lactations Category B: There are no adequate and well controlled studies in pregnant women; therefore it should be used during pregnancy only if clearly needed. Nursing Mothers: Amoxicillin has been shown to be excreted in human milk. Use of this drug by nursing mothers may lead to sensitization of infants. Caution should be exercised when it is administered to a nursing woman.
Dosage And Administration It does not contain the same amount of clavulanic acid as any of the other suspensions of THIS DRUG. Therefore, the 200 mg/5 mL and 400 mg/5 mL suspensions should not be substituted for ES-600 suspension. Pediatric patients 3 months and older: the recommended dose is 90 mg/kg/day divided every 12 hours, administered for 10 days Body Weight (kg) Volume 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 suspension ES-600 in this group is not available. Adults: Adults who have difficulty swallowing should not be given ES-600 in place of the 500-mg or 875-mg tablet of THIS DRUG. Directions for Mixing Oral Suspension: Prepare the 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 (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously (in case there is no volume measuring tool add water up to the bottle neck, and shake well(. When first reconstituted, allow to stand for 5 minutes to ensure full dispersion. Once reconstituted, the suspension must be stored in a refrigerator (at 2°C to 8°C) and used within 10 days. Shake well before taking each dose. Directions for Mixing Oral Suspension 600 mg shown in the following table : Bottle Size Amount of Water Required for Reconstitution 60 ml 40 ml 75 ml 65 ml 125 ml 110 ml
OVERDOSE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with this drug. Crystalluria, in some cases leading to renal failure, has also been reported after overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin/clavulanate potassium crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin/clavulanate potassium. Amoxicillin/clavulanate potassium may be removed from circulation by hemodialysis.
Storage Conditions Store at room temperature, below 25º C, away from moisture , light and heat. Store reconstituted suspension under refrigeration 2-8 ° c . Discard unused suspension after 7 days. Keep out of reach of children Prescription only medicine