amoxicillin and clavulanate potassium

(redirected from Augmentin ES-600)

amoxicillin and clavulanate potassium

Apo-Amoxi-Clav (CA), Augmentin, Augmentin-Duo (UK), Augmentin XR, Clavulin (CA), Novo-Clavamoxin (CA)

Pharmacologic class: Aminopenicillin

Therapeutic class: Anti-infective

Pregnancy risk category B

Action

Amoxicillin inhibits transpeptidase, preventing cross-linking of bacterial cell wall and leading to cell death. Addition of clavulanate (a beta-lactam) increases drug's resistance to beta-lactamase (an enzyme produced by bacteria that may inactivate amoxicillin).

Availability

Oral suspension: 125 mg amoxicillin with 31.25 mg clavulanic acid/5 ml, 200 mg amoxicillin with 28.5 mg clavulanic acid/5 ml, 250 mg amoxicillin with 62.5 mg clavulanic acid/5 ml, 400 mg amoxicillin with 57 mg clavulanic acid/5 ml, 600 mg amoxicillin with 42.9 mg clavulanic acid/5 ml

Tablets (chewable): 200 mg amoxicillin with 28.5 mg clavulanate, 400 mg amoxicillin with 57 mg clavulanate

Tablets (extended-release): 1,000 mg amoxicillin with 62.5 mg clavulanate

Tablets (film-coated): 250 mg amoxicillin with 125 mg clavulanate, 500 mg amoxicillin with 125 mg clavulanate, 875 mg amoxicillin with 125 mg clavulanate

Indications and dosages

Lower respiratory tract infections, otitis media, sinusitis, skin and skin-structure infections, and urinary tract infections (UTIs) caused by susceptible strains of gram-negative and gram-positive organisms

Adults and children weighing more than 40 kg (88 lb): 500 mg q 12 hours or 250 mg P.O. q 8 hours (based on amoxicillin component). For severe infections, 875 mg P.O. q 12 hours or 500 mg P.O. q 8 hours.

Serious infections and community-acquired pneumonia

Adults and children weighing more than 40 kg (88 lb): 875 mg P.O. q 12 hours or 500 mg P.O. q 8 hours

Infants and children ages 3 months and older weighing less than 40 kg (88 lb): 20 to 45 mg/kg/day P.O. in divided doses q 12 hours or 20 or 25 to 40 mg/kg/day in divided doses q 8 hours, based on severity of infection and amoxicillin component (125 mg/5 ml or 250 mg/5 ml suspension)

Infants younger than 3 months: 30 mg/kg/day P.O. (based on amoxicillin component) divided q 12 hours. (125 mg/5 ml oral suspension is recommended.)

Recurrent or persistent acute otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis in children ages 2 and younger and in children who have received antibiotic therapy within last 3 months

Children ages 3 months to 12 years: 90 mg/kg/day of Augmentin ES-600 P.O. q 12 hours for 10 days

Dosage adjustment

• Severe renal impairment

• Hemodialysis

• Infants ages 3 months and younger

Contraindications

• Hypersensitivity to drug or any penicillin

• Phenylketonuria (some products)

• History of cholestatic jaundice or hepatic dysfunction associated with this drug

Precautions

Use cautiously in:

• severe renal insufficiency, infectious mononucleosis

• pregnant patients.

Administration

Ask about history of penicillin allergy before giving.

• Give with or without food.

• Know that maximum dosage for infants ages 3 months and younger is 30 mg/kg/day divided q 12 hours.

• Be aware that 12-hour dosing is recommended to reduce diarrhea.

Adverse reactions

CNS: lethargy, hallucinations, anxiety, confusion, agitation, depression, dizziness, fatigue, hyperactivity, insomnia, behavioral changes, seizures (with high doses)

GI: nausea, vomiting, diarrhea, abdominal pain, stomatitis, glossitis, gastritis, black "hairy" tongue, furry tongue, enterocolitis, pseudomembranous colitis

GU: vaginitis, nephropathy, interstitial nephritis

Hematologic: anemia, thrombocytopenia, thrombocytopenic purpura, leukopenia, hemolytic anemia, agranulocytosis, bone narrow depression, eosinophilia

Hepatic: cholestatic hepatitis

Respiratory: wheezing

Skin: rash

Other: superinfections (oral and rectal candidiasis), fever, anaphylaxis

Interactions

Drug-drug. Any food: enhanced clavulanate absorption

Chloramphenicol, macrolides, sulfonamides, tetracycline: decreased amoxicillin efficacy

Hormonal contraceptives: decreased contraceptive efficacy

Probenecid: decreased renal excretion and increased blood level of amoxicillin

Drug-food. Any food: enhanced clavulanate absorption

Drug-herbs. Khat: decreased antimicrobial effect

Patient monitoring

• Monitor patient carefully for signs and symptoms of hypersensitivity reaction.

Monitor for seizures when giving high doses.

• Check patient's temperature and watch for other signs and symptoms of superinfection, especially oral or rectal candidiasis.

Patient teaching

Instruct patient to immediately report signs or symptoms of hypersensitivity reaction, such as rash, fever, or chills.

• Tell patient he may take drug with or without food.

• Inform patient that drug lowers resistance to some types of infections. Instruct him to report new signs or symptoms of infection (especially of mouth or rectum).

• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.

• Tell patient taking hormonal contraceptives that drug may reduce contraceptive efficacy. Suggest she use alternative birth control method.

• Inform parents that they may give liquid form of drug directly to child or may mix it with foods or beverages.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, foods, and herbs mentioned above.

References in periodicals archive ?
The child was placed on amoxicillin and clavulanate (Augmentin ES-600) 42.9 mg/5 mL suspension 90 mg/kg orally for seven days and topical bacitracin ointment twice a day.
According to the company, the FDA's division of Bioequivalence has determined the Ranbaxy formulation to be bioequivalent and therefore therapeutically equivalent to GlaxoSmithKline PLC's Augmentin ES-600 for Oral Suspension, in the same strength.
Augmentin ES-600 suspension, for children, contains 600 mg of amoxicillin and 42.9 mg of clavulanate per 5 mL.
The new pediatric formulation (Augmentin ES-600) for the treatment of acute otitis media contains a 14:1 ratio of the two drugs, and the new adult formulation (Augmentin XR) for the treatment of community-acquired pneumonia or sinusitis contains a 16:1 ratio.
The availability of Augmentin ES-600 coincides with the beginning of the cough, cold, and flu season.
Augmentin ES-600 is approved by the FDA for the treatment of children with recurrent or persistent middle ear infections due to Streptococcus pneumonia (penicillin MICs 2 g/mL), Haemophilus influenzae (including [beta]-lactamase producing strains), or Moraxella catarrhalis (including [beta]-lactamase producing strains).
Other products launched late in 2004 include gabapentin capsules and tablets, AB-rated to Pfizer Inc.'s Neurontin; flumazenil injection, AB-rated to Roche Laboratories Inc.'s Romazicon; omeprazole delayed-release capsules, AB-rated to AstraZeneca PLC's Prilosec; ribavirin capsules, AB-rated to Schering-Plough Corp.'s Rebetol; and amoxicillin and clavulanate potassium for oral suspension USP, AB-rated to GSK's Augmentin ES-600.
He presented the results of an unusually large multicenter randomized trial pitting Augmentin ES-600 (GlaxoSmithKline) against Zithromax (Pfizer), two of the most widely prescribed agents for acute otitis media in children.
The GlaxoSmithKline-sponsored study involved 731 children aged 6-30 months with stringently diagnosed acute otitis media (AOM) who were randomized to the Food and Drug Administration-approved doses of the drugs: 90 mg/day of Augmentin ES-600 divided into two daily doses for 10 days, or 10 mg/kg of Zithromax on day 1 followed by 5 mg/kg per day for the next 4 days.
But those drugs (Augmentin ES-600 for acute otitis media and Augmentin XR, an extended-release version) only partly offset the loss of antibacterial revenues for the company.