Adult Dosing

Bacterial infections (tablets; suspension)

• 500/125 mg (amoxicillin/clavulanate) PO bid; alt: 250/125 mg (amoxicillin/clavulanate) PO tid
• Severe infections and infections of the respiratory tract: 500/125 mg (amoxicillin/clavulanate) PO tid or 875/125 mg (amoxicillin/clavulanate) PO bid
• In adults with swallowing difficulty, give 125 mg/5 mL or 250 mg/5 mL instead of 500-mg tablet; 200 mg/5 mL or 400 mg/5 mL instead of 875-mg tablet

Community-acquired pneumonia (ETABS)

• 2 tabs (amoxicillin 1000/clavulanic acid 62.5 mg ) PO bid x 7-10 days

Acute bacterial sinusitis (ETABS)

• 2 tabs (amoxicillin 1000/clavulanic acid 62.5 mg ) PO bid x 10 days

Bronchiectasis [Not FDA Approved]

• 875/125 mg (amoxicillin/clavulanate) PO q12 hrs or 500/125 mg (amoxicillin/clavulanate) PO q8 hrs

Peritonsillar abscess [Non-FDA Approved]

• 875/125 mg (amoxicillin/clavulanate) PO bid; In adults with swallowing difficulty, can use liquid formula instead of tablet 250 mg/5 mL; 17.5ml PO bid

COPD exacerbation[Non-FDA Approved]

• 875/125 mg (amoxicillin/clavulanate) PO bid

• Tablets (250 mg or 500 mg) cannot be used to provide the same dosages as extended release tablets because the ETABS contain 62.5 mg of clavulanic acid, while the 250-mg and 500-mg TABS each contain 125 mg of clavulanic acid. Also, the ETABS provide an extended time course of plasma amoxicillin concentrations compared to immediate-release tablets
• To be taken at the start of a meal to enhance the absorption of amoxicillin and to minimize the potential for gastrointestinal intolerance

Pediatric Dosing

Bacterial infections

Less severe infections

• <3 months: 30 mg/kg/day PO divided bid, based on amoxicillin component
• >3 mo, <40 kg: 25 mg/kg/day PO divided bid, alt: 20 mg/kg/day divided tid, based on amoxicillin component
• >40 kg: 500/125 mg (amoxicillin/clavulanate) PO bid; alt: 250/125 mg (amoxicillin/clavulanate) PO tid

Otitis media, sinusitis, lower respiratory tract infections, and more severe infections

• <3 months: 30 mg/kg/day PO divided bid, based on amoxicillin component
• >3 mo, <40 kg: 45 mg/kg/day PO divided bid, alt: 40 mg/kg/day divided tid, based on amoxicillin component
• >40 kg: 500/125 mg (amoxicillin/clavulanate) PO tid or 875/125 mg (amoxicillin/clavulanate) PO bid

Bronchiectasis [Not FDA Approved]

• 3 months: 30 mg/kg/day PO divided bid, based on amoxicillin component
• >3 mo, <40 kg: 45 mg/kg/day PO divided tid
• 40 kg: 875/125 mg (amoxicillin/clavulanate) PO bid; alt: 500/125 mg (amoxicillin/clavulanate) PO tid

Peritonsillar abscess [Non-FDA Approved]

• <3 months: 30 mg/kg/day PO divided bid, based on amoxicillin component
• >3 mo, <40 kg: 20-40 mg/kg/day PO divided bid, alt: 25-45 mg/kg/day divided tid, based on amoxicillin component
• >40 kg: 500/125 mg (amoxicillin/clavulanate) PO bid; alt: 250/125 mg (amoxicillin/clavulanate) PO tid

Pediatrics Pneumonia [Non-FDA Approved]

• >40 kg: 80–90 mg/kg/day PO divided bid

• The 250-mg tablet contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the 250-mg tablet and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable
• The 250-mg tablet should not be used until the child weighs at least 40 kg and more
• To be taken at the start of a meal to enhance the absorption of amoxicillin and to minimize the potential for gastrointestinal intolerance

[Outline]

• Adult Dosing
• Pediatric Dosing

Tablets and oral suspension

• Lower respiratory tract infections
• Otitis media
• Sinusitis
• Skin and skin structure infections
• Urinary Tract Infections

Extended release tablets

• Community-acquired pneumonia
• Acute bacterial sinusitis

• Hypersensitivity to any of the ingredients or class of the product
• Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate
• Severe renal impairment (Extended release tablets)

• N/A

Renal Dose Adjustment: (Based on CrCl)

Immediate release tablets; Suspension

• <30 mL/min: Avoid administration of 875-mg tablet
• 10-30 mL/min: 250 or 500 mg PO bid
• <10 mL/min: 250 or 500 mg PO qd
• Hemodialysis: 500 or 250 mg PO qd; give usual dose as supplement both during and at the end of dialysis

Extended release tablets

• <30 mL/min: Contraindicated
• >30 mL/min: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised
• History of amoxicillin/clavulanate associated hepatotoxicity: Contraindicated

See Supplemental Patient Information

• Serious and occasionally fatal hypersensitivity reactions have been reported with penicillin therapy, more likely in patients with a history of hypersensitivity to penicillin, cephalosporins, or multiple allergens. Take a detailed history regarding previous hypersensitivity reactions before initiating the therapy
• If an allergic reaction occurs, discontinue the drug and institute appropriate therapy. In case of serious anaphylactic reactions, provide immediate emergency treatment with epinephrine, oxygen, intravenous steroids and airway management including intubation
• Clostridium difficile associated diarrhea (CDAD) ranging from mild diarrhea to fatal colitis may occur with amoxicillin/clavulanate therapy as antibacterial agents alter the normal flora of the colon leading to overgrowth of C. difficile
• C. difficile produces toxins A and B which contribute to CDAD. Hypertoxin-producing strains cause increased morbidity and mortality since these infections can be refractory to antibiotic therapy and may require colectomy. Careful medical examination is necessary since CDAD may occur >2 months after administration of drug
• If CDAD is suspected or confirmed, discontinue the treatment; provide fluid and electrolyte management, protein supplementation along with antibiotics for C. difficile, and consider surgical evaluation as clinically needed
• Hepatic toxicity, usually reversible, has been reported with amoxicillin/clavulanate therapy; use cautiously in patients with evidence of hepatic dysfunction
• Patients with mononucleosis may develop an erythematous skin rash with ampicillin; do not administer ampicillin-class antibiotics to patients with mononucleosis
• Organ system functions, including renal, hepatic, and hematopoietic function should be assessed periodically if therapy is for longer than the drug is approved for administration
• Prescribing antibiotics in the absence of proven or strongly suspected bacterial infection increases the risk of development of drug-resistant bacteria
• Superinfections with mycotic or bacterial pathogens can occur with amoxicillin/clavulanate; discontinue therapy and/or institute appropriate therapy if such infections occur

Cautions: Use cautiously in

• Renal impairment
• Electrolyte disturbances
• Cytomegalovirus infection
• Acute lymphoblastic leukemia
• HIV infection
• Elderly patients
• Phenylketonuria
• Non-anaphylactic hypersensitivity to betalactams

Supplemental Patient Information

• Advise patients to contact their physicians if they develop severe diarrhea or if the diarrhea lasts more than 2-3 days

Augmentin, Augmentin ES-600, Augmentin XR interacts with :

	CellCept
	Mycophenolate
	Myfortic

Pregnancy Category:B

Breastfeeding: Amoxicillin/clavulanate is acceptable for use during breastfeeding. Monitor infants for adverse events such as restlessness, diarrhea, and rash, which may occur occasionally. If amoxicillin-clavulanic acid is required by the mother, it is not a reason to discontinue breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 February 2011). However, manufacturer advises caution.

• GI: Clostridium difficile associated diarrhea, loose stools, nausea, vomiting, abdominal discomfort, flatulence, hepatotoxicity, cholestatic jaundice, indigestion, gastritis, stomatitis, glossitis, black hairy tongue, mucocutaneous candidiasis, enterocolitis, pseudomembranous colitis
• HYPERSENSITIVITY: Skin rashes, urticaria, pruritus, angioedema, serum sickness-like reactions, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, contact dermatitis, severe hypersensitivity reaction, anaphylactic reaction, acute generalized exanthematous pustulosis, hypersensitivity vasculitis
• GU: Vaginitis, interstitial nephritis, hematuria, vulvovaginal candidiasis
• CNS: Headache, agitation, anxiety, confusion, convulsions, dizziness, insomnia
• HEMA: Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, agranulocytosis
• MISC: Superinfection

Amoxicillin

• Antibacterial agent; having bactericidal activity against many gram-positive and limited gram-negative microorganisms. Binds to penicillin-binding protein 1A (PBP-1A) located inside the bacterial cell wall and interferes with an autolysin inhibitor
• Metabolized by liver; CYP450: unknown
• Renally excreted (50-70% unchanged)
• Half-life: 1.3 hrs

Clavulanate

• Antibacterial agent; inhibits a wide variety of beta-lactamases, commonly found in microorganisms resistant to penicillins and cephalosporins resulting in restoration of the antimicrobial activity of beta-lactam antibiotics against lactamase-secreting-resistant bacteria
• Metabolized by liver; CYP450: unknown
• Renally excreted (25-40% unchanged)
• Half-life: 1 hr

US Trade Name(s)

• Augmentin
• Augmentin ES-600
• Augmentin XR

US Availability

amoxicillin/clavulanate (generic)

• TABS: 250 mg/125 mg
• TABS: 500 mg/125 mg
• TABS: 875 mg/125 mg
• CHEW TABS: 200 mg/28.5 mg
• CHEW TABS: 400 mg/57 mg
• ETABS: 1000 mg/62.5 mg
• PWDR for SUSP: [200 mg/28.5 mg]/5 mL
• PWDR for SUSP: [400 mg/57 mg]/5 mL
• PWDR for SUSP: [600 mg/42.9 mg]/5 mL

Augmentin (amoxicillin/clavulanate)

• TABS: 250 mg/125 mg
• TABS: 500 mg/125 mg
• TABS: 875 mg/125 mg
• PWDR for SUSP: [125 mg/31.25 mg]/5 mL
• PWDR for SUSP: [250 mg/62.5 mg]/5 mL
• CHEW TABS: 200 mg/28.5 mg
• CHEW TABS: 400 mg/57 mg

Augmentin XR (amoxicillin/clavulanate)

• ETABS: 1000 mg/62.5 mg

Augmentin ES-600 (amoxicillin/clavulanate)

• PWDR for SUSP: [600 mg/42.9 mg]/5 mL

Canadian Trade Name(s)

• Apo-Amoxi Clav
• Amoxi-Clav
• Clavulin
• Novo-Clavamoxin
• ratio-Aclavulanate

Canadian Availability

Amoxi-Clav (amoxicillin/clavulanate)

• TABS: 500 mg/125 mg
• TABS: 875 mg/125 mg

Apo-Amoxi Clav (amoxicillin/clavulanate)

• TABS: 250 mg/125 mg
• TABS: 500 mg/125 mg
• TABS: 875 mg/125 mg
• PWDR for SUSP: [125 mg/31.25 mg]/5 mL
• PWDR for SUSP: [250 mg/62.5 mg]/5 mL
• PWDR for SUSP: [400 mg/57 mg]/5 mL

Clavulin (amoxicillin/clavulanate)

• TABS: 500 mg/125 mg
• TABS: 875 mg/125 mg
• PWDR for SUSP: [125 mg/31.25 mg]/5 mL
• PWDR for SUSP: [200 mg/28.5 mg]/5 mL
• PWDR for SUSP: [250 mg/62.5 mg]/5 mL
• PWDR for SUSP: [400 mg/57 mg]/5 mL

Novo-Clavamoxin (amoxicillin/clavulanate)

• TABS: 875 mg/125 mg

Ratio-Aclavulanate (amoxicillin/clavulanate)

• TABS: 500 mg/125 mg
• TABS: 875 mg/125 mg
• PWDR for SUSP: [125 mg/31.25 mg]/5 mL
• PWDR for SUSP: [250 mg/62.5 mg]/5 mL

UK Trade Name(s)

• Augmentin-Duo
• Co-amoxiclav

UK Availability

Augmentin-Duo (amoxicillin/clavulanate)

• SUSP: 400 mg/57 mg per 5 mL

Co-amoxiclav (amoxicillin/clavulanate)

• PWDR for SUSP: 125 mg/31 mg per 5 mL
• PWDR for SUSP: 250 mg/62 mg per 5 mL
• PWDR for SUSP: 400 mg/57 mg per 5 mL
• TABS: 500 mg/125 mg

Australian Trade Name(s)

• Augmentin
• Augmentin Duo
• Augmentin Duo forte
• Clamoxyl
• Clamoxyl Duo
• Clamoxyl Duo forte
• Clavulin
• Clavulin Duo
• Clavulin Duo forte
• Clavycillin
• Curam
• Curam Duo
• Curam Duo forte
• GA-Amclav
• GA-Amclav forte
• Moxiclav Duo
• Moxiclav Duo forte

Australian Availability

amoxicillin/clavulanate (generic)

• TABS: 500 mg/125 mg
• TABS: 875 mg/125 mg

Augmentin, Clamoxyl, Clavulin, Curam (amoxicillin/clavulanate)

• PWDR for SUSP: 125 mg/31.25 mg per 5 mL

Augmentin Duo, Clamoxyl Duo, Clavulin Duo, Curam Duo (amoxicillin/clavulanate)

• TABS: 500 mg/125 mg
• PWDR for SUSP: 400 mg/57 mg per 5 mL

Augmentin Duo forte, Clavulin Duo forte, Clamoxyl Duo forte, Curam Duo forte, GA-Amclav forte, Moxiclav Duo forte, Clavycillin (amoxicillin/clavulanate)

• TABS: 875 mg/125 mg

GA-Amclav, Moxiclav Duo (amoxicillin/clavulanate)

• TABS: 500 mg/125 mg

[Outline]

Antimicrobials

Antibiotics

Penicillins; Beta-lactamase Inhibitors

Infectious Disease

Antibiotics

Penicillins; Beta-lactamase Inhibitors

Pricing data from www.DrugStore.com in U.S.A.

• Augmentin XR 1000-62.5 MG TB12 [Bottle] (GLAXO SMITH KLINE)
  28 mg = $116.69
  84 mg = $330.13
• Augmentin 500-125 MG TABS [Bottle] (GLAXO SMITH KLINE)
  30 mg = $166.71
  90 mg = $482.4
• Augmentin 875-125 MG TABS [Bottle] (DR.REDDY'S LABORATORIES)
  20 mg = $169.99
  60 mg = $479.97
• Augmentin 250-125 MG TABS [Bottle] (GLAXO SMITH KLINE)
  30 mg = $118.99
  90 mg = $343.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (American Health Packaging)
• Amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Apotex Corp.)
• Amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (GlaxoSmithKline)
• Amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Lek Pharmaceuticals Inc.)
• Amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Physicians Total Care, Inc.)
• Amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Rebel Distributors Corp.)
• Amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Sandoz Inc.)
• Amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (TEVA PHARMACEUTICALS USA)
• Amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (American Health Packaging)
• Amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Apotex Corp.)
• Amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (GlaxoSmithKline)
• Amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Lek Pharmaceuticals Inc.)
• Amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Physicians Total Care, Inc.)
• Amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Rebel Distributors Corp.)
• Amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (Sandoz Inc.)
• Amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet (TEVA PHARMACEUTICALS USA)
• Amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Tablet (Sandoz Inc)
• Amoxicillin 200 MG / Clavulanate 28.5 MG Chewable Tablet (Ranbaxy Pharmaceuticals Inc.)
• Amoxicillin 200 MG / Clavulanate 28.5 MG Chewable Tablet (Sandoz Inc.)
• Amoxicillin 200 MG / Clavulanate 28.5 MG Chewable Tablet (TEVA Pharmaceuticals USA Inc)
• Amoxicillin 250 MG / Clavulanate 125 MG Oral Tablet (Apotex Corp.)
• Amoxicillin 250 MG / Clavulanate 125 MG Oral Tablet (Sandoz Inc.)
• Amoxicillin 400 MG / Clavulanate 57 MG Chewable Tablet (Physicians Total Care, Inc.)
• Amoxicillin 400 MG / Clavulanate 57 MG Chewable Tablet (Ranbaxy Pharmaceuticals Inc.)
• Amoxicillin 400 MG / Clavulanate 57 MG Chewable Tablet (Sandoz Inc.)
• Amoxicillin 400 MG / Clavulanate 57 MG Chewable Tablet (TEVA Pharmaceuticals USA Inc)
• Augmentin 250-mg Oral Tablet (GlaxoSmithKline LLC)
• Augmentin 500-mg Oral Tablet (GlaxoSmithKline LLC)
• Augmentin 875-mg Oral Tablet (GlaxoSmithKline LLC)
• Augmentin XR 12 HR 1000 MG Extended Release Tablet (GlaxoSmithKline LLC)