Augmentin

Name: Augmentin

What Is Augmentin (Amoxicillin & Clauvulanate)?

Augmentin is the brand name of a combination antibiotic drug containing amoxicillin and clavulanate potassium.

It's used to treat bacterial infections in your airways, such as a sinus infection or pneumonia.

It's also available in an extra-strength formulation (Augmentin ES), an extended-release formula (Augmentin XR), and under the brand name Amoclan.

Amoxicillin is a penicillin antibiotic that kills bacteria by blocking production of a chemical the germs need to build their cell walls.

Clavulanate is a chemical that helps antibiotics overcome some bacteria's antibiotic resistance.

The Food and Drug Administration (FDA) approved Augmentin in 1984. GlaxoSmithKline is one of several manufacturers that produce it.

Augmentin Warnings

Augmentin can cause a severe form of diarrhea called Clostridium difficile-associated diarrhea (CDAD). It's marked by loose, watery stool with an unusually foul smell.

If not treated promptly, CDAD causes dehydration and can cause sepsis in severe cases.

Since dehydration can disrupt your levels of sodium and potassium, you may have tremors, feel weak, have an irregular heartbeat, or all three.

Augmentin, like other penicillin antibiotics, can cause a severe, life-threatening allergic reaction known as anaphylaxis.

If you are sensitive to it, you may break out in hives, have trouble breathing, and your mouth, gums, and throat may swell.

Don't take Augmentin if you are allergic to it or any of the ingredients in it.

Avoid Augmentin if you've had an allergic reaction to another penicillin antibiotic or beta-lactam antibacterial drug.

Talk to your doctor before taking Augmentin if you:

  • Have liver or severe kidney problems, especially if you need dialysis to prevent kidney failure
  • Have mononucleosis
  • Have ulcerative colitis
  • Have HIV/AIDS
  • Have acute lymphoblastic leukemia (ALL)
  • Take blood thinners, such as warfarin (Jantoven, Coumadin)
  • Take Probalan (probenecid)

Augmentin and Pregnancy

Most doctors consider Augmentin generally safe to take while pregnant.

Nonetheless, talk to your doctor if you're pregnant or plan to become pregnant or are breastfeeding before taking this medication.

Taking Augmentin during pregnancy may lower your estrogen level.

Because it lowers estrogen levels, Augmentin makes birth control pills less effective.

If you are taking oral contraceptives, consider using a back-up form of contraception while taking Augmentin and for a few weeks afterward.

Augmentin may be passed to a breastfeeding infant through breast milk, though it's generally considered safe.

Nonetheless, talk to your doctors about the risks of taking Augmentin before breastfeeding.

Uses of Augmentin

Augmentin is a prescription medication used to treat symptoms of infection in the ears, nose, airways, skin, and urinary tract.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Dr. Reddy's Laboratories Ltd

  • Glaxo SmithKline Pharmaceuticals

Augmentin Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Augmentin, there are no specific foods that you must exclude from your diet.

 

Inform MD

Before taking Augmentin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to amoxicillin, clavulanic acid, cephalosporins, penicillins, or any other medications
  • have or have had kidney or liver disease
  • have allergies and asthma
  • have or have had hay fever, hives, or mononucleosis (type of viral infection)
  • have phenylketonuria (inability to process phenylalanine). The chewable tablets and powder for suspension forms contain aspartame (which contains phenylalanine)
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Other Requirements

  • Store at room temperature (tablet forms) or in the refrigerator (suspension form once made).
  • Discard the suspension form (once made) after 10 days of refrigeration.
  • Keep this and all medicines out of the reach of children.

Augmentin Dosage and Administration

Augmentin may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Augmentin is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Augmentin should be taken at the start of a meal.

Adults

The usual adult dose is one 500-mg tablet of Augmentin every 12 hours or one 250-mg tablet of Augmentin every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of Augmentin every 12 hours or one 500-mg tablet of Augmentin every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.

Two 250-mg tablets of Augmentin should not be substituted for one 500-mg tablet of Augmentin. Since both the 250-mg and 500-mg tablets of Augmentin contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of Augmentin.

The 250-mg tablet of Augmentin and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of Augmentin and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of Augmentin contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.

 Pediatric Patients

Based on the amoxicillin component, Augmentin should be dosed as follows:

Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Augmentin is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.

Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]

Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older

INFECTION DOSING REGIMEN
Every 12 hours Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona 125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours
Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours

a Each strength of suspension of Augmentin is available as a chewable tablet for use by older children.

b Duration of therapy studied and recommended for acute otitis media is 10 days.

Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.

The 250-mg tablet of Augmentin should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of Augmentin (250/125) versus the 250-mg chewable tablet of Augmentin (250/62.5).

Patients with Renal Impairment

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

 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 (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

Table 2: Amount of Water for Mixing Oral Suspension

Strength Bottle Size Amount of Waterfor Reconstitution Contents of EachTeaspoonful (5 mL)
125 mg/5 mL 75 mL100 mL150 mL 67 mL90 mL134 mL 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt
200 mg/5 mL 50 mL75 mL100 mL 50 mL75 mL95 mL 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
250 mg/5 mL 75 mL100 mL150 mL 65 mL87 mL130 mL 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL 50 mL75 mL100 mL 50 mL70 mL90 mL 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt

Note:  Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.

Drug Interactions

Probenecid

Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with Augmentin may result in increased and prolonged blood concentrations of amoxicillin. Coadministration of probenecid is not recommended.

Oral Anticoagulants

Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with Augmentin. 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

Augmentin 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 Augmentin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

Clinical Studies

Lower Respiratory Tract and Complicated Urinary Tract Infections

Data from 2 pivotal trials in 1,191 patients treated for either lower respiratory tract infections or complicated urinary tract infections compared a regimen of 875‑mg tablets of Augmentin every 12 hours to 500‑mg tablets of Augmentin dosed every 8 hours (584 and 607 patients, respectively). Comparable efficacy was demonstrated between the every 12 hours and every 8 hours dosing regimens. There was no significant difference in the percentage of adverse events in each group. The most frequently reported adverse event was diarrhea; incidence rates were similar for the 875‑mg every 12 hours and 500‑mg every 8 hours dosing regimens (15% and 14%, respectively); however, there was a statistically significant difference (p < 0.05) in rates of severe diarrhea or withdrawals with diarrhea between the regimens: 1% for 875‑mg every 12 hours regimen versus 2% for the 500‑mg every 8 hours regimen.

In one of these pivotal trials, patients with either pyelonephritis (n = 361) or a complicated urinary tract infection (i.e., patients with abnormalities of the urinary tract that predispose to relapse of bacteriuria following eradication, n = 268) were randomized (1:1) to receive either 875‑mg tablets of Augmentin every 12 hours (n=308) or 500‑mg tablets of Augmentin every 8 hours (n=321). 

The number of bacteriologically evaluable patients was comparable between the two dosing regimens. Augmentin produced comparable bacteriological success rates in patients assessed 2 to 4 days immediately following end of therapy. The bacteriologic efficacy rates were comparable at one of the follow‑up visits (5 to 9 days post‑therapy) and at a late post‑therapy visit (in the majority of cases, this was 2 to 4 weeks post-therapy), as seen in Table 7.

Table 7: Bacteriologic efficacy rates for Augmentin

Time Post Therapy 875 mg every 12 hours% (n) 500 mg every 8 hours% (n)
2 to 4 days 81% (58) 80% (54)
5 to 9 days 58% (41) 52% (52)
2 to 4 weeks 52% (101)  55% (104)

As noted before, though there was no significant difference in the percentage of adverse events in each group, there was a statistically significant difference in rates of severe diarrhea or withdrawals with diarrhea between the regimens.

 Acute Bacterial Otitis Media and Diarrhea in Pediatric Patients

One US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of Augmentin for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of Augmentin for 10 days in the treatment of acute otitis media. Only the suspension formulations were used in this trial. A total of 575 pediatric patients (aged 2 months to 12 years) were enrolled, with an even distribution among the 2 treatment groups and a comparable number of patients were evaluable (i.e., ³ 84%) per treatment group. Otitis media‑specific criteria were required for eligibility and a strong correlation was found at the end of therapy and follow‑up between these criteria and physician assessment of clinical response. The clinical efficacy rates at the end of therapy visit (defined as 2‑4 days after the completion of therapy) and at the follow‑up visit (defined as 22‑28 days post‑completion of therapy) were comparable for the 2 treatment groups, with the following cure rates obtained for the evaluable patients: At end of therapy, 87% (n = 265) and 82% (n = 260) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively. At follow‑up, 67% (n = 249) and 69% (n = 243) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.

Diarrhea was defined as either: (a) 3 or more watery or 4 or more loose/watery stools in 1 day; OR (b) 2 watery stools per day or 3 loose/watery stools per day for 2 consecutive days. The incidence of diarrhea was significantly lower in patients who received the every 12 hours regimen compared to patients who received the every 8 hours regimen (14% and 34%, respectively). In addition, the number of patients with either severe diarrhea or who were withdrawn with diarrhea was significantly lower in the every 12 hours treatment group (3% and 8% for the every 12 hours/10 day and every 8 hours/10 day, respectively). In the every 12 hours treatment group, 3 patients (1%) were withdrawn with an allergic reaction, while 1 patient in the every 8 hours group was withdrawn for this reason. The number of patients with a candidal infection of the diaper area was 4% and 6% for the every 12 hours and every 8 hours groups, respectively.

It is not known if the finding of a statistically significant reduction in diarrhea with the oral suspensions dosed every 12 hours, versus suspensions dosed every 8 hours, can be extrapolated to the chewable tablets. The presence of mannitol in the chewable tablets may contribute to a different diarrhea profile. The every 12 hour oral suspensions (200 mg/5 mL and 400 mg/5 mL) are sweetened with aspartame.

What other drugs will affect Augmentin?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • allopurinol;

  • probenecid; or

  • a blood thinner - warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with amoxicillin and clavulanate potassium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

For Healthcare Professionals

Applies to amoxicillin / clavulanate: oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet extended release

General

In general, side effects have been classified as mild and transient. Less than 3% of patients in clinical trials discontinued treatment due to side effects. The most frequent adverse reactions associated with immediate-release formulations have included diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%), and vaginitis (1%). Extended-release tablets have been most frequently associated with diarrhea (14.5%), vaginal mycosis (3.3%), nausea (2.1%), and loose stools (1.6%).[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, abdominal pain, vomiting, indigestion, gastritis, generalized abdominal cramps, stomatitis, glossitis, mucocutaneous candidiasis, enterocolitis, black "hairy" tongue, small intestinal motor disturbances, hemorrhagic colitis, and pseudomembranous colitis. Colitis and Clostridium difficile pseudomembranous colitis have been reported with amoxicillin.[Ref]

Amoxicillin has been associated with hemorrhagic, sometimes inflammatory colitis, which typically affects the ascending colon. In addition, C difficile pseudomembranous colitis should be considered in patients who develop severe or prolonged diarrhea during or following amoxicillin-clavulanate therapy.

The incidence of diarrhea appears to increase with higher doses, and to decrease with twice daily dosing regimens (of immediate release formulations).[Ref]

Hypersensitivity

Hypersensitivity reactions to amoxicillin are more likely in patients with a history of allergy, asthma, hay fever, or urticaria.[Ref]

Hypersensitivity reactions have occurred in up to 10% of patients, and may present as a skin rash, urticaria, pruritus, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome (rarely), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, exfoliative dermatitis, and toxic epidermal necrolysis. Anaphylaxis has been rarely reported (up to 0.2%). Hypersensitivity may play a role in some cases of amoxicillin-clavulanate-induced renal and hepatic toxicity. Urticarial rash, erythematous maculopapular rash, edema, hypotension, fever, eosinophilia, and dyspnea have been associated with hypersensitivity reactions to amoxicillin.[Ref]

Dermatologic

Three out of four patients with infectious mononucleosis and an amoxicillin-associated rash displayed hypersensitivity to amoxicillin and ampicillin by skin tests and lymphocyte transformation tests. Two of these patients had side-chain-specific sensitization.[Ref]

Dermatologic side effects have included rash, fixed drug eruption, bullous pemphigoid, erythema multiforme, Stevens-Johnson syndrome, and exfoliative dermatitis. Amoxicillin rashes occur more frequently in patients with unrecognized infectious mononucleosis. This rash is not necessarily indicative of a lifelong amoxicillin hypersensitivity.[Ref]

Hepatic

Hepatic side effects have included moderate elevations in serum transaminases (ALT and/or AST). Hepatic dysfunction (including cholestatic jaundice and hepatitis, increases in ALT and/or AST, serum bilirubin, and/or alkaline phosphatase) has been reported infrequently. Rare cases of jaundice, ductopenia, cholestatic hepatitis, granulomatous hepatitis, hepatic necrosis, and hepatocellular damage have also been reported. Less than 1 death per approximately 4 million prescriptions has been reported worldwide. Hepatic cholestasis and acute cytolytic hepatitis have been reported with amoxicillin use.[Ref]

In cases of amoxicillin-clavulanate-induced hepatotoxicity, biopsy findings have typically revealed evidence of cholestatic injury. However, hepatocellular and mixed-type (cholestatic and hepatocellular) injury have also been documented. In many instances, hepatotoxicity may be due to a hypersensitivity. Onset of symptoms has been delayed in some patients, with presentation occurring after therapy has been discontinued. Prolonged treatment may increase the risk of hepatotoxicity. Elderly patients may be at increased risk of developing amoxicillin-clavulanate-induced jaundice. Fatalities are rare, but have been reported.

Rechallenge with amoxicillin alone has not been followed by a recurrence of hepatitis. However, rechallenge with amoxicillin-clavulanate has resulted in a relapse of liver injury. Therefore, the clavulanic acid may be the hepatotoxic part of the drug.

In patients with liver disease, frequent monitoring of liver function tests during amoxicillin-clavulanate therapy is recommended.[Ref]

Renal

Renal side effects have rarely included crystalluria, hematuria, acute renal failure, and acute interstitial nephritis, often associated with fever, rash, and eosinophilia.[Ref]

A 45-year-old female developed massive crystalluria, gross hematuria, and acute anuric renal failure after 12 days of intravenous amoxicillin-clavulanate at a dose of 2 g amoxicillin 3 times daily (not available in the United States). The crystals were composed of amoxicillin trihydrate. The renal failure and hematuria resolved over 6 days after discontinuation of the antibiotic.[Ref]

Hematologic

Amoxicillin has been shown to induce hemolytic anemia in rare cases. A case of bone marrow "maturation arrest" resulting in neutropenia and of Henoch-Schonlein purpura syndrome has been associated with amoxicillin-clavulanate.

A patient undergoing dental extraction and receiving warfarin anticoagulation therapy had prolonged bleeding times (PT and INR), and decreased hemoglobin and hematocrit. The bleeding was felt due to vitamin K deficiency as a result of depletion of intrinsic vitamin K-producing gut flora from use of amoxicillin for prophylaxis of subacute bacterial endocarditis.[Ref]

Hematologic side effects associated with penicillins have included thrombocytopenia, anemia, hemolytic anemia, thrombocytopenic purpura, eosinophilia, agranulocytosis, and leukopenia. These are believed to be due to hypersensitivity and are usually reversible when the drug is discontinued. Mild to moderate thrombocytosis has been reported in less than 1% of patients treated with amoxicillin-clavulanate and 3.6% of patients treated with the extended-release tablets. Purpura, pancytopenia, granulocytopenia, medullary aplasia, prolongation of prothrombin time, and transient neutropenia have also been reported.[Ref]

Immunologic

Immunologic side effects associated with amoxicillin have included mucocutaneous candidiasis and vulvovaginal mycotic infection.[Ref]

Nervous system

Nervous system side effects have rarely included agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, headache, insomnia, and reversible hyperactivity. Rare cases of psychosis associated with amoxicillin therapy have been reported, but may have been due to underlying infection or concomitant medication. Rarely, somnolence and aseptic meningitis have been reported with amoxicillin.[Ref]

Genitourinary

Genitourinary side effects have included genital moniliasis (2.1%).[Ref]

Other

Amoxicillin-clavulanate may cause false-positive urine glucose tests in patients using Clinitest(R) tablets. Enzymatic glucose oxidase tests should be used during amoxicillin-clavulanate therapy.[Ref]

Other side effects have rarely included brown, yellow, or gray tooth discoloration, primarily in pediatric patients. Brushing or dental cleaning reduced or eliminated the discoloration in most cases.[Ref]

Respiratory

Respiratory side effects associated with amoxicillin have included cough and rhinorrhea.[Ref]

Some side effects of Augmentin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Amoxicillin and clavulanate potassium side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  • loss of appetite, upper stomach pain, jaundice (yellowing of the skin or eyes);

  • easy bruising or bleeding;

  • little or no urination; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea, diarrhea; or

  • vaginal itching or discharge;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses for Augmentin

Otitis Media

Treatment of acute otitis media (AOM) caused by β-lactamase producing H. influenzae or M. catarrhalis.1 3 67 74 77 78 81 82 88 89 92 93 94 95 96 98 99 101 115 AAP, AAFP, CDC, and others recommend fixed combination of amoxicillin and clavulanate (instead of amoxicillin) for initial treatment of AOM in those with severe illness (moderate to severe otalgia or fever ≥39°C)115 or when the infection is suspected of being caused by β-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis.74 76 77 78 81 89 115

Treatment of persistent or recurrent AOM caused by H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin MIC ≤2 mcg/mL) in pediatric patients.76 79 81 89 90 91 97 115 Drug of choice for retreatment of AOM that has not responded to other anti-infectives81 89 90 100 107 115 (e.g., no response to amoxicillin within 48–72 hours).115 Not indicated for AOM caused by S. pneumoniae with penicillin MIC ≥4 mcg/mL.3

Has been used for management of otitis media with effusion† (OME).68 94 102 107 Anti-infectives not usually recommended;102 103 104 105 107 116 they provide only limited benefit in enhancing resolution of effusion and may promote resistance.103 104 105 106 107 AAP, AAFP, and others recommend watchful waiting for 3 months from date of effusion onset or diagnosis in those 2 months to 12 years of age who are not at risk for speech, language, or learning problems; some suggest a short course of anti-infectives may be considered for possible short-term benefits when parent and/or caregiver expresses a strong aversion to impending surgery.116 If anti-infectives are used for treatment, amoxicillin and clavulanate or amoxicillin recommended.102 107

Pharyngitis and Tonsillitis

Treatment of symptomatic patients who have multiple, recurrent episodes of pharyngitis known to be caused by S. pyogenes (group A β-hemolytic streptococci)†.75 76 80

Not a drug of choice for treatment of streptococcal pharyngitis and tonsillitis,75 76 80 but one of several possible alternatives recommended by AAP, IDSA , and AHA when multiple episodes occur and the patient fails to respond to drugs of choice (oral penicillin V, IM penicillin G benzathine, oral amoxicillin).75 76 80

Consider that multiple, recurrent episodes of symptomatic pharyngitis occurring within several months to years may indicate that the patient is a streptococcal carrier experiencing repeated episodes of nonstreptococcal (e.g., viral) pharyngitis;75 80 treatment not usually recommended for streptococcal pharyngeal carriers.75 76 80

Respiratory Tract Infections

Treatment of acute sinusitis and lower respiratory tract infections caused by susceptible H. influenzae1 2 5 17 53 67 68 69 or M. catarrhalis.1 2 5 17 53 59

Treatment of acute sinusitis or community-acquired pneumonia (CAP) caused by or suspected to be caused by β-lactamase-producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, Klebsiella pneumoniae, oxacillin-susceptible Staphylococcus aureus).4 9

Treatment of acute sinusitis or CAP caused by or suspected of being caused by S. pneumoniae with reduced penicillin susceptibility (i.e., penicillin MIC 2 mcg/mL).4 9 18 Not indicated for treatment of infections caused by S. pneumoniae with penicillin MIC ≥4 mcg/mL.4

Recommended by IDSA and ATS as an alternative for outpatient empiric treatment of CAP in immunocompetent adults;9 18 ATS recommends use with a macrolide or doxycycline in those with cardiopulmonary disease and/or other factors that increase risk for multidrug-resistant S. pneumoniae or gram-negative bacteria.18

Skin and Skin Structure Infections

Treatment of skin or skin structure infections (e.g., abscesses, cellulitis, impetigo) caused by β-lactamase-producing S. aureus, Escherichia coli, or Klebsiella.1 2 5 33 42

Urinary Tract Infections (UTIs)

Treatment of UTIs caused by β-lactamase-producing E. coli, Klebsiella, or Enterobacter.1 2 5 14 17 27 28 32 41 43 44 45 47 49 51 53 111

Useful for outpatient treatment of recurrent UTIs or UTIs acquired in hospitals or nursing homes likely to be caused by drug-resistant S. aureus, Enterococcus, or gram-negative bacilli.111 In severe gram-negative infections, consider concomitant use of an aminoglycoside (amikacin, gentamicin, tobramycin).111

Active Tuberculosis

Alternative recommended by ATS and others for use in multiple-drug regimens for treatment of active tuberculosis† in patients with multidrug-resistant Mycobacterium tuberculosis.20 31 66

Bite Wounds

Empiric treatment of animal or human bites†.109 112 Active against most likely bite pathogens, including anaerobes, Staphylococcus, Eikenella corrodens, Pasteurella multocida.108 110 112

Alternative for treatment of infections caused by P. multocida† or E. corrodens†.111

Pelvic Inflammatory Disease

Treatment of acute pelvic inflammatory disease† (PID).36 46 52 64

Not a drug of choice for PID.36 According to CDC, may be effective when used in conjunction with doxycycline, but GI adverse effects may limit compliance.36

Interactions for Augmentin

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Allopurinol

Possible increased incidence of rash;1 2 3 4 reported with ampicillin but no data regarding amoxicillin1 2 3 4 113 114

Unclear whether potentiation of rash is caused by allopurinol or hyperuricemia present in these patients1 2 3 4 113 114

Antacids

No effect on pharmacokinetics of amoxicillin or clavulanate when antacids administered simultaneously with or 2 hours after extended-release tablets containing amoxicillin and clavulanate potassium4

Hormonal contraceptives

Possible decreased efficacy of oral contraceptives1 2 3 4

Probenecid

Decreased renal tubular secretion of amoxicillin and increased and prolonged amoxicillin plasma concentrations.1 2 3 4 56

No effect on renal elimination of clavulanic acid.1 2 3 4 5

Concomitant use not recommended1 2 3 4

Tests for glucose

Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution;1 2 3 4 reported with ampicillin but no data regarding amoxicillin1 2 3 4

Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1 2 3 4

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Amoxicillin (Trihydrate) and Clavulanate Potassium (Co-amoxiclav)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension

125 mg (of amoxicillin) per 5 mL and 31.25 mg (of clavulanic acid) per 5 mL*

Amoxicillin and Clavulanate Potassium for Oral Suspension

Teva

Augmentin (with aspartame)

GlaxoSmithKline

200 mg (of amoxicillin) per 5 mL and 28.5 mg (of clavulanic acid) per 5 mL*

Amoxicillin and Clavulanate Potassium for Oral Suspension

Ranbaxy, Sandoz, Teva

Augmentin (with aspartame)

GlaxoSmithKline

250 mg (of amoxicillin) per 5 mL and 62.5 mg (of clavulanic acid) per 5 mL

Augmentin (with aspartame)

GlaxoSmithKline

400 mg (of amoxicillin) per 5 mL and 57 mg (of clavulanic acid) per 5 mL*

Amoxicillin and Clavulanate Potassium for Oral Suspension

Ranbaxy, Sandoz, Teva

Augmentin (with aspartame)

GlaxoSmithKline

600 mg (of amoxicillin) per 5 mL and 42.9 mg (of clavulanic acid) per 5 mL*

Amoxicillin and Clavulanate Potassium for Oral Suspension

Teva

Augmentin ES-600 (with aspartame)

GlaxoSmithKline

Tablets

875 mg (of amoxicillin) and 125 mg (of clavulanic acid)*

Amoxicillin and Clavulanate Potassium Tablets (scored)

Ranbaxy, Sandoz, Teva

Augmentin (scored)

GlaxoSmithKline

Tablets, chewable

125 mg (of amoxicillin) and 31.25 mg (of clavulanic acid)

Augmentin (with aspartame)

GlaxoSmithKline

200 mg (of amoxicillin) and 28.5 mg (of clavulanic acid)*

Amoxicillin and Clavulanate Potassium Chewable Tablets

Ranbaxy, Sandoz, Teva

Augmentin (with aspartame)

GlaxoSmithKline

250 mg (of amoxicillin) and 62.5 mg (of clavulanic acid)

Augmentin (with aspartame)

GlaxoSmithKline

400 mg (of amoxicillin) and 57 mg (of clavulanic acid)

Amoxicillin and Clavulanate Potassium Chewable Tablets

Ranbaxy, Sandoz, Teva

Augmentin (with aspartame)

GlaxoSmithKline

Tablets, film-coated

250 mg (of amoxicillin) and 125 mg (of clavulanic acid)*

Amoxicillin and Clavulanate Potassium Tablets

Sandoz

Augmentin

GlaxoSmithKline

500 mg (of amoxicillin) and 125 mg (of clavulanic acid)*

Amoxicillin and Clavulanate Potassium Tablets

Ranbaxy, Sandoz, Teva

Augmentin

GlaxoSmithKline

Amoxicillin (Trihydrate), Amoxicillin Sodium, and Clavulanate Potassium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, extended-release

1 g (of amoxicillin) and 62.5 mg (of clavulanic acid)

Augmentin XR (with polyethylene glycol)

GlaxoSmithKline

Medical Disclaimer

(web3)