Augmentin

Augmentin should be taken on a full stomach to reduce stomach upset. No more than one tablet should be taken at a time since the extra clavulanic acid can cause stomach upset. Recommended adult doses are 500 mg every 8-12 hours, 250 mg every 8 hours, 875 mg every 12 hours, or 2000 mg every 12 hours. Dosing is based on the amoxicillin component. Pediatric patients weighing more than 40 kg should receive adult doses. Pediatric patients weighing less than 40 kg should receive 20 to 45 mg/kg every 8 or 12 hours.

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Reviewed on 9/14/2016 References Reference: FDA Prescribing Information

Diarrhea, nausea, or vomiting may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly. Taking this medication with food will help to reduce stomach upset.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell the doctor immediately if any of these rare but serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, easy bruising/bleeding, new signs of infection (such as fever, persistent sore throat), unusual tiredness.This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell the doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact the doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.Amoxicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

The following are discussed in more detail in other sections of the labeling:

• Anaphylactic reactions [see WARNINGS AND PRECAUTIONS]
• Hepatic Dysfunction [see WARNINGS AND PRECAUTIONS]
• CDAD [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache.

In pediatric patients (aged 2 months to 12 years), 1 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. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes. [See Clinical Studies]

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of AUGMENTIN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to AUGMENTIN.

Gastrointestinal

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. [see WARNINGS AND PRECAUTIONS]

Hypersensitivity Reactions

Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens Johnson syndrome, acute generalized exanthematouspustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. [see WARNINGS AND PRECAUTIONS]

Liver

Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with AUGMENTIN. 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, 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. Deaths have been reported. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]

Renal

Interstitial nephritis, hematuria, and crystalluria have been reported. [see OVERDOSE]

Hemic And Lymphatic Systems

Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosishave been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Thrombocytosis was noted in less than 1% of the patients treated with AUGMENTIN. There have been reports of increased prothrombin time in patients receiving AUGMENTIN and anticoagulant therapy concomitantly. [see DRUG INTERACTIONS]

Central Nervous System

Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported.

Miscellaneous

Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Augmentin falls into category B. Studies in animals have failed to demonstrate a risk to the unborn baby and there are no well-controlled studies in pregnant women. Or, animal studies have shown a harmful and undesired effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the unborn baby in any trimester.

It is not known if Augmentin will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient in Augmentin is excreted in human breast milk. The effect of Augmentin on the nursing infant is not known.

• Take Augmentin exactly as prescribed.
• Augmentin comes as an immediate-release tablet, extended-release tablet, a chewable tablet, and as a powder for oral (by mouth) suspension.
• Augmentin is usually taken 2 to 3 times every day (every 8 or 12 hours), preferably with food.
• Continue to take this medication even if you feel well. Do not stop taking Augmentin without talking to your doctor.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Augmentin at the same time.

Chewable tablets:

• Augmentin chewable tablets should be chewed before swallowing.

Extended-release tablets:

• Swallow extended-release tablets whole. Do not chew or crush unless you are taking the chewable tablets form of Augmentin.

Oral suspension:

• Tap bottle until all powder flows freely.
• Add approximately 1/3 of the total amount of water to the bottle and shake well to wet the powder. Refer to the instructions on your bottle or your pharmacist for the amount of water to add.
• Add remainder of the water and again shake well.
• After mixing the powder with water, shake the oral suspension well before use.

In the U.S.

• Amoclan
• Augmentin
• Augmentin ES-600
• Augmentin XR

In Canada

• Alti-Amoxi Clav
• Apo-Amoxi Clav
• Novo-Clavamoxin 125
• Novo-Clavamoxin 250
• Ratio-Amoxi Clav 250f

Available Dosage Forms:

• Tablet
• Tablet, Extended Release
• Powder for Suspension
• Tablet, Chewable

Therapeutic Class: Antibiotic

Pharmacologic Class: Penicillin, Aminopenicillin

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Hives or welts
• itching
• itching of the vagina or genital area
• pain during sexual intercourse
• redness of the skin
• skin rash
• thick, white vaginal discharge with no odor or with a mild odor

Rare

• Bloody or cloudy urine
• fever
• greatly decreased frequency of urination or amount of urine
• seizures
• swelling of the feet or lower legs

Incidence not known

• Abdominal or stomach cramps or tenderness
• back, leg, or stomach pains
• black, hairy tongue
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the stools
• bloody nose
• chest pain
• chills
• clay-colored stools
• cough or hoarseness
• cracks in the skin
• dark urine
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• difficulty with breathing
• difficulty with moving
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever with or without chills
• general body swelling
• general feeling of tiredness or weakness
• headache
• heavier menstrual periods
• increased thirst
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• loss of heat from the body
• lower back or side pain
• muscle stiffness
• nausea or vomiting
• pain
• pain, swelling, or redness in the joints
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• scaly skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• tightness in the chest
• troubled breathing with exertion
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• upper right abdominal or stomach pain
• vomiting of blood
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach pain
• cloudy urine
• diarrhea
• greatly decreased frequency of urination or amount of urine
• sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Anxiety
• dry mouth
• hyperventilation
• irregular heartbeats
• irritability
• restlessness
• shaking
• sleeplessness
• tooth discoloration
• trouble sitting still
• trouble with sleeping

Incidence not known

• Burning feeling in the chest or stomach
• indigestion
• redness, swelling, or soreness of the tongue
• stomach upset
• swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Augmentin (amoxicillin/clavulanate potassium) and other antibacterial drugs, Augmentin should be used only to treat 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.

Augmentin® is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:

  Lower Respiratory Tract Infections

caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.

Acute Bacterial Otitis Media

caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis.

Sinusitis

caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections

caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.

Urinary Tract Infections

caused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.

Limitations of Use

When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Augmentin should not be used.

Serious Hypersensitivity Reactions

Augmentin is contraindicated 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).

 Cholestatic Jaundice/Hepatic Dysfunction

Augmentin is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Augmentin.

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including Augmentin. 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 with Augmentin, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Augmentin should be discontinued and appropriate therapy instituted.

Hepatic Dysfunction

Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of Augmentin. 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)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Augmentin, 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.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as 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. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Skin Rash in Patients with Mononucleosis

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, Augmentin should not be administered to patients with mononucleosis.

 Potential for Microbial Overgrowth

The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfection occurs, amoxicillin/clavulanate potassium should be discontinued and appropriate therapy instituted.

 Phenylketonurics

Augmentin Chewable tablets and Augmentin Powder for Oral Solution contain aspartame which contains phenylalanine.  Each 200-mg chewable tablet of Augmentin contains 2.1 mg phenylalanine; each 400-mg chewable tablet contains 4.2 mg phenylalanine; each 5 mL of either the 200 mg/5 mL or 400 mg/5 mL oral suspension contains 7 mg phenylalanine.  The other formulations of Augmentin do not contain phenylalanine.

Development of Drug-Resistant Bacteria

Prescribing Augmentin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient, and increases the risk of the development of drug‑resistant bacteria.

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required.  A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms1.

Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin/clavulanate potassium.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin/clavulanate potassium 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. [see Dosage and Administration (2.3)]

• Take at the start of a light meal to improve the absorption of clavulanate potassium and to minimize the potential for gastrointestinal intolerance.
• Take exactly as directed by your doctor and complete the course as prescribed to reduce the risk of bacterial resistance developing.
• Call for emergency help if you experience any allergic-type reactions including a rash; a swelling of the face, lips, or throat; difficulty breathing; or a tightness in the chest.
• Augmentin may encourage the overgrowth of yeasts, such as Candida. This may be seen as oral or vaginal thrush. See your doctor if you suspect you have developed thrush as a result of Augmentin use.
• See your doctor if you develop prolonged or significant diarrhea while taking Augmentin or within several months of finishing the course.
• May cause tooth discoloration (brown, yellow, or gray staining); the risk is higher in pediatric patients. Brushing or professional dental cleaning reduced or eliminated discoloration.
• Phenylketonurics should avoid Augmentin chewable tablets and Augmentin powder for oral solution which both contain aspartame (contains phenylalanine).

Amoxicillin is a penicillin antibiotic that fights bacteria in the body.

Clavulanate potassium is a beta-lactamase inhibitor that helps prevent certain bacteria from becoming resistant to amoxicillin.

Amoxicillin and clavulanate potassium is a combination medicine used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.

Amoxicillin and clavulanate potassium may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to it, or if:

• you have severe kidney disease (or if you are on dialysis);

• you have had liver problems or jaundice while taking amoxicillin and clavulanate potassium; or

• you are allergic to any penicillin or cephalosporin antibiotic, such as Amoxil, Ceftin, Cefzil, Moxatag, Omnicef, and others.

To make sure amoxicillin and clavulanate potassium is safe for you, tell your doctor if you have ever had:

• liver disease (hepatitis or jaundice);

• kidney disease; or

• mononucleosis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amoxicillin and clavulanate potassium can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Amoxicillin and clavulanate potassium can pass into breast milk and may affect the nursing baby. Tell your doctor if you are breast-feeding.

Do not give this medicine to a child without medical advice.

The liquid or chewable tablet may contain phenylalanine. Talk to your doctor before using these forms of this medicine if you have phenylketonuria (PKU).

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause nausea, vomiting, stomach pain, diarrhea, skin rash, drowsiness, hyperactivity, and decreased urination.

Avoid taking this medicine together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

• Fixed combination of amoxicillin trihydrate (a β-lactam antibacterial classified as an aminopenicillin) and the potassium salt of clavulanic acid (a β-lactamase inhibitor).17 35 41

• Clavulanic acid synergistically expands activity of amoxicillin against β-lactamase-producing bacteria1 5 8 10 11 12 13 15 16 17 25 34 35 37 41 46 53 58 60 by irreversibly and competitively inhibiting β-lactamases.5 8 10 16 17 34 35 37 54 60 70

• Usually bactericidal.10 11 13 15 17 35 53

• Active against bacteria susceptible to amoxicillin alone and also active against many β-lactamase-producing bacteria resistant to amoxicillin alone.5 11 13 17 25 29 35 38 41 53 54 60

• Gram-positive aerobes: Active in vitro and in clinical infections against Staphylococcus (including β-lactamase-producing strains),1 4 5 17 35 37 42 108 Streptococcus pneumoniae,1 4 17 35 S. pyogenes (group A β-hemolytic streptococci),5 and Enterococcus faecalis.5

• Gram-negative aerobes: Active in vitro and in clinical infections against β-lactamase-producing strains of Haemophilus influenzae,4 5 13 17 1 35 38 H. parainfluenzae,4 Klebsiella pneumoniae,1 4 5 Moraxella catarrhalis,4 17 35 59 108 and Escherichia coli.15 17 28 1 29 35 Also active in vitro against Eikenella corrodens108 and Pasteurella multocida.108 110

• Active in vitro and in clinical infections against Mycobacteria tuberculosis, including multidrug-resistant strains.24 26 31 66 Active in vitro against some anaerobic bacteria, including Peptostreptococcus,1 4 108 Bacteroides,1 4 10 15 17 25 35 Fusobacterium,1 4 108 and Prevotella.108

• Resistance reported in some gram-negative bacteria (e.g., Citrobacter freundii, Enterobacter cloacae, Serratia marcescens, Pseudomonas aeruginosa, some strains of E. coli).5 17 35 37 41 42 49 53