a-mox-i-SIL-in

Commonly used brand name(s)

In the U.S.

• Amoxicot
• Amoxil
• DisperMox
• Moxatag
• Moxilin
• Trimox

In Canada

• Amoxil Pediatric
• Apo-Amoxi
• Apo-Amoxi Sugar-Free
• Gen-Amoxicillin
• Med Amoxicillin
• Novamoxin
• Novamoxin Reduced Sugar
• Nu-Amoxi
• Riva-Amoxicillin
• Scheinpharm Amoxicillin
• Zimamox

Available Dosage Forms:

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

Therapeutic Class: Antibiotic

Pharmacologic Class: Penicillin, Aminopenicillin

Uses For amoxicillin

Amoxicillin is used to treat bacterial infections in many different parts of the body. It is also used with other medicines (e.g., clarithromycin, lansoprazole) to treat H. pylori infection and duodenal ulcers.

Amoxicillin belongs to the group of medicines known as penicillin antibiotics. It works by killing the bacteria and preventing their growth. However, amoxicillin will not work for colds, flu, or other virus infections.

amoxicillin is available only with your doctor's prescription.

Before Using amoxicillin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For amoxicillin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amoxicillin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin in children. However, newborns and infants 3 months of age and younger have incompletely developed kidney functions, which may need a lower dose of amoxicillin.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amoxicillin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving amoxicillin.

Pregnancy

Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking amoxicillin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using amoxicillin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Chlortetracycline
• Demeclocycline
• Donepezil
• Doxycycline
• Lymecycline
• Meclocycline
• Methacycline
• Methotrexate
• Minocycline
• Oxytetracycline
• Rolitetracycline
• Tetracycline
• Venlafaxine
• Warfarin

Using amoxicillin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Khat
• Probenecid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of amoxicillin. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to penicillins or cephalosporin antibiotics (e.g., cefaclor, cefadroxil, cephalexin, Ceftin®, or Keflex®) or
• Mononucleosis (viral infection)—Should not be used in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The chewable tablet contains phenylalanine, which can make this condition worse.

Proper Use of amoxicillin

Take amoxicillin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take amoxicillin with or without food.

For patients using the oral liquid:

• Shake the bottle well before each use. Measure the dose with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
• You may mix the oral liquid with a baby formula, milk, fruit juice, water, ginger ale, or another cold drink. Be sure the child drinks all of the mixture immediately.

Keep using amoxicillin for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of amoxicillin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of amoxicillin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, powder for suspension, and tablets):
  • For bacterial infections:
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every 8 hours, or 500 to 875 mg every 12 hours.
    • Children and infants older than 3 months of age weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 8 hours, or 25 to 45 mg per kg of body weight per day, divided and given every 12 hours.
    • Infants 3 months of age and younger—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 mg per kg of body weight per day, divided and given every 12 hours.
  • For treatment of gonorrhea:
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—3-grams (g) taken as a single dose.
    • Children 2 years of age and older weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, combined with 25 mg per kg of probenecid, taken as a single dose.
    • Children younger than 2 years of age—Use is not recommended.
  • For treatment of H. pylori infection:
    • Adults—
      • Dual therapy: 1000 milligrams (mg) of amoxicillin and 30 mg of lansoprazole, each given three times a day (every 8 hours) for 14 days.
      • Triple therapy: 1000 mg of amoxicillin, 500 mg of clarithromycin, and 30 mg of lansoprazole, all given two times a day (every 12 hours) for 14 days.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of amoxicillin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store the oral liquid in the refrigerator. Throw away any unused medicine after 14 days. Do not freeze.

Precautions While Using amoxicillin

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

amoxicillin may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a skin rash; itching; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, mouth, or throat after you or your child receive amoxicillin.

Amoxicillin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking amoxicillin. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you or your child are taking amoxicillin. The results of some tests may be affected by amoxicillin.

In some young patients, tooth discoloration may occur while using amoxicillin. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.

Birth control pills may not work while you are using amoxicillin. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include a condom, a diaphragm, or a contraceptive foam or jelly.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

amoxicillin Side Effects

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:

Incidence not known

• Abdominal or stomach cramps or tenderness
• back, leg, or stomach pains
• , tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine
• bloody nose
• chest pain
• chills
• clay-colored stools
• cough
• dark urine
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• difficulty with breathing
• difficulty with swallowing
• dizziness
• fast heartbeat
• feeling of discomfort
• fever
• general body swelling
• headache
• heavier menstrual periods
• hives or welts
• increased thirst
• inflammation of the joints
• itching
• joint or muscle pain
• loss of appetite
• muscle aches
• nausea or vomiting
• nosebleeds
• pain
• pain in the lower back
• pain or burning while urinating
• 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, irritated eyes
• redness, soreness, or itching skin
• shortness of breath
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sores, welting, or blisters
• sudden decrease in the amount of urine
• swollen, lymph glands
• tenderness
• tightness in the chest
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• vomiting of blood
• watery or bloody diarrhea
• wheezing
• yellow eyes or skin

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:

Less common

• Bad, unusual, or unpleasant (after) taste
• change in taste

Incidence not known

• Agitation
• , hairy tongue
• changes in behavior
• confusion
• convulsions
• discoloration of the tooth (brown, yellow, or gray staining)
• dizziness
• sleeplessness
• trouble with sleeping
• unable to sleep
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

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.

See also: Side effects (in more detail)

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Usual Adult Dose for Actinomycosis

500 mg orally 3 times a day or 875 mg orally twice a day for six months
Initial treatment of actinomycosis should include high dose parenteral penicillin G or ampicillin for 4 to 6 weeks, followed by appropriate oral therapy.

Usual Adult Dose for Anthrax Prophylaxis

500 mg orally every 8 hours

Oral amoxicillin is not considered first-line treatment for anthrax prophylaxis; it may, however, be used to complete a 60-day prophylactic course after 10 to 14 days of ciprofloxacin or doxycycline in pregnant or lactating patients or in patients with contraindications to the other two agents. The total duration of antimicrobial therapy is 60 days.

Usual Adult Dose for Cutaneous Bacillus anthracis

Treatment for confirmed cases of cutaneous Bacillus anthracis infection: 500 mg orally three times a day

Oral amoxicillin is not considered first-line treatment for the treatment of cutaneous anthrax; it may, however, be used to complete the treatment course once clinical response to ciprofloxacin or doxycycline has been observed or if the patient has contraindications to the other two agents. The total duration of antimicrobial therapy is 60 days.

Usual Adult Dose for Bacterial Endocarditis Prophylaxis

2 g orally given one hour prior to the procedure

Amoxicillin is considered the standard agent for prophylaxis against bacterial endocarditis in at-risk individuals undergoing certain dental, oral, respiratory tract or esophageal procedures.

Amoxicillin is not appropriate as endocarditis prophylaxis for patients identified as high-risk, including those with prosthetic heart valves, prior endocarditis, and those who have had surgically constructed systemic shunts or conduits. These patients should receive appropriate parenteral antimicrobial therapy.

Usual Adult Dose for Chlamydia Infection

500 mg orally 3 times a day for 7 days in pregnant patients as an alternative to erythromycin in macrolide-sensitive individuals

Amoxicillin does not have reliable activity against Chlamydia trachomatis.

Usual Adult Dose for Cystitis

250 to 500 mg orally 3 times a day for 3 to 7 days; alternatively, 500 to 875 mg orally twice a day may be administered

Usual Adult Dose for Urinary Tract Infection

250 to 500 mg orally 3 times a day for 3 to 7 days; alternatively, 500 to 875 mg orally twice a day may be administered

Usual Adult Dose for Helicobacter pylori Infection

1 g orally 2 to 3 times a day for 14 days
Amoxicillin is used in combination with metronidazole and bismuth subsalicylate or with clarithromycin and a proton-pump inhibitor such as omeprazole or lansoprazole.

Usual Adult Dose for Lyme Disease - Arthritis

500 mg orally 3 times a day for 14 to 30 days
Early Lyme disease is often treated with an oral antibiotic such as doxycycline, cefuroxime or azithromycin, all of which are active against Borrelia burgdorferi. If amoxicillin is used, clinicians may wish to add probenecid, although the benefit of this addition is uncertain.

Up to 15% of patients with Lyme disease experience the Jarisch-Herxheimer reaction (increased fever, increased flushing rash, and increased pain) during the first 24 hours of therapy. This reaction is self-limiting, does not necessarily reflect true allergy to amoxicillin, and may be reduced in intensity by premedication with aspirin and/or prednisone.

Usual Adult Dose for Lyme Disease - Carditis

500 mg orally 3 times a day for 14 to 30 days
Early Lyme disease is often treated with an oral antibiotic such as doxycycline, cefuroxime or azithromycin, all of which are active against Borrelia burgdorferi. If amoxicillin is used, clinicians may wish to add probenecid, although the benefit of this addition is uncertain.

Up to 15% of patients with Lyme disease experience the Jarisch-Herxheimer reaction (increased fever, increased flushing rash, and increased pain) during the first 24 hours of therapy. This reaction is self-limiting, does not necessarily reflect true allergy to amoxicillin, and may be reduced in intensity by premedication with aspirin and/or prednisone.

Usual Adult Dose for Lyme Disease - Erythema Chronicum Migrans

500 mg orally 3 times a day for 14 to 30 days
Early Lyme disease is often treated with an oral antibiotic such as doxycycline, cefuroxime or azithromycin, all of which are active against Borrelia burgdorferi. If amoxicillin is used, clinicians may wish to add probenecid, although the benefit of this addition is uncertain.

Up to 15% of patients with Lyme disease experience the Jarisch-Herxheimer reaction (increased fever, increased flushing rash, and increased pain) during the first 24 hours of therapy. This reaction is self-limiting, does not necessarily reflect true allergy to amoxicillin, and may be reduced in intensity by premedication with aspirin and/or prednisone.

Usual Adult Dose for Lyme Disease - Neurologic

500 mg orally 3 times a day for 14 to 30 days
Early Lyme disease is often treated with an oral antibiotic such as doxycycline, cefuroxime or azithromycin, all of which are active against Borrelia burgdorferi. If amoxicillin is used, clinicians may wish to add probenecid, although the benefit of this addition is uncertain.

Up to 15% of patients with Lyme disease experience the Jarisch-Herxheimer reaction (increased fever, increased flushing rash, and increased pain) during the first 24 hours of therapy. This reaction is self-limiting, does not necessarily reflect true allergy to amoxicillin, and may be reduced in intensity by premedication with aspirin and/or prednisone.

Usual Adult Dose for Otitis Media

250 to 500 mg orally 3 times a day for 10 to 14 days; alternatively, 500 to 875 mg orally twice a day may be administered

Usual Adult Dose for Pneumonia

500 mg orally 3 times a day or 875 mg orally twice a day may be administered for 7 to 10 days if pneumococcal pneumonia is suspected
Only mild pneumonia due to pneumococcus should be treated with amoxicillin.

Usual Adult Dose for Sinusitis

250 to 500 mg orally 3 times a day for 10 to 14 days; alternatively, 500 to 875 mg orally twice a day may be administered
Longer courses of therapy, up to 3 or 4 weeks, may be required in refractory or recurrent cases.

Usual Adult Dose for Skin or Soft Tissue Infection

250 to 500 mg orally 3 times a day for 7 to 10 days; alternatively, 500 to 875 mg orally twice a day may be administered

Usual Adult Dose for Upper Respiratory Tract Infection

250 to 500 mg orally 3 times a day for 7 to 10 days; alternatively, 500 to 875 mg orally twice a day may be administered

Usual Adult Dose for Bronchitis

250 to 500 mg orally 3 times a day for 7 to 10 days; alternatively, 500 to 875 mg orally twice a day may be administered

Usual Adult Dose for Tonsillitis/Pharyngitis

Immediate-release: 250 to 500 mg orally 3 times a day for 7 to 10 days; alternatively, 500 to 875 mg orally twice a day may be administered
Extended-release: 775 mg orally once a day within 1 hour after a meal for 10 days; for infections secondary to Streptococcus pyogenes

Usual Adult Dose for Bacterial Infection

250 to 500 mg orally 3 times a day for 7 to 21 days; alternatively, 500 to 875 mg orally twice a day may be administered

Usual Pediatric Dose for Bacterial Endocarditis Prophylaxis

50 mg/kg orally as a single dose 1 hour prior to procedure

Amoxicillin is not appropriate as endocarditis prophylaxis for patients identified as high-risk, including those with prosthetic heart valves, prior endocarditis, and those who have had surgically constructed systemic shunts or conduits. These patients should receive appropriate parenteral antimicrobial therapy.

Usual Pediatric Dose for Anthrax Prophylaxis

80 mg/kg/day divided into equal doses administered orally every 8 hours
Maximum dose: 500 mg/dose

Oral amoxicillin is not considered first-line treatment for anthrax prophylaxis; it may, however, be used to complete a 60-day prophylactic course after 10 to 14 days of ciprofloxacin or doxycycline in pediatric patients. The total duration of antimicrobial therapy is 60 days.

Usual Pediatric Dose for Cutaneous Bacillus anthracis

Treatment for confirmed cases of cutaneous Bacillus anthracis infection: 80 mg/kg/day divided into equal doses administered orally every 8 hours
Maximum dose: 500 mg/dose

Oral amoxicillin is not considered first-line treatment for the treatment of cutaneous anthrax; it may, however, be used to complete the treatment course once clinical response to ciprofloxacin or doxycycline has been observed. The total duration of antimicrobial therapy is 60 days.

Usual Pediatric Dose for Otitis Media

4 weeks to 3 months: 20 to 30 mg/kg/day in divided doses every 12 hours
4 months to 12 years: 20 to 50 mg/kg/day in divided doses every 8 to 12 hours; acute otitis media due to highly resistant strains of Streptococcus pneumonia may require doses of 80 to 90 mg/kg/day orally divided into 2 equal doses 12 hours apart

Usual Pediatric Dose for Skin or Soft Tissue Infection

4 weeks to 3 months: 20 to 30 mg/kg/day in divided doses every 12 hours
4 months to 12 years: 20 to 50 mg/kg/day in divided doses every 8 to 12 hours; acute otitis media due to highly resistant strains of Streptococcus pneumonia may require doses of 80 to 90 mg/kg/day orally divided into 2 equal doses 12 hours apart

Usual Pediatric Dose for Urinary Tract Infection

4 weeks to 3 months: 20 to 30 mg/kg/day in divided doses every 12 hours
4 months to 12 years: 20 to 50 mg/kg/day in divided doses every 8 to 12 hours; acute otitis media due to highly resistant strains of Streptococcus pneumonia may require doses of 80 to 90 mg/kg/day orally divided into 2 equal doses 12 hours apart

Usual Pediatric Dose for Pneumonia

40 to 50 mg/kg/day orally in divided doses every 8 hours

Usual Pediatric Dose for Tonsillitis/Pharyngitis

4 weeks to 3 months: 20 to 30 mg/kg/day in divided doses every 12 hours
4 months to 12 years: 20 to 50 mg/kg/day in divided doses every 8 to 12 hour

12 years or older:
Immediate-release: 250 to 500 mg orally 3 times a day for 7 to 10 days; alternatively, 500 to 875 mg orally twice a day may be administered
Extended-release: 775 mg orally once a day within 1 hour after a meal for 10 days; for infections secondary to S pyogenes

Renal Dose Adjustments

CrCl 10 to 30 mL/min: 250 to 500 mg orally every 12 hours
CrCl 9 mL/min or less: 250 to 500 mg orally every 24 hours

The 875 mg tablets and the 775 mg extended-release tablets should not be given to patients with CrCl less than 30 mL/min.

Liver Dose Adjustments

Data not available

Precautions

The drug should be discontinued immediately at the first appearance of a skin rash or other signs of hypersensitivity.

Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibiotics and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following amoxicillin therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against C difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy.

Dose reductions are recommended in patients with severe renal impairment. It may be advisable to monitor renal function in elderly patients.

Periodic monitoring of renal, hepatic, and hematologic function is recommended in all patients during prolonged therapy.

Patients with phenylketonuria should be aware that amoxicillin chewable tablets contain phenylalanine (1.82 mg/200 mg tablet and 3.64 mg/400 mg tablet). The 200 and 400 mg tablets for oral suspension contain 5.6 mg phenylalanine per tablet.

The immediate-release formulations should not be substituted for the extended-release tablets.

Amoxicillin is not effective for the treatment of syphilis, although it may mask or delay its symptoms when used to treat gonorrhea. All gonorrhea patients should undergo serologic testing for syphilis at the time of diagnosis and 3 months after treatment.

The safety and efficacy of the extended-release tablets have not been established in patients less than 12 years of age.

Dialysis

Adults, conventional hemodialysis: 250 to 500 mg every 24 hours with supplemental doses during and after a hemodialysis session

The 775 mg extended-release tablets are not recommended for patients on hemodialysis.

Other Comments

At least 10 days of therapy is recommended for infections caused by S pyogenes to prevent acute rheumatic fever.

Immediate-release amoxicillin may be given without regard to meals. The extended-release tablets should be taken within 1 hour of finishing a meal at about the same time each day.

The oral suspension may be mixed with formula, milk, fruit juice, ginger ale, or cold drinks, and should be taken immediately after mixing.

The suspension should be discarded 14 days after reconstitution.

The tablets for oral suspension should not be chewed or swallowed whole. The dispersible tablets for oral suspension should be mixed with 2 teaspoonfuls of water, the patient should drink the entire mixture, then a small amount of water should be used to rinse the container, and the patient should drink this also. The extended-release tablets should not be chewed or crushed.

Amoxicillin Side Effects

Anaphylactic Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with AMOXIL, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

Clostridium Difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AMOXIL, 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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Development Of Drug-Resistant Bacteria

Prescribing AMOXIL 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

Use In Patients With Mononucleosis

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

Phenylketonurics

Amoxil chewable tablets contain aspartame which contains phenylalanine. Each 200 mg chewable tablet contains 1.82 mg phenylalanine; each 400 mg chewable tablet contains 3.64 mg phenylalanine. The oral suspensions of Amoxil do not contain phenylalanine and can be used by phenylketonurics.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area).

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed.

Labor And Delivery

Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.

Nursing Mothers

Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.

Pediatric Use

Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of AMOXIL should be modified in pediatric patients 12 weeks or younger ( ≤ 3 months). [See DOSAGE AND ADMINISTRATION]

Geriatric Use

An analysis of clinical studies of AMOXIL was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. 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.

Dosing In Renal Impairment

Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR < 30 mL/min). See Dosing in Renal Impairment for specific recommendations in patients with renal impairment.