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Amoxicillin is used to treat certain infections caused by bacteria, such as pneumonia; bronchitis; gonorrhea; and
infections of the ears, nose, throat, urinary tract, and skin. It is also used in combination with other medications to
eliminate H. pylori, a bacteria that causes ulcers. Amoxicillin is in a class of medications called penicillin-like
antibiotics. It works by stopping the growth of bacteria. Antibiotics will not work for colds, flu, and other viral infections.
Amoxicillin also is used sometimes to prevent anthrax infection after exposure and to treat anthrax infection of the
skin and chlamydia infections during pregnancy. Talk with your doctor about the possible risks of using this
medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
tell your doctor and pharmacist if you are allergic to amoxicillin, penicillin, cephalosporins, or any other
medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional
supplements, and herbal products you are taking. Be sure to mention any of the following: chloramphenicol
(Chlormycetin), other antibiotics, and probenecid (Benemid). Your doctor may need to change the doses of
your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had kidney disease, allergies, asthma, hay fever, hives, or
phenylketonuria.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant
while taking amoxicillin, call your doctor.
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed
dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Amoxicillin may cause side effects. Tell your doctor if any of these symptoms are severe
or do not go away:
upset stomach
vomiting
diarrhea
Some side effects can be serious. The following symptoms are uncommon, but if you
experience any of them, call your doctor immediately:
hives
seizures
pale skin
excessive tiredness
lack of energy
Amoxicillin may cause other side effects. Call your doctor if you have any unusual problems while taking this
medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's
(FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the capsules and
tablets at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any
medication that is outdated or no longer needed. The liquid medication preferably should be kept in the refrigerator,
but it may be stored at room temperature. Throw away any unused medication after 14 days. Do not freeze. Talk to
your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
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In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not
breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your
body's response to amoxicillin.
If you are diabetic, use Clinistix or TesTape (not Clinitest) to test your urine for sugar while taking this medication.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of
infection after you finish the amoxicillin, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines
you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring
this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to
carry with you in case of emergencies.
Brand names
Return to top
Amoxil
Dispermox
Larotid Suspension
Moxtag
Polymox Suspension
Trimox
Wymox
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Amoxicillin is a widely-used antibiotic drug. It belongs to the penicillin group of drugs and is
prescribed to treat certain infections that are caused by bacteria. It can also be used alongside other
medications to treat stomach ulcers caused by H. pylori infection.
Following the expiration of its patent in 1998, amoxicillin has been produced by several pharmaceutical
companies using different brand names. In the US it can be purchased as Amoxicot, Amoxil, DisperMox,
Moxilin and Trimox.
1,2
What is amoxicillin?
2.
3.
4.
Side effects
5.
Drug interactions
6.
Other precautions
You will also see introductions at the end of some sections to any recent developments that have been covered
by MNT's news stories. Also look out for links to information about related conditions.
Amoxicillin can be used to treat infections caused by bacteria but not those caused by viruses.
Amoxicillin can also be used in combination with other specific medication to treat certain stomach
ulcers.
Amoxicillin is dispensed in a wide variety of forms, ranging from tablets to liquid drops.
Amoxicillin interacts with several other forms of medication, occasionally in a negative manner.
Amoxicillin has been known to cause false positive results in urine glucose tests.
Alcohol does not affect how amoxicillin works but patients are not advised to consume it while
undergoing a course of treatment.
Patients should always discuss their current state of health and medical history with their doctor before
starting a course of amoxicillin.
What is amoxicillin?
1,2
Amoxicillin is available under a variety of different brand names in a variety of different forms.
Amoxicillin belongs to a group of drugs called the penicillins which originate from a form of fungi called
Penicillium fungi.
Penicillins are antibiotic drugs, meaning that they are used to treat infections caused by bacteria and to
eliminate the bacteria themselves.
Amoxicillin fights bacteria by preventing them from forming cell walls and stopping them from growing. This kills
the bacteria and eventually heals the infection.
Amoxicillin is not known to be effective against viral infections such as colds and flu.
Conditions such as these are best treated with antiviral medication or vaccination where available, depending
on the illness.
1,3-5
As an antibiotic, amoxicillin is used to treat certain infections that have been caused by bacteria.
The following are conditions that amoxicillin can be prescribed to treat on its own:
Bronchitis
Ear infection
Gonorrhea
Lyme disease
Pneumonia
Skin infection
Throat infection
Tonsillitis
Typhoid
1,3-4,6
Amoxicillin can be dispensed in several forms to be taken orally: as a dry tablet, chewable tablet, capsule, a
suspension (liquid preparation) or drops for children.
Amoxicillin is normally taken either twice a day (every 12 hours) or three times a day (every 8 hours),
depending on the doctor's instruction. It may be taken with or without food, and if being taken in liquid form it
can be mixed with other liquids such as baby formula, fruit juice, milk and water.
Liquids and drops should be shaken thoroughly before use to ensure that the medication is distributed evenly.
Tablets and capsules should be taken with water and chewable tablets should be crushed thoroughly before
consumption.
It is important to follow the exact dosage and frequency as instructed by health care providers. If a dose is
missed, one should be taken as soon as possible unless it is nearly time for the next dose. Never take a double
dose to make up for a missed one.
Even if the symptoms for the condition disappear, it is important that a treatment course is followed right to the
end. If a course of treatment is discontinued before it is supposed to finish it can create a strain of bacteria that
are resistant to antibiotics. There is also a chance that the infection could return.
Side effects
3,7-9
Like many forms of medication, amoxicillin can also have side effects. Some of these are more common than
others and some are more severe.
As amoxicillin can reduce the effectiveness of some forms of birth control, a secondary pregnancy prevention method such as
condoms could be recommended.
Agitation
Confusion
Diarrhea
Dizziness
Hyperactivity
Insomnia
Tooth discoloration
Chest tightness
Difficulty breathing
Itchiness
Abdominal pains
Fatigue
Pale skin
Seizures
Unexplained anxiety
Yeast infection
Amoxicillin can also reduce the effectiveness of birth control measures such as patches, rings or the birth
control pill. If these pregnancy prevention methods are being used it is best that this is discussed with a doctor.
A secondary prevention method such as condoms may be required during an amoxicillin treatment course.
Although many people have reported experiencing hair loss after taking amoxicillin, evidence has yet to be
found suggesting that it is responsible for this side effect. It is likely that any hair loss experienced would be due
to a different aspect of treatment or the condition.
Drug interactions
10,11
It is very important that a doctor is aware of what medication a patient is taking before prescribing amoxicillin.
Although amoxicillin works well with some forms of medication such as clarithromycin and lansoprazole, there
are other drugs which interact with it in less positive ways.
Amoxicillin has been known to interact with the following drugs:
Oral contraceptives
Other precautions
3,7,11
Although amoxicillin can be a very effective form of treatment for certain infections, repeated use can reduce its
effectiveness. Doctors should be informed if amoxicillin medication has been previously used by a patient.
It is a misconception that alcohol interacts with antibiotics such as amoxicillin. Consuming alcohol does not
impact on the effectiveness of amoxicillin. However, drinking alcohol is still unadvised as it can reduce the
body's energy and thus delay its recovery from infection. It can also mask potential amoxicillin side effects, thus
disguising potential health risks.
Health care providers should also be informed if the patient has any of the following pre-existing medical
conditions:
Asthma
Hay fever
Hives
Kidney disease
Mononucleosis
Phenylketonuria
References
Additional information
Citations
1.
2.
3.
4.
5.
U.S. Food and Drug Administration Commentary on Non-Labeled Dosing of Oral Amoxicillin in Adults and
Pediatrics for Post-Exposure Inhalational Anthrax , accessed 1 October 2014.
6.
7.
8.
9.
10.
11.
12.
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About amoxicillin
References
Make sure you tell your doctor if you are allergic to penicillin. Amoxicillin is a
type of penicillin - do not take it if you are allergic to penicillin.
Space your doses out evenly over the day and complete the full course of this
antibiotic, even if you feel your infection has cleared up. You can take amoxicillin
before or after food.
If you have an allergic reaction (such as any swelling around your mouth, any
difficulties breathing or a red rash) contact a doctor straightaway.
About amoxicillin
Type of
medicine
Penicillin antibiotic
Amoxicillin is used for bacterial infections, such as some respiratory infections, infections of the urine, ear
infections, and dental abscesses. It works by killing the bacteria causing the infection. You may also be
prescribed it to prevent an infection from occurring if you are at particular risk of getting an infection.
Amoxicillin is sometimes used to get rid of Helicobacter pylori. This is the bacterium believed to cause stomach
ulcers. If you are prescribed it for this reason, you will also be prescribed other medicines to take alongside it.
Related discussions
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If you are taking any other medicines. This includes any medicines you are taking which are available
to buy without a prescription, such as herbal and complementary medicines.
If you have an allergic condition, or if you have ever had an allergic reaction to a medicine. This is
particularly important if you have ever had a bad reaction to any penicillin antibiotic.
Before you start this antibiotic, read the manufacturer's printed information leaflet from inside the pack.
The leaflet will give you more information about it and a full list of side-effects which you may experience
from taking it.
Take amoxicillin exactly as your doctor tells you to. Your doctor or pharmacist will tell you how much to
take and when to take it. Your dose will also be on the label of the pack to remind you. Space the doses
out evenly during the day.
If you have been supplied amoxicillin oral powder sachets, stir the powder from the sachet into half a
glass of water. Drink the solution as soon as possible after mixing.
Even if you feel your infection has cleared up, keep taking this antibiotic until the course is finished,
unless you are told to stop.This is to prevent the infection from coming back. A course of treatment with
this antibiotic does not usually last for longer than 7-14 days. If you still feel unwell after finishing the
course, go back to see your doctor.
If you forget to take a dose, take one as soon as you remember. Try to take the correct number of
doses each day, but do not take two doses at the same time to make up.
Some people develop thrush (redness and itchiness in the mouth or vagina) after taking a course of
antibiotics. If this happens to you, speak with your doctor or pharmacist for advice.
If you (or your child) have been given liquid medicine, you may find it causes some staining of your
teeth. This is not permanent and can be removed by brushing your teeth.
If you are using combined oral hormonal contraception (the 'pill'), additional contraceptive precautions
such as condoms are not required during a course of this antibiotic unless you are sick or have diarrhoea.
If you need further advice about this, speak with your doctor or pharmacist.
This antibiotic may stop the oral typhoid vaccine from working. If you are having any vaccinations,
make sure the person treating you knows that you are taking this medicine.
Diarrhoea
know straightaway
Skin rash
Important: if you develop an itchy rash, swollen face or mouth, or have difficulty breathing, these may be signs
that you are allergic to a penicillin antibiotic. Do not take any more amoxicillin and speak with your doctor or go
to your local accident and emergency department straightaway.
If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or
pharmacist.
Store in a cool, dry place, away from direct heat and light.
If you have been given liquid medicine, this will have been made up by the pharmacy and lasts for 14
days. Make sure you check the expiry date on the bottle and do not use it after this date.
If you buy any medicines, check with a pharmacist that they are safe to take with your other
medicines.
If you are having an operation or any dental treatment, tell the person carrying out the treatment
which medicines you are taking.
Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will
dispose of them for you.
If you have any questions about this medicine ask your pharmacist.
Provide Feedback
Manufacturer's PIL, Amoxil Paediatric Suspension ; GlaxoSmithKline UK, The electronic Medicines
Compendium. Dated September 2010.
Manufacturer's PIL, Amoxil Capsules 250/500 mg ; GlaxoSmithKline UK, The electronic Medicines
Compendium. Dated September 2010.
British National Formulary; 64th Edition (Sep 2012) British Medical Association and Royal
Pharmaceutical Society of Great Britain, London
Disclaimer: This article is for information only and should not be used for the diagnosis or treatment of medical conditions. EMIS has used
all reasonable care in compiling the information but make no warranty as to its accuracy. Consult a doctor or other health care professional
for diagnosis and treatment of medical conditions. For details see our conditions.
Original Author:
Current Version:
Peer Reviewer:
Helen Allen
Helen Allen
Dr John Cox
DRUG DESCRIPTION
Formulations of AMOXIL contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad
spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it
is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:
The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45.
Capsules: Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body, contains 250 mg or
500 mg amoxicillin as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product
name AMOXIL and 250; the cap and body of the 500-mg capsule are imprinted with AMOXIL and 500. Inactive
ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium
dioxide.
Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated,
capsuleshaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg
tablet is scored on the reverse side. Inactive ingredients: Colloidal silicon dioxide, crospovidone, FD&C Red
No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,
sodium starch glycolate, and titanium dioxide.
Powder for Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or
400 mg amoxicillin as the trihydrate. Each 5 mL of the 125-mg reconstituted suspension contains 0.11 mEq
(2.51 mg) of sodium. Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of
sodium. Each 5 mL of the 250-mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium; each 5 mL
of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium. Inactive ingredients: FD&C
Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.
INDICATIONS
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXIL (amoxicillin)
and other antibacterial drugs, AMOXIL should be used only to treat infections that are proven or strongly
suspected to be caused by 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.
AMOXIL is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates
of the designated bacteria in the conditions listed below:
Infections of the ear, nose, and throat
due to Streptococcus species. (- and -hemolytic isolates only),Streptococcus
pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
Infections of the genitourinary tract
due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
Infections of the skin and skin structure
due to Streptococcus spp. (- and -hemolytic isolates only), Staphylococcusspp., or E. coli.
Patients with impaired renal function do not generally require a reduction in dose unless the
impairment is severe.
Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875mg 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
Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution
(see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
STRENGTH
Oral Suspension 125 mg/5
mL
BOTTLE SIZE
AMOUNT OF WATER
REQUIRED FOR
RECONSTITUTION
80 mL
62 mL
100 mL
78 mL
150 mL
116 mL
50 mL
39 mL
75 mL
57 mL
100 mL
76 mL
80 mL
59 mL
100 mL
74 mL
150 mL
111 mL
50 mL
36 mL
75 mL
54 mL
After reconstitution, the required amount of suspension should be placed directly on the child's tongue for
swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk,
fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion
of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.
HOW SUPPLIED
Dosage Forms And Strengths
Capsules: 250 mg, 500 mg. Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body,
contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250-mg capsule are
imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with
AMOXIL and 500.
Tablets: 500 mg, 875 mg. Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each
filmcoated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The
875-mg tablet is scored on the reverse side.
Powder for Oral Suspension: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL. Each 5 mL of
reconstituted bubble-gum-flavored suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the
trihydrate.
SIDE EFFECTS
The following are discussed in more detail in other sections of the labeling:
DRUG INTERACTIONS
Probenecid
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid
may result in increased and prolonged blood levels of amoxicillin.
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. 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
AMOXIL may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral
estrogen/progesterone contraceptives.
Other Antibacterials
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects
of penicillin. This has been demonstrated in vitro ; however, the clinical significance of this interaction is not well
documented.
Effects on Laboratory Tests
High urine concentrations of ampicillin 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 amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as
CLINISTIX) be used.
Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma
concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.
Read the Amoxil Drug Interactions Center for a complete guide to possible interactions
PRECAUTIONS
Anaphylactic Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients
on penicillin therapy including amoxicillin. Althoughanaphylaxis 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.
Potential for Microbial Overgrowth or Bacterial Resistance
The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If
superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted. Prescribing
AMOXIL either 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 evaluatecarcinogenic 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 nonmutagenic 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.
Last reviewed on RxList: 12/6/2011
This monograph has been modified to include the generic and brand name in many instances.
OVERDOSE
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
symptoms.Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients
after overdosage with amoxicillin1.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult
and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to
reduce the risk of amoxicillin 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.
Amoxicillin may be removed from circulation by hemodialysis.
CONTRAINDICATIONS
AMOXIL is contraindicated in patients who have experienced a serious hypersensitivity reaction
(e.g., anaphylaxis or Stevens-Johnson syndrome) to AMOXIL or to other -lactam antibiotics (e.g., penicillins
and cephalosporins).
REFERENCES
1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children
less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.
Last reviewed on RxList: 12/6/2011
This monograph has been modified to include the generic and brand name in many instances.
CLINICAL PHARMACOLOGY
Mechanism of Action
Amoxicillin is an antibacterial drug. [see Microbiology].
Pharmacokinetics
Absorption
Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect
of food on the absorption of amoxicillin from the tablets and suspension of AMOXIL has been partially
investigated; 400-mg and 875-mg formulations have been studied only when administered at the start of a light
meal.
Orally administered doses of 250-mg and 500-mg amoxicillin capsules result in average peak blood levels 1 to
2 hours after administration in the range of 3.5 mcg/mL to 5.0 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL,
respectively.
Mean amoxicillin pharmacokinetic parameters from an open, two-part, single-dose crossover bioequivalence
study in 27 adults comparing 875 mg of AMOXIL with 875 mg of AUGMENTIN (amoxicillin/clavulanate
potassium) showed that the 875-mg tablet of AMOXIL produces an AUC0- of 35.4 8.1 mcghr/mL and a
Cmax of 13.8 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast.
Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak
blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3.0 mcg/mL and 3.5 mcg/mL to 5.0
mcg/mL, respectively.
Oral administration of single doses of 400-mg chewable tablets and 400 mg/5 mL suspension of AMOXIL to 24
adult volunteers yielded comparable pharmacokinetic data:
Table 3: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL
suspension) in Healthy Adults
DOSE*
Amoxicillin
AUC 0- (MCGHR/ML)
CMAX (MCG/ML)
Amoxicillin (S.D.)
Amoxicillin (S.D.)
400 mg (5 mL of
suspension)
17.1 (3.1)
5.92 (1.62)
400 mg (1 chewable
tablet)
17.9 (2.4)
5.18 (1.64)
Distribution
Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except
when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound. Following a 1gram dose and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that
therapeutic levels were found in theinterstitial fluid.
Metabolism and Excretion
The half-life of amoxicillin is 61.3 minutes. Approximately 60% of an orally administered dose of amoxicillin is
excreted in the urine within 6 to 8 hours. Detectable serum levels are observed up to 8 hours after an orally
administered dose of amoxicillin. Since most of the amoxicillin is excreted unchanged in the urine, its excretion
can be delayed by concurrent administration of probenecid [see DRUG INTERACTIONS].
Microbiology
Mechanism of Action
Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active
multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.
Method of Resistance
Resistance to amoxicillin is mediated primarily through enzymes called beta-lactamases that cleave the betalactam ring of amoxicillin, rendering it inactive.
Amoxicillin has been shown to be active against most isolates of the bacteria listed below, both in vitro and in
clinical infections as described in theINDICATIONS AND USAGE section.
GRAM-POSITIVE BACTERIA
Enterococcus faecalis
Staphylococcus spp.
Streptococcus pneumoniae
Alpha and -hemolytic streptococci.
GRAM-NEGATIVE BACTERIA
Escherichia coli
Haemophilus influenzae
Neisseria gonorrhoeae
Proteus mirabilis
Helicobacter pylori
A report of Susceptible indicates the pathogen is likely to be inhibited if the antimicrobial compound in the
blood reaches concentrations that are usually achievable. A report of Intermediate indicates that result should
be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible
drugs, the test should be repeated. The intermediate category implies possible clinical applicability in body sites
where the drug is physiologically concentrated or in situations where high dosage of drug can be used. The
intermediate category also provides a buffer zone, which prevents small uncontrolled technical factors from
causing major discrepancies in interpretation. A report of Resistant indicates the pathogen is not likely to be
inhibited if the antimicrobial compound in the blood reaches concentrations that are usually achievable and
other therapy(ies) are likely to be preferred.
Quality Control
Susceptibility techniques require use of laboratory control microorganisms to control the technical aspects of
the laboratory standardized procedures. 2,3,4Standard ampicillin powder should provide the MIC values
described below. For the diffusion technique using the 10-mcg ampicillin disk, the criteria are provided in Table
5.
Table 5: Acceptable Quality Control Ranges for Amoxicillin
ATCC#
MIC RANGE
(MCG/ML)
DISC DIFFUSION
ZONE RANGE
(MM)
Escherichia coli
25922
2 to 8
16 to 22
Enterococcus
faecalis
29212
0.5 to 2
Haemophilus
influenzae
49247
2 to 8
29213
0.5 to 2
BACTERIA
Staphylococcus
aureus
25923
Streptococcus
pneumoniae
49619
13 to 21
27 to 35
0.06 to 0.25
Susceptibility Testing for Helicobacter pylori: Amoxicillin in vitrosusceptibility testing methods for
determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated,
or approved for testing H. pylori . Specimens for H. pylori and clarithromycin susceptibility test results should be
obtained on isolates from patients who fail triple therapy. If clarithromycin resistance is found, a nonclarithromycin-containing regimen should be used.
Clinical Studies
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Randomized, doubleblind clinical studies performed in the United States in patients with H. pylori and duodenal
ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of
lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in
combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori . Based on the
results of these studies, the safety and efficacy of 2 different eradication regimens were established: Triple
therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily
(see Table 6). Dual therapy:Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily
(seeTable 7). All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture
and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective
than all possible dual therapy combinations. Dual therapy was shown to be more effective than both
monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Table 6: H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy
Regimen
STUDY
Study 1
Study 2
TRIPLE THERAPY
TRIPLE THERAPY
EVALUABLE
ANALYSISA [95%
CONFIDENCE INTERVAL]
(NUMBER OF PATIENTS)
INTENT-TO-TREAT
ANALYSISB[95%
CONFIDENCE INTERVAL]
(NUMBER OF PATIENTS)
92
86
[80.0 - 97.7]
[73.3 - 93.5]
(n = 48)
(n = 55)
86
83
[75.7 - 93.6]
[72.0 - 90.8]
(n = 66)
(n = 70)
This analysis was based on evaluable patients with confirmed duodenal ulcer (active or
within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic
tests from CLOtest, histology, and/or culture. Patients were included in the analysis if they
completed the study. Additionally, if patients dropped out of the study due to an adverse
event related to the study drug, they were included in the analysis as failures of therapy.
b
Patients were included in the analysis if they had documented H. pylori infection at baseline
as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts
were included as failures of therapy.
a
Table 7: H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy
Regimen
STUDY
DUAL THERAPY
DUAL THERAPY
EVALUABLE
ANALYSISA[95%
CONFIDENCE
INTERVAL] (NUMBER
OF PATIENTS)
INTENT-TO-TREAT
ANALYSISB [95%
CONFIDENCE
INTERVAL] (NUMBER
OF PATIENTS)
Study 1
Study 2
77
70
[62.5 - 87.2]
[56.8 - 81.2]
(n = 51)
(n = 60)
66
61
[51.9 - 77.5]
[48.5 - 72.9]
This analysis was based on evaluable patients with confirmed duodenal ulcer (active or
within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic
tests from CLOtest, histology, and/or culture. Patients were included in the analysis if they
completed the study. Additionally, if patients dropped out of the study due to an adverse
event related to the study drug, they were included in the analysis as failures of therapy.
b
Patients were included in the analysis if they had documented H. pylori infection at baseline
as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts
were included as failures of therapy.
a
REFERENCES
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that
Grow Aerobically; Approved Standard 8th ed. CLSI Document M7-A8, Vol. 29, No.2. CLSI, Wayne, PA, Jan. 2009.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standard for Antimicrobial Disk Susceptibility Tests;
Approved Standard 10th ed. CLSI Document M2-A10, Vol. 29, No. 1. CLSI, Wayne, PA, 2009.
4. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: 21st
Informational Supplement. Approved Standard CLSI Document M100-S21 CLSI, Wayne, PA, January 2011.
Last reviewed on RxList: 12/6/2011
This monograph has been modified to include the generic and brand name in many instances.
PATIENT INFORMATION
Patients should be advised that AMOXIL may be taken every 8 hours or every 12 hours, depending on
the dose prescribed.
Patients should be counseled that antibacterial drugs, including AMOXIL, should only be used to treat
bacterial infections. They do not treat viral infections (e.g., the common cold). When AMOXIL is prescribed to
treat a bacterial infection, patients should be told that although it is common to feel better early in the course of
therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of
therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that
bacteria will develop resistance and will not be treatable by AMOXIL or other antibacterial drugs in the future.
Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually
ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can
develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more
months after having taken their last dose of the antibiotic. If this occurs, patients should contact their physician
as soon as possible.
Patients should be aware that AMOXIL contains a penicillin class drug product that can cause allergic
reactions in some individuals.
AMOXIL CONSUMER
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible
information about this product. This information does not assure that this product is safe, effective, or
appropriate for you. This information is not individual medical advice and does not substitute for the advice of
your health care professional. Always ask your health care professional for complete information about this
product and your specific health needs.
AMOXICILLIN - ORAL
(a-MOX-i-SIL-in)
COMMON BRAND NAME(S): Amoxil
USES: Amoxicillin is used to treat a wide variety of bacterial infections. This medication is a penicillin-type
antibiotic. It works by stopping the growth of bacteria.
This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu).
Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
Amoxicillin is also used with other medications to treat stomach/intestinal ulcers caused by the bacteria H.
pylori and to prevent the ulcers from returning.
OTHER USES: This section contains uses of this drug that are not listed in the approved US professional
labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition
that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used by people with certain heart problems (such as heart valve disease) before
medical/dental procedures (such as tooth/gum procedures) to prevent heart infection.
HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually every 8
or 12 hours. The dosage is based on your medical condition and response to treatment.
Drink plenty of fluids while using this medication unless your doctor tells you otherwise.
Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this
drug at evenly spaced intervals. To help you remember, take it at the same times each day.
Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a
few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a
return of the infection.
Tell your doctor if your condition persists or worsens.
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.
Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast
infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a
change in vaginal discharge or other new symptoms.
Tell your doctor immediately if any of these rare but serious side effects occur: dark urine, persistent nausea or
vomiting, stomach/abdominal pain, yellowing eyes or skin, easy bruising or bleeding, persistent sore throat or
fever.
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 the following symptoms
because these products may make them worse. Tell your doctor immediately if you develop: persistent
diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
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 your
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.
Read the Amoxil (amoxicillin) Side Effects Center for a complete guide to possible side effects
Learn More
PRECAUTIONS: Before taking amoxicillin, tell your doctor or pharmacist if you are allergic to it; or to penicillin
or cephalosporin antibiotics; or if you have any other allergies. This product may contain inactive ingredients,
which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease,
a certain type of viral infection (infectious mononucleosis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs,
nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits
with your doctor.
Amoxicillin passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at
the same time. This can increase your risk for serious side effects or may cause your medications not to work
correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often
prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all
the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting
treatment with this product. While using this product, do not start, stop, or change the dosage of any other
medicines you are using without your doctor's approval.
Some products that may interact with this drug include: live bacterial vaccines, methotrexate.
Before taking amoxicillin, tell your doctor or pharmacist if you are also taking probenecid. Probenecid slows
down the removal of amoxicillin from your body, causing higher levels of this antibiotic in your bloodstream. For
certain types of difficult-to-treat infections, your doctor may prescribe these 2 medications together in order to
achieve this effect. Consult your doctor or pharmacist for more details.
Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some
antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as
rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control
methods while using this antibiotic.
Amoxicillin may cause false positive results with certain diabetic urine testing products (cupric sulfate-type).
This drug may also affect the results of certain lab tests. Make sure laboratory personnel and your doctors
know you use this drug.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share
this list with your doctor and pharmacist to lessen your risk for serious medication problems.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US
residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial
poison control center. Symptoms of overdose may include: severe vomiting, persistent diarrhea, a severe
decrease in the amount of urine, or seizures.
NOTES: Do not share this medication with others.
This medication has been prescribed for your current condition only. Do not use it later for another infection
unless your doctor directs you to do so. A different medication may be necessary in that case.
With prolonged treatment, laboratory and/or medical tests (such as kidney and liver function, complete blood
counts) may be performed periodically to monitor your progress or check for side effects. Consult your doctor
for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip
the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature according to the product labeling, away from light and moisture.
Different brands of this medication have different storage needs. Check the product package for instructions on
how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard
this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company
for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
What is the most important information I should know about amoxicillin (Amoxil)?
What should I discuss with my healthcare provider before taking amoxicillin (Amoxil)?
fever, swollen glands, rash or itching, joint pain, or general ill feeling;
pale or yellowed skin, yellowing of the eyes, dark colored urine, fever, confusion or weakness;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under
your skin; 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.
Less serious side effects may include:
headache; or
What is the most important information I should know about amoxicillin (Amoxil)?
Do not use this medication if you are allergic to amoxicillin or to any other penicillin antibiotic, such as ampicillin
(Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK,
Pfizerpen), and others.
Before using amoxicillin, tell your doctor if you are allergic to cephalosporins such as Omnicef, Cefzil, Ceftin,
Keflex, and others. Also tell your doctor if you have asthma, liver or kidney disease, a bleeding or blood clotting
disorder, mononucleosis (also called "mono"), or any type of allergy.
Amoxicillin can make birth control pills less effective. Ask your doctor about using a non-hormone method of
birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy while taking amoxicillin.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is
completely cleared. Amoxicillin will not treat a viral infection such as the common cold or flu.
Do not share this medication with another person, even if they have the same symptoms you have.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is
watery or bloody, stop taking amoxicillin and call your doctor. Do not use anti-diarrhea medicine unless your
doctor tells you to.
Side Effects Centers
Amoxicillin
Moxatag
What is the most important information I should know about amoxicillin (Amoxil)?
What should I discuss with my healthcare provider before taking amoxicillin (Amoxil)?
What should I discuss with my healthcare provider before taking amoxicillin (Amoxil)?
Do not use this medication if you are allergic to amoxicillin or to any other penicillin antibiotic, such as:
oxacillin (Bactocill); or
asthma;
liver disease;
kidney disease;
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is
completely cleared. Amoxicillin will not treat a viral infection such as the common cold or flu.
Do not share this medication with another person, even if they have the same symptoms you have.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you
are using amoxicillin.
Store at room temperature away from moisture, heat, and light.
You may store liquid amoxicillin in a refrigerator but do not allow it to freeze. Throw away any liquid amoxicillin
that is not used within 14 days after it was mixed at the pharmacy.
Side Effects Centers
Amoxicillin
Moxatag
What is the most important information I should know about amoxicillin (Amoxil)?
What should I discuss with my healthcare provider before taking amoxicillin (Amoxil)?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is
watery or bloody, stop taking amoxicillin and call your doctor. Do not use anti-diarrhea medicine unless your
doctor tells you to.
probenecid (Benemid);
Remember, keep this and all other medicines out of the reach of children, never share your medicines
with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is
accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein
may be time sensitive. Multum information has been compiled for use by healthcare practitioners and
consumers in the United States and therefore Multum does not warrant that uses outside of the United States
are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs,
diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to
assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this
service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare
practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to
indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does
not assume any responsibility for any aspect of healthcare administered with the aid of information Multum
provides. The information contained herein is not intended to cover all possible uses, directions, precautions,
warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you
are taking, check with your doctor, nurse or pharmacist.
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What is the most important information I should know about amoxicillin (Amoxil)?
What should I discuss with my healthcare provider before taking amoxicillin (Amoxil)?
fever, swollen glands, rash or itching, joint pain, or general ill feeling;
pale or yellowed skin, yellowing of the eyes, dark colored urine, fever, confusion or weakness;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under
your skin; 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.
Less serious side effects may include:
headache; or
Read the Amoxil (amoxicillin) Side Effects Center for a complete guide to possible side effects
Learn More
What is the most important information I should know about amoxicillin (Amoxil)?
Do not use this medication if you are allergic to amoxicillin or to any other penicillin antibiotic, such as ampicillin
(Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK,
Pfizerpen), and others.
Before using amoxicillin, tell your doctor if you are allergic to cephalosporins such as Omnicef, Cefzil, Ceftin,
Keflex, and others. Also tell your doctor if you have asthma, liver or kidney disease, a bleeding or blood clotting
disorder, mononucleosis (also called "mono"), or any type of allergy.
Amoxicillin can make birth control pills less effective. Ask your doctor about using a non-hormone method of
birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy while taking amoxicillin.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is
completely cleared. Amoxicillin will not treat a viral infection such as the common cold or flu.
Do not share this medication with another person, even if they have the same symptoms you have.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is
watery or bloody, stop taking amoxicillin and call your doctor. Do not use anti-diarrhea medicine unless your
doctor tells you to.
What is the most important information I should know about amoxicillin (Amoxil)?
What should I discuss with my healthcare provider before taking amoxicillin (Amoxil)?
Amoxicillin is used to treat many different types of infections caused by bacteria, such as ear infections, bladder
infections, pneumonia, gonorrhea, and E. coli or salmonella infection. Amoxicillin is also sometimes used
together with another antibiotic called clarithromycin (Biaxin) to treat stomach ulcers caused by Helicobacter
pylori infection. This combination is sometimes used with a stomach acid reducer called lansoprazole
(Prevacid).
Amoxicillin may also be used for purposes not listed in this medication guide.
fever, swollen glands, rash or itching, joint pain, or general ill feeling;
pale or yellowed skin, yellowing of the eyes, dark colored urine, fever, confusion or weakness;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under
your skin; 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.
Less serious side effects may include:
headache; or
What is the most important information I should know about amoxicillin (Amoxil)?
Do not use this medication if you are allergic to amoxicillin or to any other penicillin antibiotic, such as ampicillin
(Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK,
Pfizerpen), and others.
Before using amoxicillin, tell your doctor if you are allergic to cephalosporins such as Omnicef, Cefzil, Ceftin,
Keflex, and others. Also tell your doctor if you have asthma, liver or kidney disease, a bleeding or blood clotting
disorder, mononucleosis (also called "mono"), or any type of allergy.
Amoxicillin can make birth control pills less effective. Ask your doctor about using a non-hormone method of
birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy while taking amoxicillin.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is
completely cleared. Amoxicillin will not treat a viral infection such as the common cold or flu.
Do not share this medication with another person, even if they have the same symptoms you have.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is
watery or bloody, stop taking amoxicillin and call your doctor. Do not use anti-diarrhea medicine unless your
doctor tells you to.
Side Effects Centers
Amoxicillin
Moxatag