Amoxicillin

What is Amoxicillin?

• Amoxicillin is a penicillin-class antibacterial used to treat a number of bacterial infections.

Amoxicillin

Amoxicillin2

What are the uses of this medicine?

Amoxicillin is used for treatment of fallowing infections due to susceptible strains of designated microorganisms:

• Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract.
• In combination for treatment of H. pylori infection and duodenal ulcer disease.

Amoxicillin has been shown to be active against most isolates of the bacteria listed below:

Gram-Positive Bacteria:

• Enterococcus faecalis
• Staphylococcus spp
• Streptococcus pneumoniae
• Streptococcus spp (alpha and beta-hemolytic)

Gram-Negative Bacteria:

• Escherichia coli
• Haemophilus influenzae
• Helicobacter pylori
• Proteus mirabilis

How does this medicine work?

• Amoxicillin is an antibacterial drug.
• 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.
• Resistance to amoxicillin is mediated primarily through enzymes called beta-lactamases that cleave the beta-lactam ring of amoxicillin, rendering it inactive.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin capsules or to other β-lactam antibiotics (e.g., penicillins and cephalosporins).

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• allopurinol (Lopurin, Zyloprim)
• other antibiotics
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• oral contraceptives
• probenecid (Probalan, in Col-Probenecid)

Is this medicine FDA approved?

• Amoxicillin (a mox' i sil' in) is an orally available aminopenicillin that has been available in the United States since 1980, for which currently more than 50 million prescriptions are filled yearly.

How should this medicine be used?

Recommended dosage:

• In adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours.
• In Pediatric Patients > 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours.
• The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours.

Dosing for H. pylori Infection:

• Triple Therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
• Dual Therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

• Reduce the dose in patients with severe renal impairment (GFR <30 mL/min).

Administration:

• Amoxicillin comes as a capsule, a tablet, a chewable tablet, and as a suspension (liquid) to take by mouth.
• It is usually taken every 12 hours (twice a day) or every 8 hours (three times a day) with or without food.
• The length of your treatment depends on the type of infection that you have.
• Take amoxicillin at around the same times every day.
• Shake the suspension well before each use to mix the medication evenly.
• The suspension may be placed directly on the child's tongue or added to formula, milk, fruit juice, water, ginger ale, or another cold liquid and taken immediately.
• The chewable tablets should be crushed or chewed thoroughly before they are swallowed.
• Swallow the tablets and capsules whole with a full glass of water; do not chew or crush them.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a capsule, a tablet, a chewable tablet, and as a suspension (liquid)

This medicine is available in fallowing brand namesː

• Amoxil
• Amoxil Pediatric
• Dispermox
• Larotid Suspension
• Moxtag
• Polymox Suspension
• Trimox
• Trimox Pediatric Drops
• Wymox
• Talicia

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• diarrhea
• changes in taste
• headache
• Tooth discoloration
• Mucocutaneous candidiasis

Amoxicillin may cause some serious side effects which may include:

• Hypersensitivity Reactions
• Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis
• Crystalluria
• Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis
• Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness

• The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/lansoprazole) were diarrhea, headache, and taste perversion.
• The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea and headache.

What special precautions should I follow?

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy instituted.
• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, 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. 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.
• Prescribing amoxicillin 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.
• 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.
• Patients should be counseled that antibacterial drugs, including amoxicillin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• When amoxicillin 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.
• 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.
• 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.
• Amoxicillin and other aminopenicillins have been linked with idiosyncratic liver injury, but only rarely and in isolated case reports.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Crystalluria, in some cases leading to renal failure
• Interstitial nephritis

Management of overdosage:

• In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required.
• 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.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• 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.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• AMOXICILLIN

Inactive Ingredients:

• MICROCRYSTALLINE CELLULOSE
• D&C RED NO. 28
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GELATIN, UNSPECIFIED
• MAGNESIUM STEARATE
• TITANIUM DIOXIDE
• SODIUM LAURYL SULFATE

Who manufactures and distributes this medicine?

Manufactured for:

• Northstar Rx LLC
• Memphis, TN .

Manufactured by:

• Aurobindo Pharma Limited
• Hyderabad, India.

What should I know about storage and disposal of this medication?

• 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F.
• Dispense in a tight container.

Penicillin antibiotics

• penicillins first generation (natural penicillins)
  • benzathine penicillin, procaine penicillin, penicillin g, penicillin v, penicillin vk

• penicillins second generation (penicillinase-resistant penicillins)
  • cloxacillin, dicloxacillin, flucloxacillin, methicillin, nafcillin, oxacillin

• penicillins third generation (aminopenicillins)
  • amoxicillin, ampicillin, ampicillin-sulbactam, bacampicillin, pivampicillin
• see also amoxicillin-clavulanate

• penicillins fourth generation (extended-spectrum penicillins)
  • carbenicillin, mezlocillin, piperacillin, piperacillin-tazobactam, ticarcillin, ticarcillin-clavulanate

• Dailymed label info on Amoxicillin
• FDA Amoxicillin

Amoxicillin Resources
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