Amoxicillin 500mg Tablets

Manufacturer CITRON Active Ingredient Amoxicillin Capsules and Tablets(a moks i SIL in) Pronunciation a moks i SIL in
It is used to treat bacterial infections.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antibiotic
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Pharmacologic Class
Beta-lactam antibiotic; Penicillin
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Pregnancy Category
Category B
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FDA Approved
Jan 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Amoxicillin is an antibiotic medication used to treat various bacterial infections, such as ear infections, strep throat, pneumonia, and skin infections. It works by stopping the growth of bacteria. It is not effective against viral infections like the common cold or flu.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the start of a meal to help your body absorb it effectively and reduce the risk of stomach upset. Establish a routine by taking your medication at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed by your doctor, even if you start to feel better. Do not skip doses or stop taking it early, as this can lead to antibiotic resistance.
  • Amoxicillin can be taken with or without food. If it causes stomach upset, taking it with food may help.
  • Drink plenty of fluids while taking this medication.
  • If you are taking oral contraceptives, discuss with your doctor if additional birth control methods are needed, as amoxicillin might reduce their effectiveness (though this is debated).

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg to 500 mg every 8 hours or 500 mg to 875 mg every 12 hours, depending on infection severity and type.
Dose Range: 250 - 875 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis: 500 mg every 12 hours or 250 mg every 8 hours for 10 days.
Otitis Media: 875 mg every 12 hours or 500 mg every 8 hours for 10 days.
Lower Respiratory Tract Infections: 875 mg every 12 hours or 500 mg every 8 hours for 10-14 days.
Skin/Skin Structure Infections: 875 mg every 12 hours or 500 mg every 8 hours for 7-14 days.
H. pylori Eradication: 1000 mg twice daily in combination with other agents for 7-14 days.
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing based on weight and gestational age for severe infections, typically 20-40 mg/kg/day divided every 8-12 hours.
Infant: 20-45 mg/kg/day divided every 8-12 hours, depending on infection severity. Max 1000 mg/day.
Child: 20-45 mg/kg/day divided every 8-12 hours, depending on infection severity. Max 1000 mg/day. For severe infections (e.g., otitis media), up to 80-90 mg/kg/day divided every 12 hours.
Adolescent: Adult dosing applies once weight exceeds typical pediatric range (e.g., >40 kg), or 20-45 mg/kg/day divided every 8-12 hours, up to adult maximum.
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Dose Adjustments

Renal Impairment:

Mild: CrCl >30 mL/min: No dosage adjustment needed.
Moderate: CrCl 10-30 mL/min: 250 mg or 500 mg every 12 hours, depending on infection severity.
Severe: CrCl <10 mL/min: 250 mg or 500 mg every 24 hours, depending on infection severity.
Dialysis: Hemodialysis: 250 mg or 500 mg every 24 hours, with an additional dose given during and/or at the end of dialysis. Peritoneal Dialysis: 250 mg or 500 mg every 12-24 hours.

Hepatic Impairment:

Mild: No dosage adjustment generally needed.
Moderate: No dosage adjustment generally needed.
Severe: No dosage adjustment generally needed; use with caution and monitor for signs of hepatic dysfunction.

Pharmacology

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Mechanism of Action

Amoxicillin is a bactericidal beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to one or more penicillin-binding proteins (PBPs). This binding prevents the cross-linking of peptidoglycan chains, which are essential components of the bacterial cell wall, leading to cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 75-90%
Tmax: 1-2 hours
FoodEffect: Food does not significantly affect the absorption of amoxicillin, so it can be taken with or without food.

Distribution:

Vd: 0.3-0.4 L/kg
ProteinBinding: Approximately 17-20%
CnssPenetration: Limited (increases with inflamed meninges)

Elimination:

HalfLife: 1-1.5 hours (normal renal function)
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Approximately 60% of an oral dose is excreted unchanged in urine within 6-8 hours.
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Pharmacodynamics

OnsetOfAction: Rapid (within 30 minutes to 1 hour)
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: Dependent on dosing frequency (e.g., 8-12 hours)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of drug-induced enterocolitis syndrome, a type of allergic reaction, such as:
+ Vomiting within 1 to 4 hours after taking this medication
+ Diarrhea within 24 hours after taking this medication
+ Pale or gray skin
+ Feeling tired or unwell
+ Signs of low blood pressure, including severe dizziness or passing out
Unexplained bruising or bleeding
Fever or chills
Vaginal itching or discharge
Diarrhea is a common side effect of antibiotics, but rarely, a severe form called C. diff-associated diarrhea (CDAD) may occur. If you experience:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
+ Contact your doctor right away. Do not treat diarrhea without consulting your doctor.
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening. Seek medical help immediately if you notice:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in your mouth, throat, nose, eyes, genitals, or any areas of skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Diarrhea
Upset stomach
Vomiting
Headache

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of a severe allergic reaction: rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing or swallowing. Seek immediate medical attention.
  • Severe or watery diarrhea, especially if it contains blood or mucus, with or without fever and abdominal cramps. This could be a sign of a serious intestinal infection (C. difficile).
  • Unusual bruising or bleeding.
  • Yellowing of the skin or eyes (jaundice).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are allergic to penicillin, as this may impact your ability to take this medication safely.
* If you have been diagnosed with mononucleosis (mono), as this condition may affect how you respond to this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug long-term, your doctor may recommend regular blood tests to monitor your condition.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and lab personnel that you are taking this drug. If you have diabetes and test your urine glucose levels, consult with your doctor to determine the most suitable tests to use.

Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.

A common side effect of this drug is a change in tooth color, which may appear as yellow, gray, or brown. This has been reported primarily in children, but the color change often lessens or disappears with regular brushing or dental cleaning. If you notice any changes in tooth color, consult with your doctor.

When taking this medication, birth control pills and other hormone-based birth control methods may be less effective in preventing pregnancy. To minimize the risk of unplanned pregnancy, use an additional form of birth control, such as a condom, while taking this drug.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Crystalluria (in severe cases, leading to renal failure)

What to Do:

In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive, including gastric lavage or activated charcoal if ingestion is recent, and maintaining adequate fluid intake to promote renal excretion.

Drug Interactions

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Major Interactions

  • Methotrexate: Amoxicillin may decrease renal tubular secretion of methotrexate, increasing its plasma concentrations and potential toxicity.
  • Warfarin: May enhance the anticoagulant effect of warfarin, increasing the risk of bleeding (mechanism unclear, possibly related to gut flora alteration).
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Moderate Interactions

  • Allopurinol: Concomitant use with amoxicillin may increase the incidence of skin rash, particularly in patients with hyperuricemia.
  • Oral Contraceptives: Amoxicillin may reduce the efficacy of oral contraceptives by altering gut flora and enterohepatic recirculation of estrogens (though evidence is controversial, advise backup contraception).
  • Probenecid: Decreases renal tubular secretion of amoxicillin, leading to increased and prolonged plasma concentrations of amoxicillin.
  • Tetracyclines: May antagonize the bactericidal effect of amoxicillin (bacteriostatic vs. bactericidal).
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Minor Interactions

  • Live Typhoid Vaccine (Ty21a): Antibiotics, including amoxicillin, may reduce the immunologic response to the live attenuated typhoid vaccine.

Monitoring

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Baseline Monitoring

Allergy history (especially to penicillins or cephalosporins)

Rationale: To prevent severe hypersensitivity reactions.

Timing: Prior to initiation of therapy.

Renal function (CrCl, BUN, creatinine)

Rationale: To guide dosage adjustment in patients with renal impairment.

Timing: Prior to initiation, especially in elderly or those with known renal issues.

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Routine Monitoring

Clinical response to therapy (e.g., fever, symptom resolution)

Frequency: Daily during acute treatment

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or incorrect diagnosis.

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)

Frequency: Daily during and after therapy

Target: Absence of new infections

Action Threshold: Development of new symptoms requires evaluation and potential discontinuation/treatment.

Renal function (BUN, creatinine)

Frequency: Periodically, especially in prolonged therapy or renal impairment

Target: Within patient's baseline or acceptable limits

Action Threshold: Significant increase may require dose adjustment or discontinuation.

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Symptom Monitoring

  • Skin rash, itching, hives (signs of allergic reaction)
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Difficulty breathing or swallowing (anaphylaxis)
  • Severe or watery diarrhea, abdominal cramps, fever (Clostridioides difficile-associated diarrhea)
  • Nausea, vomiting, abdominal pain
  • Unusual bleeding or bruising (if on anticoagulants)
  • Yellowing of skin or eyes, dark urine (hepatic dysfunction, rare)

Special Patient Groups

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Pregnancy

Amoxicillin is generally considered safe for use during pregnancy (Pregnancy Category B). Studies in animals have not shown harm to the fetus, and there is no evidence of harm in well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Low risk; no increased risk of congenital malformations observed.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Amoxicillin is excreted in small amounts into breast milk. It is generally considered compatible with breastfeeding (Lactation Risk L1).

Infant Risk: Low risk. Potential for mild adverse effects in the infant such as diarrhea, candidiasis (thrush, diaper rash), or allergic sensitization. Monitor breastfed infants for these effects.
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Pediatric Use

Dosing is weight-based and adjusted for age and severity of infection. Generally well-tolerated. Oral suspension is available for easier administration. Close monitoring for diarrhea and rash is important.

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Geriatric Use

No specific dosage adjustment is needed based solely on age, but renal function should be assessed, as elderly patients are more likely to have decreased renal clearance. Monitor for adverse effects, especially gastrointestinal disturbances and superinfections.

Clinical Information

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Clinical Pearls

  • Amoxicillin is a first-line agent for many common bacterial infections due to its broad spectrum, good oral bioavailability, and favorable safety profile.
  • It is often preferred over penicillin V for its improved absorption and less frequent dosing.
  • Always complete the full course of therapy to prevent antibiotic resistance and ensure eradication of the infection.
  • Advise patients to report any signs of allergic reaction immediately, even if mild, as subsequent exposures can lead to more severe reactions.
  • Amoxicillin is ineffective against beta-lactamase producing bacteria; for these, amoxicillin/clavulanate (Augmentin) is typically used.
  • For H. pylori eradication, amoxicillin is used as part of a multi-drug regimen.
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Alternative Therapies

  • Penicillin V (for susceptible streptococcal infections)
  • Cephalexin (Keflex) - a first-generation cephalosporin
  • Azithromycin (Zithromax) - a macrolide, for penicillin-allergic patients or atypical pathogens
  • Clindamycin (Cleocin) - for anaerobic infections or penicillin-allergic patients
  • Doxycycline (Vibramycin) - a tetracycline, for various bacterial infections
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (500mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.