Amoxicillin 500mg Capsules

Manufacturer AUROBINDO 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
Penicillin; Beta-lactam antibiotic
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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 a wide range of 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

To get the most benefit from this medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take this medication at the start of a meal to help it work effectively and reduce the risk of stomach upset. Consistency is key, so take this medication at the same time every day. Even if you're feeling well, continue taking this medication as directed by your doctor or healthcare provider.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs 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. Avoid taking two doses at the same time or taking extra doses.
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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 you are taking the liquid suspension, shake it well before each use and measure with a special dose-measuring spoon or cup, not a household spoon.
  • Drink plenty of fluids while taking this medication.
  • If you develop diarrhea, especially severe or bloody diarrhea, contact your doctor immediately. Do not take anti-diarrhea medication without consulting your doctor.
  • Avoid alcohol consumption as it may worsen gastrointestinal side effects, though no direct interaction is known.

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:

mild_moderate_infection: 250 mg every 8 hours or 500 mg every 12 hours
severe_infection: 500 mg every 8 hours or 875 mg every 12 hours
gonorrhea: 3 g as a single oral dose
H_pylori_eradication: 1 g twice daily (as part of multi-drug regimen)
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Pediatric Dosing

Neonatal: Not established for routine use; consult specific guidelines for premature/neonatal dosing (e.g., 20-40 mg/kg/day divided every 8-12 hours, max 500 mg/dose).
Infant: 20-45 mg/kg/day divided every 8-12 hours (max 500 mg/dose)
Child: 20-45 mg/kg/day divided every 8-12 hours (max 500 mg/dose for most infections, up to 875 mg/dose for severe infections)
Adolescent: Same as adult dosing, typically 250-500 mg every 8 hours or 500-875 mg every 12 hours.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: Use with caution; monitor for signs of hepatic dysfunction. No specific dose adjustment guidelines available, as it is minimally metabolized by the liver.
Confidence: Medium

Pharmacology

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Mechanism of Action

Amoxicillin is a bactericidal beta-lactam antibiotic. It inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which are essential for bacterial cell wall formation. This inhibition leads to the disruption of peptidoglycan synthesis, resulting in bacterial 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: 50-70% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: Dependent on dosing interval (typically 8-12 hours for therapeutic effect)
Confidence: High

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
+ If you notice signs such as:
- 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
+ Seek medical help immediately.

Other Possible Side Effects

Like all medications, this drug may cause side effects. Many people experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Upset stomach
Vomiting
Headache

This is not an exhaustive list of possible 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: hives, difficulty breathing, swelling of your face, lips, tongue, or throat. Seek emergency medical attention immediately.
  • Severe stomach pain, watery or bloody diarrhea (may occur up to 2 months after stopping treatment).
  • Unusual bruising or bleeding.
  • Pale skin, unusual tiredness, shortness of breath, cold hands and feet.
  • Fever, sore throat, swollen glands, joint pain, general ill feeling (signs of serum sickness-like reaction).
  • Dark urine, clay-colored stools, jaundice (yellowing of skin or eyes).
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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 (OTC) 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.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. They will work with you to determine the best course of treatment and minimize potential interactions or complications.
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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 for an extended period, 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 possible side effect of this medication is a change in tooth color to a yellow-gray-brown hue, which has been reported primarily in children. In most cases, the discoloration lessens or resolves 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 this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Crystalluria (crystals in urine, potentially leading to renal failure in severe cases)
  • Neurological effects (e.g., seizures) in patients with severe renal impairment or very high doses

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive and symptomatic. Hemodialysis can remove amoxicillin from circulation in cases of severe overdose with renal impairment.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity due to reduced renal clearance)
  • Warfarin (increased INR and bleeding risk; mechanism unclear, possibly affecting gut flora or direct interaction)
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Moderate Interactions

  • Allopurinol (increased incidence of skin rash, especially in hyperuricemic patients)
  • Oral Contraceptives (may reduce efficacy of oral contraceptives, though evidence is controversial and not consistently supported by clinical studies)
  • Tetracyclines (may antagonize the bactericidal effect of amoxicillin)
  • Probenecid (increases and prolongs amoxicillin plasma levels by decreasing renal tubular secretion)
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Confidence Interactions

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To guide dosage adjustment in patients with impaired renal function.

Timing: Prior to initiation, especially in elderly or those with suspected renal impairment.

Allergy history (penicillins, cephalosporins)

Rationale: To prevent severe hypersensitivity reactions.

Timing: Prior to initiation.

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Routine Monitoring

Signs and symptoms of infection resolution

Frequency: Daily

Target: Resolution of fever, pain, inflammation

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure or resistant organism.

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, C. difficile-associated diarrhea)

Frequency: Daily

Target: Absence of new infections

Action Threshold: Development of new symptoms (e.g., white patches in mouth, vaginal itching/discharge, severe diarrhea) requires evaluation and potential treatment.

INR (if on warfarin)

Frequency: More frequently (e.g., 2-3 times per week) during co-administration and for a few days after discontinuation.

Target: Individualized therapeutic range

Action Threshold: Significant increase in INR requires warfarin dose adjustment.

Renal function (CrCl)

Frequency: Periodically during prolonged therapy or if renal function changes are suspected.

Target: Stable CrCl

Action Threshold: Significant decline in CrCl requires dose adjustment.

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Symptom Monitoring

  • Rash (maculopapular, urticarial)
  • Diarrhea (especially severe or bloody)
  • Nausea/Vomiting
  • Abdominal pain
  • Signs of allergic reaction (hives, itching, swelling of face/lips/tongue, difficulty breathing)
  • Signs of superinfection (new fever, persistent sore throat, vaginal itching/discharge, white patches in mouth)

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. It is often used to treat infections during pregnancy.

Trimester-Specific Risks:

First Trimester: Low risk; commonly used for infections like UTIs.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Amoxicillin is considered compatible with breastfeeding (Lactation Risk L1). It is excreted into breast milk in small amounts. While generally safe, monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions (e.g., rash).

Infant Risk: Low risk; potential for mild gastrointestinal upset or sensitization.
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Pediatric Use

Amoxicillin is widely used and generally safe in pediatric patients. Dosing is typically weight-based. Care should be taken to ensure accurate dosing, especially with liquid formulations. Monitor for rash, diarrhea, and signs of superinfection.

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Geriatric Use

No specific dosage adjustment is needed based solely on age. However, elderly patients are more likely to have decreased renal function, which necessitates dosage adjustment based on creatinine clearance. Monitor for adverse effects, especially gastrointestinal disturbances and potential for C. difficile infection.

Clinical Information

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Clinical Pearls

  • Amoxicillin is a first-line agent for many common bacterial infections, including acute otitis media, streptococcal pharyngitis, and community-acquired pneumonia.
  • It is often combined with clavulanate (Augmentin) to extend its spectrum of activity against beta-lactamase producing bacteria.
  • Patients with infectious mononucleosis who take amoxicillin (or other penicillins) are at a high risk (70-90%) of developing a non-allergic maculopapular rash.
  • Advise patients to complete the full course of therapy, even if symptoms improve, to prevent resistance and recurrence.
  • Liquid suspensions should be refrigerated after reconstitution and discarded after 14 days.
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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)
  • Doxycycline (for certain respiratory or skin infections)
  • Clindamycin (for anaerobic infections or skin/soft tissue infections)
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Cost & Coverage

Average Cost: $10 - $30 per 30 capsules (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's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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.