Amoxicillin 125mg Chewable Tablets

Manufacturer TEVA Active Ingredient Amoxicillin Chewable Tablets(a moks i SIL in) Pronunciation uh-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 that fights bacteria. It's used to treat many different types of infections, like ear infections, strep throat, and pneumonia. Chewable tablets are often given to children. It works by stopping bacteria from building their cell walls, which kills them.
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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 beginning of a meal to enhance its effectiveness and reduce the risk of stomach upset. Be sure to chew the medication thoroughly before swallowing. 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 the best way to dispose 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. Avoid taking two doses at the same time or taking extra doses.
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Lifestyle & Tips

  • Take exactly as prescribed, even if symptoms improve, to prevent antibiotic resistance.
  • Chew the tablet thoroughly before swallowing.
  • Can be taken with or without food.
  • Do not save unused medication for future infections.
  • Report any signs of allergic reaction (rash, itching, swelling, trouble breathing) immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used for adults; higher strengths preferred.
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Pediatric Dosing

Neonatal: Not established (use caution, specific dosing for neonates is weight-based and often different formulations)
Infant: 20-45 mg/kg/day in divided doses every 8-12 hours, depending on infection severity. Max 500 mg/dose.
Child: 20-45 mg/kg/day in divided doses every 8-12 hours, depending on infection severity. Max 500 mg/dose.
Adolescent: 250-500 mg every 8 hours or 500-875 mg every 12 hours (higher strengths typically used).
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Dose Adjustments

Renal Impairment:

Mild: CrCl >30 mL/min: No 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.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.

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 inhibits the transpeptidation step of peptidoglycan synthesis, leading to bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 75-90%
Tmax: 1-2 hours
FoodEffect: Minimal effect; can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: 1-1.5 hours (normal renal function)
Clearance: Not available
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 60-80%
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: 6-8 hours (antibacterial effect, dependent on MIC)

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, some 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 first.
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 severe side effects, and some may not have any side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea
Upset stomach
Vomiting
Headache

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:

  • Severe rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or wheezing
  • Severe or watery diarrhea, especially if it contains blood or mucus
  • Unusual bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
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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 symptoms you experienced as a result of the allergy.
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.

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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.

Individuals with phenylketonuria (PKU) should discuss this condition with their doctor, as some products may contain phenylalanine.

Do not take this medication for longer than prescribed, as this may increase the risk of a second infection. A common side effect, particularly in children, is a change in tooth color to yellow-gray-brown. In most cases, this discoloration can be reduced or eliminated with regular brushing or dental cleaning. If you notice any changes in tooth color, consult with your doctor.

Women taking birth control pills or other hormone-based contraceptives should be aware that this medication may reduce their effectiveness. To prevent 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 (rare, especially with high doses)
  • Renal failure (rare)

What to Do:

Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention. Treatment is generally supportive; hemodialysis can remove amoxicillin from circulation.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity)
  • Warfarin (increased INR/bleeding risk, monitor INR)
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Moderate Interactions

  • Allopurinol (increased risk of amoxicillin-induced rash)
  • Oral contraceptives (potential decrease in efficacy, though clinical significance debated)
  • Tetracyclines (may antagonize amoxicillin's bactericidal effect)
  • Probenecid (increases amoxicillin plasma levels and prolongs half-life)

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: Amoxicillin is primarily renally excreted; dose adjustment may be needed in renal impairment.

Timing: Prior to initiation in patients with known or suspected renal impairment.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily

Target: Resolution of infection symptoms

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days; consider alternative diagnosis or treatment.

Signs of adverse reactions (e.g., rash, diarrhea)

Frequency: Daily

Target: Absence of significant adverse effects

Action Threshold: Development of rash, severe diarrhea, or other concerning symptoms; discontinue if severe allergic reaction.

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Symptom Monitoring

  • Skin rash or hives (signs of allergic reaction)
  • Difficulty breathing or swallowing (signs of severe allergic reaction)
  • Severe or persistent diarrhea (may indicate C. difficile infection)
  • Nausea, vomiting, abdominal pain
  • Unusual bruising or bleeding (if on warfarin)
  • Oral thrush or vaginal yeast infection (signs of superinfection)

Special Patient Groups

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Pregnancy

Considered generally safe for use during pregnancy. Amoxicillin is a Category B drug, meaning animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women, or animal studies have shown an adverse effect but human studies have not.

Trimester-Specific Risks:

First Trimester: Low risk; widely used.
Second Trimester: Low risk; widely used.
Third Trimester: Low risk; widely used.
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Lactation

Considered safe for use during breastfeeding (L1 - Safest). Amoxicillin is excreted in breast milk in small amounts. Monitor infant for potential diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

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

Amoxicillin chewable tablets are commonly used and well-tolerated in pediatric patients. Dosing is weight-based and adjusted for age and infection type. Close monitoring for allergic reactions is important.

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Geriatric Use

No specific dose adjustment is needed based solely on age. However, geriatric patients are more likely to have decreased renal function, which may necessitate dose 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 chewable tablets are ideal for pediatric patients who have difficulty swallowing pills.
  • Ensure the patient chews the tablet completely to ensure proper absorption and avoid choking hazards.
  • Counsel patients on the importance of completing the full course of antibiotics, even if symptoms improve, to prevent resistance.
  • Amoxicillin is a common cause of non-allergic rash, especially in patients with mononucleosis. Differentiate this from a true allergic reaction.
  • While food does not significantly affect absorption, taking it with food may help reduce gastrointestinal upset.
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Alternative Therapies

  • Cephalexin (Keflex) - another beta-lactam antibiotic
  • Azithromycin (Zithromax) - macrolide antibiotic
  • Clindamycin (Cleocin) - lincosamide antibiotic
  • Cefdinir (Omnicef) - third-generation cephalosporin
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (125mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (preferred 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.