Amoxicillin 250mg Chew Tablets

Manufacturer TEVA PHARMACEUTICALS USA Active Ingredient Amoxicillin Chewable 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. Chewable tablets should be chewed or crushed before swallowing.
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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 is 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.
  • Chew the chewable tablet thoroughly before swallowing, or crush it and mix with a small amount of liquid or soft food.
  • Drink plenty of fluids while taking this medication.
  • If you experience diarrhea, especially severe or persistent diarrhea, contact your doctor. Do not take anti-diarrhea medication without consulting your doctor.
  • Avoid sharing this medication with others, even if they have similar symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg to 875 mg orally every 8 or 12 hours, depending on indication and severity.
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: 500 mg every 12 hours or 250 mg every 8 hours for 10-14 days.
Sinusitis: 250-500 mg every 8 hours or 500-875 mg every 12 hours for 10-14 days.
Lower Respiratory Tract Infections: 500 mg every 12 hours or 250 mg every 8 hours for 7-10 days.
Skin/Skin Structure Infections: 500 mg every 12 hours or 250 mg every 8 hours for 7-10 days.
H. pylori Eradication: 1000 mg twice daily in combination with other agents for 14 days.
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing for certain conditions (e.g., neonatal sepsis prophylaxis) may exist but requires specialist guidance.
Infant: 20-45 mg/kg/day divided every 8 or 12 hours, depending on indication. Max 500 mg/dose.
Child: 20-90 mg/kg/day divided every 8 or 12 hours, depending on indication and severity. Max 875 mg/dose or 1750 mg/day.
Adolescent: Typically adult dosing, 250-875 mg every 8 or 12 hours, depending on indication.
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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; administer an additional dose during and at the end of dialysis. Peritoneal Dialysis: 250 mg every 12 hours.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed; use with caution in patients with severe hepatic dysfunction.

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 enzymes located on the bacterial cell membrane. This binding prevents the cross-linking of peptidoglycan chains, leading to the disruption of the cell wall and subsequent bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 70-90%
Tmax: 1-2 hours
FoodEffect: Food does not significantly affect the absorption of amoxicillin. It can be taken with or without food.

Distribution:

Vd: 0.3-0.4 L/kg
ProteinBinding: Approximately 17-20%
CnssPenetration: Limited (penetrates poorly into CSF unless meninges are inflamed)

Elimination:

HalfLife: 1-1.5 hours (in adults with normal renal function)
Clearance: Approximately 250-300 mL/min (renal clearance)
ExcretionRoute: Primarily renal (glomerular filtration and tubular secretion)
Unchanged: Approximately 60% of an oral dose is excreted unchanged in the urine within 6-8 hours.
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Pharmacodynamics

OnsetOfAction: Rapid (within 30 minutes to 1 hour)
PeakEffect: 1-2 hours (corresponds to Tmax)
DurationOfAction: Dependent on dosing frequency (e.g., 8 or 12 hours), maintaining concentrations above 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, such as 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. This can lead to a life-threatening bowel problem. If you experience:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
+ Seek medical help right away
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions
+ These reactions 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 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 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:

  • Severe allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
  • Severe or watery diarrhea, especially if it contains blood or mucus (may be a sign of C. difficile infection)
  • Unusual bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Persistent sore throat or fever (may indicate a new infection or lack of response to treatment)
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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 and its symptoms.
If you are allergic to penicillin, as this may impact your ability to take this medication.
* If you have been diagnosed with mononucleosis (mono), as this condition may affect the use of 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 with your existing 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 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.

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 of this drug, particularly in children, is a change in tooth color to a yellow-gray-brown hue. 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, consider using 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. It is necessary 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 (in severe cases, leading to renal failure)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is generally supportive and may include gastric lavage or activated charcoal if ingestion was recent. Hemodialysis can remove amoxicillin from circulation.

Drug Interactions

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Major Interactions

  • Methotrexate: Amoxicillin may decrease the renal tubular secretion of methotrexate, potentially increasing methotrexate plasma concentrations and toxicity.
  • Warfarin: Increased INR and bleeding risk reported with co-administration, likely due to effects on gut flora and vitamin K synthesis.
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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: Penicillins may reduce the efficacy of oral contraceptives by interfering with enterohepatic recirculation of estrogens. Advise backup contraception.
  • Probenecid: Decreases the renal tubular secretion of amoxicillin, resulting in increased and prolonged blood levels of amoxicillin.
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Minor Interactions

  • Tetracyclines: May antagonize the bactericidal effect of amoxicillin due to their bacteriostatic action.

Monitoring

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Baseline Monitoring

Allergy history (penicillins, cephalosporins)

Rationale: To prevent severe hypersensitivity reactions.

Timing: Prior to initiation of therapy.

Renal function (CrCl)

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

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

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Routine Monitoring

Clinical response to therapy (resolution of symptoms)

Frequency: Daily during treatment, then at follow-up.

Target: Improvement in signs/symptoms of infection.

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

Signs/symptoms of hypersensitivity reaction (rash, itching, dyspnea)

Frequency: Daily during treatment and for several days post-treatment.

Target: Absence of allergic symptoms.

Action Threshold: Any sign of allergic reaction requires immediate discontinuation.

Gastrointestinal symptoms (diarrhea, nausea, vomiting)

Frequency: Daily during treatment.

Target: Absence or mild, tolerable GI upset.

Action Threshold: Severe or persistent diarrhea may indicate C. difficile infection and requires investigation.

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Symptom Monitoring

  • Rash
  • Itching
  • Hives
  • Swelling (face, lips, tongue, throat)
  • Difficulty breathing or swallowing
  • Severe or persistent diarrhea
  • Abdominal pain
  • Nausea
  • Vomiting
  • Unusual bruising or bleeding
  • Yellowing of skin or eyes (jaundice)
  • Dark urine

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; no increased risk of congenital malformations observed.
Second Trimester: Low risk; commonly used for infections.
Third Trimester: Low risk; commonly used for infections, including Group B Strep prophylaxis.
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Lactation

Amoxicillin is considered compatible with breastfeeding (Lactation Risk L1). It is excreted in breast milk in small amounts, but adverse effects in breastfed infants are rare. Monitor for potential diarrhea, candidiasis (thrush), or allergic reactions in the infant.

Infant Risk: Low risk; generally considered safe.
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Pediatric Use

Widely used and generally safe in pediatric patients. Dosing is weight-based and varies by indication and severity. Chewable tablets are suitable for children who can chew safely. Close monitoring for allergic reactions and gastrointestinal side effects is important.

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Geriatric Use

No specific dose adjustment is needed based on age alone. However, elderly patients are more likely to have decreased renal function, which may necessitate dose adjustments based on creatinine clearance. Monitor renal function and for potential adverse effects.

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 not effective against beta-lactamase producing bacteria unless combined with a beta-lactamase inhibitor (e.g., amoxicillin/clavulanate).
  • A non-allergic, maculopapular rash can occur, especially in patients with mononucleosis or cytomegalovirus infection, and should not be confused with a true penicillin allergy.
  • Chewable tablets must be chewed or crushed completely before swallowing to ensure proper absorption and avoid choking hazards, especially in young children.
  • Always complete the full course of antibiotics to prevent the development of antibiotic resistance, even if symptoms improve.
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Alternative Therapies

  • Penicillin V (for susceptible streptococcal infections)
  • Cephalexin (a first-generation cephalosporin)
  • Cefdinir (a third-generation cephalosporin)
  • Azithromycin (a macrolide, for penicillin-allergic patients or atypical pathogens)
  • Clindamycin (for anaerobic infections or penicillin-allergic patients)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (250mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic) or Tier 2 (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 your 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 medication taken, the amount, and the time it happened.