Augmentin 250-125mg Tablets

Manufacturer SMITHKLINE BEECHAM Active Ingredient Amoxicillin and Clavulanate Tablets(a moks i SIL in & klav yoo LAN ate) Pronunciation a-moks-i-SIL-in & klav-yoo-LAN-ate
It is used to treat bacterial infections.
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Drug Class
Antibiotic, Penicillin
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Pharmacologic Class
Beta-lactam antibiotic with beta-lactamase inhibitor
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Pregnancy Category
Category B
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FDA Approved
Sep 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Amoxicillin and clavulanate is an antibiotic medication used to treat bacterial infections. Amoxicillin kills bacteria, and clavulanate helps amoxicillin work better by protecting it from certain bacterial defenses.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. For optimal effectiveness and to minimize the risk of stomach upset, take this medication at the beginning of a meal. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure 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. 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 with food or at the start of a meal to reduce stomach upset.
  • Complete the full course of medication, even if you feel better, to prevent antibiotic resistance and ensure the infection is fully treated.
  • Do not save medication for future infections.
  • Stay hydrated, especially if experiencing diarrhea.
  • Avoid alcohol, as it may worsen gastrointestinal side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 500 mg amoxicillin/125 mg clavulanate every 8 hours OR 875 mg amoxicillin/125 mg clavulanate every 12 hours. (Note: 250-125mg formulation is less common for adults due to higher pill burden for standard doses, but can be used as 2 tablets of 250-125mg every 8 hours for 500mg amoxicillin equivalent).
Dose Range: 250 - 875 mg

Condition-Specific Dosing:

mild_moderate_infections: 250 mg amoxicillin/125 mg clavulanate every 8 hours (for 7-10 days)
severe_infections_respiratory_tract: 500 mg amoxicillin/125 mg clavulanate every 8 hours (or 875 mg/125 mg every 12 hours)
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Pediatric Dosing

Neonatal: Not established (use caution, specific dosing for neonates is complex and often based on weight and gestational age, typically not this formulation)
Infant: 20-45 mg amoxicillin/kg/day in divided doses every 8 or 12 hours (based on amoxicillin component). For 250-125mg tablet, this would be 20-45 mg/kg/day of amoxicillin. Max 125mg clavulanate/dose.
Child: 20-45 mg amoxicillin/kg/day in divided doses every 8 or 12 hours (based on amoxicillin component). Max 125mg clavulanate/dose. For 250-125mg tablet, a child weighing 25kg might take 250mg/125mg every 8 hours for 30mg/kg/day.
Adolescent: Similar to adult dosing, typically 20-45 mg amoxicillin/kg/day up to adult maximums. Often 500 mg amoxicillin/125 mg clavulanate every 8 hours or 875 mg amoxicillin/125 mg clavulanate 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 mg amoxicillin/125 mg clavulanate every 12 hours. (Do not use 875 mg/125 mg tablets).
Severe: CrCl <10 mL/min: 250 mg amoxicillin/125 mg clavulanate every 24 hours. (Do not use 875 mg/125 mg tablets).
Dialysis: Hemodialysis: 250 mg amoxicillin/125 mg clavulanate every 24 hours. Administer an additional dose during and at the end of dialysis. Peritoneal Dialysis: No specific recommendations, generally avoid due to lack of data.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution; monitor liver function.
Severe: Use with caution; monitor liver function. Dosage adjustment not specifically defined, but close monitoring is essential due to potential for hepatotoxicity.

Pharmacology

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Mechanism of Action

Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to one or more penicillin-binding proteins (PBPs), thereby interfering with the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall. This leads to bacterial cell lysis and death. Clavulanate potassium is a beta-lactamase inhibitor that protects amoxicillin from degradation by beta-lactamase enzymes produced by many resistant bacteria. Clavulanate binds irreversibly to these enzymes, extending the antibacterial spectrum of amoxicillin to include many beta-lactamase-producing strains.
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Pharmacokinetics

Absorption:

Bioavailability: Amoxicillin: 70-90%; Clavulanate: 60-70%
Tmax: Amoxicillin: 1-2 hours; Clavulanate: 1-2 hours
FoodEffect: Absorption is optimized when taken at the start of a meal to minimize potential gastrointestinal intolerance.

Distribution:

Vd: Amoxicillin: 0.3-0.4 L/kg; Clavulanate: 0.2 L/kg
ProteinBinding: Amoxicillin: 17-20%; Clavulanate: 22-30%
CnssPenetration: Limited (increases with inflamed meninges)

Elimination:

HalfLife: Amoxicillin: 1-1.3 hours; Clavulanate: 1 hour (both prolonged in renal impairment)
Clearance: Amoxicillin: Primarily renal; Clavulanate: Primarily renal
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Amoxicillin: 50-70%; Clavulanate: 25-40%
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Pharmacodynamics

OnsetOfAction: Rapid (within 1 hour)
PeakEffect: 1-2 hours
DurationOfAction: 8-12 hours (based on dosing frequency)

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
Vaginal irritation or discharge
Fever or chills
Unexplained bruising or bleeding
Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem. If you experience:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
Liver problems, which can be fatal, may occur with this medication. Seek medical help immediately if you notice:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may occur. These reactions can be fatal and may affect other body organs. 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

Not all side effects are severe, and many people may experience no side effects or only minor ones. However, if you notice any of the following side effects or if they bother you or do not go away, contact your doctor:

For all patients taking this medication:
+ Diarrhea
+ Upset stomach
+ Vomiting
* For children:
+ Diaper rash

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 allergic reaction (hives, difficulty breathing, swelling of face/throat)
  • Severe or watery diarrhea (especially if bloody or prolonged)
  • Yellowing of skin or eyes (jaundice)
  • Unusual bruising or bleeding
  • Dark urine or pale stools
  • Persistent nausea or vomiting
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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 conditions to ensure safe treatment:

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.
Existing kidney disease, as this may affect how your body processes the medication.
Previous experiences with liver problems or jaundice (turning yellow) while taking this medication.
If you have been diagnosed with mononucleosis (mono).
Current use of probenecid, as this may interact with the 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 health conditions and other medications. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 common side effect of this medication, 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.

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, planning to become pregnant, or breastfeeding, inform your doctor. You and your doctor 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:

  • Stomach pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Rash
  • Hyperactivity
  • Drowsiness
  • Renal dysfunction (crystalluria, renal failure)
  • Electrolyte imbalance

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is supportive and symptomatic. Hemodialysis can remove amoxicillin and clavulanate from circulation.

Drug Interactions

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Major Interactions

  • Allopurinol (increased risk of rash)
  • Methotrexate (decreased renal clearance of methotrexate, leading to increased toxicity)
  • Oral anticoagulants (e.g., Warfarin - increased INR/bleeding risk, mechanism unclear, possibly affecting gut flora or vitamin K synthesis)
  • Mycophenolate mofetil (reduced mycophenolic acid concentration, potentially reducing immunosuppressive effect)
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Moderate Interactions

  • Probenecid (decreased renal tubular secretion of amoxicillin, leading to increased and prolonged amoxicillin levels)
  • Oral contraceptives (potential for reduced efficacy due to altered gut flora, though evidence is weak)
  • Typhoid vaccine (live, oral) (antibiotics may inactivate the vaccine)
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Minor Interactions

  • Tetracyclines (may antagonize the bactericidal effect of amoxicillin)

Monitoring

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Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To establish baseline for potential hepatotoxicity, especially in patients with pre-existing hepatic impairment or risk factors.

Timing: Prior to initiation, if clinically indicated.

Renal function (CrCl, BUN, creatinine)

Rationale: To guide dosage adjustment in patients with renal impairment, as both components are primarily renally excreted.

Timing: Prior to initiation.

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Routine Monitoring

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

Frequency: Daily during therapy

Target: Absence of symptoms

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

Signs and symptoms of hepatotoxicity (jaundice, dark urine, abdominal pain, fatigue)

Frequency: Periodically, especially with prolonged use or in patients with risk factors

Target: Absence of symptoms; normal LFTs

Action Threshold: Elevated LFTs or clinical signs require discontinuation and evaluation.

Bowel habits (diarrhea)

Frequency: Daily during therapy

Target: Normal bowel movements

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

INR (for patients on warfarin)

Frequency: More frequently during co-administration and after discontinuation

Target: Therapeutic range for indication

Action Threshold: INR outside target range requires dose adjustment of anticoagulant.

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Symptom Monitoring

  • Rash
  • Itching
  • Hives
  • Difficulty breathing or swallowing
  • Swelling of face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • Hoarseness
  • Severe diarrhea (watery or bloody)
  • Stomach pain or cramps
  • Nausea
  • Vomiting
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Pale stools
  • Unusual tiredness or weakness
  • Fever
  • Sore throat
  • Easy bruising or bleeding

Special Patient Groups

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Pregnancy

Generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women, but extensive clinical experience suggests no increased risk of birth defects.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed.
Second Trimester: No specific risks identified.
Third Trimester: No specific risks identified.
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Lactation

Both amoxicillin and clavulanate are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding (Lactation Risk L2 - Safer).

Infant Risk: Potential for infant sensitization (allergic reaction), diarrhea, or candidiasis (thrush). Monitor breastfed infant for rash, diarrhea, or fungal infections. Benefits of breastfeeding generally outweigh potential risks.
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Pediatric Use

Dosing is weight-based (mg/kg/day) and depends on the severity of infection. The 250-125mg tablet formulation may be suitable for older children who can swallow tablets, but suspensions are often preferred for younger children. Ensure appropriate clavulanate limits are not exceeded, especially with higher amoxicillin doses.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is necessary in elderly patients with renal impairment. Monitor for adverse effects, especially gastrointestinal and hepatic.

Clinical Information

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Clinical Pearls

  • Always ensure the correct Augmentin formulation is prescribed and dispensed, as the amoxicillin to clavulanate ratio varies (e.g., 250/125, 500/125, 875/125). The 250-125mg tablet has a 2:1 ratio, while 500-125mg and 875-125mg have 4:1 and 7:1 ratios, respectively. This is crucial for avoiding excessive clavulanate exposure, which is associated with increased risk of diarrhea and hepatotoxicity.
  • Taking Augmentin with food helps to reduce gastrointestinal side effects like nausea and diarrhea.
  • Counsel patients on the importance of completing the full course of therapy to prevent resistance, even if symptoms improve.
  • Be vigilant for signs of C. difficile-associated diarrhea (CDAD), which can occur during or after antibiotic therapy.
  • Monitor liver function tests in patients with pre-existing hepatic impairment or those on prolonged therapy, as hepatotoxicity, though rare, can be severe.
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Alternative Therapies

  • Cephalosporins (e.g., Cefuroxime, Cefdinir)
  • Macrolides (e.g., Azithromycin, Clarithromycin) - if beta-lactam allergy or atypical pathogens
  • Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) - for specific indications and resistance patterns
  • Doxycycline (for certain respiratory or skin infections)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and formulation (e.g., $20-$100+) per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic or non-preferred 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; consult your pharmacist for more information. If you have any questions or concerns about this medication, we encourage you 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 quantity, and the time it occurred.