Augmentin ES-600mg Susp 200ml

Manufacturer GLAXO SMITH KLINE Active Ingredient Amoxicillin and Clavulanate Oral Suspension (ES-600)(a moks i SIL in & klav yoo LAN ate) Pronunciation a moks i SIL in & klav yoo LAN ate
It is used to treat ear infections.
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Drug Class
Antibiotic, Beta-lactamase inhibitor combination
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Pharmacologic Class
Penicillin, Beta-lactamase inhibitor
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Pregnancy Category
Category B
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FDA Approved
Sep 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Augmentin ES-600 is an antibiotic medication used to treat certain bacterial infections, especially ear infections (acute otitis media) in children. It contains two active ingredients: amoxicillin, which kills bacteria, and clavulanate, which helps amoxicillin work better against bacteria that might otherwise be resistant.
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How to Use This Medicine

Taking This Medication

To ensure your child gets the most benefit from this medication, follow the doctor's instructions carefully. Read all the information provided and follow the instructions closely.

To minimize the risk of an upset stomach and maximize the medication's effectiveness, give it to your child at the start of a meal. Before administering, shake the liquid well and measure the dose accurately using the provided measuring device. If a measuring device is not included, ask your pharmacist for one to ensure precise measurement.

Continue giving your child this medication as directed by their doctor or healthcare provider, even if they seem to be feeling well.

Storing and Disposing of This Medication

Store the liquid suspension in the refrigerator, but do not freeze it. Discard any unused portion after 10 days. Note that some color change in the medication may occur during storage, but if you're unsure about this, consult your pharmacist.

Keep all medications in a secure location, out of the reach of children and pets.

Missing a Dose

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

  • Take this medication exactly as prescribed by your doctor, even if symptoms improve before the medication is finished. Stopping early can lead to resistant bacteria.
  • Shake the oral suspension well before each use.
  • Measure the dose accurately using the provided measuring spoon or oral syringe.
  • Take this medication at the start of a meal to reduce stomach upset and improve absorption.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 10 days.
  • Do not share this medication with others.
  • This medication is for bacterial infections only; it will not work for viral infections like the common cold or flu.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used in adults; other Augmentin formulations are available for adult dosing. Augmentin ES-600 is specifically formulated for pediatric use.
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Pediatric Dosing

Neonatal: Not established
Infant: For infants â‰Ĩ 3 months: 90 mg/kg/day (amoxicillin component) divided every 12 hours for 10 days. (e.g., 15 mL/kg/day of ES-600 suspension)
Child: For children â‰Ĩ 3 months: 90 mg/kg/day (amoxicillin component) divided every 12 hours for 10 days (e.g., 15 mL/kg/day of ES-600 suspension). Max dose: 600 mg amoxicillin/dose.
Adolescent: Not typically used in adolescents; other Augmentin formulations are available for adolescent dosing. If used, follow pediatric dosing based on weight, not exceeding adult maximums for other formulations.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for CrCl > 30 mL/min.
Moderate: CrCl 10-30 mL/min: Do not use Augmentin ES-600. Use other Augmentin formulations with a 250 mg or 500 mg amoxicillin component, dosed every 12 hours.
Severe: CrCl < 10 mL/min: Do not use Augmentin ES-600. Use other Augmentin formulations with a 250 mg or 500 mg amoxicillin component, dosed every 24 hours.
Dialysis: Hemodialysis: Do not use Augmentin ES-600. Use other Augmentin formulations with a 250 mg or 500 mg amoxicillin component, dosed every 24 hours, with an additional dose during and at the end of dialysis. Peritoneal Dialysis: Not well studied, generally avoid ES-600.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution; monitor liver function.
Severe: Use with caution; monitor liver function. Not recommended in patients with a history of Augmentin-associated cholestatic jaundice/hepatic dysfunction.

Pharmacology

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Mechanism of Action

Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial lysis. Clavulanate potassium is a beta-lactamase inhibitor that protects amoxicillin from degradation by beta-lactamase enzymes produced by many resistant bacteria, thereby extending amoxicillin's antibacterial spectrum.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90% for both amoxicillin and clavulanate.
Tmax: Amoxicillin: 1-2 hours; Clavulanate: 1-2 hours.
FoodEffect: Absorption is optimized when taken at the start of a meal. Taking with food reduces the potential for 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 in the absence of meningeal inflammation; increases with inflammation.

Elimination:

HalfLife: Amoxicillin: 1-1.3 hours; Clavulanate: 1-1.3 hours (in subjects with normal renal function).
Clearance: Primarily renal.
ExcretionRoute: Renal (glomerular filtration and tubular secretion) for amoxicillin; renal and non-renal for clavulanate.
Unchanged: Amoxicillin: Approximately 60-70% excreted unchanged in urine; Clavulanate: Approximately 25-40% excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Rapid, typically within 30 minutes to 1 hour.
PeakEffect: Corresponds to Tmax (1-2 hours).
DurationOfAction: Dependent on dosing interval, typically effective for 8-12 hours per dose.

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 or your child experience 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, 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 your child experiences:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
contact your child's doctor right away. Before treating diarrhea, consult with your child's doctor.
Liver problems, which can be fatal, have been associated with this medication. If your child exhibits signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
contact the doctor immediately.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. These reactions can affect body organs and be fatal. Seek medical help right away if your child experiences:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or any areas of skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only minor ones. If your child experiences any of the following side effects or any other side effects that bother them or do not go away, contact your child's doctor or seek medical help:

Diarrhea
Upset stomach
Vomiting
* Diaper rash

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact your child's doctor for medical advice.
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Seek Immediate Medical Attention If You Experience:

  • Severe allergic reaction (hives, difficulty breathing, swelling of your face, lips, tongue, or throat) - seek emergency medical attention.
  • Severe stomach pain, watery or bloody diarrhea (even months after your last dose) - contact your doctor immediately.
  • Yellowing of the skin or eyes (jaundice), dark urine, pale stools, unusual tiredness - contact your doctor immediately.
  • Easy bruising or bleeding, unusual weakness.
  • New signs of infection (e.g., oral thrush, vaginal yeast infection).
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Before Using This Medicine

Before Your Child Takes This Medication: Inform Your Doctor If:
- Your child has an allergy to this medication, any of its components, or other drugs, foods, or substances, and describe the allergic reaction they experienced.
- Your child is allergic to penicillin.
- Your child has kidney disease.
- Your child has previously experienced jaundice (turned yellow) or liver-related side effects while taking this medication.
- Your child has mononucleosis (mono).
- Your child is currently taking probenecid.

Important: This list does not encompass all possible drug interactions or health issues that may affect the use of this medication. It is crucial to inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins your child is taking, as well as any health problems they may have. Always verify with your doctor that it is safe to take this medication in conjunction with other drugs and health conditions. Never initiate, cease, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication.

If your child is taking this medication long-term, regular blood tests will be necessary to monitor their condition. Consult with your child's doctor to discuss the details.

This medication may interfere with certain laboratory tests. Be sure to notify all of your child's healthcare providers and laboratory personnel that your child is taking this medication.

For children with diabetes who undergo urine glucose testing, consult with your child's doctor to determine the most suitable testing methods.

If your child has phenylketonuria (PKU), consult with their doctor, as some products contain phenylalanine.

Do not administer this medication to your child for an extended period beyond the recommended duration, as this may increase the risk of a secondary infection.

A change in tooth color to yellow-gray-brown has been reported in some cases, primarily in children. In most instances, the discoloration lessened or resolved with regular brushing or dental cleaning. If you notice any changes in your child's tooth color, consult with their doctor.

For sexually active children:
Be aware that birth control pills and other hormone-based contraceptives may be less effective while taking this medication. It is recommended that your child uses an additional form of birth control, such as condoms, to prevent pregnancy.

For pregnant or breastfeeding children:
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the potential benefits and risks to both your child and the baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Call 911 or Poison Control at 1-800-222-1222 immediately. Treatment is generally supportive and symptomatic. Hemodialysis can remove amoxicillin and clavulanate from circulation.

Drug Interactions

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Major Interactions

  • Warfarin (increased INR, bleeding risk)
  • Methotrexate (increased methotrexate levels, toxicity, especially with high-dose methotrexate)
  • Oral Contraceptives (potential for reduced efficacy, though evidence is mixed)
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Moderate Interactions

  • Probenecid (increases and prolongs amoxicillin blood levels)
  • Allopurinol (increased incidence of skin rash, particularly in hyperuricemic patients)

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: To assess baseline kidney function, especially in patients with pre-existing renal impairment, as the drug is primarily renally eliminated.

Timing: Prior to initiation of therapy if renal impairment is suspected or known.

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline liver function, particularly in patients with a history of hepatic dysfunction, as hepatic dysfunction has been associated with Augmentin.

Timing: Prior to initiation of therapy if hepatic impairment is suspected or known.

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Routine Monitoring

Signs and symptoms of superinfection (e.g., oral thrush, vaginal yeast infection, new onset diarrhea)

Frequency: Daily during therapy and for several weeks post-therapy.

Target: Absence of new infections.

Action Threshold: Development of new or worsening symptoms; consider discontinuation and alternative therapy.

Renal function (BUN, creatinine)

Frequency: Periodically during prolonged therapy (e.g., >14 days) or in patients with known renal impairment.

Target: Within normal limits or stable for patient's baseline.

Action Threshold: Significant increase in BUN/creatinine; consider dose adjustment or discontinuation.

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically during prolonged therapy or in patients with known hepatic impairment.

Target: Within normal limits or stable for patient's baseline.

Action Threshold: Significant elevation of liver enzymes or bilirubin; consider discontinuation.

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Symptom Monitoring

  • Allergic reactions (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
  • Gastrointestinal disturbances (nausea, vomiting, diarrhea, abdominal pain)
  • Signs of C. difficile-associated diarrhea (severe, watery diarrhea, fever, abdominal cramps)
  • Signs of cholestatic jaundice or hepatitis (yellowing of skin/eyes, dark urine, pale stools, persistent nausea/vomiting)
  • Signs of superinfection (new or worsening symptoms of infection)

Special Patient Groups

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Pregnancy

Category B. Animal reproduction studies have shown no evidence of harm to the fetus. Human studies are limited but generally reassuring. Use only if clearly needed.

Trimester-Specific Risks:

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

Amoxicillin and clavulanate are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding, but monitor infant for potential adverse effects.

Infant Risk: Low risk. Potential for diarrhea, candidiasis (thrush, diaper rash), or sensitization in the breastfed infant. Observe infant for rash or gastrointestinal upset.
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Pediatric Use

Augmentin ES-600 is specifically formulated and dosed for pediatric patients, particularly for acute otitis media caused by penicillin-resistant S. pneumoniae. Dosing is weight-based (90 mg/kg/day of amoxicillin component). Not recommended for infants younger than 3 months.

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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. Dose adjustment is necessary for elderly patients with renal impairment.

Clinical Information

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Clinical Pearls

  • Augmentin ES-600 is specifically designed for pediatric acute otitis media (AOM) where high-dose amoxicillin is needed, particularly for suspected penicillin-resistant Streptococcus pneumoniae.
  • Always ensure the correct formulation (ES-600 vs. other Augmentin strengths) is dispensed, as the clavulanate ratio differs significantly.
  • Instruct patients to take the medication at the start of a meal to minimize gastrointestinal side effects and enhance absorption.
  • Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent the development of antibiotic resistance.
  • Counsel on the risk of C. difficile-associated diarrhea, which can occur during or even several weeks after antibiotic therapy.
  • Reconstituted suspension must be refrigerated and discarded after 10 days.
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Alternative Therapies

  • Ceftriaxone (for AOM, especially in severe cases or non-compliance)
  • Cefdinir (for AOM, but less effective against resistant S. pneumoniae)
  • Levofloxacin (for resistant infections, but generally avoided in pediatrics unless no other options)
  • Clindamycin (for penicillin-allergic patients, but limited spectrum)
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Cost & Coverage

Average Cost: Varies, typically $50-$150 per 200ml bottle
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred brand/non-preferred brand)
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General Drug Facts

If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safe and effective treatment, never share your child's medication with others, and do not administer someone else's medication to your child. Some medications may come with an additional patient information leaflet; if you have any questions or concerns about this medication, consult with your child's doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the quantity, and the time it occurred.