Augmentin 400mg/5ml Susp100ml

Manufacturer GLAXO SMITH KLINE Active Ingredient Amoxicillin and Clavulanate Suspension(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
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Pharmacologic Class
Beta-lactam antibiotic; 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?

Augmentin is an antibiotic medicine used to treat bacterial infections. It contains two ingredients: amoxicillin, which kills bacteria, and clavulanate, which helps amoxicillin work better by protecting it from certain bacterial defenses. It is important to take this medicine exactly as prescribed and to finish the entire course, even if you feel better, to prevent the infection from returning.
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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.

To minimize the risk of stomach upset and ensure the medication works effectively, take it at the start of a meal. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.

Before using the medication, shake the bottle well. If you are taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing.

Storing and Disposing of Your Medication

Store the liquid suspension in the refrigerator, but do not freeze it. Discard any unused portion after 10 days. You may notice a color change in the medication over time, which can be normal for some products. If you are unsure, consult with your pharmacist.

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

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 this medicine at the start of a meal to reduce stomach upset and improve absorption.
  • Shake the suspension well before each use.
  • Measure the dose accurately using the provided measuring spoon or oral syringe.
  • Refrigerate the reconstituted suspension and discard any unused portion after 10 days.
  • Do not share this medication with others.
  • Avoid alcohol consumption, as it may worsen gastrointestinal side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used for standard adult dosing; adult formulations (e.g., 500mg/125mg or 875mg/125mg tablets) are preferred. If suspension is used, dose based on amoxicillin component, e.g., 500mg amoxicillin/125mg clavulanate every 8 hours or 875mg amoxicillin/125mg clavulanate every 12 hours.

Condition-Specific Dosing:

severeInfections: Higher end of dosing range, e.g., 875mg/125mg every 12 hours (tablet equivalent).
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Pediatric Dosing

Neonatal: Not established for neonates (<12 weeks).
Infant: For infants â‰Ĩ 12 weeks: Dosing based on amoxicillin component. For otitis media, sinusitis, lower respiratory tract infections: 90 mg/kg/day (amoxicillin component) in 2 divided doses every 12 hours for 10 days (using 400mg/57mg per 5ml formulation). For less severe infections: 20-45 mg/kg/day (amoxicillin component) in 2-3 divided doses.
Child: For children: Dosing based on amoxicillin component. For otitis media, sinusitis, lower respiratory tract infections: 90 mg/kg/day (amoxicillin component) in 2 divided doses every 12 hours for 10 days (using 400mg/57mg per 5ml formulation). For less severe infections: 20-45 mg/kg/day (amoxicillin component) in 2-3 divided doses. Max 1750mg amoxicillin/day.
Adolescent: Dosing typically follows adult guidelines or pediatric high-dose guidelines if weight-based dosing exceeds adult maximums. Max 1750mg amoxicillin/day.
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 30 mL/min: No adjustment needed.
Moderate: CrCl 10-30 mL/min: 250mg/125mg every 12 hours (or equivalent amoxicillin dose).
Severe: CrCl < 10 mL/min: 250mg/125mg every 24 hours (or equivalent amoxicillin dose).
Dialysis: Hemodialysis: 250mg/125mg every 24 hours. Administer an additional dose during and at the end of dialysis. Peritoneal dialysis: No specific recommendations, use with caution.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution; monitor liver function. No specific dose adjustment.
Severe: Use with caution; monitor liver function. No specific dose adjustment.

Pharmacology

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Mechanism of Action

Amoxicillin, a beta-lactam antibiotic, inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death. Clavulanate potassium is a beta-lactamase inhibitor that irreversibly binds to and inactivates a wide range of bacterial beta-lactamase enzymes, preventing the degradation of amoxicillin and extending its antibacterial spectrum.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70% 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, which also helps to minimize gastrointestinal intolerance.

Distribution:

Vd: Amoxicillin: 0.3-0.4 L/kg; Clavulanate: 0.2 L/kg.
ProteinBinding: Amoxicillin: Approximately 18%; Clavulanate: Approximately 25%.
CnssPenetration: Limited in the absence of meningeal inflammation; increased with inflamed meninges.

Elimination:

HalfLife: Amoxicillin: 1-1.5 hours; Clavulanate: 1-1.5 hours (in individuals with normal renal function).
Clearance: Primarily renal clearance.
ExcretionRoute: Renal (glomerular filtration and tubular secretion) for amoxicillin; renal and non-renal for clavulanate.
Unchanged: Amoxicillin: Approximately 60-80%; Clavulanate: Approximately 25-40%.
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Pharmacodynamics

OnsetOfAction: Rapid, typically within 1 hour.
PeakEffect: Within 1-2 hours of administration.
DurationOfAction: Dependent on dosing frequency (e.g., 8-12 hours).
Confidence: Medium

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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or 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 fainting
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 life-threatening bowel problems. If you experience:
+ Stomach pain or cramps
+ Very loose, watery, or bloody stools
+ Contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.
Liver problems, which can be fatal, may occur with this medication. Seek medical help right away if you experience:
+ 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 affect body organs and be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, eyes, genitals, or 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 are concerned about any side effects or if they persist, contact your doctor:

Common side effects for all patients taking this medication:
+ Diarrhea
+ Upset stomach
+ Vomiting
* Common side effects in children:
+ Diaper rash

Reporting Side Effects

This list is not exhaustive. 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 watery diarrhea or bloody stools (may occur up to 2 months after stopping the medicine)
  • New or worsening skin rash, hives, or itching
  • Difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat (signs of a severe allergic reaction)
  • Yellowing of the skin or eyes (jaundice), dark urine, pale stools (signs of liver problems)
  • Unusual bruising or bleeding
  • Fever, sore throat, or other signs of new infection (superinfection)
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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 affect your ability to take this medication.
Existing kidney disease, as this may impact the medication's effectiveness or increase the risk of side effects.
Previous experiences with liver problems or jaundice (turning yellow) while taking this medication.
If you have been diagnosed with mononucleosis (mono).
If you are currently taking 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 treatments and health conditions. 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.

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. 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:

  • Gastrointestinal symptoms (e.g., abdominal pain, vomiting, diarrhea)
  • Rash
  • Hyperactivity
  • Drowsiness
  • Renal tubular damage (rare)
  • Crystalluria (rare, 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 largely symptomatic and supportive. 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)
  • Allopurinol (increased incidence of rash)
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Moderate Interactions

  • Oral Contraceptives (potential for reduced efficacy)
  • Probenecid (increased and prolonged amoxicillin blood levels)
  • Mycophenolate Mofetil (reduced mycophenolic acid (MPA) concentrations)

Monitoring

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Baseline Monitoring

Hypersensitivity history

Rationale: To identify potential allergic reactions to penicillins or cephalosporins.

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.

Liver function tests (ALT, AST, bilirubin)

Rationale: To establish baseline, especially in patients with pre-existing hepatic impairment or history of liver dysfunction.

Timing: Prior to initiation, if clinically indicated.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily, or as clinically indicated.

Target: Resolution of infection symptoms (e.g., fever, pain, inflammation).

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

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

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

Target: Absence of new infections.

Action Threshold: Development of new symptoms requires evaluation and appropriate treatment.

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, especially during prolonged therapy or in patients with pre-existing hepatic impairment.

Target: Within normal limits or stable.

Action Threshold: Significant elevation may require discontinuation.

Renal function (CrCl, BUN, creatinine)

Frequency: Periodically, especially during prolonged therapy or in patients with renal impairment.

Target: Stable or within acceptable limits.

Action Threshold: Significant decline may require dose adjustment or discontinuation.

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Symptom Monitoring

  • Skin rash or itching (signs of allergic reaction)
  • Severe or persistent diarrhea (may indicate C. difficile infection)
  • Nausea, vomiting, abdominal pain
  • Yellowing of skin or eyes (jaundice), dark urine, pale stools (signs of liver problems)
  • Difficulty breathing or swallowing, swelling of face/lips/tongue (signs of severe allergic reaction)
  • Unusual bruising or bleeding

Special Patient Groups

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Pregnancy

Augmentin is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.

Trimester-Specific Risks:

First Trimester: Generally considered low risk, but use with caution and only if clinically indicated.
Second Trimester: Generally considered low risk.
Third Trimester: Generally considered low risk. There have been reports of necrotizing enterocolitis in neonates born to mothers receiving amoxicillin/clavulanate during pregnancy, though a causal link is not definitively established.
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Lactation

Amoxicillin and clavulanate are excreted into breast milk. While generally considered compatible with breastfeeding (Lactation Risk L2), caution is advised. Monitor breastfed infants for potential adverse effects.

Infant Risk: Low risk. Potential for infant sensitization, diarrhea, candidiasis (thrush), or rash. Benefits of breastfeeding should be weighed against potential risks to the infant.
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Pediatric Use

Dosing is weight-based and specific formulations (e.g., 400mg/57mg per 5ml, 600mg/42.9mg per 5ml) are designed to provide appropriate amoxicillin doses while minimizing clavulanate exposure. Not recommended for neonates (<12 weeks of age) due to immature renal function.

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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. Increased risk of gastrointestinal side effects and C. difficile infection.

Clinical Information

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Clinical Pearls

  • Always ensure the correct formulation (e.g., 400mg/57mg per 5ml vs. 600mg/42.9mg per 5ml) is prescribed and dispensed, as the clavulanate ratio differs and affects dosing, especially in pediatrics.
  • Instruct patients to take Augmentin at the start of a meal to minimize gastrointestinal upset, which is a common side effect.
  • Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent bacterial resistance and relapse.
  • Reconstituted suspension must be refrigerated and discarded after 10 days.
  • Augmentin is not effective against viral infections; avoid inappropriate prescribing to reduce antibiotic resistance.
  • High incidence of diarrhea is common; advise patients on managing this side effect and to report severe or persistent diarrhea.
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Alternative Therapies

  • Cephalosporins (e.g., Cefdinir, Cefpodoxime, Cefuroxime)
  • Macrolides (e.g., Azithromycin, Clarithromycin) - for atypical pathogens or penicillin allergy
  • Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) - for specific indications and older patients
  • Tetracyclines (e.g., Doxycycline) - for specific indications and older children/adults
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 100ml bottle of 400mg/5ml suspension
Generic Available: Yes
Insurance Coverage: Generic formulations are typically covered as Tier 1 or Tier 2 by most insurance plans. Brand-name Augmentin may be Tier 3 or higher.
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.