Augmentin 400mg/5ml Susp75ml

Manufacturer GLAXOSMITH 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.
đŸˇī¸
Drug Class
Antibiotic
đŸ§Ŧ
Pharmacologic Class
Beta-lactam antibiotic; Beta-lactamase inhibitor combination
🤰
Pregnancy Category
Category B
✅
FDA Approved
Sep 1984
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Augmentin is an antibiotic that fights bacteria. It contains two medicines: amoxicillin, which kills bacteria, and clavulanate, which helps amoxicillin work better by stopping bacteria from destroying it. It's used to treat various bacterial infections.
📋

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 beginning of a meal. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better.

Before using the liquid form of this medication, shake the bottle well. Measure the liquid dose accurately using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one to ensure you take the correct dose.

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 about this, consult 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.
💡

Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Shake the suspension well before each use.
  • Use the provided measuring spoon or cup for accurate dosing.
  • Complete the entire course of medication, even if symptoms improve, to prevent resistance.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 10 days.
  • Do not share this medication with others.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

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

Condition-Specific Dosing:

Severe infections (e.g., lower respiratory tract infections, severe sinusitis): 875 mg amoxicillin / 125 mg clavulanate every 12 hours OR 500 mg amoxicillin / 125 mg clavulanate every 8 hours. (Equivalent suspension volume would be 10.94 mL of 400/57 per 5mL for 875mg dose, or 6.25 mL for 500mg dose).
Less severe infections (e.g., skin and skin structure infections, urinary tract infections): 500 mg amoxicillin / 125 mg clavulanate every 12 hours OR 250 mg amoxicillin / 125 mg clavulanate every 8 hours. (Equivalent suspension volume would be 6.25 mL of 400/57 per 5mL for 500mg dose, or 3.13 mL for 250mg dose).
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established for routine use; use with caution and specific guidance.
Infant: Dosing based on amoxicillin component (mg/kg/day) divided every 12 hours. For 400mg/5ml (80mg amoxicillin/mL): 25-45 mg/kg/day for mild-moderate infections; 45-90 mg/kg/day for severe infections (e.g., otitis media, severe sinusitis). Max 1000 mg amoxicillin/day.
Child: Dosing based on amoxicillin component (mg/kg/day) divided every 12 hours. For 400mg/5ml (80mg amoxicillin/mL): 25-45 mg/kg/day for mild-moderate infections; 45-90 mg/kg/day for severe infections (e.g., otitis media, severe sinusitis). Max 1000 mg amoxicillin/day.
Adolescent: Dosing based on amoxicillin component (mg/kg/day) divided every 12 hours, or adult dosing if weight allows. For 400mg/5ml (80mg amoxicillin/mL): 25-45 mg/kg/day for mild-moderate infections; 45-90 mg/kg/day for severe infections (e.g., otitis media, severe sinusitis). Max 1000 mg amoxicillin/day.
âš•ī¸

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 (or equivalent suspension volume).
Severe: CrCl < 10 mL/min: 250 mg amoxicillin / 125 mg clavulanate every 24 hours (or equivalent suspension volume).
Dialysis: Hemodialysis: 250 mg amoxicillin / 125 mg clavulanate every 24 hours, with an additional dose during and at the end of dialysis. Peritoneal Dialysis: No specific recommendations, generally avoid or use with extreme caution.

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

đŸ”Ŧ

Mechanism of Action

Amoxicillin is a beta-lactam antibiotic that 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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Amoxicillin: 70-90%; Clavulanate: 60-75%
Tmax: Amoxicillin: 1-2 hours; Clavulanate: 1-2 hours
FoodEffect: Absorption is optimized when taken at the start of a meal to minimize 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: 1-1.5 hours; Clavulanate: 1 hour
Clearance: Amoxicillin: Renal clearance; Clavulanate: Renal and non-renal clearance
ExcretionRoute: Amoxicillin: Primarily renal (unchanged); Clavulanate: Renal (partially unchanged) and non-renal
Unchanged: Amoxicillin: 60-70%; Clavulanate: 25-45%
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (within 1 hour)
PeakEffect: 1-2 hours
DurationOfAction: Dependent on dosing frequency (e.g., 8-12 hours)

Safety & Warnings

âš ī¸

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
+ Contact your doctor right away. Before treating diarrhea, consult with your doctor.
Liver problems have been reported with this medication, and in rare cases, have been fatal. Seek medical attention immediately 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 be fatal and may also affect internal organs. Seek medical help right away if you experience:
+ 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

All medications can cause side effects, but many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe or watery diarrhea (especially if persistent or bloody)
  • New or worsening rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat (signs of severe allergic reaction)
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bruising or bleeding
  • Dark urine or pale stools
📋

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), as this may require special consideration.
Current use of probenecid, as this medication may interact with the drug.

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 medications. Never start, stop, or change the dose of any medication without consulting your doctor first.
âš ī¸

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 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 you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Gastrointestinal symptoms (nausea, vomiting, diarrhea)
  • Abdominal pain
  • Electrolyte imbalance
  • Crystalluria (in cases of very high doses, leading to renal failure)
  • Convulsions (rare, in patients with impaired renal function or high doses)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is largely supportive, including hydration to maintain urine output and hemodialysis to remove drug from circulation.

Drug Interactions

🔴

Major Interactions

  • Warfarin (increased INR, bleeding risk)
  • Methotrexate (increased methotrexate levels, toxicity)
  • Allopurinol (increased incidence of rash)
🟡

Moderate Interactions

  • Oral Contraceptives (potential reduced efficacy)
  • Probenecid (increased and prolonged amoxicillin levels)
  • Mycophenolate Mofetil (reduced mycophenolic acid concentration)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Culture and Sensitivity

Rationale: To identify the causative pathogen and confirm susceptibility to amoxicillin/clavulanate.

Timing: Prior to initiation of therapy, if clinically appropriate.

📊

Routine Monitoring

Clinical Response

Frequency: Daily during acute treatment

Target: Resolution of symptoms, reduction in fever, improvement in infection markers.

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

Liver Function Tests (ALT, AST, Bilirubin)

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

Target: Within normal limits or stable.

Action Threshold: Significant elevation may indicate drug-induced liver injury; consider discontinuation.

Renal Function (CrCl)

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

Target: Stable or improving.

Action Threshold: Deterioration may require dose adjustment.

đŸ‘ī¸

Symptom Monitoring

  • Diarrhea (especially severe or persistent, indicative of C. difficile infection)
  • Rash (maculopapular, urticarial, or severe cutaneous reactions)
  • Nausea/Vomiting
  • Abdominal pain
  • Signs of superinfection (e.g., oral thrush, vaginal yeast infection)
  • Signs of allergic reaction (e.g., swelling of face/throat, difficulty breathing)

Special Patient Groups

🤰

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. Generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed.
Second Trimester: No increased risk of major birth defects observed.
Third Trimester: No increased risk of major birth defects observed; however, caution is advised near term due to potential for neonatal adverse effects (e.g., necrotizing enterocolitis in premature infants, though causality is not firmly established).
🤱

Lactation

L2 (Likely Compatible). Amoxicillin and clavulanate are excreted in small amounts into breast milk. Generally considered compatible with breastfeeding, but monitor infant for potential adverse effects.

Infant Risk: Low risk. Potential for diarrhea, candidiasis (thrush), or allergic sensitization in the breastfed infant. Observe infant for rash or gastrointestinal upset.
đŸ‘ļ

Pediatric Use

Widely used in pediatric patients. Dosing is weight-based (mg/kg/day) and adjusted according to the severity and type of infection. The 400mg/5ml formulation is specifically designed for pediatric use.

👴

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 in elderly patients with renal impairment.

Clinical Information

💎

Clinical Pearls

  • Always shake the oral suspension well before each dose.
  • Refrigerate the reconstituted suspension and discard after 10 days.
  • Administer at the start of a meal to enhance absorption and minimize gastrointestinal intolerance.
  • Not effective against viral infections; avoid inappropriate use to prevent antibiotic resistance.
  • Patients with a history of penicillin allergy should not receive Augmentin due to cross-reactivity.
  • Monitor for signs of C. difficile-associated diarrhea, which can occur even weeks after discontinuation.
🔄

Alternative Therapies

  • Cephalosporins (e.g., Cefdinir, Cefpodoxime, Cefuroxime for respiratory/skin infections)
  • Macrolides (e.g., Azithromycin, Clarithromycin for atypical pathogens or penicillin allergy)
  • Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin for specific severe infections, generally avoided in pediatrics)
  • Other broad-spectrum antibiotics depending on the specific pathogen and site of infection.
💰

Cost & Coverage

Average Cost: Varies widely, typically $20-$60 for a 75ml bottle of generic suspension per 75ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Brand) on most commercial and Medicare Part D plans.
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 happened.