Augmentin 125mg/5ml Susp 100ml

Manufacturer ALLEGIS PHARMACEUTICALS 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 (penicillin) and beta-lactamase inhibitor combination
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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 a wide range of bacterial infections, such as ear infections, sinus infections, skin infections, and urinary tract infections. Amoxicillin kills bacteria, and clavulanate helps amoxicillin work better by stopping certain bacteria from destroying it.
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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 help it work effectively and reduce the risk of stomach upset. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

Before using the liquid form of this medication, shake the bottle well. Measure the liquid dose carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one to ensure accurate dosing.

Storing and Disposing of Your Medication

Store the liquid (suspension) form of this medication 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 may be normal for some products. If you are unsure, consult with your pharmacist. Keep all medications in a safe place, 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 a missed dose.
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Lifestyle & Tips

  • Take this medication exactly as prescribed by your doctor, usually at the start of a meal to reduce stomach upset.
  • Shake the suspension well before each use.
  • Use an accurate measuring spoon or oral syringe to measure the dose, not a household spoon.
  • Complete the entire course of medication, even if you start feeling better. Stopping early can lead to the infection coming back and bacteria becoming resistant to antibiotics.
  • Store the suspension in the refrigerator and discard any unused portion after 10 days (or as directed by pharmacist/label).
  • Do not share this medication with others.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used for adult dosing due to concentration. Standard adult dosing for amoxicillin/clavulanate is 500 mg/125 mg every 8 hours or 875 mg/125 mg every 12 hours.

Condition-Specific Dosing:

Note: This specific 125mg/5ml suspension is primarily for pediatric use. Adult dosing would require impractically large volumes.
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Pediatric Dosing

Neonatal: Not established for routine use in neonates. Use with caution and specific guidance.
Infant: 20-45 mg/kg/day (amoxicillin component) divided every 8-12 hours. For otitis media, sinusitis, lower respiratory tract infections, typically 45 mg/kg/day.
Child: 20-45 mg/kg/day (amoxicillin component) divided every 8-12 hours. For otitis media, sinusitis, lower respiratory tract infections, typically 45 mg/kg/day. Max 1000 mg amoxicillin/day.
Adolescent: Similar to child dosing based on weight, or adult dosing if weight/age appropriate (e.g., >40 kg, can use adult formulations). For this suspension, follow pediatric mg/kg dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl >30 mL/min)
Moderate: Administer 250 mg/62.5 mg or 500 mg/125 mg every 12 hours (CrCl 10-30 mL/min)
Severe: Administer 250 mg/62.5 mg or 500 mg/125 mg every 24 hours (CrCl <10 mL/min)
Dialysis: Administer 250 mg/62.5 mg or 500 mg/125 mg every 24 hours; administer an additional dose during and at the end of dialysis. Amoxicillin and clavulanate are removed by hemodialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution; monitor hepatic function at regular intervals.
Severe: Use with caution; monitor hepatic function at regular intervals. Not recommended in patients with a history of amoxicillin/clavulanate-associated cholestatic jaundice/hepatic dysfunction.

Pharmacology

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Mechanism of Action

Amoxicillin is a penicillin-class beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to one or more penicillin-binding proteins (PBPs), thereby inhibiting 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 many beta-lactamase enzymes produced by resistant bacteria, extending the antibacterial spectrum of amoxicillin.
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Pharmacokinetics

Absorption:

Bioavailability: Amoxicillin: 70-90%; Clavulanate: 60%
Tmax: Amoxicillin: 1-2 hours; Clavulanate: 1 hour
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: ~18%; Clavulanate: ~25%
CnssPenetration: Limited in non-inflamed meninges; increased with inflamed meninges.

Elimination:

HalfLife: Amoxicillin: ~1-1.3 hours; Clavulanate: ~1 hour
Clearance: Renal clearance is primary route.
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Amoxicillin: 50-70%; Clavulanate: 25-40%
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Pharmacodynamics

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

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
+ Contact your doctor immediately. 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 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 life-threatening and may affect other organs. 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 any areas of skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands

Other Possible Side Effects

Not everyone experiences side effects, and many people have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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

Reporting Side Effects

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 your face, lips, tongue, or throat. Seek emergency medical attention immediately.
  • Severe stomach pain, watery or bloody diarrhea (even if it occurs months after your last dose).
  • Yellowing of the skin or eyes (jaundice), dark urine, clay-colored stools, or severe stomach pain (signs of liver problems).
  • Unusual bruising or bleeding.
  • Fever, sore throat, and headache with a severe blistering, peeling, and red skin rash (severe skin reaction).
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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.
If you have kidney disease or any kidney problems.
If you have experienced liver problems or jaundice (turned yellow) while taking this medication in the past.
If you have been diagnosed with mononucleosis (mono).
If you are currently taking probenecid.

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 change the dose 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, 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 and your doctor will need to discuss the potential benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe stomach pain
  • Vomiting
  • Diarrhea
  • Rash
  • Hyperactivity
  • Drowsiness
  • Kidney problems (e.g., decreased urination, blood in urine)
  • Seizures (rare)

What to Do:

Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. Treatment is supportive and symptomatic. Hemodialysis can remove the drug from the bloodstream.

Drug Interactions

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Major Interactions

  • Warfarin (increased INR/bleeding risk)
  • Methotrexate (decreased renal clearance of methotrexate, leading to increased toxicity)
  • Allopurinol (increased incidence of rash, particularly in hyperuricemic patients)
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Moderate Interactions

  • Probenecid (decreases renal tubular secretion of amoxicillin, increasing and prolonging amoxicillin blood levels)
  • Oral Contraceptives (potential for reduced efficacy, though evidence is weak for most antibiotics)
  • Mycophenolate mofetil (reduced mycophenolic acid concentration)

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 or those at risk, as the drug is primarily renally eliminated.

Timing: Prior to initiation of therapy, if indicated.

Hepatic function (ALT, AST, bilirubin)

Rationale: To assess baseline liver function, particularly in patients with pre-existing hepatic impairment or a history of drug-induced liver injury, as cholestatic jaundice has been reported.

Timing: Prior to initiation of therapy, if indicated.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily

Target: Resolution of infection symptoms (e.g., fever reduction, improved signs of infection)

Action Threshold: Lack of improvement or worsening symptoms after 48-72 hours may indicate treatment failure or resistance.

Signs of adverse reactions (e.g., rash, diarrhea, superinfection)

Frequency: Daily

Target: Absence of adverse effects

Action Threshold: Development of rash, severe diarrhea (especially C. difficile-associated diarrhea), or new infections (e.g., oral thrush, vaginal yeast infection) requires evaluation and potential discontinuation.

INR (if on warfarin)

Frequency: More frequently (e.g., 2-3 times per week initially)

Target: Individualized therapeutic range for warfarin

Action Threshold: Significant deviation from target INR requires warfarin dose adjustment.

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Symptom Monitoring

  • Skin rash or hives (signs of allergic reaction)
  • Difficulty breathing or swallowing (signs of severe allergic reaction)
  • Severe or persistent diarrhea, especially if bloody or watery (may indicate C. difficile infection)
  • Yellowing of skin or eyes (jaundice), dark urine, or abdominal pain (signs of liver problems)
  • Unusual bruising or bleeding (if on anticoagulants)
  • New onset of fever or worsening of existing fever (may indicate superinfection or treatment failure)

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. Use only if 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. Caution advised near term due to potential for increased risk of necrotizing enterocolitis in neonates, though data is limited.
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Lactation

Both amoxicillin and clavulanate are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding. Monitor the 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.
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Pediatric Use

This 125mg/5ml suspension is specifically formulated for pediatric use. Dosing is weight-based and varies depending on the severity and type of infection. Careful calculation of dose is crucial to avoid under- or overdosing. Not recommended for neonates without specific guidance.

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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, as the drug is primarily renally eliminated. Monitor renal function.

Clinical Information

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Clinical Pearls

  • Always ensure the correct formulation (e.g., 4:1 ratio vs. 7:1 ratio) is prescribed and dispensed, as clavulanate content varies.
  • Instruct patients to take the medication at the start of a meal to enhance absorption and reduce gastrointestinal side effects like diarrhea.
  • Emphasize the importance of completing the full course of therapy to prevent antibiotic resistance and recurrence of infection.
  • Counsel patients on proper storage (refrigeration for suspension) and disposal of unused medication.
  • Be aware of the potential for C. difficile-associated diarrhea, which can occur during or even months after antibiotic therapy.
  • Monitor for signs of hypersensitivity reactions, which can range from mild rash to severe anaphylaxis.
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Alternative Therapies

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

Average Cost: Price varies widely by pharmacy and insurance plan. Typically in the range of $20-$100 for a 100ml bottle of generic suspension. per 100ml bottle
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 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. If you have any questions or concerns about this medication, don't hesitate 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.