Amox-Clav 200mg/5ml Susp 50ml

Manufacturer WEST-WARD 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 (aminopenicillin) + beta-lactamase inhibitor
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Pregnancy Category
Category B
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FDA Approved
May 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medicine is an antibiotic that combines two ingredients: amoxicillin, which kills bacteria, and clavulanate, which helps amoxicillin work better by stopping bacteria from breaking it down. It's used to treat various bacterial infections.
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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 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 with food or milk to reduce stomach upset.
  • Shake the suspension well before each use.
  • Use an accurate measuring spoon or oral syringe provided with the medication, not a household spoon.
  • Complete the entire course of medication, even if symptoms improve, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 10 days.

Dosing & Administration

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Adult Dosing

Standard Dose: Typically 500 mg amoxicillin/125 mg clavulanate every 8 hours OR 875 mg amoxicillin/125 mg clavulanate every 12 hours. For 200mg/5ml suspension (40mg/ml amoxicillin), this would be 12.5 ml every 8 hours or 21.875 ml every 12 hours, respectively. Suspension is less common for adults due to volume.
Dose Range: 500 - 875 mg

Condition-Specific Dosing:

Severe infections: 875 mg/125 mg every 12 hours or 500 mg/125 mg every 8 hours.
Less severe infections: 500 mg/125 mg every 12 hours or 250 mg/125 mg every 8 hours.
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Pediatric Dosing

Neonatal: Not established (use caution, specific dosing for neonates is complex and off-label for this formulation).
Infant: Based on amoxicillin component: 20-45 mg/kg/day divided every 8 or 12 hours. For otitis media or more severe infections: 90 mg/kg/day divided every 12 hours. Max 1000 mg/day amoxicillin. For 200mg/5ml (40mg/ml amoxicillin): calculate volume based on mg/kg dose.
Child: Based on amoxicillin component: 20-45 mg/kg/day divided every 8 or 12 hours. For otitis media or more severe infections: 90 mg/kg/day divided every 12 hours. Max 1000 mg/day amoxicillin. For 200mg/5ml (40mg/ml amoxicillin): calculate volume based on mg/kg dose.
Adolescent: Typically adult dosing if weight >40 kg. If <40 kg, pediatric dosing based on weight.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl >30 mL/min).
Moderate: Adjust dose to 250 mg/125 mg every 12 hours (CrCl 10-30 mL/min). For suspension, this would be 6.25 ml every 12 hours.
Severe: Adjust dose to 250 mg/125 mg every 24 hours (CrCl <10 mL/min). For suspension, this would be 6.25 ml every 24 hours.
Dialysis: 250 mg/125 mg every 24 hours, with an additional dose administered during and at the end of dialysis. For suspension, 6.25 ml every 24 hours plus additional dose.

Hepatic Impairment:

Mild: No specific adjustment, but use with caution.
Moderate: No specific adjustment, but use with caution and monitor liver function.
Severe: Use with caution and monitor liver function closely; dosage adjustment may be necessary based on clinical judgment and liver function tests.

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 and death. Clavulanate 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 against beta-lactamase-producing strains.
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Pharmacokinetics

Absorption:

Bioavailability: Amoxicillin: 75-90%; Clavulanate: 60%
Tmax: 1-2 hours
FoodEffect: Absorption of both components 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: 250-300 mL/min; Clavulanate: 100-150 mL/min
ExcretionRoute: Primarily renal (glomerular filtration and tubular secretion)
Unchanged: Amoxicillin: 60-80%; Clavulanate: 25-40%
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

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 right away:

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 a type of allergic reaction called drug-induced enterocolitis syndrome, 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 right away 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 affect body organs and be life-threatening. Get 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

Most people taking this medication do not experience side effects or only have mild side effects. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

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: rash, hives, itching, swelling of face/lips/tongue/throat, difficulty breathing or swallowing (seek immediate medical attention).
  • Severe or watery diarrhea, especially if bloody or prolonged (may be a sign of C. difficile infection).
  • Yellowing of skin or eyes (jaundice), dark urine, pale stools (signs of liver problems).
  • Unusual bruising or bleeding.
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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).
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 health conditions and other medications. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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, 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 experience a change 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 both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Rash
  • Hyperactivity
  • Drowsiness
  • Renal dysfunction (rare, with very large doses)

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is generally supportive and symptomatic. Hemodialysis may be used to remove the drug from circulation in cases of severe renal impairment or massive overdose.

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 reduced efficacy, though controversial)
  • Probenecid (increases amoxicillin levels by decreasing renal tubular secretion)
  • Mycophenolate Mofetil (reduced mycophenolate levels)
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Minor Interactions

  • Tetracyclines (may reduce amoxicillin's bactericidal effect)
  • Chloramphenicol (may reduce amoxicillin's bactericidal effect)

Monitoring

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Baseline Monitoring

Renal function (BUN, Creatinine)

Rationale: To assess baseline kidney function, especially in elderly or those with pre-existing renal impairment, for dose adjustment.

Timing: Prior to initiation, if clinically indicated.

Liver function tests (ALT, AST, Bilirubin)

Rationale: To assess baseline liver function, particularly in patients with pre-existing hepatic disease, as hepatotoxicity is a rare but serious adverse effect.

Timing: Prior to initiation, if clinically indicated.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily

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

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

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

Frequency: Daily

Target: Absence of significant adverse effects

Action Threshold: Development of severe rash, persistent diarrhea (especially watery/bloody), or signs of allergic reaction (e.g., angioedema, dyspnea) requires immediate evaluation and potential discontinuation.

Liver function tests (ALT, AST, Bilirubin)

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

Target: Within normal limits or stable baseline

Action Threshold: Significant elevation (e.g., >3x ULN) or signs of cholestasis/hepatitis warrant discontinuation and further investigation.

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Symptom Monitoring

  • Skin rash or hives (signs of allergic reaction)
  • Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
  • Nausea, vomiting, abdominal pain
  • Yellowing of skin or eyes (jaundice), dark urine, pale stools (signs of liver dysfunction)
  • Unusual bruising or bleeding (if on warfarin)
  • Difficulty breathing or swallowing (severe allergic reaction)

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: Low risk, no evidence of increased congenital malformations.
Second Trimester: Low risk.
Third Trimester: Low risk, but caution with use near term due to potential for neonatal adverse effects (e.g., diarrhea, candidiasis).
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Lactation

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

Infant Risk: Low risk. Potential for diarrhea, candidiasis (thrush, diaper rash), or allergic sensitization in the breastfed infant. Benefits of breastfeeding should outweigh potential risks.
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Pediatric Use

Dosing is weight-based and specific to the amoxicillin component. Different concentrations (e.g., 200mg/5ml, 400mg/5ml, 600mg/5ml) are available to facilitate accurate dosing for various age groups and infection severities. Careful calculation and use of appropriate measuring devices are crucial to avoid under- or overdosing.

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Geriatric Use

No specific dose adjustment needed based on age alone, but renal function should be assessed as elderly patients are more likely to have decreased renal clearance. Dose adjustments are necessary for renal impairment.

Clinical Information

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Clinical Pearls

  • Always instruct patients to take with food or milk to minimize GI upset, especially diarrhea.
  • Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent resistance and relapse.
  • Educate patients on proper storage of the reconstituted suspension (refrigeration, discard after 10 days).
  • Be aware of the potential for C. difficile-associated diarrhea, which can occur during or even weeks after treatment.
  • Monitor for signs of hypersensitivity reactions, which can range from mild rash to severe anaphylaxis.
  • This formulation (200mg/5ml) is commonly used for pediatric patients, requiring careful weight-based dosing calculations.
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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, generally avoided in pediatrics
  • Other penicillins (e.g., Amoxicillin alone, Penicillin V) - if beta-lactamase producing strains are not suspected
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Cost & Coverage

Average Cost: Varies widely, typically $15 - $50 per 50ml bottle of 200mg/5ml suspension
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 information about what was taken, the amount, and the time it occurred.