Amox-Clav 250-125mg Tablets

Manufacturer SANDOZ Active Ingredient Amoxicillin and Clavulanate Tablets(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 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, bronchitis, urinary tract infections, and skin infections. Amoxicillin kills bacteria, and clavulanate helps amoxicillin work better by protecting it from certain bacterial defenses.
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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. For optimal effectiveness and to minimize the risk of stomach upset, take this medication at the beginning of a meal. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's 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 with food or at the start of a meal to reduce stomach upset.
  • Complete the full course of medication as prescribed, even if symptoms improve, to prevent antibiotic resistance and ensure the infection is fully treated.
  • Do not save medication for future infections.
  • Stay hydrated to help prevent kidney stone formation (rare, but reported with amoxicillin).

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg amoxicillin/125 mg clavulanate every 8 hours OR 500 mg amoxicillin/125 mg clavulanate every 12 hours for mild to moderate infections. For more severe infections, 875 mg amoxicillin/125 mg clavulanate every 12 hours.
Dose Range: 250 - 875 mg

Condition-Specific Dosing:

Otitis Media, Sinusitis, Lower Respiratory Tract Infections, Skin/Skin Structure Infections: 500 mg amoxicillin/125 mg clavulanate every 12 hours or 250 mg amoxicillin/125 mg clavulanate every 8 hours for mild to moderate infections. For more severe infections and respiratory tract infections, 875 mg amoxicillin/125 mg clavulanate every 12 hours or 500 mg amoxicillin/125 mg clavulanate every 8 hours.
Urinary Tract Infections: 500 mg amoxicillin/125 mg clavulanate every 12 hours or 250 mg amoxicillin/125 mg clavulanate every 8 hours.
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Pediatric Dosing

Neonatal: Not established (use caution, consult specialist)
Infant: Not established (use caution, consult specialist)
Child: 20-45 mg/kg/day (based on amoxicillin component) in divided doses every 8 or 12 hours, depending on the formulation and severity of infection. Max 1000 mg/day amoxicillin. The 250-125mg tablet is generally for children weighing >40 kg or adults.
Adolescent: Same as adult dosing for those weighing >40 kg.
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Dose Adjustments

Renal Impairment:

Mild: CrCl >30 mL/min: No adjustment needed.
Moderate: CrCl 10-30 mL/min: 250 mg amoxicillin/125 mg clavulanate every 12 hours.
Severe: CrCl <10 mL/min: 250 mg amoxicillin/125 mg clavulanate every 24 hours.
Dialysis: Hemodialysis: 250 mg amoxicillin/125 mg clavulanate every 24 hours. Administer an additional dose during and at the end of dialysis. Peritoneal Dialysis: No specific recommendations, generally avoid due to limited data.

Hepatic Impairment:

Mild: Adjustment not typically needed, but monitor liver function.
Moderate: Use with caution; monitor liver function regularly.
Severe: Use with caution; monitor liver function regularly. Dosage adjustment may be necessary based on clinical response 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 one or more penicillin-binding proteins (PBPs), thereby interfering with the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall. This leads to inhibition of cell wall biosynthesis and eventually to bacterial cell lysis. Clavulanate potassium is a beta-lactamase inhibitor. It irreversibly binds to and inactivates a wide range of beta-lactamase enzymes produced by many Gram-positive and Gram-negative bacteria, which would otherwise inactivate amoxicillin. This protects amoxicillin from degradation, extending its antibacterial spectrum to include beta-lactamase-producing strains.
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Pharmacokinetics

Absorption:

Bioavailability: Amoxicillin: Approximately 70-90%; Clavulanate: Approximately 60-70%
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 17-20%; Clavulanate: Approximately 25%
CnssPenetration: Limited (increased in presence of inflamed meninges)

Elimination:

HalfLife: Amoxicillin: 1-1.5 hours; Clavulanate: 1 hour (both prolonged in renal impairment)
Clearance: Primarily renal
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Amoxicillin: 50-70%; Clavulanate: 25-40%
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: Within 1-2 hours of administration
DurationOfAction: Dependent on dosing interval (e.g., 8 or 12 hours)
Confidence: High

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 immediate medical attention:

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, including 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. Seek immediate medical help 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 minor ones. If you are concerned about any side effects or if they persist, 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, 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 or watery diarrhea, especially if it contains blood or mucus (could be C. difficile infection).
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems).
  • Severe allergic reaction symptoms: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
  • Unusual bruising or bleeding.
  • New or worsening joint pain, fever, or rash (serum sickness-like 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 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 you experienced, including any 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.
If you have previously experienced liver problems or turned yellow (jaundice) while taking this medication, as this may indicate a sensitivity.
If you have been diagnosed with mononucleosis (mono), as this may require special consideration.
If you are currently taking probenecid, as this medication may interact with the drug.

Additionally, it is crucial to disclose all of your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

As well as any existing health problems, to your doctor and pharmacist. This information will help them assess potential interactions and ensure it is safe for you to take this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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.

Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.

A possible side effect of this medication is a change in tooth color, which may appear as yellow, gray, or brown. This has been reported primarily in children, but in most cases, the discoloration lessens or disappears with regular brushing or dental cleaning. If you notice any changes in tooth color, consult your doctor.

When taking this medication, birth control pills and other hormone-based birth control methods may be less effective in preventing pregnancy. To minimize the risk of unplanned pregnancy, use an additional form of birth control, such as a condom, while taking this drug.

If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Rash
  • Hyperactivity
  • Drowsiness
  • Renal dysfunction (crystalluria, acute renal failure in severe cases)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is largely supportive. Hemodialysis can remove amoxicillin and clavulanate from circulation.

Drug Interactions

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Major Interactions

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

  • Oral Contraceptives (potential for reduced efficacy of oral contraceptives)
  • Probenecid (decreased renal tubular secretion of amoxicillin, leading to increased and prolonged amoxicillin blood levels)
  • Mycophenolate Mofetil (reduced mycophenolic acid concentrations)

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To determine appropriate dosing, especially in elderly or renally impaired patients.

Timing: Prior to initiation of therapy.

Liver function tests (ALT, AST, bilirubin)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Signs/symptoms of hypersensitivity reaction (rash, itching, dyspnea)

Frequency: Daily, especially during the first few days of therapy.

Target: Absence of symptoms

Action Threshold: Discontinue drug immediately and manage symptoms.

Signs/symptoms of C. difficile-associated diarrhea (CDAD)

Frequency: Throughout therapy and for up to 2 months post-therapy.

Target: Absence of severe diarrhea

Action Threshold: Evaluate for CDAD if severe diarrhea occurs; discontinue drug if confirmed.

Liver function tests (ALT, AST, bilirubin)

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

Target: Within normal limits or stable

Action Threshold: Consider discontinuation if significant elevations occur, particularly with clinical signs of liver injury.

Renal function (CrCl)

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

Target: Stable

Action Threshold: Adjust dose if renal function declines.

INR (for patients on warfarin)

Frequency: More frequently during and after co-administration.

Target: Therapeutic range for indication

Action Threshold: Adjust warfarin dose as needed to maintain target INR.

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Symptom Monitoring

  • Diarrhea (especially severe or persistent)
  • Nausea/Vomiting
  • Abdominal pain
  • Skin rash or itching (hives)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • Signs of superinfection (e.g., oral thrush, vaginal yeast infection)

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 neonatal necrotizing enterocolitis (rarely reported with clavulanate).
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Lactation

Considered compatible with breastfeeding (L2). Both amoxicillin and clavulanate are excreted in small amounts into breast milk. Monitor breastfed infant for potential adverse effects.

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

Dosing must be carefully calculated based on the child's weight and the severity of the infection, using the amoxicillin component. The 250-125mg tablet is typically for children weighing >40 kg or adults. For younger children, suspensions are preferred. High doses of clavulanate should be avoided in very young children due to potential for gastrointestinal intolerance.

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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 in elderly patients with renal impairment. Monitor for liver and renal function.

Clinical Information

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Clinical Pearls

  • Always ensure the correct amoxicillin to clavulanate ratio is prescribed, as different formulations exist (e.g., 250/125, 500/125, 875/125, and pediatric suspensions with different ratios). The 250-125mg tablet has a 2:1 ratio.
  • Taking with food helps reduce GI side effects like diarrhea and nausea.
  • Amoxicillin/clavulanate is a common cause of drug-induced liver injury, which can be delayed in onset (up to 6 weeks after stopping) and more common in males and older patients. Monitor LFTs if symptoms arise.
  • Not effective against viral infections. Avoid inappropriate use to prevent resistance.
  • Patients with a history of penicillin allergy should be carefully assessed, as cross-reactivity can occur. However, non-severe penicillin allergies (e.g., rash) may allow for cautious use under supervision.
  • The 250-125mg tablet is often used for less severe infections or in patients who can tolerate a lower dose.
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Alternative Therapies

  • Cephalexin (Keflex)
  • Cefdinir (Omnicef)
  • Azithromycin (Zithromax)
  • Doxycycline (Vibramycin)
  • Levofloxacin (Levaquin) - generally reserved for specific indications due to broader spectrum and side effects.
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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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 evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 type and amount of medication taken, as well as the time it was taken.