Amox-Clav 250mg/5ml Susp 100ml

Manufacturer AUROBINDO 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 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 bacterial 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

To get the most out of 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 start 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're feeling well.

Before taking your medication, shake the liquid formulation well. Measure liquid doses accurately using the measuring device provided with your medication. If no device is included, ask your pharmacist for a suitable measuring tool.

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. Note that some color change may occur in certain products during storage, but this may be normal. If you're unsure, consult your pharmacist. Keep all medications in a safe place, out of the reach of children and pets.

Missing 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 a missed dose.
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Lifestyle & Tips

  • Take with food or at the start of a meal to reduce stomach upset and improve absorption of clavulanate.
  • Shake the suspension well before each use.
  • Use an accurate measuring device (oral syringe or dosing spoon) provided with the medication, not a household spoon.
  • Complete the full course of medication as prescribed, even if symptoms improve, to prevent antibiotic resistance and ensure the infection is fully treated.
  • Store the suspension in the refrigerator and discard any unused portion after 10 days.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used for adults in 250mg/5ml suspension strength. Adult dosing usually involves higher strength tablets (e.g., 500mg/125mg or 875mg/125mg).
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Pediatric Dosing

Neonatal: Not established for neonates (less than 12 weeks). Use with caution and specific guidance.
Infant: 20-45 mg/kg/day (amoxicillin component) divided every 8 or 12 hours, depending on infection severity. For 250mg/5ml suspension, this translates to 0.4-0.9 ml/kg/day divided.
Child: 20-45 mg/kg/day (amoxicillin component) divided every 8 or 12 hours, depending on infection severity. Max 1000 mg/day amoxicillin. For 250mg/5ml suspension, this translates to 0.4-0.9 ml/kg/day divided.
Adolescent: Similar to child dosing, or transition to adult tablet strengths if appropriate. Max 1000 mg/day amoxicillin.
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Dose Adjustments

Renal Impairment:

Mild: CrCl >30 mL/min: No dosage adjustment needed.
Moderate: CrCl 10-30 mL/min: 250 mg/62.5 mg every 12 hours (for 250/5ml suspension, this would be 5ml every 12 hours, but ensure total amoxicillin dose is appropriate for weight/infection).
Severe: CrCl <10 mL/min: 250 mg/62.5 mg every 24 hours (for 250/5ml suspension, this would be 5ml every 24 hours, but ensure total amoxicillin dose is appropriate for weight/infection).
Dialysis: Hemodialysis: 250 mg/62.5 mg 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: Adjustment: Use with caution; monitor liver function.
Moderate: Adjustment: Use with caution; monitor liver function.
Severe: Adjustment: Use with caution; monitor liver function. Contraindicated in patients with a history of amoxicillin/clavulanate-associated cholestatic jaundice/hepatic dysfunction.

Pharmacology

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Mechanism of Action

Amoxicillin is a bactericidal 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 that protects amoxicillin from degradation by many beta-lactamase enzymes commonly produced by resistant bacteria. It binds irreversibly to beta-lactamase enzymes, preventing them from inactivating amoxicillin.
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Pharmacokinetics

Absorption:

Bioavailability: Amoxicillin: 70-90%; Clavulanate: 60-75%
Tmax: Amoxicillin: 1-2 hours; Clavulanate: 1-2 hours
FoodEffect: Absorption is not significantly affected by food, but clavulanate absorption is enhanced when taken at the start of a meal, which may also reduce 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 (increased with inflamed meninges)

Elimination:

HalfLife: Amoxicillin: 1-1.5 hours; Clavulanate: 1 hour (both prolonged in renal impairment)
Clearance: Not available (varies by renal function)
ExcretionRoute: Primarily renal (glomerular filtration and tubular secretion)
Unchanged: Amoxicillin: 50-70%; Clavulanate: 25-40%
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Pharmacodynamics

OnsetOfAction: Rapid, 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 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, have been reported with this medication. Seek medical attention immediately if you experience:
+ Dark urine
+ Fatigue
+ 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, can occur with this medication. These reactions can be fatal 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 skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are concerned about any side effects or if they persist, contact your doctor or seek medical attention:

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, and you may experience other 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 face/lips/tongue/throat)
  • Severe stomach pain, watery or bloody diarrhea (even weeks after last dose)
  • Yellowing of skin or eyes (jaundice), dark urine, pale stools (signs of liver problems)
  • Unusual bruising or bleeding
  • Fever, sore throat, headache with a severe blistering, peeling, and red skin rash (Stevens-Johnson syndrome)
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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), as this may require special consideration.
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 in combination with your other 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 is a change in tooth color to yellow-gray-brown, which is more frequently reported in children. In most cases, the discoloration lessens or disappears with regular brushing or dental cleaning. If you notice any changes in tooth color, consult with 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, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Stomach pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Skin rash
  • Hyperactivity
  • Drowsiness
  • Renal tubular damage (rare)
  • Crystalluria (rare)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Hemodialysis may be used to remove the drug from circulation in cases of severe overdose or renal impairment.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity)
  • Warfarin (increased INR and bleeding risk)
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Moderate Interactions

  • Allopurinol (increased incidence of rash)
  • Oral Contraceptives (potential for reduced efficacy, though evidence is mixed)
  • Probenecid (increases amoxicillin levels by decreasing renal tubular secretion)
  • Mycophenolate mofetil (reduced mycophenolate exposure)
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Minor Interactions

  • Typhoid vaccine (live, oral) (may reduce therapeutic effect of vaccine)

Monitoring

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Baseline Monitoring

Allergy history (penicillins, cephalosporins)

Rationale: To prevent hypersensitivity reactions.

Timing: Prior to initiation.

Renal function (CrCl)

Rationale: To guide dose adjustment in renal impairment.

Timing: Prior to initiation, especially in patients with known or suspected renal dysfunction.

Liver function tests (ALT, AST, bilirubin)

Rationale: To establish baseline, especially in patients with pre-existing hepatic disease or risk factors for liver injury.

Timing: Prior to initiation, if clinically indicated.

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Routine Monitoring

Signs/symptoms of hypersensitivity reaction (rash, itching, swelling, difficulty breathing)

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

Target: Absence of symptoms

Action Threshold: Any sign of allergic reaction: discontinue immediately and manage symptomatically.

Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal pain)

Frequency: Daily

Target: Absence or mild, tolerable symptoms

Action Threshold: Severe or persistent diarrhea (especially watery/bloody): consider C. difficile infection, discontinue if confirmed or highly suspected.

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, if therapy is prolonged or in patients with pre-existing hepatic conditions.

Target: Within normal limits or stable

Action Threshold: Significant elevation: discontinue and investigate.

Renal function (CrCl)

Frequency: Periodically, if therapy is prolonged or in patients with changing renal status.

Target: Stable or within acceptable limits

Action Threshold: Significant decline: adjust dose or discontinue.

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Symptom Monitoring

  • Rash
  • Itching
  • Hives
  • Swelling of face/lips/tongue
  • Difficulty breathing
  • Severe or persistent diarrhea
  • Abdominal pain
  • Nausea
  • Vomiting
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness

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 is no evidence of harm in human studies. However, use only if clearly needed.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations observed.
Second Trimester: No increased risk observed.
Third Trimester: No increased risk observed.
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Lactation

Considered compatible with breastfeeding (L1). Both amoxicillin and clavulanate are excreted in small amounts into breast milk. Monitor infant for potential adverse effects such as diarrhea, candidiasis (thrush), or allergic reactions (rash).

Infant Risk: Low risk. Potential for mild gastrointestinal upset or sensitization in the infant.
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Pediatric Use

Dosing is weight-based and depends on the severity and type of infection. The 250mg/5ml suspension is commonly used for pediatric patients. Close monitoring for gastrointestinal side effects and rash is important. Not recommended for neonates (under 12 weeks) due to immature renal function.

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Geriatric Use

No specific dose adjustment based solely on age, but dose should be adjusted for renal impairment, which is more common in the elderly. Increased risk of adverse effects, particularly gastrointestinal and hepatic, should be considered. Monitor liver and kidney function.

Clinical Information

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Clinical Pearls

  • Always instruct patients to shake the suspension well before each use and to use the provided measuring device.
  • Advise patients to take the medication at the start of a meal to minimize GI upset and enhance clavulanate absorption.
  • Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent resistance.
  • Counsel patients on the signs and symptoms of C. difficile-associated diarrhea and the need to seek medical attention if it occurs.
  • Be aware of the potential for drug-induced liver injury, especially with prolonged use or in patients with pre-existing liver conditions, though it is rare.
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Alternative Therapies

  • Cephalexin (Keflex)
  • Cefdinir (Omnicef)
  • Azithromycin (Zithromax)
  • Clindamycin (Cleocin)
  • Doxycycline (Vibramycin)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and insurance plan per 100ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.