Augmentin XR 1000mg/62.5mg Tablets
It is used to treat bacterial infections.
Drug Class
Antibiotic, Beta-lactam/Beta-lactamase Inhibitor Combination
Pharmacologic Class
Penicillins, Extended-spectrum; Beta-lactamase Inhibitors
Pregnancy Category
Category B
FDA Approved
Oct 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Augmentin XR is an antibiotic medication that combines two active ingredients: amoxicillin and clavulanate. Amoxicillin kills bacteria, and clavulanate helps amoxicillin work better by protecting it from certain bacterial defenses. It's used to treat specific bacterial infections, like pneumonia or sinus infections, and is designed to be taken less frequently due to its extended-release formulation.
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 tablet with food to help your body absorb the medication. However, avoid taking it with high-fat meals, as this can affect how the medication works. Swallow the tablet whole - do not chew or crush it. If you have a tablet that can be broken in half, you may do so, but check with your doctor first to make sure this is acceptable for your specific medication.
It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets to avoid accidents. When you're finished with your medication or it expires, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs 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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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 tablet with food to help your body absorb the medication. However, avoid taking it with high-fat meals, as this can affect how the medication works. Swallow the tablet whole - do not chew or crush it. If you have a tablet that can be broken in half, you may do so, but check with your doctor first to make sure this is acceptable for your specific medication.
It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets to avoid accidents. When you're finished with your medication or it expires, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs 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 continue with 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 a snack at the start of a meal to reduce stomach upset and improve absorption.
- Swallow tablets whole; do not crush, chew, or break them.
- Complete the entire course of medication, even if you feel better, to prevent antibiotic resistance and ensure the infection is fully treated.
- Do not use for viral infections (e.g., common cold, flu) as it will not be effective and contributes to antibiotic resistance.
- Stay hydrated, especially if experiencing diarrhea.
Available Forms & Alternatives
Available Strengths:
- Augmentin 250-125mg Tablets
- Augmentin 250mg/5ml Susp 75ml
- Augmentin 400mg Chewable Tabs
- Augmentin 200mg/5ml Susp 50ml
- Augmentin 200mg/5ml Susp75ml
- Augmentin 200mg/5ml Susp100ml
- Augmentin 400mg/5ml Susp 50ml
- Augmentin 400mg/5ml Susp75ml
- Augmentin 400mg/5ml Susp100ml
- Augmentin ES-600mg Susp 200ml
- Augmentin ES-600mg Susp 125ml
- Augmentin ES 600/5ml Susp 75ml
- Augmentin 250mg/5ml Susp 150ml
- Augmentin 875-125mg Tablets
- Augmentin 500-125mg Tablets
- Augmentin XR 1000mg/62.5mg Tablets
- Augmentin 250mg/5ml Susp 100ml
- Augmentin 125mg/5ml Susp 100ml
- Augmentin 125mg/5ml Susp 150ml
Dosing & Administration
Adult Dosing
Standard Dose:
2 tablets (2000 mg amoxicillin/125 mg clavulanate) orally every 12 hours for 10 days.
Dose Range:
2000 - 2000 mg
Condition-Specific Dosing:
communityAcquiredPneumonia:
2 tablets (2000 mg amoxicillin/125 mg clavulanate) orally every 12 hours for 10 days.
acuteBacterialRhinosinusitis:
2 tablets (2000 mg amoxicillin/125 mg clavulanate) orally every 12 hours for 10 days.
Pediatric Dosing
Neonatal:
Not established (Augmentin XR is not approved for pediatric patients under 16 years of age).
Infant:
Not established (Augmentin XR is not approved for pediatric patients under 16 years of age).
Child:
Not established (Augmentin XR is not approved for pediatric patients under 16 years of age).
Adolescent:
Not established (Augmentin XR is not approved for pediatric patients under 16 years of age). For adolescents âĨ16 years, adult dosing applies.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required (CrCl > 30 mL/min).
Moderate:
No dosage adjustment required (CrCl > 30 mL/min).
Severe:
Contraindicated (CrCl < 30 mL/min).
Dialysis:
Contraindicated in patients on dialysis.
Hepatic Impairment:
Mild:
Use with caution; monitor hepatic function.
Moderate:
Use with caution; monitor hepatic function.
Severe:
Use with caution; monitor hepatic function. Not recommended due to lack of data and potential for hepatotoxicity.
Pharmacology
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 protects amoxicillin from degradation by beta-lactamase enzymes produced by resistant bacteria, thereby extending amoxicillin's spectrum of activity.
Pharmacokinetics
Absorption:
Bioavailability:
Amoxicillin: Approximately 75-90%; Clavulanate: Approximately 60%
Tmax:
Amoxicillin: 1.5 hours (immediate release), 2.5 hours (extended release); Clavulanate: 1.2 hours (immediate release), 2.1 hours (extended release)
FoodEffect:
Absorption of both amoxicillin and clavulanate is optimized when taken at the start of a meal. Taking with food reduces gastrointestinal upset.
Distribution:
Vd:
Amoxicillin: 0.3-0.4 L/kg; Clavulanate: 0.2 L/kg
ProteinBinding:
Amoxicillin: Approximately 17-20%; Clavulanate: Approximately 25%
CnssPenetration:
Limited (increases with inflamed meninges)
Elimination:
HalfLife:
Amoxicillin: 1.3 hours; Clavulanate: 1 hour (both are slightly prolonged in extended-release formulation)
Clearance:
Amoxicillin: Primarily renal; Clavulanate: Primarily renal
ExcretionRoute:
Renal (glomerular filtration and tubular secretion)
Unchanged:
Amoxicillin: 60-80%; Clavulanate: 25-40%
Pharmacodynamics
OnsetOfAction:
Rapid (within hours)
PeakEffect:
Within 2-3 hours (based on Tmax)
DurationOfAction:
12 hours (due to extended-release formulation)
Safety & Warnings
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
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
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 fainting
Vaginal irritation or discharge
Fever or chills
Unexplained bruising or bleeding
Diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea (CDAD). If you experience:
+ Stomach pain or cramps
+ Very loose, watery, or bloody stools
+ CDAD can occur during or several months after taking antibiotics. Contact your doctor immediately if you experience any of these symptoms.
Liver problems, which can be fatal, may occur with this medication. Seek medical help 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, 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 any areas of skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
For all patients taking this medication:
+ Diarrhea
+ Upset stomach
+ Vomiting
* For children:
+ Diaper rash
Reporting 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.
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
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
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 fainting
Vaginal irritation or discharge
Fever or chills
Unexplained bruising or bleeding
Diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea (CDAD). If you experience:
+ Stomach pain or cramps
+ Very loose, watery, or bloody stools
+ CDAD can occur during or several months after taking antibiotics. Contact your doctor immediately if you experience any of these symptoms.
Liver problems, which can be fatal, may occur with this medication. Seek medical help 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, 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 any areas of skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
For all patients taking this medication:
+ Diarrhea
+ Upset stomach
+ Vomiting
* For children:
+ Diaper rash
Reporting 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 allergic reaction (hives, difficulty breathing, swelling of face/throat)
- Severe or persistent diarrhea (especially if bloody or watery, which could indicate C. difficile infection)
- Yellowing of skin or eyes (jaundice), dark urine, or unusual tiredness (signs of liver problems)
- New or worsening rash
- Unusual bruising or bleeding
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 drugs. Never start, stop, or change the dose of any medication without consulting your doctor first.
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 drugs. Never start, stop, or change the dose of any medication without consulting your doctor first.
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 long-term, your doctor may recommend regular blood tests to monitor your condition.
This medication may interfere with certain laboratory tests, so be sure 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 lessened or disappeared 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 contraceptives 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. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
This medication may interfere with certain laboratory tests, so be sure 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 lessened or disappeared 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 contraceptives 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. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Rash
- Hyperactivity
- Drowsiness
- Electrolyte imbalance
- Renal dysfunction (crystalluria, renal failure)
- Convulsions (in patients with impaired renal function or high doses)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Hemodialysis may be used to remove amoxicillin and clavulanate from circulation.
Drug Interactions
Major Interactions
- Warfarin (increased INR, bleeding risk)
- Methotrexate (increased methotrexate levels and toxicity)
Moderate Interactions
- Allopurinol (increased incidence of rash)
- Oral Contraceptives (potential for reduced efficacy, though evidence is weak)
- Probenecid (increases amoxicillin levels by decreasing renal tubular secretion)
- Mycophenolate Mofetil (reduced mycophenolate levels)
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To determine appropriate dosing and identify contraindications in severe impairment.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic status, especially in patients with pre-existing liver disease, due to potential for hepatotoxicity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of hypersensitivity reactions (rash, itching, dyspnea)
Frequency: Daily during therapy
Target: Absence of symptoms
Action Threshold: Any sign of allergic reaction requires immediate discontinuation.
Signs and symptoms of superinfection (e.g., oral thrush, vaginal yeast infection, severe diarrhea)
Frequency: Daily during therapy and up to several weeks post-therapy
Target: Absence of symptoms
Action Threshold: Development of new infection or severe, persistent diarrhea (consider C. difficile infection).
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically, especially in patients with pre-existing hepatic impairment or prolonged therapy.
Target: Within normal limits or stable baseline
Action Threshold: Significant elevation (e.g., >3x ULN) or signs of liver injury.
INR (for patients on warfarin)
Frequency: More frequently (e.g., 2-3 times per week) during co-administration and for a period after discontinuation.
Target: Therapeutic INR range for indication
Action Threshold: INR outside therapeutic range, signs of bleeding.
Symptom Monitoring
- Skin rash
- Itching
- Hives
- Difficulty breathing or swallowing
- Swelling of face, throat, tongue, lips, or eyes
- Severe diarrhea (especially if bloody or watery)
- Abdominal pain or cramping
- Nausea
- Vomiting
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual tiredness or weakness
Special Patient Groups
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 increased risk of major birth defects observed.
Second Trimester:
Low risk.
Third Trimester:
Low risk. Caution advised near term due to potential for increased risk of necrotizing enterocolitis in neonates (though rare and not definitively linked to amoxicillin/clavulanate).
Lactation
Amoxicillin and clavulanate are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding (L1).
Infant Risk:
Low risk. Potential for infant sensitization, diarrhea, candidiasis (thrush). Monitor breastfed infant for gastrointestinal disturbances (diarrhea, candidiasis) or allergic reactions (rash).
Pediatric Use
Augmentin XR is not approved for pediatric patients under 16 years of age due to the high amoxicillin dose and extended-release formulation. Other formulations of amoxicillin/clavulanate (e.g., immediate-release suspensions or tablets) are available and commonly used in pediatric populations.
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 for elderly patients with renal impairment (CrCl < 30 mL/min). Monitor renal function.
Clinical Information
Clinical Pearls
- Augmentin XR is specifically formulated for twice-daily dosing and should not be substituted with other Augmentin formulations (e.g., immediate-release) on a mg-for-mg basis due to different pharmacokinetic profiles and clavulanate content.
- This formulation is indicated for specific infections like Community-Acquired Pneumonia (CAP) and Acute Bacterial Rhinosinusitis (ABRS) caused by susceptible organisms, where the higher amoxicillin dose and extended release are beneficial.
- Always take Augmentin XR with food to minimize gastrointestinal side effects and optimize absorption.
- Patients should be advised to swallow the tablets whole and not to crush, chew, or break them, as this would destroy the extended-release properties.
- Diarrhea is a common side effect; advise patients to report severe or persistent diarrhea, as it could indicate Clostridioides difficile-associated diarrhea (CDAD).
- Monitor liver function tests, especially in patients with pre-existing hepatic impairment, as hepatotoxicity (though rare) can occur, particularly with clavulanate.
Alternative Therapies
- Respiratory fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) for CAP or ABRS (consider resistance patterns and side effects)
- Cephalosporins (e.g., Cefpodoxime, Cefuroxime) for ABRS or CAP (depending on susceptibility)
- Macrolides (e.g., Azithromycin, Clarithromycin) for CAP (consider resistance)
- Doxycycline for CAP or ABRS
Cost & Coverage
Average Cost:
$150 - $300 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand name), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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'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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.