Amoxicillin 875mg Tablets

Manufacturer AUROBINDO Active Ingredient Amoxicillin Capsules and Tablets(a moks i SIL in) Pronunciation a moks i SIL in
It is used to treat bacterial infections.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antibiotic
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Pharmacologic Class
Beta-lactam antibiotic; Aminopenicillin
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Pregnancy Category
Category B
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FDA Approved
Jan 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Amoxicillin is a common antibiotic used to treat many different types of bacterial infections, such as ear infections, strep throat, pneumonia, and skin infections. It works by stopping the growth of bacteria. It is not effective against viral infections like the common cold or flu.
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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. Establish a routine by taking your medication at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of 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're unsure 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 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 dose, skip the missed dose and resume your regular 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 the medication exactly as prescribed by your doctor, even if you start to feel better. Do not skip doses or stop taking it early, as this can lead to antibiotic resistance.
  • Amoxicillin can be taken with or without food.
  • If you are taking the liquid suspension, shake it well before each use and use a measuring spoon or cup, not a household spoon.
  • Store tablets at room temperature away from moisture and heat. Store liquid suspension in the refrigerator and discard any unused portion after 14 days.

Dosing & Administration

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Adult Dosing

Standard Dose: 875 mg orally every 12 hours or 500 mg orally every 8 hours
Dose Range: 250 - 875 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis: 500 mg orally every 12 hours or 250 mg orally every 8 hours for 10 days
Acute Bacterial Sinusitis: 500 mg orally every 8 hours or 875 mg orally every 12 hours for 10-14 days
Lower Respiratory Tract Infections: 500 mg orally every 8 hours or 875 mg orally every 12 hours for 5-7 days
Skin and Skin Structure Infections: 500 mg orally every 8 hours or 875 mg orally every 12 hours for 7-10 days
Helicobacter pylori Eradication: 1000 mg orally twice daily (in combination with other agents) for 7-14 days
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Pediatric Dosing

Neonatal: Not established (use caution, specific dosing for neonates is complex and often weight-based)
Infant: 20-45 mg/kg/day in divided doses every 8 or 12 hours (max 875 mg/dose)
Child: 20-45 mg/kg/day in divided doses every 8 or 12 hours (max 875 mg/dose)
Adolescent: Same as adult dosing for specific indications, typically 250-875 mg per dose
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Dose Adjustments

Renal Impairment:

Mild: CrCl >30 mL/min: No adjustment needed
Moderate: CrCl 10-30 mL/min: 250-500 mg every 12 hours
Severe: CrCl <10 mL/min: 250-500 mg every 24 hours
Dialysis: Hemodialysis: 250-500 mg every 24 hours; administer an additional dose during and at the end of dialysis. Peritoneal Dialysis: 250 mg every 12 hours.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment (primarily renally eliminated)

Pharmacology

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Mechanism of Action

Amoxicillin is a bactericidal beta-lactam antibiotic. It inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs), which are enzymes located on the bacterial cell membrane. This binding prevents the cross-linking of peptidoglycan chains, leading to the disruption of the cell wall and ultimately bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 75-90%
Tmax: 1-2 hours
FoodEffect: Food does not significantly affect the absorption of amoxicillin, so it can be taken with or without food.

Distribution:

Vd: 0.3-0.4 L/kg
ProteinBinding: 17-20%
CnssPenetration: Limited (increases with inflamed meninges)

Elimination:

HalfLife: 1-1.5 hours (normal renal function)
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 50-70%
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Pharmacodynamics

OnsetOfAction: Rapid (within 30-60 minutes)
PeakEffect: 1-2 hours (corresponds to Tmax)
DurationOfAction: Dependent on dosing frequency, typically provides therapeutic levels for 6-8 hours (for q8h dosing) or 10-12 hours (for q12h dosing)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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
Unexplained bruising or bleeding
Fever or chills
Vaginal itching or discharge
Diarrhea is a common side effect of antibiotics, but rarely, a severe form called C. diff-associated diarrhea (CDAD) may occur. If you experience:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
+ Contact your doctor right away. Do not treat diarrhea without consulting your doctor first.
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening. Seek medical help immediately if you notice:
- 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 have only minor 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:

Diarrhea
Upset stomach
Vomiting
Headache

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:

  • Signs of a 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 several weeks after stopping the medication). This could be a sign of a serious intestinal infection (Clostridioides difficile-associated diarrhea).
  • Unusual bleeding or bruising.
  • Pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
  • Fever, sore throat, headache with a severe blistering, peeling, and red skin rash.
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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, as this may impact your ability to take this medication.
* If you have been diagnosed with mononucleosis (mono), as this condition may affect the use of this 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 treatments and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment.
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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 has decreased or resolved 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, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Crystalluria (crystals in urine, potentially leading to kidney problems in severe cases)

What to Do:

In case of overdose, call your poison control center at 1-800-222-1222. Seek emergency medical attention if symptoms are severe.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity)
  • Warfarin (increased INR/bleeding risk, though often minor)
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Moderate Interactions

  • Allopurinol (increased risk of amoxicillin-induced rash)
  • Oral Contraceptives (potential decreased efficacy of oral contraceptives, though evidence is weak)
  • Probenecid (increases and prolongs amoxicillin blood levels)
  • Tetracyclines (may antagonize the bactericidal effect of amoxicillin)
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Minor Interactions

  • Live Typhoid Vaccine (amoxicillin may reduce the immunologic response)

Monitoring

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Baseline Monitoring

Renal function (BUN, Creatinine)

Rationale: To guide dose adjustment in patients with pre-existing renal impairment.

Timing: Prior to initiation, especially in elderly or those with suspected renal issues.

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Routine Monitoring

Clinical response to therapy (e.g., resolution of fever, reduction in symptoms)

Frequency: Daily during acute treatment

Target: Improvement of symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or incorrect diagnosis.

Signs of allergic reaction (rash, itching, hives, difficulty breathing)

Frequency: Daily, especially during the first few days of treatment

Target: Absence of allergic symptoms

Action Threshold: Any sign of allergic reaction requires immediate discontinuation.

Gastrointestinal symptoms (diarrhea, abdominal pain)

Frequency: Daily throughout treatment and up to several weeks post-treatment

Target: Normal bowel habits

Action Threshold: Severe or persistent diarrhea may indicate Clostridioides difficile-associated diarrhea (CDAD).

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Symptom Monitoring

  • Skin rash (maculopapular, urticarial)
  • Pruritus (itching)
  • Dyspnea (shortness of breath)
  • Wheezing
  • Facial swelling
  • Severe or persistent diarrhea
  • Abdominal cramping
  • Nausea
  • Vomiting
  • Vaginal itching or discharge (yeast infection)

Special Patient Groups

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Pregnancy

Amoxicillin is generally considered safe for use during pregnancy (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, but extensive clinical experience suggests no increased risk of birth defects.

Trimester-Specific Risks:

First Trimester: Low risk, commonly used for infections.
Second Trimester: Low risk, commonly used for infections.
Third Trimester: Low risk, commonly used for infections.
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Lactation

Amoxicillin is excreted in small amounts into breast milk. It is generally considered compatible with breastfeeding (Lactation Risk L1).

Infant Risk: Low risk. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions (e.g., rash). The benefits of breastfeeding generally outweigh the potential risks.
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Pediatric Use

Amoxicillin is widely used and well-tolerated in pediatric patients. Dosing is typically weight-based. Close monitoring for allergic reactions and gastrointestinal side effects is important.

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Geriatric Use

No specific dose adjustment is needed based solely on age. However, elderly patients are more likely to have decreased renal function, which may necessitate dose adjustments based on creatinine clearance. Monitor renal function and for potential adverse effects.

Clinical Information

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Clinical Pearls

  • Amoxicillin is a first-line agent for many common bacterial infections due to its broad spectrum, good oral bioavailability, and favorable safety profile.
  • Always complete the full course of antibiotics, even if symptoms improve, to prevent the development of antibiotic resistance and ensure complete eradication of the infection.
  • Patients with infectious mononucleosis should avoid amoxicillin due to a high incidence of non-allergic rash.
  • Counsel patients on the risk of Clostridioides difficile-associated diarrhea (CDAD), which can occur during or even weeks after antibiotic therapy.
  • While food does not affect absorption, taking amoxicillin with food may help reduce gastrointestinal upset.
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Alternative Therapies

  • Cephalexin (a first-generation cephalosporin)
  • Azithromycin (a macrolide, for penicillin-allergic patients or atypical pathogens)
  • Doxycycline (a tetracycline, for certain respiratory or skin infections)
  • Clindamycin (for anaerobic infections or penicillin-allergic patients)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 875mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.