Amoxicillin 250mg Capsules

Manufacturer CITRON PHARMA 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
Penicillin antibiotic; Beta-lactam antibiotic
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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 an antibiotic medication used to treat a wide variety of bacterial infections, such as ear infections, strep throat, pneumonia, and skin infections. It works by stopping the growth of bacteria. It is important to take the full course of medication as prescribed, even if you start feeling better, to prevent the infection from coming back and to reduce the risk of antibiotic resistance.
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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 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 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 safe 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 disposing 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 the medication exactly as prescribed by your doctor. Do not skip doses or stop taking it early, even if you feel better.
  • Amoxicillin can be taken with or without food. If it causes stomach upset, try taking it with food.
  • Drink plenty of fluids while taking this medication.
  • Do not share your medication with others.
  • Store at room temperature away from moisture and heat.

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg to 500 mg every 8 hours or 500 mg to 875 mg every 12 hours, depending on infection severity and type.
Dose Range: 250 - 875 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis (Streptococcal): 500 mg every 12 hours or 250 mg every 8 hours for 10 days.
Otitis Media (Acute): 500 mg every 8 hours or 875 mg every 12 hours for 10-14 days.
Lower Respiratory Tract Infections: 500 mg every 8 hours or 875 mg every 12 hours for 5-10 days.
Skin/Skin Structure Infections: 250 mg every 8 hours or 500 mg every 12 hours for 7-14 days.
H. pylori Eradication: 1000 mg twice daily (as part of multi-drug regimen) for 7-14 days.
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing based on weight and gestational age for severe infections, typically 20-40 mg/kg/day divided every 8-12 hours.
Infant: 20-45 mg/kg/day divided every 8-12 hours, depending on infection severity (e.g., Otitis Media: 80-90 mg/kg/day divided every 12 hours). Max 1750 mg/day.
Child: 20-45 mg/kg/day divided every 8-12 hours, depending on infection severity. Max 1750 mg/day. For children >40 kg, adult dosing applies.
Adolescent: For adolescents >40 kg, adult dosing applies (250-875 mg every 8-12 hours).
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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, with an additional dose given during and/or at the end of dialysis. Peritoneal Dialysis: 250 mg every 12 hours.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.

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 bacterial cell wall and ultimately cell lysis.
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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
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 60-80%
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Pharmacodynamics

OnsetOfAction: Rapid (therapeutic concentrations achieved within 1-2 hours)
PeakEffect: Not applicable in the same way as other drug classes; peak plasma concentrations correlate with Tmax.
DurationOfAction: Dependent on maintaining concentrations above the minimum inhibitory concentration (MIC) for susceptible organisms, typically requiring dosing every 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 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
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. This 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.
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions
+ These reactions 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 significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

Diarrhea
Upset stomach
Vomiting
Headache

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:

  • Signs of a severe allergic reaction: rash, hives, itching, swelling (especially of the face, lips, tongue, or throat), severe dizziness, trouble breathing.
  • Severe or watery diarrhea, especially if it contains blood or mucus, which may occur up to several months after stopping the medication (could be C. difficile infection).
  • Unusual bruising or bleeding.
  • Yellowing of the skin or eyes (jaundice), dark urine, or pale stools (signs of liver problems).
  • Fever, sore throat, and body aches (could be signs of a new infection or drug 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:

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 that occurred.
If you are allergic to penicillin, as this may impact your ability to take this medication safely.
* If you have been diagnosed with mononucleosis (mono), as this condition may affect how you respond to 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 in combination with your other medications and health conditions.

Remember, do not 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.

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 the discoloration often 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, consider using 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
  • Crystalluria (crystals in urine) leading to renal failure (rare, with very large doses)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive and symptomatic. Hemodialysis may be used to remove amoxicillin from circulation in cases of severe overdose with renal impairment.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity due to reduced renal clearance)
  • Warfarin (potential for increased INR/bleeding, though mechanism complex and not fully understood, possibly affecting gut flora and vitamin K synthesis)
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Moderate Interactions

  • Allopurinol (increased incidence of skin rash, especially in patients with hyperuricemia)
  • Oral Contraceptives (potential for reduced efficacy of oral contraceptives due to altered gut flora, though evidence is weak)
  • Tetracyclines (may antagonize the bactericidal effect of amoxicillin)
  • Probenecid (increases and prolongs amoxicillin plasma levels by decreasing renal tubular secretion)

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 in patients with suspected or known renal dysfunction.

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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, resistance, or incorrect diagnosis.

Signs of allergic reaction (rash, itching, swelling)

Frequency: Daily, especially during initial doses

Target: Absence of allergic symptoms

Action Threshold: Any signs of allergic reaction require immediate discontinuation.

Gastrointestinal symptoms (nausea, vomiting, diarrhea)

Frequency: Daily

Target: Absence or mild, tolerable symptoms

Action Threshold: Severe or persistent diarrhea (especially bloody) may indicate C. difficile infection and requires investigation.

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Symptom Monitoring

  • Skin rash or hives
  • Itching
  • Swelling of face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Nausea
  • Vomiting
  • Unusual bruising or bleeding
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Pale stools
  • Fever that develops during or after treatment

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 is no evidence of harm in well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Low risk; no increased risk of major birth defects observed.
Second Trimester: Low risk; commonly used for infections.
Third Trimester: Low risk; commonly used for infections, including Group B Strep prophylaxis.
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Lactation

Amoxicillin is considered compatible with breastfeeding (Lactation Risk L1). It is excreted in breast milk in small amounts, but adverse effects in breastfed infants are rare. Monitor for diarrhea, candidiasis (thrush, diaper rash), or allergic reactions in the infant.

Infant Risk: Low risk
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Pediatric Use

Amoxicillin is widely used and well-tolerated in pediatric patients. Dosing is typically weight-based. Care should be taken to ensure accurate dosing, especially in infants and young children. Oral suspension formulations are commonly used.

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Geriatric Use

No specific dose adjustment is needed based on age alone. However, geriatric patients are more likely to have decreased renal function, which may necessitate dose adjustment based on creatinine clearance. Monitor for adverse effects, particularly gastrointestinal disturbances and potential for C. difficile infection.

Clinical Information

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Clinical Pearls

  • Amoxicillin is a first-line agent for many common bacterial infections, including acute otitis media, streptococcal pharyngitis, and community-acquired pneumonia (in certain cases).
  • It is often preferred over penicillin V for oral administration due to better absorption and less frequent dosing.
  • Patients with a history of penicillin allergy should be carefully assessed. While amoxicillin is a penicillin, cross-reactivity with cephalosporins is low (around 1-2%). However, severe penicillin allergies (e.g., anaphylaxis) contraindicate amoxicillin use.
  • Completing the full course of therapy is crucial to prevent antibiotic resistance and ensure complete eradication of the infection.
  • Diarrhea is a common side effect; advise patients to report severe or bloody diarrhea immediately due to the risk of C. difficile-associated diarrhea.
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Alternative Therapies

  • Penicillin V (for susceptible streptococcal infections)
  • Cephalexin (first-generation cephalosporin)
  • Cefdinir (third-generation cephalosporin)
  • Azithromycin (macrolide, for penicillin-allergic patients or atypical pathogens)
  • Clindamycin (lincosamide, for certain anaerobic or skin infections)
  • Doxycycline (tetracycline, for certain respiratory or skin infections)
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Cost & Coverage

Average Cost: $10 - $30 per 30 capsules (250mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred 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.