Amoxicillin 250mg/5ml Susp 80ml

Manufacturer WEST-WARD Active Ingredient Amoxicillin Suspension(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; Penicillin
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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 penicillin-type antibiotic used to treat many different types of bacterial infections, such as ear infections, strep throat, pneumonia, and urinary tract infections. It works by stopping the growth of bacteria. It will not work for viral infections like the common cold or flu.
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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.

To minimize the risk of stomach upset and ensure the medication works effectively, take it at the beginning of a meal. Before using the liquid form, shake the bottle well. Measure the liquid dose precisely using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for one to ensure accurate measurement.

You can mix the medication with formula, milk, water, or other cold beverages. After mixing, consume the dose immediately. Establish a routine by taking your medication at the same time every day. Continue taking your medication as instructed by your doctor or healthcare provider, even if you start feeling better.

Storing and Disposing of Your Medication

Store the liquid suspension at room temperature or in the refrigerator. Avoid freezing the medication. Discard any unused portion after 2 weeks.

Keep all medications in a secure location, 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 advised to do so by your pharmacist. If you have questions about the proper disposal method, consult your pharmacist, who may be aware of 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 resume your regular dosing schedule. Avoid taking two doses at once or taking extra doses.
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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, as this can lead to antibiotic resistance.
  • Shake the oral suspension well before each use.
  • Measure the liquid medicine carefully using the provided dosing syringe or spoon, not a household spoon.
  • Amoxicillin can be taken with or without food.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days (or as directed by pharmacist).
  • If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take two doses at once.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

mildToModerateInfections: 250 mg every 8 hours or 500 mg every 12 hours
severeInfections: 500 mg every 8 hours or 875 mg every 12 hours
gonorrhea: 3 g as a single oral dose with 1 g probenecid
hPyloriEradication: 1 g twice daily (as part of multi-drug regimen)
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Pediatric Dosing

Neonatal: Not established for routine use; consult specialist. Limited data suggests 20-40 mg/kg/day divided every 12 hours for specific indications.
Infant: 20-45 mg/kg/day divided every 8-12 hours (e.g., 125-250 mg/5mL suspension). Max 500 mg/dose.
Child: 20-90 mg/kg/day divided every 8-12 hours, depending on infection severity and type. Max 875 mg/dose.
Adolescent: Dosing typically follows adult guidelines (250-875 mg per dose, depending on frequency and indication).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 30 mL/min)
Moderate: 250-500 mg every 12 hours (CrCl 10-30 mL/min)
Severe: 250-500 mg every 24 hours (CrCl < 10 mL/min)
Dialysis: 250-500 mg every 24 hours, with an additional dose given after dialysis. Amoxicillin is dialyzable.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

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 essential for bacterial cell wall formation. This binding leads to the inhibition of peptidoglycan synthesis, resulting in 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. It can be taken with or without food.

Distribution:

Vd: 0.3-0.4 L/kg
ProteinBinding: Approximately 17-20%
CnssPenetration: Limited (unless meninges are inflamed)

Elimination:

HalfLife: 1-1.5 hours (normal renal function)
Clearance: Approximately 250-300 mL/min (renal clearance)
ExcretionRoute: Primarily renal (glomerular filtration and tubular secretion)
Unchanged: 60-80%
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Pharmacodynamics

OnsetOfAction: Rapid (within 30-60 minutes)
PeakEffect: 1-2 hours (corresponding to Tmax)
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

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, 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. 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 or none at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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 an 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 months after your last dose). This could be a sign of a serious bowel infection.
  • Unusual tiredness, pale skin, easy bruising or bleeding, fever, chills, body aches, flu symptoms.
  • Dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
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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 common side effect of this medication, particularly in children, is a change in tooth color to a yellow-gray-brown hue. In most cases, this discoloration can be reduced or eliminated 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, plan to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Crystalluria (crystals in urine, potentially leading to kidney problems)
  • Electrolyte imbalance
  • In rare cases, seizures or neurological symptoms

What to Do:

In case of suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention immediately. Treatment is generally supportive and may include gastric lavage, activated charcoal, and monitoring of fluid and electrolyte balance. Amoxicillin can be removed by hemodialysis.

Drug Interactions

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Major Interactions

  • Methotrexate (Amoxicillin may decrease renal tubular secretion of methotrexate, increasing its plasma concentrations and potential toxicity.)
  • Live bacterial vaccines (e.g., Typhoid vaccine, BCG vaccine - Amoxicillin may reduce the therapeutic effect of these vaccines.)
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Moderate Interactions

  • Allopurinol (Increased incidence of rash, particularly in patients with hyperuricemia.)
  • Oral Contraceptives (May reduce the efficacy of oral contraceptives, though evidence is controversial and not consistently supported by clinical studies. Advise backup contraception.)
  • Warfarin (May enhance the anticoagulant effect of warfarin, requiring increased INR monitoring.)
  • Probenecid (Decreases renal tubular secretion of amoxicillin, leading to increased and prolonged plasma concentrations of amoxicillin.)
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Minor Interactions

  • Tetracyclines (May antagonize the bactericidal effect of penicillins.)

Monitoring

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Baseline Monitoring

Allergy history (especially to penicillins or cephalosporins)

Rationale: To prevent severe hypersensitivity reactions.

Timing: Prior to first dose

Renal function (CrCl)

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

Timing: Prior to initiation in patients with suspected or known renal impairment

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Routine Monitoring

Clinical response to therapy

Frequency: Daily, throughout treatment course

Target: Resolution of signs and symptoms of infection

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

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, C. difficile-associated diarrhea)

Frequency: Daily, throughout and after treatment

Target: Absence of new infections

Action Threshold: Appearance of new symptoms requires evaluation and potential treatment.

Renal function (CrCl, BUN, creatinine)

Frequency: Periodically, for prolonged therapy or in patients with pre-existing renal impairment

Target: Within patient's baseline or acceptable limits

Action Threshold: Significant decline may necessitate dose adjustment or discontinuation.

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Symptom Monitoring

  • Rash (maculopapular, urticarial)
  • Pruritus
  • Difficulty breathing or swallowing (signs of anaphylaxis)
  • Severe or persistent diarrhea (especially watery or bloody, suggestive of C. difficile infection)
  • Nausea
  • Vomiting
  • Abdominal pain
  • Unusual bruising or bleeding (if on warfarin)
  • Signs of new infection (e.g., fever, sore throat, vaginal discharge)

Special Patient Groups

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Pregnancy

Amoxicillin is generally considered safe for use during pregnancy and is classified as 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: No increased risk of congenital malformations observed.
Second Trimester: Considered safe.
Third Trimester: Considered safe.
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Lactation

Amoxicillin is excreted in small amounts into breast milk. It is generally considered compatible with breastfeeding (Lactation Risk Category 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 weight-based and varies by indication and severity of infection. Careful calculation of dose is crucial to avoid under- or overdosing. Oral suspension formulations are commonly used for ease of administration.

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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 adjustment based on creatinine clearance. Monitor renal function in this population.

Clinical Information

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Clinical Pearls

  • Amoxicillin is one of the most commonly prescribed antibiotics, particularly in pediatric practice.
  • It is often a first-line agent for common bacterial infections like acute otitis media, streptococcal pharyngitis, and sinusitis.
  • A non-allergic, maculopapular rash is common with amoxicillin, especially if given to patients with infectious mononucleosis (Epstein-Barr virus infection). This rash is not a true allergic reaction and does not contraindicate future use of penicillins.
  • Always emphasize the importance of completing the full course of antibiotics, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
  • Amoxicillin is ineffective against viral infections; avoid inappropriate prescribing to prevent resistance.
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Alternative Therapies

  • Penicillin V (for susceptible streptococcal infections)
  • Cephalexin (Keflex - a first-generation cephalosporin)
  • Cefdinir (Omnicef - a third-generation cephalosporin)
  • Azithromycin (Zithromax - a macrolide, for penicillin-allergic patients or atypical pathogens)
  • Clindamycin (Cleocin - for anaerobic infections or penicillin-allergic patients)
  • Doxycycline (for certain respiratory or skin infections, not typically first-line for common pediatric infections)
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Cost & Coverage

Average Cost: Varies widely, typically low per 80ml suspension
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 is 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 it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 details about the overdose, including the medication taken, the amount, and the time it occurred.