Amoxicillin 400mg/5ml Susp 75ml

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
Penicillin, Beta-lactam antibiotic
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Pregnancy Category
Category B
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FDA Approved
Jan 1971
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Amoxicillin is an antibiotic used to treat various 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 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 an upset stomach 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 the 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 instructed to do so. If you have questions about the disposal of your medication, consult your pharmacist. You may also want to inquire about 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 is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses.
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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.
  • Shake the suspension well before each use.
  • Use a calibrated measuring spoon or oral syringe for accurate dosing.
  • Amoxicillin can be taken with or without food. Taking it with food may help reduce stomach upset.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days (or as directed by the pharmacist/label).

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used for adult standard dosing; this formulation is primarily pediatric. Adult dosing for Amoxicillin typically ranges from 250 mg to 875 mg per dose, 2-3 times daily, depending on infection severity and type.

Condition-Specific Dosing:

pharyngitis_tonsillitis: 500 mg every 12 hours or 250 mg every 8 hours
otitis_media: 500 mg every 12 hours or 250 mg every 8 hours
lower_respiratory_tract_infections: 500 mg every 12 hours or 250 mg every 8 hours
skin_skin_structure_infections: 500 mg every 12 hours or 250 mg every 8 hours
gonorrhea: 3 g as a single oral dose with 1 g probenecid
H_pylori_eradication: 1 g twice daily (as part of multi-drug regimen)
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing based on postmenstrual age and postnatal age for severe infections, typically 20-30 mg/kg/day divided every 12 hours.
Infant: 20-90 mg/kg/day divided every 8 or 12 hours, depending on infection severity and type. For 400mg/5ml, common doses are 45 mg/kg/day or 90 mg/kg/day.
Child: 20-90 mg/kg/day divided every 8 or 12 hours. Max 1000 mg/day. For otitis media/sinusitis, 80-90 mg/kg/day in 2 divided doses is common. For strep throat, 50 mg/kg/day in 2-3 divided doses.
Adolescent: Dosing similar to adult recommendations, typically 250-500 mg every 8 hours or 500-875 mg every 12 hours, or weight-based if lower weight.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 30 mL/min)
Moderate: Administer standard dose every 12 hours (CrCl 10-30 mL/min)
Severe: Administer standard dose every 24 hours (CrCl < 10 mL/min)
Dialysis: Administer standard dose every 24 hours; administer an additional dose after dialysis session.

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 that inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs). This binding prevents the cross-linking of peptidoglycan chains, leading to the disruption of bacterial cell wall integrity and subsequent cell lysis.
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Pharmacokinetics

Absorption:

Bioavailability: 70-90%
Tmax: 1-2 hours
FoodEffect: Food does not significantly affect the absorption of amoxicillin.

Distribution:

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

Elimination:

HalfLife: 1-1.5 hours (normal renal function)
Clearance: Not available
ExcretionRoute: Primarily renal (glomerular filtration and tubular secretion)
Unchanged: 60-80%
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1-2 hours (plasma concentration)
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
+ 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
Unexplained bruising or bleeding
Fever or chills
Vaginal itching or discharge
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 notice any of these symptoms.
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect body organs and be life-threatening
+ If you notice signs such as:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in your mouth, throat, nose, eyes, genitals, or skin
- Fever or chills
- Body aches or shortness of breath
- Swollen glands
+ Seek medical help right away.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or if they bother you or do not go away, contact your doctor:

Diarrhea
Upset stomach or vomiting
* Headache

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 months after your last dose).
  • Unusual bleeding or bruising.
  • Dark urine, clay-colored stools, or yellowing of the skin or eyes (jaundice).
  • Fever, sore throat, and 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 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 color change often lessens or disappears with regular brushing or dental cleaning. If you notice any changes in tooth color, consult 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. You and your doctor 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 rare cases, convulsions

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. 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)
  • Warfarin (increased INR and bleeding risk, monitor closely)
  • Allopurinol (increased incidence of rash, especially in hyperuricemic patients)
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Moderate Interactions

  • Oral Contraceptives (may reduce efficacy, though evidence is controversial; advise backup contraception)
  • Probenecid (increases and prolongs amoxicillin blood levels by decreasing renal tubular secretion)
  • Tetracyclines (may antagonize the bactericidal effect of amoxicillin)

Monitoring

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Baseline Monitoring

Culture and Sensitivity

Rationale: To confirm susceptibility of the causative organism to amoxicillin, especially for severe or recurrent infections.

Timing: Prior to initiation of therapy, if clinically indicated.

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Routine Monitoring

Clinical Response

Frequency: Daily during acute treatment

Target: Resolution of signs and symptoms of infection

Action Threshold: Lack of improvement or worsening symptoms after 48-72 hours may indicate treatment failure or resistant organism.

Renal Function (CrCl)

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

Target: Not applicable (used for dose adjustment)

Action Threshold: If CrCl falls below 30 mL/min, dose adjustment is required.

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Symptom Monitoring

  • Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
  • Severe diarrhea or abdominal pain (may indicate Clostridioides difficile-associated diarrhea)
  • Nausea, vomiting
  • Headache
  • 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 is no evidence of harm in well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Low risk; commonly used for infections during this trimester.
Second Trimester: Low risk; commonly used for infections during this trimester.
Third Trimester: Low risk; commonly used for infections during this trimester.
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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. Potential for mild diarrhea, candidiasis (thrush), or allergic sensitization in the breastfed infant. Monitor infant for rash or gastrointestinal upset.
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Pediatric Use

Amoxicillin is widely used and well-tolerated in pediatric patients. Dosing is weight-based and varies by indication. Careful calculation of dose based on mg/kg is crucial to avoid under- or overdosing. The 400mg/5ml suspension is specifically formulated for pediatric use.

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Geriatric Use

No specific dose adjustment is needed based solely on age. However, geriatric patients are more likely to have decreased renal function, which may necessitate dose adjustment based on creatinine clearance. Monitor renal function.

Clinical Information

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Clinical Pearls

  • Amoxicillin is a first-line antibiotic for many common bacterial infections, including acute otitis media, streptococcal pharyngitis, and community-acquired pneumonia.
  • It is often prescribed as a higher dose (e.g., 80-90 mg/kg/day) for infections where S. pneumoniae resistance is a concern (e.g., acute otitis media).
  • Amoxicillin is not effective against beta-lactamase producing bacteria. For such infections, amoxicillin-clavulanate (Augmentin) is typically used.
  • A non-allergic, maculopapular rash can occur, especially in patients with mononucleosis or cytomegalovirus infection, and should not be confused with a true penicillin allergy.
  • Always complete the full course of antibiotics to prevent the development of antibiotic resistance.
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Alternative Therapies

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

Average Cost: $10 - $30 per 75ml bottle of 400mg/5ml 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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.