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Amoxicillin 400mg/5ml Susp 50ml

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 an antibiotic medication 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 important to take the full course of medication as prescribed, even if you start feeling better, to ensure the infection is completely cleared and to prevent 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 medication 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. Before using, shake the medication well. When taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring device. You can mix the medication with formula, milk, water, or other cold drinks, but be sure to drink the mixture right away. 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 feeling well.

Storing and Disposing of Your Medication

Store the liquid suspension at room temperature or in the refrigerator, but do not freeze it. Discard any unused portion after 2 weeks. 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 the best way to dispose 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 is close to the time for your next 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.
  • Shake the oral suspension well before each use.
  • Use an accurate measuring spoon or oral syringe for the liquid form.
  • Store the liquid suspension in the refrigerator after mixing, and discard any unused portion after 14 days.
  • If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue your regular schedule. Do not take two doses at once.
  • Avoid sharing this medication with others, even if they have similar symptoms.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. Common doses: 250-500 mg every 8 hours or 500-875 mg every 12 hours.
Dose Range: 250 - 875 mg

Condition-Specific Dosing:

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

Neonatal: Not established for routine use; consult specific guidelines for neonatal infections (e.g., 20-50 mg/kg/day divided every 8-12 hours, adjusted for gestational age and renal function).
Infant: 20-90 mg/kg/day divided every 8-12 hours, depending on infection severity and site. Max 1750 mg/day.
Child: 20-90 mg/kg/day divided every 8-12 hours, depending on infection severity and site. Max 1750 mg/day. For 400mg/5ml suspension, common doses for otitis media are 80-90 mg/kg/day divided every 12 hours.
Adolescent: Typically adult dosing (250-875 mg every 8-12 hours) or up to 90 mg/kg/day divided every 8-12 hours, not to exceed adult maximums.
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Dose Adjustments

Renal Impairment:

Mild: CrCl >30 mL/min: No dosage 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 at the end of dialysis. Peritoneal Dialysis: 250 mg every 12 hours.

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 enzymes located on the bacterial cell wall. This binding inhibits the transpeptidation step of peptidoglycan synthesis, leading to the disruption of the cell wall, osmotic instability, and ultimately, cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 70-90%
Tmax: 1-2 hours (oral)
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 (poor penetration into CSF unless meninges are inflamed)

Elimination:

HalfLife: 1-1.5 hours (in individuals with normal renal function)
Clearance: Approximately 250-300 mL/min (renal clearance)
ExcretionRoute: Primarily renal (60-80% unchanged drug excreted in urine via glomerular filtration and tubular secretion)
Unchanged: 60-80%
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Pharmacodynamics

OnsetOfAction: Rapid (within 30 minutes to 1 hour)
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: Dependent on dosing interval (typically 8-12 hours for antibacterial effect)

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 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. Before treating diarrhea, consult with your doctor.
 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 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 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:

  • Severe allergic reaction: Hives, difficulty breathing, swelling of your face, lips, tongue, or throat (seek emergency medical attention).
  • Severe skin rash (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis): Red or purple skin rash that spreads and causes blistering and peeling.
  • Severe diarrhea that is watery or bloody (may be a sign of C. difficile infection), even several weeks after stopping the medication.
  • Unusual bleeding or bruising.
  • Dark urine, clay-colored stools, or yellowing of the skin or eyes (signs of liver problems).
  • Fever, sore throat, and headache with a severe blistering, peeling, and red skin rash (may indicate a severe skin 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 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, consider using an additional form of birth control, such as condoms, 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, potentially leading to renal failure in severe cases)
  • Confusion
  • Agitation
  • Myoclonic jerking
  • Seizures (rare)

What to Do:

In case of overdose, call your local poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention immediately. Treatment is generally supportive and symptomatic. Hemodialysis can remove amoxicillin from the circulation.

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 rare and mechanism not fully elucidated)
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Moderate Interactions

  • Allopurinol (increased incidence of rash, particularly in patients with hyperuricemia)
  • Oral Contraceptives (potential for decreased efficacy of oral contraceptives, though evidence is controversial and not consistently demonstrated)
  • Probenecid (increased and prolonged amoxicillin plasma concentrations due to inhibition of renal tubular secretion)
  • Tetracyclines (may antagonize the bactericidal effect of amoxicillin)

Monitoring

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Baseline Monitoring

Allergy history (penicillins, cephalosporins)

Rationale: To prevent severe hypersensitivity reactions.

Timing: Prior to initiation of therapy.

Renal function (CrCl, BUN, creatinine)

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

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

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Routine Monitoring

Signs and symptoms of infection resolution

Frequency: Daily

Target: Improvement in fever, pain, inflammation

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

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)

Frequency: Daily

Target: Absence of new infections

Action Threshold: Development of new symptoms; consider C. difficile infection if severe diarrhea occurs.

Renal function (CrCl, BUN, creatinine)

Frequency: Periodically, if prolonged therapy or pre-existing renal impairment

Target: Stable renal function

Action Threshold: Significant decline in renal function may require dose adjustment.

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Symptom Monitoring

  • Skin rash (maculopapular rash, urticaria)
  • Diarrhea (mild to severe, including C. difficile-associated diarrhea)
  • Nausea
  • Vomiting
  • Abdominal pain
  • Headache
  • Vaginal itching or discharge (yeast infection)
  • Oral thrush (white patches in mouth)

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. It is often a preferred antibiotic for various infections during pregnancy.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations observed.
Second Trimester: No increased risk of adverse outcomes observed.
Third Trimester: No increased risk of adverse outcomes observed.
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Lactation

Amoxicillin is considered compatible with breastfeeding (Lactation Risk L1). It is excreted in breast milk in small amounts. While generally safe, monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions (e.g., rash).

Infant Risk: Low risk. Potential for mild gastrointestinal upset (diarrhea) or candidiasis in the infant. Allergic reactions are rare but possible.
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Pediatric Use

Amoxicillin is widely used and generally well-tolerated in pediatric patients. Dosing is typically weight-based (mg/kg/day) and varies by indication and severity of infection. The 400mg/5ml suspension is a common concentration for pediatric use. Ensure accurate dosing using appropriate measuring devices. Monitor for diarrhea and rash, which are common in children.

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Geriatric Use

No specific dosage adjustment is required based solely on age. However, elderly patients are more likely to have decreased renal function, which may necessitate dosage adjustment based on creatinine clearance. Monitor renal function in this population. They may also be more susceptible to gastrointestinal side effects or C. difficile infection.

Clinical Information

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Clinical Pearls

  • Amoxicillin is one of the most commonly prescribed antibiotics, particularly in pediatric practice.
  • The 'amoxicillin rash' (a non-urticarial, maculopapular rash) is common, especially in patients with viral infections (e.g., mononucleosis), and is often not a true allergic reaction to penicillin. However, true allergic reactions (hives, anaphylaxis) require discontinuation.
  • Always complete the full course of therapy to prevent antibiotic resistance and ensure eradication of the infection.
  • Oral suspension must be refrigerated after reconstitution and discarded after 14 days.
  • Amoxicillin is often combined with clavulanate (Augmentin) to extend its spectrum of activity against beta-lactamase-producing bacteria.
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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 - $50 per 50ml bottle of 400mg/5ml suspension
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 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 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 details about the medication taken, the amount, and the time it happened.