Amoxicillin 400mg/5ml Susp 100ml
It is used to treat bacterial infections.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antibiotic
Pharmacologic Class
Beta-lactam antibiotic; Penicillin
Pregnancy Category
Category B
FDA Approved
Jan 1974
DEA Schedule
Not Controlled
Overview
What is this medicine?
Amoxicillin is a common antibiotic used to treat a wide range 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.
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, shake the liquid formulation well to mix the ingredients thoroughly. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to accurately measure your dose.
You can mix this 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. If you have not used the entire contents of the bottle after 2 weeks, discard the remaining amount.
Keep all medications in a secure 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 by your pharmacist. If you are unsure about the best way to dispose of your medication, consult with 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 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 to make up for the missed one.
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, shake the liquid formulation well to mix the ingredients thoroughly. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to accurately measure your dose.
You can mix this 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. If you have not used the entire contents of the bottle after 2 weeks, discard the remaining amount.
Keep all medications in a secure 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 by your pharmacist. If you are unsure about the best way to dispose of your medication, consult with 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 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 to make up for the missed one.
Lifestyle & Tips
- Take the full course of medication as prescribed, even if you feel better, to prevent antibiotic resistance and ensure the infection is fully cleared.
- Shake the suspension well before each use.
- Use a calibrated measuring spoon or cup for accurate dosing of the suspension.
- 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 pharmacist/label).
- Do not share your medication with others.
Available Forms & Alternatives
Available Strengths:
- Amoxicillin 250mg Chew Tablets
- Amoxicillin 125mg Chewable Tablets
- Amoxicillin 250mg Capsules
- Amoxicillin 500mg Capsules
- Amoxicillin 875mg Tablets
- Amoxicillin 500mg Capsules
- Amoxicillin 200mg/5ml Susp 75ml
- Amoxicillin 400mg/5ml Susp 100ml
- Amoxicillin 400mg/5ml Susp 50ml
- Amoxicillin 400mg/5ml Susp 75ml
- Amoxicillin 125mg/5ml Susp 80ml
- Amoxicillin 250mg/5ml Susp 100ml
- Amoxicillin 200mg/5ml Susp 100ml
- Amoxicillin 250mg/5ml Susp 150ml
- Amoxicillin 250mg/5ml Susp 80ml
- Amoxicillin 125mg/5ml Susp 150ml
- Amoxicillin 125mg/5ml Susp 100ml
- Amoxicillin 200mg/5ml Susp 50ml
- Amoxicillin 250mg Capsules
- Amoxicillin 500mg Tablets
Dosing & Administration
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:
500 mg every 12 hours or 250 mg every 8 hours for 10 days
Otitis Media:
500 mg every 12 hours or 250 mg every 8 hours for 10 days
Lower Respiratory Tract Infections:
500 mg every 12 hours or 250 mg every 8 hours for 10 days
Skin/Skin Structure Infections:
500 mg every 12 hours or 250 mg every 8 hours for 7-10 days
Genitourinary Tract Infections:
500 mg every 12 hours or 250 mg every 8 hours for 3-7 days
H. pylori eradication:
1000 mg twice daily in combination therapy for 7-14 days
Pediatric Dosing
Neonatal:
Not established for routine use; consult specific guidelines for neonates (e.g., for Group B Strep prophylaxis). Dosing typically 20-40 mg/kg/day divided every 8-12 hours, but specific to indication and age.
Infant:
20-45 mg/kg/day divided every 8-12 hours, depending on infection severity. Max 1000 mg/day.
Child:
20-45 mg/kg/day divided every 8-12 hours, depending on infection severity. For severe infections (e.g., otitis media, sinusitis): 80-90 mg/kg/day in 2-3 divided doses. Max 1000 mg/day.
Adolescent:
Dosing typically follows adult guidelines (250-875 mg every 8-12 hours) if weight > 40 kg, otherwise pediatric mg/kg dosing.
Dose Adjustments
Renal Impairment:
Mild:
CrCl > 30 mL/min: No adjustment needed.
Moderate:
CrCl 10-30 mL/min: 250 mg or 500 mg every 12 hours, depending on original dose and infection severity.
Severe:
CrCl < 10 mL/min: 250 mg or 500 mg every 24 hours, depending on original dose and infection severity.
Dialysis:
Hemodialysis: 250 mg or 500 mg every 24 hours, with an additional dose given during and at the end of dialysis. Peritoneal Dialysis: 250 mg or 500 mg every 12-24 hours.
Hepatic Impairment:
Mild:
No adjustment.
Moderate:
No adjustment.
Severe:
No specific adjustment recommended, but use with caution and monitor liver function in severe impairment.
Pharmacology
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 defects in the cell wall, increased osmotic pressure, and ultimately cell lysis and death.
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:
Approximately 17-20%
CnssPenetration:
Limited (increases with meningeal inflammation)
Elimination:
HalfLife:
1-1.5 hours (normal renal function)
Clearance:
Renal clearance is approximately 250-350 mL/min
ExcretionRoute:
Primarily renal (glomerular filtration and tubular secretion)
Unchanged:
50-70%
Pharmacodynamics
OnsetOfAction:
Rapid (within 30-60 minutes for measurable plasma concentrations)
PeakEffect:
1-2 hours (plasma concentration)
DurationOfAction:
Dependent on dosing interval (typically 8-12 hours for therapeutic effect)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
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, 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. CDAD can happen during or a few months after taking antibiotics. 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), and other serious reactions, may occur. These reactions can affect body organs and be fatal. 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 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.
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 help right away:
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, 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. CDAD can happen during or a few months after taking antibiotics. 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), and other serious reactions, may occur. These reactions can affect body organs and be fatal. 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 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.
Seek Immediate Medical Attention If You Experience:
- Severe allergic reaction: rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing, wheezing, dizziness. Seek immediate medical attention.
- Severe or persistent diarrhea, especially if it's watery or bloody (may be a sign of C. difficile infection).
- Unusual bruising or bleeding.
- Yellowing of the skin or eyes (jaundice), dark urine, or pale stools (signs of liver problems).
- Signs of kidney problems: changes in urination, swelling in ankles/feet.
- New or worsening joint pain, fever, or rash (may indicate serum sickness-like reaction).
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.
If you are allergic to penicillin.
* If you have been diagnosed with mononucleosis (mono).
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 health conditions and other medications.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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.
If you are allergic to penicillin.
* If you have been diagnosed with mononucleosis (mono).
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 health conditions and other medications.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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 regularly 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 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, 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.
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 regularly 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 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, 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.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Crystalluria (crystals in urine, potentially leading to kidney problems)
- In severe cases, neurological effects (e.g., seizures) may occur, especially in patients with impaired renal function.
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately. 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
Major Interactions
- Methotrexate (increased methotrexate levels and toxicity due to reduced renal clearance)
- Warfarin (enhanced anticoagulant effect, increased INR/bleeding risk)
Moderate Interactions
- Allopurinol (increased incidence of rash, particularly in hyperuricemic patients)
- Oral Contraceptives (potential for reduced efficacy of oral contraceptives, though evidence is debated)
- Tetracyclines (may antagonize the bactericidal effect of amoxicillin)
- Probenecid (increases and prolongs amoxicillin plasma levels by decreasing renal tubular secretion)
Monitoring
Baseline Monitoring
Culture and Susceptibility
Rationale: To identify the causative pathogen and confirm its susceptibility to amoxicillin, ensuring appropriate therapy.
Timing: Prior to initiating therapy, if clinically indicated.
Renal Function (CrCl, BUN, Creatinine)
Rationale: To determine baseline renal status and guide dose adjustments in patients with impaired renal function.
Timing: Before starting therapy, especially in elderly or renally impaired patients.
Routine Monitoring
Clinical Response to Therapy
Frequency: Daily
Target: Resolution of signs and symptoms of infection (e.g., fever, pain, inflammation)
Action Threshold: Lack of improvement or worsening symptoms after 48-72 hours may indicate treatment failure, resistant organism, or alternative diagnosis.
Signs of Allergic Reaction
Frequency: Daily, especially during initial doses
Target: Absence of rash, pruritus, urticaria, dyspnea, anaphylaxis
Action Threshold: Any signs of allergic reaction require immediate discontinuation and appropriate management.
Gastrointestinal Symptoms
Frequency: Daily
Target: Absence of severe diarrhea, abdominal pain, nausea, vomiting
Action Threshold: Persistent or severe diarrhea may indicate C. difficile infection; requires investigation.
Complete Blood Count (CBC) with differential
Frequency: Periodically for prolonged therapy (>2 weeks)
Target: Within normal limits
Action Threshold: Significant changes (e.g., leukopenia, thrombocytopenia) may indicate drug-induced hematologic effects.
Liver Function Tests (LFTs)
Frequency: Periodically for prolonged therapy (>2 weeks)
Target: Within normal limits
Action Threshold: Significant elevations may indicate drug-induced hepatotoxicity.
Symptom Monitoring
- Rash
- Hives
- Itching
- Difficulty breathing or swallowing
- Wheezing
- Severe diarrhea (especially if bloody or watery)
- Abdominal pain
- Nausea
- Vomiting
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Pale stools
- Fever
- Sore throat
Special Patient Groups
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 used to treat 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.
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.
Pediatric Use
Amoxicillin is widely used and generally well-tolerated in pediatric patients. Dosing is typically weight-based (mg/kg). Higher doses (80-90 mg/kg/day) are often used for common infections like acute otitis media and sinusitis due to increasing resistance of S. pneumoniae. Close monitoring for allergic reactions and gastrointestinal side effects is important.
Geriatric Use
No specific dose adjustment is needed based solely on age, but geriatric patients are more likely to have decreased renal function. Renal function should be assessed, and dosage adjusted accordingly for renal impairment. Elderly patients may also be more susceptible to gastrointestinal side effects or C. difficile infection.
Clinical Information
Clinical Pearls
- Amoxicillin is a first-line agent for many common bacterial infections, including acute otitis media, strep throat, and sinusitis.
- It is often preferred over penicillin V for its broader spectrum and better absorption.
- The 80-90 mg/kg/day dosing for pediatric otitis media and sinusitis is crucial for overcoming resistant S. pneumoniae.
- Always inquire about penicillin allergies before administration. A history of rash may not be a true allergy; differentiate between true IgE-mediated reactions and non-allergic rashes.
- Counsel patients on the importance of completing the full course of therapy to prevent resistance and recurrence.
- Reconstituted suspension must be refrigerated and discarded after 14 days.
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 penicillin-allergic patients, particularly for anaerobic infections or skin infections)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 100ml suspension (400mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Preferred Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.