Amoxicillin 125mg/5ml Susp 150ml

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 that fights bacteria. It works by stopping the growth of bacteria that cause infections. It's used to treat many different types of bacterial infections, like ear infections, strep throat, and pneumonia. 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, 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 one.

You can mix your medication with formula, milk, water, or other cold drinks. After mixing, drink the medication right away. To establish a routine, take 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. Do not freeze the medication. If you don't use the entire bottle, discard any remaining medication 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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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 dose, skip the missed dose and resume your regular 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, 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 to ensure accurate dosing.
  • 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.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days (or as directed by the pharmacist).

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:

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 10-14 days
Lower Respiratory Tract Infections: 500 mg every 12 hours or 250 mg every 8 hours for 7-10 days
Skin/Skin Structure Infections: 500 mg every 12 hours or 250 mg every 8 hours for 7-10 days
Urinary Tract Infections: 500 mg every 12 hours or 250 mg every 8 hours for 3-7 days
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Pediatric Dosing

Neonatal: Not established for routine use; consult specific guidelines for premature/full-term neonates (e.g., 20-30 mg/kg/day divided every 12 hours).
Infant: 20-45 mg/kg/day divided every 8 or 12 hours (max 1000 mg/day). For severe infections, up to 80-90 mg/kg/day divided every 8 or 12 hours.
Child: 20-45 mg/kg/day divided every 8 or 12 hours (max 1000 mg/day). For severe infections (e.g., AOM), up to 80-90 mg/kg/day divided every 8 or 12 hours.
Adolescent: Same as adult dosing, typically 250-500 mg every 8 hours or 500-875 mg every 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; administer an additional dose 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 membrane. This binding prevents the cross-linking of peptidoglycan chains, leading to defects in the cell wall and ultimately bacterial 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. It can be taken with or without food.

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: Renal clearance is approximately 250-300 mL/min.
ExcretionRoute: Primarily renal (glomerular filtration and tubular secretion)
Unchanged: 50-70% of an oral dose is excreted unchanged in the urine within 6-8 hours.
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Pharmacodynamics

OnsetOfAction: Rapid (within 30 minutes to 1 hour)
PeakEffect: 1-2 hours (corresponds to Tmax)
DurationOfAction: Dependent on dosing interval (typically 8-12 hours based on half-life and MIC)

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 a type of allergic reaction called drug-induced enterocolitis syndrome, 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, or 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 life-threatening. Seek medical help immediately if you experience:
+ 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 attention:

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.
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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). This could be a sign of a new infection (C. difficile).
  • Unusual bruising or bleeding.
  • Pale skin, unusual tiredness, lightheadedness, shortness of breath, cold hands and feet.
  • Fever, sore throat, swollen glands, rash, or other flu-like symptoms (may indicate drug reaction with eosinophilia and systemic symptoms - DRESS syndrome).
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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 symptoms you experienced as a result of the allergy.
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.

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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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 contraceptives 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. It is necessary 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 (rare, may lead to renal failure in severe cases)
  • Neurological symptoms (e.g., agitation, confusion, convulsions) in patients with severe renal impairment or very high doses

What to Do:

In case of overdose, call your local poison control center (1-800-222-1222) or seek emergency medical attention immediately. Treatment is generally supportive and may include gastric lavage or activated charcoal if ingestion was recent. 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 (enhanced anticoagulant effect, increased INR/bleeding risk)
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Moderate Interactions

  • Allopurinol (increased risk of skin rash, particularly in patients with hyperuricemia)
  • Oral Contraceptives (may reduce efficacy of oral contraceptives, though evidence is conflicting and not consistently demonstrated clinically)
  • Probenecid (increases and prolongs amoxicillin blood levels by decreasing renal tubular secretion)
  • Tetracyclines (may antagonize the bactericidal effect of penicillins)
  • Live Typhoid Vaccine (oral) (amoxicillin may inactivate the vaccine)

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 dose adjustment in patients with renal impairment.

Timing: Prior to initiation, especially in elderly or those with known renal issues.

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Routine Monitoring

Clinical response to therapy (e.g., fever, symptom resolution)

Frequency: Daily during acute illness

Target: Improvement of symptoms, resolution of infection

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 requires evaluation and potential discontinuation/alternative therapy.

Fluid intake (especially with high doses)

Frequency: Daily

Target: Adequate hydration

Action Threshold: Inadequate fluid intake may increase risk of crystalluria (rare).

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Symptom Monitoring

  • Skin rash (maculopapular, urticarial)
  • Pruritus
  • Dyspnea or wheezing
  • Facial or throat swelling
  • Severe or persistent diarrhea (especially watery or bloody)
  • Abdominal pain or cramping
  • Nausea/vomiting
  • Unusual bruising or bleeding
  • Dark urine or yellowing of skin/eyes (rare liver effects)

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: 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 excreted in small amounts into breast milk. It is generally considered compatible with breastfeeding (Lactation Risk L1).

Infant Risk: Low risk. Potential for mild gastrointestinal upset (e.g., diarrhea, thrush) in the infant, or sensitization. Monitor infant for rash or diarrhea.
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Pediatric Use

Amoxicillin is widely used and well-tolerated in pediatric patients. Dosing is typically weight-based. High-dose amoxicillin (80-90 mg/kg/day) is often recommended for common pediatric infections like acute otitis media due to increasing resistance of S. pneumoniae.

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Geriatric Use

No specific dose adjustment is needed based on age alone. However, elderly patients are more likely to have decreased renal function, which may require dose adjustment based on creatinine clearance. Monitor for signs of renal impairment and adjust dose accordingly.

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.
  • High-dose amoxicillin (80-90 mg/kg/day) is preferred for acute otitis media in children to overcome resistance of penicillin-non-susceptible S. pneumoniae.
  • Always complete the full course of antibiotics, even if symptoms improve, to prevent resistance and ensure eradication of the infection.
  • Patients should be advised to shake the oral suspension well before each use and to use an accurate measuring device.
  • While food does not significantly affect absorption, taking it with food may help reduce gastrointestinal upset.
  • Counsel patients on the signs and symptoms of C. difficile-associated diarrhea, which can occur during or even months after antibiotic therapy.
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Alternative Therapies

  • Cephalexin (Keflex) - another beta-lactam antibiotic
  • Azithromycin (Zithromax) - macrolide antibiotic (for penicillin-allergic patients or atypical pathogens)
  • Clindamycin (Cleocin) - lincosamide antibiotic (for penicillin-allergic patients, anaerobic infections)
  • Doxycycline (Vibramycin) - tetracycline antibiotic (for older children/adults, atypical pathogens)
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Cost & Coverage

Average Cost: $10 - $30 per 150ml of 125mg/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 promptly. 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.