Amoxicillin 250mg/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 medication used to treat a wide range of bacterial infections, such as ear infections, strep throat, pneumonia, and urinary tract 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 prevent the infection from coming back and to reduce the risk of antibiotic resistance.
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How to Use This Medicine

Taking Your Medication

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 stomach upset and ensure the medication works effectively, take it at the beginning of a meal. Before using, shake the bottle well. When measuring a liquid dose, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.

You can mix the medication with formula, milk, water, or other cold beverages. After mixing, drink the medication right away. 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. Do not freeze the medication. Any unused portion of the medication should be discarded after 2 weeks.

Keep all medications in a safe and secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush medications down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about the proper disposal of medications, consult with your pharmacist. You may also want to inquire about drug take-back programs in your area.

Missing 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. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Shake the oral suspension well before each use.
  • Measure the dose accurately using the provided measuring spoon or cup, not a household spoon.
  • Amoxicillin can be taken with or without food. Taking it with food may help reduce stomach upset.
  • Complete the entire course of medication as prescribed, even if symptoms improve, to ensure the infection is fully treated and prevent resistance.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.
  • Do not share your medication with others.

Dosing & Administration

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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:

mild_moderate_infection: 250 mg every 8 hours or 500 mg every 12 hours
severe_infection: 500 mg every 8 hours or 875 mg every 12 hours
gonorrhea: 3 g as a single oral dose with 1 g probenecid
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Pediatric Dosing

Neonatal: Not established for routine use; consult specialist. Dosing typically 20-50 mg/kg/day divided every 8-12 hours, adjusted for gestational/postnatal age.
Infant: 20-45 mg/kg/day in divided doses every 8 or 12 hours (max 1000 mg/day). For otitis media/sinusitis: 80-90 mg/kg/day in 2 divided doses.
Child: 20-45 mg/kg/day in divided doses every 8 or 12 hours (max 1000 mg/day). For otitis media/sinusitis: 80-90 mg/kg/day in 2 divided doses.
Adolescent: Same as adult dosing, typically 250-500 mg every 8 hours or 500-875 mg every 12 hours, depending on infection.
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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: Hemodialysis: 250-500 mg every 24 hours, plus an additional dose given during and/or at the end of dialysis. Peritoneal Dialysis: 250 mg every 12 hours.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: No specific adjustment needed

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 prevents the cross-linking of peptidoglycan chains, leading to the disruption of the cell wall and subsequent bacterial lysis.
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Pharmacokinetics

Absorption:

Bioavailability: 70-90%
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: Not available (primarily renal)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Approximately 60% of an oral dose is excreted unchanged in the urine within 6-8 hours.
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: Dependent on dosing frequency (e.g., 8 or 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 medical attention:

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. This can lead to a life-threatening bowel problem. 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 have only minor side effects or none 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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing. Seek immediate medical attention.
  • Severe or watery diarrhea, especially if it contains blood or mucus, which may occur up to several months after stopping the medication (could be C. difficile infection).
  • Unusual bruising or bleeding.
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems).
  • New signs of infection (e.g., fever, sore throat, vaginal itching or discharge) which could indicate a superinfection.
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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 the 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. This will help determine whether it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage 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 in most cases, the discoloration 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 (crystals in urine, potentially leading to renal failure in severe cases)
  • Neurological effects (e.g., seizures) in patients with impaired renal function or very high doses

What to Do:

In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive, including maintaining fluid and electrolyte balance. Hemodialysis may be used to remove amoxicillin from circulation in severe cases of renal impairment or overdose.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate toxicity due to decreased renal clearance)
  • Live bacterial vaccines (e.g., typhoid vaccine, BCG; amoxicillin may reduce therapeutic effect)
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Moderate Interactions

  • Allopurinol (increased incidence of rash, particularly in hyperuricemic patients)
  • Oral contraceptives (may decrease efficacy of oral contraceptives, though evidence is controversial and not consistently observed)
  • Probenecid (increases and prolongs amoxicillin blood levels by decreasing renal tubular secretion)
  • Warfarin (rare reports of increased INR; monitor coagulation parameters)

Monitoring

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Baseline Monitoring

Allergy history (especially to penicillins or 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

Signs and symptoms of infection resolution

Frequency: Daily

Target: Improvement in fever, pain, inflammation

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure or resistant organism; consider culture and sensitivity testing.

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

Frequency: Daily

Target: Absence of new infections

Action Threshold: Development of new infections; consider antifungal/antidiarrheal treatment or discontinuation of amoxicillin if severe C. difficile infection suspected.

Renal function (BUN, creatinine)

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

Target: Within patient's baseline or normal limits

Action Threshold: Significant increase in BUN/creatinine; adjust dose or consider alternative.

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Symptom Monitoring

  • Rash, itching, hives (signs of allergic reaction)
  • Swelling of face, lips, tongue, or throat (angioedema, severe allergic reaction)
  • Difficulty breathing or swallowing (severe allergic reaction)
  • Severe diarrhea, abdominal pain, fever (Clostridioides difficile-associated diarrhea)
  • Unusual bleeding or bruising (rare, associated with coagulation issues)
  • Yellowing of skin or eyes, dark urine (signs of liver problems, rare)

Special Patient Groups

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Pregnancy

Amoxicillin is generally considered safe for use during pregnancy and is a commonly prescribed antibiotic for pregnant women. It is classified as Pregnancy Category B.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of birth defects.
Second Trimester: No evidence of increased risk of adverse effects.
Third Trimester: No evidence of increased risk of adverse effects.
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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 infant sensitization, diarrhea, candidiasis (thrush, diaper rash). Monitor breastfed infant for adverse effects.
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Pediatric Use

Amoxicillin is widely used in pediatric patients. Dosing is typically weight-based (mg/kg/day) and varies by indication. Close monitoring for allergic reactions and superinfections is important.

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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.

Clinical Information

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Clinical Pearls

  • Amoxicillin suspension must be shaken well before each use and stored in the refrigerator after reconstitution. Discard after 14 days.
  • It is crucial to complete the full course of therapy to prevent the development of antibiotic resistance and ensure complete eradication of the infection.
  • Patients should be advised about the potential for diarrhea, which can range from mild to severe (C. difficile-associated diarrhea).
  • Always inquire about penicillin allergies before prescribing amoxicillin, as severe hypersensitivity reactions can occur.
  • Amoxicillin is often combined with clavulanate (e.g., Augmentin) to overcome beta-lactamase resistance in certain bacterial strains.
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Alternative Therapies

  • Cephalexin (Keflex)
  • Cefdinir (Omnicef)
  • Azithromycin (Zithromax)
  • Clindamycin (Cleocin)
  • Doxycycline (Vibramycin)
  • Trimethoprim/Sulfamethoxazole (Bactrim)
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Cost & Coverage

Average Cost: $15 - $50 per 150ml suspension (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic) or Tier 2 (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 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.