Amoxicillin 125mg/5ml Susp 100ml

Manufacturer WEST-WARD Active Ingredient Amoxicillin Suspension(a moks i SIL in) Pronunciation uh-moks-uh-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; Aminopenicillin
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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 used to treat many different types of bacterial infections, such as ear infections, strep throat, pneumonia, and skin infections. It works by killing the bacteria that cause these infections. 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 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, 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. Do not freeze the medication. Any unused portion of the medication should be discarded 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. Unless instructed to do so by your pharmacist, do not flush medications down the toilet or pour them down the drain. If you have questions about the proper disposal of medications, 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 full course of medication as prescribed, even if you feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Shake the oral suspension well before each use.
  • Measure liquid medicine carefully 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.
  • Store the liquid suspension in the refrigerator after mixing, and discard any unused portion after 14 days.

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 10-14 days
skin_skin_structure_infections: 500 mg every 12 hours or 250 mg every 8 hours for 7-14 days
h_pylori_eradication: 1000 mg twice daily (as part of triple therapy) for 7-14 days
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Pediatric Dosing

Neonatal: Not established for routine use; consult specific guidelines for neonates (e.g., 20-40 mg/kg/day divided every 8-12 hours, adjusted for gestational age and weight).
Infant: 20-45 mg/kg/day divided every 8-12 hours, depending on infection severity. Max 875 mg/dose.
Child: 20-45 mg/kg/day divided every 8-12 hours, depending on infection severity. Max 875 mg/dose. For severe infections (e.g., otitis media), up to 80-90 mg/kg/day divided every 12 hours.
Adolescent: Adult dosing applies (250-875 mg every 8-12 hours).
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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: 250-500 mg every 24 hours, with an additional dose given during and/or at the end of dialysis. Amoxicillin is dialyzable.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No specific adjustment recommended, but monitor for adverse effects as elimination may be slightly prolonged.

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 the disruption of the cell wall, increased osmotic pressure, and ultimately cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 70-90%
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: 17-20%
CnssPenetration: Limited (increased with inflamed meninges)

Elimination:

HalfLife: 1-1.5 hours (normal renal function)
Clearance: Renal clearance is approximately 250-300 mL/min
ExcretionRoute: Renal (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: 6-8 hours (based on dosing interval)
Confidence: High

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, 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)
+ Other serious reactions
+ These reactions 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

Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Diarrhea
Upset stomach
Vomiting
Headache

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 stomach pain, watery or bloody diarrhea (may occur up to 2 months after treatment).
  • Fever, swollen glands, rash, joint pain, or feeling generally unwell (may be signs of a severe skin reaction).
  • Unusual bleeding or bruising.
  • Pale skin, unusual tiredness, lightheadedness, shortness of breath, cold hands and feet.
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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 long-term, 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 lessened 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 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, but possible with very high doses, leading to kidney problems)

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is generally supportive; hemodialysis can remove amoxicillin from the circulation.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity)
  • Warfarin (enhanced anticoagulant effect, increased INR/bleeding risk)
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Moderate Interactions

  • Allopurinol (increased risk of rash)
  • Oral Contraceptives (potential reduction in efficacy, though clinical significance debated)
  • Probenecid (increases and prolongs amoxicillin blood levels)
  • Tetracyclines (may antagonize bactericidal effect of amoxicillin)

Monitoring

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Baseline Monitoring

Allergy history (penicillins, cephalosporins)

Rationale: To prevent severe hypersensitivity reactions.

Timing: Prior to first dose

Renal function (CrCl, BUN, creatinine)

Rationale: To guide dose adjustment in patients with impaired renal function.

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

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Routine Monitoring

Signs/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/symptoms of adverse reactions (e.g., rash, diarrhea, superinfection)

Frequency: Daily throughout therapy

Target: Absence of new symptoms

Action Threshold: Development of rash, severe diarrhea (C. difficile), or new infections (oral/vaginal candidiasis) requires evaluation and potential discontinuation.

INR (if on warfarin)

Frequency: More frequently (e.g., 2-3 times per week) during co-administration

Target: Patient-specific therapeutic range

Action Threshold: INR outside target range requires dose adjustment of warfarin.

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Symptom Monitoring

  • Skin rash (maculopapular, urticarial)
  • Diarrhea (especially severe or bloody)
  • Nausea/vomiting
  • Abdominal pain
  • Oral thrush (white patches in mouth)
  • Vaginal yeast infection (itching, discharge)
  • Difficulty breathing, swelling of face/throat (signs of severe allergic reaction)

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; no increased risk of congenital malformations observed.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Amoxicillin is excreted in small amounts into breast milk. It is generally considered compatible with breastfeeding (Lactation Risk L2).

Infant Risk: Low risk. Potential for infant sensitization, diarrhea, or candidiasis (thrush). Monitor breastfed infant for rash, diarrhea, or signs of fungal infection.
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Pediatric Use

Amoxicillin is widely used and generally well-tolerated in pediatric patients. Dosing is weight-based (mg/kg/day) and varies by indication and severity. Close monitoring for adverse effects, especially diarrhea and rash, is important.

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Geriatric Use

No specific dose adjustment is needed based on age alone, but dose adjustments are necessary for age-related decreases in renal function. Elderly patients may be more susceptible to adverse effects, particularly gastrointestinal disturbances and superinfections.

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.
  • It is often combined with clavulanate (Augmentin) to extend its spectrum of activity against beta-lactamase-producing bacteria.
  • Patients with infectious mononucleosis treated with amoxicillin (or ampicillin) have a high incidence of non-allergic maculopapular rash.
  • Ensure patients complete the entire prescribed course of therapy to prevent resistance and relapse.
  • Liquid suspension must be refrigerated after reconstitution and discarded after 14 days.
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Alternative Therapies

  • Penicillin V (for susceptible streptococcal infections)
  • Cephalexin (first-generation cephalosporin)
  • Azithromycin (macrolide, for penicillin-allergic patients or atypical pathogens)
  • Clindamycin (lincosamide, for certain anaerobic or skin infections)
  • Doxycycline (tetracycline, for certain respiratory or skin infections)
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Cost & Coverage

Average Cost: $10 - $50 per 100ml suspension (125mg/5ml)
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 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.