Amoxicillin 125mg/5ml Susp 80ml

Manufacturer WEST-WARD Active Ingredient Amoxicillin Suspension(a moks i SIL in) Pronunciation uh-mox-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
Penicillin; Beta-lactam Antibiotic
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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 not effective against viral infections like the common cold or flu.
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How to Use This Medicine

Taking Your Medication

To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Take this medication at the beginning of a meal to enhance its effectiveness and minimize the risk of stomach upset. Before using, shake the medication well. When measuring liquid doses, use the provided measuring device or ask your pharmacist for one if it's not included. You can mix this medication with formula, milk, water, or other cold beverages, but be sure to consume the mixture immediately. Establish a routine by taking this medication at the same time every day. Continue using this medication as directed by your doctor or healthcare provider, even if you're feeling well.

Storage and Disposal

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 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. If you're unsure about the best disposal method, consult 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at once or taking extra doses.
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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, as this can lead to antibiotic resistance.
  • Shake the oral suspension well before each use.
  • Measure the liquid medicine with the provided measuring spoon or cup, not a household spoon.
  • Amoxicillin suspension should be stored in the refrigerator and discarded after 14 days.
  • You can take amoxicillin with or without food. If it causes stomach upset, try taking it with food.
  • Stay well-hydrated while taking this medication.

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:

mildToModerateInfections: 250 mg every 8 hours or 500 mg every 12 hours
severeInfections: 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; specific dosing for certain conditions may exist but requires specialist consultation.
Infant: 20-45 mg/kg/day in divided doses every 8 or 12 hours (e.g., 125mg/5ml suspension: 2.5ml to 5ml per dose based on weight and frequency). For otitis media, 80-90 mg/kg/day in 2 divided doses.
Child: 20-45 mg/kg/day in divided doses every 8 or 12 hours (e.g., 125mg/5ml suspension: 2.5ml to 5ml per dose based on weight and frequency). For otitis media, 80-90 mg/kg/day in 2 divided doses. Max 1000 mg/day.
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 typically 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 administered during or after dialysis. Amoxicillin is dialyzable.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed. Use with caution and monitor for adverse effects.

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 located on the bacterial cell wall. This binding inhibits the transpeptidation step of peptidoglycan synthesis, leading to the disruption of the cell wall and ultimately bacterial 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. It can be taken with or without food.

Distribution:

Vd: Approximately 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: Primarily renal clearance via glomerular filtration and tubular secretion.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 60-80% of an oral dose is excreted unchanged in the urine within 6 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 frequency (e.g., 8 or 12 hours for sustained therapeutic levels)

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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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. If you experience:
+ Stomach pain or cramps
+ Very loose, watery, or bloody stools
+ CDAD may occur during or a few months after taking antibiotics; contact your doctor immediately
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever or chills
- Body aches or shortness of breath
- Swollen glands

Other Possible Side Effects

Most people experience no side effects or only minor ones while taking this medication. However, if you notice any of the following side effects or if they bother you or persist, contact your doctor:

Diarrhea
Upset stomach or 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:

  • 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 (even if it occurs months after your last dose).
  • Unusual weakness or tiredness, fever, chills, body aches, flu-like symptoms.
  • Easy bruising or bleeding, unusual paleness.
  • Dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
  • Rash, fever, swollen glands, joint pain, or general ill feeling (may be signs of 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 dosage 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 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 change 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, 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. You will need 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 (presence of crystals in urine, potentially leading to kidney problems in severe cases)

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 may include gastric lavage or activated charcoal if ingestion is 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)
  • Live Typhoid Vaccine (oral) (amoxicillin may reduce the immunologic response to the vaccine)
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Moderate Interactions

  • Allopurinol (increased risk of rash, particularly in patients with hyperuricemia)
  • Oral Contraceptives (may reduce efficacy, though clinical significance is debated; advise backup contraception)
  • Probenecid (increases and prolongs amoxicillin plasma levels by inhibiting renal tubular secretion)
  • Warfarin (may enhance anticoagulant effect; monitor INR)

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)

Rationale: To determine appropriate dosing, especially in elderly or renally impaired patients.

Timing: Prior to initiation, if renal impairment is suspected or known.

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Routine Monitoring

Signs of superinfection (e.g., oral candidiasis, C. difficile-associated diarrhea)

Frequency: Throughout therapy and for several weeks post-therapy.

Target: Absence of new infections.

Action Threshold: If symptoms appear, evaluate and treat appropriately; consider discontinuing amoxicillin.

Resolution of infection symptoms

Frequency: Daily/regularly during treatment.

Target: Improvement in fever, pain, inflammation, etc.

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or incorrect diagnosis.

Fluid intake (for suspension)

Frequency: Daily

Target: Adequate hydration

Action Threshold: Ensure patient is well-hydrated to prevent crystalluria, though rare with amoxicillin.

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Symptom Monitoring

  • Rash or itching (signs of allergic reaction)
  • Diarrhea (common side effect, but severe or persistent diarrhea may indicate C. difficile infection)
  • Nausea/vomiting
  • Unusual bruising or bleeding (rare, but possible hematologic effects)
  • Signs of new infection (e.g., fever, sore throat, vaginal discharge)

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 major birth defects observed.
Second Trimester: Low risk; commonly used for infections during this trimester.
Third Trimester: Low risk; commonly used for infections during this trimester.
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Lactation

Amoxicillin is excreted in breast milk in small amounts. 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).
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Pediatric Use

Amoxicillin is widely used and well-tolerated in pediatric patients. Dosing is weight-based. Care should be taken to ensure accurate measurement of the suspension dose. Higher doses (e.g., 80-90 mg/kg/day) are often used for resistant S. pneumoniae in otitis media.

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Geriatric Use

No specific dose adjustment is needed based on age alone. However, geriatric patients are more likely to have decreased renal function, which may necessitate dose adjustment based on creatinine clearance. Monitor for signs of superinfection and C. difficile-associated diarrhea.

Clinical Information

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Clinical Pearls

  • Amoxicillin is a common cause of non-allergic rash, especially in patients with viral infections (e.g., infectious mononucleosis). This rash is typically maculopapular, non-pruritic, and does not preclude future use of penicillins.
  • It is not effective against beta-lactamase producing bacteria (e.g., many strains of H. influenzae, M. catarrhalis, S. aureus). For these, amoxicillin/clavulanate (Augmentin) is often used.
  • Ensure patients complete the full course of therapy to prevent resistance and recurrence of infection.
  • Oral suspension must be shaken well before each use and refrigerated after reconstitution. Discard after 14 days.
  • Amoxicillin is a first-line agent for many common bacterial infections, including acute otitis media, streptococcal pharyngitis, and community-acquired pneumonia (in certain cases).
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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 or skin/soft tissue infections)
  • Doxycycline (for certain respiratory or skin infections)
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Cost & Coverage

Average Cost: $10 - $30 per 80ml 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 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 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, the amount, and the time it happened.