Amoxicillin 250mg/5ml Susp 100ml

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 belongs to the penicillin family. It works by killing bacteria that cause infections in your body, such as ear infections, strep throat, pneumonia, and skin infections. It does not work against viruses 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 an upset stomach 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 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. 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 your medication, consult with your pharmacist. You may also want to inquire about drug take-back programs available 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. 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

  • Take the full course of medication as prescribed, even if you feel better, to prevent antibiotic resistance and ensure the infection is fully treated.
  • Shake the suspension well before each use.
  • Use a calibrated measuring spoon or cup for accurate dosing.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days (or as directed by pharmacist).
  • Report any signs of allergic reaction (rash, itching, swelling, difficulty breathing) immediately.
  • Report severe or persistent diarrhea, as it could be a sign of a more serious infection (C. difficile).

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 to moderate infections: 250 mg every 8 hours or 500 mg every 12 hours
Severe infections: 500 mg every 8 hours or 875 mg every 12 hours
Gonorrhea (uncomplicated): 3 g as a single oral dose
H. pylori eradication: 1 g twice daily (as part of multi-drug regimen)
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing for certain conditions may exist (e.g., neonatal sepsis prophylaxis, but typically not first-line amoxicillin). Consult specialist.
Infant: 20-45 mg/kg/day in divided doses every 8 or 12 hours, depending on infection severity. Max 500 mg/dose.
Child: 20-45 mg/kg/day in divided doses every 8 or 12 hours, depending on infection severity. Max 875 mg/day.
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: 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 after dialysis session.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Amoxicillin is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs). This inhibits the transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to cell lysis and death.
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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: 17-20%
CnssPenetration: Limited (increases with inflamed meninges)

Elimination:

HalfLife: 1-1.5 hours (normal renal function)
Clearance: Renal clearance (glomerular filtration and tubular secretion)
ExcretionRoute: Renal (urine)
Unchanged: 50-70%
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Pharmacodynamics

OnsetOfAction: Rapid (within 30 minutes to 1 hour)
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: Dependent on dosing interval (typically 8 or 12 hours)

Safety & Warnings

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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, 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. 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 notice any of the following side effects or any other unusual symptoms, 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, 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:

  • Severe skin rash, hives, or peeling skin
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Severe or watery diarrhea, especially if bloody
  • Unusual bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Persistent sore throat or fever (may indicate 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 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 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 change in tooth color to yellow-gray-brown has been reported in some individuals taking this drug, particularly in children. In most cases, the discoloration 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 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, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor 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 (in severe cases, leading to renal failure)

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is generally supportive and symptomatic. Hemodialysis may be used in cases of severe renal impairment or significant overdose.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity)
  • Warfarin (increased INR and bleeding risk)
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Moderate Interactions

  • Allopurinol (increased risk of skin rash)
  • Oral contraceptives (may reduce efficacy of oral contraceptives, though clinical significance is debated)
  • Probenecid (increases and prolongs amoxicillin blood levels)
  • Tetracyclines (may antagonize the bactericidal effect of penicillins)

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 suspected renal dysfunction.

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Routine Monitoring

Signs and symptoms of infection resolution

Frequency: Daily during therapy

Target: Improvement in fever, pain, inflammation

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistant organism.

Signs of hypersensitivity reaction (rash, itching, dyspnea)

Frequency: Daily during therapy and for several days post-therapy

Target: Absence of allergic symptoms

Action Threshold: Any sign of allergic reaction requires immediate discontinuation.

Gastrointestinal symptoms (diarrhea, nausea, vomiting)

Frequency: Daily during therapy

Target: Absence or mild, manageable symptoms

Action Threshold: Severe or persistent diarrhea may indicate C. difficile infection.

INR (if on warfarin)

Frequency: More frequently (e.g., 2-3 times per week) during co-administration and for a few days after discontinuation.

Target: Therapeutic INR range for indication

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

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Symptom Monitoring

  • Skin rash (hives, maculopapular rash)
  • Itching
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Difficulty breathing or wheezing
  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Nausea
  • Vomiting
  • Unusual bruising or bleeding
  • Dark urine or yellowing of skin/eyes (jaundice)

Special Patient Groups

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Pregnancy

Amoxicillin is generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm to the fetus, and there is no evidence of harm in pregnant women. However, it should only be used if clearly needed.

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 considered compatible with breastfeeding (L1). It is excreted in breast milk in small amounts. While generally safe, monitor breastfed infants for potential adverse effects.

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

Amoxicillin is widely used and generally safe in pediatric populations. Dosing is weight-based. Care should be taken to ensure accurate dosing with appropriate measuring devices. Risk of rash (especially in patients with mononucleosis) should be considered.

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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 C. difficile-associated diarrhea.

Clinical Information

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Clinical Pearls

  • Amoxicillin is a first-line agent for many common bacterial infections, including otitis media, sinusitis, and strep throat.
  • The suspension must be shaken well before each dose to ensure uniform distribution of the medication.
  • Advise patients to complete the entire prescribed course of therapy, even if symptoms improve, to prevent the development of antibiotic resistance.
  • A non-allergic rash (maculopapular rash) can occur, especially in patients with infectious mononucleosis, and is not necessarily a contraindication to future penicillin use.
  • Refrigeration of the reconstituted suspension is crucial for maintaining stability and taste.
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Alternative Therapies

  • Cephalexin (a first-generation cephalosporin)
  • Cefdinir (a third-generation cephalosporin)
  • Azithromycin (a macrolide, for penicillin-allergic patients)
  • Clindamycin (for specific anaerobic infections or penicillin-allergic patients)
  • Doxycycline (for certain respiratory or skin infections)
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Cost & Coverage

Average Cost: Varies widely, typically low per 100ml 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.