Amoxicillin 200mg/5ml Susp 100ml

Manufacturer HIKMA /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
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 killing the bacteria that cause these infections. It is a penicillin-type antibiotic.
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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. Avoid freezing 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. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you have questions about the proper disposal of your medication, 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. 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 full course of medication as prescribed, even if you start feeling better. Stopping early can lead to the infection coming back and bacteria becoming resistant to antibiotics.
  • Shake the oral suspension well before each use.
  • Measure the liquid medication accurately using the provided measuring spoon or oral syringe, not a household spoon.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days (or as directed by pharmacist).
  • Do not share your medication with others.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used for adult standard dosing in 200mg/5ml suspension strength, but if used, dose would be based on mg/kg or equivalent to tablet forms (e.g., 500mg to 875mg per dose).

Condition-Specific Dosing:

pharyngitis_tonsillitis: 500 mg every 12 hours or 250 mg every 8 hours
otitis_media: 500 mg every 12 hours or 250 mg every 8 hours
lower_respiratory_tract_infections: 500 mg every 12 hours or 250 mg every 8 hours
skin_skin_structure_infections: 500 mg every 12 hours or 250 mg every 8 hours
urinary_tract_infections: 500 mg every 12 hours or 250 mg every 8 hours
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing based on gestational age and postnatal age for very specific indications, typically 20-30 mg/kg/day divided every 12 hours.
Infant: 20-45 mg/kg/day divided every 8 or 12 hours, depending on infection severity. For otitis media, 80-90 mg/kg/day divided every 12 hours.
Child: 20-45 mg/kg/day divided every 8 or 12 hours, depending on infection severity. For otitis media, 80-90 mg/kg/day divided every 12 hours. Max 500 mg/dose.
Adolescent: Similar to adult dosing, typically 250-500 mg every 8 hours or 500-875 mg every 12 hours, depending on infection severity and type. For suspension, often 20-45 mg/kg/day divided every 8 or 12 hours, up to adult max dose.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 30 mL/min)
Moderate: Dose reduction or increased dosing interval (CrCl 10-30 mL/min): 250-500 mg every 12 hours.
Severe: Significant dose reduction or increased dosing interval (CrCl < 10 mL/min): 250-500 mg every 24 hours.
Dialysis: Hemodialysis: 250-500 mg every 24 hours, with an additional dose given after dialysis. Peritoneal Dialysis: 250 mg every 12 hours.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No 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 defects in the cell wall, increased osmotic pressure, and ultimately 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: Approximately 17-20%
CnssPenetration: Limited (poor penetration into CSF unless meninges are inflamed)

Elimination:

HalfLife: 1-1.5 hours (normal renal function)
Clearance: Approximately 250-300 mL/min (renal clearance)
ExcretionRoute: Primarily renal (glomerular filtration and tubular secretion)
Unchanged: 60-80%
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: Dependent on dosing interval (e.g., 8-12 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 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, 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 fainting
Unexplained bruising or bleeding
Fever or chills
Vaginal itching or discharge
Diarrhea (common with antibiotics), especially if it is severe, bloody, or watery, or if you experience stomach pain or cramps
Note: In rare cases, antibiotics can cause a severe form of diarrhea called C. diff-associated diarrhea (CDAD), which can lead to life-threatening bowel problems. CDAD may occur during or after treatment with antibiotics.
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect the skin and other organs
Note: These reactions can be fatal. 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 skin
- Fever or chills
- Body aches or shortness of breath
- Swollen glands

Other Possible Side Effects

Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea
Upset stomach or vomiting
Headache

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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 serious intestinal infection.
  • Unusual bruising or bleeding.
  • Pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
  • Fever, sore throat, swollen glands, rash, or joint pain (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 dose of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment.
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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 common side effect of this medication, particularly in children, is a change in tooth color to a yellow-gray-brown hue. In most cases, this discoloration can be reduced or eliminated 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, consider using an additional form of birth control, such as condoms, while taking this drug.

If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Crystalluria (crystals in urine, potentially leading to kidney problems)
  • Renal failure (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)
  • Warfarin (increased INR and bleeding risk, mechanism unclear but possibly due to altered gut flora or direct effect)
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Moderate Interactions

  • Allopurinol (increased incidence of skin rash, especially in hyperuricemic patients)
  • Oral Contraceptives (may reduce efficacy of oral contraceptives, though evidence is controversial and not consistently demonstrated)
  • Probenecid (increases and prolongs amoxicillin plasma levels by decreasing renal tubular secretion)
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Minor Interactions

  • Tetracyclines (may antagonize the bactericidal effect of amoxicillin)

Monitoring

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Baseline Monitoring

Culture and Sensitivity (if applicable)

Rationale: To identify the causative pathogen and its susceptibility to amoxicillin, guiding appropriate therapy.

Timing: Prior to initiation of therapy

Renal Function (CrCl, BUN, Creatinine)

Rationale: To assess baseline renal function, as amoxicillin is primarily renally eliminated and dose adjustments are necessary in renal impairment.

Timing: Prior to initiation of therapy, especially in elderly or patients with known renal issues

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Routine Monitoring

Clinical Response to Therapy

Frequency: Daily

Target: Resolution of signs and symptoms of infection (e.g., fever reduction, decreased pain, improved general well-being)

Action Threshold: Lack of improvement or worsening symptoms after 48-72 hours may indicate treatment failure, resistance, or incorrect diagnosis.

Signs of Allergic Reaction

Frequency: Daily, especially during the first few days of therapy

Target: Absence of rash, pruritus, urticaria, dyspnea, or anaphylaxis

Action Threshold: Any signs of allergic reaction warrant immediate discontinuation and appropriate management.

Gastrointestinal Symptoms

Frequency: Daily

Target: Absence of severe diarrhea, abdominal pain, or pseudomembranous colitis

Action Threshold: Persistent or severe diarrhea may indicate Clostridioides difficile-associated diarrhea (CDAD) and requires investigation.

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Symptom Monitoring

  • Skin rash (maculopapular, urticarial)
  • Pruritus (itching)
  • Dyspnea (shortness of breath)
  • Wheezing
  • Facial or throat swelling (angioedema)
  • Severe or persistent diarrhea
  • Abdominal pain/cramping
  • Nausea
  • Vomiting
  • Oral thrush (white patches in mouth)
  • Vaginal yeast infection (itching, 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, including Group B Strep prophylaxis.
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Lactation

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

Infant Risk: Low risk. Potential for mild gastrointestinal upset (e.g., diarrhea, candidiasis/thrush) in the infant. Allergic sensitization is theoretically possible but rare.
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Pediatric Use

Amoxicillin is widely used and well-tolerated in pediatric patients. Dosing is weight-based and varies by indication and severity of infection. Careful calculation of dose and accurate measurement of suspension are crucial to avoid under- or overdosing.

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Geriatric Use

No specific dose adjustment is needed based solely on age. However, geriatric patients are more likely to have decreased renal function, which necessitates dose adjustment based on creatinine clearance. Monitor renal function closely in this population.

Clinical Information

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Clinical Pearls

  • Always instruct patients to shake the oral suspension well before each use to ensure uniform dosing.
  • Emphasize the importance of completing the entire course of antibiotics, even if symptoms improve, to prevent resistance and recurrence.
  • Advise patients to store the reconstituted suspension in the refrigerator and discard after 14 days.
  • Amoxicillin is a common cause of non-allergic rash (maculopapular rash), especially in patients with mononucleosis. This is not a true allergy and does not contraindicate future penicillin use.
  • Counsel patients on potential for C. difficile-associated diarrhea (CDAD) and to report persistent, severe diarrhea.
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Alternative Therapies

  • Penicillin V (for susceptible infections)
  • Cephalexin (Keflex - a first-generation cephalosporin)
  • Cefdinir (Omnicef - a third-generation cephalosporin)
  • Azithromycin (Zithromax - a macrolide, for penicillin-allergic patients or atypical pathogens)
  • Clindamycin (Cleocin - for anaerobic infections or penicillin-allergic patients)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 100ml bottle of 200mg/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 substance taken, the amount, and the time it occurred.