Amoxicillin 200mg/5ml Susp 75ml

Manufacturer SANDOZ 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; Aminopenicillin
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Pregnancy 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 a common antibiotic used to treat various bacterial infections, such as ear infections, strep throat, and pneumonia. It works by killing the bacteria causing the infection.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Take your medication at the start of a meal to help it work effectively and reduce the risk of stomach upset. Before using, shake the medication well. When measuring liquid doses, 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 your medication with formula, milk, water, or other cold drinks. After mixing, drink the medication right away. To maintain a consistent routine, take your medication at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

Store the liquid suspension at room temperature or in the refrigerator. Do not freeze the medication. Discard any unused portion after 2 weeks. Keep all medications in a safe place, out of the 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 have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are 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 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 medication exactly as prescribed by your doctor, even if you start feeling better. Do not skip doses or stop taking it early, as this can lead to antibiotic resistance.
  • Shake the suspension well before each use.
  • Use a calibrated measuring spoon or oral syringe provided with the medication to ensure accurate dosing.
  • Amoxicillin can be taken with or without food. If it causes stomach upset, try taking it with food.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days (or as directed by the pharmacist).

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 days
Sinusitis: 250-500 mg every 8 hours or 500-875 mg every 12 hours for 10-14 days
Lower Respiratory Tract Infections: 500 mg every 8 hours or 875 mg every 12 hours for 10-14 days
Skin/Skin Structure Infections: 250-500 mg every 8 hours or 500-875 mg every 12 hours for 7-14 days
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Pediatric Dosing

Neonatal: Not established for routine use; consult specialist. (Typically 20-40 mg/kg/day divided every 8-12 hours, but specific data limited for neonates)
Infant: 20-45 mg/kg/day divided every 8-12 hours (e.g., 200mg/5ml suspension: 10-22.5 mg/kg/dose every 12 hours or 6.7-15 mg/kg/dose every 8 hours). Max 500 mg/dose.
Child: 20-45 mg/kg/day divided every 8-12 hours. For severe infections (e.g., otitis media, sinusitis): 80-90 mg/kg/day divided every 12 hours. 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: CrCl >30 mL/min: No adjustment needed.
Moderate: CrCl 10-30 mL/min: 250-500 mg every 12 hours.
Severe: CrCl <10 mL/min: 250-500 mg every 24 hours.
Dialysis: Hemodialysis: 250-500 mg every 24 hours, with an additional dose given during and at the end of dialysis. Peritoneal Dialysis: 250 mg every 12 hours.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed (not significantly metabolized by liver).

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, leading to bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 75-90%
Tmax: 1-2 hours
FoodEffect: Minimal effect on absorption; 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: Not available
ExcretionRoute: Renal (primarily unchanged drug via tubular secretion and glomerular filtration)
Unchanged: 50-70%
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Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose)
PeakEffect: Within 1-2 hours of administration
DurationOfAction: Dependent on dosing frequency (typically 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
+ Trouble 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, especially if it is severe or accompanied by stomach pain, cramps, or very loose, watery, or bloody stools (see below for more information on diarrhea)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect the skin and other organs
Note: These reactions can 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

Diarrhea: A Common Side Effect

Diarrhea is a common side effect of antibiotics, including this medication. In rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) can occur. CDAD can happen during or several months after taking antibiotics. If you experience any of the following symptoms, contact your doctor right away:

Stomach pain or cramps
Very loose, watery, or bloody stools
Do not treat diarrhea without consulting your doctor first.

Other Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, 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 help:

Diarrhea
Upset stomach or vomiting
Headache

Reporting 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:

  • Signs of a severe allergic reaction: rash, hives, itching, swelling of the face/lips/tongue/throat, severe dizziness, trouble breathing. Seek immediate medical attention.
  • Severe or watery diarrhea, especially if it contains blood or mucus, which may occur during or even several weeks after stopping treatment (could be C. difficile infection).
  • Unusual bruising or bleeding (rare, but important if taking blood thinners).
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems, very rare).
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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 (OTC) 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.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. This includes any changes to this medication or any other drugs you are taking. Your doctor will work with you to determine the best course of treatment and help you manage any potential interactions or health problems.
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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 lessened or disappeared 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. 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 kidney problems in severe cases)

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.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity)
  • Warfarin (increased INR/bleeding risk, though rare and mechanism unclear)
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Moderate Interactions

  • Allopurinol (increased risk of amoxicillin-induced rash)
  • Oral Contraceptives (potential decrease in efficacy, though controversial and likely minimal)
  • Probenecid (decreased renal tubular secretion of amoxicillin, leading to increased and prolonged amoxicillin levels)
  • Tetracyclines (may antagonize bactericidal effect of amoxicillin)

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To guide dose adjustment in patients with pre-existing renal impairment.

Timing: Prior to initiation in patients with known or suspected renal dysfunction.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily

Target: Resolution of signs/symptoms of infection

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

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

Frequency: Daily

Target: Absence of adverse reactions

Action Threshold: Development of rash, severe diarrhea, or other allergic reactions requires immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Skin rash (hives, itching)
  • Difficulty breathing or swallowing (signs of anaphylaxis)
  • Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
  • Nausea, vomiting, abdominal pain
  • Unusual bruising or bleeding (rare, with warfarin interaction)

Special Patient Groups

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Pregnancy

Amoxicillin is generally considered safe for use during pregnancy. It is a Category B drug, meaning animal reproduction studies have shown no risk to the fetus, but there are no adequate and well-controlled studies in pregnant humans.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations observed.
Second Trimester: No specific risks identified.
Third Trimester: No specific risks identified.
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Lactation

Amoxicillin is considered compatible with breastfeeding. It is excreted in breast milk in small amounts.

Infant Risk: L1 (Safest). Potential for mild diarrhea, candidiasis (thrush), or allergic sensitization in the infant, but generally well-tolerated. Monitor infant for adverse effects.
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Pediatric Use

Widely used and generally safe in pediatric patients. Dosing is weight-based and varies by indication and severity. Oral suspension formulations are commonly used for ease of administration.

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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 may necessitate dose adjustment based on creatinine clearance.

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 sinusitis.
  • It is generally well-tolerated, with gastrointestinal upset (nausea, diarrhea) and rash being the most common side effects.
  • Patients should be advised to complete the full course of therapy to prevent the development of antibiotic resistance and ensure complete eradication of the infection.
  • The 200mg/5ml suspension is a common pediatric formulation, requiring careful calculation of dose based on weight and concentration.
  • While rare, amoxicillin can cause a non-allergic rash, especially in patients with mononucleosis. This rash is typically maculopapular and not indicative of a true penicillin allergy.
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Alternative Therapies

  • Cephalexin (Keflex)
  • Cefdinir (Omnicef)
  • Azithromycin (Zithromax)
  • Clindamycin (Cleocin)
  • Doxycycline (Vibramycin) - for older children/adults
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Cost & Coverage

Average Cost: $10 - $30 per 75ml 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 safe and effective treatment, 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.