Amoxicillin 200mg/5ml Susp 50ml

Manufacturer HIKMA /WESTWARD 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 fights bacteria. It's used to treat many different types of infections, like ear infections, strep throat, pneumonia, and skin infections. It works by stopping bacteria from building their cell walls, which kills them.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most out of your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. For optimal effectiveness and to minimize the risk of stomach upset, take this medication at the beginning of a meal. Before using, shake the bottle well to ensure the ingredients are properly mixed. 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 this medication with formula, milk, water, or other cold beverages. However, be sure to drink the mixture immediately after preparation. Establish a routine by taking your medication at the same time every day. Continue taking your medication as prescribed 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, but do not freeze it. Discard any unused portion after 2 weeks. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications responsibly. Do not flush them down the toilet or pour them down the drain unless 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'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 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 antibiotic resistance and ensure the infection is fully treated.
  • Shake the suspension well before each use.
  • Use a calibrated measuring spoon or oral syringe 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 severe or persistent diarrhea to your doctor, 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_moderate_infection: 250 mg every 8 hours or 500 mg every 12 hours
severe_infection: 500 mg every 8 hours or 875 mg every 12 hours
gonorrhea: 3 g as a single oral dose with 1 g probenecid
H_pylori_eradication: 1 g twice daily (as part of multi-drug regimen)
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Pediatric Dosing

Neonatal: Not established (use with caution, consult specialist)
Infant: 20-45 mg/kg/day in divided doses every 8 or 12 hours (max 500 mg/dose)
Child: 20-45 mg/kg/day in divided doses every 8 or 12 hours (max 875 mg/day)
Adolescent: 250-500 mg every 8 hours or 500-875 mg every 12 hours (based on weight/severity, typically adult dosing for >40kg)
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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; administer an additional dose during or after dialysis

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

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 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 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: Renal clearance (glomerular filtration and tubular secretion)
ExcretionRoute: Renal (urine)
Unchanged: 60-80%
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: Dependent on dosing interval (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 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, 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. 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, which 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
Nausea or 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 allergic reaction (hives, difficulty breathing, swelling of face/throat)
  • Severe or bloody diarrhea
  • Yellowing of skin or eyes (jaundice)
  • Unusual bruising or bleeding
  • 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 (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.

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 a condom, 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 (in severe cases, leading to renal failure)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive; hemodialysis can remove amoxicillin from circulation.

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity)
  • Warfarin (increased INR/bleeding risk, monitor closely)
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Moderate Interactions

  • Allopurinol (increased risk of amoxicillin-induced rash)
  • Oral Contraceptives (potential decreased efficacy of oral contraceptives, though clinical significance debated)
  • Tetracyclines (may decrease amoxicillin's bactericidal effect)
  • Probenecid (increases and prolongs amoxicillin blood levels)

Monitoring

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Baseline Monitoring

Renal function (CrCl)

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

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

Allergy history (penicillins, cephalosporins)

Rationale: To prevent severe hypersensitivity reactions.

Timing: Prior to administration.

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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 after 48-72 hours; consider alternative therapy or further diagnostics.

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

Frequency: Daily throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: Development of new symptoms; initiate appropriate treatment.

Complete Blood Count (CBC) with differential

Frequency: Periodically for prolonged therapy (>2 weeks)

Target: Normal ranges for WBC, RBC, platelets

Action Threshold: Significant changes (e.g., leukopenia, thrombocytopenia, hemolytic anemia); discontinue if severe.

Liver function tests (LFTs)

Frequency: Periodically for prolonged therapy (>2 weeks)

Target: Normal ranges for AST, ALT, bilirubin

Action Threshold: Significant elevation; discontinue if severe.

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Symptom Monitoring

  • Rash (maculopapular, urticarial)
  • Pruritus
  • Diarrhea (especially severe or bloody)
  • Nausea/Vomiting
  • Abdominal pain
  • Difficulty breathing/wheezing (signs of anaphylaxis)
  • Swelling of face/lips/tongue (signs of angioedema)
  • Unusual bruising or bleeding
  • Yellowing of skin or 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.

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.

Infant Risk: L1 (Safest); potential for mild diarrhea, candidiasis, or allergic sensitization in the infant, but generally well-tolerated. Monitor infant for rash or GI upset.
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Pediatric Use

Dosing is weight-based and varies by age and infection severity. Neonates and very young infants may have altered pharmacokinetics requiring careful consideration. Oral suspension is commonly used for ease of administration.

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Geriatric Use

No specific dose adjustment is needed based on age alone, but dose adjustments are necessary for age-related decline in renal function. Elderly patients may be more susceptible to adverse effects like C. difficile-associated diarrhea.

Clinical Information

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Clinical Pearls

  • Amoxicillin is a broad-spectrum penicillin, effective against many common bacterial infections, but it is susceptible to beta-lactamase enzymes.
  • It is often combined with clavulanate (Augmentin) to extend its spectrum of activity against beta-lactamase producing bacteria.
  • A non-allergic rash (maculopapular rash) can occur, especially in patients with mononucleosis, which is distinct from a true penicillin allergy.
  • Advise patients to complete the entire course of therapy to prevent resistance and recurrence of infection.
  • Oral suspension must be reconstituted with water and stored in the refrigerator; shake well before each use.
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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 certain anaerobic infections or penicillin-allergic patients)
  • Doxycycline (for certain atypical infections or penicillin-allergic patients)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and formulation (e.g., $10-$50) per 50ml 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's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.