Cefadroxil 500mg/5ml Susp 100ml

Manufacturer AUROBINDO Active Ingredient Cefadroxil Suspension(sef a DROKS il) Pronunciation sef a DROKS il
It is used to treat bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
First-generation Cephalosporin
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Pregnancy Category
Category B
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FDA Approved
Dec 1977
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cefadroxil is an antibiotic medication used to treat various bacterial infections, such as infections of the throat, skin, and urinary tract. It works by stopping the growth of bacteria. It is important to take the full course of medication as prescribed, even if you start feeling better, to ensure the infection is completely cleared and to prevent antibiotic resistance.
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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 prescription and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.

Before taking a dose, shake the liquid medication well. To ensure accurate dosing, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to help you measure your doses correctly.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to complete the full course of treatment as prescribed.

Storing and Disposing of Your Medication

Store your medication in the refrigerator to maintain its potency. If you don't use the entire contents within 2 weeks, discard any remaining medication. Do not freeze your medication. Keep all medications in a safe and secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.

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. 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 with food or milk if stomach upset occurs.
  • Shake the suspension well before each use.
  • Use an accurate measuring device (e.g., oral syringe, measuring spoon) for the liquid form.
  • Complete the entire course of medication, even if symptoms improve.
  • Store the suspension in the refrigerator after reconstitution and discard any unused portion after 14 days.

Dosing & Administration

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Adult Dosing

Standard Dose: 1000 mg once daily or 500 mg twice daily
Dose Range: 500 - 2000 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis (Group A Beta-Hemolytic Streptococci): 1000 mg once daily or 500 mg twice daily for 10 days
Skin and Skin Structure Infections: 1000 mg once daily or 500 mg twice daily
Urinary Tract Infections (uncomplicated): 1000 mg once daily or 500 mg twice daily
Urinary Tract Infections (complicated): 1000 mg twice daily
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Pediatric Dosing

Neonatal: Not established
Infant: 30 mg/kg/day in 1-2 divided doses (max 100 mg/kg/day or 2 g/day)
Child: 30 mg/kg/day in 1-2 divided doses (max 100 mg/kg/day or 2 g/day)
Adolescent: 30 mg/kg/day in 1-2 divided doses (max 100 mg/kg/day or 2 g/day), or adult dose if weight allows
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-75 mL/min: 500 mg every 12 hours
Moderate: CrCl 25-49 mL/min: 500 mg every 24 hours
Severe: CrCl 10-24 mL/min: 500 mg every 36 hours
Dialysis: CrCl <10 mL/min: 500 mg every 48 hours. Administer dose after dialysis on dialysis days.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Cefadroxil 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 final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: 1.5 to 2 hours
FoodEffect: Food does not affect the extent of absorption, but may delay the peak concentration (Tmax) and decrease peak concentration (Cmax). Can be taken with food to minimize GI upset.

Distribution:

Vd: 0.25-0.3 L/kg
ProteinBinding: Approximately 20%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1.5 hours (normal renal function)
Clearance: Primarily renal clearance
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Approximately 90% within 24 hours
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1.5 to 2 hours (plasma concentration)
DurationOfAction: Dependent on MIC and dosing frequency, typically allows for once or twice daily dosing due to sustained tissue levels.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Seizures
Difficulty urinating or changes in urine output
Vaginal itching or discharge
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (this could be a sign of a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD)

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea

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 allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
  • Severe or watery diarrhea, especially if persistent or bloody (may indicate Clostridioides difficile-associated diarrhea)
  • New signs of infection (e.g., fever, sore throat, chills) which could indicate a superinfection
  • Unusual bruising or bleeding
  • Yellowing of skin or eyes (jaundice)
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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 symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Natural products, such as herbal supplements
Vitamins
Any existing health problems

Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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. Adhere to the prescribed duration of treatment, as prolonged use may increase the risk of a second infection.

If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be aware that 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 a sulfite allergy, consult your doctor before taking this medication, as some products may contain sulfites. Additionally, if you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of this medication to you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal discomfort
  • Hematuria (blood in urine)
  • Hyperactivity
  • Convulsions (rare)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is primarily supportive. Gastric lavage or activated charcoal may be considered if ingestion is recent. Hemodialysis may be useful in severe cases of renal impairment.

Drug Interactions

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Moderate Interactions

  • Probenecid
  • Oral anticoagulants (e.g., Warfarin)
  • Live bacterial vaccines (e.g., Typhoid vaccine)
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Minor Interactions

  • Metformin (potential for increased metformin levels)

Monitoring

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Baseline Monitoring

Renal function (serum creatinine, BUN, CrCl)

Rationale: Cefadroxil is primarily renally eliminated; dosage adjustment is necessary in patients with impaired renal function.

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

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Routine Monitoring

Clinical response to therapy (resolution of infection symptoms)

Frequency: Daily

Target: Improvement in symptoms (e.g., fever, pain, inflammation)

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or need for alternative therapy.

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)

Frequency: Throughout therapy and shortly after discontinuation

Target: Absence of new infections

Action Threshold: Development of new symptoms requires evaluation and appropriate treatment (e.g., C. difficile infection).

Renal function (serum creatinine, BUN)

Frequency: Periodically, especially in patients with pre-existing renal impairment or those on prolonged therapy

Target: Stable renal function

Action Threshold: Significant increase in creatinine or BUN may necessitate dose adjustment or discontinuation.

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Symptom Monitoring

  • Rash
  • Hives
  • Itching
  • Swelling (face, lips, tongue, throat)
  • Difficulty breathing or swallowing
  • Severe or watery diarrhea
  • Abdominal pain or cramps
  • Nausea
  • Vomiting
  • Headache
  • Dizziness
  • Vaginal itching or discharge
  • Oral thrush (white patches in mouth)

Special Patient Groups

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Pregnancy

Cefadroxil is classified as Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. Adequate and well-controlled studies in pregnant women are lacking, but human experience suggests no increased risk of birth defects or other adverse outcomes.

Trimester-Specific Risks:

First Trimester: Low risk based on animal data and limited human experience.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Cefadroxil is excreted in human milk in low concentrations. It is generally considered compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: L2 (Safer)
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Pediatric Use

Dosing is weight-based. Safety and efficacy have been established for pediatric patients. Close monitoring for adverse effects, especially GI upset and rash, is recommended. Ensure accurate measurement of suspension doses.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is necessary in elderly patients with impaired renal function, as renal clearance may decrease with age.

Clinical Information

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Clinical Pearls

  • Cefadroxil is a first-generation cephalosporin, effective against many Gram-positive bacteria (e.g., Staphylococcus aureus, Streptococcus pyogenes) and some Gram-negative bacteria (e.g., E. coli, Klebsiella pneumoniae, Proteus mirabilis).
  • It is often chosen for skin and soft tissue infections, urinary tract infections, and pharyngitis/tonsillitis due to its convenient once or twice daily dosing.
  • Patients with a history of severe allergic reactions to penicillin should generally avoid cefadroxil due to potential cross-reactivity (though lower for first-generation cephalosporins).
  • Advise patients to complete the full course of therapy to prevent bacterial resistance and recurrence of infection.
  • Reconstituted suspension must be refrigerated and discarded after 14 days.
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Alternative Therapies

  • Cephalexin (another first-generation cephalosporin)
  • Amoxicillin (for susceptible infections)
  • Amoxicillin/clavulanate
  • Other appropriate antibiotics based on culture and sensitivity results for specific infections.
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Cost & Coverage

Average Cost: Check current market prices per 100ml suspension
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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.