Cefadroxil 500mg/5ml Susp 75ml

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
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 those affecting the skin, throat, or urinary tract. It works by stopping the growth of bacteria. It's important to take the full course of medication as prescribed, even if you start feeling better, to prevent the infection from returning.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Before using the liquid form, shake the bottle well and measure your dose carefully using the provided measuring device. If one is not included, ask your pharmacist for a suitable device.

It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well. This will help ensure you receive the full benefits of the treatment.

Storing and Disposing of Your Medication

Store your medication in the refrigerator to maintain its effectiveness. Any unused portion should be discarded after 2 weeks. Do not freeze your medication. Keep all medications in a safe and secure location, out of the reach of children and pets.

Missing 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 the missed one.
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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 (oral syringe or measuring spoon) for the liquid form.
  • Store the suspension in the refrigerator and discard any unused portion after 14 days.
  • Do not share this medication with others.
  • Avoid alcohol if experiencing gastrointestinal side effects, as it may worsen them.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 to 2 grams per day, administered as a single dose or in two divided doses (e.g., 500 mg BID or 1 gram daily)
Dose Range: 500 - 2000 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis (Group A Beta-Hemolytic Streptococci): 1 gram once daily or 500 mg twice daily for 10 days
Skin and Skin Structure Infections: 1 gram once daily or 500 mg twice daily
Urinary Tract Infections (uncomplicated): 1 to 2 grams per day, administered as a single dose or in two divided doses (e.g., 1 gram daily or 500 mg twice daily)
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Pediatric Dosing

Neonatal: Not established (use with caution, consult specific guidelines)
Infant: 30 mg/kg/day in divided doses every 12 hours
Child: 30 mg/kg/day in divided doses every 12 hours (max 100 mg/kg/day, not to exceed adult dose)
Adolescent: Same as adult dosing for specific indications
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 50 mL/min)
Moderate: Initial dose 1 gram, then 500 mg every 12 hours (CrCl 25-50 mL/min)
Severe: Initial dose 1 gram, then 500 mg every 24-36 hours (CrCl 10-25 mL/min)
Dialysis: Initial dose 1 gram, then 500 mg every 36-48 hours or after dialysis (CrCl < 10 mL/min)

Hepatic Impairment:

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

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 significantly affect the absorption of cefadroxil, but peak serum concentrations may be delayed.

Distribution:

Vd: 0.21 L/kg
ProteinBinding: Approximately 20%
CnssPenetration: Limited (does not achieve therapeutic concentrations in CSF)

Elimination:

HalfLife: Approximately 1.5 hours (normal renal function)
Clearance: Renal clearance is approximately 100 mL/min/1.73 m²
ExcretionRoute: Primarily 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 (corresponding to Tmax)
DurationOfAction: 12 to 24 hours (due to sustained therapeutic concentrations)
Confidence: High

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, watery, or bloody (see below for more information on diarrhea)

Important Information About Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. CDAD can happen during or several months after taking antibiotics and may lead to a life-threatening bowel problem. 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.

Other Possible Side Effects

Like all medications, this drug may cause side effects. Many people do not experience side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:

Diarrhea

This is not an exhaustive list of all possible 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 severe allergic reaction (difficulty breathing, swelling of face/throat, severe rash)
  • Severe, watery, or bloody diarrhea (may indicate C. difficile infection)
  • Unusual bruising or bleeding
  • Signs of kidney problems (change in urine amount)
  • New or worsening joint pain
  • 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 your safety, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Do not initiate, discontinue, or modify the dose 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. Do not exceed the prescribed duration of treatment, as this 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. Additionally, be aware that this medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory 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. Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, 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 discomfort
  • Hematuria (blood in urine)
  • Hyperreflexia
  • Seizures (rare)

What to Do:

Call 1-800-222-1222 (Poison Control). Seek immediate medical attention. Treatment is supportive; hemodialysis may be useful in severe cases.

Drug Interactions

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Major Interactions

  • Live bacterial vaccines (e.g., BCG, typhoid oral): May reduce therapeutic effect of vaccine.
  • Warfarin: May enhance anticoagulant effect (monitor INR).
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Moderate Interactions

  • Probenecid: May increase cefadroxil serum concentrations and prolong half-life by decreasing renal tubular secretion.
  • Aminoglycosides: Potential for increased nephrotoxicity when co-administered, though less common with cephalosporins than with penicillins.
  • Loop diuretics (e.g., furosemide): May increase risk of nephrotoxicity.
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Minor Interactions

  • Oral contraceptives: Theoretical risk of reduced efficacy, though clinical significance is low.

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: Cefadroxil is primarily renally eliminated; dose adjustment is required in renal impairment.

Timing: Prior to initiation, especially in patients with known or suspected renal impairment.

Culture and sensitivity testing

Rationale: To confirm susceptibility of the causative organism to cefadroxil.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily

Target: Resolution of signs and symptoms of infection

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

Signs of hypersensitivity reaction (rash, itching, dyspnea)

Frequency: Daily, especially during initial days of therapy

Target: Absence of allergic symptoms

Action Threshold: Development of rash, urticaria, or anaphylaxis requires immediate discontinuation.

Bowel habits (for C. difficile-associated diarrhea)

Frequency: Daily

Target: Normal bowel movements

Action Threshold: Persistent severe diarrhea, abdominal pain, or fever should prompt C. difficile testing.

INR (if co-administered with warfarin)

Frequency: As per warfarin monitoring guidelines, with increased frequency upon initiation or discontinuation of cefadroxil.

Target: Therapeutic INR range for indication

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

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Symptom Monitoring

  • Rash
  • Hives
  • Itching
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, tongue, lips, or eyes
  • Severe diarrhea (possibly bloody or watery)
  • Abdominal pain or cramps
  • Nausea
  • Vomiting
  • Headache
  • 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. Animal reproduction studies have shown no evidence of harm to the fetus. Human studies are limited but generally show no increased risk of birth defects. It is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, no evidence of teratogenicity.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Cefadroxil is excreted in small amounts into breast milk. 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: Low risk
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Pediatric Use

Dosing is weight-based. Safety and efficacy have been established in pediatric patients. Neonates should be treated with caution due to immature renal function; specific dosing for neonates is not well-established.

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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. Dose adjustment may be necessary based on renal function, which often declines with age.

Clinical Information

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Clinical Pearls

  • Cefadroxil's longer half-life compared to other first-generation cephalosporins allows for once or twice daily dosing, which can improve patient adherence.
  • It is effective against common Gram-positive bacteria (e.g., Streptococcus pyogenes, Staphylococcus aureus) and some Gram-negative bacteria (e.g., E. coli, Klebsiella pneumoniae, Proteus mirabilis).
  • Always complete the full course of therapy, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
  • Patients with a history of penicillin allergy should be monitored closely for cross-reactivity, although it is generally low with first-generation cephalosporins (approx. 5-10%).
  • Oral suspension must be refrigerated after reconstitution and discarded after 14 days.
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Alternative Therapies

  • Other first-generation cephalosporins (e.g., Cephalexin, Cefazolin)
  • Penicillins (e.g., Amoxicillin, Penicillin V)
  • Macrolides (e.g., Azithromycin, Clarithromycin) for penicillin-allergic patients
  • Other classes of antibiotics depending on the specific infection and susceptibility (e.g., Trimethoprim/Sulfamethoxazole for UTIs)
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Cost & Coverage

Average Cost: Not available Not available
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.