Duricef 500mg (o.5gm) Capsules

Manufacturer WARNER CHILCOTT Active Ingredient Cefadroxil Capsules and Tablets(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; Beta-lactam antibiotic
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Pregnancy Category
Category B
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FDA Approved
Aug 1978
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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 killing the bacteria that cause these infections.
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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. You can take this medication with or without food. If it causes stomach upset, taking it with food may help. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any 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'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 the medication exactly as prescribed by your doctor, even if you start to feel better. Do not skip doses or stop taking it early.
  • You can take cefadroxil with or without food. If it upsets your stomach, try taking it with food or milk.
  • Drink plenty of fluids while taking this medication.
  • Avoid alcohol consumption as it may worsen gastrointestinal side effects, although no direct interaction is known.

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 twice daily or 1 gram once daily)
Dose Range: 500 - 2000 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis (due to Streptococcus pyogenes): 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
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Pediatric Dosing

Neonatal: Not established (use with caution, consult specialist)
Infant: 30 mg/kg/day in divided doses every 12 hours (max 1 gram/day)
Child: 30 mg/kg/day in divided doses every 12 hours (max 1 gram/day)
Adolescent: 30 mg/kg/day in divided doses every 12 hours (max 1 gram/day), or adult dosing if weight appropriate
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed (CrCl >50 mL/min)
Moderate: CrCl 25-50 mL/min: 500 mg every 12-24 hours
Severe: CrCl 10-24 mL/min: 500 mg every 24-36 hours
Dialysis: CrCl <10 mL/min: 500 mg every 36-48 hours. Administer after hemodialysis on dialysis days.

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: >90%
Tmax: 1.5 to 2 hours
FoodEffect: Food does not significantly affect the absorption of cefadroxil, but taking it with food may reduce gastrointestinal upset.

Distribution:

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

Elimination:

HalfLife: Approximately 1.5 to 2 hours (prolonged in renal impairment)
Clearance: Primarily renal clearance
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: >90% excreted unchanged in urine within 24 hours
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: Within 1.5 to 2 hours (corresponding to Tmax)
DurationOfAction: Dependent on half-life and dosing frequency, typically allows for once or twice daily dosing

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 (a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD, may occur)

Common and Less Severe Side Effects

Most people experience no side effects or only mild side effects when taking this medication. However, if you notice any of the following side effects and they bother you or do not go away, contact your doctor:

Diarrhea

Reporting Side Effects

Not all possible side effects are listed 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:

  • Severe diarrhea (watery or bloody stools), especially if it occurs weeks after stopping the medication (could be C. difficile infection).
  • Signs of an allergic reaction: rash, itching, hives, swelling of the face/lips/tongue/throat, difficulty breathing.
  • Unusual tiredness or weakness, yellowing of the skin or eyes (jaundice), dark urine (signs of liver problems, rare).
  • Easy bruising or bleeding (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 symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions.
* Any existing health problems, as this medication may interact with them.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. 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. Older adults, 65 years and older, should exercise caution when using this medication, as they may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal discomfort
  • Hematuria (blood in urine)
  • Hyperreflexia
  • Seizures (rare, especially in patients with renal impairment)

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and may include gastric lavage or activated charcoal if ingestion is recent. Hemodialysis may be useful in severe cases, especially with renal impairment.

Drug Interactions

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Major Interactions

  • Live bacterial vaccines (e.g., Typhoid vaccine, oral): May reduce therapeutic effect of the vaccine.
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Moderate Interactions

  • Probenecid: May increase cefadroxil serum concentrations and prolong its half-life by decreasing renal tubular secretion.
  • Oral anticoagulants (e.g., Warfarin): May enhance the anticoagulant effect (rare, monitor INR).
  • Aminoglycosides: Potential for increased nephrotoxicity (though less common with cephalosporins than with aminoglycosides alone).

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, BUN, CrCl)

Rationale: Cefadroxil is primarily renally eliminated; baseline assessment is crucial for dose adjustment in patients with impaired renal function.

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

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Routine Monitoring

Clinical response to therapy (resolution of infection symptoms)

Frequency: Daily during acute treatment

Target: Improvement in signs/symptoms of infection

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

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

Frequency: Throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: Development of new infections, especially C. difficile-associated diarrhea, requires immediate evaluation and management.

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/BUN may necessitate dose adjustment or discontinuation.

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Symptom Monitoring

  • Rash or hives (signs of allergic reaction)
  • Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
  • Nausea, vomiting, abdominal pain
  • Difficulty breathing or swallowing (signs of severe allergic reaction)
  • Unusual bruising or bleeding (rare, with anticoagulants)

Special Patient Groups

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Pregnancy

Cefadroxil is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated a fetal risk, but there are no adequate and well-controlled studies in pregnant women. It is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital anomalies observed in human studies.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

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

Infant Risk: Low risk (L2)
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Pediatric Use

Dosing is weight-based and well-established for infants and children. Use with caution in neonates as safety and efficacy are not fully established. Monitor for potential gastrointestinal upset or allergic reactions.

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Geriatric Use

No specific dose adjustment is needed based on age alone, but elderly patients are more likely to have decreased renal function, which necessitates dose adjustment based on creatinine clearance. Monitor renal function closely.

Clinical Information

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Clinical Pearls

  • Cefadroxil is a first-generation cephalosporin, often used for uncomplicated urinary tract infections, skin and skin structure infections, and pharyngitis/tonsillitis caused by susceptible organisms.
  • Its long half-life allows for convenient once or twice daily dosing, which can improve patient adherence.
  • Can be taken with food to minimize gastrointestinal upset.
  • It is a good alternative for patients who are allergic to penicillin but can tolerate cephalosporins (note: cross-reactivity can occur, especially with immediate hypersensitivity reactions to penicillin).
  • Ensure completion of the full course of therapy to prevent bacterial resistance and relapse.
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Alternative Therapies

  • Cephalexin (another first-generation cephalosporin, often dosed more frequently)
  • Amoxicillin (for susceptible infections, if no penicillin allergy)
  • Trimethoprim/sulfamethoxazole (for UTIs, if susceptible)
  • Macrolides (e.g., Azithromycin, for pharyngitis if penicillin/cephalosporin allergy)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 capsules (500mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.