Cefadroxil 1gm Tablets

Manufacturer TEVA PHARMACEUTICALS USA 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, Cephalosporin
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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
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 of the throat, urinary tract, and skin. It works by killing the bacteria that cause these infections. It is 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 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, but 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 to feel better.

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 disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. 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. 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.
  • Drink plenty of fluids while taking this medication.
  • Do not skip doses or stop taking the medication early, even if symptoms improve, to prevent antibiotic resistance and ensure complete eradication of the infection.
  • Store at room temperature away from moisture and heat.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 gm once daily or 500 mg twice daily
Dose Range: 500 - 2000 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis (Streptococcal): 1 gm once daily or 500 mg twice daily for 10 days
Urinary Tract Infections (uncomplicated): 1 gm once daily or 500 mg twice daily for 7-10 days
Skin and Skin Structure Infections: 1 gm once daily or 500 mg twice daily for 7-10 days
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Pediatric Dosing

Neonatal: Not established
Infant: 30 mg/kg/day in 1-2 divided doses
Child: 30 mg/kg/day in 1-2 divided doses (max 1 gm/day)
Adolescent: 30 mg/kg/day in 1-2 divided doses (max 1 gm/day) or adult dose if weight appropriate
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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: >90%
Tmax: 1.5-2 hours
FoodEffect: Food does not affect the extent of absorption but may delay the peak concentration (Tmax) and decrease peak concentration (Cmax). Taking with food may reduce gastrointestinal upset.

Distribution:

Vd: 0.2-0.3 L/kg
ProteinBinding: 20%
CnssPenetration: Limited (does not achieve therapeutic concentrations in CSF)

Elimination:

HalfLife: 1.5-2 hours (normal renal function); significantly prolonged in renal impairment
Clearance: Primarily renal clearance
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: >90%
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: Within 1.5-2 hours (plasma concentration)
DurationOfAction: Dependent on time above MIC (T>MIC), typically allows for once or twice daily dosing due to sustained tissue levels.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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 immediately. Before treating diarrhea, consult with your doctor.

Other Side Effects

Like all medications, this drug may cause side effects. Many people experience no side effects or only minor 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 help:

Diarrhea

This is not an exhaustive list of 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 an allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
  • Severe, watery, or bloody diarrhea (may occur up to 2 months after treatment)
  • Unusual bruising or bleeding
  • Fever, chills, body aches, flu symptoms
  • Sore throat, swollen glands
  • Pale skin, easy bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
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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 identify potential interactions.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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)
  • Kidney dysfunction (rare)
  • Seizures (especially in patients with renal impairment)

What to Do:

In case of overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and may include gastric lavage or activated charcoal if ingestion is recent. Hemodialysis may be useful in severe cases, especially in patients with impaired renal function.

Drug Interactions

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Major Interactions

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

  • Probenecid: May decrease renal tubular secretion of cefadroxil, leading to increased and prolonged plasma concentrations.
  • Aminoglycosides: Increased risk of nephrotoxicity (rare with cefadroxil, more common with other cephalosporins).
  • Loop diuretics (e.g., furosemide): Increased risk of nephrotoxicity (rare with cefadroxil).
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Minor Interactions

  • Oral contraceptives: Theoretical risk of reduced efficacy (advise backup method, though clinical significance is low).

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine, CrCl)

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

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

Target: Improvement in fever, pain, inflammation

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure or resistant organism.

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

Frequency: Throughout therapy and up to several weeks post-therapy

Target: Absence of new infections

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

Renal function (BUN, serum creatinine)

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

Target: Stable renal function

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

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Cefadroxil is generally considered safe for use during pregnancy (Pregnancy Category B). Animal reproduction studies have not demonstrated a risk to the fetus, and there are no adequate and well-controlled studies in pregnant women. Use only if 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 (Lactation Risk L2 - Safer). Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: Low risk of adverse effects; potential for alteration of gut flora, candidiasis, or allergic sensitization.
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Pediatric Use

Cefadroxil is safe and effective for use in pediatric patients. Dosing is typically weight-based. Renal function should be monitored, especially in neonates and infants.

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Geriatric Use

No specific dose adjustment is needed based on age alone. However, 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, effective against many Gram-positive bacteria (e.g., Streptococcus pyogenes, Staphylococcus aureus) and some Gram-negative bacteria (e.g., E. coli, Klebsiella pneumoniae, Proteus mirabilis).
  • It is often chosen for uncomplicated urinary tract infections, pharyngitis/tonsillitis, and skin/skin structure infections due to its convenient once or twice daily dosing.
  • Advise patients to complete the entire course of therapy to prevent resistance and recurrence of infection.
  • Can be taken with or without food; taking with food may help reduce gastrointestinal upset.
  • Patients with a history of penicillin allergy should be monitored closely due to potential cross-reactivity (though generally low for first-generation cephalosporins, around 5-10%).
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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
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for specific indications like complicated UTIs
  • Sulfonamides (e.g., trimethoprim/sulfamethoxazole) for UTIs
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
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'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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.