Cefadroxil 250mg/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 skin infections, throat infections (strep throat), and urinary tract infections. It works by killing the bacteria that cause these infections.
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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 potency. 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 the medication exactly as prescribed by your doctor, even if you start feeling better. Do not skip doses or stop taking it early.
  • You can take cefadroxil with or without food. If it causes stomach upset, try taking it with food or milk.
  • Shake the suspension well before each use.
  • Use a measuring spoon or cup to ensure accurate dosing of the liquid suspension.
  • Store the suspension in the refrigerator after mixing and discard any unused portion after 14 days.
  • Drink plenty of fluids to help prevent kidney stones, although this is not a common side effect with cefadroxil.

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.
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

Skin and Skin Structure Infections: 1 gram daily or 500 mg twice daily
Pharyngitis/Tonsillitis (Group A Beta-Hemolytic Streptococci): 1 gram daily or 500 mg twice daily for 10 days
Urinary Tract Infections (Uncomplicated): 1 to 2 grams daily or 500 mg twice daily
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Pediatric Dosing

Neonatal: Not established
Infant: 30 mg/kg/day in two divided doses (e.g., 15 mg/kg every 12 hours)
Child: 30 mg/kg/day in two divided doses (e.g., 15 mg/kg every 12 hours), up to a maximum of 2 grams/day. For Group A Beta-Hemolytic Streptococci pharyngitis/tonsillitis, 30 mg/kg/day as a single dose or in two divided doses for 10 days.
Adolescent: 30 mg/kg/day in two divided doses, up to a maximum of 2 grams/day, or adult dosing if weight allows.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-75 mL/min: No adjustment needed.
Moderate: CrCl 25-49 mL/min: 500 mg every 12 hours or 1 gram every 24 hours.
Severe: CrCl 10-24 mL/min: 500 mg every 24 hours.
Dialysis: CrCl <10 mL/min: 500 mg every 36 hours. Administer after dialysis 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: Approximately 90%
Tmax: 1.5 to 2 hours
FoodEffect: Food does not significantly affect the absorption of cefadroxil. It may be taken with or without food.

Distribution:

Vd: Approximately 0.31 L/kg
ProteinBinding: Approximately 20%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1.5 hours (prolonged in renal impairment)
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: 12 to 24 hours (based on dosing frequency)

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. 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 or watery diarrhea, especially if it contains blood or mucus (may be a sign of C. difficile infection)
  • New or worsening rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or wheezing
  • Severe stomach pain or cramps
  • Unusual bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Signs of a new infection (e.g., oral thrush, vaginal yeast infection)
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change 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. 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 both 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)
  • Hyperreflexia
  • Seizures (rare)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is primarily supportive. Hemodialysis may be useful in removing the drug from the blood, especially in patients with impaired renal function.

Drug Interactions

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Moderate Interactions

  • Probenecid (may increase cefadroxil levels)
  • Oral anticoagulants (e.g., warfarin - may enhance anticoagulant effect, monitor INR)
  • Aminoglycosides (potential for increased nephrotoxicity, though less common with cephalosporins than with penicillins)
  • Live bacterial vaccines (e.g., typhoid vaccine - may decrease therapeutic effect of vaccine)
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Minor Interactions

  • Metformin (theoretical interaction, monitor for metformin toxicity if co-administered with high doses of cefadroxil)

Monitoring

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Baseline Monitoring

Culture and Susceptibility

Rationale: To identify the causative pathogen and confirm its susceptibility to cefadroxil.

Timing: Prior to initiating therapy, if clinically indicated.

Renal Function (CrCl, BUN, Creatinine)

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

Timing: Prior to initiating therapy in patients with known or suspected renal impairment.

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Routine Monitoring

Signs and Symptoms of Infection Resolution

Frequency: Daily

Target: Improvement in fever, pain, inflammation, etc.

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

Adverse Effects (e.g., GI upset, rash, superinfection)

Frequency: Daily

Target: Absence or mild, tolerable side effects.

Action Threshold: Severe diarrhea (C. difficile), widespread rash, signs of anaphylaxis, or new infections (e.g., oral thrush, vaginal yeast infection) require immediate evaluation.

Renal Function

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

Target: Stable renal function.

Action Threshold: Significant decline in renal function may necessitate dose adjustment or discontinuation.

INR (if on warfarin)

Frequency: More frequently during co-administration.

Target: Within therapeutic range.

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

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Symptom Monitoring

  • Diarrhea (especially severe or bloody)
  • Rash or hives
  • Difficulty breathing or swallowing
  • Swelling of face, lips, tongue, or throat
  • Fever
  • New onset of vaginal itching or discharge
  • White patches in the mouth or on the tongue
  • Joint pain or swelling

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 available data suggest no increased risk of major birth defects or miscarriage. 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 human milk in low concentrations. The amount ingested by the infant is generally small and unlikely to cause adverse effects. Monitor breastfed infants for potential changes in bowel flora (e.g., diarrhea, candidiasis) or allergic reactions (e.g., rash). Generally considered compatible with breastfeeding (L2).

Infant Risk: Low risk of adverse effects. Potential for disruption of infant gut flora or sensitization.
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Pediatric Use

Dosing is weight-based. Safety and efficacy have been established in pediatric patients. Close monitoring for adverse effects, especially gastrointestinal disturbances and hypersensitivity reactions, is important. Ensure accurate measurement of liquid suspension doses.

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Geriatric Use

No specific dose adjustment is needed based solely on age. However, elderly patients are more likely to have decreased renal function, which necessitates dose adjustment based on creatinine clearance. Monitor renal function closely in this population.

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 its convenient once or twice-daily dosing, which can improve patient adherence.
  • The suspension form must be refrigerated after reconstitution and discarded after 14 days.
  • Patients with a history of penicillin allergy should be carefully evaluated due to potential cross-reactivity with cephalosporins, though the risk with first-generation cephalosporins is generally low (around 5-10%).
  • Always complete the full course of therapy, even if symptoms improve, to prevent the development of antibiotic resistance.
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Alternative Therapies

  • Other first-generation cephalosporins (e.g., cephalexin, cefazolin)
  • Penicillins (e.g., amoxicillin, penicillin V, dicloxacillin)
  • Macrolides (e.g., azithromycin, erythromycin - for penicillin-allergic patients)
  • Clindamycin
  • Trimethoprim/sulfamethoxazole (for UTIs)
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Cost & Coverage

Average Cost: Varies, typically low per 100ml suspension
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 is 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 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.