Cephalexin 250mg Capsules

Manufacturer TEVA Active Ingredient Cephalexin Capsules and Tablets(sef a LEKS in) Pronunciation sef a LEKS in
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
B
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FDA Approved
Jan 1971
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cephalexin is an antibiotic medication used to treat various bacterial infections, such as those affecting the skin, bones, ears, throat, and urinary tract. It works by stopping the growth of bacteria. It is not effective against viral infections like the common cold or flu.
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How to Use This Medicine

Taking Your Medication

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. Continue taking the medication as directed, even if your symptoms improve.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a 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, as this can lead to the infection returning or becoming harder to treat.
  • You can take cephalexin 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 some side effects like stomach upset.

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg to 500 mg every 6 hours or 500 mg every 12 hours
Dose Range: 250 - 1000 mg

Condition-Specific Dosing:

Mild to moderate infections: 250 mg every 6 hours or 500 mg every 12 hours
Severe infections or skin and soft tissue infections: 500 mg every 6 hours
Streptococcal pharyngitis: 250 mg every 6 hours or 500 mg every 12 hours for at least 10 days
Urinary tract infections: 250 mg every 6 hours or 500 mg every 12 hours
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Pediatric Dosing

Neonatal: Not established (use caution, consult specific guidelines)
Infant: 25-50 mg/kg/day in divided doses (e.g., every 6 or 12 hours), up to 100 mg/kg/day for severe infections
Child: 25-50 mg/kg/day in divided doses (e.g., every 6 or 12 hours), up to 100 mg/kg/day for severe infections (max 4 g/day)
Adolescent: Same as adult dosing (250-500 mg every 6-12 hours, max 4 g/day)
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Dose Adjustments

Renal Impairment:

Mild: CrCl 30-59 mL/min: No dose adjustment usually needed, but consider extending dosing interval to every 8-12 hours for standard doses.
Moderate: CrCl 15-29 mL/min: 250 mg every 8-12 hours
Severe: CrCl <15 mL/min: 250 mg every 12-24 hours
Dialysis: 250 mg every 12-24 hours; administer an additional 250 mg after each dialysis session on dialysis days.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Cephalexin is a first-generation cephalosporin antibiotic. It is bactericidal and acts by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, which are enzymes involved in the final stages of peptidoglycan synthesis (transpeptidation and carboxypeptidation). This binding prevents the cross-linking of peptidoglycan chains, leading to a defective and unstable cell wall, ultimately resulting in bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: 1 hour (fasted state)
FoodEffect: Food may delay absorption and decrease peak concentrations, but total amount absorbed remains unchanged. Can be taken with food to reduce GI upset.

Distribution:

Vd: 0.26 L/kg
ProteinBinding: Approximately 10-15%
CnssPenetration: Limited (does not achieve therapeutic concentrations in CSF)

Elimination:

HalfLife: 0.5-1.2 hours (normal renal function)
Clearance: Approximately 210 mL/min
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Approximately 80-90% excreted unchanged in urine within 8 hours
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Pharmacodynamics

OnsetOfAction: Rapid (within 1 hour)
PeakEffect: 1 hour (peak plasma concentration)
DurationOfAction: Dependent on dosing interval, typically effective for 6-12 hours based on half-life and MIC

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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 a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), such as:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
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 extremely tired or weak
Confusion
Hallucinations (seeing or hearing things that are not there)
Difficulty urinating or changes in urine output
Seizures
Severe dizziness
Severe headache
Severe joint pain
Vaginal itching or discharge

Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. In rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur. This condition can lead to a life-threatening bowel problem. If you experience any of the following symptoms, contact your doctor immediately:

Stomach pain
Cramps
Very loose, watery, or bloody stools

Do not treat diarrhea without consulting your doctor.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor:

Stomach pain or diarrhea
* Upset stomach or vomiting

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 a severe allergic reaction: rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing or swallowing, dizziness.
  • Severe, watery, or bloody diarrhea (may occur up to several months after stopping the medication and could be a sign of a serious intestinal infection).
  • Unusual bruising or bleeding.
  • Yellowing of the skin or eyes (jaundice).
  • Dark urine or pale stools.
  • Fever or sore throat that doesn't go away.
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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.
If you are currently taking probenecid, as this may interact with the medication.

Additionally, to ensure safe use, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, as these may affect the safety and efficacy of the medication

Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the medication is suitable for your specific health needs.
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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. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.

If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you, as this medication may affect the accuracy of certain tests. Additionally, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication, as it may impact the results of some lab tests.

Do not take this medication for longer than prescribed, as this can increase the risk of developing a secondary infection.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to 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
  • Stomach pain
  • Diarrhea
  • Blood in the urine
  • Kidney problems (rare)
  • Seizures (rare)

What to Do:

If you suspect an overdose, contact a poison control center immediately (call 1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

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Moderate Interactions

Monitoring

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Baseline Monitoring

Renal function (serum creatinine, BUN, eGFR/CrCl)

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

Timing: Prior to initiation, especially in elderly or patients with known renal issues.

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Routine Monitoring

Clinical response to therapy (resolution of infection symptoms)

Frequency: Daily during acute treatment

Target: Improvement in fever, pain, inflammation

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

Signs/symptoms of adverse reactions (e.g., rash, diarrhea, allergic reaction)

Frequency: Daily

Target: Absence of adverse effects

Action Threshold: Development of rash, severe diarrhea (especially watery/bloody), difficulty breathing, or other signs of allergy/intolerance.

Renal function (serum creatinine, BUN)

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

Target: Stable renal function

Action Threshold: Significant increase in serum creatinine or BUN, indicating potential renal toxicity or need for dose adjustment.

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Symptom Monitoring

  • Skin rash or hives
  • Itching
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Difficulty breathing or swallowing
  • Severe diarrhea (watery or bloody)
  • Abdominal pain or cramping
  • Nausea or vomiting
  • Vaginal itching or discharge (yeast infection)
  • Unusual tiredness or weakness
  • Yellowing of skin or eyes (jaundice)

Special Patient Groups

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Pregnancy

Cephalexin is generally considered safe for use during pregnancy (Pregnancy Category B). Animal studies have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women, but extensive clinical experience suggests no increased risk of birth defects.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations observed.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Cephalexin is excreted in small amounts into breast milk (Lactation Risk L2 - Likely Compatible). It is generally considered safe for nursing infants. Monitor the infant for potential changes in bowel flora (e.g., diarrhea, candidiasis) or allergic reactions (e.g., rash).

Infant Risk: Low risk of adverse effects. Potential for mild gastrointestinal upset or sensitization.
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Pediatric Use

Cephalexin is widely used and generally safe in pediatric patients. Dosing is weight-based. Neonatal use should be approached with caution and specific guidelines consulted due to immature renal function.

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Geriatric Use

Elderly patients may have reduced renal function, which can lead to higher and more prolonged plasma concentrations of cephalexin. Dose adjustment based on creatinine clearance is recommended in elderly patients with impaired renal function. Monitor for adverse effects, especially gastrointestinal disturbances and C. difficile infection.

Clinical Information

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Clinical Pearls

  • Cephalexin is a first-generation cephalosporin, primarily active against 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 used for skin and soft tissue infections, UTIs, and respiratory tract infections.
  • It is generally well-tolerated, with gastrointestinal upset (nausea, diarrhea) being the most common side effect. Taking it with food can help mitigate GI upset.
  • Patients with a history of penicillin allergy should be carefully assessed. While cross-reactivity between penicillins and first-generation cephalosporins is low (around 1-5%), it can occur. Avoid in patients with a history of severe, immediate hypersensitivity reactions to penicillins.
  • Always complete the full course of therapy, even if symptoms improve, to prevent the development of antibiotic resistance and ensure complete eradication of the infection.
  • Cephalexin does not cover MRSA (Methicillin-Resistant Staphylococcus aureus) or Pseudomonas aeruginosa.
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Alternative Therapies

  • Amoxicillin
  • Dicloxacillin
  • Cefadroxil
  • Cefazolin (IV)
  • Clindamycin
  • Trimethoprim/Sulfamethoxazole (for UTIs)
  • Doxycycline (for skin infections)
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (250mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.