Cephalexin 250mg/5ml Susp 200ml

Manufacturer TEVA Active Ingredient Cephalexin Suspension(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
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 used to treat various bacterial infections, such as those of the skin, ears, throat, and urinary tract. It works by stopping the growth of bacteria.
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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. Continue using the medication even if your symptoms improve.

Before taking a liquid dose, shake the container well. Measure the dose carefully using the device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.

Storing and Disposing of Your Medication

Store the medication in the refrigerator and discard any unused portion after 2 weeks. Keep the lid tightly closed and store all medications in a safe place, 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.
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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 antibiotic resistance.
  • Shake the oral suspension well before each use.
  • Measure the liquid medicine carefully using the provided measuring spoon or cup, not a household spoon.
  • Cephalexin can be taken with or without food. If it causes stomach upset, try taking it with food or milk.
  • Store the suspension in the refrigerator and discard any unused portion after 14 days (or as directed by the pharmacist).
  • 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: 250 mg to 1 g every 6 hours or 500 mg every 12 hours, depending on infection severity and type.
Dose Range: 250 - 1000 mg

Condition-Specific Dosing:

Mild to moderate infections: 250 mg every 6 hours or 500 mg every 12 hours
Skin and soft tissue infections: 500 mg every 12 hours
Streptococcal pharyngitis: 250 mg every 6 hours or 500 mg every 12 hours for 10 days
Urinary tract infections: 250 mg every 6 hours or 500 mg every 12 hours
Severe infections: 500 mg to 1 g every 6 hours
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Pediatric Dosing

Neonatal: Not established (use with caution, consult specific guidelines)
Infant: 25-50 mg/kg/day in divided doses every 6-12 hours; for severe infections, up to 100 mg/kg/day. Max 4 g/day.
Child: 25-50 mg/kg/day in divided doses every 6-12 hours; for severe infections, up to 100 mg/kg/day. Max 4 g/day.
Adolescent: Same as adult dosing (250 mg to 1 g every 6 hours or 500 mg every 12 hours), depending on weight and infection.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 30-59 mL/min: No adjustment typically needed, but consider extending dosing interval to every 8-12 hours for higher doses.
Moderate: CrCl 15-29 mL/min: 250-500 mg every 8-12 hours.
Severe: CrCl < 15 mL/min: 250-500 mg every 12-24 hours.
Dialysis: Hemodialysis: 250-500 mg after each dialysis session. Peritoneal Dialysis: 250 mg every 12 hours.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.

Pharmacology

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Mechanism of Action

Cephalexin is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs). This binding prevents the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to inhibition of cell wall assembly and eventual bacterial cell lysis.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: Approximately 1 hour (oral)
FoodEffect: Food may delay the rate of absorption (Tmax) but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 0.26 L/kg
ProteinBinding: Approximately 10-15%
CnssPenetration: Limited (does not readily cross the blood-brain barrier unless meninges are inflamed)

Elimination:

HalfLife: Approximately 0.5-1.2 hours (normal renal function)
Clearance: Approximately 210 mL/min (renal clearance)
ExcretionRoute: Primarily renal (glomerular filtration and tubular secretion)
Unchanged: 70-90% of the dose is excreted unchanged in the urine within 8 hours.
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Pharmacodynamics

OnsetOfAction: Rapid (within 1 hour for antibacterial effect)
PeakEffect: Approximately 1 hour post-dose
DurationOfAction: Dependent on dosing interval (typically 6-12 hours due to short half-life)

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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or 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
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 symptoms and they bother you or do not go away, contact your doctor:

Stomach pain or diarrhea
* Upset stomach or vomiting

Reporting Side Effects

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:

  • Severe allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing)
  • Severe or watery diarrhea, especially if it contains blood or mucus (may be a sign of C. difficile infection)
  • Unusual bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Signs of kidney problems (e.g., swelling in ankles/feet, changes in urination)
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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 treatment, 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 existing health problems

This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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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 interfere with certain test results. Additionally, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the outcome of certain lab tests.

Do not take this medication for longer than prescribed, as this can increase the risk of a secondary infection. It is also crucial to discuss your pregnancy status or plans with your doctor, as well as whether you are breastfeeding, to carefully weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Epigastric distress
  • Diarrhea
  • Hematuria (blood in urine)
  • Rarely, seizures (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 was recent. Hemodialysis may be useful in severe cases, especially with renal impairment.

Drug Interactions

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Major Interactions

  • Metformin (increased metformin plasma concentrations and risk of lactic acidosis)
  • Probenecid (decreased renal excretion of cephalexin, leading to increased and prolonged plasma concentrations)
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Moderate Interactions

  • Warfarin (potential for increased INR/bleeding risk, especially with prolonged use or in patients with risk factors)
  • Live bacterial vaccines (e.g., typhoid vaccine, may reduce efficacy of vaccine)
  • Aminoglycosides (potential for increased nephrotoxicity, though less common with cephalexin than other cephalosporins)

Monitoring

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Baseline Monitoring

Culture and Sensitivity

Rationale: To identify the causative pathogen and determine its susceptibility to cephalexin, guiding appropriate therapy.

Timing: Prior to initiation of therapy, if clinically indicated.

Renal Function (BUN, Creatinine)

Rationale: To establish baseline renal function, especially in elderly patients or those with pre-existing renal impairment, as cephalexin is primarily renally eliminated.

Timing: Prior to initiation of therapy in at-risk patients.

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Routine Monitoring

Clinical Response to Therapy

Frequency: Daily during acute treatment

Target: Resolution of signs and symptoms of infection (e.g., fever reduction, decreased pain, wound healing)

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

Signs of Adverse Reactions

Frequency: Daily throughout therapy

Target: Absence of rash, severe diarrhea, nausea, vomiting, or signs of superinfection.

Action Threshold: Development of new or worsening symptoms requires evaluation and potential discontinuation.

Renal Function (BUN, Creatinine)

Frequency: Periodically, especially in patients with impaired renal function or on prolonged therapy.

Target: Stable or improving renal function.

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

INR (for patients on Warfarin)

Frequency: More frequently (e.g., weekly) when initiating or discontinuing cephalexin.

Target: Therapeutic INR range for the patient's indication.

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

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Symptom Monitoring

  • Rash or hives (signs of allergic reaction)
  • Severe, watery diarrhea or bloody stools (signs of Clostridioides difficile-associated diarrhea)
  • Nausea, vomiting, abdominal pain
  • Oral thrush or vaginal yeast infection (signs of superinfection)
  • Unusual bruising or bleeding (if on warfarin)
  • Signs of kidney problems (e.g., decreased urination, swelling)

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 human experience suggests low risk.

Trimester-Specific Risks:

First Trimester: Low risk of teratogenicity based on available data.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Cephalexin is excreted in low concentrations in human breast milk. It is generally considered compatible with breastfeeding (Lactation Risk L2).

Infant Risk: Low risk. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions (e.g., rash).
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Pediatric Use

Cephalexin is widely used and generally well-tolerated in pediatric patients. Dosing is weight-based. Close monitoring for adverse effects, especially gastrointestinal disturbances and allergic reactions, is important.

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Geriatric Use

No specific dose adjustment is required based solely on age, but renal function should be assessed in elderly patients, as they are more likely to have age-related decline in kidney function. Dose adjustments should be made based on creatinine clearance.

Clinical Information

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Clinical Pearls

  • Cephalexin 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 a common choice for skin and soft tissue infections (e.g., cellulitis, impetigo), uncomplicated urinary tract infections, and streptococcal pharyngitis.
  • Not effective against MRSA (Methicillin-resistant Staphylococcus aureus) or Pseudomonas aeruginosa.
  • Often prescribed for patients with penicillin allergies who can tolerate cephalosporins (cross-reactivity is low, but caution is advised).
  • The oral suspension should be refrigerated after reconstitution and discarded after 14 days.
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Alternative Therapies

  • Other first-generation cephalosporins (e.g., Cefazolin IV)
  • Penicillins (e.g., Amoxicillin, Dicloxacillin, Penicillin V)
  • Macrolides (e.g., Azithromycin, Clarithromycin - for penicillin-allergic patients)
  • Clindamycin (for skin/soft tissue infections, including some MRSA strains)
  • Trimethoprim/Sulfamethoxazole (for UTIs, some skin infections)
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Cost & Coverage

Average Cost: Varies widely, typically low per 200ml suspension
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and appropriate care.