Cephalexin 125mg/5ml Susp 200ml

Manufacturer BIOCRAFT 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 medication used to treat various bacterial infections, such as those affecting the skin, ears, throat, bones, 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 dose, shake the liquid medication well. To ensure accurate dosing, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.

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 is 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 feeling 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 medication 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, taking it with food or milk may help.
  • Stay hydrated by drinking plenty of fluids unless otherwise advised by your doctor.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

mildToModerateInfections: 250 mg every 6 hours or 500 mg every 12 hours
severeInfections: 500 mg every 6 hours or 1 g every 12 hours
skinAndSoftTissueInfections: 500 mg every 12 hours
streptococcalPharyngitis: 250 mg every 6 hours or 500 mg every 12 hours for at least 10 days
urinaryTractInfections: 250 mg every 6 hours or 500 mg every 12 hours
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Pediatric Dosing

Neonatal: Not established (use with caution, consult specialist)
Infant: 25 to 50 mg/kg/day in divided doses every 6 or 8 hours (max 100 mg/kg/day)
Child: 25 to 50 mg/kg/day in divided doses every 6 or 8 hours (max 100 mg/kg/day)
Adolescent: 25 to 50 mg/kg/day in divided doses every 6 or 8 hours (max 100 mg/kg/day, or adult dose if weight allows)
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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 mg every 8-12 hours
Severe: CrCl < 15 mL/min: 250 mg every 12-24 hours
Dialysis: Hemodialysis: 250 mg initially, then 250 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 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: Approximately 1 hour (fasted state)
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

Elimination:

HalfLife: Approximately 0.5 to 1.2 hours (normal renal function)
Clearance: Primarily renal clearance via glomerular filtration and tubular secretion
ExcretionRoute: Renal
Unchanged: 70-90%
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Pharmacodynamics

OnsetOfAction: Rapid (within 1 hour)
PeakEffect: Approximately 1 hour post-dose
DurationOfAction: Dependent on dosing interval (typically 6-12 hours)

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
+ Difficulty 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
+ Fatigue
+ 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 (may be a sign of C. difficile-associated diarrhea, a potentially life-threatening condition)

Common Side Effects

Most people taking this medication will not experience severe side effects. However, some may encounter mild or moderate side effects, such as:

Stomach pain or diarrhea
Upset stomach or vomiting

If any of these side effects or other symptoms bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

If you have questions or concerns about side effects, you can:

Contact your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch
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Seek Immediate Medical Attention If You Experience:

  • Severe allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
  • Severe or watery diarrhea (may occur up to several months after treatment)
  • Abdominal pain or cramps
  • Unusual bleeding or bruising
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Persistent sore throat or fever (may indicate blood dyscrasias, though 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.
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 drugs and health conditions. Never start, stop, or adjust 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 accuracy 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 primarily supportive. Gastric lavage may be indicated if performed within 1 hour of ingestion. Hemodialysis may be useful in severe cases, especially with renal impairment.

Drug Interactions

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Major Interactions

  • Metformin (increased metformin plasma concentrations, monitor for 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, monitor INR)
  • Live bacterial vaccines (e.g., typhoid vaccine - may decrease therapeutic effect of vaccine)
  • Cholestyramine (may reduce absorption of cephalexin if given concurrently)
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Minor Interactions

  • Oral contraceptives (theoretical risk of reduced efficacy, but generally not clinically significant)

Monitoring

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Baseline Monitoring

Culture and Sensitivity (if indicated)

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

Timing: Prior to initiation of therapy

Renal Function (CrCl, SCr)

Rationale: Cephalexin is primarily renally eliminated; dose adjustment may be necessary in patients with impaired renal function.

Timing: Before starting therapy, especially in elderly or renally impaired patients

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Routine Monitoring

Clinical Response to Therapy

Frequency: Daily

Target: Resolution of signs and symptoms of infection

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

Signs of Hypersensitivity Reactions

Frequency: Daily, especially during initial days

Target: Absence of rash, urticaria, pruritus, dyspnea, or anaphylaxis

Action Threshold: Any signs of allergic reaction require immediate discontinuation and appropriate management.

Gastrointestinal Symptoms

Frequency: Daily

Target: Absence of severe diarrhea, abdominal pain, nausea, vomiting

Action Threshold: Persistent or severe diarrhea may indicate Clostridioides difficile-associated diarrhea (CDAD).

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Symptom Monitoring

  • Rash
  • Hives (urticaria)
  • Itching
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, tongue, lips, or eyes
  • Severe diarrhea (watery or bloody stools)
  • Abdominal pain or cramps
  • Nausea
  • Vomiting
  • Vaginal itching or discharge (yeast infection)

Special Patient Groups

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Pregnancy

Cephalexin is generally considered safe for use during pregnancy (Pregnancy Category B). Animal reproduction studies have not shown a risk 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 human milk in low concentrations. It is generally considered compatible with breastfeeding (Lactation Risk L2). Monitor breastfed infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reaction (rash).

Infant Risk: Low risk
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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, particularly gastrointestinal disturbances and hypersensitivity reactions, is important.

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Geriatric Use

No specific dose adjustment is needed based solely on age, but renal function should be assessed in elderly patients, as they are more likely to have age-related decreases in renal 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 commonly used for skin and soft tissue infections (e.g., cellulitis, impetigo), urinary tract infections, and respiratory tract infections (e.g., pharyngitis, tonsillitis).
  • It is NOT effective against MRSA (Methicillin-Resistant Staphylococcus aureus) or most anaerobic bacteria.
  • Patients with a history of severe penicillin allergy (e.g., anaphylaxis) should generally avoid cephalexin due to potential cross-reactivity, although the risk is low (around 1-5%).
  • Oral suspension should be refrigerated after reconstitution and discarded after 14 days.
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Alternative Therapies

  • Amoxicillin/clavulanate (Augmentin)
  • Cefadroxil (another first-gen cephalosporin)
  • Dicloxacillin (penicillinase-resistant penicillin)
  • Clindamycin (for skin/soft tissue infections, including some MRSA strains)
  • Trimethoprim/sulfamethoxazole (Bactrim, for UTIs and some skin infections)
  • Macrolides (e.g., azithromycin, clarithromycin, for respiratory infections in penicillin-allergic patients)
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Cost & Coverage

Average Cost: Not available per 200ml bottle
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'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 medication, including the amount taken and the time it happened, to ensure you receive the best possible care.