Oxacillin Sodium 2gm Inj, 50ml

Manufacturer BAXTER HEALTHCARE CORP Active Ingredient Oxacillin(oks a SIL in) Pronunciation oks-a-SIL-in
It is used to treat bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Penicillin; Beta-lactam antibiotic; Penicillinase-resistant penicillin
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Pregnancy Category
Category B
FDA Approved
Jan 1962
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Oxacillin is an antibiotic medication used to treat certain types of bacterial infections, especially those caused by Staphylococcus bacteria that are resistant to other penicillins. It works by killing the bacteria that cause the infection.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This medication can be administered in two ways: as an intramuscular injection (a shot into a muscle) or as an intravenous infusion (into a vein) over a specified period of time. In some cases, it may also be given as a direct injection into a vein.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Complete the entire course of medication as prescribed, even if you start feeling better. Stopping early can lead to the infection returning or becoming harder to treat.
  • Do not share this medication with others.
  • Report any new or worsening symptoms to your healthcare provider.
  • Maintain good hygiene to prevent the spread of infection.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 to 2 grams IV every 4 to 6 hours
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

moderateToSevereInfections: 1 gram IV every 4 to 6 hours
severeInfections: 2 grams IV every 4 to 6 hours
endocarditis: 2 grams IV every 4 hours
osteomyelitis: 2 grams IV every 4 hours
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Pediatric Dosing

Neonatal: 25-50 mg/kg/dose IV every 6-12 hours (frequency depends on postnatal age and weight)
Infant: 100-200 mg/kg/day IV divided every 4-6 hours (Max 12 g/day)
Child: 100-200 mg/kg/day IV divided every 4-6 hours (Max 12 g/day)
Adolescent: 1-2 grams IV every 4 to 6 hours (Max 12 g/day)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed (CrCl >50 mL/min)
Moderate: No adjustment typically needed (CrCl 10-50 mL/min)
Severe: Consider extending dosing interval to every 8-12 hours (CrCl <10 mL/min)
Dialysis: Administer usual dose after dialysis; not significantly removed by hemodialysis

Hepatic Impairment:

Mild: No specific adjustment recommended, monitor LFTs
Moderate: Use with caution, monitor LFTs; dose adjustment may be necessary in severe cases or with concomitant renal impairment
Severe: Use with caution, monitor LFTs; dose adjustment may be necessary, consider reduced dose or extended interval

Pharmacology

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Mechanism of Action

Oxacillin is a penicillinase-resistant penicillin 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 bacterial cell walls, leading to inhibition of cell wall biosynthesis and eventually bacterial cell lysis.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Not applicable (IV administration, immediate peak)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.15-0.2 L/kg
ProteinBinding: Approximately 90-95%
CnssPenetration: Limited (unless meninges are inflamed)

Elimination:

HalfLife: Approximately 0.5-1.5 hours (prolonged in renal impairment)
Clearance: Approximately 100-200 mL/min/1.73m²
ExcretionRoute: Primarily renal (tubular secretion and glomerular filtration) and biliary excretion
Unchanged: Approximately 30-60% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid (IV administration)
PeakEffect: Within minutes of IV infusion completion
DurationOfAction: Dependent on half-life and dosing interval (typically 4-6 hours)

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
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Muscle or joint pain
Mouth irritation
Feeling extremely tired or weak
Severe stomach pain
Twitching
Seizures
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain, cramps, or fever (a rare but potentially life-threatening condition called Clostridioides difficile-associated diarrhea, or CDAD, may occur)
Unexplained bruising or bleeding, signs of infection (such as fever, chills, or sore throat), or feeling extremely tired or weak, which may indicate low blood cell counts

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:

Diarrhea
Upset stomach or vomiting
* Change in tongue color

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:

  • Severe or persistent diarrhea (may be a sign of C. difficile infection)
  • New or worsening rash, hives, or itching
  • Difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat (signs of allergic reaction)
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bruising or bleeding
  • Fever or chills that develop after starting the medication
  • 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, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are allergic to penicillin, as this may be relevant to your treatment.
If you are currently taking tetracycline, as this may interact with the medication.

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with 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

Important Warnings and Cautions for Patients Taking This Medication

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 medication long-term, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.

Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.

If you are following a low-sodium or sodium-free diet, consult your doctor before taking this medication, as some products may contain sodium.

Patients 65 years or older should exercise caution when taking this medication, as they may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

Special Considerations for Children

When administering this medication to children, use with caution, as the risk of certain side effects may be higher in pediatric patients.
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Overdose Information

Overdose Symptoms:

  • Neuromuscular hyperexcitability (e.g., twitching, myoclonus, seizures)
  • Nausea
  • Vomiting
  • Diarrhea
  • Electrolyte disturbances (e.g., hypernatremia with high doses of sodium salt)

What to Do:

Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive and symptomatic. Hemodialysis may be used in severe cases, especially with renal impairment.

Drug Interactions

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Major Interactions

  • Methotrexate (decreased renal clearance of methotrexate, leading to increased methotrexate levels and potential toxicity)
  • Warfarin (potential for enhanced anticoagulant effect, monitor INR)
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Moderate Interactions

  • Tetracyclines (may antagonize the bactericidal effect of penicillins, avoid concomitant use if possible)
  • Probenecid (increases and prolongs oxacillin serum concentrations by decreasing renal tubular secretion)
  • Oral Contraceptives (theoretical risk of reduced efficacy, though clinical significance is debated)
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Minor Interactions

  • Aminoglycosides (physical incompatibility in solution, do not mix)

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

Rationale: To establish baseline kidney function and guide dosing, especially in patients with pre-existing renal impairment.

Timing: Prior to initiation of therapy

Hepatic function (ALT, AST, bilirubin)

Rationale: To establish baseline liver function, as oxacillin is hepatically metabolized and can cause liver enzyme elevations.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC) with differential

Rationale: To establish baseline hematologic parameters and monitor for potential hematologic adverse effects (e.g., eosinophilia, leukopenia, neutropenia).

Timing: Prior to initiation of therapy

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Routine Monitoring

Renal function (BUN, serum creatinine)

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

Target: Within normal limits or stable from baseline

Action Threshold: Significant increase in BUN/creatinine; consider dose adjustment or alternative therapy

Hepatic function (ALT, AST)

Frequency: Weekly or bi-weekly during prolonged therapy (e.g., >2 weeks)

Target: Within normal limits or stable from baseline

Action Threshold: Significant elevation (e.g., >3x ULN); consider discontinuation or alternative therapy

Complete Blood Count (CBC) with differential

Frequency: Weekly or bi-weekly during prolonged therapy

Target: Within normal limits or stable from baseline

Action Threshold: Significant changes (e.g., eosinophilia >5%, leukopenia, neutropenia); consider discontinuation

Signs and symptoms of superinfection

Frequency: Daily

Target: Absence of new infections

Action Threshold: Development of new fever, persistent diarrhea (C. difficile), oral/vaginal candidiasis; initiate appropriate treatment

IV site for phlebitis/irritation

Frequency: Daily or with each dose

Target: Absence of redness, swelling, pain

Action Threshold: Signs of phlebitis; consider warm compresses, elevation, or changing IV site

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Symptom Monitoring

  • Skin rash or hives
  • Fever
  • Diarrhea (especially severe or persistent)
  • Nausea/vomiting
  • Abdominal pain
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual bleeding or bruising
  • Signs of allergic reaction (swelling of face/throat, difficulty breathing)
  • Signs of superinfection (e.g., oral thrush, vaginal yeast infection)

Special Patient Groups

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Pregnancy

Oxacillin is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. It is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital anomalies observed in human studies.
Second Trimester: Generally considered safe, no specific risks identified.
Third Trimester: Generally considered safe, no specific risks identified.
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Lactation

Oxacillin is excreted in breast milk in small amounts. It is generally considered compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions (e.g., rash).

Infant Risk: Low risk; monitor for gastrointestinal upset or hypersensitivity reactions.
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Pediatric Use

Dosing must be carefully calculated based on age, weight, and severity of infection. Neonates and infants may have immature renal function, requiring careful monitoring and potential dose adjustments. Close monitoring for adverse effects is crucial.

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Geriatric Use

No specific dose adjustment is typically required based solely on age, but geriatric patients are more likely to have age-related decreases in renal function. Monitor renal and hepatic function closely, and adjust dose if significant impairment is present. They may also be more susceptible to adverse effects.

Clinical Information

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Clinical Pearls

  • Oxacillin is a penicillinase-resistant penicillin, making it effective against Staphylococcus aureus (MSSA) that produces penicillinase, but it is NOT effective against Methicillin-Resistant Staphylococcus aureus (MRSA).
  • Administer IV infusions slowly (over 30-60 minutes) to minimize the risk of vein irritation and phlebitis.
  • High doses or prolonged therapy may lead to hepatic dysfunction (elevated LFTs) or hematologic abnormalities (e.g., eosinophilia, neutropenia); regular monitoring is important.
  • Consider alternative agents if a patient has a history of severe hypersensitivity (e.g., anaphylaxis) to penicillins, although cross-reactivity with cephalosporins is low.
  • Ensure adequate hydration to prevent crystalluria, especially with high doses.
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Alternative Therapies

  • Nafcillin (another penicillinase-resistant penicillin)
  • Dicloxacillin (oral penicillinase-resistant penicillin)
  • Cefazolin (a first-generation cephalosporin, often used for MSSA infections)
  • Clindamycin (for certain MSSA infections, but resistance patterns vary)
  • Vancomycin (if MRSA is suspected or confirmed, or for severe penicillin allergies)
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Cost & Coverage

Average Cost: $10 - $50 per 2g vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.