Pfizerpen G 20mu Inj, 1vial

Manufacturer PFIZER U.S. Active Ingredient Penicillin G (Parenteral/ Aqueous)(pen i SIL in jee, pa REN ter al, AYE kwee us) Pronunciation pen i SIL in jee, pa REN ter al, AYE kwee us
It is used to treat bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Beta-lactam antibiotic; Cell wall synthesis inhibitor
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Pregnancy Category
Category B
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Penicillin G is an antibiotic used to treat many different types of bacterial infections. It works by killing the bacteria that cause the infection. It is given as an injection, either into a vein (IV) or a muscle (IM).
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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. It's essential to follow the instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein over a specified period.

Storing and Disposing of Your Medication

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

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • Complete the full course of treatment as prescribed, even if you start feeling better. Stopping early can lead to resistant bacteria.
  • Report any signs of allergic reaction immediately, such as rash, itching, swelling, or difficulty breathing.
  • Stay well-hydrated unless otherwise advised by your doctor.
  • Avoid alcohol consumption, as it may worsen some side effects or interact with other medications you might be taking for the infection.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication and severity. For moderate to severe infections: 2 to 24 million units/day IV/IM in divided doses every 4-6 hours.
Dose Range: 2000000 - 24000000 mg

Condition-Specific Dosing:

Syphilis (neurosyphilis): 3-4 million units IV every 4 hours for 10-14 days
Bacterial Endocarditis: 12-24 million units/day IV in divided doses every 4-6 hours for 4-6 weeks
Streptococcal infections (severe): 1-5 million units IV every 4-6 hours
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Pediatric Dosing

Neonatal: Varies by age (postnatal and gestational) and indication. E.g., 25,000-50,000 units/kg/dose IV every 8-12 hours.
Infant: Varies by age and indication. E.g., 100,000-250,000 units/kg/day IV/IM in divided doses every 4-6 hours.
Child: Varies by age and indication. E.g., 100,000-400,000 units/kg/day IV/IM in divided doses every 4-6 hours (max 24 million units/day).
Adolescent: Typically adult dosing, adjusted for weight and renal function.
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Dose Adjustments

Renal Impairment:

Mild: No significant adjustment needed (CrCl > 50 mL/min).
Moderate: Dose reduction or increased dosing interval. E.g., CrCl 10-50 mL/min: Administer usual dose every 8-12 hours.
Severe: Significant dose reduction or increased dosing interval. E.g., CrCl < 10 mL/min: Administer usual dose every 12-18 hours.
Dialysis: Hemodialysis: Administer dose after dialysis. Peritoneal Dialysis: Supplemental dose may be needed. Monitor clinical response and drug levels if available.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Penicillin G is a bactericidal beta-lactam antibiotic that inhibits 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 (transpeptidases). This binding prevents the cross-linking of peptidoglycan chains, leading to a defective cell wall, increased osmotic pressure, and ultimately cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM)
Tmax: Rapid (minutes for IV, 30-60 minutes for IM)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: 0.3-0.4 L/kg
ProteinBinding: 45-65%
CnssPenetration: Limited (poor penetration into CSF unless meninges are inflamed)

Elimination:

HalfLife: 0.4-0.9 hours (normal renal function)
Clearance: Approximately 300 mL/min (renal clearance)
ExcretionRoute: Primarily renal (tubular secretion and glomerular filtration)
Unchanged: 50-90%
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Pharmacodynamics

OnsetOfAction: Rapid (minutes for IV)
PeakEffect: Rapid (at Tmax)
DurationOfAction: Dependent on dose and renal function (typically 4-6 hours for therapeutic levels)

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, including:
+ 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
Rarely, allergic reactions can be fatal.
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Severe dizziness or fainting
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Chest pain or pressure
Headache
Rapid heartbeat
Rapid breathing
Flushing
Yellowing of the skin or eyes
Muscle or joint pain
Stomach pain
Twitching
Seizures
Difficulty urinating or changes in urine output
Diarrhea (common with antibiotics), especially if severe, bloody, or watery. Rarely, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or severe diarrhea, contact your doctor immediately.

Additional Side Effects to Discuss with Your Doctor

Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not resolve:

Diarrhea
Upset stomach or vomiting
Mouth irritation or mouth sores
Change in tongue color
Irritation at the injection site (if given via muscle injection)
* Nerve damage (if given via muscle injection), which can cause numbness, tingling, or weakness. If you experience any of these symptoms, contact your doctor immediately.

Reporting 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 (hives, rash, swelling of face/lips/tongue/throat, difficulty breathing)
  • Severe or watery diarrhea, especially if bloody (may be a sign of C. difficile infection)
  • New or worsening fever, chills, or sore throat (may indicate a new infection or superinfection)
  • Unusual bleeding or bruising
  • Seizures or confusion (rare, usually with very high doses or renal impairment)
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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 you experienced, including any symptoms that occurred.
If you are currently taking any of the following medications: chloramphenicol, erythromycin, sulfa-drugs (like sulfamethoxazole), or tetracycline drugs (like doxycycline). If you are unsure about any of these medications, consult with your doctor or pharmacist.

Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect your use of this medication.

To ensure your safety, it is crucial to inform your doctor and pharmacist about:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that 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.

Do not use this medication for longer than prescribed, as this can increase the risk of a second infection. High doses of this drug can cause severe and potentially life-threatening electrolyte imbalances. Discuss any concerns with your doctor.

If you have diabetes and regularly test your urine glucose, consult with your doctor to determine the most suitable testing methods to use while taking this medication. Additionally, inform your doctor and laboratory personnel that you are taking this drug, as it may affect the results of certain lab tests.

If you are following a low-sodium or low-potassium diet, discuss this with your doctor to ensure safe use of this medication. Be aware that this drug can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that can also affect internal organs. These reactions can be fatal. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

When administering this drug to newborns, exercise caution, as the risk of side effects may be higher in this population. If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Neurological toxicity (e.g., seizures, confusion, hallucinations, myoclonus), especially in patients with renal impairment or high doses
  • Electrolyte imbalances (e.g., hyperkalemia with potassium penicillin G, hypernatremia with sodium penicillin G)
  • Nausea
  • Vomiting
  • Diarrhea

What to Do:

Seek immediate medical attention. Treatment is supportive and symptomatic. Hemodialysis can remove penicillin G from the blood. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Methotrexate (increased methotrexate levels and toxicity due to competition for renal tubular secretion)
  • Tetracyclines (may antagonize the bactericidal effect of penicillin G; avoid concomitant use)
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Moderate Interactions

  • Probenecid (decreases renal tubular secretion of penicillin G, leading to increased and prolonged plasma concentrations)
  • Oral Contraceptives (theoretical risk of reduced efficacy, though clinical evidence is weak; advise backup contraception)
  • Warfarin (may enhance anticoagulant effect by altering gut flora or displacing from protein binding, monitor INR)
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Minor Interactions

  • Aminoglycosides (physical incompatibility in solution; administer separately)
  • Live Bacterial Vaccines (e.g., typhoid vaccine; antibiotics may reduce vaccine efficacy)

Monitoring

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Baseline Monitoring

Allergy history (especially to penicillins or cephalosporins)

Rationale: To prevent severe hypersensitivity reactions (e.g., anaphylaxis)

Timing: Prior to first dose

Renal function (BUN, serum creatinine, CrCl)

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

Timing: Prior to initiation of therapy

Electrolytes (especially potassium)

Rationale: High doses of potassium penicillin G can lead to hyperkalemia.

Timing: Prior to initiation, especially with high doses

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Routine Monitoring

Clinical response to therapy (e.g., fever, WBC count, infection signs)

Frequency: Daily or as clinically indicated

Target: Resolution of infection symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or need for dose adjustment.

Renal function (BUN, serum creatinine)

Frequency: Every 2-3 days or weekly, more frequently in patients with pre-existing renal impairment or on high doses

Target: Within patient's baseline or acceptable limits

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

Electrolytes (potassium, sodium)

Frequency: Every 2-3 days or weekly, especially with high doses of potassium penicillin G

Target: Within normal limits

Action Threshold: Hyperkalemia or hyponatremia (with sodium penicillin G) may require intervention or change in formulation.

Signs of hypersensitivity (rash, pruritus, urticaria, dyspnea)

Frequency: Continuously during therapy

Target: Absence of allergic symptoms

Action Threshold: Any sign of allergic reaction requires immediate discontinuation and management.

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)

Frequency: Continuously during therapy

Target: Absence of new infections

Action Threshold: Development of new infections, especially C. difficile-associated diarrhea, requires investigation and appropriate treatment.

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Symptom Monitoring

  • Rash
  • Hives
  • Itching
  • Swelling of face/lips/tongue/throat
  • Difficulty breathing or swallowing
  • Wheezing
  • Severe diarrhea (especially watery or bloody)
  • Abdominal cramps
  • Fever
  • Sore throat
  • Unusual bleeding or bruising
  • Seizures
  • Confusion
  • Hallucinations
  • Muscle twitching

Special Patient Groups

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Pregnancy

Penicillin G is generally considered safe and is a commonly used antibiotic during pregnancy. It crosses the placenta but is not associated with an increased risk of birth defects.

Trimester-Specific Risks:

First Trimester: Low risk; no evidence of teratogenicity.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Penicillin G is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding. Monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: Low risk (L1)
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Pediatric Use

Dosing must be carefully calculated based on age, weight, and renal function. Neonates and infants have immature renal function, requiring specific dosing adjustments and close monitoring. High doses can lead to neurotoxicity.

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Geriatric Use

Elderly patients are more likely to have age-related decline in renal function, which necessitates careful dose adjustment based on creatinine clearance. They may also be more susceptible to central nervous system side effects (e.g., seizures) and electrolyte imbalances, especially with high doses.

Clinical Information

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Clinical Pearls

  • Always confirm patient allergy history before administering penicillin G, as severe hypersensitivity reactions (including anaphylaxis) can occur.
  • Penicillin G is highly effective against susceptible Gram-positive bacteria (e.g., Streptococcus spp.) and some Gram-negative cocci (e.g., Neisseria meningitidis), but it is susceptible to beta-lactamase enzymes.
  • For IV administration, ensure proper dilution and infusion rate to avoid vein irritation.
  • High doses of potassium penicillin G can lead to significant potassium load, requiring electrolyte monitoring, especially in patients with renal impairment or those receiving other potassium-sparing agents.
  • Neurotoxicity (e.g., seizures) is a rare but serious side effect, particularly in patients with renal failure, high doses, or pre-existing CNS disorders. Monitor for changes in mental status or seizure activity.
  • Penicillin G is not effective against penicillinase-producing Staphylococcus aureus or most Gram-negative rods.
  • Intrathecal administration is generally not recommended due to the risk of neurotoxicity.
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Alternative Therapies

  • Other beta-lactam antibiotics (e.g., ampicillin, amoxicillin, cephalosporins, carbapenems) depending on the specific pathogen and infection site.
  • Macrolides (e.g., azithromycin, erythromycin) for penicillin-allergic patients with susceptible infections.
  • Vancomycin (for serious Gram-positive infections, especially MRSA or in penicillin-allergic patients where other options are not suitable).
  • Clindamycin (for certain anaerobic infections or Gram-positive infections in penicillin-allergic patients).
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Cost & Coverage

Average Cost: Not available per vial
Generic Available: Yes
Insurance Coverage: Tier 1 (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 the 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 or pharmacist, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, as community drug take-back programs may be available. Some medications may include an additional patient information leaflet, which can be obtained from your pharmacist. 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 amount, and the time of ingestion.