Penicillin Gk 20mu Inj, 1 Vial

Manufacturer ATHENEX PHARMACEUTICAL 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 that fights bacterial infections. It works by stopping bacteria from building their cell walls, which kills them. It's given as an injection, either into a vein (IV) or a muscle (IM), and is used for serious infections like pneumonia, meningitis, and syphilis.
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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 be sure to follow all instructions provided. This medication is administered either as an intramuscular injection or as an intravenous infusion, which is given over a period of time directly 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 full course of treatment as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Report any signs of allergic reaction (rash, itching, swelling, difficulty breathing) immediately.
  • Inform your healthcare provider about all medications you are taking, including over-the-counter drugs, supplements, and herbal products.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. Common range: 1 to 4 million units (MU) IV/IM every 4 to 6 hours.
Dose Range: 1000000 - 24000000 mg

Condition-Specific Dosing:

Streptococcal infections (moderate to severe): 1 to 2 MU IV/IM every 4 to 6 hours
Syphilis (neurosyphilis): 3 to 4 MU IV every 4 hours for 10-14 days
Bacterial Endocarditis: 2 to 4 MU IV every 4 hours (total 12-24 MU/day) for 4-6 weeks
Meningitis: 3 to 4 MU IV every 4 hours
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Pediatric Dosing

Neonatal: 50,000 to 100,000 units/kg/day IV/IM divided every 8 to 12 hours (dose varies by age, weight, and indication)
Infant: 100,000 to 250,000 units/kg/day IV/IM divided every 4 to 6 hours (dose varies by age, weight, and indication)
Child: 100,000 to 400,000 units/kg/day IV/IM divided every 4 to 6 hours (max 24 MU/day; dose varies by age, weight, and indication)
Adolescent: Adult dosing may apply for certain indications, otherwise weight-based dosing similar to child
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-70 mL/min: No significant adjustment needed, but monitor.
Moderate: CrCl 10-50 mL/min: Administer usual dose every 6-8 hours or reduce dose by 25-50%.
Severe: CrCl < 10 mL/min: Administer usual dose every 8-12 hours or reduce dose by 50-75%.
Dialysis: Hemodialysis: Administer dose after dialysis. Peritoneal Dialysis: Administer usual dose every 8-12 hours. Supplemental doses may be needed.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Penicillin G is a bactericidal 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. 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); High (IM, but slower absorption)
Tmax: IV: Immediate; IM: 30-60 minutes
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: 0.3-0.4 L/kg
ProteinBinding: 45-65%
CnssPenetration: Limited (unless meninges are inflamed, then therapeutic concentrations are achieved)

Elimination:

HalfLife: 0.5-1 hour (in patients with normal renal function)
Clearance: Primarily renal clearance (glomerular filtration and active tubular secretion)
ExcretionRoute: Urine
Unchanged: 50-90%
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Pharmacodynamics

OnsetOfAction: Rapid (minutes for IV)
PeakEffect: Within minutes (IV); 30-60 minutes (IM)
DurationOfAction: Dependent on half-life and dosing frequency (typically 4-6 hours for IV/IM aqueous forms)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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
Note: In rare cases, 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, especially if it is severe, bloody, or watery (see below for more information on diarrhea)

Important Information About Diarrhea:

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) can occur. CDAD can happen during or several months after taking antibiotics and may lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or severe diarrhea, contact your doctor immediately.

Injection-Specific Side Effects:

If you receive this medication via injection into a muscle, there is a risk of nerve damage. This can be long-lasting and may cause numbness, tingling, or weakness. If you experience any of these symptoms, contact your doctor right away.

Other Possible Side Effects:

Most people do not experience significant side effects, but some may occur. If you have any of the following side effects or any other concerns, contact your doctor:

Diarrhea
Upset stomach or vomiting
Mouth irritation or mouth sores
Change in tongue color
* Irritation at the injection site

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 (anaphylaxis): difficulty breathing, swelling of face/throat, rapid heartbeat, dizziness, severe rash.
  • Severe diarrhea, especially if bloody or watery, which could be a sign of C. difficile infection.
  • New or worsening fever, chills, or other signs of infection (could indicate superinfection or treatment failure).
  • Unusual bleeding or bruising.
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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
+ Sulfonamides (e.g., sulfamethoxazole)
+ Tetracyclines (e.g., 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 interactions. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Share information about your health problems, as they may interact with this medication.
* 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.

Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection. High doses of this medication can lead to severe and potentially life-threatening electrolyte imbalances. Discuss any concerns with your doctor.

If you have diabetes and regularly test your urine glucose levels, consult 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 treatment. Be aware that this medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that may 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; mouth, throat, nose, eye, genital, or skin sores; fever; chills; body aches; shortness of breath; or swollen glands.

When administering this medication 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, 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:

  • Neurological toxicity (e.g., seizures, confusion, twitching, hyperreflexia), especially with very high doses or in patients with renal impairment.
  • Electrolyte imbalances (e.g., hyperkalemia with potassium salt).
  • Nausea, vomiting, diarrhea.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and may include discontinuation of the drug, management of seizures, and correction of electrolyte imbalances. Hemodialysis can remove penicillin G from the body.

Drug Interactions

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Major Interactions

  • Tetracyclines (may antagonize bactericidal effect of penicillin G)
  • Methotrexate (penicillin G may decrease renal clearance of methotrexate, increasing its toxicity)
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Moderate Interactions

  • Probenecid (decreases renal tubular secretion of penicillin G, prolonging its half-life and increasing serum concentrations)
  • Aminoglycosides (physical incompatibility in solution; synergistic in some infections but must be administered separately)
  • Oral Contraceptives (theoretical reduction in efficacy, though evidence is weak and not clinically significant for most patients)
  • Warfarin (may enhance anticoagulant effect, monitor INR)

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine, CrCl)

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

Timing: Prior to initiation of therapy

Electrolytes (especially potassium)

Rationale: High doses of Penicillin G Potassium can contribute significant potassium load, risking hyperkalemia.

Timing: Prior to initiation of therapy, especially for high-dose regimens

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Routine Monitoring

Clinical response to therapy (e.g., fever, white blood cell count, infection signs)

Frequency: Daily or as clinically indicated

Target: Improvement of infection symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistance

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 creatinine or BUN may require dose adjustment

Electrolytes (especially potassium)

Frequency: Daily or every 2-3 days for high-dose regimens of Penicillin G Potassium

Target: Normal serum potassium levels (3.5-5.0 mEq/L)

Action Threshold: Hyperkalemia (potassium > 5.0 mEq/L) requires intervention

Signs and symptoms of hypersensitivity reactions

Frequency: Continuously during therapy, especially during initial doses

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

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

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, C. difficile-associated diarrhea)

Frequency: As clinically indicated

Target: Absence of new infections

Action Threshold: Development of new infections requires evaluation and appropriate treatment

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Symptom Monitoring

  • Rash
  • Hives
  • Itching
  • Swelling of face/lips/tongue
  • Difficulty breathing or swallowing
  • Wheezing
  • Fever
  • Severe diarrhea (especially if bloody or watery)
  • Abdominal cramps
  • Unusual bleeding or bruising
  • Sore throat
  • Oral thrush (white patches in mouth)
  • Vaginal itching or discharge

Special Patient Groups

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Pregnancy

Penicillin G is generally considered safe for use during pregnancy (Category B). Studies in animals have not shown fetal harm, and adequate and well-controlled studies in pregnant women have not demonstrated a risk to the fetus.

Trimester-Specific Risks:

First Trimester: Low risk, commonly used for infections like syphilis.
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 (e.g., rash).

Infant Risk: Low
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Pediatric Use

Dosing is weight-based and highly dependent on the specific infection and severity. Neonates and infants may have reduced renal clearance, requiring careful dose adjustment and monitoring. High doses of Penicillin G Potassium can lead to hyperkalemia, especially in neonates and infants.

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Geriatric Use

Elderly patients are more likely to have age-related decline in renal function, which can lead to increased serum concentrations and prolonged half-life of penicillin G. Dose adjustments based on creatinine clearance are often necessary. Monitor for signs of neurotoxicity and electrolyte imbalances.

Clinical Information

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Clinical Pearls

  • Penicillin G is a time-dependent antibiotic; maintaining drug concentrations above the MIC for a prolonged period is crucial for efficacy.
  • The '20mu' in 'Penicillin Gk 20mu Inj' likely refers to 20 million units (MU) per vial, a common presentation for high-dose IV use.
  • Penicillin G Potassium contains approximately 1.7 mEq of potassium per 1 million units. High doses (e.g., 20-24 MU/day) can contribute a significant potassium load, requiring careful monitoring of serum potassium, especially in patients with renal impairment or those receiving other potassium-sparing agents.
  • Always inquire about penicillin allergy history before administration. For patients with a history of mild rash, a cephalosporin may be considered, but for severe reactions (anaphylaxis), penicillin G is contraindicated, and desensitization may be an option in life-threatening infections where no alternative exists.
  • Administer IV doses slowly (e.g., over 30-60 minutes) to minimize vein irritation and potential for seizures with rapid infusion of high doses.
  • Procaine Penicillin G and Benzathine Penicillin G are different formulations with prolonged absorption and are NOT interchangeable with aqueous Penicillin G for IV administration or for indications requiring high, sustained serum levels.
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Alternative Therapies

  • Other beta-lactam antibiotics (e.g., ampicillin, amoxicillin, cephalosporins, carbapenems) depending on susceptibility and infection type.
  • Macrolides (e.g., azithromycin, erythromycin) for penicillin-allergic patients with susceptible infections.
  • Vancomycin (for Gram-positive infections, especially MRSA or in severe penicillin allergy).
  • Clindamycin (for anaerobic infections or certain Gram-positive infections in penicillin-allergic patients).
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Cost & Coverage

Average Cost: Relatively inexpensive (generic) per vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which can be a safe and convenient way to dispose of unwanted medications. 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 your medication, consult 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 information about the medication taken, the amount, and the time it was taken, as this will help healthcare providers deliver appropriate care.