Penicillin Vk 250mg/5ml Soln 100ml

Manufacturer TEVA PHARMACEUTICALS USA Active Ingredient Penicillin V Potassium Oral Solution(pen i SIL in vee poe TASS ee um) Pronunciation pen i SIL in vee poe TASS ee um
It is used to treat or prevent bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Penicillin antibiotic; Beta-lactam antibiotic
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Pregnancy Category
Category B
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FDA Approved
Jul 1959
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Penicillin V potassium is an antibiotic medicine used to treat bacterial infections like strep throat, ear infections, and skin infections. It works by killing the bacteria that cause these infections. It's important to take all of your medicine as prescribed, even if you start feeling better, to make sure the infection is completely gone and to prevent antibiotic resistance.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.

Take your medication on an empty stomach, either 1 hour before or 2 hours after meals. However, if it causes stomach upset, you can take it with food.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
When taking the liquid form of this medication, measure your dose carefully using the measuring device provided. If one is not included, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

Store the liquid form of this medication in the refrigerator.
Discard any unused liquid medication after 2 weeks.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take the medicine exactly as prescribed by your doctor, even if symptoms improve.
  • Complete the full course of treatment to prevent recurrence and antibiotic resistance.
  • Shake the oral solution well before each use.
  • Measure the dose accurately using the provided measuring device.
  • Store the reconstituted oral solution in the refrigerator and discard any unused portion after 14 days (or as directed by pharmacist/label).
  • Do not share your medication with others.

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg to 500 mg orally every 6 to 8 hours
Dose Range: 250 - 500 mg

Condition-Specific Dosing:

Streptococcal infections: 250 mg every 6-8 hours for 10 days
Pneumococcal infections: 250 mg to 500 mg every 6 hours until afebrile for at least 2 days
Staphylococcal infections (mild): 250 mg to 500 mg every 6 to 8 hours
Fusospirochetosis (Vincent's infection): 250 mg to 500 mg every 6 to 8 hours
Prophylaxis of rheumatic fever: 125 mg to 250 mg orally twice daily
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Pediatric Dosing

Neonatal: Not established (use caution, consult specific guidelines)
Infant: 25-50 mg/kg/day in 3-4 divided doses (max 3 g/day)
Child: 25-50 mg/kg/day in 3-4 divided doses (max 3 g/day); for streptococcal pharyngitis, 250 mg 2-3 times daily for 10 days for children >12 years or >27 kg
Adolescent: Adult dosing (250-500 mg every 6-8 hours) or 25-50 mg/kg/day in 3-4 divided doses (max 3 g/day)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 50 mL/min)
Moderate: No adjustment needed (CrCl 10-50 mL/min)
Severe: Reduce dose or extend interval (e.g., 250 mg every 8-12 hours for CrCl < 10 mL/min)
Dialysis: Administer dose after dialysis; supplemental dose may be needed

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment (primarily renally eliminated)

Pharmacology

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Mechanism of Action

Penicillin V potassium is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall. This binding prevents the cross-linking of peptidoglycan units, leading to the disruption of the cell wall and subsequent bacterial lysis.
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Pharmacokinetics

Absorption:

Bioavailability: 60-73%
Tmax: 0.5-1 hour
FoodEffect: Food may decrease the rate and extent of absorption, but generally not clinically significant enough to preclude administration with food if necessary to reduce GI upset.

Distribution:

Vd: 0.3-0.8 L/kg
ProteinBinding: 75-80%
CnssPenetration: Limited (poor penetration into CSF unless meninges are inflamed)

Elimination:

HalfLife: 0.5-1 hour
Clearance: Not available
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 25-50%
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: Within 1 hour of oral administration
DurationOfAction: Dependent on dosing interval (typically 6-8 hours)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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
In rare cases, allergic reactions can be fatal.

Diarrhea and Bowel Problems

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to a life-threatening bowel problem. If you experience any of the following symptoms, contact your doctor immediately:

Stomach pain
Cramps
Very loose, watery, or bloody stools
CDAD can occur during or several months after taking antibiotics.
Before treating diarrhea, consult your doctor.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Upset stomach or vomiting
Stomach pain or diarrhea
Black, hairy tongue

Reporting Side Effects

This list is not exhaustive, and you may experience other 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:

  • Signs of allergic reaction: rash, hives, itching, swelling (especially of face/throat), severe dizziness, trouble breathing. Seek immediate medical attention.
  • Severe or watery diarrhea, especially if bloody, which may occur even months after stopping the medication. This could be a sign of a serious infection (C. difficile).
  • New or worsening fever, sore throat, or other signs of infection (could indicate a new infection or treatment failure).
  • Unusual bruising or bleeding (rare, but possible blood dyscrasias).
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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.
Certain health conditions that may affect your ability to take this medication, such as:
+ Gastrointestinal (GI) tract problems, including an enlarged stomach or esophagus spasms
+ Severe illness
+ Diarrhea, upset stomach, or vomiting

This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:

Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

This information will help your doctor determine whether it is safe for you to take this medication with your existing medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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 using this drug for an extended period, 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 become pregnant, plan to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to carefully weigh the benefits and risks of using this medication during this time to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Neuromuscular hypersensitivity (e.g., twitching, convulsions) in severe cases, especially with renal impairment

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is generally supportive; hemodialysis may be useful in severe cases of renal impairment.

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 V potassium)
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Moderate Interactions

  • Oral contraceptives (theoretical reduction in efficacy, though clinical significance is debated and generally not considered a primary concern)
  • Warfarin (potential for enhanced anticoagulant effect, monitor INR)
  • Probenecid (increases and prolongs penicillin V potassium plasma levels by decreasing renal tubular secretion)

Monitoring

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Baseline Monitoring

Allergy history (especially to penicillins or cephalosporins)

Rationale: To prevent severe hypersensitivity reactions

Timing: Prior to initiation of therapy

Renal function (CrCl, BUN, creatinine)

Rationale: To guide dosing in patients with renal impairment, especially for prolonged therapy

Timing: Prior to initiation, if renal impairment is suspected or known

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Routine Monitoring

Signs and symptoms of infection resolution

Frequency: Daily

Target: Improvement in fever, pain, swelling, etc.

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure or resistant organism

Signs and symptoms of hypersensitivity reactions (rash, itching, dyspnea)

Frequency: Daily

Target: Absence of allergic reaction

Action Threshold: Any sign of allergic reaction requires immediate discontinuation

Gastrointestinal symptoms (nausea, vomiting, diarrhea)

Frequency: Daily

Target: Absence or mild, tolerable GI upset

Action Threshold: Severe or persistent diarrhea may indicate C. difficile infection

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Symptom Monitoring

  • Skin rash
  • Hives
  • Itching
  • Swelling of face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Wheezing
  • Severe diarrhea (especially if bloody or watery)
  • Abdominal pain or cramps
  • Nausea
  • Vomiting
  • Oral thrush (white patches in mouth)
  • Vaginal yeast infection (itching, discharge)

Special Patient Groups

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Pregnancy

Generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm, and there is no evidence of harm in pregnant women. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, no evidence of increased congenital anomalies.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Considered compatible with breastfeeding (L1). Penicillin V potassium is excreted in small amounts into breast milk. Monitor breastfed infant for diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: Low risk; potential for mild gastrointestinal upset or sensitization in the infant.
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Pediatric Use

Dosing is weight-based for younger children. Neonatal use requires caution and specific guidelines due to immature renal function. Oral solution formulation is suitable for pediatric administration. Ensure accurate dosing with appropriate measuring devices.

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Geriatric Use

No specific dose adjustment is typically needed based on age alone, but dose adjustments may be necessary for age-related decline in renal function. Elderly patients may be more susceptible to adverse effects, particularly gastrointestinal disturbances.

Clinical Information

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Clinical Pearls

  • Penicillin V potassium is the oral penicillin of choice for streptococcal pharyngitis due to its narrow spectrum and efficacy.
  • It is acid-stable, allowing for oral administration, unlike penicillin G.
  • Food can decrease absorption, but it's often given with food to minimize GI upset; advise patients to take consistently (either always with or always without food).
  • Always complete the full course of therapy, even if symptoms improve, to prevent antibiotic resistance and relapse.
  • Counsel patients on the signs of C. difficile-associated diarrhea (CDAD) and to seek medical attention if severe diarrhea occurs.
  • Refrigeration is required for the reconstituted oral solution to maintain potency and palatability.
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Alternative Therapies

  • Amoxicillin (for many similar bacterial infections)
  • Cephalexin (a first-generation cephalosporin, often used for skin/soft tissue infections)
  • Azithromycin or Clarithromycin (macrolides, for penicillin-allergic patients or specific indications)
  • Clindamycin (for anaerobic infections or specific Gram-positive infections, including some resistant strains)
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Cost & Coverage

Average Cost: Varies widely, typically low per 100ml oral solution
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 for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.