Penicillin Vk 125mg/5ml Soln 200ml

Manufacturer BIOCRAFT 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
Beta-lactam antibiotic; Penicillin
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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 V potassium is an antibiotic used to treat various bacterial infections, such as strep throat, ear infections, and skin infections. It works by killing the bacteria that cause these infections. It's important to take all of the medicine as prescribed, even if you start feeling better, to ensure the infection is fully cleared 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 medication 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.

Measuring Your Dose

If you are taking a liquid form of this medication, make sure to measure your dose accurately. 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 liquid form of this medication in the refrigerator.
Discard any unused portion 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 the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.

What to Do If You Miss 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 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 on an empty stomach (1 hour before or 2 hours after meals) for best absorption.
  • Complete the full course of medication as prescribed, even if symptoms improve.
  • Do not share medication with others.
  • Store at room temperature, away from moisture and heat. Refrigerate oral solution after reconstitution and discard after 14 days.

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg to 500 mg (400,000 to 800,000 units) orally every 6 to 8 hours
Dose Range: 250 - 500 mg

Condition-Specific Dosing:

Streptococcal infections (mild to moderate): 250 mg every 6 to 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 to moderate): 250 mg to 500 mg every 6 to 8 hours
Fusospirochetosis (Vincent's infection) of the oropharynx: 250 mg every 6 to 8 hours
Prophylaxis of rheumatic fever: 125 mg to 250 mg orally twice daily continuously
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Pediatric Dosing

Neonatal: Not established (use with caution, consult specialist)
Infant: 15-50 mg/kg/day (25,000-90,000 units/kg/day) orally divided every 6-8 hours
Child: 15-50 mg/kg/day (25,000-90,000 units/kg/day) orally divided every 6-8 hours; maximum 3 g/day. For streptococcal infections: 250 mg (400,000 units) every 6 to 8 hours for 10 days.
Adolescent: Same as adult dosing, typically 250 mg to 500 mg every 6 to 8 hours
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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: Administer normal dose every 8-12 hours (CrCl <10 mL/min)
Dialysis: Administer normal dose after dialysis on dialysis days; supplemental dose may be needed

Hepatic Impairment:

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

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 chains, which are essential components of the bacterial cell wall, leading to osmotic instability and cell lysis.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60-73%
Tmax: 30-60 minutes
FoodEffect: Food (especially fatty meals) can decrease the rate and extent of absorption; administer 1 hour before or 2 hours after meals for optimal absorption.

Distribution:

Vd: Approximately 0.3-0.4 L/kg
ProteinBinding: Approximately 80%
CnssPenetration: Limited (poor penetration into CSF unless meninges are inflamed)

Elimination:

HalfLife: 0.5-1 hour
Clearance: Approximately 200-300 mL/min (renal clearance)
ExcretionRoute: Renal (primarily via tubular secretion and glomerular filtration)
Unchanged: Approximately 25-50% of an oral dose is excreted unchanged in urine within 6 hours
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: Within 1 hour (plasma concentration)
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 C. diff-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 for guidance.

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 of face/lips/tongue/throat, difficulty breathing.
  • Severe or persistent diarrhea, especially if bloody or watery, which could indicate a serious intestinal infection (Clostridioides difficile-associated diarrhea).
  • Unusual bruising or bleeding.
  • Yellowing of skin or eyes (jaundice).
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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.
Certain health conditions, including:
+ Gastrointestinal (GI) tract problems, such as 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 prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

This information will help your doctor determine whether it is safe for you to take this medication 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

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 any concerns or questions you have 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 pregnant, planning 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 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 hyperexcitability (e.g., twitching, tremors, hyperreflexia)
  • Seizures (especially in patients with renal impairment or high doses)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is largely supportive. Hemodialysis may be useful in removing penicillin V from the circulation in patients with severe 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

  • Probenecid (decreases renal tubular secretion of penicillin, leading to increased and prolonged penicillin levels)
  • Oral Contraceptives (theoretical risk of reduced efficacy, though clinical evidence is limited and controversial)
  • Warfarin (may enhance anticoagulant effect, monitor INR)
  • Live bacterial vaccines (e.g., typhoid vaccine; antibiotics may reduce therapeutic effect)

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

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Routine Monitoring

Signs and symptoms of infection resolution

Frequency: Daily

Target: Improvement in fever, pain, inflammation

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

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

Frequency: Daily, especially during initial doses

Target: Absence of allergic symptoms

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

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

Renal function (BUN, creatinine)

Frequency: Periodically, especially in patients with pre-existing renal impairment or on prolonged high-dose therapy

Target: Within normal limits or stable baseline

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

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Symptom Monitoring

  • Rash
  • Hives
  • Itching
  • Swelling (face, lips, tongue, throat)
  • Difficulty breathing or swallowing
  • Wheezing
  • Severe diarrhea
  • Abdominal cramps
  • Fever
  • Sore throat
  • Unusual bleeding or bruising
  • Yellowing of skin or eyes (jaundice)
  • Dark urine

Special Patient Groups

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Pregnancy

Penicillin V potassium is generally considered safe for use during pregnancy (Pregnancy Category B). Animal reproduction studies have not demonstrated a fetal risk, and there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, generally considered safe.
Second Trimester: Low risk, generally considered safe.
Third Trimester: Low risk, generally considered safe.
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Lactation

Penicillin V potassium is excreted in small amounts into breast milk. It is generally considered compatible with breastfeeding (Lactation Risk L1). 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

Dosing is weight-based for infants and children. Neonatal dosing is not well-established and should be used with caution under specialist guidance. Close monitoring for adverse effects, especially GI upset and allergic reactions, is important.

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Geriatric Use

No specific dose adjustment is typically required based on age alone, but elderly patients are more likely to have decreased renal function, which may necessitate dose adjustment based on creatinine clearance. Monitor for adverse effects and ensure adequate hydration.

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.
  • Advise patients to take the medication on an empty stomach for optimal absorption, though it can be taken with food if GI upset occurs.
  • Emphasize the importance of completing the entire course of therapy to prevent relapse and development of antibiotic resistance.
  • Counsel patients on signs of allergic reaction and to seek immediate medical attention if they occur.
  • Oral solution must be refrigerated after reconstitution and discarded after 14 days.
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Alternative Therapies

  • Amoxicillin (for broader spectrum or better absorption)
  • Cephalexin (first-generation cephalosporin, for penicillin-allergic patients without severe allergy)
  • Clindamycin (for penicillin-allergic patients, especially for skin/soft tissue infections)
  • Azithromycin (macrolide, for penicillin-allergic patients, especially for respiratory infections)
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Cost & Coverage

Average Cost: Varies widely, generally low per 200ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 details about the medication taken, the amount, and the time it happened.