Penicillin Vk 250mg/5ml Soln 200ml

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
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.
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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 portion of the 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 by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a drug take-back program 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 scheduled 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 medication exactly as prescribed by your doctor, even if you start feeling better. Do not skip doses or stop taking it early, as this can lead to antibiotic resistance.
  • Take on an empty stomach (1 hour before or 2 hours after meals) for best absorption, but if it causes stomach upset, you can take it with food.
  • Shake the oral suspension well before each use.
  • Use a measuring spoon or cup for the liquid form, not a household spoon, to ensure accurate dosing.
  • Store the liquid medication in the refrigerator and discard any unused portion after 14 days (or as directed by pharmacist).

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 Pharyngitis: 250 mg orally every 6 to 8 hours for 10 days, or 500 mg orally every 12 hours for 10 days
Pneumococcal Infections (mild to moderate): 250 mg to 500 mg orally every 6 hours
Staphylococcal Infections (mild to moderate): 250 mg to 500 mg orally every 6 to 8 hours
Fusospirochetosis (Vincent's infection): 250 mg to 500 mg orally every 6 to 8 hours
Rheumatic Fever Prophylaxis: 125 mg to 250 mg orally twice daily
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Pediatric Dosing

Neonatal: Not established (use caution, consult specialist)
Infant: 15 mg/kg/day to 50 mg/kg/day orally divided every 6 to 8 hours (max 500 mg/dose)
Child: 25 mg/kg/day to 50 mg/kg/day orally divided every 6 to 8 hours (max 500 mg/dose); for Streptococcal Pharyngitis: 250 mg orally 2-3 times daily for 10 days (for children >27 kg or 12 years), or 125 mg orally 2-3 times daily for 10 days (for children <27 kg or <12 years)
Adolescent: Same as adult dosing for specific indications (e.g., 250 mg to 500 mg orally every 6 to 8 hours)
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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), but monitor for accumulation with higher doses
Severe: Reduce dose or extend interval (CrCl <10 mL/min): 250 mg every 8-12 hours or 250 mg every 6 hours for severe infections, but extend interval to every 12 hours
Dialysis: Hemodialysis: Administer dose after dialysis. Peritoneal Dialysis: No supplemental dose 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 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. This binding prevents the cross-linking of peptidoglycan chains, leading to a defective cell wall, increased osmotic pressure, and ultimately bacterial cell lysis and death (bactericidal action).
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Pharmacokinetics

Absorption:

Bioavailability: 60-75%
Tmax: 0.5-1 hour
FoodEffect: Food may decrease the rate and extent of absorption, but it is generally recommended to take on an empty stomach (1 hour before or 2 hours after meals) for optimal absorption, though it can be taken with food if GI upset occurs.

Distribution:

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

Elimination:

HalfLife: 0.5-1 hour (prolonged in renal impairment)
Clearance: Primarily renal
ExcretionRoute: Renal (tubular secretion and glomerular filtration)
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 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, 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 if they persist or bother you, 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 or swallowing, wheezing. Seek immediate medical attention.
  • Severe or persistent diarrhea, especially if it's watery or bloody, with or without fever and stomach cramps. This could be a sign of a serious bowel infection (Clostridioides difficile-associated diarrhea).
  • New or worsening symptoms of infection after starting the medication.
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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 symptoms you experienced.
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 and medications with your doctor.

To ensure your safety, please 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
* All your health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you 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 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 with your doctor.

Do not take this medication for longer than prescribed, as this may increase the risk of developing 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 to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Electrolyte imbalance (e.g., hyperkalemia due to potassium salt)
  • Neuromuscular excitability or seizures (especially in patients with severe renal impairment)

What to Do:

Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention immediately. 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 (increased methotrexate levels and toxicity due to competition for renal tubular secretion)
  • Live bacterial vaccines (e.g., typhoid vaccine, BCG): Penicillin V may reduce the therapeutic effect of these vaccines.
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Moderate Interactions

  • Tetracyclines (may antagonize the bactericidal effect of penicillin V)
  • Probenecid (decreases renal tubular secretion of penicillin V, leading to increased and prolonged serum levels)
  • Oral contraceptives (theoretical risk of reduced efficacy, though clinical significance is debated)
  • Warfarin (potential for increased INR/bleeding risk, though rare and mechanism unclear; monitor INR)
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Minor Interactions

  • Allopurinol (increased risk of rash with ampicillin, less clear for penicillin V)

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 (BUN, creatinine)

Rationale: To guide dosing in patients with renal impairment and monitor for potential nephrotoxicity (rare)

Timing: Prior to initiation, especially in patients with pre-existing renal disease

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Routine Monitoring

Clinical response to therapy (e.g., fever, symptoms of infection)

Frequency: Daily

Target: Resolution of symptoms

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

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

Frequency: Daily, especially during the first few days of therapy

Target: Absence of allergic symptoms

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

Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)

Frequency: Daily

Target: Absence or mildness of symptoms

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

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Symptom Monitoring

  • Rash
  • Hives
  • Itching
  • Swelling (face, lips, tongue, throat)
  • Difficulty breathing or swallowing
  • Wheezing
  • Severe diarrhea (especially if bloody or watery)
  • Abdominal cramps
  • Nausea
  • Vomiting
  • Fever

Special Patient Groups

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Pregnancy

Penicillin V is generally considered safe for use during pregnancy. It is a Category B drug, meaning animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women, or animal studies have shown an adverse effect but human studies have not.

Trimester-Specific Risks:

First Trimester: Low risk, commonly used.
Second Trimester: Low risk, commonly used.
Third Trimester: Low risk, commonly used.
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Lactation

Penicillin V is considered compatible with breastfeeding (L1 - Safest). It is excreted into breast milk in small amounts, but adverse effects in breastfed infants are unlikely. Monitor for diarrhea, candidiasis, or allergic reactions in the infant.

Infant Risk: Low risk
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Pediatric Use

Dosing must be carefully calculated based on weight and age. Generally well-tolerated. Monitor for gastrointestinal upset and allergic reactions. Neonatal use is generally not recommended due to immature renal function and potential for accumulation; alternative penicillins or antibiotics are usually preferred.

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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 decreases in renal function. Monitor renal function and for potential adverse effects more closely due to increased sensitivity and polypharmacy.

Clinical Information

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Clinical Pearls

  • Penicillin V is the oral penicillin of choice for most susceptible infections, particularly streptococcal pharyngitis.
  • It is acid-stable, allowing for oral administration, unlike penicillin G.
  • Advise patients to complete the full course of therapy to prevent resistance and ensure eradication of infection.
  • Counsel patients on the importance of taking the medication on an empty stomach for optimal absorption, but if GI upset occurs, it can be taken with food.
  • Always inquire about penicillin allergies before administration, as severe hypersensitivity reactions can occur.
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Alternative Therapies

  • Amoxicillin (for broader spectrum or better absorption)
  • Cephalexin (a first-generation cephalosporin, often used for skin infections or in penicillin-allergic patients with non-severe allergy)
  • Azithromycin or Clindamycin (for penicillin-allergic patients, depending on the infection and susceptibility)
  • Erythromycin (macrolide, for penicillin-allergic patients)
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Cost & Coverage

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

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. 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 this medication, don't hesitate to reach out to 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 occurred.