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Penicillin V

Penicillin V potassium · phenoxymethylpenicillin

An oral penicillin for susceptible mild-to-moderate bacterial infections and selected prophylaxis. Current CDC strep-throat courses are separated from label regimens; historical 1984 endocarditis directions reproduced in the label are not offered as current clinical dosing.

Therapeutic class
Beta-lactam antibacterial · oral penicillin
Representative product
Penicillin V potassium · 500 mg tablet
Reference focus
Oral tablets and solutions · current strep guidance
Essential safety

Confirm the infection and penicillin-allergy history.

Serious anaphylaxis can occur with oral therapy. Stop and seek emergency care for breathing difficulty, swelling or collapse. Persistent watery/bloody diarrhea can indicate C. difficile even after treatment. Severe invasive disease needs another route/therapy; penicillin V is not an injectable penicillin substitute.

Warnings and precautions
01

Indications

Treat susceptible bacterial infections; do not use for viral illness.

Labeled oral indications

Mild-to-moderately severe susceptible streptococcal infections without bacteremia, respiratory pneumococcal infections, proven penicillin-sensitive mild staphylococcal skin/soft-tissue infections and fusospirochetal oropharyngeal infection. Culture/susceptibility and local epidemiology guide selection; many staphylococci produce penicillinase. Acute severe pneumonia, empyema, bacteremia, pericarditis, meningitis or arthritis should not be treated with penicillin V.

Prophylaxis and outdated label context

Label secondary prophylaxis after rheumatic fever/chorea remains a distinct clinical indication. Its endocarditis prophylaxis cites a 1984 AHA/ADA statement and lists an old oral penicillinV algorithm. The current AHA 2024 card instead restricts dental prophylaxis to selected highest-risk cardiac conditions and lists a single preprocedure amoxicillin regimen, not penicillinV. Do not execute the old label endocarditis dose; verify contemporary cardiology/dental guidance.

02

Dosage and administration

Select infection-specific milligrams, interval and course.

Current CDC confirmed GAS pharyngitis

Children: 250 mg twice or three times daily for 10 days. Adolescents/adults: 250 mg four times daily or 500 mg twice daily for 10 days. Confirm GAS by positive rapid antigen test or culture; do not treat viral pharyngitis. CDC recommends culture confirmation after a negative rapid test in symptomatic children older than 3. This guideline-specific regimen differs from some older label interval wording.

Selected label · age ≥ 12 infection regimens

Streptococcal upper-respiratory/scarlet-fever/erysipelas: 125–250 mg every 6–8 hours for 10 days. Pneumococcal respiratory infection: 250–500 mg every 6 hours until afebrile at least 2 days. Susceptible mild staphylococcal skin/soft-tissue or Vincent’s oropharyngeal infection: 250–500 mg every 6–8 hours, duration/response clinician-selected; necessary dental care accompanies gum infection. The label supplies no universal resistance-independent empiric course.

Secondary prophylaxis and administration

Label recurrent rheumatic fever/chorea prevention: 125–250 mg twice daily on a continuing basis, with patient-specific duration/eligibility. May take with meals, although empty-stomach blood levels are somewhat higher. Complete the prescribed course and interval; do not share or save antibiotics. No new automatic repeat-course or home IV regimen is supplied.

Liquid preparation and organ considerations

125 mg/5 mL (25 mg/mL) and 250 mg/5 mL (50 mg/mL); verify before calculating volume. Selected 100 mL bottle requires 75 mL water,200 mL bottle 150 mL, added in stages with vigorous shaking by the dispenser. Refrigerate after mixing/discard 14 days. Renal dysfunction delays excretion; the selected U.S. label supplies no numeric renal/hepatic algorithm, so individualized clinical assessment is required rather than a guessed percentage reduction.

03

Safety

Allergy and antibiotic-associated colitis can be serious.

Warnings and precautions

Obtain penicillin/cephalosporin/other-allergen history before therapy. Stop for allergy; anaphylaxis requires emergency epinephrine/airway care. Consider C. difficile for significant diarrhea, including > 2 months after antibiotics, and obtain directed assessment rather than suppress symptoms independently. Severe illness, vomiting or GI dysfunction can prevent therapeutic oral absorption. Prolonged use may select resistant organisms/fungi. Review potassium content in renal disease or potassium-retaining therapy.

Contraindications

Previous hypersensitivity reaction to any penicillin. Susceptibility, severity and oral-absorption limitations require separate treatment selection; lack of a contraindication does not make penicillin V suitable for invasive infection.

Boxed warning status

Selected U.S. label has no boxed warning. Its prominent anaphylaxis and C. difficile warnings remain clinically significant.

Adverse reactions

Nausea/vomiting, epigastric discomfort, diarrhea and black hairy tongue are reported. Allergy ranges from rash/urticaria/serum-sickness-like reactions to laryngeal edema and fatal anaphylaxis. Some severe hematologic, neurologic or renal reports mainly concern high-dose parenteral penicillin and are not incidence estimates for this oral product. Excess/accidental dosing requires medical/Poison Help review; no “safe overdose” threshold is given.

04

Drug interactions

Review renal-clearance, anticoagulant and potassium interactions.

Clinically relevant interactions

Comparable UK primary SmPC: probenecid reduces penicillinV excretion; penicillins can increase methotrexate toxicity. Review warfarin/INR control, oral typhoid-vaccine timing, and potassium-sparing drugs because hyperkalemia is possible. Nonenzymatic urine-glucose tests may be falsely positive. These are interaction assessments, not imported UK dose instructions or a blanket claim that ordinary noninducing antibiotics disable hormonal contraception.

05

Use in specific populations

Use diagnosis-specific pediatric guidance and assess organ function.

Pediatric and older patients

U.S. label usual infection regimens are written for adults/children ≥ 12. Current CDC GAS regimen supplies a separate pediatric course, not a universal dose for every infant infection. Excretion is delayed in neonates/young infants and renal dysfunction. Older patients need organ-function/co-therapy assessment; no numeric age-only adjustment is supplied.

Pregnancy and lactation

The selected U.S. label gives no dedicated modern reproductive-risk summary. Comparable manufacturer UK SmPC supports pregnancy use when clinically needed with caution; trace milk exposure can alter infant flora or cause allergy/sensitization. Discuss indication and infant symptoms rather than claim no risk or copy parenteral-penicillin advice.

Renal and hepatic considerations

Renal impairment can substantially delay excretion. Evaluate kidney function, potassium load, infection response and tolerability; selected U.S. label does not define an eGFR-based adjustment or liver-dose formula. Potassium per tablet: 250 mg contains 0.71 mEq;500 mg 1.43 mEq. This is clinically relevant ingredient content, not the antibacterial dose.

06

Clinical pharmacology

Acid-stable oral penicillin inhibits bacterial cell-wall synthesis.

Mechanism and disposition

Bactericidal during active multiplication through cell-wall synthesis inhibition; penicillinase-producing organisms resist. Oral absorption is incomplete; U.S. label protein binding about 80% with rapid renal elimination and delayed excretion in renal dysfunction. Comparable UK SmPC reports an approximately 30-minute half-life, prolonged in renal failure. No serum target or CNS-infection regimen is inferred.

07

Monitoring and counseling

Follow infection response, allergy, diarrhea and adherence.

Monitoring priorities

Check microbiologic diagnosis/susceptibility when indicated, clinical response and oral intake. Assess allergy, significant diarrhea/superinfection and renal/potassium context. Obtain cultures/labs when clinically warranted; the label’s blanket post-strep culture language is older provenance and should be reconciled with current diagnosis/follow-up guidance rather than presented as a mandatory universal test.

Patient counseling

Take exactly as prescribed and finish the indicated course; never treat a viral cold or share leftovers. Verify liquid concentration and measured dose, keep mixed solution refrigerated and discard 14 days. Breathing difficulty/swelling/collapse needs emergency care; watery/bloody diarrhea or fever/cramps warrants prompt review even after finishing. Report poor oral intake/vomiting or lack of improvement.

08

Product identification

Verify oral ingredient, strength and freshly mixed concentration.

Representative product

Selected 500 mg mottled white/off-white oval scored tablet: 9/3 across one face,1174 reverse; NDC 62135-099-40,40-tablet bottle. Verify actual package; not evidence of stock.

Dosage forms and strengths

Tablets 250 and 500 mg, corresponding 400,000 and 800,000 penicillinV units. Oral solutions 125 or 250 mg per 5 mL after reconstitution. Selected FDA ANDA 060711 tablets and ANDA 060456 solutions list Prescription products. Ingredient-potassium content and microbiological units are not alternative routes or mg-for-mg substitutes for penicillin G preparations.

Storage and handling

Tablets/dry powder 20–25°C, tightly closed containers; dispense tablets with required child-resistant closure. Add water only at dispensing. Mixed solution must be refrigerated and discarded after 14 days. Keep children away and follow actual bottle expiry and concentration.

09

References

Original sources for the clinical and product information.

  1. DailyMed / National Library of MedicineChartwell · current tablets and oral solution full label

    Full public manufacturer label and patient instructions; SPL version 2, effective 20260723. Product-specific directions reviewed October 1, 2026.

  2. Centers for Disease Control and PreventionCDC · current group A streptococcal pharyngitis guidance

    Full public current page retrieved/read; diagnosis, treatment, complete penicillin V dose and duration sections.

  3. Manufacturer-approved UK SmPC / eMCBrown & Burk · UK phenoxymethylpenicillin SmPC

    Current public manufacturer SmPC, text revision September9,2024; full relevant4.5,4.6,5.2 read. Comparable primary safety/PK reference where U.S. label lacks detail; no UK dose substituted for U.S. regimens.

  4. American Heart AssociationAHA · 2024 infective-endocarditis prevention wallet card

    Full two-page public primary PDF read through webtool;2024version0824. Current prophylaxis differs from1984statement reproduced in current penicillinVlabel.

  5. U.S. Food and Drug AdministrationFDA · ANDA060711 current product record

    Current official FDA status checked October 1, 2026; status does not establish stock.

  6. U.S. Food and Drug AdministrationFDA · ANDA060456 current product record

    Current official FDA status checked October 1, 2026; status does not establish stock.

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