Penicillin VK

Although the incidence of reactions to oral penicillins has been reported with much less frequency than following parenteral therapy, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been reported with oral penicillin.

The most common reactions to oral penicillin are nausea, vomiting, epigastric distress, diarrhea, and black hairy tongue. The hypersensitivity reactions reported are skin eruptions (maculopapular to exfoliative dermatitis), urticaria and other serum-sicknesslike reactions, laryngeal edema, and anaphylaxis.

Fever and eosinophilia may frequently be the only reaction observed. Hemolytic anemia, leukopenia, thrombocytopenia, neuropathy, and nephropathy are infrequent reactions and usually associated with high doses of parenteral penicillin.

Penicillin VK may be found in some form under the following brand names:

• PC Pen VK

• Truxcillin-VK

• V-Cil-K

Serious side effects have been reported with penicillin V potassium including:

• hypersensitivity (severe allergic reaction). This type of reaction may be serious and possibly fatal. These reactions are more likely to occur in those with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Tell your healthcare provider right away if you start to develop signs or symptoms of a hypersensitivity reaction, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • fainting
  • rash

• diarrhea. Diarrhea is a common problem caused by antibiotics, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, contact your doctor, as this may be a sign of an infection of the bowels.
• superinfection. Penicillin V potassium should not be used for extended periods. Prolonged use can lead to the growth of dangerous organisms that are resistant to penicillin V potassium. Take this medication for the duration prescribed by your doctor.

Do not take penicillin V potassium if you are allergic to any of its ingredients.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Penicillin V potassium has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Penicillin VK, a choice should be made whether to stop nursing or to stop use of penicillin V potassium. The importance of the drug to the mother should be considered.

Take penicillin V potassium exactly as prescribed.

This medication comes in tablet and oral (by mouth) solution forms and may be taken 2 to 4 times a day, with or without food.

Continue to take this medication even if you feel well. Do not stop taking penicillin V potassium without talking to your doctor.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of penicillin V potassium at the same time.

If you take too much penicillin V potassium, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store penicillin V potassium tablets at room temperature between 20° to 25°C (68° to 77°F).
• Store penicillin V potassium solution (after mixing with water) in the refrigerator. Discard any unused solution (not tablets) after 14 days.
• Keep the bottle for the solution tightly closed.
• Keep this and all medicines out of the reach of children.

Applies to penicillin v potassium: capsule, powder for solution, powder for suspension, solution, suspension, syrup, tablet, tablet for suspension, tablet chewable, tablet extended release

Along with its needed effects, penicillin v potassium (the active ingredient contained in Penicillin VK) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking penicillin v potassium and get emergency help immediately if any of the following effects occur:

• Fast or irregular breathing
• fever
• joint pain
• lightheadedness or fainting (sudden)
• puffiness or swelling around the face
• red, scaly skin
• shortness of breath
• skin rash, hives, itching

Check with your doctor immediately if any of the following side effects occur while taking penicillin v potassium:

• Abdominal or stomach cramps and pain (severe)
• abdominal tenderness
• convulsions (seizures)
• decreased amount of urine
• diarrhea (watery and severe), which may also be bloody
• mental depression
• nausea and vomiting
• pain at place of injection
• sore throat and fever
• unusual bleeding or bruising
• yellow eyes or skin

• Agitation or combativeness
• anxiety
• confusion
• fear of impending death
• feeling, hearing, or seeing things that are not real

Some side effects of penicillin v potassium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea (mild)
• headache
• sore mouth or tongue
• vaginal itching and discharge
• white patches in the mouth and/or on the tongue

Applies to penicillin v potassium: oral powder for reconstitution, oral tablet

General

The most common side effects are gastrointestinal effects and hypersensitivity reactions. In general, hypersensitivity reactions have been reported much less frequently after oral than after parenteral therapy; however, all degrees of hypersensitivity (including fatal anaphylaxis) have been reported with oral penicillin.[Ref]

Gastrointestinal

Onset of Clostridium difficile-associated diarrhea has been reported during or after antibacterial therapy.[Ref]

Common (1% to 10%): Nausea, vomiting, abdominal pain, diarrhea
Rare (0.01% to 0.1%): Sore mouth, black hairy tongue (discoloration of tongue), pseudomembranous colitis
Frequency not reported: Epigastric distress, stomatitis, glossitis, soft stools, pancreatitis, intestinal necrosis, blood in the stool[Ref]

Hypersensitivity

Hypersensitivity reactions with penicillin were more common and more serious with IV therapy, but have also been reported with oral therapy. An initial sensitizing exposure is required to stimulate the production of antigen-specific IgE before clinical manifestations of hypersensitivity were seen on the second exposure. There were numerous "hidden" environmental or occupational exposures to penicillin including in utero exposure, breast milk exposure, and occupational exposure.[Ref]

Common (1% to 10%): Allergic reactions (usually manifested as skin reactions)
Rare (0.01% to 0.1%): Severe allergic reactions (causing angioedema, laryngeal edema, anaphylaxis [severe or fatal])
Frequency not reported: Serum sickness-like reactions (chills, fever, edema, arthralgia, prostration), hypersensitivity/allergic reactions (including skin eruptions [maculopapular to exfoliative dermatitis], pruritus, urticaria, angioneurotic edema, erythema multiforme, joint pain, fever, eosinophilia, hypersensitivity myocarditis, hemolytic anemia, interstitial nephritis, anaphylactic shock [sometimes fatal] with collapse, anaphylactoid reactions [asthma, purpura, gastrointestinal symptoms])[Ref]

Dermatologic

Common (1% to 10%): Rash (urticarial, erythematous, morbilliform), pruritus
Rare (0.01% to 0.1%): Exfoliative dermatitis
Frequency not reported: Peeling, mucosal ulceration, urticaria[Ref]

Hematologic

Very rare (less than 0.01%): Changes in blood counts, hemolytic anemia, leukopenia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis
Frequency not reported: Coagulation disorders (including prolonged bleeding time, platelet dysfunction), anemia, lymphadenopathy[Ref]

Hepatic

Very rare (less than 0.01%): Hepatitis, cholestatic jaundice
Frequency not reported: Increased AST, reversible hepatotoxicity, jaundice, prolonged cholestasis[Ref]

Renal

Nephropathy has typically been associated with high doses of parenteral penicillin.[Ref]

Very rare (less than 0.01%): Interstitial nephritis
Frequency not reported: Nephropathy[Ref]

Nervous system

Frequency not reported: Central nervous system (CNS) toxicity (including convulsions), paresthesia, neuropathy, myoclonus, seizures, decreased mentation, abnormal taste perception, tinnitus, neurologic reactions, aseptic meningitis[Ref]

CNS toxicity has been reported, especially with high doses or in severe renal dysfunction. Paresthesia has been reported with prolonged use. Neuropathy has typically been associated with high doses of parenteral penicillin.

Severe neurologic reactions were most often seen with penicillin doses of 18 to 80 million units daily. These reactions frequently abated after discontinuation of penicillin. In several cases, penicillin was restarted at a lower dose with no further sequelae. In 1 review, the authors found that cerebral spinal fluid (CSF) penicillin levels were higher in patients with seizures than in those without. CSF penicillin levels ranged from 12 to 61 units/mL in the seizure group with the highest CSF levels, compared to 7.8 units/mL in the group without seizures.[Ref]

Other

Frequency not reported: Overgrowth of nonsusceptible organisms (e.g., Candida), fatigue, asthenia, pain, aggravation of existing disorders[Ref]

Genitourinary

Frequency not reported: Vulvovaginitis[Ref]

Psychiatric

Frequency not reported: Auditory hallucinations, visual hallucinations

Respiratory

Frequency not reported: Hypoxia, apnea, dyspnea

Some side effects of Penicillin VK may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.