Pfizerpen

Aqueous penicillin G (parenteral) is indicated in the therapy of severe infections caused by penicillin G-susceptible microorganisms when rapid and high penicillin levels are required in the conditions listed below. Therapy should be guided by bacteriological studies (including susceptibility tests) and by clinical response.

The following infections will usually respond to adequate dosage of aqueous penicillin G (parenteral):

Streptococcal infections.

NOTE: Streptococci in groups A, C, H, G, L, and M are very sensitive to penicillin G. Some group D organisms are sensitive to the high serum levels obtained with aqueous penicillin G.

Aqueous penicillin G (parenteral) is the penicillin dosage form of choice for bacteremia, empyema, severe pneumonia, pericarditis, endocarditis, meningitis, and other severe infections caused by sensitive strains of the gram-positive species listed above.

Pneumococcal infections.

Staphylococcal infections-penicillin G sensitive.

Other infections

Anthrax.

Actinomycosis.

Clostridial infections (including tetanus).

Diphtheria (to prevent carrier state).

Erysipeloid (Erysipelothrix insidiosa) endocarditis.

Fusospirochetal infections-severe infections of the oropharynx (Vincent's), lower respiratory tract and genital area due to Fusobacterium fusiformisans spirochetes.

Gram-negative bacillary infections (bacteremias)-(E. coli, A. aerogenes, A. faecalis, Salmonella, Shigella and P. mirabilis).

Listeria infections (Listeria monocytogenes).

Meningitis and endocarditis.

Pasteurella infections (Pasteurella multocida).

Bacteremia and meningitis.

Rat-bite fever (Spirillum minus or Streptobacillus moniliformis).

Gonorrheal endocarditis and arthritis (N. gonorrhoeae).

Syphilis (T. pallidum) including congenital syphilis.

Meningococcic meningitis.

Although no controlled clinical efficacy studies have been conducted, aqueous crystalline penicillin G for injection and penicillin G procaine suspension have been suggested by the American Heart Association and the American Dental Association for use as part of a combined parenteral-oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic, or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen.

NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1

To reduce the development of drug-resistant bacteria and maintain effectiveness of Pfizerpen (penicillin g potassium) and other antibacterial drugs, Pfizerpen (penicillin g potassium) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillin, cephalosporins, or other allergens. If an allergic reaction occurs, the drug should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management including intubation, should also be administered as indicated.

• Defitelio

© Pfizerpen Patient Information is supplied by Cerner Multum, Inc. and Pfizerpen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Pfizerpen is a prescription medication used to treat bacterial infections that affect the blood, heart, lungs, joints, and genital areas.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Pfizerpen including:

• hypersensitivity (severe allergic reaction). Signs 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
  • new or increasing irregularities in your heart rate
• superinfection. Pfizerpen should not be used for extended periods. Prolonged use can lead to the growth of dangerous organisms that are resistant or unresponsive to this medication. Take Pfizerpen for the duration prescribed by your doctor.

Do not take Pfizerpen if you are allergic to any of its ingredients.

TakePfizerpen exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Pfizerpen dose your doctor recommends will be based on:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range for Pfizerpen is 300,000 to 20,000,000 units daily.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking this medication and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Penicillins may cause diarrhea in some patients.

• Check with your doctor if severe diarrhea occurs. Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor. Diarrhea medicines may make your diarrhea worse or make it last longer.
• For mild diarrhea, diarrhea medicine containing kaolin or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your diarrhea worse or make it last longer.
• If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking ampicillin, amoxicillin, or penicillin V. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking any of these penicillins. If you have any questions about this, check with your health care professional.

For diabetic patients:

• Penicillins may cause false test results with some urine sugar tests. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

NDC 0049-0520-22
contains 10 of NDC 0049-0520-23
Buffered

Pfizerpen®
(penicillin G potassium, USP)
For Injection

5,000,000
Units* per vial
(Five million
units* per vial)

Intramuscular or Intravenous Use

10 Vials

Rx ONLY

NOVAPLUS®

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
• Very bad dizziness or passing out.
• Fever.
• Feeling very tired or weak.
• Yellow skin or eyes.
• Muscle or joint pain.
• Stomach pain.
• Any unexplained bruising or bleeding.
• Twitching.
• Seizures.
• Not able to pass urine or change in how much urine is passed.
• It is common to have diarrhea when taking this drug. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this drug or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.