BICILLIN CR 600000 [iU]/2mL
penicillin G benzathine and penicillin G procaine · INJECTION, SUSPENSION · Pfizer Laboratories Div Pfizer Inc
BICILLIN CR is a injection, suspension containing penicillin g benzathine and penicillin g procaine at 600000 [iU]/2mL, taken intramuscular. Manufactured by Pfizer Laboratories Div Pfizer Inc.
Key Facts
- Brand Name
- BICILLIN CR
- Generic Name
- penicillin G benzathine and penicillin G procaine
- NDC Code (Product)
60793-601- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Strength
- 600000 [iU]/2mL
- Dosage Form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- NDA050138
- Marketing Start
- 05/18/1953
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin C-R and other antibacterial drugs, Bicillin C-R should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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. This drug is indicated in the treatment of moderately severe infections due to penicillin-G-susceptible microorganisms that are susceptible to serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response. Bicillin C-R is indicated in the treatment of the following in adults and pediatric patients: Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci. NOTE: Streptococci in Groups A, C, G, H, L, and M are very sensitive to penicillin G. Ot…
Dosage & Administration
DOSAGE AND ADMINISTRATION Streptococcal Infections Group A Infections of the upper-respiratory tract, skin and soft-tissue infections, scarlet fever, and erysipelas. The following doses are recommended: Adults and pediatric patients over 60 lbs. in weight: 2,400,000 units. Pediatric patients from 30 to 60 lbs.: 900,000 units to 1,200,000 units. Pediatric patients under 30 lbs.: 600,000 units. NOTE: Treatment with the recommended dosage is usually given at a single session using multiple IM sites when indicated. An alternative dosage schedule may be used, giving one-half (1/2) the total dose on day 1 and one-half (1/2) on day 3. This will also insure the penicillinemia required over a 10-day period; however, this alternate schedule should be used only when the physician can be assured of the patient's cooperation. Pneumococcal Infections (except pneumococcal meningitis) 600,000 units in pediatric patients and 1,200,000 units in adults, repeated every 2 or 3 days until the temperature is normal for 48 hours. Other forms of penicillin may be necessary for severe cases. Method of Administration Bicillin C-R is intended for Intramuscular Injection ONLY. Do not inject into or near an art…
Warnings
WARNINGS WARNING: NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS , and DOSAGE AND ADMINISTRATION sections of the labeling. The combination of penicillin G benzathine and penicillin G procaine should only be prescribed for the indications listed in this insert. Anaphylaxis SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) 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 BICILLIN C-R CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. IF AN ALLERGIC REA…
Contraindications
CONTRAINDICATIONS A previous hypersensitivity reaction to any penicillin or to procaine is a contraindication.
Drug Interactions
Drug Interactions Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided. Concurrent administration of penicillin and probenecid increases and prolongs serum penicillin levels by decreasing the apparent volume of distribution and slowing the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazin…
Adverse Reactions
ADVERSE REACTIONS As with other penicillins, untoward reactions of the sensitivity phenomena are likely to occur, particularly in individuals who have previously demonstrated hypersensitivity to penicillins or in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported with Bicillin C-R during post-marketing experience: Skin and Appendages: Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) (See WARNINGS .) The following have been reported with parenteral penicillin G (the active moiety in Bicillin C-R): General: Hypersensitivity reactions including the following: skin eruptions (maculopapular to exfoliative dermatitis), urticaria, laryngeal edema, fever, eosinophilia; other serum sickness-like reactions (including chills, fever, edema, arthralgia, and prostration); and anaphylaxis including shock and death: severe cutaneous adverse reactions (SCAR), such as toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) (See WARNINGS .) Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if nec…
Frequently Asked Questions
What is BICILLIN CR used for?
BICILLIN CR contains penicillin G benzathine and penicillin G procaine. It is a injection, suspension taken intramuscular. Consult your doctor for specific uses.
Is BICILLIN CR a controlled substance?
BICILLIN CR is not classified as a controlled substance by the DEA.
What is the generic name for BICILLIN CR?
The generic name for BICILLIN CR is penicillin G benzathine and penicillin G procaine. There are 1 other brand versions of penicillin G benzathine and penicillin G procaine.
What is the NDC code for BICILLIN CR 600000 [iU]/2mL?
The NDC (National Drug Code) for BICILLIN CR 600000 [iU]/2mL is 60793-601, listed by Pfizer Laboratories Div Pfizer Inc.