Penicillin G Procaine
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Questions & Answers
Side Effects & Adverse Reactions
Penicillin G procaine should only be prescribed for the indications listed in this insert.
NOTE: This drug is no longer indicated in the treatment of gonorrhea.
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 ANY PENICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, THE DRUG SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including penicillin G, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridium. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis."
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management of fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Immediate toxic reactions to procaine may occur in some individuals, particularly when a large single dose is administered (4.8 million units). These reactions may be manifested by mental disturbances, including anxiety, confusion, agitation, depression, weakness, seizures, hallucinations, combativeness, and expressed "fear of impending death." The reactions noted in carefully controlled studies occurred in approximately one in 500 patients who received large doses of penicillin G procaine. Reactions are transient, lasting from 15 to 30 minutes.
Do not inject into or near an artery or nerve.
Injection into or near a nerve may result in permanent neurological damage.
Inadvertent intravascular administration, including inadvertent direct intra-arterial injection or injection immediately adjacent to arteries, of Penicillin G Procaine Injectable Suspension and other penicillin preparations has resulted in severe neurovascular damage, including transverse myelitis with permanent paralysis, gangrene requiring amputation of digits and more proximal portions of extremities, and necrosis and sloughing at and surrounding the injection site. Such severe effects have been reported following injections into the buttock, thigh, and deltoid areas. Other serious complications of suspected intravascular administration which have been reported include immediate pallor, mottling, or cyanosis of the extremity, both distal and proximal to the injection site, followed by bleb formation; severe edema requiring anterior and/or posterior compartment fasciotomy in the lower extremity. The above-described severe effects and complications have most often occurred in infants and small children. Prompt consultation with an appropriate specialist is indicated if any evidence of compromise of the blood supply occurs at, proximal to, or distal to the site of injection.1-9 (See PRECAUTIONS, and DOSAGE AND ADMINISTRATION.)
Quadriceps femoris fibrosis and atrophy have been reported following repeated intramuscular injections of penicillin preparations into the anterolateral thigh.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Penicillin G procaine is indicated in the treatment of moderately severe infections in both adults and pediatric patients due to penicillin-G-susceptible microorganisms that are susceptible to the low and persistent serum levels common to this particular dosage form in the indications listed below. Therapy should be guided by bacteriological studies (including susceptibility tests) and by clinical response.
NOTE: When high, sustained serum levels are required, aqueous penicillin G, either IM or IV, should be used.
The following infections will usually respond to adequate dosages of intramuscular penicillin G procaine: Moderately severe to severe infections of the upper respiratory tract, skin and soft-tissue infections, scarlet fever, and erysipelas due to susceptible streptococci (Group A-without bacteremia).
NOTE: Streptococci in Groups A, C, G, H, L, and M are very sensitive to penicillin G. Other groups, including Group D (enterococcus), are resistant. Aqueous penicillin is recommended for streptococcal infections with bacteremia.
Moderately severe infections of the respiratory tract due to susceptible pneumococci.
NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology are better treated with aqueous penicillin G during the acute stage.
Moderately severe infections of the skin and soft tissues due to susceptible staphylococci(penicillin G-susceptible).
NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Indicated surgical procedures should be performed.
Fusospirochetosis (Vincent's gingivitis and pharyngitis). Moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes.
NOTE: Necessary dental care should be accomplished in infections involving the gum tissue.
Syphilis (all stages) due to susceptible Treponema pallidum.
NOTE: This drug should not be used in the treatment of beta-lactamase producing organisms which include most strains of Neisseria gonorrhea.
Yaws, Bejel, Pinta due to susceptible organisms.
Penicillin G procaine is an adjunct to antitoxin for prevention of the carrier stage of diphtheria due to susceptible C. diphtheriae.
Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of the disease following exposure to aerosolized Bacillus anthracis.
Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum minus organisms.
Erysipeloid due to susceptible Erysipelothrix rhusiopathiae.
Subacute bacterial endocarditis, only in extremely sensitive infections, due to susceptible Group A streptococci.
History
There is currently no drug history available for this drug.
Other Information
This product is designed to provide a stable aqueous suspension of penicillin G procaine, ready for immediate use. This eliminates the necessity for addition of any diluent, required for the usual dry formulation of injectable penicillin.
Penicillin G procaine is chemically designated as (2S, 5R, 6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with 2-(diethylamino)ethyl p-aminobenzoate (1:1) monohydrate.
Its molecular formula is C16H18N2O4S•C13H20N2O2•H2O with a molecular weight of 588.72. Its structural formula is as follows:
Each syringe, 1,200,000 units (2 mL size) or 600,000 units (1 mL size), contains penicillin G procaine in a stabilized aqueous suspension with sodium citrate buffer; and as w/v, approximately 0.5% lecithin, 0.5% carboxymethylcellulose, 0.5% povidone, 0.1% methylparaben, and 0.01% propylparaben.
Penicillin G Procaine Injectable Suspension is viscous and opaque. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use.
Sources
Penicillin G Procaine Manufacturers
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Pfizer Laboratories Div Pfizer Inc
![Penicillin G Procaine Injection, Suspension [Pfizer Laboratories Div Pfizer Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Penicillin G Procaine | Mylan Pharmaceuticals Inc.
2.1 Usual Dosage and AdministrationThe usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects.
AdultsThe usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours), followed by a maintenance dose of 100 mg daily. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For Pediatric Patients Above 8 Years of AgeThe recommended dosage schedule for children weighing 45 kg or less is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by 2.2 mg/kg of body weight given as a single daily dose or divided into two doses on subsequent days. For more severe infections up to 4.4 mg/kg of body weight may be used. For children over 45 kg, the usual adult dose should be used.
Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline-class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].
If gastric irritation occurs, doxycycline may be given with food or milk [see Clinical Pharmacology (12)].
When used in streptococcal infections, therapy should be continued for 10 days.
Uncomplicated Urethral, Endocervical, or Rectal Infection Caused by Chlamydia Trachomatis100 mg by mouth twice a day for 7 days. As an alternate dosing regimen for uncomplicated urethral or endocervical infection caused by Chlamydia trachomatis, administer 200 mg by mouth once a day for 7 days.
Uncomplicated Gonococcal Infections in Adults (Except Anorectal Infections in Men)100 mg, by mouth, twice-a-day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.
Nongonococcal Urethritis (NGU) Caused by U. Urealyticum100 mg by mouth twice-a-day for 7 days.
Syphilis–EarlyPatients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 2 weeks.
Syphilis of More Than One Year’s DurationPatients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 4 weeks.
Acute Epididymo-Orchitis Caused by C. Trachomatis100 mg, by mouth, twice-a-day for at least 10 days.
2.2 For Prophylaxis of MalariaFor adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 or 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
2.3 Inhalational Anthrax (Post-Exposure) Adults100 mg, of doxycycline, by mouth, twice-a-day for 60 days.
Childrenweighing less than 45 kg, 2.2 mg/kg of body weight, by mouth, twice-a-day for 60 days. Children weighing 45 kg or more should receive the adult dose.
2.4 Sprinkling the Tablet over ApplesauceDoxycycline hyclate delayed-release tablets may also be administered by carefully breaking up the tablet and sprinkling the tablet contents (delayed-release beads) on a spoonful of applesauce. The delayed-release beads must not be crushed or damaged when breaking up the tablet. Any loss of beads in the transfer would prevent using the dose. The applesauce/doxycycline mixture should be swallowed immediately without chewing and may be followed by a glass of water if desired. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. In the event that a prepared dose of applesauce/doxycycline cannot be taken immediately, the mixture should be discarded and not stored for later use.
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