PENICILLIN G PROCAINE

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Overview

What is PENICILLIN G PROCAINE?

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 (2, 5, 6)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with 2-(diethylamino)ethyl -aminobenzoate (1:1) monohydrate.

Its molecular formula is CHNOS∙CHNO∙HO 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 , , , and sections prior to use.

What does PENICILLIN G PROCAINE look like?

What are the available doses of PENICILLIN G PROCAINE?

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What should I talk to my health care provider before I take PENICILLIN G PROCAINE?

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How should I use PENICILLIN G PROCAINE?

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 .

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 .

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 ).

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 .

NOTE: This drug should not be used in the treatment of beta-lactamase producing organisms which include most strains of .

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 .

Anthrax due to , including inhalational anthrax (post-exposure): to reduce the incidence or progression of the disease following exposure to aerosolized .

Rat-bite fever due to susceptible and organisms.

Erysipeloid due to susceptible e.

Subacute bacterial endocarditis, only in extremely sensitive infections, due to susceptible Group A .

Do not inject into or near an artery or nerve. Injection into or near a nerve may result in permanent neurologic damage (see

).

Penicillin G procaine (aqueous) is for intramuscular injection only.

Administer by DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock. In neonates, infants and small children, the midlateral aspect of the thigh may be preferable. When doses are repeated, vary the injection site.

Because of the high concentration of suspended material in this product, the needle may be blocked if the injection is not made at a slow, steady rate.

Pneumonia (pneumococcal), moderately severe (uncomplicated): 600,000 to 1,000,000 units daily.

Streptococcal infections (Group A), moderately severe to severe tonsillitis, erysipelas, scarlet fever, upper respiratory tract, skin and soft tissue: 600,000 to 1,000,000 units daily for 10-day minimum.

Staphylococcal infections, moderately severe to severe: 600,000 to 1,000,000 units daily.

In pneumonia, streptococcal (Group A) and staphylococcal infections in pediatric patients under 60 pounds: 300,000 units daily.

Bacterial endocarditis (Group A streptococci) only in extremely sensitive infections: 600,000 to 1,000,000 units daily.

Penicillin G procaine is not recommended for prophylaxis against bacterial endocarditis. For prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract, use penicillin V. For patients unable to take oral medications, aqueous penicillin G is recommended.

What interacts with PENICILLIN G PROCAINE?

A previous hypersensitivity reaction to any penicillin is a contraindication.

What are the warnings of PENICILLIN G PROCAINE?

Antiepileptic drugs should not be suddenly discontinued because of the possibility of increasing seizure frequency.

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.

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 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.

Pseudomembranous Colitis

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.

Procaine Reactions

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.

Method of Administration

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. (See , and .)

Quadriceps femoris fibrosis and atrophy have been reported following repeated intramuscular injections of penicillin preparations into the anterolateral thigh.

What are the precautions of PENICILLIN G PROCAINE?

General

Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.

Care should be taken to avoid intravenous or intra-arterial administration, or injection into or near major peripheral nerves or blood vessels, since such injections may produce neurovascular damage. (See , and .)

A small percentage of patients are sensitive to procaine. If there is a history of sensitivity, make the usual test: Inject intradermally 0.1 mL of a 1 to 2 percent procaine solution. Development of an erythema, wheal, flare, or eruption indicates procaine sensitivity. Sensitivity should be treated by the usual methods, including barbiturates, and procaine penicillin preparations should not be used. Antihistaminics appear beneficial in treatment of procaine reactions.

The use of antibiotics may result in overgrowth of nonsusceptible organisms. Constant observation of the patient is essential. If new infections due to bacteria or fungi appear during therapy, the drug should be discontinued and appropriate measures taken.

Whenever allergic reactions occur, penicillin should be withdrawn unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to penicillin therapy.

Laboratory Tests

In suspected staphylococcal infections, proper laboratory studies, including susceptibility tests, should be performed.

In prolonged therapy with penicillin, and particularly with high-dosage schedules, periodic evaluation of the renal and hematopoietic systems is recommended. In such situations, use of penicillin for more than 2 weeks may be associated with an increased risk of neutropenia and an increased incidence of serum sickness-like reactions.

When treating gonococcal infections in which primary or secondary syphilis may be suspected, proper diagnostic procedures, including dark-field examinations, should be done. In all cases in which concomitant syphilis is suspected, monthly serological tests should be made for at least four months.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been conducted with these drugs.

Pregnancy

Reproduction studies performed in the mouse, rat, and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to penicillin G. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Penicillins are excreted in human milk. Caution should be exercised when penicillins are administered to a nursing woman.

Pediatric Use

Because of incompletely developed renal function in newborns, penicillin elimination may be delayed. Guidelines for administration of this drug to pediatric patients are presented in .

Geriatric Use

Clinical studies of penicillin G procaine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. (See ) Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

What are the side effects of PENICILLIN G PROCAINE?

Allergic Reactions

Penicillin is a substance of low toxicity but does possess a significant index of sensitization. The following hypersensitivity reactions associated with use of penicillin have been reported: Skin rashes, ranging from maculopapular eruptions to exfoliative dermatitis; urticaria; serum-sicknesslike reactions, including chills, fever, edema, arthralgia, and prostration. Severe and often fatal anaphylaxis has been reported (see ). As with other treatments for syphilis, the Jarisch-Herxheimer reaction has been reported.

Procaine toxicity manifestations and hypersensitivity reactions have been reported (see and ).

Gastrointestinal

Pseudomembranous colitis has been reported with the use of penicillin G. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see ).

What should I look out for while using PENICILLIN G PROCAINE?

A previous hypersensitivity reaction to any penicillin is a contraindication.

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.

What might happen if I take too much PENICILLIN G PROCAINE?

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How should I store and handle PENICILLIN G PROCAINE?

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Penicillin G Procaine Injectable Suspension is supplied in packages of 10 syringes as follows:1 mL size, containing 600,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-130-10.2 mL size, containing 1,200,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-131-10.Store in a refrigerator, 2° to 8°C (36° to 46°F).Keep from freezing.Penicillin G Procaine Injectable Suspension is supplied in packages of 10 syringes as follows:1 mL size, containing 600,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-130-10.2 mL size, containing 1,200,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-131-10.Store in a refrigerator, 2° to 8°C (36° to 46°F).Keep from freezing.Penicillin G Procaine Injectable Suspension is supplied in packages of 10 syringes as follows:1 mL size, containing 600,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-130-10.2 mL size, containing 1,200,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-131-10.Store in a refrigerator, 2° to 8°C (36° to 46°F).Keep from freezing.Penicillin G Procaine Injectable Suspension is supplied in packages of 10 syringes as follows:1 mL size, containing 600,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-130-10.2 mL size, containing 1,200,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-131-10.Store in a refrigerator, 2° to 8°C (36° to 46°F).Keep from freezing.Penicillin G Procaine Injectable Suspension is supplied in packages of 10 syringes as follows:1 mL size, containing 600,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-130-10.2 mL size, containing 1,200,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), 60793-131-10.Store in a refrigerator, 2° to 8°C (36° to 46°F).Keep from freezing.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Penicillin G procaine is an equimolecular compound of procaine and penicillin G, administered intramuscularly as a suspension. It dissolves slowly at the site of injection, giving a plateau type of blood level at about 4 hours which falls slowly over a period of the next 15 to 20 hours.

Approximately 60% of penicillin G is bound to serum protein. The drug is distributed throughout the body tissues in widely varying amounts. Highest levels are found in the kidneys with lesser amounts in the liver, skin, and intestines. Penicillin G penetrates into all other tissues to a lesser degree with a very small level found in the cerebrospinal fluid. With normal kidney function, the drug is excreted rapidly by tubular excretion. In neonates and young infants and in individuals with impaired kidney functions, excretion is considerably delayed. Approximately 60 to 90 percent of a dose of parenteral penicillin G is excreted in the urine within 24 to 36 hours.

Non-Clinical Toxicology

A previous hypersensitivity reaction to any penicillin is a contraindication.

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.

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.

Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.

Care should be taken to avoid intravenous or intra-arterial administration, or injection into or near major peripheral nerves or blood vessels, since such injections may produce neurovascular damage. (See , and .)

A small percentage of patients are sensitive to procaine. If there is a history of sensitivity, make the usual test: Inject intradermally 0.1 mL of a 1 to 2 percent procaine solution. Development of an erythema, wheal, flare, or eruption indicates procaine sensitivity. Sensitivity should be treated by the usual methods, including barbiturates, and procaine penicillin preparations should not be used. Antihistaminics appear beneficial in treatment of procaine reactions.

The use of antibiotics may result in overgrowth of nonsusceptible organisms. Constant observation of the patient is essential. If new infections due to bacteria or fungi appear during therapy, the drug should be discontinued and appropriate measures taken.

Whenever allergic reactions occur, penicillin should be withdrawn unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to penicillin therapy.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

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