Penicillin G Procaine Information
Penicillin g procaine (Otc-petmed) Description
This product is designed to provide a stable aqueous suspension of Penicillin g procaine (Otc-petmed) , 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 (Otc-petmed) 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 (Otc-petmed) 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 (Otc-petmed) Injectable Suspension is viscous and opaque. Read , , , and sections prior to use.
Penicillin g procaine (Otc-petmed) Clinical Pharmacology
Penicillin g procaine (Otc-petmed) 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.
Penicillin g procaine (Otc-petmed) Indications And Usage
Penicillin g procaine (Otc-petmed) 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 (Otc-petmed) : 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 (Otc-petmed) 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 .
Penicillin g procaine (Otc-petmed) Contraindications
A previous hypersensitivity reaction to any penicillin is a contraindication.
Penicillin g procaine (Otc-petmed) Warnings
Penicillin g procaine (Otc-petmed) should only be prescribed for the indications listed in this insert.
NOTE: This drug is no longer indicated in the treatment of gonorrhea.
Penicillin g procaine (Otc-petmed) Precautions
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.
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.
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 g procaine (Otc-petmed) Adverse 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 ).
Penicillin g procaine (Otc-petmed) Dosage And Administration
Penicillin g procaine (Otc-petmed) (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 (Otc-petmed) 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.
Penicillin g procaine (Otc-petmed) How Supplied
Penicillin g procaine (Otc-petmed) 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.
Penicillin g procaine (Otc-petmed) References
Prescribing Information as of August 2006.
Manufactured and Distributed by:
King Pharmaceuticals, Inc., Bristol, TN 37620
Penicillin g procaine (Otc-petmed) Labelgraphics
Penicillin g procaine (Otc-petmed) Labelgraphics
Penicillin g procaine (Otc-petmed) Labelgraphics
Penicillin g procaine (Otc-petmed) Labelgraphics
