Buffered Penicillin G Potassium
FDA Drug Information • Also known as: Buffered Penicillin G Potassium
- Brand Names
- Buffered Penicillin G Potassium
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Buffered Penicillin G Potassium for Injection, USP is sterile penicillin G potassium powder for reconstitution. It is an antibacterial agent intended for intravenous or intramuscularly use. Chemically, Penicillin G Potassium is monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo (3.2.0) heptane-2-carboxylate, and has the following chemical structure: Penicillin G potassium, a water soluble benzylpenicillin, is a white to almost white crystalline powder which is almost odorless and/or after reconstitution a colorless solution. The pH of freshly constituted solutions usually ranges from 6 to 8.5. Sodium citrate and citric acid have been added as a buffer. Buffered Penicillin G Potassium for Injection, USP is supplied in vials equivalent to 1,000,000 units (1 million units), 5,000,000 units (5 million units), or 20,000,000 units (20 million units) of penicillin G as the potassium salt. Each million unit contains approximately 7.9 milligrams of sodium (0.34 mEq) and 65.6 milligrams of potassium (1.68 mEq). STRUCTURE
What Is Buffered Penicillin G Potassium Used For?
INDICATIONS & USAGE Therapy Buffered Penicillin G Potassium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Buffered Penicillin G Potassium for Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin G Potassium and other antibacterial drugs, 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. INDICATIONS
Dosage and Administration
DOSAGE & ADMINISTRTION Buffered Penicillin G Potassium for Injection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows: Pediatric patients This product should not be administered to patients requiring less than one million units per dose. (see PRECAUTIONS – Pediatric Use). Renal Impairment Penicillin G is relatively nontoxic, and dosage adjustments are generally required only in cases of severe renal impairment. The recommended dosage regimens are as follows: Creatinine clearance less than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8 to 10 hours. Uremic patients with a creatinine clearance greater than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 4 to 5 hours. Additional dosage modifications should be made in patients with hepatic disease and renal impairment. For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for Group A β-hemolytic streptococcal infections should be maintained for at least 10 days to reduce the risk of rheumatic fever. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Preparation of Solution Solutions of penicillin should be prepared as follows: Loosen powder. Hold vial horizontally and rotate it while slowly directing the stream of diluent against the wall of the vial. Shake vial vigorously after all the diluent has been added. Depending on the route of administration, use Sterile Water for Injection, USP or Sterile Isotonic Sodium Chloride Solution for Parenteral use. Note: Penicillins are rapidly inactivated in the presence of carbohydrate solutions at alkaline pH. Reconstitution The following table shows the amount of solvent required for solution of various concentrations: When the required volume of solvent is greater than the capacity of the vial, the penicillin can be dissolved by first injecting only a portion of the solvent into the vial, then withdrawing the resultant solution and combining it with the remainder of the solvent in a larger sterile container. Penicillin G Potassium for Injection, USP is highly water soluble. It may be dissolved in small amounts of Water for Injection, or Sterile Isotonic Sodium Chloride Solution for Parenteral Use. All solutions should be stored in a refrigerator. When refrigerated, penicillin solutions may be stored for seven days without significant loss of potency. Buffered Penicillin G Potassium for Injection may be given intramuscularly or by continuous intravenous drip for dosages of 500,000, 1,000,000 or 5,000,000 units. It is also suitable for intrapleural, intraarticular, and other local installations. THE 20,000,000 UNIT (20 MILLION...
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Body as a whole The Jarisch-Herxheimer reaction is a systemic reaction, that may occur after the initiation of penicillin therapy in patients with syphilis or other spirochetal infections (i.e., Lyme disease and Relapsing fever). The reaction begins one to two hours after initiation of therapy and disappears within 12 to 24 hours. It is characterized by fever, chills, myalgias, headache, exacerbation of cutaneous lesions, tachycardia, hyperventiliation, vasodilation with flushing and mild hypotension. The pathogenesis of the Herxheimer reaction may be due to the release from the spirochaete of host stable pyrogen. Hypersensitivity reactions The reported incidence of allergic reactions to all penicillins ranges from 0.7 to 10 percent in different studies (see WARNINGS ). Sensitization is usually the result of previous treatment with a penicillin, but some individuals have had immediate reactions when first treated. In such cases, it is postulated that prior exposure to penicillin may have occurred via trace amounts present in milk or vaccines. Two types of allergic reactions to penicillin are noted clinically – Immediate and delayed. Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angloneurotic edema, laryngospasm, bronchospasm, hypotension, vascular collapse and death (see WARNINGS ). Such immediate anaphylactic reactions are very rare and usually occur after parenteral therapy, but a few cases of anaphylaxis have been reported following oral therapy. Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus, fever and, occasionally, laryngeal edema. Delayed reactions to penicillin therapy usually occur within 1 to 2 weeks after initiation of therapy. Manifestations include serum sickness-like symptoms, i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain and various skin rashes, ranging from maculopapular eruptions to exfoliative dermatitis. Contact dermatitis has been observed in individuals who prepare penicillin solutions. Gastrointestinal system Pseudomembranous colitis has been reported with the onset occurring during or after penicillin G treatment. Nausea, vomiting, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral therapy. Hematologic system Reactions include neutropenia, which resolves after penicillin therapy is discontinued; Coombspositive hemolytic anemia, an uncommon reaction, occurs in patients treated with intravenous penicillin G in doses greater than 10 million units/day and who have previously received large doses of the drug; and with large doses of penicillin, a bleeding diathesis, can occur secondary to platelet dysfunction. Metabolic Buffered Penicillin G Potassium for Injection, USP (1 million units contains 0.3 mEq of sodium and 1.68 mEq of potassium) may cause serious and even fatal electrolyte disturbances, i.e., hyperkalemia, when given intravenously in large doses. Nervous system Neurotoxic reactions including hyperreflexia, myoclonic twitches, seizures and coma have been reported following the administration of massive intravenous doses, and are more likely in patients with impaired renal function. Urogenital system Renal tubular damage and interstitial nephritis have been associated with large intravenous doses of penicillin G. Manifestations of this reaction may include fever, rash, eosinophilia, proteinuria, eosinophiluria, hematuria and a rise in serum urea nitrogen. Discontinuation of penicillin G results in resolution in the majority of patients. Local reactions Phlebitis and thrombophlebitis may occur with intravenous administration.
Warnings and Precautions
WARNINGS 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 PENICILLIN G, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, PENICILLIN G 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 clostridia. 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 with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against C. difficile.
Contraindications
CONTRAINDICATIONS A history of hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.
Overdosage
OVERDOSAGE Dose related toxicity may arise with the use of massive doses of intravenous penicillins (40 to 100 million units per day), particularly in patients with severe renal impairment (see PRECAUTIONS ). The manifestations may include agitation, confusion, asterixis, hallucinations, stupor, coma, multifocal myoclonus, seizures and encephalopathy. Hyperkalemia is also possible (see ADVERSE REACTIONS – Metabolic). In case of overdosage, discontinue penicillin, treat symptomatically and institute supportive measures as required. If necessary, hemodialysis may be used to reduce blood levels of penicillin G, although the degree of effectiveness of this procedure is questionable.
How Supplied
HOW SUPPLIED BUFFERED PENICILLIN G POTASSIUM FOR INJECTION, USP is supplied in the following dosage forms. NDC 51662-1436-1 BUFFERED PENICILLIN G POTASSIUM FOR INJECTION, USP 5,000,000 UNITS (5 MILLION UNITS) HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Buffered Penicillin G Potassium for Injection, USP, is supplied in dry powder form in vials containing 1,000,000 units (1 million units) × 10’s (NDC 0781-6134-95), 5,000,000 units (5 million units) × 10’s (NDC 0781-6135-95), and 20,000,000 units (20 million units) × 1’s (NDC 0781-6136-94) of crystalline penicillin G as the potassium salt; buffered with sodium citrate and citric acid to an optimum pH. STORAGE Store the dry powder at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. Sterile constituted solution may be kept in refrigerator 2° to 8°C (36° to 46°F) for 7 days without significant loss of potency.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.