Penicillin G potassium

Penicillin G potassium is a fast-acting antibiotic that fights bacteria in your body.

Penicillin G potassium is used to treat many different types of severe infections, including strep and staph infections, diphtheria, meningitis, gonorrhea, and syphilis.

Penicillin G potassium is also used to prevent infections of the heart valves in people with certain heart conditions who need to have dental work or surgery.

Penicillin G potassium may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.

To make sure penicillin G potassium is safe for you, tell your doctor if you have:

• asthma or a history of allergies;
• liver disease;
• kidney disease;
• heart disease;
• if you take a diuretic or "water pill"; or
• if you take any other antibiotics, including sulfa drugs.

Penicillin G potassium is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Penicillin G potassium can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Storage And Handling

Penicillin G Potassium Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL single dose GALAXY containers (PL 2040 Plastic) as follows:

2G3542 NDC 0338-1021-41 1,000,000 units Penicillin G
2G3543 NDC 0338-1023-41 2,000,000 units Penicillin G
2G3544 NDC-0338-1025-41 3,000,000 units Penicillin G

Store at or below -20°C/-4°F. [See Directions for Use of GALAXY Container (PL 2040 Plastic).]

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Revised: June 2014

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, hyperventilation, vasodilation with flushing and mild hypotension. The pathogenesis of the Herxheimer reaction may be due to the release from the spirochetes of heat-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 angioneurotic 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 1-2 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; Coombs-positive 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: Penicillin G Potassium, USP (1 million units contains 1.7 mEq of potassium ion) 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, and pain at the injection site has been reported with intravenous administration.

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.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Penicillin G Potassium Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Penicillin G Potassium is part of the drug class:

• Beta lactamase sensitive penicillins

Serious side effects have been reported with penicillin G potassium. See the “Drug Precautions” section.

Common side effects include:

• an allergic reaction, with symptoms of itching, redness and warmth of skin, and swelling that may occur
• itching of the skin
• skin rash

This is not a complete list of penicillin G potassium side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take penicillin G potassium exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV), muscle (IM), into the lung spaces, or into the spine (IT) by a healthcare professional.

Penicillin G potassium is a fast-acting antibiotic that fights bacteria in your body.

Penicillin G potassium is used to treat many different types of severe infections, including strep and staph infections, diphtheria, meningitis, gonorrhea, and syphilis.

Penicillin G potassium is also used to prevent infections of the heart valves in people with certain heart conditions who need to have dental work or surgery.

Penicillin G potassium may also be used for purposes not listed in this medication guide.

Penicillin G potassium is injected into a muscle or into a vein through an IV. You may be shown how to use an injection at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Penicillin G potassium may also be injected into the membrane surrounding the lungs, or into the fluid surrounding the spinal cord. A healthcare provider will give you this type of injection.

Penicillin G potassium is a powder medicine that must be mixed with a liquid (solvent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Store the powder at room temperature away from moisture and heat.

After mixing the powder with a liquid, store in the refrigerator and use it within 7 days. Do not freeze.

Penicillin G potassium that is supplied as a frozen solution should be stored in a deep freezer at a temperature of 4 degrees below 0 (F).

Thaw the solution either in a refrigerator or at room temperature. Do not heat the medicine to thaw it more quickly. Once the solution has been thawed, it should look clear.

Penicillin G potassium that is thawed in the refrigerator should be used within 14 days. If you have thawed the medicine at room temperature, you must use it within 24 hours. Do not refreeze.

Do not use penicillin G potassium if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

This medicine can cause false results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using penicillin G potassium.

If you use this medicine long-term, your blood may need to be tested to make sure the medicine is not causing harmful effects. Your kidney or liver function may also need to be tested.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Penicillin G potassium will not treat a viral infection such as the flu or a common cold.

After you have finished your treatment with penicillin G potassium, your doctor may want to do tests to make sure your infection has completely cleared up.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• red or scaly skin;

• fever, chills, swollen glands, muscle or joint pain, fast heartbeats, general ill feeling;

• a light-headed feeling, like you might pass out;

• severe stomach pain, diarrhea that is watery or bloody;

• little or no urinating;

• bruising, severe tingling, numbness, pain, muscle weakness;

• seizure (convulsions); or

• unusual changes in mood or behavior.

Common side effects may include:

• mild diarrhea;

• headache;

• black or hairy tongue; or

• pain, swelling, bruising, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.