Drugplain

Ampicillin sodium 2 g/1

Ampicillin Sodium · INJECTION, POWDER, FOR SOLUTION · Civica, Inc.

1 Recall on RecordCurrently in Shortage
Plain English

Ampicillin sodium is an antibiotic injection used to treat bacterial infections. It is given as an intramuscular injection and works by stopping the growth of bacteria.

Key Facts

Brand Name
Ampicillin sodium
Generic Name
Ampicillin Sodium
NDC Code (Product)
72572-094
Manufacturer
Civica, Inc.
Strength
2 g/1
Dosage Form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #
ANDA201025
Marketing Start
09/08/2025

Recall History

1 Recall on Record
Class II05/29/2020

Pfizer Inc.

Presence of Particulate Matter: particulate matter identified after reconstitution.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective842 reports
foetal exposure during pregnancy653 reports
drug hypersensitivity605 reports
maternal exposure during pregnancy532 reports
premature baby511 reports
off label use423 reports
pyrexia368 reports
premature delivery337 reports
acute kidney injury327 reports
renal failure315 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by Streptococcus pneumoniae , Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae , and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis ). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis . Gastrointestinal In

Dosage & Administration

DOSAGE AND ADMINISTRATION Infections of the respiratory tract and soft tissues. Patients weighing 40 kg (88 lbs) or more: 250 mg to 500 mg every 6 hours. Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals. Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females). Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours. Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals. In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Urethritis in males due to N. gonorrhoeae . Adults –Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required. In the treatment

Warnings

WARNINGS Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been well-documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin. Before initiating therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted. SERIOUS ANAPHYLACTOID 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

Contraindications

CONTRAINDICATIONS A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

Adverse Reactions

ADVERSE REACTIONS As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of ampicillin: Gastrointestinal Glossitis, stomatitis, black “hairy” tongue, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. (These reactions are usually associated with oral dosage forms.) Hypersensitivity Reactions Skin rashes and urticaria have been reported frequently. A few cases of exfoliative dermatitis and erythema multiforme have been reported. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form. Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, ampicillin should be discontinued, unless, in the opinion of the physician, the condition being treated is life th

Frequently Asked Questions

What is Ampicillin sodium used for?

Ampicillin sodium is an antibiotic injection used to treat bacterial infections. It is given as an intramuscular injection and works by stopping the growth of bacteria.

Is Ampicillin sodium a controlled substance?

Ampicillin sodium is not classified as a controlled substance by the DEA.

What is the generic name for Ampicillin sodium?

The generic name for Ampicillin sodium is Ampicillin Sodium. There are 11 other brand versions of Ampicillin Sodium.

What is the NDC code for Ampicillin sodium 2 g/1?

The NDC (National Drug Code) for Ampicillin sodium 2 g/1 is 72572-094, listed by Civica, Inc..