AMPICILLIN- ampicillin sodium_injection, powder, for solution

CLINICAL PHARMACOLOGY
Ampicillin for injection diffuses readily into most body tissues and fluids. However, penetration into the cerebrospinal fluid and brain occurs only when the meninges are inflamed. Ampicillin is excreted largely unchanged in the urine and its excretion can be delayed by concurrent administration of probenecid. Due to maturational changes in renal function, ampicillin half-life decreases as postmenstrual age (a sum of gestational age and postnatal age) increases for infants with postnatal age of less than 28 days. The active form appears in the bile in higher concentrations than those found in serum. Ampicillin is the least serum-bound of all the penicillins, averaging about 20% compared to approximately 60 to 90% for other penicillins. Ampicillin for injection is well-tolerated by most patients and has been given in doses of 2 grams daily for many weeks without adverse reactions. While in vitro INDICATIONS AND USAGE Antibacterial Activity in vitro streptococci Streptococcus pneumoniae staphylococci Clostridium B. anthracis Listeria monocytogenes enterococci. influenzae N. gonorrhoeae N. meningitidis Proteus mirabilis Salmonella Shigella E. coli Susceptibility Testing.
Microbiology
While in vitro INDICATIONS AND USAGE Antibacterial Activity in vitro streptococci Streptococcus pneumoniae staphylococci Clostridium B. anthracis Listeria monocytogenes enterococci. H. influenzae N. gonorrhoeae N. meningitidis Proteus mirabilis Salmonella Shigella E. coli Susceptibility Testing

Ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Streptococcus pneumoniae, S taphylococcus aureus H. influenzae streptococci E. coli Streptococci Listeria m onocytogenes N. meningitidis Septicemia and Endocarditis Streptococcus staphylococci enterococci E. coli Proteus mirabilis Salmonella E. coli Proteus mirabilis Salmonella typhi Salmonella Shigella

DOSAGE AND ADMINISTRATION
Infections of the respiratory tract and soft tissues. Neisseria gonorrhoeae N. gonorrhoeae Bacterial Meningitis Table 1 Table 1: Dosage in Neonates (less than or equal to 28 days of postnatal age) for Bacterial Meningitis and Septicemia Gestational age (weeks) Postnatal age (days) Dosage less than or equal to 34 less than or equal to 7 100 mg/kg/day in equally divided doses every 12 hours less than or equal to 34 greater than or equal to 8 and less than 28 150 mg/kg/day in equally divided doses every 12 hours greater than 34 less than or equal to 28 150 mg/kg/day in equally divided doses every 8 hours Septicemia Adults and children Table 1 Treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A minimum of 10 days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis. Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period. en dash NDC Label Recommended Withdrawable Concentration 55150-111-10 250 mg 1 mL 1 mL 250 mg 55150-112-10 500 mg 1. 8 mL 2 mL 250 mg 55150-113-10 1 gram 3. 5 mL 4 mL 250 mg 55150-114-20 2 grams 6. 8 mL 8 mL 250 mg While ampicillin for injection, USP, 1 g and 2 g, are primarily for intravenous use, they may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3. 8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively. The resulting solution will provide a concentration of 250 mg per mL. en dash en dash (For Direct Intravenous Use ) Room Temperature (25°C) Diluent Concentrations Stability Periods Sterile Water for Injection up to 30 mg/mL 8 hours 0. 9% Sodium Chloride Injection, USP up to 30 mg/mL 8 hours 5% Dextrose Injection, USP 10 to 20 mg/mL 1 hour 5% Dextrose Injection, USP up to 2 mg/mL 2 hours 5% Dextrose and 0. 45% Sodium up to 2 mg/mL 2 hours Lactated Ringer’s Injection, USP up to 30 mg/mL 8 hours Refrigerated (4°C) Diluent Concentrations Stability Periods Sterile Water for Injection 30 mg/mL 48 hours Sterile Water for Injection up to 20 mg/mL 72 hours 0. 9% Sodium Chloride Injection, USP 30 mg/mL 24 hours 0. 9% Sodium Chloride Injection, USP up to 20 mg/mL 48 hours Lactated Ringer''s Injection, USP up to 30 mg/mL 24 hours 5% Dextrose Injection, USP up to 20 mg/mL 1 hour 5% Dextrose and 0. 45% Sodium up to 10 mg/mL 1 hour Only those solutions listed above should be used for the intravenous infusion of ampicillin for injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.
DIRECTIONS FOR USE
Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period. en dash NDC Label Recommended Withdrawable Concentration 55150-111-10 250 mg 1 mL 1 mL 250 mg 55150-112-10 500 mg 1.8 mL 2 mL 250 mg 55150-113-10 1 gram 3.5 mL 4 mL 250 mg 55150-114-20 2 grams 6.8 mL 8 mL 250 mg While ampicillin for injection, USP, 1 g and 2 g, are primarily for intravenous use, they may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.5 or 6.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively. The resulting solution will provide a concentration of 250 mg per mL. en dash en dash (For Direct Intravenous Use ) Room Temperature (25°C) Diluent Concentrations Stability Periods Sterile Water for Injection up to 30 mg/mL 8 hours 0.9% Sodium Chloride Injection, USP up to 30 mg/mL 8 hours 5% Dextrose Injection, USP 10 to 20 mg/mL 1 hour 5% Dextrose Injection, USP up to 2 mg/mL 2 hours 5% Dextrose and 0.45% Sodium up to 2 mg/mL 2 hours Lactated Ringer’s Injection, USP up to 30 mg/mL 8 hours Refrigerated (4°C) Diluent Concentrations Stability Periods Sterile Water for Injection 30 mg/mL 48 hours Sterile Water for Injection up to 20 mg/mL 72 hours 0.9% Sodium Chloride Injection, USP 30 mg/mL 24 hours 0.9% Sodium Chloride Injection, USP up to 20 mg/mL 48 hours Lactated Ringer''s Injection, USP up to 30 mg/mL 24 hours 5% Dextrose Injection, USP up to 20 mg/mL 1 hour 5% Dextrose and 0.45% Sodium up to 10 mg/mL 1 hour Only those solutions listed above should be used for the intravenous infusion of ampicillin for injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

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. 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-threatening and amenable only to ampicillin therapy. Serious anaphylactic reactions require the immediate use of epinephrine, oxygen, and intravenous steroids. en dash en dash

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

Pregnancy
Reproduction studies have been performed in laboratory animals at doses several times the human dose and have revealed no evidence of adverse effects due to ampicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
Ampicillin is excreted in trace amounts in human milk. Therefore, caution should be exercised when ampicillin-class antibiotics are administered to a nursing woman.
Pediatric Use
Guidelines for the administration of these drugs to children, including neonates are presented in DOSAGE AND ADMINISTRATION

Drug Interactions
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
Drug/Laboratory Test Interactions
With high urine concentrations of ampicillin, false-positive glucose reactions may occur if Clinitest, Benedict’s Solution, or Fehling’s Solution are used. Therefore, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or Tes-Tape) be used.

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. C. difficile. C. difficile C. difficile C. difficile,
Carcinogenesis,Mutagenesis, and Impairment of Fertility
No long-term animal studies have been conducted with this drug.
Labor and Delivery
Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pig showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions, but moderately increased the height and duration of contractions. However, it is not known whether use of these drugs in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.
OVERDOSAGE
In cases of overdose, discontinue medication, treat symptomatically, and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not peritoneal dialysis.

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