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Ampicillin, Ampicillin Sodium, Ampicillin Trihydrate

Ampicillin is an aminopenicillin antibiotic.

Uses

Ampicillin shares the uses of other aminopenicillins and is used principally for the treatment of infections caused by susceptible gram-negative bacteria (e.g., Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Salmonella). Ampicillin also is used for the treatment of infections caused by susceptible gram-positive bacteria (e.g., Streptococcus pneumoniae, enterococci, nonpenicillinase-producing staphylococci, Listeria); however, like other aminopenicillins, ampicillin generally should not be used for the treatment of streptococcal or staphylococcal infections when a natural penicillin would be effective.

Orally administered ampicillin should not be used for the initial treatment of severe, life-threatening infections, but may be used as follow-up therapy after parenteral ampicillin therapy. For specific information on the uses of ampicillin, see Uses in the Aminopenicillins General Statement 8:12.16.08.

Dosage and Administration

Reconstitution and Administration

Anhydrous ampicillin (no longer commercially available in the US) and ampicillin trihydrate are administered orally, and ampicillin sodium may be administered by IM or slow IV injection or by IV infusion. Although ampicillin may be given orally with meals, maximum absorption is achieved when the drug is administered 1 hour before or 2 hours after meals.

Parenteral forms of ampicillin should be used only in the treatment of moderately severe or severe infections. Direct IV injections should be made slowly over 10-15 minutes to avoid the possibility of seizures.

For intermittent IV infusion, the concentration of ampicillin and rate of infusion should be adjusted so that the total dose of the drug is administered before 10% or more of the drug is inactivated in the IV solution. (See Chemistry and Stability: Stability.) Ampicillin sodium preparations for parenteral use should be reconstituted according to the manufacturers’ instructions. Ampicillin sodium solutions should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Dosage

Dosage of ampicillin sodium and ampicillin trihydrate is expressed in terms of ampicillin. The manufacturers’ dosage recommendations for adults usually are the same for both parenteral and oral routes; however, higher serum concentrations usually are attained parenterally, and this route is used for severe infections.

General Adult Dosage

The usual adult dosage of ampicillin for the treatment of respiratory tract or skin and skin structure infections is 250-500 mg every 6 hours. For the treatment of GI or urinary tract infections, the usual adult dosage is 500 mg every 6 hours.

For severe infections, larger doses may be required. The usual adult dosage of ampicillin for the treatment of septicemia or bacterial meningitis is 8-14 g or 150-200 mg/kg daily given parenterally in equally divided doses every 3-4 hours.

For the initial treatment of septicemia or meningitis, ampicillin should be given IV for at least 3 days but may then be given IM. General Pediatric Dosage For oral therapy, most manufacturers state that children weighing more than 20 kg may receive the usual adult dosage of ampicillin.

For parenteral therapy, some manufacturers recommend that the usual adult dosage be used in children weighing more than 20 kg, whereas other manufacturers and many clinicians recommend that the usual adult dosage be used in those weighing more than 40 kg. Pediatric dosage should not exceed dosage recommended for similar infections in adults.

For the treatment of respiratory tract or skin and skin structure infections, the usual dosage of ampicillin for children weighing 40 kg or less is 25-50 mg/kg daily administered in equally divided doses every 6 hours.

For the treatment of GI or urinary tract infections, the usual dosage for children weighing 40 kg or less is 50-100 mg/kg daily given in equally divided doses every 6 hours.

For the treatment of septicemia or CNS infections, the usual pediatric dosage recommended by the manufacturers is 100-200 mg/kg daily given in divided doses every 3-4 hours, starting with IV administration for 3 days and continuing with IM administration. Alternatively, the American Academy of Pediatrics (AAP) and other clinicians recommend that children older than 1 month of age receive oral ampicillin in a dosage of 50-100 mg/kg daily given in divided doses every 6 hours for the treatment of mild to moderate infections and an IM or IV dosage of 100-150 mg/kg daily given in divided doses every 6 hours for the treatment of mild to moderate infections or a dosage of 200-400 mg/kg daily given in divided doses every 6 hours for the treatment of severe infections. Some clinicians suggest a maximum dosage of 12 g daily in children.

For neonates younger than 1 week of age, the AAP recommends that IM or IV ampicillin be given in a dosage of 25-50 mg/kg every 12 hours in those weighing 2 kg or less or every 8 hours in those weighing more than 2 kg. For neonates 1-4 weeks of age, the AAP recommends an IM or IV dosage of 25-50 mg/kg every 8 hours for those weighing 1.2-2 kg or every 6 hours for those weighing more than 2 kg. Neonates 4 weeks of age or younger who weigh less than 1.2 kg should receive 25-50 mg/kg every 12 hours.

The higher ampicillin dosage usually is recommended for the treatment of meningitis in neonates. For the treatment of meningitis caused by group B streptococci, the AAP recommends that neonates 7 days of age or younger receive a dosage of 200-300 mg/kg daily given IV in 3 divided doses and that neonates older than 7 days of age receive a dosage of 300 mg/kg daily given in 4-6 divided doses.

For empiric treatment of bacterial meningitis in neonates and children younger than 2 months of age, many clinicians recommend that an IV ampicillin dosage of 100-300 mg/kg daily be given in divided doses in conjunction with IM gentamicin pending results of in vitro susceptibility tests.

For the empiric treatment of bacterial meningitis in children 2 months to 12 years of age, many clinicians recommend that an IV ampicillin dosage of 200-400 mg/kg daily be given in divided doses every 4-6 hours in conjunction with IV chloramphenicol. If bacterial susceptibility data are not available and clinical and bacteriologic response is unsatisfactory after 24-48 hours, other appropriate anti-infective therapy should be substituted.

For initial therapy of life-threatening septicemia in neonates, ampicillin has been administered IM in conjunction with an aminoglycoside (e.g., gentamicin). Full-term and premature neonates younger than 7 days of age have been given ampicillin 50 mg/kg daily in equally divided doses every 12 hours. Premature neonates 7-28 days of age have been given 100 mg/kg daily in equally divided doses every 8 hours, and full-term neonates 7-28 days of age have been given 150 mg/kg daily in equally divided doses every 8 hours.

Treatment of Enterococcal Endocarditis For the treatment of enterococcal endocarditis, the American Heart Association (AHA) and others recommend that adults receive an ampicillin dosage of 12 g daily (by continuous IV infusion or in 6 equally divided IV doses) in conjunction with gentamicin (1 mg/kg IM or IV every 8 hours).

Treatment with both drugs generally should be continued for 4-6 weeks, but patients who had symptoms of infection for more than 3 months before treatment was initiated and patients with prosthetic heart valves require a minimum of 6 weeks of therapy with both drugs.

Gonorrhea and Associated Infections

Some manufacturers state that adults and children weighing 45 kg or more may receive a single 3.5-g dose of oral ampicillin (with 1 g of oral probenecid) for the treatment of acute, uncomplicated gonorrhea caused by susceptible nonpenicillinase-producing Neisseria gonorrhoeae.

However, penicillins are not included in current US Centers for Disease Control and Prevention (CDC) recommendations for the treatment of gonorrhea.

Prevention of Perinatal Group B Streptococcal Disease

When intrapartum chemoprophylaxis for the prevention of perinatal group B streptococcal (GBS) disease is indicated in the mother to prevent early-onset GBS disease in her neonate and ampicillin is used as an alternative to penicillin G, the CDC and AAP recommend that an initial ampicillin dose of 2 g be given IV at the onset of labor or after membrane rupture followed by 1 g every 4 hours until delivery.

Regardless of whether chemoprophylaxis was administered to the mother, appropriate diagnostic evaluations and empiric anti-infective therapy should be initiated in the mother and/or neonate if signs or symptoms of active infection develop. For information on when prevention of perinatal GBS disease is indicated, see Uses: Prevention of Perinatal Group B Streptococcal Disease, in the Natural Penicillins General Statement 8:12.16.04.

Prevention of Bacterial Endocarditis

Ampicillin Trihydrate

When selecting anti-infectives for the prevention of bacterial endocarditis, the current recommendations published by the AHA should be consulted. When a parenteral regimen is used for prophylaxis of bacterial endocarditis in patients at high or moderate risk undergoing certain dental procedures or minor upper respiratory tract surgery or instrumentation (see Uses: Prevention of Bacterial Endocarditis, in the Aminopenicillins General Statement 8:12..08), the AHA, American Dental Association (ADA), and others currently recommend that adults receive a single 2-g dose of ampicillin and that children receive a single 50-mg/kg dose of IM or IV ampicillin given within 30 minutes of starting the procedure.

For prophylaxis of enterococcal endocarditis in patients at high or moderate risk undergoing certain GI, biliary tract, or genitourinary tract surgery or instrumentation (see Prophylaxis of Bacterial Endocarditis under Uses: Prophylaxis in the Aminopenicillins General Statement 8:12.16.08), use of a 2-dose parenteral regimen is recommended for most patients; however, the AHA and others state that a single-dose regimen of parenteral ampicillin or oral amoxicillin can be considered for those with cardiac conditions that put them only at moderate risk of enterococcal endocarditis.

When a 2-dose regimen is used for prophylaxis of enterococcal endocarditis in patients at high or moderate risk, the first dose should consist of IM or IV ampicillin (2 g in adults or 50 mg/kg in children) given in conjunction with IM or IV gentamicin (1.5 mg/kg) and administered within 30 minutes of starting the procedure; the second dose administered 6 hours later can consist of IM or IV ampicillin (1 g in adults or 25 mg/kg in children) or, alternatively, oral amoxicillin (1 g in adults or 25 mg/kg in children). If the single-dose ampicillin regimen is used for prophylaxis of enterococcal endocarditis in patients at moderate risk, the AHA and others recommend that adults receive a single 2-g dose and children receive a single 50-mg/kg dose given IM or IV within 30 minutes of starting the procedure.

Duration of Therapy

The duration of ampicillin therapy depends on the type and severity of infection and should be determined by the clinical and bacteriologic response of the patient. For most infections, except gonorrhea, therapy should be continued for at least 48-72 hours after the patient becomes asymptomatic or evidence of eradication of the infection has been obtained. Persistent infections may require several weeks of therapy.

Dosage in Renal Impairment

In patients with renal impairment, doses and/or frequency of administration of ampicillin should be modified in response to the degree of renal impairment, severity of the infection, and susceptibility of the causative organism.

Some clinicians suggest that adults with glomerular filtration rates of 10-50 mL/minute receive the usual dose of ampicillin every 6-12 hours and that adults with glomerular filtration rates less than 10 mL/minute receive the usual dose every 12-16 hours.

Alternatively, some clinicians suggest that modification of usual dosage of ampicillin is unnecessary in adults with creatinine clearances of 30 mL/minute or greater, but adults with creatinine clearances of 10 mL/minute or less should receive the usual dose of the drug every 8 hours. Patients undergoing hemodialysis should receive a supplemental dose of ampicillin after each dialysis period.

Cautions

Adverse Effects

Adverse effects reported with ampicillin are similar to those reported with other aminopenicillins; however, diarrhea and rash have been reported more frequently with ampicillin than with other currently available aminopenicillins. For information on adverse effects reported with aminopenicillins, seeCautions in the Aminopenicillins General Statement 8:12.16.08.

Precautions and Contraindications

Ampicillin shares the toxic potentials of the penicillins, including the risk of hypersensitivity reactions, and the usual precautions of penicillin therapy should be observed. Prior to initiation of therapy with ampicillin careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other drugs. There is clinical and laboratory evidence of partial cross-allergenicity among penicillins and other b-lactam antibiotics including cephalosporins, cephamycins, and 1-oxa-b-lactams.

Ampicillin is contraindicated in patients who are hypersensitive to any penicillin. Because a high percentage of patients with infectious mononucleosis have developed rash during therapy with aminopenicillins, ampicillin probably should not be used in patients with this disease. Renal, hepatic, and hematologic systems should be evaluated periodically during prolonged therapy with ampicillin.

For a more complete discussion of these and other precautions associated with the use of ampicillin, see Cautions: Precautions and Contraindications, in the Aminopenicillins General Statement 8:12.16.08.

Pregnancy and Lactation

Safe use of ampicillin during pregnancy has not been established. There are no adequate or controlled studies using ampicillin in pregnant women, and the drug should be used during pregnancy only when clearly needed. However, ampicillin has been administered to pregnant women, especially in the treatment of urinary tract infections, without evidence of adverse effects to the fetus.

Because ampicillin is distributed into milk, the drug should be used with caution in nursing women. Spectrum Based on its spectrum of activity, ampicillin is classified as an aminopenicillin.

For information on the classification of penicillins based on spectra of activity, see the Preface to the General Statements on Penicillins 8:12.16. Ampicillin generally has the same spectrum of activity and the same level of activity against susceptible organisms as amoxicillin; however, ampicillin is less active in vitro on a weight basis than amoxicillin against enterococci and Salmonella but more active than amoxicillin against Shigella andEnterobacter.

For specific information on in vitro susceptibility testing and information on the spectrum of activity of ampicillin and resistance to the drug, see the sections on Spectrum and on Resistance in the Aminopenicillins General Statement 8:12.16.08.

Pharmacokinetics

For additional information on absorption and distribution of ampicillin and information on elimination of the drug, see Pharmacokinetics in the Aminopenicillins General Statement 8:12.16.08.

Absorption

Anhydrous ampicillin (no longer commercially available in the US) and ampicillin trihydrate generally are stable in the presence of acidic gastric secretions, and 30-55% of an oral dose of the drugs is absorbed from the GI tract in fasting adults.

Although peak serum concentrations may occur as soon as 1 hour after administration, the maximum serum concentration usually is attained in approximately 2 hours. Two hours after oral administration of 250 mg of ampicillin in fasting individuals, average peak serum concentrations of 1.8-2.9 mcg/mL are attained. A 500-mg oral dose results in average peak serum concentrations of 3-6 mcg/mL.

Concentrations of the antibiotic in serum are less than 1 mcg/mL 6 hours after a 500-mg oral dose. Although higher peak serum ampicillin concentrations and larger areas under the serum concentration-time curves (AUCs) have been reported following oral administration of anhydrous ampicillin than following the trihydrate, the differences are generally not considered clinically important. As oral dosage of ampicillin is increased from 500 mg to 2 g, the fraction of the dose absorbed from the GI tract decreases and, there is a nonlinear relationship between dosage and peak serum concentrations or AUCs of ampicillin.

Presence of food in the GI tract generally decreases the rate and extent of absorption of ampicillin.

Following IM administration of ampicillin sodium, peak serum concentrations generally are attained more quickly and are higher than those resulting from equivalent doses of ampicillin given orally. In premature neonates younger than 7 days of age, IM administration of a single ampicillin dose of 50 mg/kg has been reported to produce mean serum concentrations of 104, 87, 60, and 31 mcg/mL at 1, 4, 8, and 12 hours, respectively, after the dose.

The same dose in full-term neonates younger than 7 days of age produced mean serum concentrations of 75, 64, 34, and 20 mcg/mL at the same time intervals.

Following IV administration over 20 minutes of a single 2-g dose of ampicillin in healthy adults, serum concentrations of ampicillin averaged 47.6, 23.3, 10.8, and 3.7mcg/mL at 30 minutes, 1 hour, 2 hours, and 4 hours, respectively, after the infusion. Serum ampicillin concentrations are higher and the serum half-life is prolonged in patients with impaired renal function. Serum concentrations of the drug also are higher and more prolonged in premature or full-term neonates younger than 6 days of age than in full-term neonates 6 days of age or older.

Distribution

In one study in neonates with meningitis, average ampicillin concentrations in CSF ranged from 1-28 mcg/mL (11-65% of simultaneous serum concentrations) during the 7-hour period following IV administration of 40-70 mg/kg. Highest CSF concentrations occurred at 3-7 hours. Ampicillin is distributed into bile. Biliary concentrations of ampicillin in patients with normal biliary function may be 1-30 times greater than simultaneous serum concentrations following a single oral dose of ampicillin.

Chemistry and Stability

Chemistry

Ampicillin is an aminopenicillin. Ampicillin differs structurally from penicillin G only in the presence of an amino group at the a-position on the benzene ring at R on the penicillin nucleus.

Ampicillin is commercially available as ampicillin trihydrate for oral administration and as the sodium salt for parenteral administration. Potency of ampicillin trihydrate and ampicillin sodium is expressed in terms of ampicillin and is calculated on the anhydrous basis. Ampicillin trihydrate occurs as a white, practically odorless, crystalline powder that is slightly soluble in water.

Ampicillin trihydrate reportedly has aqueous solubility of about 6 mg/mL at 20°C and about 10 mg/mL at 40°C. Ampicillin sodium occurs as a white to off-white, odorless or practically odorless, crystalline, hygroscopic powder and is very soluble in water, in 0.9% sodium chloride, and in dextrose solutions.

Reconstituted solutions of ampicillin sodium containing 10 mg of ampicillin per mL have a pH of 8-10. When reconstituted as directed, ampicillin trihydrate oral suspensions have a pH of 5-7.5. Commercially available ampicillin sodium powder for injection contains 2.9-3. mEq of sodium per g of ampicillin.

Stability

Ampicillin capsules and powder for oral suspension should be stored in tight containers at 15-30°C. Following reconstitution, oral suspension of ampicillin trihydrate preferably should be refrigerated at 2-8°C but is stable for 7 days at room temperature or 14 days at 2-8°C.

Following reconstitution with sterile or bacteriostatic water for injection, ampicillin sodium solutions for IM or direct IV injection should be used within 1 hour after reconstitution and should not be frozen.

The stability of ampicillin sodium in solution is concentration dependent and decreases as the concentration of the drug increases. Ampicillin sodium appears to be especially susceptible to inactivation in solutions containing dextrose, which appears to have a catalytic effect on hydrolysis of the drug.

The manufacturers report that when stored at room temperature (25°C), ampicillin sodium solutions containing 30 mg or less of ampicillin per mL in sterile water for injection, 0.9% sodium chloride injection, 1/6 M sodium lactate injection, or lactated Ringer’s injection lose less than 10% of activity within 8 hours and solutions containing 2 mg or less of ampicillin per mL in 5% dextrose, 5% dextrose and 0.45% sodium chloride, or 10% invert sugar lose less than 10% of activity within 4 hours. At concentrations of 10-20 mg/mL in 5% dextrose, ampicillin loses less than 10% of its activity within 2 hours at room temperature.

When refrigerated at 4°C, ampicillin sodium solutions containing 30 mg of ampicillin per mL are stable for 48 hours in sterile water for injection or 0.9% sodium chloride injection and solutions containing 30 mg or less per mL are stable for 24 hours in lactated Ringer’s or 8 hours in 1/6 M sodium lactate injection. Solutions of the drug containing 20 mg or less of ampicillin per mL are stable at 4°C for 72 hours in sterile water for injection or 0.9% sodium chloride injection, 4 hours in 5% dextrose, or 3 hours in 10% invert sugar and solutions containing 10 mg or less per mL are stable for 4 hours at 4°C in 5% dextrose and 0.45% sodium chloride.

Following reconstitution of the commercially available 10-g pharmacy bulk package of ampicillin sodium, solutions containing 100 mg of ampicillin per mL should either be used or discarded within 2 hours if stored at room temperature or within 4 hours if refrigerated. If reconstituted solutions of the 10-g bulk unit containing 100 mg/mL are stored for less than 1 hour at room temperature prior to dilution with a compatible IV solution, previously stated stability information associated with the diluents is applicable. Ampicillin sodium is potentially physically and/or chemically incompatible with some drugs, including aminoglycosides, but the compatibility depends on several factors (e.g., concentrations of the drugs, specific diluents used, resulting pH, temperature).

For information on the in vitro and in vivo incompatibility of penicillins and aminoglycosides, see Drug Interactions: Aminoglycosides, in the Aminopenicillins General Statement 8:12..08. Specialized references should be consulted for specific compatibility information.

Because of the potential for incompatibility, ampicillin sodium and aminoglycosides should not be admixed. For further information on chemistry and stability, mechanism of action, spectrum, resistance, pharmacokinetics, uses, cautions, drug interactions, laboratory test interferences, and dosage and administration of ampicillin, see the Aminopenicillins General Statement 8:12.16.08.

Preparations

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