North China Pharma


Full Prescribing Info
Ampicillin sodium.
Each vial contains Ampicillin Sodium equivalent to 500 mg and 1 gram.
Pharmacology: Pharmacokinetics: Ampicillin is relatively stable in the acid gastric section and is moderately well absorbed from the gastro-intestinal tract after oral administration. Food can interfere with the absorption of Ampicillin so doses should preferable be taken at least 30 minutes before meals. Peak concentrations in plasma are obtained in about 1 to 2 hours and following a dose of 500 mg by mouth are reported to range from 2 to 6 μg per mL. Ampicillin is given by injection as the sodium salt and following the intramuscular administration of 500 mg peak plasma concentrations occur within about 1 hour and reported to range from 7 to 14 μg per mL.
Ampicillin is widely distributed and therapeutic concentration can be achieved in ascetic, pleural and joint fluids. It crosses the placental into the fetal circulation and small amounts are excreted in breast milk. There is little diffusion into the cerebrospinal fluid except when the meninges are inflamed. About 20% is bound to plasma proteins and the half-life is about 1 to 1.5 hours, but this may be increased in neonates and the elderly; in renal failure half-lives or 7 to 20 hours have been reported.
Ampicillin is metabolized to some extent to penicilloic acid which is excreted in the urine.
Renal clearance of Ampicillin occurs partly by glomerular filtration and party by tubular secretion; it is retarded by the concomitant administration of probenecid. About 20 to 40% of an orally administered dose may be excreted unchanged in the urine in 6 hours; urinary concentrations have ranged from 0.25 to 1 mg per mL following a dose of 500 mg, following parenteral administration about 60 to 80% is excreted in the urine within 6 hours. Ampicillin is removed by haemodialysis. High concentrations are reached in bile; it undergoes enterohepatic recycling and some is excreted in the feces.
Used in the treatment of a variety of infections due to susceptible organism including biliary-tract infections; endocarditis, bronchitis, gastro-enteritis, gonorrhea, listeriosis, meningitis, upper and lower respiratory tract infections, otitis media, perinatal streptococcal infections, peritonitis, septicemia, typhoid and paratyphoid fever and urinary tract infections.
Dosage/Direction for Use
I.M./I.V. daily in divided doses every 4 to 6 hours (have been administered intravenously over 10 to 15 minutes for serious infections). Or as prescribed by the physician.
Directions for Reconstitution: 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.
For Intramuscular Use: Dissolve contents of a vial with the amount of Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, listed in the table as follows: See table.

Click on icon to see table/diagram/image

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.
For Direct Intravenous Use: Add 5 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP to the 125, 250, and 500 mg vials and administer slowly over a 3- to 5- minute period. Ampicillin for Injection, USP, 1 g or 2 g, may also be given by direct Intravenous administration. Dissolve in 7.4 or 14.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively, and administer slowly over at least 10 to 15 minutes. CAUTION: More rapid administration may result in convulsive seizures.
For Administration by Intravenous Drip: Reconstitute as previously directed (For Direct Intravenous Use) prior to diluting with Intravenous Solution. Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated. Discard any remaining portion after use.
Hypersensitivity to Penicillin.
Special Precautions
Ampicillin should be discontinued if a skin rash occurs. It should preferably not be given to patients, with infectious mononucleosis since they are especially susceptible to ampicillin-included skin rashes; patients with lymphatic leukaemic of possibly HIV infection may also be at increased risk of developing skin rashes.
Adverse Reactions
Skin rashes are among the most common side effects and are generally either urticarial or maculopapular; the urticarial reactions are typical of penicillin hypersensitivity while the erythematous maculopapular eruptions are characteristics of Ampicillin and Amoxicillin often appear more than 7 days after commencing treatment. There has been controversy over whether the maculopapular rash is an allergic rash is an allergic or toxic response but since in practice it may be difficult to distinguish between them skin testing for hypersensitivity may be advisable before another penicillin is used in patients who have had ampicillin rashes. Most patients with infectious mononucleosis develop a maculopapular rash when treated with ampicillin, and patients with other lymphoid disorders such as lymphatic leukemia also appear to be at higher risk.
Gastro-intestinal adverse effects particularly diarrhea and also nausea and vomiting occur quite frequently usually following administration by mouth. Pseudomembranous colitis has also been reported.
MIMS Class
ATC Classification
J01CA01 - ampicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Powd for inj (vial) 500 mg x 10's. 1 g x 10's.
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