Ampicillin Trihydrate

AMPICILLIN TRIHYDRATE- ampicillin trihydrate capsule
Golden State Medical Supply, Inc.

Rx Only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin capsules, Ampicillin for Oral Suspension and other antibacterial drugs, Ampicillin capsules and Ampicillin for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Ampicillin is designed chemically as (2S, 5R, 6R)-6-[(R)-2-Amino-2-phenylacetamido]-3, 3-dimethyl-7-oxo-4-this-l-azabicyclo[3.2.0]heptane-2-carbxylic acid trihydrate. It has the following chemical structure:

Chemical Structure -- Ampicillin
(click image for full-size original)

The molecular formula is C16 H19 N3 O4 S.3H2 O, and the molecular weight is 403.45.


Ampicillin Capsules, USP for oral administration provides ampicillin trihydrate equivalent to 250 mg and 500 mg ampicillin. Ampicillin capsules, USP also contain magnesium stearate, NF. The capsule shell contains black iron oxide; FD&C red No. 28; FD&C blue No. 1; gelatin, NF; silicon dioxide, NF; sodium lauryl sulfate, NF; titanium dioxide USP.

CLINICAL PHARMACOLOGY

Ampicillin is bactericidal at low concentrations and is clinically effective not only against the gram-positive organisms usually susceptible to penicillin G but also against a variety of gram-negative organisms. It is stable in the presence of gastric acid and is well absorbed from the gastrointestinal tract. It diffuses readily into most body tissues and fluids; however, penetration into the cerebrospinal fluid and brain occurs only with meningeal inflammation. Ampicillin is excreted largely unchanged in the urine; its excretion can be delayed by concurrent administration of probenecid which inhibits the renal tubular secretion of ampicillin. In blood serum, ampicillin is the least bound of all the penicillins; an average of about 20 percent of the drug is bound to plasma proteins as compared to 60 to 90 percent of the other penicillins. The administration of 500 mg dose of ampicillin capsules results in an average peak blood serum level of approximately 3.0 mcg/mL; the average peak serum level for the same dose of ampicillin for oral suspension is approximately 3.4 mcg/mL.

Microbiology: While in vitro studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections other than those included in the INDICATIONS AND USAGE section has not been documented.

GRAM-POSITIVE: strains of alpha- and beta-hemolytic streptococci, Streptococcus pneumoniae , those strains of staphylococci, which do not produce penicillinase, Clostridium sp., Bacillus anthracis, Corynebacterium xerose , and most strains of enteracocci.

GRAM-NEGATIVE: Hemophilus influenzae; Neisseria gonorrhoeae and N. Meningitidis; Proteus mirabilis , and many strains of Salmonella (including S. typhosa), Shigella , and Escherichia coli.

NOTE: Ampicillin is inactivated by penicillinase and therefore is ineffective against penicillinase-producing organisms including certain strains at staphylococci, Pseudomonas aeruginosa, P. Vulgaris, Klebsiella pneumoniae, Enterobacter aerogenes , and some strains of E. coli. Ampicillin is not active against Rickettsia, Mycoplasma, and “large viruses” (Miyagawanella).

TESTING FOR SUSCEPTIBILITY: The invading organism should be cultured and its susceptibility demonstrated as a guide to therapy. If the Kirby-Bauer method of disc susceptibility is used, a 10 mcg ampicillin disc should be used to determine the relative in vitro susceptibility.

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin capsules, Ampicillin for Oral Suspension and other antibacterial drugs, Ampicillin capsules and Ampicillin for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting of modifying anitimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy.

Ampicillin Capsules are indicated in the treatment of infections caused by susceptible strains of the designated organism listed below;

Infections of the Genitourinary Tract Including Gonorrhea: E. coli, P. mirabilis , enterococci, Shigella, S. typhosa and other Salmonella, and nonpenicillinase-producing N. gononhoeae.

Infections of the Respiratory Tract: Nonpenicillinase-producing H. influenzae and staphylococci, and streptococci including Streptococcus pneumoniae.

Infections of the Gastrointestinal Tract: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis , and enterococci.

Meningitis: N. Meningitides.

Bacteriology studies to determine the causative organisms and their sensetivity to ampicillin should be performed. Therapy may be instituted prior to the results of susceptibility testing.

CONTRAINDICATIONS

A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication. Ampicillin is also contraindicated in infections caused by penicillinase-producing organisms.

WARNINGS

SERIOUS AND OCCASIONAL FATAL HYPERSENSITIVITY (ANAPHYLACTOID) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL ADMINISTRATION, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE APT TO OCCUR IN INDIVIDUALS WITH A HISTORY AT 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 WHO HAVE EXPERIENCED SEVERE HYPERSENSITIVITY REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH ANY 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.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ampicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile , is one primary cause of “antibiotic-associated colitis”.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

PRECAUTIONS

General

Prescribing Ampicillin capsules in the absence of a proven or strongly suspected bacterial infection of a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms, including fungi.

Should superinfection occur, appropriate measures should be taken.

Patients with gonorrhea who also have syphilis should be given additional appropriate parenteral penicillin treatment.

Treatment with ampicillin does not preclude the need for surgical procedures, particularly in staphylococcal infections.

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