Ampicillin
Indication
PRINCIPEN Capsules (Ampicillin Capsules) and PRINCIPEN for Oral
Suspension (Ampicillin for Oral Suspension) 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: O. 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.
Description
Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Ampicillin is designated chemically as (2S, 5R, 6R)-6-[(8)-2-Amino-2-phenylacetamido]-3,3-dimethyl-t-oxo-4-thia-1- azabicyclo[3.2.0] heptane-2-carboxylic acid. The chemical formula is C16H19N3O4S·3H2O and its molecular weight is 403.45.
This is the anhydrous form of ampicillin. It is prepared as the trihydrate form attached to 3 water (H2O) molecules.
PRINCIPEN Capsules (Ampicillin Capsules USP) for oral administration provide ampicillin trihydrate equivalent to 250 mg and 500 mg ampicillin.
Inactive ingredients: black iron oxide, gelatin, FD&C Blue #1, FD&C Red #3, FD&C Red #40, lactose monohydrate, silica gel, and titanium dioxide.
PRINCIPEN for Oral Suspension
(Ampicillin for oral suspension USP) provide, after constitution,
ampicillin trihydrate equivalent to 125 mg and 250 mg ampicillin per 5
mL.
Inactive ingredients: antifoam AF emulsion,
Atmos 300, colloidal silicon dioxide, FD&C Red #40, lecithin,
natural and artificial flavors, sucrose, sodium citrate, sodium benzoate, and vanillin.
Side Effect
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 penicillin 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: glositis, stamatitis, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. These reactions are usually associated with oral dosage forms of the drugs.
Hypersensitivity Reactions: An erythematous, mildly pruritic, maculopapular skin rash has been reported fairly frequently. The rash, which usually does not develop within the first week of therapy, may cover the entire body including the soles, palms, and oral mucosa. The eruption usually disappears in three to seven days.
Other hypersensitivity reactions that have been reported are: skin rash, pruritus, urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form of the drug
Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled by 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 anaphylactoid reactions require emergency measure.
Liver: Moderate elevation in serum glutamic oxalaacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown.
Hemic and Lymphatic Systems: Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukapenia, and agranulacytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Other: Other adverse reactions that have been reported with the use at ampicillin are laryngeal stride and high fever. An occasional patient may complain of sore mouth or tongue as with any oral penicillin preparation.
Dosage
Adults and Children Weight Over 20 kg.
For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg qid in equally spaced doses; severe or chronic infections may require larger doses.
For the treatment of gonerrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endo-cervical and anal canals. Prolonged intensive therapy is needed for complications such as proshtitis and epididymitis. For respiratory tract infections, the usual dose is 250 mg qid in equally spaced doses.
Children Weighing 20 kg or Less
For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, qid in equally divided and spaced doses. For respiratory infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults,
All Patients, Irrespective of Age and Weight
Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one half-hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence at bacterial eradication has been obtained. In infections caused by hemolytic strains of streptococci, a minimum of 10 days treatment is recommended to guard against the risk of rheumatic fever of glomerulonephritis (see PRECAUTIONS —
Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.
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: O. 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.
Description
Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Ampicillin is designated chemically as (2S, 5R, 6R)-6-[(8)-2-Amino-2-phenylacetamido]-3,3-dimethyl-t-oxo-4-thia-1- azabicyclo[3.2.0] heptane-2-carboxylic acid. The chemical formula is C16H19N3O4S·3H2O and its molecular weight is 403.45.
The following adverse reactions have been reported as associated with the use of ampicillin:
Gastrointestinal: glositis, stamatitis, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. These reactions are usually associated with oral dosage forms of the drugs.
Hypersensitivity Reactions: An erythematous, mildly pruritic, maculopapular skin rash has been reported fairly frequently. The rash, which usually does not develop within the first week of therapy, may cover the entire body including the soles, palms, and oral mucosa. The eruption usually disappears in three to seven days.
Other hypersensitivity reactions that have been reported are: skin rash, pruritus, urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form of the drug
Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled by 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 anaphylactoid reactions require emergency measure.
Liver: Moderate elevation in serum glutamic oxalaacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown.
Hemic and Lymphatic Systems: Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukapenia, and agranulacytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Other: Other adverse reactions that have been reported with the use at ampicillin are laryngeal stride and high fever. An occasional patient may complain of sore mouth or tongue as with any oral penicillin preparation.
Adults and Children Weight Over 20 kg.
For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg qid in equally spaced doses; severe or chronic infections may require larger doses.
For the treatment of gonerrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endo-cervical and anal canals. Prolonged intensive therapy is needed for complications such as proshtitis and epididymitis. For respiratory tract infections, the usual dose is 250 mg qid in equally spaced doses.
Children Weighing 20 kg or Less
For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, qid in equally divided and spaced doses. For respiratory infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults,
All Patients, Irrespective of Age and Weight
Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one half-hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence at bacterial eradication has been obtained. In infections caused by hemolytic strains of streptococci, a minimum of 10 days treatment is recommended to guard against the risk of rheumatic fever of glomerulonephritis (see PRECAUTIONS —
Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.