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Principen

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Principen

Principen

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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 PRECAUTIONSLaboratory 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.

HOW SUPPLIED

PRINCIPEN Capsules (Ampicillin Capsules USP):

250 mg/capsule: Size 2 capsule with a light gray body and scarlet cap. Printed in black ink with BRISTOL 7902 on both body and cap.

    bottles of 100 NDC 0003-0122-50
    bottles of 500 NDC 0003-0122-60
    Unimatic, unit dose packs of 100 NDC 0003-0122-51

500 mg/capsule: Size 0 capsule with a light gray body and scarlet cap. Printed in black ink with BRISTOL 7093 on both body and cap.

    bottles of 100 NDC 0003-0134-50
    bottles of 500 NDC 0003-0134-60
    Unimatic, unit dose packs of 100 NDC 0003-0134-51

PRINCIPEN for Oral Suspension (Ampicillin for Oral Suspension USP):

Ampicilin 125: When constituted as directed on the container label, a pleasant fruit-flavored suspension containing: 125 mg per 6 mL, In bottle sizes for preparation of

    100 mL NDC 0003-0969-09
    150 mL NDC 0003-0969-52
    200 mL NOC 0003-0969-61

Ampicilin 260: When constituted as directed on the container label, a pleasant fruit-flavored suspension containing: 250 mg per 5 mL, In bottle sizes for preparation of

    100 mL NDC 0003-0972-52
    200 mL NDC 0003-0972-61

Storage

Capsules: Store at room temperature; avoid excessive heat; keep tightly closed.

Ampicilin for oral suspension: Store at room temperature; after constitution, discard unused portion after 7 days if kept at room temperature or after 14 days if refrigerated; keep bottles tightly closed.

For Rx only

Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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