Ampicillin 500 mg Capsule, 500-count — NDC 0781-2145-05 (Billing 00781-2145-05)

WARNINGS SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.

THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE THERAPY WITH ANY PENICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, APPROPRIATE THERAPY SHOULD BE CONSIDERED.

SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Severe Cutaneous Adverse Reactions Ampicillin may cause severe cutaneous adverse reactions (SCARs), such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), exfoliative dermatitis, erythema multiforme, and acute generalized exanthematous pustulosis (AGEP).

If patients develop a skin rash, they should be monitored closely, and ampicillin discontinued if lesions progress. Hepatotoxicity Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of ampicillin. Hepatic toxicity is usually reversible; however, deaths have been reported.

Hepatic function should be monitored at regular intervals in patients with hepatic impairment. Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ampicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

ADVERSE REACTIONS 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: Infections and Infestations: Clostridioides difficile -associated diarrhea (see WARNINGS section).

Gastrointestinal : glossitis, stomatitis, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. These reactions are usually associated with oral dosage forms of the drugs. Hypersensitivity Reactions : Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, and acute generalized exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics (see WARNINGS ).

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. Linear IgA bullous dermatosis has been reported. 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 anaphylactic reactions require emergency measures (see WARNINGS ).

Liver : Moderate elevation in serum glutamic oxaloacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown. Hemic and Lymphatic Systems : Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Other adverse reactions that have been reported with the use of ampicillin are laryngeal stridor and high fever. An occasional patient may complain of sore mouth or tongue as with any oral penicillin preparation.

Drug Interactions When administered concurrently, the following drugs may interact with ampicillin. Allopurinol : Substantially increased incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

Bacteriostatic Antibiotics : Chloramphenicol, erythromycins, sulfonamides, or tetracyclines may interfere with the bactericidal effect of penicillins. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well-documented. Oral Contraceptives : May be less effective and increased breakthrough bleeding may occur.

Probenecid : May decrease renal tubular secretion of ampicillin resulting in increased blood levels and/or ampicillin toxicity.

Drug/Laboratory Test Interactions After treatment with ampicillin, a false-positive reaction for glucose in the urine may occur with copper sulfate tests (Benedict’s solution, Fehling’s solution, or Clinitest ® tablets) but not with enzyme based tests such as Clinistix ® and Tes-Tape ® . Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol has been noted.

PRECAUTIONS General A high percentage of patients with mononucleosis who receive ampicillin develop a skin rash. Thus, ampicillin class antibacterial should not be administered to patients with mononucleosis. In patients treated with ampicillin the possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy.

If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted. Prescribing ampicillin in the absence of a proven or strongly suspected bacterial infection or 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.

Information for the Patient 1. The patient should inform the physician of any history of sensitivity to allergens, including previous hypersensitivity reactions to penicillins and cephalosporins (see WARNINGS ). 2.

Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking ampicillin immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see WARNINGS ]. 3.

Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible.

4. Ampicillin should be taken with a full glass (8 oz) of water, one-half hour before or two hours after meals. 5.

Diabetic patients should consult with the physician before changing diet or dosage of diabetes medication (see PRECAUTIONS–Drug/Laboratory Test Interactions ). 6. Patients should be counseled that antibacterial drugs including ampicillin should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When ampicillin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ampicillin or other antibacterial drugs in the future.

Laboratory Tests In prolonged therapy, and particularly with high dosage regimens, periodic evaluation of the renal, hepatic, and hematopoietic systems is recommended. In streptococcal infections, therapy, must be sufficient to eliminate the organism (10 days minimum); otherwise the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment to determine whether streptococci have been eradicated.

Cases of gonococcal infection with a suspected lesion of syphilis should have darkfield examinations ruling out syphilis before receiving ampicillin. Patients who do not have suspected lesions of syphilis and are treated with ampicillin should have a follow-up serologic test for syphilis each month for four months to detect syphilis that may have been masked from treatment for gonorrhea. Drug Interactions When administered concurrently, the following drugs may interact with ampicillin.

Allopurinol : Substantially increased incidence of skin rash… [Excerpted — this section continues on DailyMed.]