Spectrobid Side Effects

Generic name: bacampicillin

Note: This document contains side effect information about bacampicillin. Some of the dosage forms listed on this page may not apply to the brand name Spectrobid.

Some side effects of Spectrobid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bacampicillin: oral tablet

If you experience any of the following serious side effects, stop taking bacampicillin (the active ingredient contained in Spectrobid) and seek emergency medical attention or contact your doctor immediatley:

• an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);

• seizures;

• severe watery diarrhea and abdominal cramps; or

• unusual bleeding or bruising.

Other, less serious side effects may be more likely to occur. Continue to take bacampicillin and talk to your doctor if you experience

• mild nausea, vomiting, diarrhea, or abdominal pain;

• white patches on the tongue (thrush/yeast infection);

• itching or discharge of the vagina (vaginal yeast infection); or

• black, "hairy" tongue or sore mouth or tongue.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to bacampicillin: oral tablet

Hypersensitivity

Besides the urticarial rash of hypersensitivity to bacampicillin (the active ingredient contained in Spectrobid) a delayed hypersensitivity maculopapular rash may occur 10 to 12 days after bacampicillin therapy is begun.

Hypersensitivity reactions have included rare cases of interstitial nephritis, Henoch-Schonlein Purpura, focal glomerulonephritis and Stevens-Johnson syndrome.

Hypersensitivity reactions occur in up to 5% of patients treated with bacampicillin. Such reactions may include urticarial rashes, edema, hypotension, fever, eosinophilia, Stevens-Johnson syndrome, and dyspnea. Anaphylaxis is rare. Bacampicillin should not be given to patients with a penicillin allergy.

Gastrointestinal

Gastrointestinal adverse effects occur in 2% to 5% of treated patients and may include diarrhea, nausea, vomiting, and abdominal cramps. Rare cases of hepatitis and pancreatitis have been reported with ampicillin, the active form of bacampicillin (the active ingredient contained in Spectrobid) Monitoring of liver function tests is recommended in patients with liver dysfunction.

Bacampicillin-associated diarrhea is usually self-limited and is likely related to alterations in the intestinal microflora. Such alterations may predispose patients to the development of diarrhea from Clostridium difficile toxin. Rare cases of transiently increased liver function tests and chronic cholestasis associated with ampicillin have been reported.

Acute pancreatitis associated with ampicillin has been reported and confirmed by rechallenge with ampicillin in a patient with no other obvious cause of pancreatitis.

Hematologic

Rare cases of thrombocytopenia, leukopenia, red cell aplasia, and anemia have been reported.

Hematologic adverse effects of bacampicillin are rare and include thrombocytopenia, red cell aplasia, and anemia.

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