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Ticar (Ticarcillin Disodium) - Warnings and Precautions

 
 



WARNINGS

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients receiving penicillin. These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens.

There are reports of patients with a history of penicillin hypersensitivity reactions who experience severe hypersensitivity reactions when treated with a cephalosporin. Before therapy with a penicillin, careful inquiry should be made about previous hypersensitivity reactions to penicillins, cephalosporins and other allergens. If a reaction occurs, the drug should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to ticarcillin therapy. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.

Some patients receiving high doses of ticarcillin may develop hemorrhagic manifestations associated with abnormalities of coagulation tests, such as bleeding time and platelet aggregation. On withdrawal of the drug, the bleeding should cease and coagulation abnormalities revert to normal. Other causes of abnormal bleeding should also be considered. Patients with renal impairment, in whom excretion of ticarcillin is delayed, should be observed for bleeding manifestations. Such patients should be dosed strictly according to recommendations (see DOSAGE AND ADMINISTRATION). If bleeding manifestations appear, ticarcillin treatment should be discontinued and appropriate therapy instituted.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Ticar , and has ranged 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 1 primary cause of “antibiotic-associated colitis.”

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 effective against C. difficile.

PRECAUTIONS

Although Ticar exhibits the characteristic low toxicity of the penicillins, as with any other potent agent, it is advisable to check periodically for organ system dysfunction (including renal, hepatic and hematopoietic) during prolonged treatment. If overgrowth of resistant organisms occurs, the appropriate therapy should be initiated.

Since the theoretical sodium content is 5.2 mEq (120 mg) per gram of ticarcillin, and the actual vial content can be as high as 6.5 mEq/gram, electrolyte and cardiac status should be monitored carefully.

In a few patients receiving intravenous ticarcillin, hypokalemia has been reported. Serum potassium should be measured periodically, and, if necessary, corrective therapy should be implemented.

As with any penicillin, the possibility of an allergic response, including anaphylaxis, exists, particularly in hypersensitive patients.

Usage During Pregnancy

Reproduction studies have been performed in mice and rats and have revealed no evidence of impaired fertility or harm to the fetus due to ticarcillin. There are no well-controlled studies in pregnant women, but investigational experience does not include any positive evidence of adverse effects on the fetus. Although there is no clearly defined risk, such experience cannot exclude the possibility of infrequent or subtle damage to the fetus. Ticarcillin should be used in pregnant women only when clearly needed.

Page last updated: 2006-01-26

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