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The following are discussed in more detail in other sections of the labeling:
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions occurring in ≥ 1% of 867 patients receiving TIMENTIN 3.1 grams in clinical studies included rash, nausea, diarrhea, and phlebitis at the injection site. The most common laboratory abnormalities ( ≥ 3%) were elevations in eosinophils, serum aspartate aminotransferase (AST), and serum alanine aminotransferase (ALT).
Available safety data for pediatric patients treated with TIMENTIN demonstrate a similar adverse event profile to that observed in adult patients.
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use of TIMENTIN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These adverse reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to TIMENTIN.
Skin rash, pruritus, urticaria, arthralgia, myalgia, drug fever, chills, chest discomfort, anaphylactic reactions, and bullous reactions (including erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome).
Central Nervous System
Headache, giddiness, neuromuscular hyperirritability, or convulsive seizures.
Disturbances of taste and smell, stomatitis, flatulence, nausea, vomiting and diarrhea, epigastric pain, and pseudomembranous colitis have been reported. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see WARNINGS AND PRECAUTIONS].
Hemic and Lymphatic Systems
Abnormalities of Hepatic Function Tests
Elevation of AST, ALT, serum alkaline phosphatase, serum LDH, and serum bilirubin. There have been reports of transient hepatitis and cholestatic jaundice, as with some other penicillins and some cephalosporins.
Renal and Urinary Effects
Read the Timentin Injection (ticarcillin disodium and clavulanate potassium galaxy) Side Effects Center for a complete guide to possible side effects
The mixing of TIMENTIN with an aminoglycoside in solutions for parenteral administration can result in substantial inactivation of the aminoglycoside.
Probenecid interferes with the renal tubular secretion of ticarcillin, thereby increasing serum concentrations and prolonging serum half-life of ticarcillin. Probenecid does not affect the serum levels of clavulanic acid.
Effects On Laboratory Tests
High urine concentrations of ticarcillin may produce false-positive protein reactions (pseudoproteinuria) with certain methods. The bromphenol blue reagent strip test has been reported to be a reliable method for testing protein reactions [see WARNINGS AND PRECAUTIONS].
Clavulanic acid in TIMENTIN may cause a nonspecific binding of IgG and albumin by red cell membranes, leading to a false-positive Coombs test. A positive Coombs test should be interpreted with caution during treatment with TIMENTIN [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 6/27/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Timentin Injection Information
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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