"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(Generic versions may still be available.)
In clinical studies involving 1,118 patients, the following adverse effects were considered to be related to cinoxacin therapy:
Gastrointestinal: Nausea was reported most commonly and occurred in less than 3 in 100 patients. Other side effects, occurring less frequently (1 in 100), were anorexia, vomiting, abdominal cramps/pain, perverse taste, and diarrhea.
Central Nervous System: The most frequent side effects were headache and dizziness, reported by 1 in 100 patients. Other adverse reactions possibly related to Cinobac (cinoxacin) include insomnia, drowsiness, tingling sensation, perineal burning, photophobia, and tinnitus. These were reported by less than 1 in 100 patients.
Hypersensitivity: Rash, urticaria, pruritus, edema, angioedema, and eosinophilia were reported by less than 3 in 100 patients. Rare cases of anaphylactic reactions have been reported. Toxic epidermal necrolysis has been reported very rarely. Erythema multiforme and Stevens-Johnson syndrome have been reported with cinoxacin and other drugs in this class.
Hematologic: Rare reports of thrombocytopenia.
Laboratory values reported to be abnormal were, in descending order of frequency, elevation of BUN (1 in 100), AST (SGOT), ALT (SGPT), serum creatinine, and alkaline phosphatase; and reduction in hematocrit/hemoglobin (each less than 1 in 100).
Although not observed in the 1,118 patients treated with cinoxacin the following side effects have been reported for other drugs in the same pharmacologically active and chemically related class: restlessness nervousness, change in color perception, difficulty in focusing, decrease in visual acuity, double vision, weakness, constipation, erythema and bullae feelings of disorientation or agitation or acute anxiety, palpitation, soreness of the gums, joint stiffness, swelling of the extremities, and toxic psychosis or convulsions (rare). All adverse reactions observed with drugs in this class were reversible.
The most frequently reported adverse events in post marketing surveillance of cinoxacin have been rash and anaphylactic reactions. Other frequently reported reactions have been pruritus, urticaria, allergic reactions, nausea, abdominal pain, and headache.
Read the Cinobac (cinoxacin) Side Effects Center for a complete guide to possible side effects
Elevated plasma levels of theophylline have been reported with concomitant use of some quinolones. There have been reports of theophylline-related side-effects in patients on concomitant theophylline-quinolone therapy. Therefore, monitoring of theophylline plasma levels should be considered and dosage of theophylline adjusted as required.
Quinolones have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of its plasma half-life. Although this interaction has not been reported with cinoxacin, caution should be exercised when cinoxacin is given concomitantly with caffeine-containing products.
Antacids or sucralfate substantially interfere with the absorption of some quinolones, resulting in low urine levels. Also, concomitant administration of quinolones with products containing iron, multivitamins containing zinc, or Videx (didanosine) chewable/buffered tablets or the pediatric powder for oral solution may result in low urine levels.
Quinolones, including cinoxacin, may enhance the effects of oral anticoagulants, such as warfarin or its derivatives. When these products are administered concomitantly, prothrombin time or other suitable coagulation tests should be closely monitored.
Seizures have been reported in patients taking another quinolone class antimicrobial and the nonsteroidal anti-inflammatory drug fenbufen concurrently. Animal studies also suggest an increased potential for seizures when these 2 drugs are given concomitantly. Fenbufen is not approved in the United States at this time. Physicians are provided this information to increase awareness of the potential for serious interactions when cinoxacin and certain nonsteroidal anti-inflammatory agents are administered concomitantly.
Elevated cyclosporine serum levels have been reported with the concomitant use of quinolones and cyclosporine.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Cinobac 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.
Find out what women really need.