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THE SAFETY AND EFFECTIVENESS OF CINOXACIN IN PEDIATRIC PATIENTS, PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED (SEE PEDIATRIC USE, PREGNANCY, AND NURSING MOTHERS SUBSECTIONS IN THE
PRECAUTIONS SECTION). The oral administration of a single 250-mg/kg dose of cinoxacin causes lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed lesions of the cartilage. Other quinolones also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone class antimicrobials. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of previous hypersensitivity reactions. If an allergic reaction to cinoxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated.
Convulsions and abnormal electroencephalograms have been reported in a few patients receiving quinolone class antimicrobials. No causal relationship has been established. Convulsions, increased intracranial pressure, and toxic psychoses have also been reported in patients receiving other drugs in this class.
Quinolones may also cause central nervous system (CNS) stimulation with tremors, restlessness, light-headedness, confusion, or hallucinations. If these reactions occur in patients receiving cinoxacin, the drug should be discontinued and appropriate measures instituted. As with all quinolones cinoxacin should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, and other factors that predispose to seizures (see ADVERSE REACTIONS).
Achilles and other tendon ruptures that require surgical repair or resulted in prolonged disability have been reported with quinolones. Cinoxacin should be discontinued if the patient experiences pain, inflammation, or tendon rupture.
Since Cinobac (cinoxacin) is eliminated primarily by the kidney, the usual dosage should be lower in patients with reduced renal function (see DOSAGE AND ADMINISTRATION). Administration of Cinobac (cinoxacin) is not recommended for anuric patients.
In clinical trials with large doses of quinolones, crystalluria was reported in some volunteers. Although crystalluria is not expected to occur with the usually recommended dosages of cinoxacin, patients should be well hydrated, and alkalinization of urine should be avoided.
Moderate to severe phototoxicity reactions have been observed in patients who were exposed to direct sunlight while receiving some members of this drug class. Excessive sunlight should be avoided. Therapy should be discontinued if phototoxicity occurs.
Information for Patients
See PATIENT INFORMATION section.
See DRUG INTERACTIONS section.
Teratogenic Effects: Pregnancy Category C: Reproduction studies have been performed in rats and rabbits at doses up to 10 times the daily human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cinoxacin. There are, however, no adequate and well-controlled studies in pregnant women. Cinoxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (see
It is not known whether cinoxacin is excreted in human milk. Because other drugs in this class are excreted in human milk and because of the potential for serious adverse reactions from cinoxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Following a single 500 mg dose of cinoxacin, peak serum concentrations in geriatric patients were similar to those in all adults. With repeated administration of cinoxacin, no accumulation of drug was found in the twenty patients ages 70-89 (see Geriatric under Clinical Pharmacology). No dosage adjustment is required based on age alone. In geriatric patients with reduced renal function, the dosage should be reduced (see Impaired Renal Function under Dosage and Administration).
Clinical studies of cinoxacin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Last reviewed on RxList: 12/8/2004
Additional Cinobac Information
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