"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
There is limited experience of acute overdose with ROMAZICON (flumazenil) .
There is no specific antidote for overdose with ROMAZICON (flumazenil) . Treatment of an overdose with ROMAZICON (flumazenil) should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Intravenous bolus administration of doses ranging from 2.5 to 100 mg (exceeding those recommended) of ROMAZICON (flumazenil) , when administered to healthy normal volunteers in the absence of a benzodiazepine agonist, produced no serious adverse reactions, severe signs or symptoms, or clinically significant laboratory test abnormalities. In clinical studies, most adverse reactions to flumazenil were an extension of the pharmacologic effects of the drug in reversing benzodiazepine effects.
Reversal with an excessively high dose of ROMAZICON (flumazenil) may produce anxiety, agitation, increased muscle tone, hyperesthesia and possibly convulsions. Convulsions have been treated with barbiturates, benzodiazepines and phenytoin, generally with prompt resolution of the seizures (see WARNINGS).
ROMAZICON (flumazenil) is contraindicated:
- in patients with a known hypersensitivity to flumazenil or benzodiazepines.
- in patients who have been given a benzodiazepine for control of a potentially life-threatening condition (eg, control of intracranial pressure or status epilepticus).
- in patients who are showing signs of serious cyclic antidepressant overdose (see WARNINGS).
Last reviewed on RxList: 10/23/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Romazicon Information
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