, particularly those who may have suicidal tendencies, protective measures may be necessary. diazepam injection has produced hypotension or muscular weakness in some patients particularly when used with narcotics, barbiturates, or alcohol. the clearance of diazepam and certain other benzodiazepines can be delayed in association with cimetidine administration. the clinical significance of this is unclear.

remedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.

g diazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see drug abuse and dependence: abuse ). before prescribing diazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction. use of diazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of diazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction. do not exceed the recommended dosing frequency; avoid or minimize concomitant use of cns depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. if a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. dependence and withdrawal reactions after use of diazepam more frequently than recommended for patients using diazepam more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam (a patient-specific plan should be used to taper the dose). patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. acute withdrawal reactions the continued use of benzodiazepines, including diazepam may lead to clinically significant physical dependence. although diazepam is indicated only for intermittent use (see indications and usage and dosage and administration ), if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of diazepam, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see drug abuse and dependence, dependence ). protracted withdrawal syndrome in some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see drug abuse and dependence: dependence ). when used intravenously, the following procedures should be undertaken to reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, and, rarely, vascular impairment; the solution should be injected slowly, taking at least one minute for each 5 mg (1 ml) given except for treatment of status epilepticus in children (see dosage and administration ); do not use small veins, such as those on the dorsum of the hand or wrist; extreme care should be taken to avoid intra-arterial administration or extravasation. do not mix or dilute diazepam injection with other solutions or drugs in syringe or infusion container. if it is not feasible to administer diazepam directly intravenous, it may be injected slowly through the infusion tubing as close as possible to the vein insertion. extreme care must be used in administering diazepam injection, particularly by the intravenous route, to the elderly, to very ill patients, and to those with limited pulmonary reserve because of the possibility that apnea and/or cardiac arrest may occur. concomitant use of barbiturates, alcohol or other central nervous system depressants increases depression with increased risk of apnea. resuscitative equipment including that necessary to support respiration should be readily available. when diazepam is used with a narcotic analgesic, the dosage of the narcotic should be reduced by at least one-third and administered in small increments. in some cases the use of a narcotic may not be necessary. diazepam injection should not be administered to patients in shock, coma, or in acute alcoholic intoxication with depression of vital signs. as is true of most cns-acting drugs, patients receiving diazepam should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle. tonic status epilepticus has been precipitated in patients treated with intravenous diazepam for petit mal status or petit mal variant status. usage in pregnancy an increased risk of congenital malformations associated with the use of minor tranquilizers (diazepam, meprobamate, and chlordiazepoxide) during the first trimester of pregnancy has been suggested in several studies. because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. the possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. in humans, measurable amounts of diazepam were found in maternal and cord blood, indicating placental transfer of the drug. until additional information is available, diazepam injection is not recommended for obstetrical use. pediatric use: efficacy and safety of parenteral diazepam has not been established in the neonate (30 days or less of age). prolonged central nervous system depression has been observed in neonates, apparently due to inability to biotransform diazepam into inactive metabolites. in pediatric use for the treatment of status epilepticus, in order to obtain maximal clinical effect with the minimum amount of drug and thus to reduce the risk of hazardous side effects, such as apnea or prolonged periods of somnolence, it is recommended that the drug be given as a slow intravenous push over 1 minute (see dosage and administration ). the safety and tolerability of the recommended dosage regimen is supported by a randomized, double-blind study that included 162 pediatric patients ages 3 months to 17 years who received intravenous diazepam for the treatment of status epilepticus. in this study, 16% of pediatric patients who received diazepam experienced severe or life-threatening respiratory depression. benzyl alcohol has been reported to be associated with a fatal gasping syndrome in premature infants.

has been reported in patients treated with diazepam injection at doses significantly greater than recommended. in these cases, diazepam was being used to treat alcohol withdrawal symptoms at doses greater than 900 mg/day. propylene glycol toxicity is associated with an anion gap metabolic acidosis, serum hyperosmolality, and increased lactate. propylene glycol toxicity can cause acute tubular necrosis (which can progress to multi-organ failure), mental status changes, hypotension, seizures, and cardiac arrhythmias. patients at high risk for propylene glycol toxicity include those with renal dysfunction, hepatic dysfunction, impaired alcohol dehydrogenase enzymes, or other comorbidities (such as a history of alcoholism). until additional information is available, diazepam injection is not recommended for obstetrical use. lower doses (usually 2 mg to 5 mg) should be used for elderly and debilitated patients. risks from concomitant use with opioids advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when diazepam is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider. advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see warnings: risks from concomitant use with opioids and precautions: drug interactions ). abuse, misuse, and addiction inform patients that the use of diazepam more frequently than recommended, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see warnings and drug abuse and dependence ). withdrawal reactions inform patients that use of diazepam more frequently than recommended may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of diazepam may precipitate acute withdrawal reactions, which can be life-threatening. inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see warnings and drug abuse and dependence ).

epilepticus in children, the solution should be injected slowly, taking one minute for administration (see warnings , particularly for use in children). for other indications, the solution should be injected slowly taking at least one minute for each 5 mg (1 ml) given. do not use small veins, such as those on the dorsum of the hand or wrist. extreme care should be taken to avoid intra-arterial administration or extravasation. do not mix or dilute diazepam with other solutions or drugs in syringe or infusion container. if it is not feasible to administer diazepam directly intravenous, it may be injected slowly through the infusion tubing as close as possible to the vein insertion. usual adult dosage dosage range in children (intravenous administration should be made slowly) moderate anxiety disorders and symptoms of anxiety 2 mg to 5 mg, intramuscular or intravenous . repeat in 3 to 4 hours, if necessary. severe anxiety disorders and symptoms of anxiety 5 mg to 10 mg, intramuscular or intravenous . repeat in 3 to 4 hours, if necessary. acute alcohol withdrawal: as an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens, and hallucinosis. 10 mg, intramuscular or intravenous initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. endoscopic procedures: adjunctively, if apprehension, anxiety or acute stress reaction are present prior to endoscopic procedures. dosage of narcotics should be reduced by at least a third and in some cases may be omitted. see precautions for peroral procedures. titrate intravenous dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. generally 10 mg or less is adequate, but up to 20 mg intravenous may be given, particularly when concomitant narcotics are omitted. if intravenous cannot be used, 5 mg to10 mg intramuscular approximately 30 minutes prior to the procedure. muscle spasm associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome, or tetanus. 5 mg to 10 mg, intramuscular or intravenous initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. for tetanus, larger doses may be required. for tetanus in infants over 30 days of age, 1 mg to 2 mg intramuscular or intravenous, slowly, repeated every 3 to 4 hours as necessary. in children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. respiratory assistance should be available. status epilepticus and severe recurrent convulsive seizures: in the convulsing patient, the intravenous route is by far preferred. this injection should be administered slowly. however, if intravenous administration is impossible, the intramuscular route may be used. 5 mg to 10 mg initially (intravenous preferred). this injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg. if necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration. extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status. children 3 months up to 17 years of age with status epilepticus: first dose: 0.2 mg/kg (maximum 8 mg) by slow intravenous push (one minute in duration). second dose (if necessary; 5 minutes after the first dose): 0.1 mg/kg (maximum 4 mg) by slow intravenous push (one minute in duration). eeg monitoring of the seizure may be helpful. preoperative medication to relieve anxiety and tension. (if atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.) 10 mg, intramuscular (preferred route), before surgery. cardioversion to relieve anxiety and tension and to reduce recall of procedure. 5 mg to 15 mg, intravenous, within 5 to 10 minutes prior to the procedure. once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

ents during and after diazepam therapy and are of no known significance. in peroral endoscopic procedures, coughing, depressed respiration, dyspnea, hyperventilation, laryngospasm, and pain in throat or chest have been reported. because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy.

, particularly those who may have suicidal tendencies, protective measures may be necessary. diazepam injection has produced hypotension or muscular weakness in some patients particularly when used with narcotics, barbiturates, or alcohol. the clearance of diazepam and certain other benzodiazepines can be delayed in association with cimetidine administration. the clinical significance of this is unclear.

ession. benzyl alcohol has been reported to be associated with a fatal gasping syndrome in premature infants.