Diazepam Auto-Injector C-IV

Important Safety Information

Intravenous administration of diazepam with the auto-injector is contraindicated.

Diazepam injection is contraindicated in patients with a known hypersensitivity to this drug; acute narrow angle glaucoma; and open angle glaucoma unless patients are receiving appropriate therapy.

Diazepam auto-injector is to be administered only by the intramuscular (IM) route.

Extreme care must be used in administering injectable diazepam to the elderly, to very ill patients and to those with limited pulmonary reserve. 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.

Diazepam injection should not be administered to patients in shock, coma, or in acute alcoholic intoxication with depression of vital signs.

Patients receiving diazepam should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.

The use of diazepam during the first trimester of pregnancy should almost always be avoided. Diazepam injection is not recommended for obstetrical use.

The cumulative maximum dose of diazepam should not exceed 30 mg; the interval between doses should be no less than 10 minutes.

Side effects most commonly reported with diazepam injection are drowsiness, fatigue and ataxia, venous thrombosis, and phlebitis at the site of injection. Manifestations of diazepam overdosage include somnolence, confusion, coma and diminished reflexes.

Withdrawal symptoms have occurred following the abrupt discontinuation of diazepam.