Valium Injection
INDICATIONS
Valium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient’s
Valium is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus.
Valium Injection is a useful adjunct in status epilepticus and severe recurrent convulsive seizures.
Valium is a useful premedication (the IM 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.
DOSAGE AND ADMINISTRATION
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in adults ranges from 2 mg to 20 mg IM or IV, depending on the indication and its severity. In some conditions, eg, tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within 1 hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered (see WARNINGS and ADVERSE REACTIONS).
For dosage in pediatric patients above the age of 30 days, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Valium Injection should be injected deeply into the muscle.
Intravenous Use: (See WARNINGS and PRECAUTIONS: Pediatric Use.) The solution should be injected slowly, taking at least 1 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 intraarterial administration or extravasation.
Do not mix or dilute Valium with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer Valium directly IV, it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
| USUAL ADULT DOSAGE | DOSAGE RANGE IN PEDIATRIC PATIENTS (IV administration should be made slowly) | |
| Moderate Anxiety Disorders and Symptoms of Anxiety. | 2 mg to 5 mg, IM or IV. Repeat in 3 to 4 hours, if necessary. | |
| Severe Anxiety Disorders and Symptoms of Anxiety. | 5 mg to 10 mg, IM or IV. 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, IM or IV initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. | |
Endoscopic Procedures: Adjunctively, if apprehension, anxiety or acute stress reactions 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 IV 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 IV may be given, particularly when concomitant narcotics are omitted. If IV can not be used, 5 mg to 10 mg IM 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, IM or IV initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required. | For tetanus in pediatric patients between 30 days and 5 years of age, 1 mg to 2 mg IM or IV, slowly, repeated every 3 to 4 hours as necessary. In pediatric patients 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 IV route is by far preferred. This injection should be administered slowly. However, if IV administration is impossible, the IM route may be used. | 5 mg to 10 mg initially (IV 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 Valium 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. | Pediatric patients between the ages of 30 days and 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (IV preferred). Pediatric patients 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow IV administration preferred). Repeat in 2 to 4 hours if necessary. 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, IM (preferred route), before surgery. | |
Cardioversion: To relieve anxiety and tension and to reduce recall of procedure. | 5 mg to 15 mg, IV, within 5 to 10 minutes prior to the procedure. |
Once the acute symptomatology has been properly controlled with Valium Injection, the patient may be placed on oral therapy with Valium if further treatment is required.
HOW SUPPLIED
Vials, 10 mL, boxes of 1 (NDC 0004-1932-09). Tel-E-Ject® (disposable syringes), 2 mL, boxes of 10 (NDC 0004-1933-06).
ANIMAL PHARMACOLOGY
Oral LD50 of diazepam is 720 mg/kg in mice and 1240 mg/kg in rats. Intraperitoneal administration of 400 mg/kg to a monkey resulted in death on the sixth day.
Reproduction Studies: A series of rat reproduction studies was performed with diazepam in oral doses of 1, 10, 80 and 100 mg/kg given for periods ranging from 60 to 228 days prior to mating. At 100 mg/kg there was a decrease in the number of pregnancies and surviving offspring in these rats. These effects may be attributable to prolonged sedative activity, resulting in lack of interest in mating and lessened maternal nursing and care of the young. Neonatal survival of rats at doses lower than 100 mg/kg was within normal limits. Several neonates, both controls and experimentals, in these rat reproduction studies showed skeletal or other defects. Further studies in rats at doses up to and including 80 mg/kg/day did not reveal significant teratological effects on the offspring. Rabbits were maintained on doses of 1, 2, 5 and 8 mg/kg from day 6 through day 18 of gestation. No adverse effects on reproduction and no teratological changes were noted.
Distributed by: 25745742-0399 25637632-0399, Revised: March 1999 Printed in U.S.A. Copyright © 1997 by Roche Products Inc. All rights reserved.
Generic Name: Diazepam Injection
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