DIAZEPAM (Page 3 of 3)

OVERDOSAGE

Overdose of benzodiazepines is usually manifested by central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, confusion, and lethargy. In more serious cases, symptoms may include ataxia, diminished reflexes, hypotonia, hypotension, respiratory depression, coma (rarely), and death (very rarely). Overdose of benzodiazepines in combination with other CNS depressants (including alcohol) may be fatal and should be closely monitored

Management of Overdosage

Following overdose with oral benzodiazepines, general supportive measures should be employed including the monitoring of respiration, pulse, and blood pressure. Vomiting should be induced (within 1 hour) if the patient is conscious. Gastric lavage should be undertaken with the airway protected if the patient is unconscious. Intravenous fluids should be administered. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiac function in intensive care. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained.

Should hypotension develop, treatment may include intravenous fluid therapy, repositioning, judicious use of vasopressors appropriate to the clinical situation, if indicated, and other appropriate countermeasures. Dialysis is of limited value.

As with the management of intentional overdosage with any drug, it should be considered that multiple agents may have been ingested.

Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. Caution should be observed in the use of flumazenil in epileptic patients treated with benzodiazepines. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS , and PRECAUTIONS , should be consulted prior to use.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE).

DOSAGE AND ADMINISTRATION

Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.

ADULTS: USUAL DAILY DOSE
Management of Anxiety Disorders and Relief of Symptoms of Anxiety Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed.
Adjunctively for Relief of Skeletal Muscle Spasm 2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated.
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated.

HOW SUPPLIED

Diazepam Tablets USP, 5 mg are available as yellow, round, flat faced, beveled edge tablets, debossed “Z” and “3926” with a bisect on one side and “5” on the other side containing 5 mg diazepam USP
as follows:

Manfactured by Ivax Pharmaceuticals
Repackaged and Distributed for private label by Apotheca, Inc.

  • 12634-529-91 Blister Pack UD of 1
  • 12634-529-55 Blister Pack Card of 15
  • 12634-529-96 Bottle of 6
  • 12634-529-80 Bottle of 20

Diazepam Tablets USP,10 mg are available as blue, round, flat-faced, beveled-edge, bisected tablet. Debossed with stylized Barr on one side and 555/164 on the other side containing 10 mg diazepam USP as follows:

Manufactured by Barr Laboratories, Inc.
Repackaged and Distributed for private label by Apotheca, Inc.

  • 12634-698-91 Blister Pack UD of 1
  • 12634-698-59 Blister Pack Card of 30
  • 12634-698-71 Bottle of 30

Storage and Dispensing

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

A Schedule CS-CIV controlled drug substance.

PACKAGE LABEL, PRINCIPAL DISPLAY PANEL

12634-698-71 30 Tablets

DIAZEPAM Tablets, USP

CS-CIV

10MG

Rx Only

Each tablet contains:

diazepam USP, 10mg

USUAL ADULT DOSAGE:

For indications, dosage recommendations,

see accompanying package insert.

Keep This and all Medication Out of The Reach of Children

Manufactured by:

Barr Laboratories, Inc.

NDC 0555-0164-05

Repackaged and Distributed by:

Apotheca, Inc.

Phoenix, AZ. 85006

image of label
(click image for full-size original)

12634-529-80 Bottle 20 Tablets

DIAZEPAM 5MG CIV

Generic for Valium Rx Only

Manufactured by:

Ivax Pharmaceuticals, Inc.

Repackaged by:

Apotheca, Inc.

Phoenix, AZ.

image of label
(click image for full-size original)
DIAZEPAM diazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-529(NDC:0172-3926)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIAZEPAM (DIAZEPAM) DIAZEPAM 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color yellow (yellow) Score 2 pieces
Shape ROUND (round) Size 8mm
Flavor Imprint Code 3926;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12634-529-91 1 TABLET (TABLET) in 1 BLISTER PACK None
2 NDC:12634-529-55 15 TABLET (TABLET) in 1 BLISTER PACK None
3 NDC:12634-529-96 6 TABLET (TABLET) in 1 BOTTLE None
4 NDC:12634-529-80 20 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071321 12/09/2009
DIAZEPAM diazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-698(NDC:0555-0164)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIAZEPAM (DIAZEPAM) DIAZEPAM 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color blue (BLUE) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code Barr;555164
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12634-698-91 1 TABLET (TABLET) in 1 BLISTER PACK None
2 NDC:12634-698-59 30 TABLET (TABLET) in 1 BLISTER PACK None
3 NDC:12634-698-71 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070154 01/15/2009
Labeler — Apotheca, Inc. (051457844)

Revised: 03/2010 Apotheca, Inc.

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