Diazepam


General Injectables And Vaccines, Inc.
Human Prescription Drug
NDC 52584-213
Diazepam is a human prescription drug labeled by 'General Injectables And Vaccines, Inc.'. National Drug Code (NDC) number for Diazepam is 52584-213. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Diazepam drug includes Diazepam - 5 mg/mL . The currest status of Diazepam drug is Active.

Drug Information:

Drug NDC: 52584-213
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Diazepam
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Diazepam
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: General Injectables And Vaccines, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:DIAZEPAM - 5 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAMUSCULAR
INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 27 Aug, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 01 Oct, 2023
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA071583
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 25 Dec, 2025
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:General Injectables and Vaccines, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:309845
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
NUI:N0000175694
M0002356
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:Q3JTX2Q7TU
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Benzodiazepine [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:Benzodiazepines [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Benzodiazepine [EPC]
Benzodiazepines [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
DEA Schedule:CIV
This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
52584-213-121 VIAL, MULTI-DOSE in 1 BAG (52584-213-12) / 10 mL in 1 VIAL, MULTI-DOSE27 Aug, 201901 Oct, 2023No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Diazepam diazepam diazepam diazepam

Boxed Warning:

Warning: risks from concomitant use with opioids concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see warnings, precautions; drug interactions]. reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. limit dosages and durations to the minimum required. follow patients for signs and symptoms of respiratory depression and sedation.

Indications and Usage:

Indications and usage diazepam 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, diazepam 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 recall of the procedures. (see warnings.) diazepam 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. diazepam is a useful adjunct in status epilepticus and severe recurrent convulsive s
eizures. diazepam is a useful premedication (the i.m. 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.

Warnings:

Warnings risks from concomitant use with opioids concomitant use of benzodiazepines, including diazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. because of these risks, reserve concomitant prescribing of benzodiazepines and opioids in patients for whom alternative treatment options are inadequate. observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. if a decision is made to prescribe diazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. advise both patients and caregivers about the risks of respiratory depression and sedation when diazepam is used with opioids (see precautions; drug interactions). abuse, misuse, and addiction the use of benzodiazepines, including
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 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; 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. 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. use in children 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, 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 slowly over a three-minute period in a dosage not to exceed 0.25 mg/kg. after an interval of 15 to 30 minutes the initial dosage can be safely repeated. if, however, relief of symptoms is not obtained after a third administration, adjunctive therapy appropriate to the condition being treated is recommended. benzyl alcohol has been reported to be associated with a fatal gasping syndrome in premature infants.

Dosage and Administration:

Dosage and administration dosage should be individualized for maximum beneficial effect. the usual recommended dose in older children and adults ranges from 2 mg to 20 mg im or iv, depending on the indication and its severity. in some conditions, e.g., tetanus, larger doses may be required. (see dosage for specific indications.) in acute conditions the injection may be repeated within one 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 infants above the age of 30 days and children, see the specific indications below. when intravenous use is indicated, facilities for respiratory assistance should be readily available. intramuscular: diazepam injection, usp should be injected deeply into the muscle. intravenous use: (see warnings, particularly for use in chil
dren.) 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 flask. if it is not feasible to administer diazepam directly iv., it may be injected slowly through the infusion tubing as close as possible to the vein insertion. 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. note: solution may appear colorless to light yellow. image description image description

Contraindications:

Contraindications diazepam 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.

Adverse Reactions:

Adverse reactions side effects most commonly reported were drowsiness, fatigue and ataxia; venous thrombosis and phlebitis at the site of injection. other adverse reactions less frequently reported include: cns: confusion, depression, dysarthria, headache, hypoactivity, slurred speech, syncope, tremor, vertigo. g.i.: constipation, nausea. g.u.: incontinence, changes in libido, urinary retention. cardiovascular: bradycardia, cardiovascular collapse, hypotension. eent: blurred vision, diplopia, nystagmus. skin: urticaria, skin rash. other: hiccups, changes in salivation, neutropenia, jaundice. paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported; should these occur, use of the drug should be discontinued. minor changes in eeg patterns, usually low-voltage fast activity, have been observed in patients during and after diazepam therapy and are of no known signific
ance. 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.

Overdosage:

Management of overdosage manifestations of diazepam overdosage include somnolence, confusion, coma, and diminished reflexes. respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal. general supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. hypotension may be combated by the use of norepinephrine or metaraminol. dialysis is of limited value. 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 re-sedation, 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. the complete flumazenil package insert including contraindications, warnings , and precautions should be consulted prior to use.

Description:

Description diazepam injection, usp is a sterile, nonpyrogenic solution intended for intramuscular or intravenous administration. each milliliter (ml) contains 5 mg diazepam; 40% propylene glycol; 10% alcohol; 5% sodium benzoate and benzoic acid added as buffers; and 1.5% benzyl alcohol added as a preservative. ph 6.6 (6.2 to 6.9). note: solution may appear colorless to light yellow. diazepam is a benzodiazepine derivative chemically designated as 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2h-1,4-benzodiazepin-2-one. it is a colorless crystalline compound, insoluble in water, with the following molecular structure: formula1.jpg

Clinical Pharmacology:

Clinical pharmacology in animals, diazepam appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. diazepam, unlike chlorpromazine and reserpine, has no demonstrable peripheral autonomic blocking action, nor does it produce extrapyramidal side effects; however, animals treated with diazepam do have a transient ataxia at higher doses. diazepam was found to have transient cardiovascular depressor effects in dogs. long-term experiments in rats revealed no disturbances of endocrine function. injections into animals have produced localized irritation of tissue surrounding injection sites and some thickening of veins after intravenous use.

How Supplied:

How supplied diazepam injection, usp is supplied as follows: 10 ml multiple dose vials containing 50 mg (5 mg/ml) box of 10 fliptop vial ndc 0409-3213-12 store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] protect from light.

Package Label Principal Display Panel:

Sample package label label1.jpg


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