Diazepam
Tablet · Oral, Intramuscular, Intravenous
Uses
Diazepam is indicated for the management of anxiety disorders 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. Note: Because the autoinjector provides a minimum dose of 10 mg diazepam, it should not be used to treat individuals with mild and moderate degrees of anxiety and anxiety related disorders that would ordinarily be managed with intramuscular doses of less than 10 mg. 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 injection is a useful adjunct in status epilepticus and severe recurrent convulsive seizures. Diazepam is useful premedication for relief of anxiety and tension in patients who are to undergo surgical procedures.
Dosage and administration
Administration of the Diazepam Autoinjector 1. Pull off gray safety cap 2. Place Black end on mid outer thigh 3. Push hard until injector functions 4. Withdraw after 10 seconds Dosage Caution: Because the autoinjector automatically delivers a fixed dose of 10 mg of diazepam, it cannot be used in situations requiring lower total doses or those in which small incremental increases of diazepam are required. The usual recommended dose in older children and adults ranges from 10 mg to 20 mg I.M. depending on the indication and its severity. The cumulative total dose and individual maximum dose for intramuscular administration will vary with the specific indication (See dosage for specific indications). Intramuscular When instructions are followed properly the Diazepam Autoinjector injects deeply into the muscle. Intravenous Use The Diazepam Autoinjector is not designed or intended for intravenous use. Severe Anxiety Disorders and Symptoms of Anxiety Usual Adult Dosage: 10 mg, I. M. 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. Usual Adult Dosage: 10 mg, I. M. initially, then 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. Usual Adult Dosage: 10 mg I. M., approximately 30 minutes prior to the procedure. Muscle Spasm Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus. Usual Adult Dosage: 10 mg, I. M., initially, then 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required. Status Epilepticus and Severe Recurrent Convulsive Seizures In the convulsing patient, the I.V. route is preferred. However, if conditions preclude intravenous administration, the I.M. route may be used. Usual Adult Dosage: 10 mg, initially. 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 re-administration should be made with this consideration. Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status. Preoperative Medication To relieve anxiety and tension. (if atropine, scopolamine or other premedications are desired, they must be administered in separate syringes). Usual Adult Dosage: 10 mg, I.M. (preferred route), before surgery. General 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 the solution and container permit.
Dosage forms and strengths
Dosage Caution: Because the autoinjector automatically delivers a fixed dose of 10 mg of diazepam, it cannot be used in situations requiring lower total doses or those in which small incremental increases of diazepam are required. The usual recommended dose in older children and adults ranges from 10 mg to 20 mg I.M. depending on the indication and its severity. The cumulative total dose and individual maximum dose for intramuscular administration will vary with the specific indication (See dosage for specific indications). Intramuscular When instructions are followed properly the Diazepam Autoinjector injects deeply into the muscle. Intravenous Use The Diazepam Autoinjector is not designed or intended for intravenous use. Severe Anxiety Disorders and Symptoms of Anxiety Usual Adult Dosage: 10 mg, I. M. 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. Usual Adult Dosage: 10 mg, I. M. initially, then 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. Usual Adult Dosage: 10 mg I. M., approximately 30 minutes prior to the procedure. Muscle Spasm Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus. Usual Adult Dosage: 10 mg, I. M., initially, then 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required. Status Epilepticus and Severe Recurrent Convulsive Seizures In the convulsing patient, the I.V. route is preferred. However, if conditions preclude intravenous administration, the I.M. route may be used. Usual Adult Dosage: 10 mg, initially. 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 re-administration should be made with this consideration. Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status. Preoperative Medication To relieve anxiety and tension. (if atropine, scopolamine or other premedications are desired, they must be administered in separate syringes). Usual Adult Dosage: 10 mg, I.M. (preferred route), before surgery. General 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 the solution and container permit.
Contraindications
CONTRAINDICATIONS INTRAVENOUS ADMINISTRATION OF DIAZEPAM WITH THE AUTOINJECTOR 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.
Warnings
Diazepam Autoinjector is to be administered only by the intramuscular (I.M.) route. 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 for 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 ). Abuse, Misuse, and Addiction The use of benzodiazepines, including Diazepam injection, 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, that 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 injection and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. Use of Diazepam injection, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of Diazepam injection 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 injection More Frequently Than Recommended For patients using Diazepam injection more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue Diazepam injection (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 injection 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 injection, 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 ). Respiratory and Central Nervous System Depression Extreme care must be used in administering injectable diazepam 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 (see PRECAUTIONS ) . 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. Use in Patients with Petit Mal Status Tonic status epilepticus has been precipitated in patients treated with I.V. diazepam for petit mal status or petit mal variant status. Neonatal Sedation and Withdrawal Syndrome Use of Diazepam injection late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate (see PRECAUTIONS: Pregnancy ). Monitor neonates exposed to Diazepam injection during pregnancy or labor for signs of sedation and monitor neonates exposed to Diazepam injection during pregnancy for signs of withdrawal; manage these neonates accordingly. 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.
Precautions
Drug Interactions Effect of Concomitant Use of Benzodiazepines and Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites, and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation. Concomitant Use with Other Psychotropic Agents or Anticonvulsant Drugs If diazepam is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed particularly with known compounds which may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants. In highly anxious patients with evidence of accompanying depression, particularly those who may have suicidal tendencies, protective measures may be necessary. The usual precautions in treating patients with impaired hepatic function should be observed. Metabolites of diazepam are excreted by the kidney; to avoid their excess accumulation, caution should be exercised in the administration to patients with compromised kidney function. Concomitant Use with Cimetidine The clearance of diazepam and certain other benzodiazepines can be delayed in association with Tagamet (cimetidine) administration. The clinical significance of this is unclear. Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as Diazepam injection, during pregnancy. Healthcare providers are encouraged to recommend that pregnant women taking Diazepam injection enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888- 233- 2334 or online at http://www.aedpregnancyregistry.org/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome , and Clinical Considerations ). Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Human Data ) . In animal studies, administration of diazepam during the organogenesis period of pregnancy resulted in increased incidences of fetal malformations at doses greater than those used clinically. Data for diazepam and other benzodiazepines suggest the possibility of increased neuronal cell death and long-term effects on neurobehavioral and immunological function based on findings in animals following prenatal or early postnatal exposure at clinically relevant doses (see Animal Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to Diazepam injection during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to Diazepam injection during pregnancy for signs of withdrawal. Manage these neonates accordingly (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome ). Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings. Animal Data Diazepam has been shown to produce increased incidences of fetal malformations in mice and hamsters when given orally at single doses of 100 mg/kg or greater (approximately 8 times the maximum recommended human dose [1 mg/kg/day] or greater on a mg/m 2 basis). Cleft palate and exencephaly are the most common and consistently reported malformations produced in these species by administration of high, maternally-toxic doses of diazepam during organogenesis. In published animal studies, administration of benzodiazepines or other drugs that enhance GABAergic neurotransmission to neonatal rats has been reported to result in widespread apoptotic neurodegeneration in the developing brain at plasma concentration relevant for seizure control in humans. The window of vulnerability to these changes in rats (postnatal days 0-14) includes a period of brain development that takes place during the third trimester of pregnancy in humans. Nursing Mothers Risk Summary Diazepam is present in breastmilk. There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. There are no data on the effects of diazepam on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Diazepam injection and any potential adverse effects on the breastfed infant from Diazepam injection or from the underlying maternal condition.
Side effects
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 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.
Drug interactions
Drug Interactions Effect of Concomitant Use of Benzodiazepines and Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites, and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation. Concomitant Use with Other Psychotropic Agents or Anticonvulsant Drugs If diazepam is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed particularly with known compounds which may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants. In highly anxious patients with evidence of accompanying depression, particularly those who may have suicidal tendencies, protective measures may be necessary. The usual precautions in treating patients with impaired hepatic function should be observed. Metabolites of diazepam are excreted by the kidney; to avoid their excess accumulation, caution should be exercised in the administration to patients with compromised kidney function. Concomitant Use with Cimetidine The clearance of diazepam and certain other benzodiazepines can be delayed in association with Tagamet (cimetidine) administration. The clinical significance of this is unclear.
Pregnancy
Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as Diazepam injection, during pregnancy. Healthcare providers are encouraged to recommend that pregnant women taking Diazepam injection enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888- 233- 2334 or online at http://www.aedpregnancyregistry.org/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome , and Clinical Considerations ). Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Human Data ) . In animal studies, administration of diazepam during the organogenesis period of pregnancy resulted in increased incidences of fetal malformations at doses greater than those used clinically. Data for diazepam and other benzodiazepines suggest the possibility of increased neuronal cell death and long-term effects on neurobehavioral and immunological function based on findings in animals following prenatal or early postnatal exposure at clinically relevant doses (see Animal Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to Diazepam injection during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to Diazepam injection during pregnancy for signs of withdrawal. Manage these neonates accordingly (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome ). Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings. Animal Data Diazepam has been shown to produce increased incidences of fetal malformations in mice and hamsters when given orally at single doses of 100 mg/kg or greater (approximately 8 times the maximum recommended human dose [1 mg/kg/day] or greater on a mg/m 2 basis). Cleft palate and exencephaly are the most common and consistently reported malformations produced in these species by administration of high, maternally-toxic doses of diazepam during organogenesis. In published animal studies, administration of benzodiazepines or other drugs that enhance GABAergic neurotransmission to neonatal rats has been reported to result in widespread apoptotic neurodegeneration in the developing brain at plasma concentration relevant for seizure control in humans. The window of vulnerability to these changes in rats (postnatal days 0-14) includes a period of brain development that takes place during the third trimester of pregnancy in humans.
Pediatric 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.
Overdosage
Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see Warnings: Abuse, Misuse, and Addiction ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway maintenance. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage. See the flumazenil injection Prescribing Information. Consider contacting the Poison Help line (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.
Description
Diazepam injection is a sterile solution packaged within a device that delivers its entire 2 mL contents automatically upon activation. Each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% ethyl alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative. Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3- dihydro- 1-methyl-5-phenyl- 2H-1, 4-benzodiazepine-2-one. It is a colorless crystalline compound, insoluble in water and has a molecular weight of 284.74. Its structural formula is as follows: Chemical Structure
How supplied
Diazepam injection, 5 mg per mL, is available in 2 mL Disposable Autoinjectors. STORAGE Store at 25°C (77°F); Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Do not refrigerate.
Storage
Store at 25°C (77°F); Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Do not refrigerate.
Label text from the FDA structured product label by Meridian Medical Technologies LLC (revised Dec 18, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Diazepam in 117 products
Diazepam NDC products (117)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-3390 | Diazepam 2 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-2249 | Diazepam 5 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-1913 | Diazepam 5 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-1726 | Diazepam 10 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-0195 | Diazepam 2 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 80425-0512 | Diazepam 10 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0511 | Diazepam 10 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0496 | Diazepam 5 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0120 | Diazepam 10 mg/1 Tablet | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CIV |
| 62332-811 | Diazepam 10 mg/2mL Injection, Solution | Alembic Pharmaceuticals Inc. | ANDA · DEA CIV |
| 46708-811 | Diazepam 10 mg/2mL Injection, Solution | Alembic Pharmaceuticals Limited | ANDA · DEA CIV |
| 60687-755 | Diazepam 5 mg/5mL Solution | American Health Packaging | ANDA · DEA CIV |
| 71610-424 | Diazepam 10 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 43353-825 | Diazepam 2 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-270 | Diazepam 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 76420-316 | Diazepam 10 mg/1 Tablet | ASCLEMED USA INC. | ANDA · DEA CIV |
| 76420-314 | Diazepam 2 mg/1 Tablet | ASCLEMED USA INC. | ANDA · DEA CIV |
| 76420-315 | Diazepam 5 mg/1 Tablet | ASCLEMED USA INC. | ANDA · DEA CIV |
| 76420-784 | Diazepam 10 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-783 | Diazepam 2 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-533 | Diazepam 5 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CIV |
| 59651-652 | Diazepam 2 mg/1 Tablet | Aurobindo Pharma Limited | ANDA · DEA CIV |
| 59651-653 | Diazepam 5 mg/1 Tablet | Aurobindo Pharma Limited | ANDA · DEA CIV |
| 59651-654 | Diazepam 10 mg/1 Tablet | Aurobindo Pharma Limited | ANDA · DEA CIV |
| 43066-121 | Diazepam 10 mg/2mL Injection, Solution | Baxter Healthcare Corporation | ANDA · DEA CIV |
| 43066-123 | Diazepam 20 mg/4mL Injection, Solution | Baxter Healthcare Corporation | ANDA · DEA CIV |
| 71335-0444 | Diazepam 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-1523 | Diazepam 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-2948 | Diazepam 2 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-1584 | Diazepam 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2239 | Diazepam 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2306 | Diazepam 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2247 | Diazepam 2 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 55154-5554 | Diazepam 5 mg/1 Tablet | Cardinal Health 107, LLC | ANDA · DEA CIV |
| 68999-767 | Diazepam 5 mg/5mL Solution | Chartwell Governmental & Specialty RX, LLC. | ANDA · DEA CIV |
| 62135-787 | Diazepam 5 mg/1 Tablet | Chartwell RX, LLC | ANDA · DEA CIV |
| 62135-786 | Diazepam 2 mg/1 Tablet | Chartwell RX, LLC | ANDA · DEA CIV |
| 62135-768 | Diazepam 5 mg/mL Solution | Chartwell RX, LLC | ANDA · DEA CIV |
| 62135-767 | Diazepam 5 mg/5mL Solution | Chartwell RX, LLC | ANDA · DEA CIV |
| 62135-788 | Diazepam 10 mg/1 Tablet | Chartwell RX, LLC | ANDA · DEA CIV |
| 72572-175 | Diazepam 5 mg/mL Injection | Civica, Inc. | ANDA · DEA CIV |
| 72572-140 | Diazepam 10 mg/2mL Injection, Solution | Civica, Inc. | ANDA · DEA CIV |
| 58118-3925 | Diazepam 2 mg/1 Tablet | Clinical Solutions Wholesale, LLC | ANDA · DEA CIV |
| 58118-3926 | Diazepam 5 mg/1 Tablet | Clinical Solutions Wholesale, LLC | ANDA · DEA CIV |
| 58118-4047 | Diazepam 10 mg/1 Tablet | Clinical Solutions Wholesale, LLC | ANDA · DEA CIV |
| 67046-0943 | Diazepam 5 mg/1 Tablet | Coupler LLC | ANDA · DEA CIV |
| 67046-0944 | Diazepam 10 mg/1 Tablet | Coupler LLC | ANDA · DEA CIV |
| 72189-552 | Diazepam 10 mg/1 Tablet | Direct_Rx | ANDA · DEA CIV |
| 72189-570 | Diazepam 2 mg/1 Tablet | Direct_rx | ANDA · DEA CIV |
| 61919-906 | Diazepam 10 mg/1 Tablet | Direct_Rx | ANDA · DEA CIV |
| 61919-409 | Diazepam 5 mg/1 Tablet | Direct_Rx | ANDA · DEA CIV |
| 43598-106 | Diazepam 10 mg/2mL Injection, Solution | Dr. Reddy's Laboratories Inc | ANDA · DEA CIV |
| 76045-204 | Diazepam 10 mg/2mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CIV |
| 0404-9848 | Diazepam 5 mg/mL Injection, Solution | Henry Schein, Inc. | ANDA · DEA CIV |
| 0404-9769 | Diazepam 5 mg/mL Injection | Henry Schein, Inc. | ANDA · DEA CIV |
| 0404-9762 | Diazepam 5 mg/mL Injection | Henry Schein, Inc. | ANDA · DEA CIV |
| 0054-3188 | Diazepam 5 mg/5mL Solution | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6283 | Diazepam 5 mg/mL Injection, Solution | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6244 | Diazepam 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6243 | Diazepam 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0409-1273 | Diazepam 5 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIV |
| 0409-3213 | Diazepam 5 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIV |
| 43386-280 | Diazepam 10 mg/2g Gel | Lupin Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 43386-281 | Diazepam 20 mg/4g Gel | Lupin Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 71872-7259 | Diazepam 5 mg/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA · DEA CIV |
| 71872-7260 | Diazepam 5 mg/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA · DEA CIV |
| 51079-284 | Diazepam 2 mg/1 Tablet | Mylan Institutional Inc. | ANDA · DEA CIV |
| 51079-285 | Diazepam 5 mg/1 Tablet | Mylan Institutional Inc. | ANDA · DEA CIV |
| 51079-286 | Diazepam 10 mg/1 Tablet | Mylan Institutional Inc. | ANDA · DEA CIV |
| 0378-0271 | Diazepam 2 mg/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA · DEA CIV |
| 0378-0345 | Diazepam 5 mg/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA · DEA CIV |
| 0378-0477 | Diazepam 10 mg/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA · DEA CIV |
| 69339-137 | Diazepam 5 mg/mL Injection, Solution | Natco Pharma USA LLC | ANDA · DEA CIV |
| 69339-136 | Diazepam 10 mg/2mL Injection, Solution | Natco Pharma USA LLC | ANDA · DEA CIV |
| 68475-803 | Diazepam 10 mg/2mL Gel | Navinta LLC | ANDA · DEA CIV |
| 68475-804 | Diazepam 20 mg/4mL Gel | Navinta LLC | ANDA · DEA CIV |
| 68475-802 | Diazepam 2.5 mg/.5mL Gel | Navinta LLC | ANDA · DEA CIV |
| 68071-3686 | Diazepam 5 mg/1 Tablet | NuCare Pharmaceuticals, Inc | ANDA · DEA CIV |
| 68071-3682 | Diazepam 5 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68071-4922 | Diazepam 5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-4829 | Diazepam 10 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-4770 | Diazepam 5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 55289-092 | Diazepam 10 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 43063-840 | Diazepam 2 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 43063-970 | Diazepam 5 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 43063-987 | Diazepam 10 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 0121-0905 | Diazepam 5 mg/5mL Solution | Pharmaceutical Associates, Inc. | ANDA · DEA CIV |
| 68094-750 | Diazepam 5 mg/5mL Solution | Precision Dose Inc. | ANDA · DEA CIV |
| 68788-8466 | Diazepam 5 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-8462 | Diazepam 10 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 82804-186 | Diazepam 10 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CIV |
| 63187-173 | Diazepam 5 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CIV |
| 63187-544 | Diazepam 10 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CIV |
| 70518-4704 | Diazepam 10 mg/2mL Injection, Solution | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-2358 | Diazepam 10 mg/2mL Injection, Solution | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-1713 | Diazepam 5 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-0162 | Diazepam 10 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-0014 | Diazepam 10 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 48433-027 | Diazepam 2 mg/1 Tablet | Safecor Health, LLC | ANDA · DEA CIV |
| 48433-028 | Diazepam 5 mg/1 Tablet | Safecor Health, LLC | ANDA · DEA CIV |
| 48433-029 | Diazepam 10 mg/1 Tablet | Safecor Health, LLC | ANDA · DEA CIV |
| 25021-618 | Diazepam 5 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA · DEA CIV |
| 11534-199 | Diazepam 10 mg/1 Tablet | Sunrise Pharmaceutical, Inc. | ANDA · DEA CIV |
| 11534-203 | Diazepam 5 mg/1 Tablet | Sunrise Pharmaceutical, Inc. | ANDA · DEA CIV |
| 11534-202 | Diazepam 2 mg/1 Tablet | Sunrise Pharmaceutical, Inc. | ANDA · DEA CIV |
| 0172-3926 | Diazepam 5 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CIV |
| 0172-3927 | Diazepam 10 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CIV |
| 0172-3925 | Diazepam 2 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CIV |
| 87441-026 | Diazepam 5 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA · DEA CIV |
| 87441-025 | Diazepam 10 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA · DEA CIV |
| 70710-2080 | Diazepam 20 mg/4mL Gel | Zydus Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 70710-2079 | Diazepam 10 mg/2mL Gel | Zydus Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 70710-2078 | Diazepam 2.5 mg/.5mL Gel | Zydus Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 11704-600 | Diazepam 10 mg/2mL Injection | Meridian Medical Technologies LLC | NDA · DEA CIV |
| 68682-650 | Diazepam 2.5 mg/.5mL Gel | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC · DEA CIV |
| 68682-652 | Diazepam 10 mg/2mL Gel | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC · DEA CIV |
| 68682-655 | Diazepam 20 mg/4mL Gel | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC · DEA CIV |
Diazepam recalls
- D-1041-2018 Aug 15, 2018 · Class III · Terminated
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton. - D-1359-2016 Jul 20, 2016 · Class II · Terminated
Crystallization: Product contains particulate identified to be crystallized active ingredient. - D-927-2013 Sep 4, 2013 · Class II · Terminated
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials. - D-501-2013 Jun 12, 2013 · Class II · Terminated
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. - D-313-2013 May 15, 2013 · Class II · Terminated
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. - D-309-2013 May 8, 2013 · Class II · Terminated
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. - D-1369-2012 Jun 20, 2012 · Class II · Terminated
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Frequently asked questions
What is Diazepam used for?
Diazepam is indicated for the management of anxiety disorders 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. Note: Because the autoinjector provides a minimum dose of 10 mg diazepam, it should not be used to treat individuals with mild and moderate degrees of anxiety and…
What are the side effects of Diazepam?
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:… See the full label for the complete list.
Who makes Diazepam?
Diazepam is listed by 48 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC, Alembic Pharmaceuticals Inc..
Has Diazepam been recalled?
The FDA enforcement database lists 7 recalls for Diazepam, most recently D-1041-2018 (class iii): Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.