Diazepam

Diazepam

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Questions & Answers

Side Effects & Adverse Reactions

Diazepam is not recommended in the treatment of psychotic patients and should not be employed instead of appropriate treatment.

Since diazepam has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during diazepam therapy.

As with other agents that have anticonvulsant activity, when diazepam is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of diazepam in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.

 

An increased risk of congenital malformations and other developmental abnormalities associated with the use of benzodiazepine drugs during pregnancy has been suggested. There may also be non-teratogenic risks associated with the use of benzodiazepines during pregnancy. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy. In addition, children born to mothers receiving benzodiazepines on a regular basis late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period.

Diazepam has been shown to be teratogenic in mice and hamsters when given orally at daily doses of 100 mg/kg or greater (approximately eight times the maximum recommended human dose [MRHD = 1 mg/kg/day] or greater on a mg/m2 basis). Cleft palate and encephalopathy are the most common and consistently reported malformations produced in these species by administration of high, maternally toxic doses of diazepam during organogenesis. Rodent studies have indicated that prenatal exposure to diazepam doses similar to those used clinically can produce long-term changes in cellular immune responses, brain neurochemistry, and behavior.

In general, the use of diazepam in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should also be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug.

 

Special care must be taken when diazepam is used during labor and delivery, as high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia, and moderate respiratory depression in the neonates. With newborn infants it must be remembered that the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants).

 

Diazepam passes into breast milk. Breastfeeding is therefore not recommended in patients receiving diazepam.

 

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Diazepam Tablets USP are 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 Tablets USP may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

Diazepam Tablets USP are 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, and stiff-man syndrome.

Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.

The effectiveness of Diazepam Tablets USP in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

 

History

There is currently no drug history available for this drug.

Other Information

Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is:

MM1

C16H13ClN2O M.W. 284.75

Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.

 

Diazepam Manufacturers


  • Remedyrepack Inc.
    Diazepam Tablet [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Diazepam Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • A-s Medication Solutions Llc
    Diazepam Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Diazepam Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Diazepam Tablet [A-s Medication Solutions Llc]
  • Direct Rx
    Diazepam Tablet [Direct Rx]
  • U.s. Army Medical Research And Development Command (Mcmr-rcq-hr)
    Diazepam Injection [U.s. Army Medical Research And Development Command (Mcmr-rcq-hr)]
  • Apotheca, Inc.
    Diazepam Tablet [Apotheca, Inc.]
  • Stat Rx Usa Llc
    Diazepam Tablet [Stat Rx Usa Llc]
  • Redpharm Drug Inc.
    Diazepam Tablet [Redpharm Drug Inc.]
  • Rebel Distributors Corp
    Diazepam Injection, Solution [Rebel Distributors Corp]
  • General Injectables And Vaccines, Inc.
    Diazepam (Diazepam) Injection [General Injectables And Vaccines, Inc.]
  • Blenheim Pharmacal, Inc.
    Diazepam Tablet [Blenheim Pharmacal, Inc.]
  • Contract Pharmacy Services-pa
    Diazepam Tablet [Contract Pharmacy Services-pa]
  • Pd-rx Pharmaceuticals, Inc.
    Diazepam Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Diazepam Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • General Injectables And Vaccines, Inc.
    Diazepam Injection, Solution [General Injectables And Vaccines, Inc.]
  • Stat Rx Usa Llc
    Diazepam Tablet [Stat Rx Usa Llc]
  • Cardinal Health
    Diazepam Tablet [Cardinal Health]
  • Physicians Total Care, Inc.
    Diazepam Injection, Solution [Physicians Total Care, Inc.]
  • Unit Dose Services
    Diazepam Tablet [Unit Dose Services]
  • Pd-rx Pharmaceuticals, Inc.
    Diazepam Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Mckesson Contract Packaging
    Diazepam Tablet [Mckesson Contract Packaging]
  • Pd-rx Pharmaceuticals, Inc.
    Diazepam Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Physicians Total Care, Inc.
    Diazepam Tablet [Physicians Total Care, Inc.]
  • Bryant Ranch Prepack
    Diazepam Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Diazepam Tablet [Bryant Ranch Prepack]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Diazepam Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Diazepam Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Bryant Ranch Prepack
    Diazepam Tablet [Bryant Ranch Prepack]
  • Aphena Pharma Solutions – Tennessee, Llc
    Diazepam Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • A-s Medication Solutions Llc
    Diazepam Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Diazepam Tablet [A-s Medication Solutions Llc]
  • Unit Dose Services
    Diazepam Tablet [Unit Dose Services]
  • A-s Medication Solutions Llc
    Diazepam Injection, Solution [A-s Medication Solutions Llc]
  • Remedyrepack Inc.
    Diazepam Tablet [Remedyrepack Inc. ]
  • Preferred Pharmaceuticals, Inc
    Diazepam Tablet [Preferred Pharmaceuticals, Inc]
  • Dispensing Solutions, Inc.
    Diazepam Tablet [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Diazepam Tablet [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Diazepam Tablet [Dispensing Solutions, Inc.]
  • Cardinal Health
    Diazepam Tablet [Cardinal Health]
  • Aidarex Pharmaceuticals Llc
    Diazepam Tablet [Aidarex Pharmaceuticals Llc]
  • Mylan Institutional Inc.
    Diazepam Tablet [Mylan Institutional Inc.]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
    Diazepam Tablet [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
  • Ivax Pharmaceuticals, Inc.
    Diazepam Tablet [Ivax Pharmaceuticals, Inc.]
  • Qualitest Pharmaceuticals
    Diazepam Tablet [Qualitest Pharmaceuticals]
  • Kaiser Foundation Hospitals
    Diazepam Tablet [Kaiser Foundation Hospitals]
  • Hospira, Inc.
    Diazepam Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Diazepam Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Diazepam Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Diazepam Injection, Solution [Hospira, Inc.]
  • Direct Rx
    Diazepam Tablet [Direct Rx]
  • Watson Laboratories, Inc.
    Diazepam Tablet [Watson Laboratories, Inc.]
  • Aphena Pharma Solutions – Tennessee, Llc
    Diazepam Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Cardinal Health
    Diazepam Tablet [Cardinal Health]
  • Cardinal Health
    Diazepam Injection, Solution [Cardinal Health]
  • Hospira, Inc.
    Diazepam Injection, Solution [Hospira, Inc.]
  • Mylan Pharmaceuticals Inc.
    Diazepam Tablet [Mylan Pharmaceuticals Inc.]
  • Cardinal Health
    Diazepam Tablet [Cardinal Health]
  • Cardinal Health
    Diazepam Injection, Solution [Cardinal Health]
  • Bryant Ranch Prepack
    Diazepam Tablet [Bryant Ranch Prepack]
  • Tya Pharmaceuticals
    Diazepam Tablet [Tya Pharmaceuticals]
  • Tya Pharmaceuticals
    Diazepam Tablet [Tya Pharmaceuticals]
  • Preferred Pharmaceuticals, Inc.
    Diazepam Tablet [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Diazepam Tablet [Preferred Pharmaceuticals, Inc.]
  • Proficient Rx Lp
    Diazepam Tablet [Proficient Rx Lp]
  • Major Pharmaceuticals
    Diazepam Tablet [Major Pharmaceuticals]
  • A-s Medication Solutions Llc
    Diazepam Tablet [A-s Medication Solutions Llc]
  • Direct Rx
    Diazepam Tablet [Direct Rx]
  • Proficient Rx Lp
    Diazepam Tablet [Proficient Rx Lp]

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