Diazepam 10 mg/2mL
Diazepam · INJECTION, SOLUTION · Alembic Pharmaceuticals Limited
Diazepam is a injection, solution containing diazepam at 10 mg/2mL, taken intramuscular. Manufactured by Alembic Pharmaceuticals Limited.
Key Facts
- Brand Name
- Diazepam
- Generic Name
- Diazepam
- NDC Code (Product)
46708-811- Manufacturer
- Alembic Pharmaceuticals Limited
- Strength
- 10 mg/2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA218450
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 04/25/2024
Recall History
Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Valeant Pharmaceuticals North America LLC
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Hospira Inc.
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Hospira Inc.
Crystallization: Product contains particulate identified to be crystallized active ingredient.
RXQ Compounding LLC
Lack of Assurance of Sterility
Meridian Medical Technologies a Pfizer Company
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Clinical Specialties Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Lannett Company, Inc.
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Diazepam tablets 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 may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets 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 tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets 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.
Dosage & Administration
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. Discontinuation or …
Warnings
WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepiones, including diazepam tablets, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs 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 tablets 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. In patients already receiving an opioid analgesic, prescribe a lower initial dose of diazepam tablets than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking diazepam tablets, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sed…
Contraindications
CONTRAINDICATIONS Diazepam tablets are contraindicated in patients with a known hypersensitivity to diazepam and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. Diazepam tablets are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. They may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow-angle glaucoma.
Drug Interactions
Drug Interactions 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 monitor patients closely for respiratory depression and sedation. Centrally Acting Agents If diazepam tablets are to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of diazepam tablets, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines, narcotics, barbiturates, MAO inhibitors and other antidepressants. Alcohol Concomitant use with alcohol is not recommended due to enhancement of the sedative effect. Antacids D…
Adverse Reactions
ADVERSE REACTIONS Side effects most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia. The following have also been reported: Central Nervous System: confusion, depression, dysarthria, headache, slurred speech, tremor, vertigo Gastrointestinal System: constipation, nausea, gastrointestinal disturbances Special Senses: blurred vision, diplopia, dizziness Cardiovascular System: hypotension Psychiatric and Paradoxical Reactions: stimulation, restlessness, acute hyperexcited states, anxiety, agitation, aggressiveness, irritability, rage, hallucinations, psychoses, delusions, increased muscle spasticity, insomnia, sleep disturbances, and nightmares. Inappropriate behavior and other adverse behavioral effects have been reported when using benzodiazepines. Should these occur, use of the drug should be discontinued. They are more likely to occur in children and in the elderly. Urogenital System: incontinence, changes in libido, urinary retention Skin and Appendages: skin reactions Laboratories: elevated transaminases and alkaline phosphatase Other: changes in salivation, including dry mouth, hypersalivation Antegrade amnesia may occur using therapeutic dosages, the ri…
Frequently Asked Questions
What is Diazepam used for?
Diazepam contains Diazepam. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Diazepam a controlled substance?
Yes, Diazepam is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Diazepam?
The generic name for Diazepam is Diazepam. There are 1 other brand versions of Diazepam.
What is the NDC code for Diazepam 10 mg/2mL?
The NDC (National Drug Code) for Diazepam 10 mg/2mL is 46708-811, listed by Alembic Pharmaceuticals Limited.