Diazepam is a benzodiazepine used to treat anxiety, acute alcohol withdrawal, and seizures, also used to relieve muscle spasms and to provide sedation before medical procedures. It works by enhancing the effects of a certain natural chemical in the body (GABA)
Diazepam is a benzodiazepine derivative. The chemical name of diazepam 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, insoluble in water. The empirical formula is C 16H 13ClN 2O and the molecular weight is 284.75. The structural formula is as follows:
Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose.
Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10.
Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1.
Indications and Usage for Diazepam
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 may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
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; 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 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.
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 that may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants (see Drug Interactions).
The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression or anxiety associated with depression, particularly the recognition that suicidal tendencies may be present and protective measures may be necessary.
Psychiatric and paradoxical reactions are known to occur when using benzodiazepines (see ADVERSE REACTIONS). Should this occur, use of the drug should be discontinued. These reactions are more likely to occur in children and the elderly.
A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of respiratory depression.
Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse (see DRUG ABUSE AND DEPENDENCE).
In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (2 mg to 2.5 mg once or twice daily, initially, to be increased gradually as needed and tolerated).
Some loss of response to the effects of benzodiazepines may develop after repeated use of diazepam for a prolonged time.
Diazepam 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.
|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
|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 Dosage Reduction of Diazepam
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactionsand DRUG ABUSE AND DEPENDENCE: Dependence).
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.
DIAZEPAM (dye az’ e pam) TABLETS, C-IV
|What is the most important information I should know about Diazepam Tablets?
Physical dependence and withdrawal reactions.Diazepam tablets can cause physical dependence and withdrawal reactions.
|What are diazepam tablets?
|Do not take diazepam tablets if you:
|Before you take diazepam tablets, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.
|How should I take diazepam tablets?
|What are the possible side effects of diazepam tablets?
Diazepam tablets may cause serious side effects, including:
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
|How can I watch for early symptoms of suicidal thoughts and actions?
Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
|These are not all the possible side effects of diazepam tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects Here
|How should I store diazepam tablets?
|General information about the safe and effective use of diazepam tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use diazepam tablets for a condition for which it was not prescribed. Do not give diazepam tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about diazepam tablets that is written for health professionals.
|What are the ingredients in diazepam tablets?
Inactive ingredients:anhydrous lactose, magnesium stearate, and microcrystalline cellulose. The 5 mg tablets also contain D&C Yellow No. 10 and the 10 mg tablets also contain FD&C Blue No. 1.
Medication Guides available Here
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