Prazepam


Generic Medicine Info
Indications and Dosage
Oral
Anxiety
Adult: For cases that are severe, disabling, or subjecting the patient to extreme distress: 30 mg daily as a single or in divided doses, may be increased to 60 mg daily according to patient response. Usual dose range: 10-60 mg daily. Use the lowest dose that can control the symptoms. Max treatment duration: 4-6 weeks (including tapering off process).
Elderly: Initiate at a lower dose or a dose of no more than 15 mg daily. May increase gradually according to patient response.
Special Patient Group
Debilitated patient: Initiate at a lower dose or a dose of no more than 15 mg daily. May increase gradually according to patient response.
Hepatic Impairment
Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Myasthenia gravis, sleep apnoea syndrome, severe respiratory insufficiency. Severe hepatic impairment.
Special Precautions
Patient with suspected, known, or history of alcohol or drug abuse. Not recommended for the primary treatment of psychotic illness. Not indicated for use as monotherapy to treat depression or anxiety associated depression. Avoid abrupt withdrawal. Elderly and debilitated patients. Pregnancy and lactation. Concomitant use with opioids.
Adverse Reactions
Significant: Tolerance (may develop after repeated use for a few weeks), physical and psychological dependence; anterograde amnesia; rebound insomnia and anxiety; psychiatric and paradoxical reactions (e.g. restlessness, agitation, irritability, aggressiveness, rage, delusion, hallucination, nightmare, psychoses, behavioural changes).
Cardiac disorders: Palpitations.
Eye disorders: Blurred or double vision.
Gastrointestinal disorders: Dry mouth, gastrointestinal disturbances.
General disorders and administration site conditions: Fatigue, weakness.
Musculoskeletal and connective tissue disorders: Joint pain.
Nervous system disorders: Drowsiness, ataxia, dizziness, headache, lightheadedness, slurred speech, tremor, hyperactivity.
Psychiatric disorders: Confusion, vivid dreams, depression.
Skin and subcutaneous tissue disorders: Rash, diaphoresis.
Patient Counseling Information
This drug may cause sedation, amnesia, impaired concentration and muscular function; if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor blood counts and LFTs periodically in patients on prolonged therapy. Reassess patient regularly and evaluate the need for continued treatment.
Overdosage
Symptoms: Mental confusion, lethargy, drowsiness; ataxia, hypotonia, hypotension, respiratory depression. Rarely, coma and death. Management: Induce vomiting in conscious patients within 1 hour of ingestion. Perform gastric lavage while protecting the airway in unconscious patients. Administer activated charcoal to reduce absorption if emptying of the stomach has no advantage. May give flumazenil as an antidote. Monitor respiratory and CV functions.
Drug Interactions
Additive CNS depressant effects including respiratory depression with antipsychotics (e.g. clozapine), hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, anti-epileptics, anaesthetics, and sedative antihistamines. May result in enhanced euphoria leading to an increased risk in psychological dependence with narcotic analgesics. May enhance therapeutic effect with oral contraceptives and certain CYP450 enzyme inhibitors. May reduce metabolism and increase the risk of potential toxicity with CYP3A4 enzyme inhibitors.
Potentially Fatal: May cause profound sedation, respiratory depression, and coma with opioids.
Food Interaction
Alcohol may potentiate the sedative effect of prazepam.
Action
Description: Prazepam is a long-acting benzodiazepine derivative that is converted in the liver to desmethyldiazepam (active metabolite). It has similar clinical activity to other benzodiazepines, including anxiolytic, sedative, anticonvulsant, and central muscle relaxant properties.
Pharmacokinetics:
Metabolism: Undergoes extensive first-pass metabolism in the liver to desmethyldiazepam (nordazepam) and oxazepam.
Chemical Structure

Chemical Structure Image
Prazepam

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 4890, Prazepam. https://pubchem.ncbi.nlm.nih.gov/compound/Prazepam. Accessed Aug. 25, 2021.

MIMS Class
ATC Classification
N05BA11 - prazepam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
References
Anon. Prazepam. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/08/2021.

Buckingham R (ed). Prazepam. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/08/2021.

Prazepam. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 13/08/2021.

Disclaimer: This information is independently developed by MIMS based on Prazepam from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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