Nitrazepam


Concise Prescribing Info
Indications/Uses
Insomnia.
Dosage/Direction for Use
Adult : PO 5 mg at bedtime; increase to 10 mg if needed.
Dosage Details
Oral
Short-term management of insomnia
Adult: 5 mg at night; increase to 10 mg if necessary.
Elderly: (or debilitated patients): 2.5-5mg at bed time. Dose should not exceed half of the usual adult dose. Max: 5mg/day.

Oral
Infantile spasms
Child: Infants: 125 mcg/kg bid; gradually increase to 250-500 mcg/kg bid.
Administration
May be taken with or without food.
Contraindications
Myasthenia gravis, narrow-angle glaucoma, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic impairment, porphyria.
Special Precautions
May induce anterograde amnesia; caution patients to have uninterrupted sleep of 7-8 hr after ingestion of dose. May impair ability to drive or operate machinery. Depression, especially if suicidal risk may be present. History of drug abuse or acute alcoholism. Hepatic and renal impairment. Respiratory disease. Debilitated patients. Patients who are at risk of falls. Children, elderly. Pregnancy and lactation.
Adverse Reactions
Hypotension, palpitation; agitation, aggressiveness, amnesia, ataxia, confusion, delusions, disorientation, dizziness, fatigue, hallucination, hangover, headache, irritability, nightmares, psychoses, rage, restlessness, sedation; rash; changes in libido; constipation, diarrhoea, excessive salivation, heartburn, nausea, vomiting; granulocytopenia, leukopenia; falling, muscle weakness; blurred or double vision; tinnitus (associated with withdrawal); aspiration, increased bronchial secretion, dyspnoea.
Overdosage
Symptoms: Somnolence, drowsiness, confusion, ataxia, impaired reflexes, coma, dyspnoea, hypotension, respiratory and cardiovascular depression. Management: Supportive. Gastric lavage may be beneficial if performed soon after ingestion. Flumazenil may reverse benzodiazepine-induced CNS depression.
Drug Interactions
CNS depressant effect increased with alcohol, barbiturates, TCAs, phenothiazines, morphine derivatives. Effects may be antagonised by theophylline. Increased levels/effects with probenecid. Reduced levels/effects with rifampicin. May reduce effects of levodopa.
Food Interaction
Increased CNS depression may occur with valerian, kava kava, St John's wort, gotu kola.
Lab Interference
May cause false elevations (about 15%) in clozapine plasma levels.
Action
Description: Nitrazepam is a benzodiazepine with a pronounced sleep-inducing activity. It depresses the reticular-activating system in the brainstem by enhancing the inhibitory effect of GABA on brain cells, thus preventing excessive brain activity.
Onset: 30-60 min.
Duration: 6-8 hr.
Pharmacokinetics:
Absorption: Fairly absorbed from the GI tract (oral). Peak plasma levels in 2-3 hr.
Distribution: Crosses the blood-brain barrier and placenta; enters breast milk (trace amounts). Protein-binding: 87%.
Metabolism: Hepatic by nitroreduction followed by acetylation.
Excretion: Urine (as free or conjugated metabolites); 24-30 hr (elimination half-life).
Storage
Store at room temperature. Protect from light and moisture.
Disclaimer: This information is independently developed by MIMS based on Nitrazepam 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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