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Pronunciation:

(PRA ze pam)

Generic Available:

Yes

Use:

Treatment of anxiety

Use - Unlabeled/Investigational:

Ethanol withdrawal; duodenal ulcer; narcotic addiction; spasticity; partial seizures

Restrictions:

Not available in U.S.

Pregnancy Risk Factor:

Contraindications:

Hypersensitivity to prazepam or any component of the formulation (cross-sensitivity with other benzodiazepines may exist); narrow-angle glaucoma; pregnancy

Warnings/Precautions:

Use with caution in elderly or debilitated patients, patients with hepatic disease (including alcoholics), or renal impairment. Use with caution in patients with respiratory disease, or impaired gag reflex. Avoid use in patients with sleep apnea.

Causes CNS depression (dose-related) resulting in sedation, dizziness, confusion, or ataxia which may impair physical and mental capabilities. Patients must be cautioned about performing tasks which require mental alertness (operating machinery or driving). Use with caution in patients receiving other CNS depressants or psychoactive agents. Effects with other sedative drugs or ethanol may be potentiated. Benzodiazepines have been associated with falls and traumatic injury and should be used with extreme caution in patients who are at risk of these events (especially the elderly).

Use caution in patients with depression, particularly if suicidal risk may be present. Use with caution in patients with a history of drug dependence. Benzodiazepines have been associated with dependence and acute withdrawal symptoms on discontinuation or reduction in dose. Acute withdrawal, including seizures, may be precipitated after administration of flumazenil to patients receiving long-term benzodiazepine therapy.

Benzodiazepines have been associated with anterograde amnesia. Paradoxical reactions, including hyperactive or aggressive behavior have been reported with benzodiazepines, particularly in adolescent/pediatric or psychiatric patients. Does not have analgesic, antidepressant, or antipsychotic properties.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Hypotension, syncope

Central nervous system: Drowsiness, fatigue, impaired coordination, lightheadedness, memory impairment, insomnia, depression, headache, anxiety, confusion, nervousness, dizziness, akathisia, ataxia, vivid dreams

Dermatologic: Rash, pruritus

Endocrine & metabolic: Decreased libido, menstrual irregularities

Gastrointestinal: Xerostomia, constipation, diarrhea, decreased salivation, nausea, vomiting, increased or decreased appetite, increased salivation, weight gain/loss

Hematologic: Blood dyscrasias

Neuromuscular & skeletal: Dysarthria, tremor, muscle cramps, rigidity, weakness, reflex slowing

Ocular: Blurred vision, increased lenticular pressure

Otic: Tinnitus

Respiratory: Nasal congestion, hyperventilation

Miscellaneous: Diaphoresis, drug dependence

Drug Interactions:

Substrate of CYP3A4 (minor)

CNS depressants: Sedative effects and/or respiratory depression may be additive with CNS depressants; includes ethanol, barbiturates, narcotic analgesics, and other sedative agents; monitor for increased effect

Oral contraceptives: May decrease the clearance of some benzodiazepines (those which undergo oxidative metabolism); monitor for increased benzodiazepine effect

Theophylline: May partially antagonize some of the effects of benzodiazepines; monitor for decreased response; may require higher doses for sedation

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).

Mechanism of Action:

Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites within the central nervous system, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization (a less excitable state) and stabilization.

Pharmacodynamics/Kinetics:

Duration: 48 hours

Half-life elimination, serum: Parent drug: 78 minutes; Desmethyldiazepam: 30-100 hours

Dosage:

Adults: Oral: 30 mg/day in divided doses, may increase gradually to a maximum of 60 mg/day

Monitoring Parameters:

Respiratory and cardiovascular status

Patient Education:

Avoid alcohol and other CNS depressants; avoid activities needing good psychomotor coordination until CNS effects are known; drug may cause physical or psychological dependence; avoid abrupt discontinuation after prolonged use

Additional Information:

Not available in U.S.

Prazepam offers no significant advantage over other benzodiazepines.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Dosage Forms:

Capsule: 5 mg, 10 mg, 20 mg

Tablet: 5 mg, 10 mg

International Brand Names:

Centrax® (IE); Demetrin® (AT, CH, CZ, DE, HK, PT, SI, YU, ZA); Equipaz® (AR); Lysanxia® (BE, FR, LU); Mono Demetrin® (DE); Pozapam® (TH); Prasepine® (TH); Prazene® (IT); Reapam® (NL); Trepidan® (IT)

References

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings,"Chest, 2003, 123(3):897-922.

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