Xionil

• Anxiety Disorders:
• Management of generalized anxiety disorder (GAD) and situational anxiety.
• Panic Disorders:
• Adjunctive treatment in panic attacks and agoraphobia.
• Muscle Spasms:
• Relief of skeletal muscle spasticity and tension.
• Preoperative Sedation:
• Sedative and anxiolytic agent before surgical or diagnostic procedures.
• Off-label Uses:
• Short-term treatment of insomnia related to anxiety.
• Adjunct in alcohol withdrawal syndrome.

• Adults:
• Typical dose: 3 to 6 mg daily, divided into 2 or 3 doses.
• Dosage may be adjusted depending on severity and patient response; maximum usually 12 mg/day.
• Elderly or debilitated patients:
• Start at lower doses (e.g., 1.5 mg twice daily) due to increased sensitivity and risk of sedation.
• Pediatrics:
• Not generally recommended due to lack of safety data.
• Renal or Hepatic Impairment:
• Use with caution; dose reduction may be necessary.
• Administration:
• Oral route; tablets swallowed whole with or without food.

Bromazepam is a benzodiazepine derivative that acts by enhancing the effect of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) at the GABA-A receptor complex. Binding of bromazepam to the benzodiazepine site on the receptor increases the frequency of chloride channel opening, leading to hyperpolarization of neurons. This results in central nervous system depression, manifesting as anxiolytic, sedative, muscle relaxant, and anticonvulsant effects.

• Absorption:
• Well absorbed orally with peak plasma concentrations within 1 to 2 hours.
• Distribution:
• Widely distributed throughout the body, including the CNS; plasma protein binding ~70%.
• Metabolism:
• Extensively metabolized in the liver via hydroxylation and conjugation (CYP3A4 involved).
• Active Metabolites:
• Some metabolites contribute to clinical effect and prolong duration.
• Elimination:
• Metabolites excreted primarily via the kidneys.
• Half-life:
• Elimination half-life ranges from 10 to 20 hours, prolonged in elderly or hepatic impairment.

• Pregnancy:
• FDA Category D: Positive evidence of risk. Use only if benefits outweigh risks.
• Associated with risk of fetal malformations and neonatal withdrawal or sedation.
• Lactation:
• Excreted in breast milk; may cause sedation or feeding difficulties in the infant.
• Breastfeeding is generally not recommended during treatment.

• Primary class: Benzodiazepine
• Subclass: Anxiolytic, Sedative-Hypnotic

• Known hypersensitivity to bromazepam or benzodiazepines
• Acute narrow-angle glaucoma
• Severe respiratory insufficiency
• Severe hepatic impairment (e.g., hepatic failure)
• Myasthenia gravis
• Sleep apnea syndrome

• Dependence and Withdrawal: Risk of physical and psychological dependence; taper gradually to discontinue.
• CNS Depression: May cause sedation, impaired coordination, and increased risk of falls, especially in elderly.
• Respiratory Depression: Use cautiously in patients with compromised respiratory function.
• Cognitive Impairment: May cause memory impairment or confusion.
• Psychiatric Effects: Possible paradoxical reactions such as agitation, irritability, aggression, or hallucinations.
• Use in Elderly: Increased sensitivity; start with low dose and monitor closely.
• Avoid Alcohol: Concomitant use increases CNS depression and risk of severe sedation.

• Common:
• Drowsiness, fatigue, dizziness, muscle weakness
• Ataxia, impaired coordination
• Dry mouth
• Less common:
• Confusion, memory impairment
• Headache
• Gastrointestinal disturbances (nausea, constipation)
• Rare but serious:
• Respiratory depression
• Paradoxical reactions (agitation, aggression)
• Dependence, withdrawal seizures on abrupt discontinuation

• CNS Depressants: Enhanced sedation with alcohol, opioids, barbiturates, and other benzodiazepines.
• CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin): Increase bromazepam levels and effects.
• CYP3A4 Inducers (e.g., rifampin, carbamazepine): Decrease efficacy by increasing metabolism.
• Oral Contraceptives: May increase bromazepam plasma concentrations.
• Theophylline, Clozapine: Possible antagonism of sedative effects.

• No major changes in indication; ongoing emphasis on cautious use due to dependence potential.
• Guidelines recommend short-term use, preferably under specialist supervision.
• Increased awareness of risks of misuse and recommendations for patient education on dependence.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep in tightly closed container.
• Keep out of reach of children.