Sedalam®
Alprazolam
0.5 & 1 mg Tablet
Anxiety disorders: Treatment of generalized anxiety disorder, short-term anxiety, and anxiety associated with depression; treatment of panic disorder with or without agoraphobia.
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.
Method of Administration:
Anxiety disorders (adjunctive therapy or monotherapy):
Oral: Initial: 0.25 mg 3 to 4 times daily; may increase dose based on response and tolerability in increments ≤1 mg/day at intervals ≥3 days up to a usual dose of 2 to 6 mg/day in 3 to 4 divided doses. Some patients may require up to 8 mg/day for optimal response; manufacturer’s labeling maximum: 10 mg/day. With doses >4 mg/day, increase more gradually to minimize adverse effects; periodically reassess and consider dosage reduction.
Notes
Contraindications:
Hypersensitivity to alprazolam, any component of the formulation, or other benzodiazepines (cross-sensitivity with other benzodiazepines may exist); concurrent therapy with strong cytochrome P-450 3A (CYP3A) inhibitors (eg, itraconazole, ketoconazole), except ritonavir; acute narrow angle glaucoma.
Interactions:
CarBAMazepine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of CarBAMazepine. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of ALPRAZolam. Risk X: Avoid combination
Methadone: Benzodiazepines may enhance the CNS depressant effect of Methadone. Management: Clinicians should generally avoid concurrent use of methadone and benzodiazepines when possible; any combined use should be undertaken with extra caution. Risk D: Consider therapy modification
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification
Pregnancy and Lactation:
Benzodiazepines have the potential to cause harm to the fetus. Teratogenic effects have been observed with some benzodiazepines.
Alprazolam is present in breast milk and is not recommended.
Warning and Precaution:
- Depression: Use caution in patients with depression, particularly if suicidal risk may be present; episodes of mania or hypomania have occurred in depressed patients treated with alprazolam.
- Hepatic impairment: Use with caution in patients with hepatic impairment.
- Renal impairment: Use with caution in patients with renal impairment or predisposition to urate nephropathy; has weak uricosuric properties.
- Respiratory disease: Use with caution in patients with respiratory disease.
Adverse Reactions:
Drowsiness, fatigue, sedation, ataxia, memory impairment, irritability, cognitive dysfunction, dysarthria, dizziness, depression, Skin rash, Weight gain, weight loss, decreased libido, Increased appetite, decreased appetite, constipation, xerostomia, Difficulty in micturition
Storage:
Store below 30 and protect from light and moisture.