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Products > Human Product > CNS drugs > Alprazolam

Alprazolam


 

Category:

Benzodiazepine

 

Composition:

Each tablet contains Alprazolam 0.5 or 1 mg

 

Indications:

Alprazolam is a short acting benzodiazepine with general properties similar to those of diazepam. It also appears to possess antidepressant activity . It is used in the short-term treatment of anxiety disorders, anxiety associated with depression, panic disorders with or without agoraphobia  and   premenstrual syndrome.

 

Dosage and administration:

 

Anxiety Disorders

Management of Disorders or Short-Term Relief of Symptoms:
Initial: 0.25-0.5mg tid
Titrate: May increase at intervals of 3-4 days
Max: 4mg/day in divided doses

 

Panic Disorder

With or without Agoraphobia:
Initial: 0.5mg tid
Titrate: May increase by ≤1mg/day every 3-4 days; slower titration to doses >4mg/day
Range: 1-10mg/day

Hepatic Impairment
Advanced Liver Disease:
Initial: 0.25mg bid-tid
Titrate: May increase gradually prn

Elderly
Elderly/Debilitated:
Initial: 0.25mg bid-tid
Titrate: May increase gradually prn

Discontinuation
Reduce dose gradually when discontinuing therapy or when decreasing daily dosage. Decrease daily dose by no more than 0.5mg every 3 days; some patients may require an even slower dosage reduction

 

 

 

 

Pregnancy and breastfeeding:

Category D, not for use in nursing.

 

Contraindications:

Known sensitivity to this drug or other benzodiazepines, acute narrow-angle glaucoma, concomitant ketoconazole or itraconazole.

 

Warning and precautions:

May be used with treated open-angle glaucoma.

Increased risk of dependence with doses >4mg/day, treatment for >12 weeks, and in panic disorder patients.

Seizures, including status epilepticus, reported with dose reduction or abrupt discontinuation.

Early am anxiety and emergence of anxiety symptoms between doses reported; give same total daily dose divided as more frequent administrations.

Withdrawal reactions may occur; reduce dose or discontinue therapy gradually.

May impair mental/physical abilities.

May cause fetal harm; avoid use during 1st trimester.

Hypomania/mania reported in patients with depression.

Caution with severe depression, suicidal ideation/plans, impaired renal/hepatic/pulmonary function, elderly, and debilitated patients.

Has a weak uricosuric effect.

Decreased systemic elimination rate with alcoholic liver disease/obesity.

 

Adverse reactions:

Drowsiness, lightheadedness, fatigue/tiredness, irritability, depression, headache, confusion, insomnia, dry mouth, constipation, diarrhea, nausea/vominting, tachycardia/palpitations, blurred vision, nasal congestion.

 

Drug interactions:

Not recommended with azole antifungals.

 Avoid with very potent CYP3A inhibitors.

Caution with alcohol, other CNS depressants, diltiazem, isoniazid, macrolides (eg, erythromycin, clarithromycin), grapefruit juice, sertraline, paroxetine, ergotamine, cyclosporine, amiodarone, nicardipine, nifedipine, and other CYP3A inhibitors.

Additive CNS depressant effects with psychotropics, anticonvulsants, antihistaminics, ethanol, and other drugs that produce CNS depression.

Increased digoxin concentrations reported (especially in patients >65 yrs of age); monitor for signs/symptoms of digoxin toxicity.

May increase plasma concentrations of imipramine and desipramine.

 Fluoxetine, fluvoxamine, nefazodone, cimetidine, and oral contraceptives may increase concentrations.

 CYP3A inducers (eg, carbamazepine), propoxyphene, and smoking may decrease levels.

 May require dose adjustment or discontinuation with HIV protease inhibitors (eg, ritonavir).

 

Storage:

Store below 30 °C.  

Keep out of reach of children.
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