Alzolam Tablet

Alzolam is a triazolo analogue of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alzolam is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA) - benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose related CNS depressant activity varying from mild impairment of task performance to hypnosis.

Uses

  • * Anxiety disorder
  • * Short term relief of anxiety
  • * Anxiety associated with depression
  • * Panic disorder, with or without agoraphobia.

Alzolam is also used to associated treatment for these conditions: Anxiety, Generalized Anxiety Disorder (GAD), Panic Disorder

Trade Name Alzolam
Generic Alprazolam
Other Names Alprazolam
Weight 0.25mg, 0.5mg
Type Tablet
Formula C17H13ClN4
Weight Average: 308.765
Monoisotopic: 308.082874143
Protein binding

Alprazolam is 80% protein bound in serum. The majority of this protein binding is to serum albumin. Alprazolam is also bound to alpha1-acid glycoprotein with low frequency.

Therapeutic Class Benzodiazepine sedatives
Manufacturer Ordain Health Care Global Private Limited, Sun Pharma, Sun Pharmaceutical (bangladesh) Limited
Available Country India, Bangladesh
Last Updated: June 23, 2021 at 9:00 am

Dosage

Alzolam dosage

Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may

be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. The maximum dose should not

exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a

successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.

Dosage should be individualized for maximum beneficial effect with a lowest possible dose. If side-effects occur at

starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more

than 0.5 mg every three days.

In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times

daily and may be gradually increased if needed and tolerated. Safety and effectiveness of Alzolam in individuals

below 18 years of age have not been established.

Alzolam XR 1 should be administered once daily, preferably in the morning by patients who are on multiple dosage

regimen of Alzolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.

Side Effects

Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation etc.

Precaution

Because Alzolam may produce psychological and physical dependence, increment of dose or abrupt discontinuation of Alzolam therapy should not be done without physician's advice. Duration of therapy must be determined by the physicians. Alzolam should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency or sleep apnea.

Interaction

Alzolam produces additive CNS depressant effects when co-administered with other psychotropic medications, anticonvulsants, antihistaminics, ethanol and other drugs which themselves produce CNS depression.

Food Interaction

  • Avoid alcohol. Alcohol may potentiate the CNS depressant effects of this drug.
  • Avoid grapefruit products.
  • Limit caffeine intake.
  • Take with or without food. Food increases the Cmax of extended release alprazolam by 25%, but the AUC and half life are not affected.

Volume of Distribution

Volume of distribution following oral administration is 0.8-1.3L/kg. Alzolam crosses the blood-brain barrier.

Half Life

11.2 hours in healthy patients. The half life is 16.3h in the elderly, 5.8-65.3h in patients with alcoholic liver disease, 9.9-40.4h in obese patients. The half life is 25% higher in Asian patients compared to Caucasians. Other studies have shown the half life to be 9-16h.

Clearance

Oral clearance is 0.90±0.21mL/min/kg but this increases to 2.13±0.54mL/min/kg when given with CYP3A inducers. Other studies have demonstrated a clearance of 0.70-1.5mL/min/kg.

Pregnancy & Breastfeeding use

Pregnancy: Alzolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy.

Lactation: Like other benzodiazepines, Alzolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alzolam.

Contraindication

Contraindicated in patients with hypersensitivity to alprazolam or other benzodiazepines. Alzolam is also contraindicated in patients with myasthenia gravis, acute narrow angle glaucoma, during pregnancy and also in infants.

Special Warning

Use in Children: Safety and efficacy of Alzolam in patients under the age of 18 years has not been established.

Acute Overdose

Manifestations of Alzolam over dosage include somnolence, confusion, impaired coordination, diminished reflexes and coma. In such cases of over dosage general supportive measures should be employed along with immediate gastric lavage.

Interaction with other Medicine

The CNS-depressant action of Alzolam may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral contraceptives.

Storage Condition

Alzolam tablets should be stored in a cool and dry place, protected from light and moisture.

Alzolam contains Alprazolam see full prescribing information from innovator Monograph