Drug Interaction:
Benzodiapines include-
Alprozolam, Chlordiazepoxide, Clonazepam, Clorazepate,Diazepam, Halazepam, Lorazepam, Oxazepam, Prazazepam
Refer Diazepam-
Cimetidine and Fluoxetine reduce the clearance of alprozolam
Dose should be reduced to 1/3rd when administered concurrent with cimetidine.
Alprozolam enhances activity of Imipramine and Desipramine.
Potentiates action of alcohol and CNS depressents.
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 96
Name of the Drug- Alprazolam SR 0.25mg +
Sertraline (as Hcl) 25mg/50mg tablet Pharmacological Classification- For Panic disorder with or without agoraphobia
Date of Approval- 09-08-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)
LIST OF DRUGS DURING 2006
Sr.No- 136
Name of the Drug- Alprazolam Dispersible Tablet
0.125mg/0.25mg/0.50mg Pharmacological Classification- For anxiety
Date of Approval- 20-09-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)
Short term anxiety disorders, anxiety with depression, panic disorder.
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Alprozolam CNS Pharmacia & 16-09-2002
Upjohn
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Alprozolam Anxiolytic agent June 1988
2.Alprozolam dis tab 0.125mg/0.25mg/0.50mg 20-09- 2006
For anxiety
3.Alprozolam SR 0.25mg + Seratraline Hcl 25mg/50mg 09-08-2006
tablet
For Panic disorder with with or without agoraphobia
Adverse Reaction:
Occasionaly causes blood dyscrasias.
Psychological and physical dependence,
withdrawal syndrome,
fatigue,muscle weakness
,ataxia,dizziness,
confusion and depression.
Contra-Indications:
Hypersen to benzodiapines,acute narrow angle glaucoma
. Myasthenia gravis,pregnancy, lactation.
Special precautions:
Dosage reduction or withdrawal gradual.
Not for primary therapy or depressive disorders.
Dependence.Geriatric or debilitated patients.
Epilepsy,impaired hepatic renal function.
Discontinue if pardoxical excitement.
Children- below 18.
Dosages/ Overdosage Etc:
Date of Approval 1988
Indications:
Short term anxiety disorders, anxiety with depression, panic disorder.
Dosage:
Individualise dosage. Cautiously increase to avoid adverse effects. Initial dose 0.25 to 0.5mg 3 times daily, to a maximum of 4mg/day in divided doses. Decrease dose if side effects occur.
Panic disorder - initial dose is 0.5mg 3 times daily,depending on response increase dose at 3 to 4 days intervals by more than 1mg/day.
Other Information:
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Alprozolam CNS Pharmacia & 16-09-2002
Upjohn
Patient Information:
Benzodiapines include
Alprozolam, Chlordiazepoxide, Clonazepam, Clorazepate,Diazepam, Halazepam, Lorazepam, Oxazepam, Prazazepam
Refer Diazepam
1.May cause drowsiness,avoid driving or other tasks requiring alertness.
2.Avoid alcohol and CNS depressants.
3.Patients on long-term or high dosage therapy make experience withdrawal symptoms or abrupt cessation of therapy. Do not discontinue therapy abruptly or change dosage except on advice of physician.
4. Concomittant ingestion with antacids may alter the rate of absorption of these drugs
5. Side effects eg sleepiness/drowsiness mat be reduced if taken after meals
Pharmacology/ Pharmacokinetics:
Benzodiapenes include
Diazepam, temazepam, Lorazepam, Oxazepam, Halazepam, Demooxepam, Alprozolam, Chlordiazepoxide.
Pharmacology:
Benzodiazepines appear to potentiate the effects of gamma-aminobutyrate (GABA)( ie they facilitate inhibitory GABA neurotrasmission ) and other inhibitory transmittes by binding to benzodiazepine receptor sites.
The activity of the benzodiazepines may involve the following sites; spinal cord(muscle relaxation); brain stem (anticonvulsant properties); cerebellum (ataxia); limbic and cortical atreas (emotional behaviour).
Pharmacokinetics:
Benzodiapines are readily absorbed following oral administration
Interaction with Food:
Side effects eg sleepiness/drowsiness may be reduced if taken immediately after meals
Pregnancy and lactation:
Pregnancy:
Avoid using these drugs during pregnancy. Consider the possibility that a woman of child bearing potential may be pregnant at the time of institution of the therapy.
Advice patients that if they become pregnant during therapy,they should discuss the desirability of discontinuing the drug.
Lactation:
The drug is excreted in breast milk and accumulation of the drug or its metabolites to toxic levels is possible.
Manufacturer Details