Indication:
LIST OF DRUGS DURING 2004
Sr.No- 232
Name of the Drug- Escitalopram (10mg) +
Clonazepam (0.5mg) Pharmacological Classification- For co-morbid depression & anxiety disorder
Date of Approval- 27-08-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
LIST OF DRUGS DURING 2007
Sr.No- 188
Name of the Drug- Escitalopram oxalate 10mg +
Clonazepam 0.5mg tablet
(addl.stgth)
Pharmacological classification- For comorbid depression and anxiety disorder
,
Date of Approval- 12-12-07
Approved by US FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Escitalopram 10mg + 20-08-2004
Clonazepam 0.5mg
For Co-morbid Depression and Anxiety disorder
2. Escitalopram Oxalate 24-01-2003
Anti-depressant
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Each mouth dissolving tablet contains: 04-04-2014
Escitalopram Oxalate eq.to Escitalopram 10mg+
Clonazepam IP 0.5mg
Addl.dosage Form
For treatment of patients with comorbid depression and
anxiety disorder
3. Escitalopram Oxalate 10mg + 12-12-2007
Clonazepam 0.5mg tablet
Addl.stgth
For Co-morbid Depression and anxiety disorder
4.Escitalopram (as oxalate) 10mg + 31-08-2004
Clonazepam 0.5mg tablet
For treatment of patients with comorbid depression and
anxiety disorders
5.Escitapram 5mg + 13-12-2007
Clonazepam 0.5mg tablet
For the treatment of patients with comorbid depression
and anxiety disorders
Major depressive disorders
Selective serotonin reuptake inhibitors include-
Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Citalopram, Escitalopram
Refer- Fluoxetine
Patient Information:
Selective serotonin reuptake inhibitors includ- Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Citalopram, Escitalopram
Refer- Fluoxetine
Use with caution during works requiring mental alertness eg, operating hazardous machinery, including automobiles
Pharmacology/ Pharmacokinetics:
Pharmacology:
The mechanism of antidepressant action of escitalopram is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT) It has minimum effects on nonepinephrine and dopamine neuronal reuptake. Escitalopram is 100-fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake and inhibition of neuronal firing rate.
Pharmacokinetics:
Escitalopram displays high bioavailability(80%) after oral,administration. Absorption of escitalopram is not affected with food. Peak plasma concentrations are observed 5 +/- 1.5 hours after a single oral dose (20mg tablet) Approximately 56% of escitalopram is protein bound. Escitalopram is metabolised by hepaticCYP isozymes to S-desmethyl-citalopram (S-DCT) and S-di-demethylcitalopram (S-DDCT) . Escitalopram is at least 7 times more potent than S-DCT and S-SSCT, respy, in the inhibition of serotonin reuptake. The oral clearance of escitalopram is 600ml/min. Seven percent of administered drug is excreted through urine. About 8% of it is excreted as it is and 10% as S-demethlcitalopram (S-DCT)