Zytapram

Escitalopram.

Each film-coated tablet contains: Escitalopram Oxalate equivalent to Escitalopram 10 mg.

Pharmacology: Pharmacokinetics: Absorption is independent of food intake (mean Tmax is 4 hours after multiple dosing). The apparent volume of distribution (Vd, beta/F) after oral administration is about 12 to 26 L/kg. The plasma protein binding of Escitalopram is approximately 55%. Escitalopram is metabolised in the liver to the didemethylated metabolites are partly excreted as glucoronides. Unchanged Escitalopram is the predominant compound in plasma. After multiple dosing the mean concentrations of the dimethyl and didemethyl metabolites are usually 28-31 % and 5% of the Escitalopram concentration, respectively. The elimination half-life after multiple dosing is about 30 hours and the oral plasma clearance is about 0.60L/min. Escitalopram and major metabolites are like racemic citalopram assumed to be eliminated by the hepatic (metabolic) and renal routes with the major part of the dose.

Used in the treatment of depression, panic disorder with or without agoraphobia, generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder.

It is given orally as the oxalate although doses are expressed in terms of the base; Escitalopram oxalate 12.8 mg is equivalent to about 10 mg of Escitalopram.
In the treatment of depression, the usual dose is 10 mg once daily increased, after at least a week, to a maximum of 20 mg once daily if necessary.
For the treatment of panic disorder With or without agoraphobia, initial doses are 5 mg once daily, increased after a week to 10 mg once daily; further increases up to a maximum of 20 mg daily may be necessary in some patients.
Initial treatment with half the usual recommended dose and a lower maximum dose should be considered in elderly patients. Patients with hepatic impairment or those who are poor metaboliser with respect to the cytochrome P450 isoenzyme CYP2C19 may also require lower doses.
Escitalopram should be withdrawn gradually to reduce the risk of withdrawal symptoms.

Hypersensitivity to escitalopram or to any of the excipients. Children; as safety and efficacy have not been established in this population.
Monoamine Oxidase Inhibitors: Cases of serious reactions have been reported in patients receiving an SSRI such as Escitalopram in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued an SSRI and have been started on a MAOI.

Mania: Escitalopram should be discontinued in any patient entering a manic phase.
Paradoxial Anxiety: Some patients with panic disorder may experience increased anxiety symptoms at the start of treatment with antidepressants.
Seizures: Escitalopram should be discontinued in any patient who develops seizures. It should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be closely monitored.
Diabetes Mellitus: Patients with diabetes mellitus, treatment with Escitalopram may alter glycaemic control, due to improvement of depressive symptoms.
Suicide: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored during this period.
Haemorrhage: there have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura, with Escitalopram.

Adverse reactions observed with Escitalopram are most frequently during the first one or two weeks of treatment and may decrease in intensity and frequency with continued treatment. After prolonged administration abrupt cessation of Escitalopram may produce withdrawal reactions in some patients.
Common (>1/100, <1/10): Both genders: Nausea, insomnia, somnolence, sweating increased, diarrhea, constipation, dizziness, fatigue, appetite decreased, sinusitis, libido decreased, pyrexia, yawning.
Gender Specific: Ejaculation disorder, impotence, abnormal orgasm (female).
Uncommon (>1/1000, <1/100): Sleep disorder, taste disturbance.

Escitalopram has a low potential for clinically significant medicine interactions. In vitro studies have shown that the biotransformation of escitalopram to its demethylated metabolites depends on three parallel pathways (cytochrome P450, 2C19, 3A4 and 2D6). Escitalopram is very weak inhibitor of isoenzyme CYP1A2, 2C9, 2C19, 2E1 and 3A.
Ritonavir: The pharmacokinetics of single closes of Escitalopram was not changed by co-administration with single dose of ritonavir (CYP3A4 inhibitor).
Ketoconazole: Co-administration with ketoconazole (potent CYP3A4 inhibitor) did not change the pharmacokinetics of racemic citalopram.
MAOI, Sumatriptan and Tramadol: Co-administration with MAO inhibitors may cause serotonin syndrome. Co-administration with other serotogenic medicines (eg, tramadol, sumatriptan) as well as other antidepressants with serotonergic properties may lead to an enhancement of serotonin associated effects, eg serotonin syndrome.

Store at temperatures not exceeding 30°C.

Antidepressants

N06AB10 - escitalopram ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.

Rx