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SILOPRAM 40

Product Name:
SILOPRAM 40
Composition:

Citalopram 40 mg.

Pharmaceutical Form:

Tablets

Packing:

20 F.C. Tabs.

Public Price:

 375 sp

Pharmacist Price:

 325 sp

Pharmacologic Category:

Miscellaneous

Properties:

Cilopram is a selective and potent serotonin reuptake inhibitor (SSRI) with antidepressant effect.
Cilopram has no or very low affinity for a series of receptors including muscarine cholinergic receptors, histamine receptors and adrenoceptors. This absence of effects on receptors could explain why citalopram produces fewer of the traditional adverse effects of tricyclic antidepressants such as dry mouths, blurred vision, sedation, cardiotoxicity and orthostatic hypotension.

Unlike other available SSRls, Silopram is only a very weak inhibitor of the Cytochrome P450 II D6 metabolic pathway with a consequent reduction in potential for adverse events and interactions.
The antidepressant effect usually sets in after 2 to 4 weeks.

Cilopram does not affect the cardiac conduction system or blood pressure. This is particularly important for elderly patients. In addition Cilopram does not affect the haematological, hepatic or renal systems. The low frequency of side effects and the minimal sedative properties of Cilopram make it especially useful in long-term treatment. Moreover, Silopram neither causes weight gain nor potentiates the effect of alcohol.

<b>Pharmacokinetics:</b>
Biotransformation of Citalopram is mainly hepatic.The oral bioavailability of Citalopram is about 80 %.Maximum Citalopram plasma levels are reached 2 to 4 hours after dosing. The protein binding is below 80 %. Metabolism proceeds by demethylation, deamination and oxidation. Unchanged Citalopram is the predominant compound in plasma. The Kinetics is linear. Steady-state conditions are achieved in 1-2 weeks.
The biological half-life is about 1 ½ days. Excretion is via urine and faeces.

Indications:

Treatment of depression .The efficacy of Citalopram in the treatment of depression was established in 4 to 6 weeks.

Contraindications:

Hypersensitivity to Cilopram.

Side Effects:

Adverse effects observed with Siloprm are in general mild and transient. They are most prominent during the first one or two weeks of treatment and usually attenuate as the depressive state improves.

The most commonly observed adverse events associated with the use of Cilopram and not seen at an equal incidence among placebo-treated patients were: dry mouth, nausea, somnolence, increased sweating and tremor.The incidence of each in excess over placebo is low(<10%).

In exceptional cases seizures have occurred.
Cilopram may cause a small reductin in heart rate which normally is without clinical importance. However, in patients with pre-existing low heart rate this may lead to bradycardia.

Precautions:

As with other SSRls, Silopram should not be given to patients receiving Monoamine Oxidase Inhibitors (MAOIs), or for 14 days after their discontinuation. Treatment with MAOIs may be intoduced 7 days after discontinuation of Cilopram.

Should the patient enter a manic phase Silopram should be discontinued and appropriate treatment with a neuroleptic instituted.
As with all antidepressant treatment the possibility of suicide in depressed patients remains until significant remission occurs because release of inhibition may precede the antidepressant action.

<b>Use during pregnancy and lactation:</b>
The safety of Cilopram during human pregnancy and lacation has not been established .
Cilopram appears in milk with nursing mothers.

<b>Effects on ability to drive or use machines:</b>
Cilopram does not impair intellectual function and psychomotor performance. However, patients who are prescribed psychotropic medication should be cautioned about their ability to drive a car and operate machinery.

Drug Interactions:

Simultaneous administration of Silopram and MAO inhibitors may cause hypertensive crises (serotonin syndrome).

Sumatriptan\'s serotonergic effects are suspected to be enhanced by SSRls. Until further evidence is available it is advised not to use Citalopram simultaneously with sumatriptan.
Cimetidine caused a moderate increase in the average steady-state levels of Cilopram. It is therefor advised to exercise caution at the upper end of the dose range of Cilopram when it is used concomitantly with high doses of cimetidine.

There was no interaction with lithium or alcohol, and no pharmacokinetic interactions of
Clinical importance with phenothiazines or tricyclic antidepressants.
No pharmacodynamic interactions have been found in clinical studies in which Cilopram has been given concomitantly with benzodiazepines, neuroleptics, analgesics,lithium antihistamines, antihypertensive drugs, betablockers and other cardiovascular drugs.

Dosage:

Cilopram is administered as single daily dose. Silopram tablets can be taken any time of the day without regard to food intake.

Adult:
Cilopram should be administered as a single oral dose of 20 mg daily. Dependent on individual patient response and severity of depression the dose may be increased to a maximum of 60 mg daily.
Elderly (above 65 years):
The recommended daily dose is 20mg.
Dependent on individual patient response and severity of depression the does may be increased to a maximum of 40mg daily.
Children:
Not recommended, as safety and efficacy have not been established in this
population.

<b>Reduced hepatic function:</b>
Dosage should be restricted to the lower end of the dose range.

<b>Reduced renal function:</b>
Dosage adjustment is not necessary in cases of mild or moderate renal impairment.
No information is available in cases of severe renal impairment.

<b>Duration of treatment:</b>
A treatment period of at least 6 months is usually necessary to minimize potential for relapse

Over Dosage:

<b>Symptoms:</b>
When Cilopram has been taken alone recorded symptoms/signs were: somnolence, coma, stiffened expression, episode of grand mal convulsion , sinus tachycardia , occasional nodal rhythm, sweating, nausea, vomiting, cyanosis, hyperventilation. No case was fatal. The clinical picture was inconsistent.

<b>Treatment:</b>
There is no specific antidote . Treatment is symptomatic and supportive . Gastric lavage should be carried out as soon as possible after oral ingestion . Medical surveillance is advisable.