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Lecital

Afrab-Chem Ltd
No. 22, Abimbola Street, Isolo Industrial Estate, Isolo, P.O. Box 1647, Lagos, Nigeria.
Email: info@afrabchem.com
Tel: 234-1-2700057
Fax: 234-1-4520328
Website: http://afrabchem.com/

Brand Name

Lecital

Manufacturer

Joswe Medicals, Na'ur Jordan

Therapeutic Class

Antidepressants and mood stabilisers

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet 20 mg (NRN:04-8632): Each tablet contains Citalopram HBr equiv to 20 mg Citalopram.

Pack size: Blistered pack of 30 tablets.

Tablet 40 mg (NRN:04-8902): Each tablet contains Citalopram HBr equiv. to 40 mg Citalopram.

Pack size: Blistered pack of 30 tablets.

Pharmacology

Lecital is a potent and the most selective inhibitor of serotonin uptake with antidepressant effect. Lecital has no or very low affinity for a series of receptors including muscarinic and 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 mouth, blurred vision, sedation, cardiotoxicity and orthostatic hypotension.

Unlike other available SSRIs, Lecital is only a weak inhibitor of the cytochrome P450 2D6 metabolic pathway with a consequent reduction in potential for adverse events and interactions.

The antidepressant effect usually sets in after 2 to 4 weeks.

Lecital does not affect the cardiac conduction system or blood pressure. This is particularly important for elderly patients. In addition Lecital does not affect the haematological, hepatic or renal systems.

The low frequency of side effects and the minimal sedative properties of Lecital make it especially useful in long term treatment. Moreover, Lecital neither causes weight gain nor potentiates the effect of alcohol.

Pharmacokinetics:

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 reached in 1-2 weeks. The biological half-life is 1½ days. Excretion is via urine and faeces.

Indications

Treatment of depression.

Contra-indications

Hypersensitivity to Citalopram or any other ingredient used in the formulation.

Precautions/Warnings

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

Should the patient enter a manic phase, Citalopram should be discontinued and appropriate treatment with a neuroleptic (e.g. Zuclopenthixol) 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.

Interactions

Simultaneous administration of Citalopram and MAO inhibitors may cause hypertensive crisis (serotonin syndrome). Sumatriptan's serotonergic effects are suspected to be enhanced by SSRIs. Until further evidence is available it is advised not to use citalopram simultaneously with sumatriptan.

Pharmacokinetic interaction studies have shown that during Citalopram treatment only a weak inhibition of the sparteine oxygenase (CYP2D6) was indicated whilst the mephenytoin oxygenase was not influenced by Citalopram treatment.

Cimetidine caused a moderate increase in the average steady-state levels of Citalopram. It is therefore advised to exercise caution at the upper end of the dose range of Citalopram 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 Citalopram has been given concomitantly with benzodiazepines, neuroleptics, analgesics, lithium, antihistamines, antihypertensive drugs, betablockers and other cardiovascular drugs.

There is little clinical experience of concurrent use of Citalopram and ECT.

Use during pregnancy and lactation: The safety of citalopram during human pregnancy and lactation has not been established. Therefore, it is recommended that pregnant or lactating women are not treated with citalopram unless the potential clinical benefit outweighs the theoretical risk.

Animal studies have not shown any evidence of teratogenic potential and citalopram does not affect reproduction or perinatal conditions. Citalopram appears in milk in very low concentrations.

Effects on ability to drive or use machines: Citalopram does not impair intellectual function and psychomotor performance. However, patients who are prescribed psychotropic medication may be expected to have some impairment of general attention and concentration either due to the illness itself, the medication or both and should be cautioned about their ability to drive a car and operate machinery.

Adverse Effects

Adverse effects observed with Citalopram 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 Citalopram 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 (1<10%).

In comparative clinical trials with tricyclic antidepressants, the incidence of adverse events occurring with citalopram was found to be lower in all cases.

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

Dosage & Administration

Lecital administered as a single daily dose. Tablets can be taken any time of the day without regard to food intake.

Adults: Lecital should be administered as a single oral dose of 20 mg daily. Dependending 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 20 mg. Dependending on individual patient response and severity of depression the dose may be increased to a maximum of 40 mg daily.

Children: Not recommended, as safety and efficacy have not been established in this population.

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

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

Duration of treatment: A treatment period of at least 6 months is usually necessary to minimize potential for relapse.

Overdosage:

Symptoms: When citalopram 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.

Treatment: 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.

Storage/Handling Recommendations

Lecital should be stored at room temperature (below 30oC).

Review Date

2017-09-24 11:04:36