Each tablet contains citalopram HBr corresponding to citalopram 20 mg and lactose.
A selective and potent serotonin re-uptake inhibitor (SSRI).
Pharmacology: Citalopram is a potent selective and inhibitor of serotonin uptake with antidepressant effect.
Cipram 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 eg, dry mouth, blurred vision, sedation, cardiotoxicity and orthostatic hypotension. Unlike other available SSRIs, Cipram is only a very weak inhibitor of the cytochrome P-450 II D6 metabolic pathway with a consequent reduction in potential for adverse events and interactions.
The antidepressant effect usually sets in after 2-4 weeks.
Cipram does not affect the cardiac conduction system or blood pressure. This is particularly important for elderly patients. In addition, Cipram does not affect the haematological, hepatic or renal systems. The low frequency of side effects and the minimal sedative properties of Cipram make it especially useful in long-term treatment. Moreover, Cipram 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 2-4 hrs after dosing. The protein-binding is <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 1½ days. Excretion is via urine and faeces.
Treatment of depression and prevention of relapse or recurrence; panic disorder with or without agoraphobia; obsessive-compulsive disorder (OCD).
Depression: Adults: Cipram should be administered as a single oral dose of 20 mg. Depending on individual patient response and severity of depression, the dose may be increased to a maximum of 60 mg daily.
Elderly (>65 years): The recommended daily oral dose is 20 mg. Dependent on individual patient response and severity of depression the dose may be increased to a maximum of 40 mg daily.
Panic Disorder: Adults: 10 mg daily for the 1st week, then increase to 20 mg daily, up to a maximum of 60 mg daily.
Obsessive-Compulsive Disorder: Adults: Initially 20 mg, may be increased to a maximum of 60 mg. Elderly: Half of the adult dose and a maximum of 40 mg daily.
Children: Not recommended, as safety and efficacy have not been established in this population.
Patients with Reduced Renal Function: Dosage adjustment is not necessary in patients with mild to moderate renal impairment. No information is available for treatment of patients with severely reduced renal function (creatinine clearance <20 mL/min).
Patients with Reduced Hepatic Function: Patients with reduced hepatic function should receive dosages of >30 mg/day. Citalopram can be taken any time of the day without regard to food intake.
Duration of Treatment: The antidepressive effect usually sets in after 2-4 weeks. Treatment with antidepressants is symptomatic and must therefore be continued for an appropriate length of time usually for ≥6 months in order to prevent relapse.
Symptoms: When Cipram 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.
Hypersensitivity to citalopram and any of its components. Concomitant treatment with monoamine oxidase inhibitors (MAOIs).
Cipram should not be used in the treatment of children and adolescents <18 years. Suicide related behaviours (suicide attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If based on clinical need, a decision to treat is nevertheless taken, the patients should be carefully monitored for the appearance of suicidal symptoms.
The possibility of suicide attempt is inherent in depression and may persist until significant improvement occurs, either spontaneously or following treatment.
Patients being treated with antidepressants should be monitored carefully especially at the beginning of treatment for clinical worsening and/or the emergence of suicidality (suicidal ideation and behaviour) or unusual changes in behavior.
Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber.
This precaution should also be observed when treating other psychiatric disorders because of the possibility of co-morbidity with major depressive disorder.
As with other SSRIs, citalopram should not be given to patients receiving MAOIs. Treatment with citalopram may be instituted 14 days after discontinuation of nonselective MAOIs and minimum 1 day after discontinuation of moclobemide and selegiline. Treatment with MAOIs may be introduced 7 days after discontinuation of citalopram. Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported as a rare adverse reaction with the use of SSRIs. Especially elderly patients seems to be a risk group. After prolonged administration, abrupt cessation of SSRIs may produce withdrawal symptoms eg, dizziness, paraesthesia, tremor, anxiety, nausea and palpitation in some patients. It is recommended that discontinuation of treatment should proceed by tapering off the dosage over 1-2 weeks to avoid occurrence of withdrawal symptoms. These symptoms are not indicative of addiction.
In patients with manic-depressive illness, a change towards the manic phase may occur. Should the patient enter a manic phase, citalopram should be discontinued. Although animal experiments have shown that citalopram has no epileptogenic potential, it should, like other antidepressants, be used with caution in patients with a history of seizures.
As described for other psychotropics, citalopram may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients. In addition, the depressive illness itself may affect patients glucose balance.
Rarely the occurrence of "serotonin syndrome" has been reported in patients receiving SSRIs. A combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia, may indicate the development of this condition.
Effects on the Ability to Drive or Operate Machinery: Citalopram does not impair intellectual functions and psychomotor performance. However, patients who are prescribed psychotropics may be expected to have some impairment of general attention and concentration and should be cautioned about their ability to drive a car and operate machinery.
Use in pregnancy & lactation: Clinical experience of the use of citalopram in pregnant women is limited. Reproduction toxicity studies have not given evidence of an increased incidence of fetal damage or other deleterious effects on the reproductive process. Citalopram is secreted into breastmilk. It is estimated that the suckling infant will receive about 5% of the weight related maternal daily dose (mg/kg). No or only minor events have been observed in the infants. However, the existing information is sufficient for assessment of the risk to the child. Caution is recommended.
Clinical experience of the use of citalopram in pregnant women is limited. Reproduction toxicity studies have not given evidence of an increased incidence of fetal damage or other deleterious effects on the reproductive process. Citalopram is secreted into breastmilk. It is estimated that the suckling infant will receive about 5% of the weight related maternal daily dose (mg/kg). No or only minor events have been observed in the infants. However, the existing information is sufficient for assessment of the risk to the child. Caution is recommended.
Adverse effects observed with Cipram are in general mild and transient. They are most prominent during the first 1 or 2 weeks of treatment and usually attenuate as the depressive state improves.
The most commonly observed adverse events associated with the use of Cipram 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 comparative clinical trials with tricyclic antidepressants, the incidence of adverse events occurring with Cipram was found to be lower in all cases.
In exceptional cases, seizures have occurred. Cipram may cause a small reduction in heart rate which normally is without clinical importance. However, in patients with preexisting low heart rate this may lead to bradycardia.
Simultaneous administration of citalopram and MAOIs may cause serotonin syndrome. A pharmacokinetic interaction study of citalopram and metoprolol has shown a 2-fold increase in metoprolol concentrations. There was no statistically significant increase in the effect of metoprolol on blood pressure and heart rate in healthy volunteers by adding citalopram. Cimetidine cause a moderate increase in the average steady-state level of citalopram. Caution should be exercised at the upper end of the dose range of citalopram when it is used concomitantly with high doses of cimetidine. There is no interaction with lithium and alcohol, and no clinically important interactions with levomepromazine and imipramine. Studies have shown that citalopram is unlikely to have any effect on the pharmacokinetics of carbamazepine and its metabolite carbamazepine-epoxide. Citalopram does not cause any changes in the pharmacokinetics of digoxin. No pharmacodynamic interactions have been found in clinical studies in which citalopram has been given concomitantly with benzodiazepines, neuroleptics, analgesics, antihistamines, antihypertensive drugs, β-blockers and other cardiovascular drugs.
Incompatibilities: Not applicable.
Store at room temperature (below 25°C).
N06AB04 - citalopram ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
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