Cipramil - the description, contraindications, application

The latin name: Cipramil

Cipramil Pharmacological groups: Antidepressants

Cipramil Working substance: Citalopram

Cipramil Application: Depression of a various etiology.

Cipramil Contraindications: Hypersensitivity, simultaneous reception of inhibitors.

Cipramil Restrictions to application: Pregnancy, a feeding a breast, children's age (safety and efficiency of application for children are not determined).

Cipramil Application at pregnancy and a feeding a breast: it is Possible, if the expected effect of therapy exceeds potential risk for a fetus and the child (adequate and strictly controllable researches of safety of application for pregnant and feeding women were not carried out).

Cipramil Side effects: the Side effects connected to the termination of treatment in near-term placebo - controllable tests. By results of a placebo - controllable of tests in up to 6 weeks of 16 % from 1063 patients receiving a Citalopram in doses from 10 up to 80 mg day, have interrupted treatment because of occurrence of side effects, in comparison about 8 % from 446 patients receiving a placebo. The side effects connected to the termination of treatment and recognized caused Citalopram (i.e. observed at least at 1 % of the patients receiving a Citalopram, in 2 times the placebo is more often), include the following: an asthenia of 1 % (1 %), a nausea of 4 % (0 %), dryness in a mouth of 1 % (1 %), a vomiting of 1 % (0 %), a giddiness of 2 % (1 %), 3 % (1 %), a sleepiness of 2 % (1 %), an agitation of 1 % (1 %). The side effects observed in a placebo - controllable clinical tests. In the table side effects are submitted, which were observed at the patients receiving a Citalopram in doses from 10 up to 80 mg day during 6 weeks (are specified the adverse effects marked not less than at 2 % of patients and exceeding on frequency a placebo). The adverse effects marked in these clinical tests at 2 % of patients and observed less often, than a placebo: a headache, an asthenia, a giddiness, a constipation, palpitation, a pharyngitis, infringement of an emiction, a dorsodynia. The estimation of dependence of frequency of occurrence of side effects from a dose was carried out at the fixed doses at patients with the depression, receiving a placebo or a Citalopram in doses 10, 20, 40 and 60 mg. With use Jonckheer ` s the paste positive correlation (p 0,05) for the following effects is revealed: fatigability, an impotency, , a sleepiness, a yawning. Change of the vital functions. It is not revealed clinically significant changes of indexs of the vital functions (pulse, a garden, ), including orthostatic changes at change of a position of a body on a background of treatment by a Citalopram in comparison about a placebo. Change of mass of a body. In controllable tests downstroke of mass of a body has made about 0,5 kg (changes in group the placebo was not). Change of laboratory indexs. Clinically significant changes of laboratory tests it was not observed. Change the ELECTROCARDIOGRAM. Comparison the ELECTROCARDIOGRAM at the patients receiving a Citalopram (n=802) and a placebo (n=241), has shown, that statistically significant difference was only downstroke of the HEART RATE on a background of reception of a Citalopram.

Cipramil Interaction: Simultaneous application with inhibitors can result in to build-up of pressure and exaltation. The Citalopram can strengthen effects , etc. serotonergic agents, rises a level a metoprolol in plasma (the result of interaction is not clinically significant) and plasma concentration (on 50 %) an active metabolite of Imipraminum (the clinical importance of effect is unknown). Cimetidinum rises AUC (on 43 %) and Cmax (on 39 %) a Citalopram. It is not revealed clinically significant interaction with digoxin, warfarin, Karbamazepinum, , a ketoconazole, a lithium (at collateral application it is necessary to take care since the lithium can enlarge serotonergic effect of a Citalopram) and alcohol.

Cipramil Overdosage: In clinical tests at an overdosage of a Citalopram (up to 2000 mg) lethal cases it is not marked. In postmarketing reports on overdosage , including a Citalopram, 12 lethal outcomes, 10 of which - are fixed at a combination with other. and-or alcohol and 2 - at reception only a Citalopram (3920 mg and 2800 mg); it was reported also about 1 case of an overdosage without a lethal outcome at reception of 6000 mg. Signs: a giddiness, the raised diaphoresis, a nausea, a vomiting, a tremor, a sleepiness, a sinus tachycardia. In more infrequent cases - an amnesia, a confusion of consciousness, a coma, cramps, a hyperventilation mild, a cyanosis, , change the ELECTROCARDIOGRAM (including elongation QT c a nodal rhythm both a ventricular arrhythmia and 1 chance " torsades de pointes "). Treatment: a gastric lavage and application of absorbent coal. Maintenance of permeability of respiratory paths for maintenance of adequate ventilation and an oxygenation. Careful observation and monitoring of the vital functions is recommended, including to function of heart, symptomatic and a maintenance therapy. Efficiency of such actions as rising of volume of distribution, an artificial diuresis, a dialysis, a hemoperfusion and a metabolic hemotransfusion is improbable. The specific antidote is absent.

Cipramil Way of application and dose: Inside, once in day, at any time, without dependence from reception of nutrition. An initial dose - 20 milligram/day, maximal - 60 milligram/day. For patients than 65 years and patients with infringements of function of a liver an advisable dose - 20 mg, maximal - 40 milligram/day (if necessary) are more senior.

Cipramil Precautionary measures: At weak and moderately expressed infringements of function of kidneys of updating of doses it is not required, at serious infringements of function of kidneys it is required to take care. At collateral reception of drugs from group of inhibitors of revertive capture of a serotonin in a combination with inhibitors change of a mental condition (including an agitation, down to a delirium and a coma) was reported about occurrence at patients serious, sometimes lethal reactions, including a hyperthermia, a rigidity, instability of indexs of the vital functions with possible fast fluctuations. It was reported about the same reactions at the patients who have begun reception of inhibitors soon after the termination of treatment by a Citalopram. Therefore it is not necessary to combine a Citalopram with inhibitors or to appoint it within first two weeks after their cancellation. Upon termination of course of treatment by a Citalopram also it is necessary to make a time-out 2 weeks before reception of inhibitors . It is necessary to take into account an opportunity of development of a hyponatremia (it was reported about several cases), and also a set of symptoms of an inadequate secretion an ADH, taking place at the termination of treatment and-or medical intervention. By results of a placebo - controllable of tests, in some of which patients with bipolar frustration, at 0,2 % of patients from 1063, receiving a Citalopram have been included (in comparison with 446 patients receiving a placebo), activation of a mania / hypomania was marked. It is necessary to appoint with care a Citalopram (as well as other antidepressants) to patients with a mania in an anamnesis. Care is necessary, as well as at reception of other antidepressants, at presence in an anamnesis of epileptic attacks. In connection with an opportunity of suicidal attempts at patients with depression careful overseeing by patients in the beginning of treatment and purpose of minimum efficient doses for downstroke of risk of an overdosage is necessary. In researches on the healthy volunteers receiving doses 40 milligram/day, it is not marked downstrokes of cogitative activity and rate of psychomotor reactions. However patients should be warned about necessity to take care at work with potentially dangerous mechanisms, including at driving the automobile. Clinical experience of application of a Citalopram at presence at patients of accompanying diseases circumscribed. It is necessary to take care at the diseases accompanying with infringement of a metabolism or a hemodynamics. It has not been lead regular observations at patients with a myocardial infarction or unstable cardiac diseases since these patients were excluded from clinical premarketing researches. However the analysis the ELECTROCARDIOGRAM at 1116 patients receiving a Citalopram, shows, that reception of a Citalopram is not connected to development of clinically significant deviations on the ELECTROCARDIOGRAM. It is necessary to take care at simultaneous reception with other. the central action. In experimental, and also in clinical researches it is not revealed cases of abusing, tolerance, physical dependence. However these observations were not systematical, close overseeing by patients at which in an anamnesis abusing pharmaceuticals is marked therefore is required.

Trading names of drugs with working substance Citalopram:
Cipramil (Cipramil)