Universal reference book for medicines
Name of the preparation: SEDOPRAM (SEDOPRAM)

Active substance: citalopram

Type: Antidepressant

Manufacturer: SEDICO South Egypt Drug Industries (Egypt)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Antidepressant.
The mechanism of action is associated with selective blockade of reverse neuronal seizure of serotonin in synapses of CNS neurons with a minimal effect on the reuptake of noradrenaline and dopamine. Has little or no ability to bind to a variety of receptors, including serotonin HT 1A -, 5HT 2A -, dopamine D 1 - and D 2 -,? 1 -,? 2 - and? -adrenoceptors, histamine H 1 -receptors, GABA-receptors, m-cholinergic receptors and benzodiazepine receptors.
Promotes mood improvement, relieves feelings of anxiety, reduces feelings of fear and tension, eliminates dysphoria, reduces obsessive conditions, almost does not cause sedation.

A persistent clinical effect develops after 7-10 days of regular admission.

PHARMACOKINETICS
After ingestion C max citalopram in plasma is achieved after 2-4 hours Bioavailability with oral administration is about 80%.

Changes in the concentration of citalopram in plasma are linear.
C ss in plasma is established after 1-2 weeks of therapy.
Binding to plasma proteins is less than 80%.

In the blood plasma, citalopram is present mostly unchanged.
Metabolized by demethylation, deamination and oxidation.
T 1/2 is 1.5 days.

It is excreted by the kidneys and through the intestines.

INDICATIONS
Depression of various genesis (endogenous and exogenous);
affective (depressive, bipolar, dysthymic) disorders; mixed anxiety-depressive disorders; anxiety-phobic disorders (phobic, panic, obsessive-compulsive, generalized anxiety, post-traumatic stress disorders); somatization disorder; psychosomatic diseases with autonomic dysfunction (including autonomic dysfunction of the cardiovascular system, respiratory system, gastrointestinal tract, genitourinary system); vascular dementia with depressive symptoms; depressive disorders in women (premenstrual dysphoria, depression of pregnant women, postpartum depression, premenopausal depression);eating disorders (anorexia, bulimia); depression with alcoholism; depression in the elderly.
DOSING MODE
Take 1 time / day.

For adults, depending on the indications, the initial dose is 10-20 mg / day, if necessary, it is possible to increase to 60 mg / day.
In patients older than 65 years - 20 mg / day, if necessary, it is possible to increase to 40 mg / day.
The duration of therapy (to prevent relapse) is 6 months or more.

SIDE EFFECT
From the nervous system: dizziness, headache, tremor, drowsiness, insomnia, agitation, nervousness, migraine, paresthesia;
sleep disorder, impaired concentration, amnesia, anxiety, decreased libido, increased appetite, anorexia, apathy, suicidal attempts, confusion of thoughts, asthenia, mood changes, aggressive behavior, emotional lability, agitation, mania, hypomania, panic behavior, paranoid reaction, psychosis, excessive fatigue, anxiety, extrapyramidal disorders, convulsions, euphoria, serotonin syndrome (agitation, confusion, diarrhea, hyperthermia, hyperreflexia, ataxia, increased sweating s, uncontrolled behavior), hallucinations, depersonalization; in exceptional cases when used in high doses - convulsive seizures.
From the cardiovascular system: atrial flutter, tachycardia, bradycardia, orthostatic hypotension, increase or decrease in blood pressure, supraventricular and ventricular arrhythmias.

On the part of the digestive system: nausea, dry mouth, constipation, diarrhea, indigestion, vomiting, abdominal pain, flatulence, anorexia, increased salivation, increased activity of liver enzymes.

On the part of the urinary system: frequent urination, polyuria.

Metabolic disorders: decreased or increased body weight, hyponatremia, hyperthermia.

On the part of the respiratory system: rhinitis, sinusitis, cough, shortness of breath.

On the part of the reproductive system: violations of ejaculation, increased or decreased libido, female anorgasmia, dysmenorrhea, impotence, menstrual irregularities, galactorrhea.

From the skin: increased sweating, rash, itching, photosensitivity, epidermal necrolysis, angioedema.

From the senses: a violation of accommodation, visual impairment, mydriasis, a taste disorder, tinnitus.

From the musculoskeletal system: myalgia, arthralgia.

From the coagulation system: rarely - the development of bleeding (eg, bleeding due to gynecological causes, gastrointestinal bleeding, ecchymosis), thrombocytopenia.

Other: asthenia, fatigue, allergic reactions, fainting, malaise, mastodonia, yawning, gnashing of teeth, anaphylactoid reaction.

CONTRAINDICATIONS
Hypersensitivity to citalopram.

PREGNANCY AND LACTATION
The safety of citalopram during pregnancy and lactation is not established.
The use is justified only in those cases when the potential benefit of therapy for the mother exceeds the possible risk for the fetus and the child.
In experimental studies, there was no teratogenic effect and no effect of citalopram on reproductive function and perinatal development of the fetus.

APPLICATION FOR FUNCTIONS OF THE LIVER
With mild and moderately expressed renal failure, correction of the citalopram dosage regimen is not required, information on the use of severe renal failure is lacking.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with hepatic insufficiency, citalopram should be used in minimal doses.

APPLICATION FOR CHILDREN
The efficacy and safety of citalopram in children is not established.

SPECIAL INSTRUCTIONS
In patients with hepatic insufficiency, citalopram should be used in minimal doses.

With mild and moderately expressed renal failure, correction of the citalopram dosage regimen is not required, information on the use of severe renal failure is lacking.

When citalopram is used, a slight decrease in heart rate is possible, which is not clinically important, however, in patients with an initially lowered heart rate, citalopram may cause a more pronounced bradycardia.

Citalopram should not be used concomitantly with MAO inhibitors.

Caitolopram should be used with caution at the highest doses while taking cimetidine in high doses.

Use in Pediatrics

The efficacy and safety of citalopram in children is not established.

Impact on the ability to drive vehicles and manage mechanisms

It should be borne in mind that in patients with depression, there is often a decrease in the ability to concentrate, which can be exacerbated by the use of psychotropic drugs.

DRUG INTERACTION
With simultaneous application with MAO inhibitors, the development of hypertensive crisis (serotonin syndrome) is possible.
Therefore, concurrent use of citalopram with MAO inhibitors is contraindicated and within 14 days after discontinuation of their administration.
It inhibits the isoenzyme CYP2D6 to a very small extent, so it does not interact with drugs metabolized by this isoenzyme.

However, the decrease in citalopram concentration in the blood plasma can not be ruled out due to the enhancement of its metabolism due to the induction of microsomal liver enzymes by carbamazepine in their simultaneous application.

With simultaneous application of cimetidine, a moderate increase in C ss of citalopram in blood plasma is possible.

The effects of sumatriptan and other serotonergic agents may be intensified by citalopram when applied simultaneously.

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