Umorap - instructions for use, doses, side effects, contraindications

sheath: coloring Opadrai II YS-30-18056 white (lactose monohydrate, hydroxypropylmethylcellulose (hypromellose), titanium dioxide, triacetin), Opaprai II dye YS-19-19054 transparent (hydroxypropylmethylcellulose (hypromellose), maltodextrin, triacetin).

Description:

Tablets of 20 mg and 40 mg: white round biconvex tablets covered with a film sheath, with a risk and engraving "HUM 20 "or"HUM 40 "on one side and the company logo on the other.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.04 Citalopram

Pharmacodynamics:

Citalopram is an antidepressant from the group of selective serotonin reuptake inhibitors (SSRIs).

Citalopram, possessing a pronounced ability to inhibit the reuptake of serotonin, does not or has a very weak ability to bind to a variety of receptors, including histamine, muscarinic and adrenoreceptors. Citalopram in a very small

degree inhibits cytochrome P450IID6 and, consequently, does not interact with drugs metabolized by this enzyme. Thus, side effects and toxic effects are manifested to a much lesser extent. The antidepressant effect usually develops after 2-4 weeks of treatment. Citalopram practically has no effect on the conduction system of the heart and blood pressure, on haematological parameters, liver and kidney function, does not cause an increase in body weight.

Citalopram does not interfere with the cognitive functions of a person, does not cause sedation, in experimental studies, the drug does not show teratogenic effects, effects on reproductive function and perinatal development of offspring.

Pharmacokinetics:

Bioavailability of citalopram with oral intake is about 80% and is practically independent of food intake. Maximum concentration (TFROM_max) in plasma is achieved in 2-4 hours after administration. Binding to plasma proteins is less than 80%. The plasma is present unchanged. At doses of 10-60 mg / day pharmacokinetic parameters have a linear dependence. The volume of distribution is 12 l / kg. The equilibrium concentration (C_ss) with a daily one-time reception is established after 7-14 days. Penetrates into breast milk.

Metabolized by demethylation, deamination and oxidation involving cytochrome P450 (isoenzymes CYP3A4 and CYP2C19) with the formation of less pharmacologically active metabolites.

The half-life (T_1/2) of the drug is 1.5 days. Excretion is performed by the kidneys and with feces.

Patients over the age of 65 years

There is a longer biological half-life (1.5-3.75 days) and lower clearance values (0.08-0.3 l / min). Concentrations that were observed in the equilibrium state in elderly patients were almost twice as high as those observed in younger patients who received the same dose.

Lack of liver function

In patients with reduced liver function citalopram. output more slowly. The biological half-life of citalopram is almost doubled and the equilibrium concentrations of citalopram in plasma are almost twice as high as in patients with normal liver function after administration of the same dose.

Lack of kidney function

The excretion of citalopram proceeds more slowly in patients with a small and moderate degree of renal dysfunction without a significant effect on the pharmacokinetics.

Indications:

Depression of various etiologies, treatment and prevention.

Panic disorders with fear or without fear of open space.

Obsessive-compulsive disorder (obsessive-compulsive neurosis).

Contraindications:

Hypersensitivity to citalopram or to any component that is part of the drug.

The drug should not be used in combination with monoamine oxidase (MAO) inhibitors, sumatriptan and other serotonergic drugs, and also within 14 days after stopping their intake. Treatment with MAO inhibitors can be started no earlier than 7 days after stopping citalopram.

Children's age (efficacy and safety of use not established).

Carefully:

With insufficient liver and / or kidney function, in the presence of convulsive fits in the anamnesis, drug dependence, manic disorders (in the anamnesis), patients over 65 years of age,

Pregnancy and lactation:

Do not assign citalopram pregnant and breastfeeding women, if the potential clinical benefit does not prevail over the theoretical risk, because the safety of the drug during pregnancy and lactation in humans is not established.

Dosing and Administration:

The drug UMORAP ® is taken orally once a day at any time of the day, regardless of food intake.

Depression

The recommended daily dose is 20 mg of citalopram. Depending on the patient's individual response to treatment and the severity of the disease, the dose can be increased. The maximum daily dose is 60 mg.

Panic disorders

The recommended initial daily dose is 10-20 mg of citalopram, after which the dose is gradually increased to a maximum of 60 mg per day.

Obsessive-compulsive disorder

The recommended daily dose of citalopram is 20 mg. Depending on the patient's individual response to treatment, the dose can be increased. The maximum daily dose is 60 mg.

Patients aged 65 years and over

The maximum daily dose is not more than 40 mg.

Impaired renal function

Patients with mildly or moderately impaired renal function may apply the drug in normal doses. At present, experience with citalopram treatment in patients with severe renal insufficiency (creatinine clearance up to 20 ml / min) is insufficient.

Disturbed liver function

Patients with impaired liver function should not be prescribed more than 30 mg of citalopram per day.

Duration of treatment

Usually, the antidepressant effect of the drug is observed after 2-4 weeks of treatment. Treatment with antidepressants is symptomatic and should be carried out for a long time. Usually, to prevent recurrence, treatment should be carried out for 6 months or even a longer period of time. In the case of patients with recurrent depression, maintenance treatment should be carried out for several years to prevent the onset of subsequent phases of the disease. If the treatment is completed, the drug should be withdrawn gradually within a few weeks.

In the treatment of panic disorder, the maximum effect of citalopram is observed after 3months of treatment. This effect persists throughout the period of maintenance therapy.

In the treatment of obsessive-compulsive disorder, the effect of the drug appears after 2-4 weeks of treatment; With further continuation of treatment, further improvement can be observed.

Side effects:

From the nervous system: rarely asthenia, drowsiness or insomnia, anxiety, tremor, agitation, memory disorders, apathy, extrapyramidal effects, mood changes, aggressive behavior, depersonalization, emotional lability, euphoria, manic and / or psychotic (including hallucinations) disorders, panic reactions, serotonin syndrome (agitation, confusion, diarrhea, hyperthermia, hyperreflexia, ataxia).

From the digestive tract: rarely dry mouth, nausea, vomiting, hypersalivation, flatulence, diarrhea, abdominal pain, anorexia.

From the cardiovascular system: rarely - bradycardia, lowering of blood pressure (BP), orthostatic hypotension, arrhythmia.

From the hematopoiesis: rarely - thrombocytopenia, bleeding.

From the sense organs: rarely - mydriasis, paresis of accommodation, a taste disorder.

On the part of the reproductive system: violation of sexual function: violation of ejaculation, decreased libido, impotence, menstrual irregularities.

Allergic reactions: skin rash, rarely - epidermal necrosis, rhinitis, sinusitis.

Other: rarely - hyperthermia, polyuria, mastodonia, galactorrhea, hyponatremia, violation of urination, arthralgia, myalgia, yawning, gnashing of teeth, increase or decrease in body weight, dyspnea.

Overdose:

Symptoms: nausea, dizziness, drowsiness, dysarthria, heart rhythm and conduction disorder (lengthening of the interval QT, sinus tachycardia, nodal rhythm on the ECG), increased sweating, cyanosis, tremor, amnesia, confusion, rhabdomyolysis, convulsions, coma.

Treatment: gastric lavage, symptomatic and maintenance therapy; there is no specific antidote.

Interaction:

Citalopram enhances the effect of sumatriptan and other serotonergic drugs.

Does not affect the effects of ethanol, lithium preparations, benzodiazepines, antipsychotics (neuroleptics), narcotic analgesics, beta-blockers, phenothiazines,tricyclic antidepressants, antihistamines and hypotensive drugs.

To an insignificant degree inhibits cytochrome CYP2D6, and therefore weakly interacts with drugs that are metabolized with his participation.

With the simultaneous administration of citalopram with MAO inhibitors, the development of hypertensive crisis (serotonin syndrome) is possible.

Cimetidine increases the concentration in the blood and increases the effect of citalopram.

With a simultaneous appointment with warfarin, prothrombin time increases by 5%.

Special instructions:

When developing a manic condition, the drug should be discarded.

Patients with drug dependence (including history) need supervision and control over the use of the drug.

Treatment with MAO inhibitors can be initiated no earlier than 7 days after stopping citalopram.

Care should be taken when prescribing during breastfeeding because of the risk of drowsiness in infants, a reduction in the sucking reflex, and weight loss.

In elderly patients, a dose reduction of citalopram is required.

During the treatment should avoid drinking alcohol.

Effect on the ability to drive transp. cf. and fur:Citalopram usually does not affect the intellectual and psychomotor functions and abilities. Nevertheless, it is recommended that patients who take psychotropic medications are informed that their ability to concentrate and show attention may be impaired to some extent as a result of their illness and / or the effects of medications taken. Therefore, during the treatment period, care should be taken when managing moving funds and engaging in other activities that require increased concentration and speed of the psychomotor reaction.

Form release / dosage:Tablets, film-coated, 20 mg and 40 mg.

Packaging:

For 14 tablets in a PVC / aluminum blister.

For 1 or 2 blisters in a cardboard pack together with instructions for use.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006519/08

Date of registration:13.08.2008

The owner of the registration certificate: Laboratorios Bago S.A. Laboratorios Bago S.A. Argentina

Manufacturer: & nbsp

Laboratorios BAGO, S.A. Argentina

Representation: & nbspBBC FARMA BV BBC FARMA BV Netherlands

Information update date: & nbsp27.09.2015

Illustrated instructions

Instructions

Uorop® (Humorap®)