Universal reference book for medicines
Product name: OPRA (OPRA ® )

Active substance: citalopram

Type: Antidepressant

Manufacturer: ACTAVIS GROUP PTC ehf.
(Iceland)
Composition, form of production and packaging
Tablets covered with a film coat of
white or almost white color, round, biconcave, with risk from both sides and lateral risks.

1 tab.

citalopram (in the form of hydrobromide) 20 mg

Excipients: mannitol - 132.55 mg, microcrystalline cellulose - 17.885 mg, silicon dioxide colloid - 625 μg, magnesium stearate - 3.95 mg

The composition of the membrane: hypromellose - 2.19 mg, titanium dioxide (E171) - 880 μg, macrogol 6000 - 530 μg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
Tablets covered with a film coat of white or almost white color, round, biconcave, with risk from both sides and lateral risks.

1 tab.

citalopram (in the form of hydrobromide) 40 mg

Excipients: mannitol - 265.1 mg, microcrystalline cellulose - 35.77 mg, silicon dioxide colloid - 1.25 mg, magnesium stearate - 7.9 mg

Sheath composition: hypromellose - 4.38 mg, titanium dioxide (E171) - 1.76 mg, macrogol 6000 - 1.06 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
1 tab.

citalopram (in the form of hydrobromide) 20 mg

- "- 40 mg

Excipients: mannitol, microcrystalline cellulose, silicon dioxide, colloidal anhydrous, magnesium stearate, hypromellose, titanium dioxide, macrogol 6000.

10 pieces.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Antidepressant from the group of selective serotonin reuptake inhibitors.

Citalopram, possessing a pronounced ability to inhibit the reuptake of serotonin, does not or has a very weak ability to bind to receptors, including histamine, muscarinic and adrenoreceptors.
Citalopram only inhibits the isoenzyme CYP2D6 to a very small extent and, therefore, does not interact with the drugs metabolized by this enzyme. Thus, side effects and toxic effects are manifested to a much lesser extent. Antidepressant effect usually develops after 2-4 weeks of treatment.
Citalopram has virtually no effect on the conduction system of the heart and blood pressure, on hematologic indices, liver and kidney function, does not cause weight gain.

Citalopram does not interfere with human cognitive function, does not cause sedation.

PHARMACOKINETICS

Suction

After ingestion, the bioavailability of citalopram is about 80% and is virtually independent of food intake.
C max in plasma is achieved 2-4 hours after administration.
Distribution

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. V d - 12 l / kg. C ss with a daily one-time admission is set after 7-14 days. Excreted in breast milk.
Metabolism

Metabolized by demethylation, deamination and oxidation with the participation of CYP3A4 and CYP2C19 isoenzymes with the formation of less pharmacologically active metabolites.

Excretion

T 1/2 is 1.5 days.
It is excreted in urine and feces.
Pharmacokinetics in special clinical cases

Patients over the age of 65 years have a longer biological half-life (1.5-3.75 days) and a lower clearance (0.08-0.3 l / min).
C ss in elderly patients was almost 2 times higher than the concentrations observed in younger patients who received the drug at the same dose.
In patients with reduced liver function, citalopram is withdrawn more slowly.
The biological half-life of citalopram is almost 2-fold and C ss in plasma is almost 2 times higher than in patients with normal liver function after taking the drug at the same dose.
The excretion of citalopram has been slowed in patients with mild and moderate renal insufficiency without a significant effect on the pharmacokinetics.
Currently, the experience of treating patients with severe renal insufficiency (creatinine clearance less than 20 ml / min) is insufficient.
INDICATIONS

- treatment of depressive diseases and prevention of their relapse;

- treatment of panic disorder with or without fear of open space;

- Treatment of obsessive-compulsive disorder (obsessive-compulsive neurosis).

DOSING MODE

The drug is administered orally 1 time / day at any time or during a meal, or on an empty stomach.

With depression, the daily dose is 20 mg.
Depending on the patient's individual response to treatment and the severity of the disease, the daily dose can be increased to 60 mg.
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 performed for 6 months or even longer. In the case of periodic (recurrent) depression, maintenance treatment should be performed 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 panic disorders, the drug is prescribed at a dose of 10 mg / day during the first week of treatment, after which the daily dose is increased to 20 mg.
Depending on the patient's individual response to treatment and the severity of the disease, the daily dose can be increased to 60 mg.
In the treatment of panic disorder, the maximum effect of citalopram is observed after 3 months of treatment.
This effect persists throughout the period of maintenance therapy.
In obsessive-compulsive disorders, the daily dose is 20 mg.
Depending on the patient's individual response to treatment, the dose can be increased by 20 mg to a maximum daily dose of 60 mg.
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.
For patients aged 65 years and older, the initial daily dose may be increased to 40 mg.

Patients with hepatic dysfunction should not be prescribed a drug at a dose of more than 30 mg / day.

Patients with mild or moderate renal dysfunction should be prescribed in usual doses.
Information on citalopram treatment in patients with severe renal insufficiency (KK ≥ 20 ml / min) is not available.
SIDE EFFECT

From the side of the central nervous system: rarely - asthenia, fatigue, drowsiness or insomnia, anxiety, tremor, agitation, amnesia, apathy, extrapyramidal symptoms, mood changes, aggressive behavior, hallucinations, depersonalization, emotional lability, euphoria, mania, hypomania, panic behavior, paranoid reaction, psychosis, serotonin syndrome (agitation, confusion, diarrhea, hyperthermia, hyperreflexia, ataxia, unusual fatigue, tremor, increased sweating, agitation, uncontrolled behaviore).

On the part of the digestive system: rarely - dry mouth, nausea, vomiting, hypersalivation, flatulence, diarrhea, abdominal pain, anorexia.

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

On the part of the organs of hematopoiesis: rarely - thrombocytopenia, bleeding.

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

On the part of the reproductive system: violation of ejaculation, decreased libido, impotence, menstrual irregularities;
rarely - mastodynia, galactorrhea.
Allergic reactions: skin rash;
rarely - toxic epidermal necrolysis, rhinitis, sinusitis.
Other: rarely - hyperthermia, polyuria, hyponatremia, violation of urination, arthralgia, myalgia, yawning, gnashing of teeth, increase or decrease in body weight.

CONTRAINDICATIONS

- simultaneous administration with MAO inhibitors, as well as the period within 14 days after stopping their intake (treatment with MAO inhibitors can be started no earlier than 7 days after stopping citalopram intake);

- children's age till 18 years;

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

Caution should be given to the drug with insufficient liver and / or kidney function, with convulsive seizures in history, in old age.

PREGNANCY AND LACTATION

Do not prescribe Opra during pregnancy and during breastfeeding, if the potential clinical benefit for the mother does not exceed the theoretical risk for the fetus and the baby, because
the safety of the drug during pregnancy and lactation in humans is not established.
Care should be taken when prescribing the drug during breast-feeding due to the risk of drowsiness in infants, a decrease in the sucking reflex, and loss of body weight.

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with hepatic dysfunction should not be prescribed a drug at a dose of more than 30 mg / day.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Patients with mild or moderate renal dysfunction should be prescribed in usual doses.
Information on citalopram treatment in patients with severe renal insufficiency (KK ≥ 20 ml / min) is not available.
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.

Citalopram does not affect the intellectual and psychomotor functions and abilities.
Nevertheless, it is recommended that patients who receive psychotropic medications are informed that their ability to concentrate and show attention may be impaired to some extent as a result of their illness or the action of the medication taken, or as a result of a combination of these two factors.
OVERDOSE

Symptoms: nausea, dizziness, drowsiness, dysarthria, increased sweating, cyanosis, tremor, amnesia, confusion, sinus tachycardia, nodal rhythm, conduction disorder (prolongation of the QT interval), rhabdomyolysis, seizures, coma.

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

With simultaneous application of citalopram enhances the effect of sumatriptan and other serotonergic drugs.

With the simultaneous use of citalopram does not affect the effects of ethanol, lithium drugs, benzodiazepines, antipsychotics (neuroleptics), opioid analgesics, beta-blockers, phenothiazines, tricyclic antidepressants, antihistamines and hypotensive drugs.

Citalopram to a small extent inhibits the isoenzyme CYP2D6, and therefore weakly interacts with drugs that are metabolized with the participation of this isoenzyme.

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

With simultaneous use of cimetidine increases the concentration of citalopram in the blood and enhances its effect.

At simultaneous appointment with warfarin prothrombin time increases by 5%.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 4 years.
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