Citalift (Tablets) Instructions for Use

ATC Code

N06AB04 (Citalopram)

Active Substance

Citalopram (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antidepressant

Pharmacotherapeutic Group

Antidepressant

Pharmacological Action

Antidepressant. The mechanism of action is associated with the selective blockade of the neuronal reuptake of serotonin in the synapses of the CNS neurons with a minimal effect on the reuptake of norepinephrine and dopamine.

It has little or no ability to bind to a number of receptors, including serotonin HT_1A-, 5HT_2A-, dopamine D₁– and D₂-, α₁-, α₂– and β-adrenergic receptors, histamine H₁-receptors, GABA receptors, m-cholinergic receptors and benzodiazepine receptors.

It helps to improve mood, relieves anxiety, reduces feelings of fear and tension, eliminates dysphoria, reduces obsessive states, and practically does not cause a sedative effect.

A stable clinical effect develops after 7-10 days of regular use.

Pharmacokinetics

After oral administration, C_max of citalopram in plasma is reached in 2-4 hours. Oral bioavailability is about 80%.

Changes in plasma citalopram concentrations are linear. C_ss in plasma is established after 1-2 weeks of therapy.

Plasma protein binding is less than 80%.

In blood plasma, Citalopram is present mainly in unchanged form. It is metabolized by demethylation, deamination and oxidation.

T_1/2 is 1.5 days.

It is excreted by the kidneys and through the intestines.

Indications

Depressions of various origins (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 dementias with depressive symptoms; depressive disorders in women (premenstrual dysphoria, depression in pregnancy, postpartum depression, depression in premenopause); eating disorders (anorexia, bulimia); depression in alcoholism; depression in the elderly.

ICD codes

Dosage Regimen

Take tablets orally once daily, with or without food.

For adult patients, initiate therapy at 10 mg to 20 mg once daily. Based on individual patient response and tolerability, increase the dose gradually. The maximum recommended dose is 60 mg once daily.

For geriatric patients over 65 years of age, initiate therapy at 20 mg once daily. If necessary, increase the dose to a maximum of 40 mg once daily. Monitor these patients closely.

For patients with mild to moderate hepatic impairment, use the lowest effective dose. Do not exceed 30 mg daily in these patients. Avoid use in severe hepatic impairment.

For patients with mild to moderate renal impairment, no initial dosage adjustment is required. Use with caution and monitor for adverse effects. Avoid use in severe renal impairment due to lack of data.

When discontinuing treatment, gradually reduce the dose over a period of one to two weeks to prevent withdrawal symptoms. Do not abruptly stop therapy.

To prevent relapse of depression, continue therapy for at least six months after symptom remission. For patients with a history of recurrent depression, consider longer-term maintenance therapy.

Monitor all patients for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of therapy and following dosage changes.

Adverse Reactions

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, suicide attempts, confusion, asthenia, mood changes, aggressive behavior, emotional lability, agitation, mania, hypomania, panic behavior, paranoid reaction, psychosis, excessive fatigue, restlessness, extrapyramidal disorders, convulsions, euphoria, serotonin syndrome (agitation, confusion, diarrhea, hyperthermia, hyperreflexia, ataxia, increased sweating, 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.

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

From the urinary system: frequent urination, polyuria.

Metabolic disorders: decrease or increase in body weight, hyponatremia, hyperthermia.

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

From the reproductive system: ejaculation disorders, increase or decrease in libido, female anorgasmia, dysmenorrhea, impotence, menstrual cycle disorders, galactorrhea.

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

From the sensory organs: accommodation disorder, visual impairment, mydriasis, taste disturbance, tinnitus.

From the musculoskeletal system: myalgia, arthralgia.

From the blood coagulation system: rarely – development of bleeding (for example, bleeding due to gynecological causes, gastrointestinal bleeding, ecchymoses), thrombocytopenia.

Other: asthenia, fatigue, allergic reactions, fainting, malaise, mastodynia, yawning, teeth grinding, anaphylactoid reaction.

Contraindications

Hypersensitivity to citalopram.

Use in Pregnancy and Lactation

The safety of using citalopram during pregnancy and lactation has not been established. Use is justified only in cases where the potential benefit of therapy for the mother outweighs the possible risk to the fetus and child.

In experimental studies, no teratogenic effect or any effect of citalopram on reproductive function and perinatal development of the fetus was revealed.

Use in Hepatic Impairment

In patients with hepatic insufficiency, Citalopram should be used in minimal doses.

Use in Renal Impairment

In mild and moderate renal failure, no adjustment of the citalopram dosage regimen is required; there is no information on use in severe renal failure.

Pediatric Use

The efficacy and safety of using citalopram in children have not been established.

Special Precautions

In patients with hepatic insufficiency, Citalopram should be used in minimal doses.

In mild and moderate renal failure, no adjustment of the citalopram dosage regimen is required; there is no information on use in severe renal failure.

When using citalopram, a slight decrease in heart rate is possible, which has no clinical significance, however, in patients with initially reduced heart rate, Citalopram may cause more pronounced bradycardia.

Citalopram should not be used simultaneously with MAO inhibitors.

Citalopram should be used with caution in maximum doses while taking cimetidine in high doses.

Use in pediatrics

The efficacy and safety of using citalopram in children have not been established.

Effect on the ability to drive vehicles and operate machinery

It should be borne in mind that patients with depression often have a reduced ability to concentrate, which may be aggravated by the use of psychotropic drugs.

Drug Interactions

When used simultaneously with MAO inhibitors, the development of a hypertensive crisis (serotonin syndrome) is possible. Therefore, the simultaneous use of citalopram with MAO inhibitors and within 14 days after their discontinuation is contraindicated.

It inhibits the CYP2D6 isoenzyme to a very small extent, therefore it does not interact with drugs metabolized by this isoenzyme.

However, a decrease in the plasma concentration of citalopram due to increased metabolism as a result of induction of liver microsomal enzymes by carbamazepine during their simultaneous use cannot be ruled out.

With simultaneous use 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 enhanced by citalopram when used simultaneously.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.