📌 COMPOSITION

Each F/C tablet contains: Citalopram Hydrobromide USP equivalent to Citalopram 20 mg.

📌 DESCRIPTION

Citex 20 (Citalopram) is an antidepressant drug. It is the most selective serotonin reuptake inhibitor (SSRI). It acts by prevention of the reuptake of monoamine transmitters such as serotonin, which potentiates their action in the brain. Citex 20 is readily absorbed from the gastrointestinal tract, and the maximum plasma concentration is reached 2-4 hours after oral doses. It is widely distributed throughout the body, and less than 80% binds with plasma protein. Citalopram is metabolised to active and inactive metabolites, and the elimination half‑life is about 36 hours. It is excreted mainly via the liver (85%) and the remainder via the kidneys.

📌 INDICATIONS

Citex 20 is used for treatment of:

• Depression.
• Panic disorder with or without agoraphobia.
• Obsessive‑Compulsive Disorder (OCD).

📌 DOSAGE AND ADMINISTRATION

Citex 20 is taken every day as a single dose with or without food and swallowed with water.

Adults:

• In case of Depression: The initial dose is 20 mg (one tablet) daily. After at least one week and depending on patient response, the dose may be increased to a maximum of 40 mg (2 tablets).
• In case of Panic disorder: The initial dose is 10 mg (1/2 tablet) daily for the first week before increasing the dose to 20 mg (one tablet). Depending on patient response, the dose may be increased to a maximum of 40 mg (2 tablets).
• In case of Obsessive‑Compulsive Disorder: The initial dose is 20 mg (one tablet) daily. After at least one week and depending on patient response, the dose may be increased to a maximum of 40 mg (2 tablets).

Elderly patients (above 65 years of age):

The dose should be decreased to half of the recommended dose (10-20 mg) daily. The recommended maximum dose for the elderly is 20 mg (one tablet).

Hepatic impairment patients:

An initial dose of 10 mg (1/2 tablet) daily for the first two weeks of treatment is recommended in patients with mild to moderate hepatic impairment. Depending on patient response, the dose may be increased to a maximum of 20 mg (one tablet). Caution and extra careful dosing is advised in patients with severely reduced hepatic function.

Renal impairment patients:

There is no need for dose adjustment in mild to moderate renal impairment, although information is lacking on appropriate dosage in severe renal impairment (Creatinine Clearance < 20 ml/min).

Children and adolescents (< 18 years):

Citalopram is not given to children and adolescents less than 18 years.

📌 RESTRICTIONS ON USE

Contraindications

• Known hypersensitivity to Citalopram.
• Taking monoamine oxidase inhibitors (MAOIs) at the same time with Citalopram.
• Concomitant administration of Citalopram with pimozide or any other drug that prolongs the QT interval.

Precautions

Citalopram should be used with caution in patients with:

• Epilepsy or a history of such disorders (Treatment should be avoided if the epilepsy is poorly controlled, and treatment should be stopped if seizures develop or when there is an increase in frequency).
• Cardiac diseases or a history of bleeding disorders.
• Diabetes or narrow‑angle‑closure glaucoma or history of glaucoma.
• Severe liver or renal impairment.
• Depression, because suicide is an inherent risk in depressed patients. So patients should be closely monitored during early therapy until significant improvement is observed.

Citalopram should be withdrawn gradually to reduce the risk of withdrawal symptoms during dosage reduction or stopping treatment. Withdrawal common symptoms include: dizziness, numbness, tingling, gastrointestinal disturbances (nausea and vomiting), headache, sweating, anxiety, sleeping disorders, emotional instability, irritability and visual disturbances.

If the depressed patient develops akathisia symptoms, increasing the dose of Citalopram may be determinate.

If the patient with manic‑depressive illness changes towards the manic phase, Citalopram should be discontinued.

Drinking alcohol should be avoided.

Effects on the capacity to drive vehicles or use machines

Generally, Citalopram does not cause drowsiness, but if the patient feels dizzy or sleepy when starting to take the medicine, he should avoid driving vehicles or using machines.

Use in Pregnancy and Lactation

Citalopram should not be taken by pregnant women or breastfeeding mothers.

📌 DRUG INTERACTIONS

• Occasionally, Citalopram has been associated with bleeding disorders and other effects on the blood; caution is advised when it is given with drugs known to affect platelet function (e.g., some antipsychotic drugs, tricyclic antidepressants, acetylsalicylic acid, non‑steroidal anti‑inflammatory drugs).
• Using Citalopram with other antidepressants may lead to severe adverse reactions including serotonin syndrome.
• Citalopram should be used with caution with lithium and tryptophan.
• The dose of selegiline must not exceed 10 mg daily if used with Citalopram (20 mg daily).
• The blood levels of metoprolol are increased when used with Citalopram.
• Use of Citalopram with sumatriptan may increase the risk of side effects.
• Citalopram blood levels may be moderately increased when used with high doses of cimetidine.
• At least one week should elapse between withdrawing Citalopram and starting any drug liable to provoke a serious reaction (as phenelzine).
• Concomitant intake of St. John's Wort (Hypericum perforatum) with Citalopram may increase the risk of side effects.

📌 SIDE EFFECTS

The following side effects are often mild and usually disappear after a few days of treatment:

• Common side effects: Dry mouth, increased sweating, agitation, decreased appetite, sleeplessness, feeling sleepy, yawning, diarrhoea, nausea, fatigue and decreased sex drive.
• Very rare side effects: Hypersensitivity (rash), seizures, cutaneous bleeding disorder and unusual muscle movement or stiffness.

The following side effects are very rare but serious, and if they appear, the doctor should be consulted immediately:

• Signs of hyponatraemia as feeling sick and unwell with weak muscles or confused.
• Signs of serotonin syndrome as high fever, agitation, confusion, trembling and abrupt contractions of muscles.

📌 OVERDOSAGE

Symptoms of overdose may include: nausea, vomiting, sweating, drowsiness, blue discoloration of the skin, seizures, unconsciousness, fast heartbeats, ECG abnormalities, tremor and serotonin syndrome. There is no specific antidote to Citalopram, but the treatment of overdose involves appropriate symptomatic and supportive therapy, including the maintenance of clear airways and monitoring of ECG and vital signs until stable. Activated charcoal may be given by mouth to adults and children if the amount ingested was large (5 mg/kg) and treatment is within an hour of Citalopram ingestion. Osmotically working laxative (as sodium sulphate) and stomach evacuation should be considered. If consciousness is impaired, the patient should be intubated. Control frequent or prolonged convulsions with intravenous diazepam.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Citex 20: Pack of 20 tablets and hospital packs of different sizes.