COMPOSITION: Each tablet contains:
Citalopram hydrobromide equivalent to 20 mg citalopram
PHARMACOLOGICAL CLASSIFICATION: A 1.2 Psychoanaleptics (anti-depressants)
PHARMACOLOGICAL ACTION: Citalopram, a bicyclic phthalone derivative, is a selective serotonin reuptake inhibitor (SSRI). It has an antidepressant effect. Citalopram selectively inhibits the reuptake of serotonin: It has no effect on the uptake of noradrenaline, dopamine or GABA. Citalopram and its metabolites have no antimuscarinic effects and are less cardiotoxic. Prevention of the reuptake of the monoamine transmitters serotonin potentiates their action in the brain, which appears to be associated with antidepressant activity. Citalopram is readily absorbed from the gastrointestinal tract and oral bioavailability is high (>80%) maximum plasma concentrations are reached within 4 hours (interval 1-6 hours) after oral administration. Citalopram is widely distributed throughout the body (the volume of distribution is ± 14 litres per kg). Steady state levels are obtained within 1 to 2 weeks. Protein binding is about 80%. Citalopram is metabolised by demethylation, deamination and oxidation to inactive metabolites. The elimination half-life of citalopram is reported to be about 36 hours (interval 28-42 hours ). It is excreted in the urine and faeces. Citalopram is distributed into breast milk in very low concentrations.
INDICATIONS: CILIFT is indicated for the following:
Panic disorder with or without agoraphobia.
Hypersensitivity to CILIFT
Severe hepatic or renal failure (creatinine clearance of less than 20 mL/min).
Safely in pregnancy and lactation has not been established.
WARNINGS: CILIFT should not generally be given to patients receiving Monoamine Oxidase Inhibitors (MAOI's) or for at least 14 days after their discontinuation. MAOI's should not be introduced for seven days after discontinuing CILIFT.
There is little clinical experience of concurrent use of CILIFT and electro-convulsive treatment.
If the patient enters a manic state, CILIFT should be discontinued.
CILIFT may impair performance of skilled tasks and, if affected, patients should not drive or operate machinery.
DOSAGE AND DIRECTIONS FOR USE In the treatment of depression: Adults.
The dose of CILIFT is 20 to 60 mg (1 - 3 tablets) daily as a single oral dose.
The dose may be taken in the morning or the evening not necessarily with food. Elderly patients/patients with hepatic impairment:
The recommended daily dose is 20 mg. Depending on individual patient response. This may be increased to a maximum of 30 mg daily.
Children up to 18 years of age:
Not recommended, as safety and efficacy have not been established.
Note: In order to minimise the potential for relapse, CILIFT treatment should continue for at least 6 months. In the treatment of panic disorder with or without agoraphobia: Adults:
The initial dose is 10 mg (half a tablet) daily by mouth, increasing to 20 mg (1 tablet) daily after one week. The dose may be increased thereafter as required up to a maximum of 60 mg (3 tablets) daily.
Children up to 18 years of age:
Not recommended, as safety and efficacy have not been established. Reduced hepatic function: Dosage should be halved. Reduced renal function: Dosage adjustment is not necessary in cases of mild or moderate renal impairment.
Note: CILIFT should be withdrawn gradually to reduce the risk of withdrawal symptoms.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects: Commonly occurring side-effects include:
Generally: Headache, sweating, fatigue, tremor, weight loss/weight gain, dizziness.
Cardiovascular: Palpitations, a decrease in pulse rate has been reported.
Central nervous system: Anxiety, restlessness, nervousness, insomnia, somnolence, drowsiness and parasthesia.
Gastro-intestinal: Dry mouth, nausea, vomiting, dyspepsia, constipation/diarrhoea.
Urogenital: Micturition disorder
Eyes: Accommodation disturbances.
Generally: Malaise, yawning.
Central nervous system: Convulsions, extrapyramidal side effects, agitation, confusion, impaired concentration, sexual dysfunction (decreased libido, ejaculation disorder) and mania.
Skin: Pruritis or skin rashes
Respiratory system: Nasal congestion.
Blood: Hyponatremia (particularly in the elderly). Special Precautions: Patients should be closely monitored during early therapy until improvement in depression is observed because suicide is an inherent risk in depressed patients. CILIFT should be used with caution in patients with epilepsy or a history of such disorders (and should be avoided if the epilepsy is poorly controlled). Interactions: Simultaneous administration of MAOI's (see "WARNINGS").
Concomitant administration with other antidepressant therapy may result in severe adverse reactions including the "serotonin syndrome".
At least one week should elapse between withdrawing an SSRI and starting any medicine liable to provoke a serious reaction (e.g. phenelzine).
CILIFT interacts with imipramine, moclobemide, selegeline and sumatriptan.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Overdosage of CILIFT may result in weakness, tiredness, sedation, nausea, dizziness, tremor and somnolence.
Treatment is symptomatic and supportive.
Gastric lavage should be carried out. The use of activated charcoal by mouth as an adjunct to gastric lavage has been suggested.
IDENTIFICATION: A round, white to off-white, biconvex film-coated tablet, bisected on one side.
PRESENTATION: A clear transparent blister pack 30's (3 blister packs of 10 tablets each)
STORAGE INSTRUCTIONS: Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 36/1.2/0092
NAME AND BUSINESS ADDRESS OF APPLICANT: PHARMACARE LIMITED
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 24 January 2003.
Updated on this site: September 2003 Current: September 2004 Source: Community Pharmacy