INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CIPRAMIL 20 mg Tablets

ZA-069-22-20-13404

SCHEDULING STATUS:
S5

PROPRIETARY NAME:
(and dosage form)

CIPRAMIL 20 mg Tablets

COMPOSITION:
Each tablet contains
citalopram hydrobromide corresponding to 20 mg citalopram.

PHARMACOLOGICAL CLASSIFICATION:
A 1.2 Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION:
Citalopram is a bicyclic phthalane derivative with antidepressant effect. The substance is a racemate, in which one of the enantiomers is responsible for the effect. The pharmacodynamic effect is specifically related to a selective inhibition of serotonin (5-HT) uptake. Citalopram has no effect on the uptake of noradrenaline, dopamine or GABA. Moreover neither citalopram nor its metabolites have antidopaminergic, antiadrenergic, antiserotoninergic, antihistaminergic or anticholinergic (antimuscarinic) properties. After prolonged treatment, the 5-HT- uptake inhibitory efficacy is unchanged and citalopram does not induce changes in the density of neurotransmitter receptors at the recommended dosages. Citalopram has no effect on the cardiac conduction system, blood pressure or blood picture.
Pharmacokinetic data are based on the racemate. The oral bioavailability is high (>80%). Maximum plasma levels are reached within 4 hours (interval 1 - 6 hours) after administration. A linear relationship has been demonstrated between steady-state plasma levels and administered dose and varies four-fold between individuals treated with the same dose. Steady state levels are reached within 1 - 2 weeks. The volume of distribution is about 14 L/kg. The protein binding is about 80%.
Unchanged citalopram is a predominant compound in plasma. The metabolites have the same pharmacological effect as citalopram, but are less potent. It is not known whether the kinetics of the active enantiomer differs in patients, who are slow metabolisers of spartein/debrisoquine or mephenytoin. The biological half-life is about 36 hours (interval 28 - 42 hours). The systemic plasma clearance is about 0.4 L/min.
Longer half-lives and decreased clearance value due to a reduced rate of metabolism have been demonstrated in elderly patients, and therefore these patients should be given a lower dose. Patients with reduced liver function have a slower elimination. Patients with reduced kidney function have a decreased elimination, especially by low creatinine clearance. The excretion proceeds with the urine. In steady-state about 30% of the administered dose is identified in the urine, 12% as unchanged substance.
Citalopram is a weak inhibitor of the cytochrome P450 IID6 metabolic pathway with a consequent reduction in potential for adverse events and interactions.

INDICATIONS:
Treatment of depression and prevention of relapse.
Treatment of panic disorder with or without agoraphobia.
Treatment of obsessive compulsive disorder (OCD).

CONTRA-INDICATIONS:
Hypersensitivity to CIPRAMIL.
Severely impaired renal function (creatinine clearance less than 20 mL/min).
Safety in pregnancy and lactation has not been established.

WARNINGS:
CIPRAMIL should not be given to patients receiving Monoamine Oxidase Inhibitors (MAOIs), or for 14 days after their discontinuation. MAOIs should not be introduced for seven days after discontinuation of CIPRAMIL.
CIPRAMIL should be discontinued if the patient enters a manic phase.
There is little clinical experience of concurrent use of CIPRAMIL and electroconvulsive treatment.
CIPRAMILdoes not impair intellectual function or psychomotor performance. Nevertheless, patients who are depressed and require treatment may have an impaired ability to drive or operate machinery. They should be warned of the possibility and advised to avoid such tasks if so affected.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
Treating Depression
  CIPRAMIL should be administered as a single oral dose of 20 mg daily. Dependent on individual patient response this may be increased to a maximum of 60 mg daily. The dose may be taken in the morning or evening, not necessarily with food.
Duration of treatment
The antidepressant effect usually sets in after 2 to 4 weeks. Treatment with antidepressants is symptomatic and must therefore be continued for an appropriate length of time, usually up to 6 months after recovery in order to prevent relapse.Treating Panic Disorder
A single dose of 10 mg is recommended for the first week before increasing the dose to 20 mg daily. The dose may be further increased, up to a maximum of 60 mg daily, dependent on individual patient response.Treating OCD
An initial dose of 20 mg is recommended. Although the dose effect has not been demonstrated this dose can be increased in increments of 20 mg to 60 mg daily, if necessary, based on clinical judgement.Duration of Treatment
The onset of action in treating OCD is 2-4 weeks with further improvement over time.Elderly:
The recommended daily dose is 20 mg. Dependent on individual patient response this may be increased to a maximum of 30 mg daily.Children up to the age of 18 years:
Not recommended, as safety and efficacy have not been established in this population.Reduced hepatic function:
Dosage should be halved.Reduced renal function:
Dosage adjustment is not necessary in cases of mild or moderate renal impairment.Duration of treatment:
  A treatment period of at least six months is usually necessary to minimise potential for relapse.
  When stopping therapy the drug should be gradually withdrawn during a couple of weeks.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most commonly observed adverse events associated with the use of CIPRAMIL and not seen at an equal incidence among placebo-treated patients were: sweating, somnolence, nausea, tremor, dry mouth and asthenia.
Adverse events usually decrease in intensity and frequency as the depressive state improves.
Clinical evidence shows that citalopram is not associated with tachycardia or postural hypotension. A decrease in pulse rate has been reported.
Common:
Generally:
  headache, sweating, asthenia/fatigue, tremor, weight loss/weight gain, dizziness
Circulation:
palpitationsCentral nervous system:
sleep disturbances, paraethesia, restlessnessGastro-intestinal:
nausea, constipation, diarrhoea, dyspepsia, dry mouthUrogenital:
micturition disorderEyes:
accommodation disturbancesLess common:
Generally:
malaise, yawningCentral nervous system:
agitation, confusion, impaired concentration, decreased libido, ejaculation disorder, mania.Gastro-intestinal:
salivationSkin: rash
Respiratory system:
nose congestionEyes:
mydriasisVery rare:
Convulsions, hepatitis, serotonin syndrome, neuroleptic malignant syndrome.
Interactions:
Simultaneous administration of MAOIs (see Warnings).
There was no interaction with lithium. Citalopram interacts with imipramine, moclobemide, selegiline and sumatriptan.
The weak inhibition of the sparteine metabolism will have only a minor effect on the elimination of agents which are dependent on the sparteine oxygenase.
No pharmacodynamic interactions have been found in clinical studies in which citalopram has been given concomitantly with benzodiazepines, neuroleptics, analgesics, lithium, antihistamines, antihypertensive agents, betablockers and other cardiovascular agents.
In animal studies cimetidine had little or no influence on citalopram kinetics.
Plasma protein binding of citalopram is 80%. The potential for interactions with agents which are highly protein bound is thought to be minimal.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may give rise to tiredness, weakness, sedation, dizziness, tremor, nausea and somnolence. Treatment is symptomatic and supportive. Gastric lavage should be carried out as soon as possible after oral ingestion. Medical surveillance for about 24 hours is advisable.

IDENTIFICATION:
Oval (8 x 5.5 mm), white, scored, film-coated and marked “C”and “N”symmetrically around the score.

PRESENTATION:
Blister packs containing 28 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER:
29/1.2/0232

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
H. Lundbeck (Pty) Ltd
372 Oak Avenue
Ferndale
RANDBURG

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17 November 2001

Updated on this site: February 2004
Current: December 2004
Source: Community Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004