Cipramil is a common
selective serotonin reuptake inhibitor (
SSRI) drug. An
antidepressant and also used in the treatment of
anxiety-based psychological conditions (such as
obessive-compulsive disorder and
social phobia).
(Personal note: I was prescribed Cipramil by a psychiatrist once, for 6 months, but to tell you the truth I did not feel like it did anything for me).
I thought that it was a rather innocuous drug, however, a few people have reported strange and alarming side effects:
A woman from Norway reported: "...I experienced the most terrible kind of "electric surges" throughout my body. It was as if my head was going to blow away. I also got huge bruises on my arms. After I stopped taking the pills I thought that my body would return to its normal state. BUT IT DID NOT. The "electric surges" continued during the days, weeks and months to come. I have lost all contact with my body. I can no longer feel hunger."
Anyway, here is the official lowdown on the drug from the bottle insert:
CIPRAMIL 20 mg
Tablets
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 panic disorder with or without agoraphobia.
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.
Cipramil does 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.
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.
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 elapse
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: palpitations
Central nervous system: sleep disturbances, paraethesia, restlessness
Gastro-intestinal: nausea, constipation, diarrhoea, dyspepsia, dry mouth
Urogenital: micturition disorder
Eyes: accommodation disturbances
Less common:
Generally: malaise, yawning
Central nervous system: agitation, confusion, impaired concentration, decreased libido, ejaculation disorder, mania.
Gastro-intestinal: salivation
Skin: rash
Respiratory system: nose congestion
Eyes: mydriasis
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:
Cipramil 20 mg Tablets:
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:
Cipramil 20 mg Tablets: 29/1.2/0232