Re: lofepramine.

Posted by SLS on December 11, 2000, at 9:13:34

In reply to lofepramine., posted by jeanette.hursey on December 11, 2000, at 5:03:07

Dear Jeanette,
Generic name: lofepramine
Trade name: Emdalen, Gamanil
Lofepramine is a tricyclic antidepressant. It is like imipramine
(Tofranil) or amitriptyline (Elavil), but with less side effects.
Lofepramine has been around for a long time and it works in many
people. I don't know much more about it. I included the drug
company information below.

-------------------------------------------------

EMDALEN® TABLETS
SCHEDULING STATUS:
Schedule 5
PROPRIETARY NAME
(and dosage form):
EMDALEN® TABLETS
COMPOSITION:
Each Emdalen tablet contains 76,1 mg lofepramine hydrochloride
equivalent to 70 mg lofepramine.
PHARMACOLOGICAL CLASSIFICATION:
Antidepressant - tricyclic
PHARMACOLOGICAL ACTION:
Inhibit the uptake of tyramine and noradrenaline into peripheral
adrenergic nerves.
Emdalen is a tricyclic antidepressant used in the treatment of
ambulant depressive patients –it improves the mood, reduces
anxiety. As a result of its high lipophilicty, Emdalen is rapidly
absorbed. Maximum serum concentrations are reached one hour after
oral administration. Excretion of Emdalen is rapid and occurs via
the urine and faeces. As with other tricyclic antidepressants the
mechanism of action in man of Emdalen is not fully understood.
However, clinical trials utilising the fact that tricyclic
antidepressants inhibit the uptake of tyramine and noradrenaline
into peripheral adrenergic nerves have shown Emdalen to have the
same qualitative effect as other clinically effective
antidepressants. Emdalen is not a monoamine oxidase inhibitor.
INDICATIONS:
Emdalen is used in the treatment of depressive illnesses.
CONTRA-INDICATIONS:
1. Emdalen is contra-indicated in the acute phase of myocardial
infarction.
2. Emdalen is contra-indicated in patients who have shown prior
hypersensitivity to lofepramine.
3. Emdalen should be prescribed with caution during pregnancy and
is not advised during the first trimester unless there are
compelling reasons for its use.
4. Emdalen is contra-indicated in acute alcoholic, hypnotic,
analgesic and psychotropic drug poisoning and acute deliria.
WARNINGS:
This medicine should at all times be kept out of reach of
children, as even small doses may be fatal to them.
DOSAGE AND DIRECTIONS FOR USE :
Dosage of Emdalen depends on the individual requirements according
to the severity of the depression and individual sensitivity of
the patient.
Mild to moderate depression: An initial dose of 70 to 140 mg in
divided doses is recommended for the first three days. If
necessary, this dose can be increased in the course of the first
week to 140 to 210 mg per day in divided doses. Moderately severe
to severe depression: A dosage of 140 to 210 mg per day is
recommended and should it be necessary in individual cases, a
dosage of 210 mg per day may be exceeded. After onset of the
desired effect it is advisable to reduce the dose to a maintenance
dose. Maintenance dose: 70 mg two times daily. Emdalen tablets are
best taken with liquid during or after meals.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Peripheral anticholinergic side-effects, notably dry mouth,
constipation, urinary retention and papillary dilatation with
blurred vision and changes in visual accommodation. When
anticholinergic effects are severe the medicine should be
discontinued or reduced. Drowsiness or excessive sedation in
certain patients. On the other hand disorientation and agitation,
insomnia and restlessness can also occur with normal doses. The
risk of central nervous system depression is greater when
administered together with other central nervous system
depressants e.g. alcohol, barbiturates.
NOTE: Elderly patients are more prone to all these effects, and
therapy should be initiated at lower than standard doses in the
elderly.
SPECIAL PRECAUTIONS:**
a. At the time of initiation of therapy patients should be advised
not to drive a motor vehicle, climb dangerous heights or operate
dangerous machinery for at least several days. In these situations
impaired decision making could lead to accidents.
b. Caution should be observed with patients suffering from a
depressive phase of manic depressive psychosis, as occasionally
hypomania or mania can be precipitated in such patients. Withdraw
the drug if the depression turns into a manic phase.
c. In elderly male patients suffering from prostatism, urinary
retention may be precipitated. Use with caution in patients with
severe liver and kidney disorders.
d. In patients suffering from cardiac disease special caution
should be observed because of the occasional problems of
tachycardia, dysrythmias, orthostatic hypotension and other
unwanted effects on blood pressure, aggravation of condition
disturbances, and electrocardiographic abnormalities. Regular
cardiological and electrocardiographic examination is advised.
e. Epilepsy may be aggravated.
f. The medicine should not usually be given to patients receiving
other central nervous system depressants e.g. barbiturates, and to
patients receiving monoamine oxidase inhibitors only after a
suitable interval (the drugs may be given together if the dosages
are carefully controlled, preferably in hospital). The pressor
effects of the direct acting sympathomimetic agents, adrenaline
and noradrenaline are enhanced, and the use of local anaesthetics
containing these vasoconstrictors should be avoided as
hypertensive reactions may occur. The simultaneous administration
of anticholinergic agents may be dangerous. The hypotensive effect
of certain antihypertensive agents may be reduced.
g. Narrow angle glaucoma may be aggravated.
h. Withdraw the drug if allergic skin reactions appear.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage and poisoning may be characterised by central nervous
system depression or excitation, severe anticholinergic effects
and cardiotoxicity. The following symptoms and signs are
characteristic of acute overdosage: Drowsiness, restlessness,
ataxia, stupor, coma, pyrexia, palpitations, tachycardia, cardiac
arrhythmias, hypotension and in severe cases, respiratory
depression.
Epileptiform seizures may occur. Mixed poisoning with other
central nervous system depressants is not uncommon. Treatment: The
stomach should be emptied by aspiration and lavage. Treatment is
symptomatic.
CONDITIONS OF REGISTRATION:
Advertising to the professions only.
IDENTIFICATION:
Violet-brown, round slightly convex lacquered tablet, scored on
one side, approximately 10 mm in diameter and 4,5 mm thick.
PRESENTATION:
Emdalen is available as 70 mg tablets in bottles of 30 and 100
tablets.
STORAGE INSTRUCTIONS:
Store below 25°C.
Keep all medicines out of reach of children.
REGISTRATION NUMBER:
N/1.2/205.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Merck (Pty) Ltd
Reg. No 70/04059/07
11 Fedlife Park, Tonetti Street, Midrand 1685
Tel: (011) 315-1100
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
5 July, 1984.
® = Registered Trade Mark F14006
90E0697

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lofepramine. jeanette.hursey 12/11/00
Re: lofepramine. SLS 12/11/00
Re: lofepramine. Sigolene 12/13/00

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