Hydergine
Liquid & Hydergine Tablets
Hydergine
Liquid
Ingredients:
Dihydroergotoxine mesylate. 1 ml of
drops in liquid (to be taken by mouth) = 1 mg dihydroergotoxine mesylate, 50 mg
ethanol (96%), metansulphonic acid, glycerine, demineralised water.
Properties:
Experimental studies carried out on animals have shown that dihydroergotoxine
mesylate modifies cerebral neurotransmission, stimulates dopaminergic and serotoninergic
receptors and blocks alpha-adrenoreceptors. It also improves diminished metabolic
cerebral function; this effect can be seen in modifications of the brain's electrical
activity and particularly in the energy spectrum of the electroencephalogram.
This effect has also been confirmed in the course of studies on man. It has furthermore
been proven that dihydroergotoxine mesylate reduces the time of cerebral circulation. 
Indications:
Controlled clinical
assays have revealed that dihydroergotoxine improves symptoms of mental deterioration
related to ageing, such as instability, dizziness, headaches, difficulty in concentrating,
disorientation, memory loss, lack of initiative, depression, lack of sociability,
difficulties in carrying out everyday activities and in personal care.
The
role played by this medicine in the treatment of cerebrovascular insufficiency
has not been clearly established; it is merely symptomatic.
Dosage:
Administration of this medicine must be determined by a doctor according to the
needs and response of each patient.
As a general rule, we recommend the administration
of 4.5 mg/day in a single dose or in separate doses to be taken before meals (30
drops, 3 times daily). In certain cases, a 9-mg/day dosage may be needed.
Contraindications:
Hypersensitivity to the product.
Patients with
acute or chronic psychoses of any etiology.
Precautions:
Before
beginning treatment, a complete diagnosis should be carried out to exclude pathologies
for which this type of substance does not provide effective results (delirium,
dementia).
This medicine should be used with caution with severe bradycardia.
Since it contains ethanol as an excipient, it may be prove to be a risk if administered
to patients with hepatic illnesses, alcoholism, epilepsy, or to pregnant women
and children.
Expectant and nursing mothers:
Because of the lack
of data available concerning the effect that this pharmaceutical product may have
on humans, avoid using it except when absolutely necessary.
Adverse effects:
Although rare, these include nasal congestion, nausea and gastric problems, which
may be prevented by taking the pharmaceutical product with food.
Such adverse
effects tend to disappear with no need to take specific measures.
It may cause
skin irritation of an allergic nature, headaches, reddening or blurred vision.
Incompatibilities:
It may enhance the action of medicines for the treatment
of hypertension or those that lower cardiac rhythm (digitalis therapy, beta blockers).
Intoxication and its treatment:
Accidental overdose may cause migraines,
facial reddening and nasal congestion and, in more serious cases, nausea and vomiting,
muscular weakness and significant hypotension. In extreme cases, it can cause
coma.
Symptomatic medication is to be aimed above all at maintaining haemodynamic
constants. Should the patient suffer from hypotension, do not administer adrenalin,
but rather noradrenaline or angiotensin.
In the event of overdose or accidental
swallowing, consult the Toxicology Information Service.
Available in:
40-ml container of drop solution
Keep this and all other medicines
safely out of the reach of children.
Hydergine
Tablets: Chemical:
Co-dergocrine Mesylate
(Ergoloid Mesylate)
Excipients:
Lactose, corn starch, polyvinyl
pyrrolidone, magnesium stearate, talc.
Adverse Effects:
Side-effects occasionally
reported with co-dergocrine mesylate include nausea, vomiting, headache, blurred
vision, skin rashes, nasal stuffiness, flushing of the skin, dizziness, bradycardia,
and orthostatic hypertension. Local irritation has been reported following sublingual
administration.
Effects on the Cardiovascular System:
Of 8 patients
given co-dergocrine mesylate 1.5 mg three times daily for the treatment of dementia,
3 developed severe sinus bradycardia associated with general deterioration in
their condition, necessitating withdrawal of the treatment. (1) However, Cohen
(2) reported that no sinus bradycardia had been observed in 40 elderly patients
in whom the dose was built up to 1.5 mg three times daily over 3 weeks. 1. Cayley
ACD, et al. Sinus bradycardia following treatment with Hydergine for cerebrovascular
insufficiency. Br Med J 1975- 4: 384-5. 2. Cohen C. Sinus bradycardia following
treatment with Hydergine. Br Med J 1975- 4: 581. Uses
and Administration:
Unlike the natural ergot alkaloids, co-dergocrine
mesylate has only limited vasoconstrictor effects. It is used with the intention
of treating symptoms of mild to moderate impairment of mental function in the
elderly in doses of 3 or 4.5 mg daily by mouth, preferably before meals. Higher
doses have also been used. It is also given sublingually in doses of 3 mg daily.
Doses of 300 mcg have been given intramuscularly, subcutaneously, or by intravenous
infusion. In some countries, co-dergocrine mesylate has been used in the treatment
of hypertension and in peripheral vascular disease. Co-dergocrine mesylate has
been used similarly to the mesylate. References to some uses of co-dergocrine
mesylate.
1. Bellani M, et al. Treatment of hypertension in the elderly: a
controlled clinical trial of dihydroergotoxine mesylate in comparison with nifedipine.
Curr Ther Res 1983- 34: 1014-22.
2. Hajioff J, Wallace M. Effect of co-dergocrine
mesylate on tardive dyskinesia: a preliminary report. Psychopharmacology (Berlin)
1983- 79: 1-3.
3. Uehlinger DE, et al. Cardiovascular regulation and lipoprotein
profile during administration of co-dergocrine in essential hypertension. Eur
J Clin Pharmacol 1989- 36: 119-25. Senile
Dementia:
There is still much uncertainty about the use of co-dergocrine
mesylate in the treatment of senile dementia. It was originally thought to act
as a peripheral and cerebral vasodilator and vasodilatation was considered an
effective treatment for senile dementia due to cerebral ischaemia. However, cerebral
ischaemia is no longer believed to be central to the problem. Co-dergocrine mesylate
is now classified as a metabolic enhancer. Optimal dosage has not been established-
standard oral doses are 3 mg daily in the US and 4.5 mg daily in Europe and Japan,
but in some countries as much as 12 mg daily is used without reports of serious
side-effects. Some workers have found little difference between doses of 3 and
6 mg daily in patients with senile dementia, whereas others have concluded that
6mg daily was superior in a study of patients with multi-infarct dementia’s
or mental disturbances after stroke. The overall trend seems to be to use larger
doses, orally rather than sublingually, for longer periods. A review in 1979 focused
on 22 controlled studies of co-dergocrine mesylate in senile dementia, but although
each study showed significant improvement on some behavioral or psychological
measure, conclusions as to the therapeutic usefulness of co-dergocrine mesylate
were guarded. Improvements ranging
from 11 to 21% were calculated for mood depression, confusion, mental alertness,
orientation, recent memory, emotional lability, and self-care from 4 studies submitted
to the FDA, but specific clinical effects reported have varied widely. Patients
selected for evaluation of co-dergocrine mesylate should be limited to those with
senile dementia of the Alzheimer or multi-infarct type and the 2 groups should
be considered separately. Patients with advanced disease are unlikely to benefit.
Although many clinicians continue to regard co-dergocrine mesylate as a placebo
it is one of the few potentially effective treatments available for senile dementia
of the Alzheimer type. It is suggested that doses of at least 6 mg daily should
be given for 6 months and treatment continued, possibly at a lower dose, if improvement
or stabilization of decline is seen- if treatment has not been successful it should
be abandoned. Hollister LE, Yesavage J. Ergoloid mesylates for senile dementias:
unanswered questions. Ann Intern Med 1984- 100: 894-8. Further references to co-dergocrine
mesylate in senile dementia. 1. Huber F, et al. Effects of long-term ergoloid
mesylates (`Hydergine') administration in healthy pensioners: 5-year results.
Curr Med Res Opin 1986- 10: 256-79. 2. Orgogozo JM, Spiegel R. Critical review
of clinical trials in senile dementia- I. Postgrad Med J 1987- 63: 237-40. Hydergine
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