Dear Johanna,
Following is the patient insert listing the
recommended dosage and possible adverse effects of
Artane. The insert strongly recommends the doctor
dispensing the drug carefully monitor the patient.
The dosage you state your father was taking would be
at the lower end of the recommended dosage. If the
doctor started him immediately on that amount, even
though he had taken the drug several weeks before, I
would think it might explain the severity of your
Dad's hallucinations. If there is a neurologist out
there willing to risk putting forward an opinion I
would sure be interested in hearing it. The
pharmaceutical company recommends a gradual
introduction of the drug. Of particular interest to
you could be the following found about 1/2 way through
the section on adverse effects:
"Isolated instances of suppurative parotitis secondary
to excessive dryness of the mouth, skin rashes,
dilatation of the colon, paralytic ileus and certain
psychiatric manifestations such as delusions and
hallucinations, plus one doubtful case of paranoia all
of which may occur with any of the atropine-like
medicines, have been less frequently reported with
ARTANE*."
My question is why they use the word "doubtful" case
of paranoia. If the manifestation was reported by a
patient in the trial of the drug, why do they assume
the patient would lie?
ARTANE* 2 Tablets
ARTANE* 5 Tablets
SCHEDULING STATUS:
S5
Zimbabwe PP
2 mg Appl. No: Z193
5 mg Appl. No: Z197
PROPRIETARY NAME
(and dosage form):
ARTANE* 2 Tablets
ARTANE* 5 Tablets
COMPOSITION:
Tablet containing 2 mg or 5 mg trihexyphenidyl
hydrochloride.
PHARMACOLOGICAL CLASSIFICATION:
Category A 5.4.1 Anti-Parkinsonism preparations
PHARMACOLOGICAL ACTION:
ARTANE* trihexyphenidyl HCl Lederle, is a synthetic
antispasmodic medicine and is the substituted
piperidine salt,
3-(1-piperidyl)-1-phenyl-cyclohexyl-1-propanol
hydrochloride, which exerts a direct inhibitory effect
upon the parasympathetic nervous system. It also has a
relaxing effect on smooth musculature; exerted both
directly upon the muscle tissue itself and indirectly
through an inhibitory effect upon the parasympathetic
nervous system. Its therapeutic properties are similar
to those of atropine, although undesirable side
effects are ordinarily less frequent and severe than
with the latter.
INDICATIONS:
This medicine is indicated as an adjunct in the
therapy of all forms of Parkinsonism
(postencephalitic, arteriosclerotic and idiopathic).
It is useful in the prevention or control of
extrapyramidal disorders due to central nervous system
medicines such as reserpine and phenothiazines. These
disorders are similar to those encountered in
Parkinson’s disease and include: tremor, rigidity and
increased salivation, akathisia manifested by extreme
restlessness, and dyskinesias characterised by spastic
contractions and involuntary movements.
It decreases sialorrhoea, but with less excessive
mouth-dryness, blurred vision or mydriasis than are
encountered with atropine.
CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients. Although
trihexyphenidyl HCl is not contraindicated for
patients with cardiac, liver or kidney disorders, or
with hypertension, such patients should be maintained
under close observation.
WARNINGS:
Patients to be treated with ARTANE* should have a
gonioscope evaluation and close monitoring of
intraocular pressures at regular periodic intervals.
DOSAGE AND DIRECTIONS FOR USE:
Dosage should be individualised. The initial dose
should be low and then increased gradually, especially
in patients over 60 years of age. Whether ARTANE*
trihexyphenidyl HCl may best be given before or after
meals should be determined by the way the patient
reacts. Postencephalitic patients, who are usually
more prone to excessive salivation, may prefer to take
it after meals and may, in addition, require small
amounts of atropine which, under such circumstances,
is sometimes an effective adjuvant. If ARTANE*
trihexyphenidyl HCl tends to dry the mount
excessively, it may be better to take it before meals,
unless it causes nausea. If taken after meals, the
thirst sometimes induced can be allayed by mint
candies, chewing gum or water.
As initial therapy for Parkinsonism, 1 mg of ARTANE*
may be administered the first day. The dose may then
be increased by 2 mg increments at intervals of three
to five days, until a total of 6 to 10 mg is given
daily. The total daily dose will depend upon what is
found to be the optimal level. Many patients derive
maximum benefit from this daily total of 6 to 10 mg
but some patients, chiefly those in the
postencephalitic group, may require a total daily dose
of 12 to 15 mg. The lower levels of daily intake of
ARTANE* are tolerated best if divided into 3 doses and
taken at mealtimes. High doses may be divided into 4
parts, with 3 doses administered at mealtimes and the
fourth at bedtime.
Concomitant Use of ARTANE* trihexyphenidyl HCl Tablets
with Levodopa:
When ARTANE* is used concomitantly with levodopa, the
usual dose of each may need to be reduced. Careful
adjustment is necessary, depending on side effects and
degree of symptom control. ARTANE* dosage of 1 to 2 mg
three times a day is usually adequate.
Concomitant Use of ARTANE* trihexyphenidyl HCl Tablets
with Other Parasympathetic Inhibitors:
ARTANE* trihexyphenidyl HCl tablets may be
substituted, in whole or in part, for other
parasympathetic inhibitors. The usual technique is
partial substitution initially, with progressive
reduction in the other medication as the dose of
trihexyphenidyl HCl is increased.
ARTANE* trihexyphenidyl HCl in Drug-Induced
Parkinsonism:
The size and frequency of the dose of ARTANE* needed
to control extrapyramidal reactions to commonly
employed tranquillisers, notably the phenothiazines,
thioxanthenes and butyrophenones must be determined
empirically. The total daily dosage usually ranges
between 5 and 15 mg although, in some cases, these
reactions have been satisfactorily controlled on as
little as 1 mg daily. It may be advisable to commence
therapy with a single 1 mg dose. If the extrapyramidal
manifestations are not controlled in a few hours, the
subsequent doses may be progressively increased until
satisfactory control is achieved. Satisfactory control
may sometimes be more rapidly achieved by temporarily
reducing the dosage of the tranquilliser on
instituting ARTANE* therapy and then adjusting dosage
of both medicines until the desired ataractic effect
is retained without onset of extrapyramidal reactions.
It is sometimes possible to maintain the patient on a
reduced ARTANE* dosage after the reactions have
remained under control for several days. Instances
have been reported in which these reactions have
remained in remission for long periods after therapy
was discontinued.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side Effects:
Minor side effects such as dryness of the mouth,
blurring of vision, dizziness, mild nausea or
nervousness will be experienced by 30 to 50 per cent
of all patients. These sensations, however, are much
less troublesome with ARTANE* trihexyphenidyl HCl than
with belladonna alkaloids and are usually less
disturbing than unalleviated Parkinsonism. Such
reactions tend to become less pronounced and even to
disappear as treatment continues. Even before these
reactions have remitted spontaneously, they may often
be controlled by careful adjustment of dosage form,
amount of medicine, or interval between doses.
Isolated instances of suppurative parotitis secondary
to excessive dryness of the mouth, skin rashes,
dilatation of the colon, paralytic ileus and certain
psychiatric manifestations such as delusions and
hallucinations, plus one doubtful case of paranoia all
of which may occur with any of the atropine-like
medicines, have been less frequently reported with
ARTANE*.
Patients with arteriosclerosis or with a history of
idiosyncrasy to other medicines may exhibit reactions
of mental confusion, agitation, disturbed behaviour or
nausea and vomiting. Such patients should be allowed
to develop a tolerance through the initial
administration of a small dose and gradual increase in
dose until an effective level is reached. If a severe
reaction should occur, administration of the medicine
should be discontinued for a few days and then resumed
at a lower dosage. Psychiatric disturbances can result
from indiscriminate use (leading to overdosage) to
sustain continued euphoria.
Potential side effects associated with the use of any
atropine-like medicines include constipation,
drowsiness, urinary hesitancy or retention,
tachycardia, dilation of the pupil, increased
intraocular tension, weakness, vomiting and headache.
The occurrence of angle-closure glaucoma due to
long-term treatment with trihexyphenidyl hydrochloride
has been reported.
Precautions:
Since the use of trihexyphenidyl HCl must, of
necessity continue indefinitely and since it has
atropine-like properties, patients should be subjected
to constant and careful long-term observation to avoid
allergic and other untoward reactions. Inasmuch as
trihexyphenidyl HCl possesses some parasympatholytic
activity, it should be used with caution in patients
with glaucoma, obstructive disease of the
gastrointestinal or genitourinary tracts, and in
elderly males with possible prostatic hypertrophy.
Geriatric patients, particualarly over the age of 60,
frequently develop increased sensitivity to the
actions of medicines of this type, and hence, require
strict dosage regulation. Incipient glaucoma may be
precipitated by parasympatholytic medicines such as
trihexyphenidyl HCl.
It is advisable to have periodic gonioscopic
evaluations in all patients who are to be treated with
trihexyphenidyl hydrochloride or any related medicine.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS
TREATMENT:
Symptoms which may occur may be any of those described
under ‘SIDE EFFECTS AND SPECIAL PRECAUTIONS’. Any such
symptoms should be treated symptomatically and
supportively.
IDENTIFICATION:
2 mg Tablets: White, flat, round tablets, 8 mm in
diameter, scored on one side with “Lederle”above and
“4434”below the score; unmarked on the other side.
5 mg Tablets: White, flat, round tablets, 9.5 mm in
diameter, scored on one side.
PRESENTATION:
2 mg tablets: Containers of 100 tablets.
Product code 4434
5 mg tablets: Containers of 100 tablets.
Product code 4436.
STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.
REFERENCE NUMBERS:
2 mg C786 (Act 101/1965)
5 mg C787 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Wyeth South Africa (Pty) Ltd
Thornhill Office Park
94 Bekker Road
Vorna Valley, Ext 60
Midrand, 1683
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1997
Best Regards,
Vicky Lynn
__________________________________________________
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