The most frequently occurring effect is initial
drowsiness that generally subsides with continued usage of the drug or lowering
of the dose.
Noted less frequently were depression, hyperactivity and
Extrapyramidal symptoms noted below may occur in susceptible
individuals and are usually reversible with appropriate management.
Motor restlessness may occur early.
Akinesia, characterized by rigidity, immobility and
reduction of voluntary movements and tremor, have been observed. Occurrence is
less frequent than akathisia.
Class effect: Symptoms of dystonia, prolonged
abnormal contractions of muscle groups, may occur in susceptible individuals
during the first few days of treatment. Dystonic symptoms include: spasm of the
neck muscles, sometimes progressing to tightness of the throat, swallowing
difficulty, difficulty breathing, and/or protrusion of the tongue. While these
symptoms can occur at low doses, they occur more frequently and with greater
severity with high potency and at higher doses of first generation
antipsychotic drugs. An elevated risk of acute dystonia is observed in males
and younger age groups.
Antipsychotic drugs are known to cause a syndrome of
dyskinetic movements commonly referred to as tardive dyskinesia. The movements
may appear during treatment or upon withdrawal of treatment and may be either
reversible or irreversible (i.e., persistent) upon cessation of further
The syndrome is known to have a variable latency for
development and the duration of the latency cannot be determined reliably. It
is thus wise to assume that any antipsychotic agent has the capacity to induce
the syndrome and act accordingly until sufficient data has been collected to settle
the issue definitively for a specific drug product. In the case of
antipsychotics known to produce the irreversible syndrome, the following has
Tardive dyskinesia has appeared in some patients on
long-term therapy and has also appeared after drug therapy has been
discontinued. The risk appears to be greater in elderly patients on high-dose
therapy, especially females. The symptoms are persistent and in some patients
appear to be irreversible. The syndrome is characterized by rhythmical involuntary
movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue,
puffing of cheeks, puckering of mouth, chewing movements). There may be
involuntary movements of extremities.
There is no known effective treatment of tardive
dyskinesia; antiparkinsonism agents usually do not alleviate the symptoms of
this syndrome. It is suggested that all antipsychotic agents be discontinued if
these symptoms appear. Should it be necessary to reinstitute treatment, or
increase the dosage of the agent, or switch to a different antipsychotic agent,
the syndrome may be masked. It has been reported that fine vermicular movements
of the tongue may be an early sign of the syndrome and if the medication is
stopped at that time the syndrome may not develop (See WARNINGS).
Autonomic Nervous System
Occasionally blurring of vision, tachycardia, nausea, dry
mouth and salivation have been reported. Urinary retention and constipation may
occur particularly if anticholinergic drugs are used to treat extrapyramidal
symptoms. One patient being treated with MOBAN experienced priapism which
required surgical intervention, apparently resulting in residual impairment of
There have been rare reports of leucopenia and
leucocytosis. If such reactions occur, treatment with MOBAN may continue if
clinical symptoms are absent. Alterations of blood glucose, B.U.N., and red
blood cells have not been considered clinically significant.
Metabolic And Endocrine Effects
Alteration of thyroid function has not been significant.
Amenorrhea has been reported infrequently. Resumption of menses in previously
amenorrheic women has been reported. Initially heavy menses may occur.
Galactorrhea and gynecomastia have been reported infrequently. Increase in
libido has been noted in some patients. Impotence has not been reported.
Although both weight gain and weight loss have been in the direction of normal
or ideal weight, excessive weight gain has not occurred with MOBAN.
There have been rare reports of clinically significant
alterations in liver function in association with MOBAN use.
Rare, transient, non-specific T wave changes have been
reported on E.K.G. Association with a clinical syndrome has not been
established. Rarely has significant hypotension been reported.
Lens opacities and pigmentary retinopathy have not been
reported where patients have received MOBAN. In some patients, phenothiazine
induced lenticular opacities have resolved following discontinuation of the
phenothiazine while continuing therapy with MOBAN.
Early, non-specific skin rash, probably of allergic
origin, has occasionally been reported. Skin pigmentation has not been seen
with MOBAN usage alone.
MOBAN has certain pharmacological similarities to other
antipsychotic agents. Because adverse reactions are often extensions of the
pharmacological activity of a drug, all of the known pharmacological effects
associated with other antipsychotic drugs should be kept in mind when MOBAN is
used. Upon abrupt withdrawal after prolonged high dosage an abstinence syndrome
has not been noted.