A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Serentil Side Effects, and Drug Interactions - Mesoridazine Besylate
Serentil Side Effects, and Drug Interactions - Mesoridazine Besylate
SIDE EFFECTS
Drowsiness and hypotension were the most prevalent side effects encountered.
Side effects tended to reach their maximum level of severity early with
the exception of a few (rigidity and motoric effects) which occurred later
in therapy.
With the exceptions of tremor and rigidity, adverse reactions were generally
found among those patients who received relatively high doses early in
treatment. Clinical data showed no tendency for the investigators to terminate
treatment because of side effects.
Serentil® (mesoridazine besylate) has demonstrated a remarkably
low incidence of adverse reactions when compared with other phenothiazine
compounds.
Central Nervous System: Drowsiness, Parkinson’s syndrome,
dizziness, weakness, tremor, restlessness, ataxia, dystonia, rigidity,
slurring, akathisia, motoric reactions (opisthotonos) have been reported.
Autonomic Nervous System: Dry mouth, nausea and vomiting,
fainting, stuffy nose, photophobia, constipation and blurred vision have
occurred in some instances.
Genitourinary System: Inhibition of ejaculation, impotence,
enuresis, incontinence, and pariapism have been reported.
Skin: Itching, rash, hypertrophic papillae of the tongue
and angioneurotic edema have been reported.
Cardiovascular System: Hypotension and tachycardia have
been reported. EKG changes have occurred in some instances (see Phenothiazine
Derivatives: Cardiovascular Effects, below).
Phenothiazine Derivatives
It should be noted that efficacy, indications and untoward effects have
varied with the different phenothiazines. The physician should be aware
that the following have occurred with one or more phenothiazines and should
be considered whenever one of these drugs is used.
Autonomic Reactions: Miosis, obstipation, anorexia, paralytic
ileus.
Cutaneous Reactions: Erythema, exfoliative dermatitis,
contact dermatitis.
Blood Dyscrasias: Agranalocytosis, leukopenia, eosinophilia,
thrombocytopenia, anemia, aplastic anemia, pancytopenia.
Allergic Reactions: Fever, laryngeal edema, angioneurotic
edema, asthma.
Hepatotoxicity: Jaundice, biliary stasis.
Cardiovascular Effects: Changes in the terminal portion
of the electrocardiogram, including prolongation of the Q-T interval,
lowering and inversion of the T wave and appearance of a wave tentatively
identified as a bifid T or a U wave have been observed in some patients
receiving the phenothiazine tranquilizers, including Serentil®
(mesoridazine besylate). To date, these appear to be due to altered repolarization
and not related to myocardial damage. They appear to be reversible. While
there is no evidence at present that these changes are in any way precursors
of any significant disturbance of cardiac rhythm, it should be noted that
sudden and unexpected deaths apparently due to cardiac arrest have occurred
in patients previously showing characteristic electrocardiographic changes
while taking the drug. The use of periodic electrocardiograms has been
proposed but would appear to be of questionable value as a predictive
device. Hypotension, rarely resulting in cardiac arrest, has been noted.
Extrapyramidal Symptoms: Akathisia, agitation, motor restlessness,
dystonic reactions, trisman, torticollis, opisthotonos, oculogyric crises,
tremor, muscular rigidity, akinesia.
Tardive Dyskinesla: Chronic use of neuroleptics may be
associated with the development of tardive dyskinesia. The salient features
of this syndrome are described in the WARNINGS
section and below.
The syndrome is characterized by involuntary choreoathetoid movements
which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusion
of the tongue, puffing of cheeks, puckering of the mouth, chewing movements),
trunk and extremities. The severity of the syndrome and the degree of
impairment produced vary widely.
The syndrome may become clinically recognizable either during treatment,
upon dosage reduction, or upon withdrawal of treatment. Movements may
decrease in intensity and may disappear altogether if further treatment
with neuroleptics is withheld. It is generally believed that reversibility
is more likely after short rather than long-term neuroleptic exposure.
Consequently, early detection of tardive clyskinesia is important. To
increase the likelihood of detecting the syndrome at the earliest possible
time, the dosage of neuroleptic drug should be reduced periodically (if
clinically possible) and the patient observed for signs of the disorder.
This maneuver is critical, for neuroleptic drugs may mask the signs of
the syndrome.
Endocrine Disturbances: Menstrual irregularities, altered
libido, gynecomastia, lactation, weight gain, edema. False positive pregnancy
tests have been reported.
Urinary Disturbances: Retention, incontinence.
Others: Hyperpyreuia: Behavioral effects suggestive of
a paradoxical reaction have been reported. These include excitement, bizarre
dreams, aggravation of psychoses and toxic confusional states. More recently,
a peculiar skin-eye syndrome has been recognized as a side effect following
long-term treatment with phenothiazines. This reaction is marked by progressive
pigmentation of areas of the skin or conjunctiva and/or accompanied by
discoloration of the exposed sclera and cornea. Opacities of the anterior
lens and cornea described as irregular or stellate in shape have also
been reported. Systemic lupus erythematosus-like syndrome.
DRUG INTERACTIONS
No information provided.
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