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 Indications, Dosage, Storage, Stability - Mesoridazine Besylate
Serentil Indications, Dosage, Storage, Stability - Mesoridazine Besylate
INDICATIONS
In clinical studies Serentil® (mesoridazine besylate) has
been found useful in the following disease states:
Schizophrenia: Serentil® (mesoridazine besylate) is
effective in the treatment of schizophrenia. It substantially reduces
the severity of emotional withdrawal, conceptual disorganization, anxiety,
tension, hallucinatory behavior, suspiciousness and blunted affect in
schizophrenic patients. As with other phenothiazines, patients refractory
to previous medication may respond to Serentil (mesoridazine besylate).
Behavioral Problems in Mental Deficiency and Chronic Brain Syndrome:
The effect of Serentil® (mesoridazine besylate) was found
to be excellent or good in the management of hyperactivity and uncooperativeness
associated with mental deficiency and chronic brain syndrome.
Alcoholism - Acute and Chronic: Serentil® (mesoridazine
besylate) ameliorates anxiety, tension, depression, nausea and vomiting
in both acute and chronic alcoholics without producing hepatic dysfunction
or hindering the functional recovery of the impaired liver.
Psychoneurotic Manifestations: Serentil® (mesoridazine
besylate) reduces the symptoms of anxiety and tension, prevalent symptoms
often associated with neurotic components of many disorders, and benefits
personality disorders in general.
DOSAGE AND ADMINISTRATION
The dosage of Serentil® (mesoridazine besylate) as in most
medications, should be adjusted to the needs of the individual. The lowest
effective dosage should always be used. When maximum response is achieved,
dosage may be reduced gradually to a maintenance level.
Schizophrenia: For most patients, regardless of severity, a starting
dose of 50 mg t.i.d. is recommended. The usual optimum total daily dose
range is 100-400 mg per day.
Behavioral Problems in Mental Deficiency and Chronic Brain Syndrome:
For most patients a starting dose of 25mg t.i.d. is recommended. The usual
optimum total daily dose range is 75-300 mg per day.
Alcoholism: For most patients the usual starting dose is 25 mg
b.i.d. The usual optimum total daily dose range is 50-200 mg per day.
Psychoneurotic Manifestations: For most patients the usual starting
dose is 10 mg t.i.d. The usual optimum total daily dose range is 30-150
mg per day.
Injectable Form
In those situations in which an intramuscular form of medication is indicated,
Serentil® (mesoridazine besylate) injectable is available.
For most patients a starting dose of 25 mg is recommended. The dose may
be repeated in 30 to 60 minutes, if necessary. The usual optimum total
daily dose range is 25-200 mg per day.
HOW SUPPLIED
Tablets
10 mg (NDC 0597-0020-01),
25 mg (NDC 0597-0021-01),
50 mg (NDC 0597-0022-01), and
100 mg (NDC 0597-0023-01) mesoridazine (as the besylate). Bottles
of 100.
Ampuls
1 mL [25 mg mesoridazine (as the besylate)]. Boxes of 20 (NDC 0597-0027-02).
Concentrate
Contains 25 mg mesoridazine (as the besylate) per mL, alcohol, USP, 0.61%
by volume. Immediate containers: Amber glass bottles of 4 fl o (118 mL)
packaged in cartons of 12 bottles, with an accompanying dropper graduated
to deliver 10 mg, 25 mg, and 50 mg of mesoridazine (as the besylate) (NDC
0597-0025-04).
Storage
Tablets: Below 86°F(30°C).
Injection: Below 86°F(30°C); protect from light.
Oral solution: Below 77°F(25°C); protect from light; dispense
in amber glass bottles only.
The concentrate may be diluted with distilled water, acidified tap water,
orange juice or grape juice.
Each dose should be diluted just prior to administration. Preparation
and storage of bulk dilutions is not recommended.
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