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MELLARIL

 * Generic Name: thioridazine hcl
 * Brand Name: Mellaril
 * Drug Class: Antipsychotics, Phenothiazine

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 7/19/2022

home drugs a-z list mellaril (thioridazine hcl) drug

   
   
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DRUG SUMMARY

WHAT IS MELLARIL?

Mellaril (thioridazine HCl) is an anti-psychotic medication in the phenothiazine
class used to treat psychotic disorders such as schizophrenia, and is usually
given after other medications have been tried without successful treatment of
schizophrenia.

WHAT ARE SIDE EFFECTS OF MELLARIL?

Common side effects of Mellaril include:

 * dizziness,
 * drowsiness,
 * difficulty urinating,
 * restlessness,
 * headache,
 * blurred vision,
 * dry mouth,
 * stuffy nose,
 * vomiting,
 * constipation,
 * diarrhea,
 * breast swelling or discharge,
 * changes in your menstrual periods,
 * weight gain,
 * swelling in your hands or feet,
 * impotence,
 * trouble having an orgasm,
 * increased or decreased interest in sex, or
 * itching or skin rash

Seek medical care or call 911 at once if you have the following serious side
effects:

 * Serious eye symptoms such as sudden vision loss, blurred vision, tunnel
   vision, eye pain or swelling, or seeing halos around lights;
 * Serious heart symptoms such as fast, irregular, or pounding heartbeats;
   fluttering in your chest; shortness of breath; and sudden dizziness,
   lightheartedness, or passing out;
 * Severe headache, confusion, slurred speech, arm or leg weakness, trouble
   walking, loss of coordination, feeling unsteady, very stiff muscles, high
   fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur.
Check with your physician for additional information about side effects.

DOSAGE FOR MELLARIL

The usual starting dose of Mellaril for adult schizophrenic patients is 50-100
mg three times a day. Total daily dosage ranges from 200-800 mg, divided into
two to four doses. Pediatric dose is determined by the child's weight.

WHAT DRUGS, SUBSTANCES, OR SUPPLEMENTS INTERACT WITH MELLARIL?

Mellaril may interact with cold or allergy medicine, sedatives, narcotic pain
medicine, sleeping pills, muscle relaxers, medicine for seizures, depression or
anxiety, other anti-psychotic medications, atropine, lithium, antibiotics, birth
control pills or hormone replacement estrogens, blood thinners, asthma
medications or bronchodilators, incontinence medications, insulin or oral
diabetes medications, medication for nausea, vomiting, or motion sickness,
medications used for general anesthesia, medicines used to prevent organ
transplant rejection, numbing medicines, stimulants, ADHD medications, ulcer or
irritable bowel medications, medicines to treat Parkinson's disease, restless
leg syndrome, or pituitary gland tumor. Many other medicines can cause serious
medical problems if taken with Mellaril. Tell your doctor all prescription and
over-the-counter medications and supplements you use.

MELLARIL DURING PREGNANCY OR BREASTFEEDING

During pregnancy, Mellaril should be used only when prescribed. Do not stop
taking this medication unless directed by your doctor. Babies born to mothers
who have used this drug during the last 3 months of pregnancy may infrequently
develop symptoms including muscle stiffness or shakiness, drowsiness,
feeding/breathing difficulties, or constant crying. If you notice symptoms in
your newborn during their first month, tell the doctor. It is unknown if this
drug passes into breast milk. Consult your doctor before breastfeeding.

ADDITIONAL INFORMATION

Our Mellaril (thioridazine HCl) Side Effects Drug Center provides a
comprehensive view of available drug information on the potential side effects
when taking this medication.


FDA DRUG INFORMATION

 * Drug Description
 * Indications
 * Dosage
 * Side Effects
 * Drug Interactions
 * Warnings
 * Precautions
 * Overdose
 * Contraindications
 * Clinical Pharmacology
 * Medication Guide

WARNING

MELLARIL® (THIORIDAZINE HCl) HAS BEEN SHOWN TO PROLONG THE QTc INTERVAL IN A
DOSE RELATED MANNER, AND DRUGS WITH THIS POTENTIAL, INCLUDING MELLARIL
(thioridazine hcl) , HAVE BEEN ASSOCIATED WITH TORSADE DE POINTES-TYPE
ARRHYTHMIAS AND SUDDEN DEATH. DUE TO ITS POTENTIAL FOR SIGNIFICANT, POSSIBLY
LIFE-THREATENING, PROARRHYTHMIC EFFECTS, MELLARIL (thioridazine hcl) SHOULD BE
RESERVED FOR USE IN THE TREATMENT OF SCHIZOPHRENIC PATIENTS WHO FAIL TO SHOW AN
ACCEPTABLE RESPONSE TO ADEQUATE COURSES OF TREATMENT WITH OTHER ANTIPSYCHOTIC
DRUGS, EITHER BECAUSE OF INSUFFICIENT EFFECTIVENESS OR THE INABILITY TO ACHIEVE
AN EFFECTIVE DOSE DUE TO INTOLERABLE ADVERSE EFFECTS FROM THOSE DRUGS. (SEE
WARNINGS, CONTRAINDICATIONS, AND INDICATIONS).


DESCRIPTION FOR MELLARIL

Mellaril® (thioridazine HCl) is 2-methylmercapto-10-[2-(N-methyl-2-piperidyl)
ethyl] phenothiazine.







10 mg, 15 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg Tablets

Active Ingredient: thioridazine HCl, USP

10 MG TABLETS

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C
Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin, lactose, methylparaben,
povidone, propylparaben, sodium benzoate, starch, stearic acid, sucrose,
synthetic black iron oxide, talc, titanium dioxide, and other ingredients.

15 MG TABLETS

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C Red
#7, gelatin, lactose, methylparaben, povidone, propylparaben, starch, stearic
acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other
ingredients.

25 MG TABLETS

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, gelatin,
lactose, methylparaben, povidone, propylparaben, sodium benzoate, starch,
stearic acid, sucrose, synthetic black iron oxide, synthetic iron oxide, talc,
titanium dioxide, and other ingredients.

50 MG TABLETS

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, gelatin,
lactose, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron
oxide, talc, titanium dioxide, and other ingredients.

100 MG TABLETS

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C
Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Yellow #6, lactose, methylparaben,
povidone, propylparaben, sodium benzoate, sorbitol, starch, stearic acid,
sucrose, synthetic black iron oxide, talc, titanium dioxide, and other
ingredients.

150 MG TABLETS

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C
Yellow #10, FD&C Green #3, FD&C Yellow #6, lactose, methylparaben, povidone,
propylparaben, sodium benzoate, starch, stearic acid, sucrose, synthetic black
iron oxide, talc, titanium dioxide, and other ingredients.

200 MG TABLETS

Inactive Ingredients: acacia, ammonium calcium alginate, calcium sulfate
dihydrate, carnauba wax, colloidal silicon dioxide, D&C Red #7, lactose,
magnesium stearate, methylparaben, povidone, propylparaben, sodium benzoate,
starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium
dioxide, and other ingredients.

30 MG/ML AND 100 MG/ML ORAL SOLUTION (CONCENTRATE)

Active Ingredient: thioridazine HCl, USP

30 MG/ML ORAL SOLUTION (CONCENTRATE)

Inactive Ingredients: alcohol, 3.0%, flavor, methylparaben, propylparaben,
purified water, and sorbitol solution. May contain sodium hydroxide or
hydrochloric acid to adjust the pH.

100 MG/ML ORAL SOLUTION (CONCENTRATE)

Inactive Ingredients: alcohol, 4.2%, flavor, glycerin, methylparaben,
propylparaben, purified water, sorbitol solution, and sucrose. May contain
sodium hydroxide or hydrochloric acid to adjust pH.

5 MG/ML AND 20 MG/ML ORAL SUSPENSION

Active Ingredient: each mL contains thioridazine, USP, equivalent to 5 mg and 20
mg thioridazine HCl, USP, respectively.

5 MG/ML ORAL SUSPENSION

Inactive Ingredients: carbomer 934, flavor, polysorbate 80, purified water,
sodium hydroxide, and sucrose.

20 MG/ML ORAL SUSPENSION

Inactive Ingredients: carbomer 934, D&C Yellow #10, FD&C Yellow #6, flavor,
polysorbate 80, purified water, sodium hydroxide, and sucrose.




USES FOR MELLARIL

Mellaril® (thioridazine HCl) is indicated for the management of schizophrenic
patients who fail to respond adequately to treatment with other antipsychotic
drugs. Due to the risk of significant, potentially life-threatening,
proarrhythmic effects with Mellaril (thioridazine hcl) treatment, Mellaril
(thioridazine hcl) should be used only in patients who have failed to respond
adequately to treatment with appropriate courses of other antipsychotic drugs,
either because of insufficient effectiveness or

the inability to achieve an effective dose due to intolerable adverse effects
from those drugs. Consequently, before initiating treatment with Mellaril
(thioridazine hcl) , it is strongly recommended that a patient be given at least
2 trials, each with a different antipsychotic drug product, at an adequate dose,
and for an adequate duration (see WARNINGS and CONTRAINDICATIONS).

However, the prescriber should be aware that Mellaril (thioridazine hcl) has not
been systematically evaluated in controlled trials in treatment refractory
schizophrenic patients and its efficacy in such patients is unknown.


DOSAGE FOR MELLARIL

Since Mellaril (thioridazine HCl) is associated with a dose-related prolongation
of the QTc interval, which is a potentially life-threatening event, its use
should be reserved for schizophrenic patients who fail to respond adequately to
treatment with other antipsychotic drugs. Dosage must be individualized and the
smallest effective dosage should be determined for each patient (see INDICATIONS
and WARNINGS).

ADULTS

The usual starting dose for adult schizophrenic patients is 50-100 mg three
times a day, with a gradual increment to a maximum of 800 mg daily if necessary.
Once effective control of symptoms has been achieved, the dosage may be reduced
gradually to determine the minimum maintenance dose. The total daily dosage
ranges from 200-800 mg, divided into two to four doses.

PEDIATRIC PATIENTS

For pediatric patients with schizophrenia who are unresponsive to other agents,
the recommended initial dose is 0.5 mg/kg/day given in divided doses. Dosage may
be increased gradually until optimum therapeutic effect is obtained or the
maximum dose of 3 mg/kg/day has been reached.


HOW SUPPLIED

MELLARIL® (THIORIDAZINE HCL) TABLETS

10 mg

Bright chartreuse, coated tablets; "S" imprinted on one side, "78-2'' imprinted
on the other side, in black.

Bottle of 100..........................................NDC 0078-0002-05
Bottle of 1000........................................NDC 0078-0002-09
Unit dose package of 100............NDC 0078-0002-06

15 mg

Pink, coated tablets; " S" imprinted on one side, "78-8'' imprinted on the other
side, in black.

Bottle of 100..........................................NDC 0078-0008-05

25 mg

Light tan, coated tablets; "S" imprinted on one side, "MELLARIL (thioridazine
hcl) 25'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0003-05
Bottle of 1000........................................NDC 0078-0003-09
Unit dose package of 100............NDC 0078-0003-06

50 mg

White, coated tablets; "S" imprinted on one side, "MELLARIL (thioridazine hcl)
50'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0004-05
Bottle of 1000........................................NDC 0078-0004-09
Unit dose package of 100............NDC 0078-0004-06

100 mg

Light green, coated tablets; " ^4&" imprinted on one side, "MELLARIL
(thioridazine hcl) 100'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0005-05
Bottle of 1000........................................NDC 0078-0005-09
Unit dose package of 100............NDC 0078-0005-06

150 mg

Yellow, coated tablets; "S" imprinted on one side, "MELLARIL (thioridazine hcl)
150'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0006-05

200 mg

Pink, coated tablets, " ^4&" imprinted on one side, "MELLARIL (thioridazine hcl)
200'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0007-05
Unit dose package of 100............NDC 0078-0007-06

STORE AND DISPENSE

Below 86°F (30°C); tight container.

MELLARIL® (THIORIDAZINE HCL) ORAL SOLUTION (CONCENTRATE)

30 mg/mL

A clear, straw-yellow liquid with a cherry-like odor. Each mL contains 30 mg
thioridazine hydrochloride, USP, alcohol, 3.0% by volume. Immediate container:
amber glass bottles of 4 fl. oz. (118 mL) as follows: 4 fl. oz. bottles, in
cartons of 12 bottles, with an accompanying dropper graduated to deliver 10 mg,
25 mg, and 50 mg of thioridazine hydrochloride, USP (NDC 0078-0001-31).

100 mg/mL

A clear, light-yellow liquid with a strawberry-like odor. Each mL contains 100
mg thioridazine hydrochloride, USP, alcohol, 4.2% by volume. Immediate
container: amber glass bottles of 4 fl. oz. (118 mL), in cartons of 12 bottles,
with an accompanying dropper graduated to deliver 100 mg, 150 mg, and 200 mg of
thioridazine hydrochloride, USP (NDC 0078-0009-31).

STORE AND DISPENSE

Below 86°F (30°C); tight, amber glass bottle.

The oral solution (concentrate) may be diluted with distilled water, acidified
tap water, or suitable juices. Each dose should be so diluted just prior to
administration - preparation and storage of bulk dilutions is not recommended.

MELLARIL (THIORIDAZINE HCL) -S® (THIORIDAZINE) ORAL SUSPENSION

5 mg/mL

An off-white suspension with a buttermint taste and a peppermint odor. Each mL
contains thioridazine, USP, equivalent to 5 mg thioridazine hydrochloride, USP.
Buttermint-flavored in pint bottles (NDC 0078-0068-33).

20 mg/mL

A yellow suspension with a buttermint taste and a peppermint odor. Each mL
contains thioridazine, USP, equivalent to 20 mg thioridazine hydrochloride, USP.
Buttermint-flavored in pint bottles (NDC 0078-0069-33).

STORE AND DISPENSE

Below 77°F (25°C); tight, amber glass bottle.

Additional information available to physicians. Novartis Pharmaceuticals
Corporation, East Hanover, New Jersey 07936. Revised: June 2000.




SIDE EFFECTS FOR MELLARIL

In the recommended dosage ranges with Mellaril® (thioridazine HCl) most side
effects are mild and transient.

Central Nervous System: Drowsiness may be encountered on occasion, especially
where large doses are given early in treatment. Generally, this effect tends to
subside with continued therapy or a reduction in dosage. Pseudoparkinsonism and
other extrapyramidal symptoms may occur but are infrequent. Nocturnal confusion,
hyperactivity, lethargy, psychotic reactions, restlessness, and headache have
been reported but are extremely rare.

Autonomic Nervous System: Dryness of mouth, blurred vision, constipation,
nausea, vomiting, diarrhea, nasal stuffiness, and pallor have been seen.

Endocrine System: Galactorrhea, breast engorgement, amenorrhea, inhibition of
ejaculation, and peripheral edema have been described.

Skin: Dermatitis and skin eruptions of the urticarial type have been observed
infrequently. Photosensitivity is extremely rare.

Cardiovascular System: Mellaril (thioridazine hcl) produces a dose related
prolongation of the QTc interval, which is associated with the ability to cause
torsade de pointes-type arrhythmias, a potentially fatal polymorphic ventricular
tachycardia, and sudden death (see WARNINGS). Both torsade de pointes-type
arrhythmias and sudden death have been reported in association with Mellaril
(thioridazine hcl) . A causal relationship between these events and Mellaril
(thioridazine hcl) therapy has not been established but, given the ability of
Mellaril (thioridazine hcl) to prolong the QTc interval, such a relationship is
possible. Other ECG changes have been reported (see Phenothiazine Derivatives:
Cardiovascular Effects).

Other: Rare cases described as parotid swelling have been reported following
administration of Mellaril (thioridazine hcl) .

POST INTRODUCTION REPORTS

These are voluntary reports of adverse events temporally associated with
Mellaril (thioridazine hcl) that were received since marketing, and there may be
no causal relationship between Mellaril (thioridazine hcl) use and these events:
priapism.

PHENOTHIAZINE DERIVATIVES

It should be noted that efficacy, indications, and untoward effects have varied
with the different phenothiazines. It has been reported that old age lowers the
tolerance for pheno-thiazines. The most common neurological side effects in
these patients are parkinsonism and akathisia. There appears to be an increased
risk of agranulocytosis and leukopenia in the geriatric population. 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: Agranulocytosis, 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
to include prolongation of the QT interval, depression and inversion of the T
wave, and the appearance of a wave tentatively identified as a bifid T wave or a
U wave have been observed in patients receiving phenothiazines, including
Mellaril (thioridazine hcl) . To date, these appear to be due to altered
repolarization, not related to myocardial damage, and reversible. Nonetheless,
significant prolongation of the QT interval has been associated with serious
ventricular arrhythmias and sudden death (see WARNINGS). Hypotension, rarely
resulting in cardiac arrest, has been reported.

Extrapyramidal Symptoms: Akathisia, agitation, motor restlessness, dystonic
reactions, trismus, torticollis, opisthotonus, oculogyric crises, tremor,
muscular rigidity, akinesia.

Tardive Dyskinesia: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 subsequently.

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 dyskinesia 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.

Neuroleptic Malignant Syndrome (NMS): Chronic use of neuroleptics may be
associated with the development of Neuroleptic Malignant Syndrome. The salient
features of this syndrome are described in the WARNINGS section and
subsequently. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity,
altered mental status, and evidence of autonomic instability (irregular pulse or
blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

Endocrine Disturbances:Menstrual irregularities, altered libido, gynecomastia,
lactation, weight gain, edema. False positive pregnancy tests have been
reported.

Urinary Disturbances: Retention, incontinence.

Others: Hyperpyrexia. 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 FOR MELLARIL

Reduced cytochrome P450 2D6 isozyme activity, drugs which inhibit this isozyme
(e.g., fluoxetine and paroxetine), and certain other drugs (e.g., fluvoxamine,
propranolol, and pindolol) appear to appreciably inhibit the metabolism of
thioridazine. The resulting elevated levels of thioridazine would be expected to
augment the prolongation of the QTc interval associated with Mellaril
(thioridazine hcl) and may increase the risk of serious, potentially fatal,
cardiac arrhythmias, such as torsade de pointes-type arrhythmias. Such an
increased risk may result also from the additive effect of co-administering
Mellaril (thioridazine hcl) with other agents that prolong the QTc interval.
Therefore, Mellaril (thioridazine hcl) is contraindicated with these drugs as
well as in patients, comprising about 7% of the normal population, who are known
to have a genetic defect leading to reduced levels of activity of P450 2D6 (see
WARNINGS and CONTRAINDICATIONS).

DRUGS THAT INHIBIT CYTOCHROME P450 2D6

In a study of 19 healthy male subjects, which included 6 slow and 13 rapid
hydroxylators of debrisoquin, a single 25 mg oral dose of thioridazine produced
a 2.4-fold higher Cmax and a 4.5-fold higher AUC for thioridazine in the slow
hydroxylators compared to rapid hydroxylators. The rate of debrisoquin
hydroxylation is felt to depend on the level of cytochrome P450 2D6 isozyme
activity. Thus, this study suggests that drugs that inhibit P450 2D6 or the
presence of reduced activity levels of this isozyme will produce elevated plasma
levels of thioridazine. Therefore, the co-administration of drugs that inhibit
P450 2D6 with Mellaril (thioridazine hcl) and the use of Mellaril (thioridazine
hcl) in patients known to have reduced activity of P450 2D6 are contraindicated.

DRUGS THAT REDUCE THE CLEARANCE OF MELLARIL® (THIORIDAZINE HCL) THROUGH OTHER
MECHANISMS

Fluvoxamine: The effect of fluvoxamine (25 mg b.i.d. for one week) on
thioridazine steady state concentration was evaluated in 10 male in-patients
with schizophrenia. Concentrations of thioridazine and its two active
metabolites, mesoridazine and sulforidazine, increased three-fold following
co-administration of fluvoxamine. Fluvoxamine and Mellaril (thioridazine hcl)
should not be co-administered.

Propranolol: Concurrent administration of propranolol (100-800 mg daily) has
been reported to produce increases in plasma levels of thioridazine
(approximately 50%-400%) and its metabolites (approximately 80%-300%).
Propranolol and Mellaril (thioridazine hcl) should not be co-administered.

Pindolol: Concurrent administration of pindolol and thioridazine have resulted
in moderate, dose-related increases in the serum levels of thioridazine and two
of its metabolites, as well as higher than expected serum pindolol levels.
Pindolol and Mellaril (thioridazine hcl) should not be co-administered.

DRUGS THAT PROLONG THE QTC INTERVAL

There are no studies of the co-administration of Mellaril (thioridazine hcl) and
other drugs that prolong the QTc interval. However, it is expected that such
co-administration would produce additive prolongation of the QTc interval and,
thus, such use is contraindicated.




WARNINGS FOR MELLARIL

POTENTIAL FOR PROARRHYTHMIC EFFECTS

DUE TO THE POTENTIAL FOR SIGNIFICANT, POSSIBLY LIFE-THREATENING, PROARRHYTHMIC
EFFECTS WITH MELLARIL® (THIORIDAZINE HCl) TREATMENT, MELLARIL (thioridazine hcl)
SHOULD BE RESERVED FOR USE IN THE TREATMENT OF SCHIZOPHRENIC PATIENTS WHO FAIL
TO SHOW AN ACCEPTABLE RESPONSE TO ADEQUATE COURSES OF TREATMENT WITH OTHER
ANTIPSYCHOTIC DRUGS, EITHER BECAUSE OF INSUFFICIENT EFFECTIVENESS OR THE
INABILITY TO ACHIEVE AN EFFECTIVE DOSE DUE TO INTOLERABLE ADVERSE EFFECTS FROM
THOSE DRUGS. CONSEQUENTLY, BEFORE INITIATING TREATMENT WITH MELLARIL
(thioridazine hcl) , IT IS STRONGLY RECOMMENDED THAT A PATIENT BE GIVEN AT LEAST
TWO TRIALS, EACH WITH A DIFFERENT ANTIPSYCHOTIC DRUG PRODUCT, AT AN ADEQUATE
DOSE, AND FOR AN ADEQUATE DURATION. MELLARIL (thioridazine hcl) HAS NOT BEEN
SYSTEMATICALLY EVALUATED IN CONTROLLED TRIALS IN THE TREATMENT OF REFRACTORY
SCHIZOPHRENIC PATIENTS AND ITS EFFICACY IN SUCH PATIENTS IS UNKNOWN.

A crossover study in nine healthy males comparing single doses of thioridazine
10 mg and 50 mg with placebo demonstrated a dose-related prolongation of the QTc
interval. The mean maximum increase in QTc interval following the 50 mg dose was
about 23 msec; greater prolongation may be observed in the clinical treatment of
unscreened patients.

Prolongation of the QTc interval has been associated with the ability to cause
torsade de pointes-type arrhythmias, a potentially fatal polymorphic ventricular
tachycardia, and sudden death. There are several published case reports of
torsade de pointes and sudden death associated with thioridazine treatment. A
causal relationship between these events and Mellaril (thioridazine hcl) therapy
has not been established but, given the ability of Mellaril (thioridazine hcl)
to prolong the QTc interval, such a relationship is possible.

Certain circumstances may increase the risk of torsade de pointes and/or sudden
death in association with the use of drugs that prolong the QTc interval,
including 1) bradycardia, 2) hypokalemia, 3) concomitant use of other drugs that
prolong the QTc interval, 4) presence of congenital prolongation of the QT
interval, and 5) for thioridazine in particular, its use in patients with
reduced activity of P450 2D6 or its co-administration with drugs that may
inhibit P450 2D6 or by some other mechanism interfere with the clearance of
thioridazine (see CONTRAINDICATIONS and PRECAUTIONS).

It is recommended that patients being considered for Mellaril (thioridazine hcl)
treatment have a baseline ECG performed and serum potassium levels measured.
Serum potassium should be normalized before initiating treatment and patients
with a QTc interval greater than 450 msec should not receive Mellaril
(thioridazine hcl) treatment. It may also be useful to periodically monitor
ECG's and serum potassium during Mellaril (thioridazine hcl) treatment,
especially during a period of dose adjustment. Mellaril (thioridazine hcl)
should be discontinued in patients who are found to have a QTc interval over 500
msec.

Patients taking Mellaril (thioridazine hcl) who experience symptoms that may be
associated with the occurrence of torsade de pointes (e.g., dizziness,
palpitations, or syncope) may warrant further cardiac evaluation; in particular,
Holter monitoring should be considered.

TARDIVE DYSKINESIA

Tardive dyskinesia, a syndrome consisting of potentially irreversible,
involuntary, dyskinetic movements may develop in patients treated with
neuroleptic (antipsychotic) drugs. Although the prevalence of the syndrome
appears to be highest among the elderly, especially elderly women, it is
impossible to rely upon prevalence estimates to predict, at the inception of
neuroleptic treatment, which patients are likely to develop the syndrome.
Whether neuroleptic drug products differ in their potential to cause tardive
dyskinesia is unknown.

Both the risk of developing the syndrome and the likelihood that it will become
irreversible are believed to increase as the duration of treatment and the total
cumulative dose of neuroleptic drugs administered to the patient increase.
However, the syndrome can develop, although much less commonly, after relatively
brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia,
although the syndrome may remit, partially or completely, if neuroleptic
treatment is withdrawn. Neuroleptic treatment itself, however, may suppress (or
partially suppress) the signs and symptoms of the syndrome and thereby may
possibly mask the underlying disease process. The effect that symptomatic
suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, neuroleptics should be prescribed in a manner that
is most likely to minimize the occurrence of tardive dyskinesia. Chronic
neuroleptic treatment should generally be reserved for patients who suffer from
a chronic illness that, 1) is known to respond to neuroleptic drugs, and, 2) for
whom alternative, equally effective, but potentially less harmful treatments are
not available or appropriate. In patients who do require chronic treatment, the
smallest dose and the shortest duration of treatment producing a satisfactory
clinical response should be sought. The need for continued treatment should be
reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on neuroleptics,
drug discontinuation should be considered. However, some patients may require
treatment despite the presence of the syndrome.

(For further information about the description of tardive dyskinesia and its
clinical detection, please refer to the sections on Information for Patients and
ADVERSE REACTIONS.)

It has been suggested in regard to phenothiazines in general, that people who
have demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice)
to one may be more prone to demonstrate a reaction to others. Attention should
be paid to the fact that phenothiazines are capable of potentiating central
nervous system depressants (e.g., anesthetics, opiates, alcohol, etc.) as well
as atropine and phosphorus insecticides. Physicians should carefully consider
benefit versus risk when treating less severe disorders.

Reproductive studies in animals and clinical experience to date have failed to
show a teratogenic effect with Mellaril (thioridazine hcl) . However, in view of
the desirability of keeping the administration of all drugs to a minimum during
pregnancy, Mellaril (thioridazine hcl) should be given only when the benefits
derived from treatment exceed the possible risks to mother and fetus.

NEUROLEPTIC MALIGNANT SYNDROME (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic
Malignant Syndrome (NMS) has been reported in association with antipsychotic
drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered
mental status, and evidence of autonomic instability (irregular pulse or blood
pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In
arriving at a diagnosis, it is important to identify cases where the clinical
presentation includes both serious medical illness (e.g., pneumonia, systemic
infection, etc.) and untreated or inadequately treated extrapyramidal signs and
symptoms (EPS). Other important considerations in the differential diagnosis
include central anticholinergic toxicity, heat stroke, drug fever, and primary
central nervous system (CNS) pathology.

The management of NMS should include, 1) immediate discontinuation of
antipsychotic drugs and other drugs not essential to concurrent therapy, 2)
intensive symptomatic treatment and medical monitoring, and 3) treatment of any
concomitant serious medical problems for which specific treatments are
available. There is no general agreement about specific pharmacological
treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the
potential reintroduction of drug therapy should be carefully considered. The
patient should be carefully monitored, since recurrences of NMS have been
reported.

CENTRAL NERVOUS SYSTEM DEPRESSANTS

As in the case of other phenothiazines, Mellaril (thioridazine hcl) is capable
of potentiating central nervous system depressants (e.g., alcohol, anesthetics,
barbiturates, narcotics, opiates, other psychoactive drugs, etc.) as well as
atropine and phosphorus insecticides. Severe respiratory depression and
respiratory arrest have been reported when a patient was given a phenothiazine
and a concomitant high dose of a barbiturate.


PRECAUTIONS FOR MELLARIL

Leukopenia and/or agranulocytosis and convulsive seizures have been reported but
are infrequent. Mellaril® (thioridazine HCl) has been shown to be helpful in the
treatment of behavioral disorders in epileptic patients, but anticonvulsant
medication should also be maintained. Pigmentary retinopathy, which has been
observed primarily in patients taking larger than recommended doses, is
characterized by diminution of visual acuity, brownish coloring of vision, and
impairment of night vision; examination of the fundus discloses deposits of
pigment. The possibility of this complication may be reduced by remaining within
the recommended limits of dosage.

Where patients are participating in activities requiring complete mental
alertness (e.g., driving) it is advisable to administer the phenothiazines
cautiously and to increase the dosage gradually. Female patients appear to have
a greater tendency to orthostatic hypotension than male patients. The
administration of epinephrine should be avoided in the treatment of drug-induced
hypotension in view of the fact that phenothiazines may induce a reversed
epinephrine effect on occasion. Should a vasoconstrictor be required, the most
suitable are levarterenol and phenylephrine.

Neuroleptic drugs elevate prolactin levels; the elevation persists during
chronic administration. Tissue culture experiments indicate that approximately
one-third of human breast cancers are prolactin dependent in vitro, a factor of
potential importance if the prescription of these drugs is contemplated in a
patient with a previously detected breast cancer. Although disturbances such as
galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the
clinical significance of elevated serum prolactin levels is unknown for most
patients. An increase in mammary neoplasms has been found in rodents after
chronic administration of neuroleptic drugs. Neither clinical studies nor
epidemiologic studies conducted to date, however, have shown an association
between chronic administration of these drugs and mammary tumorigenesis; the
available evidence is considered too limited to be conclusive at this time.

PEDIATRIC USE

See DOSAGE section Pediatric Patients.


OVERDOSE INFORMATION FOR MELLARIL

Many of the symptoms observed are extensions of the side effects described under
ADVERSE REACTIONS. Mellaril® (thioridazine hcl) (thioridazine HCl) can be toxic
in overdose, with cardiac toxicity being of particular concern. Frequent ECG and
vital sign monitoring of overdosed patients is recommended. Observation for
several days may be required because of the risk of delayed effects.

SIGNS AND SYMPTOMS

Effects and clinical complications of acute overdose involving phenothiazines
may include:

Cardiovascular: Cardiac arrhythmias, hypotension, shock, ECG changes, increased
QT and PR intervals, non-specific ST and T wave changes, bradycardia, sinus
tachycardia, atrioventricular block, ventricular tachycardia, ventricular
fibrillation, Torsade de pointes, myocardial depression.

Central Nervous System: Sedation, extrapyramidal effects, confusion, agitation,
hypothermia, hyperthermia, restlessness, seizures, areflexia, coma.

Autonomic Nervous System: Mydriasis, miosis, dry skin, dry mouth, nasal
congestion, urinary retention, blurred vision.

Respiratory: Respiratory depression, apnea, pulmonary edema.

Gastrointestinal: Hypomotility, constipation, ileus.

Renal: Oliguria, uremia.

Toxic dose and blood concentration ranges for the phenothiazines have not been
firmly established. It has been suggested that the toxic blood concentration
range for thioridazine begins at 1.0 mg/dL, and 2-8 mg/dL is the lethal
concentration range.

TREATMENT

An airway must be established and maintained. Adequate oxygenation and
ventilation must be ensured.

Cardiovascular monitoring should commence immediately and should include
continuous electrocardiographic monitoring to detect possible arrhythmias.
Treatment may include one or more of the following therapeutic interventions:
correction of electrolyte abnormalities and acid-base balance, lidocaine,
phenytoin, isoproterenol, ventricular pacing, and defibrillation. Disopyramide,
procainamide, and quinidine may produce additive QT-prolonging effects when
administered to patients with acute overdosage of Mellaril and should be avoided
(see WARNINGS and CONTRAINDICATIONS). Caution must be exercised when
administering lidocaine, as it may increase the risk of developing seizures.

Treatment of hypotension may require intravenous fluids and vasopressors.
Phenylephrine, levarterenol, or metaraminol are the appropriate pressor agents
for use in the management of refractory hypotension. The potent α adrenergic
blocking properties of the phenothiazines makes the use of vasopressors with
mixed α and β adrenergic agonist properties inappropriate, including epinephrine
and dopamine. Paradoxical vasodilation may result. In addition, it is reasonable
to expect that the α adrenergic-blocking properties of bretylium might be
additive to those of Mellaril (thioridazine hcl) , resulting in problematic
hypotension.

In managing overdosage, the physician should always consider the possibility of
multiple drug involvement. Gastric lavage and repeated doses of activated
charcoal should be considered. Induction of emesis is less preferable to gastric
lavage because of the risk of dystonia and the potential for aspiration of
vomitus. Emesis should not be induced in patients expected to deteriorate
rapidly, or those with impaired consciousness.

Acute extrapyramidal symptoms may be treated with diphenhydramine hydrochloride
or benztropine mesylate.

Avoid the use of barbiturates when treating seizures, as they may potentiate
phenothiazine-induced respiratory depression.

Forced diuresis, hemoperfusion, hemodialysis and manipulation of urine pH are of
unlikely benefit in the treatment of phenothiazine overdose due to their large
volume of distribution and extensive plasma protein binding.

Up-to-date information about the treatment of overdose can often be obtained
from a certified Regional Poison Control Center. Telephone numbers of certified
Regional Poison Control Centers are listed in the Physicians' Desk Reference®**.


CONTRAINDICATIONS FOR MELLARIL

Mellaril® (thioridazine HCl) use should be avoided in combination with other
drugs that are known to prolong the QTc interval and in patients with congenital
long QT syndrome or a history of cardiac arrhythmias.

Reduced cytochrome P450 2D6 isozyme activity drugs that inhibit this isozyme
(e.g., fluoxetine and paroxetine) and certain other drugs (e.g., fluvoxamine,
propranolol, and pindolol) appear to appreciably inhibit the metabolism of
thioridazine. The resulting elevated levels of thioridazine would be expected to
augment the prolongation of the QTc interval associated with Mellaril
(thioridazine hcl) and may increase the risk of serious, potentially fatal,
cardiac arrhythmias, such as torsade de pointes-type arrhythmias. Such an
increased risk may result also from the additive effect of co-administering
Mellaril (thioridazine hcl) with other agents that prolong the QTc interval.
Therefore, Mellaril (thioridazine hcl) is contraindicated with these drugs as
well as in patients, comprising about 7% of the normal population, who are known
to have a genetic defect leading to reduced levels of activity of P450 2D6 (see
WARNINGS and PRECAUTIONS).

In common with other phenothiazines, Mellaril (thioridazine hcl) is
contraindicated in severe central nervous system depression or comatose states
from any cause including drug induced central nervous system depression (see
WARNINGS). It should also be noted that hypertensive or hypotensive heart
disease of extreme degree is a contraindication of phenothiazine administration.


CLINICAL PHARMACOLOGY FOR MELLARIL

The basic pharmacological activity of Mellaril® (thioridazine HCl) is similar to
that of other phenothiazines, but is associated with minimal extrapyramidal
stimulation.

However, thioridazine has been shown to prolong the QTc interval in a
dose-dependent fashion. This effect may increase the risk of serious,
potentially fatal, ventricular arrhythmias, such as torsade de pointes-type
arrhythmias. Due to this risk, Mellaril (thioridazine hcl) is indicated only for
schizophrenic patients who have not been responsive to or cannot tolerate other
antipsychotic agents (see WARNINGS and CONTRAINDICATIONS). However, the
prescriber should be aware that Mellaril (thioridazine hcl) has not been
systematically evaluated in controlled trials in treatment refractory
schizophrenic patients and its efficacy in such patients is unknown.


PATIENT INFORMATION FOR MELLARIL

Patients should be informed that Mellaril (thioridazine hcl) has been associated
with potentially fatal heart rhythm disturbances. The risk of such events may be
increased when certain drugs are given together with Mellaril (thioridazine hcl)
. Therefore, patients should inform the prescriber that they are receiving
Mellaril (thioridazine hcl) treatment before taking any new medication.

Given the likelihood that some patients exposed chronically to neuroleptics will
develop tardive dyskinesia, it is advised that all patients in whom chronic use
is contemplated be given, if possible, full information about this risk. The
decision to inform patients and/or their guardians must obviously take into
account the clinical circumstances and the competency of the patient to
understand the information provided.


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