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MELLARIL (THIORIDAZINE HCL): ADVERSE REACTIONS, SIDE EFFECTS

In the recommended dosage ranges with Thioridazine Hydrochloride (Mellaril) 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. Hyperactivity, nocturnal confusion, psychotic reactions, lethargy, restlessness, and headache have been reported but are extremely rare.

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

Endocrine System: Breast engorgement, galactorrhea, 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 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. Both torsade de pointes-type arrhythmias and sudden death have been reported in association with Mellaril (Thioridazine). A causal relationship between these events and Thioridazine (Mellaril) therapy has not been established but, given the ability of Mellaril to prolong the QTc interval, such a relationship is possible. Other ECG changes have been reported.

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

Post Introduction Reports

These are voluntary reports of adverse events temporally associated with Mellaril (Thioridazine Hydrochloride) 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: Obstipation, miosis, anorexia, paralytic ileus.

Cutaneous Reactions: Exfoliative dermatitis, erythema, contact dermatitis.

Blood Dyscrasias: Leukopenia, agranulocytosis, eosinophilia, anemia, thrombocytopenia, aplastic anemia, pancytopenia.

Allergic Reactions: Laryngeal edema, fever, 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. 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. Hypotension, rarely resulting in cardiac arrest, has been reported.

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

Tardive Dyskinesia: Chronic use of neuroleptics may be associated with the development of tardive dyskinesia.

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. 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: Altered libido, menstrual irregularities, gynecomastia, weight gain, lactation, 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.

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