Pigmentary retinopathy has been observed after long-term treatment, mostly in patients receiving doses exceeding the recommended maximum of 800 mg/day. Patients receiving higher doses of phenothiazines for prolonged periods should have complete eye examinations at regular intervals.

Patients with liver disease need regular monitoring of liver function.

Usage in Children:: Do not give to children under 1 year old.

Pregnancy and Withdrawl: There have been no well-controlled studies conducted with pregnant women to determine the effect of thioridazine on the fetus. Therefore, thioridazine should be used in women who are or might become pregnant only if the clinical condition clearly justifies potential risk to the fetus.

Limited data suggest that thioridazine is likely to be excreted in human breast milk. As a general rule, a woman taking a drug should not nurse since the possibility exists that the drug may be excreted in breast milk and be harmful to the child.

Interference with Cognitive or Motor Performance: Since thioridazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as operating an automobile or machinery, the patient should be cautioned accordingly.

Drug Interactions

Phenothiazines may enhance the CNS-depressant effects of alcohol, antihistamines and other CNS depressants as well as atropine and phosphorus insecticides; the antimuscarinic effects of anticholinergic agents; and the inhibitory cardiac effects of quinidine.

Phenothiazines may reduce the antiparkinsonian effects of levodopa.

Concomitant use of lithium may aggravate extrapyramidal symptoms and neurotoxicity caused by neuroleptic agents.

Thioridazine may lower the seizure threshold in epileptic patients.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes guanethidine, and medicines for high blood pressure, heart conditions, depression, and bladder or bowel spasms. Inform your doctor of any other medical conditions including seizure disorders, depression, allergies, pregnancy, or breast-feeding.

Adverse Reactions

Do not become overheated in hot weather, during exercise, or other activities since heat stroke may occur while you are using this medicine. This medicine may cause increased sensitivity to the sun. Avoid exposure to the sun or sunlamps until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

DO NOT DRINK ALCOHOL while you are taking this medicine.

CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience changes in vision; changes in breasts; changes in menstrual period; sore throat; inability to move eyes; muscle spasms of face, neck, or back; difficulty swallowing; mask-like face; tremors of hands; restlessness; tension in legs; shuffling walk or stiff arms or legs; puffing of cheeks; lip smacking or puckering; twitching or twisting movements; or weakness of arms or legs. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Side effects that may go away during treatment, include drowsiness, dizziness, nasal congestion, blurred vision, dry mouth, or constipation. If they continue or are bothersome, check with your doctor.

Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the phenothiazine drugs require that each of the reactions be considered when Thioridazine is administered.

Cardiovascular: Orthostatic hypotension, tachycardia, ECG changes.

Psychiatric: Oversedation, impaired psychomotor function, paradoxical effects (such as agitation, excitement, insomnia, bizarre dreams, aggravation of psychotic symptoms), toxic confusional states.

Neurological: Dry mouth, fainting, nasal stuffiness, photophobia, miosis, blurred vision.

Allergic: Fever, laryngeal edema, angioneurotic edema, asthma.

Hematologic: Bone marrow depression including agranulocytosis; eosinophilia; purpura; thrombocytopenia.

Gastrointestinal: Anorexia, gastric irritation, nausea, vomiting, constipation, diarrhea, obstipation, paralytic ileus, pallor.

Endocrine: Menstrual irregularities, altered libido, gynecomastia, galactorrhea, breast engorgement, weight change, edema, false positive pregnancy tests, disturbances of erection and of ejaculation (failure or priapism).

Urinary: Retention, incontinence.

Other: Jaundice