Drug Profile

Pregnancy Warning

There are reported cases of prolonged jaundice, overactivity or underactivity (hyperreflexia or hyporeflexia), and extrapyramidal signs in infants born to women who were taking these drugs. Studies in rats demonstrated decreased performance with the possibility of permanent neurological damage. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.

Breast-feeding Warning

These drugs are excreted in the breast milk of nursing mothers. Because of the potential for serious adverse effects, you should not take these drugs while nursing.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Thioridazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis.

Decreased Sweating

These drugs may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or in hot weather while you are taking one of these medications, since overheating may result in heatstroke. Also, hot baths or saunas may make you feel dizzy or faint when you are taking these medications.

Anticholinergic Effects

Warning: Special Mental and Physical Adverse Effects

Older adults are especially sensitive to the harmful anticholinergic effects of these drugs. Drugs in this family should not be used unless absolutely necessary.

Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention

Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma

Sensitivity to Cold

Drugs such as chlorpromazine (THORAZINE), fluphenazine (PROLIXIN), prochlorperazine (COMPAZINE), thioridazine (Mellaril), and trifluoperazine (STELAZINE) may make you more sensitive to cold temperatures. Dress warmly during cold weather. Be careful during prolonged exposure to cold, such as in winter sports or swimming in cold water.

Do not use if you have or have had:

• cardiovascular disease
• severe high or low blood pressure
• comatose states
• history of heart arrhythmias
• genetic defect in drug metabolizing enzyme (2D6)
• severe central nervous system depression
• pregnancy or are breast-feeding

Tell your doctor if you have or have had:

• allergies to phenothiazines, parabans, sulfites, FD&C Yellow No. 5
• alcohol dependence
• blood disease
• breast cancer
• enlarged prostate or difficulty urinating
• heart or blood vessel disease
• Parkinson’s disease
• lung disease
• epilepsy, seizures
• glaucoma
• liver disease
• kidney disease
• stomach ulcer
• Reye’s syndrome
• severe lethargy
• previous brain damage

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

• It may take two to three weeks before you can tell that the drug is working.
• Do not stop taking this drug suddenly. Your doctor must give you a schedule to lower your dose gradually, to prevent withdrawal symptoms such as nausea, vomiting, and stomach upset.
• Until you know how you react to this drug, do not drive or perform other activities requiring alertness. These drugs may cause blurred vision, drowsiness, and fainting.
• Do not drink alcohol or use other drugs that can cause drowsiness.
• You may feel dizzy when rising from a lying or sitting position. When getting out of bed, hang your feet over the side of the bed for a few minutes, then get up slowly. When getting out of a chair, stay by the chair until you are sure that you are not dizzy.
• If you plan to have any surgery, including dental, tell your doctor that you take this drug.
• Take caution during exercise or in hot weather or when taking hot baths to avoid heatstroke.
• Avoid unprotected skin exposure to the sun. Use sunblock products that protect against both UVA and UVB rays. Don’t use sunlamps or tanning booths.
• Wear sunglasses outdoors.
• Avoid spilling liquid medication on skin or clothing; it can cause irritation.
• Avoid use of over-the-counter medications for colds or allergies.
• Try sugarless gum, candy, or ice or a saliva substitute for dry mouth.
• Long-acting injected liquid form requires precautions for 6 to 12 weeks after stopping the drug.

• If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
• Do not share your medication with others.
• Take the drug at the same time(s) each day.
• Take tablet with food or milk.
• The liquid dosage form should be diluted just before use in tomato or fruit juice, milk, syrup, carbonated beverages, coffee, tea, water, applesauce, jelly, or ketchup.
• Do not break, chew, or crush the tablet.
• Extended-release tablet should be swallowed whole.
• Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Do not freeze the liquid form. Keep out of reach of children.
• If you take antacids or diarrhea drugs, take them at least two hours before taking your antipsychotic drug.

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

alcohol, amphetamines, ANECTINE, benztropine, bromocriptine, cabergoline, CAPOTEN, captopril, carbamazepine, COGENTIN, COUMADIN, DEMEROL, desipramine, DEXEDRINE, diazoxide, DILANTIN, DOSTINEX, ESKALITH, GLUCOPHAGE, GLUCOVANCE, guanethidine, halofantrine, INDERAL, INDERAL LA, ISMELIN, lithium, LITHOBID, LITHONATE, meperidine, METAGLIP, metformin, NORPRAMIN, NORVIR, ORAP, PARLODEL, PERMAX, pergolide, phenytoin, pimozide, polymyxin B, POLY-RX, PROGLYCEM, propranolol, RIFADIN, rifampin, RIMACTANE, ritonavir, TEGRETOL, tramadol, ULTRACET, ULTRAM, warfarin.

Call your doctor immediately if you experience:

• signs of tardive dyskinesia (can also occur after drug is discontinued): lip smacking, chewing movements, puffing of cheeks, rapid, darting tongue movements, uncontrolled movements of arms or legs
• signs of parkinsonism: difficulty speaking or swallowing, loss of balance, masklike face, muscle spasms, stiffness of arms or legs, trembling and shaking, unusual twisting movements of body
• signs of restless leg (akathisia): restless pacing, a feeling of the “jitters”
• signs of akinesia: weakness, muscular fatigue, listlessness, depression. Although often confused with true depression, akinesia is actually the most common of a group of adverse effects called extrapyramidal effects.
• signs of dystonia (can also occur after drug is discontinued): spasms of face and body; uncontrolled twisting movements; increased blinking or spasms of eyelid
• signs of neuroleptic malignant syndrome (NMS): troubled or fast breathing, high or low blood pressure, increased sweating, loss of bladder control, muscle stiffness, seizures, unusual tiredness, weakness, fast heartbeat, irregular pulse, pale skin
• changed or blurred vision; difficulty seeing at night
• difficulty urinating
• dark urine
• fever and sore throat
• yellow eyes or skin
• abdominal or stomach pains
• skin rash or severe sunburn
• fainting or low blood pressure
• abnormal bleeding or bruising
• sore mouth or gums
• nightmares
• nausea or vomiting
• diarrhea
• irregular or slow heart rate

Call your doctor if these symptoms continue:

• blurred vision
• stuffy nose
• constipation
• decreased sweating
• dizziness
• drowsiness
• changes in menstrual period
• decreased sexual ability
• rough or fuzzy tongue
• watering of mouth
• increased sensitivity of eyes to light
• unusual secretion of milk
• swelling or pain in breasts
• unusual weight gain

Call your doctor if these symptoms continue after you stop taking the drug:

• persistent tardive dyskinesia (see adverse effects above)
• persistent tardive dystonia (see adverse effects above)
• dizziness
• nausea, vomiting, stomach pain
• trembling of hands and fingers

Ask your doctor which of these tests should be done periodically while you are taking this drug:

• complete blood count
• blood pressure
• electrocardiogram (ECG, EKG)
• blood potassium level
• eye tests
• urine tests
• liver function tests
• levels of medication in blood
• observation for early signs of tardive dyskinesia
• determination of abnormal movement
• urine tests for bile and bilirubin