Thiothixene Hcl

NOTE: Not all of the following adverse reactions have been reported with Navane (thiothixene hcl) . However, since Navane (thiothixene hcl) has certain chemical and pharmacologic similarities to the phenothiazines, all of the known side effects and toxicity associated with phenothiazine therapy should be borne in mind when Navane (thiothixene hcl) is used.

Cardiovascular Effects: Tachycardia, hypotension, lightheadedness, and syncope. In the event hypotension occurs, epinephrine should not be used as a pressor agent since a paradoxical further lowering of blood pressure may result. Nonspecific EKG changes have been observed in some patients receiving Navane (thiothixene hcl) . These changes are usually reversible and frequently disappear on continued Navane (thiothixene hcl) therapy. The incidence of these changes is lower than that observed with some phenothiazines. The clinical significance of these changes is not known.

CNS Effects: Drowsiness, usually mild, may occur although it usually subsides with continuation of Navane (thiothixene hcl) therapy. The incidence of sedation appears similar to that of the piperazine group of phenothiazines but less than that of certain aliphatic phenothiazines. Restlessness, agitation and insomnia have been noted with Navane (thiothixene hcl) . Seizures and paradoxical exacerbation of psychotic symptoms have occurred with Navane (thiothixene hcl) infrequently.

Hyperreflexia has been reported in infants delivered from mothers having received structurally related drugs.

In addition, phenothiazine derivatives have been associated with cerebral edema and cerebrospinal fluid abnormalities.

Extrapyramidal Symptoms

Extrapyramidal symptoms, such as pseudoparkinsonism, akathisia and dystonia have been reported (see Dystonia, Class effect). Management of these extra-pyramidal symptoms depends upon the type and severity. Rapid relief of acute symptoms may require the use of an injectable antiparkinson agent. More slowly emerging symptoms may be managed by reducing the dosage of Navane (thiothixene hcl) and/or administering an oral antiparkinson agent.

Dystonia

Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Persistent Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy with thiothixene(1) or may occur after drug therapy has been discontinued. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities.

Since early detection of tardive dyskinesia is important, patients should be monitored on an ongoing basis. It has been reported that fine vermicular movement of the tongue may be an early sign of the syndrome. If this or any other presentation of the syndrome is observed, the clinician should consider possible discontinuation of antipsychotic medication. (See WARNINGS section.)

Hepatic Effects: Elevations of serum transaminase and alkaline phosphatase, usually transient, have been infrequently observed in some patients. No clinically confirmed cases of jaundice attributable to Navane (thiothixene) have been reported.

Hematologic Effects: As is true with certain other psychotropic drugs, leukopenia and leucocytosis, which are usually transient, can occur occasionally with Navane (thiothixene hcl) . Other antipsychotic drugs have been associated with agranulocytosis, eosinophilia, hemolytic anemia, thrombocytopenia and pancytopenia.

Allergic Reactions: Rash, pruritus, urticaria, photosensitivity and rare cases of anaphylaxis have been reported with Navane (thiothixene hcl) . Undue exposure to sunlight should be avoided. Although not experienced with Navane (thiothixene hcl) , exfoliative dermatitis and contact dermatitis (in nursing personnel) have been reported with certain phenothiazines.

Endocrine/Reproductive: Hyperprolactinemia(3); lactation, menstrual irregularities, moderate breast enlargement and amenorrhea have occurred in a small percentage of females receiving Navane (thiothixene hcl) . If persistent, this may necessitate a reduction in dosage or the discontinuation of therapy. Phenothiazines have been associated with false positive pregnancy tests, gynecomastia, hypoglycemia, hyperglycemia and glycosuria.

Autonomic Effects: Dry mouth, blurred vision, nasal congestion, constipation, increased sweating, increased salivation and impotence have occurred infrequently with Navane (thiothixene hcl) therapy. Phenothiazines have been associated with miosis, mydriasis, and adynamic ileus.

Other Adverse Reactions: Hyperpyrexia, anorexia, nausea, vomiting, diarrhea, increase in appetite and weight, weakness or fatigue, polydipsia, and peripheral edema.

Although not reported with Navane (thiothixene hcl) , evidence indicates there is a relationship between phenothiazine therapy and the occurrence of a systemic lupus erythematosus-like syndrome.

Neuroleptic Malignant Syndrome (NMS): Please refer to the text regarding NMS in the WARNINGS section.

NOTE: Sudden deaths have occasionally been reported in patients who have received certain phenothiazine derivatives. In some cases the cause of death was apparently cardiac arrest or asphyxia due to failure of the cough reflex. In others, the cause could not be determined nor could it be established that death was due to phenothiazine administration.

Thiothixene is not for use in psychotic conditions related to dementia. Thiothixene may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to thiothixene, or if you have a blood cell disorder such as anemia or low white blood cells or platelets, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

Call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Thiothixene may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not drink alcohol. Thiothixene can increase the effects of alcohol, which could be dangerous.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Thiothixene can decrease perspiration and you may be more prone to heat stroke.

Thiothixene is not for use in psychotic conditions related to dementia. Thiothixene may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use thiothixene if you are allergic to it, or if you have:

• a blood cell disorder such as anemia, low white blood cell counts, or low platelets; or
• drowsiness, slow breathing, weak pulse, or decreased alertness caused by taking certain medications or drinking alcohol.

To make sure you can safely take thiothixene, tell your doctor if you have any of these other conditions:

• epilepsy or other seizure disorder;
• heart disease;
• a history of low white blood cell (WBC) counts;
• a history of breast cancer; or
• if you are addicted to alcohol.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking thiothixene, do not stop taking it without your doctor's advice.

It is not known whether thiothixene passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Thiothixene should not be given to a child younger than 12 years old.