Navane Side Effects

Generic Name: thiothixene

Please note - some side effects for Navane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Navane - for the Consumer

Navane

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Navane:

Appetite loss; blurred vision; confusion; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; nasal congestion; nausea; sleeplessness; tired feeling; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; changes in breasts; changes in menstrual period; changes in sexual function; changes in vision or other vision problems; chest pain; difficulty speaking; difficulty swallowing; fainting; fast, slow, or irregular heartbeat; fever; inability to move eyes; inability to urinate; involuntary movements of the tongue, face, mouth, or jaw; lip smacking or puckering; mask-like face; mental confusion; muscle spasms of face, neck, or back; numbness of the arms and legs; prolonged or painful erection; puffing of cheeks; restlessness; seizures; severe stomach pain; shuffling walk or stiff arms or legs; sore throat; tension in leg; tightness in the throat or jaw; tremors of hands; twitching or twisting movements; unusual or excessive sweating; weakness of arms or legs; yellowing of skin or eyes.

Navane Side Effects - for the Professional

Navane

NOTE: Not all of the following adverse reactions have been reported with Navane. However, since Navane 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 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. These changes are usually reversible and frequently disappear on continued Navane 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 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. Seizures and paradoxical exacerbation of psychotic symptoms have occurred with Navane 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. 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 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.

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. 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. Undue exposure to sunlight should be avoided. Although not experienced with Navane, 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. 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 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, 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.

Side Effects by Body System

Nervous system

Nervous system side effects are common and include drowsiness, dystonia, akathisia, and other extrapyramidal effects in up to 46% of treated patients. Patients with renal insufficiency may be particularly prone to the extrapyramidal effects of thiothixene.

Akathisia has been reported in up to 20% of patients receiving a single dose of thiothixene and 63% of patients receiving chronic treatment. Laryngeal-pharyngeal dystonia has also been reported rarely. In some cases, dystonia has been associated with rhabdomyolysis leading to acute renal failure.

Treatment of dystonic reactions and extrapyramidal effects, in addition to general supportive measures, may include judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden, or diphenhydramine.

Other

Other side effects including tardive dyskinesia have been reported and may be irreversible. Neuroleptic malignant syndrome has been reported to occur in as many as 0.5% to 1.0% of patients taking neuroleptic agents. Thiothixene has been specifically implicated. Sudden death after parenteral administration of thiothixene has been rarely reported in patients without underlying medical illness.

Involuntary rhythmical movements of the tongue, face and mouth characterize tardive dyskinesia. Early recognition of premonitory symptoms of tardive dyskinesia (like hyperkinetic dysarthria and fine vermiform movements of the tongue) may allow discontinuation of thiothixene before irreversible dyskinesia ensues. Tardive dyskinesia has been reported to occur in patients taking as little as 5 mg of thiothixene daily for eight months.

Fever, altered consciousness, autonomic dysfunction and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of neuroleptic therapy and intensive monitoring and supportive care are indicated.

Gastrointestinal

The anticholinergic effects of thiothixene have been implicated as a cause of esophageal atony and esophageal dilatation in one patient. That patient was also taking benztropine. The esophageal atony and dilatation resolved after dose reductions.

Gastrointestinal side effects including nausea, vomiting, constipation, excessive salivation, and dry mouth have been reported.

Psychiatric

Psychiatric side effects have included bizarre nightmares involving torture, worsening of underlying psychiatric illness, and agitation.

Endocrine

Endocrine side effects including hyperprolactinemia, galactorrhea, amenorrhea, and (less frequently) hyponatremia have been reported.

Ocular

Ocular side effects including pigmentary retinopathy and lenticular pigmentation have been reported.

Some clinicians have recommended periodic slit lamp examination for patients on chronic thiothixene therapy.

Hematologic

Hematologic side effects including cases of reversible thrombocytopenia and leukopenia have been reported rarely.

Genitourinary

Genitourinary side effects including priapism, urinary incontinence, nocturnal enuresis, and spontaneous ejaculation have been reported.

Immunologic

Immunologic side effects including Raynaud's phenomenon and a lupus-like syndrome have been reported.

Cardiovascular

Cardiovascular side effects including nonspecific EKG changes of uncertain clinical significance, orthostatic hypotension, tachycardia, and syncope have been reported.

Hypersensitivity

Hypersensitivity side effects including a telangiectatic macular eruption of the palms has been reported. Thiothixene may also predispose patients to photosensitivity.

Oncologic

Oncologic side effects including endometrial adenocarcinoma have been reported in association with thiothixene induced hyperprolactinemia.

Some investigators have suggested that endometrial sampling be performed in women taking neuroleptics if warranted by clinical suspicion.

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