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Navane

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Navane

Navane Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Navane (thiothixene hcl) is used to treat schizophrenia. It is an antipsychotic medication. This medication is available in generic form. Common side effects include dizziness or drowsiness, feeling restless or agitated, sleep problems (insomnia), breast swelling or discharge, changes in your menstrual periods, nausea, vomiting, diarrhea, constipation, changes in weight or appetite, dry mouth, increased thirst, or impotence, loss of interest in sex.

In milder conditions, an initial dose of 2 mg of Navane three times daily is recommended. If indicated, an increase to 15 mg/day total daily dose may be effective. In severe conditions, an initial dose of 5 mg twice daily is recommended. The usual optimal dose is 20 to 30 mg daily. Navane may interact with other medicines that make you sleepy (i.e., cold or allergy medicine, narcotics, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), carbamazepine, blood pressure medications, atropine, benztropine, dimenhydrinate, methscopolamine, scopolamine, bronchodilators, glycopyrrolate, mepenzolate, bladder or urinary medications, or irritable bowel medications. Tell your doctor all medications you use. During pregnancy, Navane should be taken only if prescribed. It may be harmful to a fetus. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.

Our Navane (thiothixene hcl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Navane in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking thiothixene and call your doctor at once if you have a serious side effect such as:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking);
  • trouble swallowing;
  • vision changes;
  • swelling in your hands or feet;
  • seizure (convulsions);
  • pale skin, easy bruising or bleeding, unusual weakness; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • dizziness or drowsiness;
  • feeling restless or agitated;
  • sleep problems (insomnia);
  • breast swelling or discharge;
  • changes in your menstrual periods;
  • nausea, vomiting, diarrhea, constipation;
  • changes in weight or appetite;
  • dry mouth, increased thirst; or
  • impotence, loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Navane (Thiothixene Hcl) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Navane FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Read the entire FDA prescribing information for Navane (Thiothixene Hcl) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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