Navigation

Navane

  • Generic Name: thiothixene hcl
  • Brand Name: Navane

Navane (Thiothixene Hcl) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

Navane Side Effects Center

Navane (thiothixene hcl) is an antipsychotic medication used to treat schizophrenia. Navane is available in generic form. Common side effects of Navane include:

  • dizziness,
  • 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,
  • impotence, or
  • loss of interest in sex.

Tell your doctor if you have serious side effects of Navane including:

  • 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;
  • tremors (uncontrolled shaking);
  • trouble swallowing;
  • vision changes;
  • swelling in your hands or feet;
  • seizures (convulsions);
  • pale skin, easy bruising or bleeding, unusual weakness; or
  • fever, chills, body aches, flu symptoms.

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 breastfeeding.

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.

 

Navane Consumer Information

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

High doses or long-term use of thiothixene can cause a serious movement disorder that may not be reversible. The longer you use thiothixene, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • stiffness in your neck, tightness in your throat, trouble breathing or swallowing;
  • seizure (convulsions);
  • a light-headed feeling, like you might pass out;
  • severe constipation;
  • low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

  • dry mouth;
  • blurred vision;
  • nausea, vomiting, diarrhea, constipation;
  • fast heartbeats, feeling restless;
  • breast swelling or discharge;
  • changes in weight or appetite; or
  • swelling in your hands or feet.

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)

 

Navane Professional Information

SIDE EFFECTS

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 (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 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 thiothixene1 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. 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

Hyperprolactinemia3; 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.

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

&Copy; Navane Patient Information is supplied by Cerner Multum, Inc. and Navane Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.