advertisement
advertisement

Thiothixene Full Prescribing Information

Brand Name: Navane
Generic Name: Thiothixene

Navane, Thiothixene. is an antipsychotic used in treatment of schizophrenia, psychotic disorders. Uses, dosage, side-effects of Navane.

Contents:

Description
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Navane patient information (in plain English)

Description

Thiothixene (Navane) helps to treat schizophrenia. Thiothixene is an antipsychotic that helps patients with psychotic disorders keep in touch with reality.

top

Indications and Usage

An antipsychotic agent useful in the management of schizophrenia and other psychotic disorders.

As with other antipsychotic agents, some patients resistant to previous medication have responded favorably to thiothixene. It may also be of value in the management of withdrawn, apathetic schizophrenic patients.

Thiothixene is not recommended for the treatment of nonpsychotic mental and emotional disorders.

top

Contraindications

Known hypersensitivity to the drug. It is not known whether a cross sensitivity between the thioxanthenes and the phenothiazines exists, but this possibility should be considered.

Circulatory collapse, comatose states, CNS depression due to any cause and blood dyscrasias.

 

Children:
Safety for use in children under 12 years of age has not yet been established.

top


 

advertisement

Warnings

May cause drowsiness, dizziness, or blurred vision. Alcohol can increase dizziness and drowsiness. Avoid alcoholic drinks. You can get a hangover effect the morning after a bedtime dose.

Interference with Cognitive and Motor Performance: Psychotropic medications may impair judgement, thinking or motor skills. Consequently, patients should be cautioned against driving a car or operating hazardous machinery until they are reasonably certain that Navane does not affect them adversely.

Pregnancy and Nursing Mothers: The safety of Thiothixene (Navane) during pregnancy and lactation has not been established. Therefore, Thiothixene should not be used during pregnancy, unless, in the opinion of the physician, the expected benefits to the patient markedly outweigh the possible hazards to the fetus. Thiothixene should not be administered to nursing mothers unless, in the opinion of the treating physician, the expected benefits to the patient markedly outweigh the possible hazards to the child.

top

Precautions

Visit your prescriber or health care professional for regular checks on your progress. It may be several weeks before you see the full effects of thiothixene. Do not suddenly stop taking thiothixene. You may need to gradually reduce the dose. Only stop taking thiothixene on your prescriber's advice.

Do not treat yourself for colds, diarrhea or allergies. Ask your prescriber or health care professional for advice, some nonprescription medicines may increase possible side effects.

If you are going to have surgery tell your prescriber or health care professional that you are taking thiothixene.

Thiothixene may make you more sensitive to sun or ultraviolet light. Keep out of the sun, or wear protective clothing outdoors and use a sunscreen (at least SPF 15). Do not use sun lamps, or sun tanning beds or booths. To protect your eyes wear sunglasses even on cloudy days.

Avoid extreme heat or cold. Thiothixene can stop you sweating and increase your body temperature. It can also make your body unable to stand extreme cold. Avoid hot baths and saunas. Be careful about exercising especially in hot weather. Dress warmly in cold weather and do not stay out long in the cold.

Thiothixene may make your mouth dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help. Be careful when brushing and flossing your teeth to avoid mouth infections or damage to your gums. See your dentist regularly.

Do not take antacids or medicine for diarrhea within 2 hours of taking loxapine.

In consideration of the known capability of thiothixene and certain other antipsycotic drugs to precipitate convulsions, extreme caution should be used in patients with a history of convulsive disorders or those in a state of alcohol withdrawal, since it may lower the convulsive threshold.

Production or aggravation of ECG changes has occurred with thiothixene and therefore caution should be observed when there is increased risk to the patient.

Thiothixene should be used with caution in patients who are known or are suspected to have glaucoma, and in those who might be exposed to extreme heat or who are receiving atropine or related drugs.

Careful observation should be made for pigmentary retinopathy, and lenticular pigmentation (fine lenticular pigmentation has been noted in a small number of patients treated with thiothixene for prolonged periods). Blood dyscrasias (agranulocytosis, pancytopenia, thrombocytopenic purpura), and liver damage (jaundice, biliary stasis), have been reported with related drugs.

To lessen the likelihood of adverse reactions related to drug accumulation, patients on long-term therapy, particularly on high doses, should be evaluated periodically to decide whether the maintenance dosage could be lowered or drug therapy discontinued. Periodic blood counts and liver function tests should be performed. Sudden onset of severe CNS or vasomotor symptoms should be kept in mind.

top

Drug Interactions

Tell your doctor what other medication you take (including nonprescription), especially: Methyldopa, guanethidine, other drugs used for mental conditions, amoxapine, metoclopramide, pemoline, promethazine, antidepressants, drugs that have sedating effects (antihistamines, sedatives, sleeping pills, tranquilizers, narcotic pain medication and muscle relaxants), quinidine, levodopa, guanadrel or reserpine. Do not start or stop any medicine without doctor or pharmacist approval.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Check with your health care professional before stopping or starting any of your medicines.

top

Adverse Reactions

Thiothixene, Navane side effects that you should report to your prescriber or health care professional as soon as possible:

  • changes in vision
  • confusion
  • difficulty breathing
  • difficulty in speaking or swallowing
  • difficulty passing urine, or sudden loss of bladder control
  • dizziness or lightheadedness, fainting spells
  • fast or irregular heartbeat (palpitations)
  • fever, chills, or sore throat-hot, dry skin or lack of sweating
  • increased sweating
  • loss of balance or difficulty walking
  • seizures (convulsions)
  • stiffness, spasms, trembling
  • uncontrollable tongue or chewing movements, smacking lips or puffing cheeks
  • uncontrollable muscle spasms, in the face hands, arms, or legs, twisting body movements
  • unusual weakness or tiredness.

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

-anxiety or agitation -breast pain or swelling -constipation -decreased sexual ability -drowsiness -dry mouth -increased sensitivity to the sun (severe sunburn) -menstrual changes -nausea or vomiting -pain or irritation at the injection site -skin rash -unusual production of breast milk -weight gain.

top

Overdose

Signs and Symptoms

Signs of overdose include muscular twitching, drowsiness, and dizziness. Symptoms of gross overdosage may include CNS depression, rigidity, weakness, torticollis, tremor, salivation, dysphagia, hypotension, disturbances of gait, or coma.

Treatment

Essentially symptomatic and supportive. Early gastric lavage may be helpful. Keep patient under careful observation and maintain an open airway, since involvement of the extrapyramidal system may produce dysphagia and respiratory difficulty in severe overdosage. If hypotension occurs, the standard measures for managing circulatory shock should be used (i.v. fluids and/or vasoconstrictors).

top

Dosage

HOW TO USE THIS MEDICINE:

DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed.

  • Follow the directions for using this medicine provided by your doctor.
  • Take this medicine with water. If thiothixene upsets your stomach, you can take it with food.
  • Store this medicine at room temperature, away from heat and light.
  • If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. If you take only one dose a day at bedtime and forget, do not take it in the morning without calling your prescriber or health care professional for advice. Do not take double or extra doses.
  • Do not stop taking this medicine without first checking with your doctor.

Adults: The usual optimal dosage of thiothixene (Navane) is in the range of 15 to 30 mg daily. In most conditions, the initial dosage should be 5 to 10 mg daily. The dosage should be gradually increased to the optimally effective level based on patient response. An increase to 60 mg/day may be necessary; however, exceeding a total daily dosage of 60 mg/day rarely increases beneficial response.

Patients on the average therapeutic dosage may be maintained on once a day therapy. Higher dosage can be given in 2 or 3 equally divided doses. The dosage should be reduced to the lowest possible maintenance level as soon as possible.

Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

top

How Supplied

Each hard gelatin capsule contains: Thiothixene 2 mg (white); 5 mg (orange and white); 10 mg (orange) and sodium lauryl sulfate 400 mcg (0.4 mg). Also contains cornstarch, lactose and magnesium stearate/sodium lauryl sulfate. Capsule shells also contain gelatin, sodium lauryl sulfate, sodium metabisulfite, titanium dioxide and dyes FD & C Red #3 and FD & C Yellow #6 (5 and 10 mg only). Tartrazine-free. Bottles of 100.

Navane Patient Information Sheet

Detailed Info on Signs, Symptoms, Causes, Treatments of Schizophrenia


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

Copyright © 2007 Healthyplace Inc. All rights reserved.

back to top

back to: Psychiatric Medications Pharmacology Homepage

Last Updated: 09 April 2017
Reviewed by Harry Croft, MD

Related Articles

Follow Us

advertisement

Mental Health Newsletter

Sign up for the HealthyPlace mental health newsletter for latest news, articles, events.

Mental Health
Newsletter Subscribe Now!

Mental Health Newsletter

Sign up for the HealthyPlace mental health newsletter for latest news, articles, events.

Log in

Login to your account

Username *
Password *
Remember Me
advertisement
X
advertisement
X
advertisement
X
Back To Top