Brand Names:

• Navane

Dosage Forms:

• Capsule

Uses of This Medicine:

The family of medicines known as thioxanthenes are used in the treatment of nervous, mental, and emotional conditions. Improvement in such conditions is thought to result from the effect of these medicines on nerve pathways in specific areas of the brain.

Thioxanthene medicines are available only with your doctor's prescription.

Before Using This Medicine:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, who are usually more sensitive than adults to the side effects of thioxanthenes.

Older adults—

Constipation, dizziness or fainting, drowsiness, dryness of mouth, trembling of the hands and fingers, and symptoms of tardive dyskinesia (such as rapid, worm-like movements of the tongue or any other uncontrolled movements of the mouth, tongue, or jaw, and/or arms and legs) are especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of thioxanthenes.

Pregnancy—

Studies have not been done in pregnant women. Although animal studies have not shown that thioxanthenes cause birth defects, the studies have shown that these medicines cause a decrease in fertility and fewer successful pregnancies.

Breast-feeding—

It is not known if thioxanthenes pass into the breast milk. However, similar medicines for nervous, mental, or emotional conditions do pass into breast milk and may cause drowsiness and increase the risk of other problems in the nursing baby. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Bromopride
• Levoketoconazole
• Metoclopramide
• Potassium Citrate

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Adagrasib
• Alfuzosin
• Amantadine
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Bupropion
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duloxetine
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Fedratinib
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lithium
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methacholine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Revefenacin
• Ribociclib
• Risperidone
• Ritonavir
• Scopolamine
• Secretin Human
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tiotropium
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse—Drinking alcohol will add to the central nervous system (CNS) depressant effects of thioxanthenes.

• Blood disease or
• Enlarged prostate or
• Glaucoma or
• Heart or blood vessel disease or
• Lung disease or
• Parkinson's disease or
• Stomach ulcers or
• Urination problems—Thioxanthenes may make the condition worse.

• Liver disease—Higher blood levels of thioxanthenes may occur, increasing the chance of side effects.

• Reye's syndrome—The risk of liver problems may be increased.

• Seizure disorders—The risk of seizures may be increased.

Proper Use of This Medicine:

This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients taking thiothixene oral solution:

• This medicine must be diluted before you take it. Just before taking, measure the dose with the specially marked dropper. Mix the medicine with a full glass of water, milk, tomato or fruit juice, soup, or carbonated beverage.

Do not take more of this medicine or take it more often than your doctor ordered. This is particularly important when this medicine is given to children, since they may react very strongly to its effects.

Sometimes this medicine must be taken for several weeks before its full effect is reached.

Dosing—

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of psychosis:
  • For oral dosage forms (suspension or tablets):
    • Adults and teenagers—25 to 50 milligrams (mg) three or four times a day.
    • Children 6 to 12 years of age—10 to 25 mg three or four times a day.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
  • For injection dosage form:
    • Adults and teenagers—25 to 50 mg, injected into a muscle, three or four times a day.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

• For treatment of psychosis:
  • For oral dosage form (tablets):
    • Adults—To start, 1 milligram (mg) three times a day. Your doctor may increase your dose if needed, depending on your condition.
    • Children—Use and dose must be determined by your doctor.
  • For long-acting injection dosage form:
    • Adults—To start, 20 to 40 milligrams (mg) injected into a muscle. Your doctor will determine whether your dose needs to be changed, depending on your condition.
    • Children—Use and dose must be determined by your doctor.

• For treatment of psychosis:
  • For oral dosage forms (capsules and solution):
    • Adults and teenagers—To start, 2 milligrams (mg) three times a day, or 5 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 60 mg a day.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For injection dosage form:
    • Adults and teenagers—4 milligrams (mg), injected into a muscle, two to four times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 30 mg a day.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Your doctor should check your progress at regular visits. This will allow the dosage of the medicine to be adjusted when necessary and also will reduce the possibility of side effects.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This is to prevent side effects and to prevent your condition from becoming worse.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any such depressants while you are using this medicine.

Do not take this medicine within an hour of taking antacids or medicine for diarrhea. Taking them too close together may make this medicine less effective.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking thioxanthenes together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

This medicine may cause some people to become drowsy or less alert than they are normally, especially during the first few weeks the medicine is being taken. Even if you take this medicine only at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur while you are taking this medicine, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Thioxanthenes may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you are taking a liquid form of this medicine, try to avoid spilling it on your skin or clothing. Skin rash and irritation have been caused by similar medicines.

If you are receiving this medicine by injection:

• The effects of the long-acting injection form of this medicine may last for up to 3 weeks. The precautions and side effects information for this medicine applies during this period of time.

Side Effects of This Medicine:

Along with their needed effects, thioxanthenes can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. Some of these side effects, including severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures, may be the sign of a condition called neuroleptic malignant syndrome. You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

Convulsions (seizures)

difficulty in breathing

fast heartbeat

high fever

high or low (irregular) blood pressure

increased sweating

loss of bladder control

muscle stiffness (severe)

unusually pale skin

unusual tiredness

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Difficulty in talking or swallowing

inability to move eyes

lip smacking or puckering

loss of balance control

mask-like face

muscle spasms, especially of the neck and back

puffing of cheeks

rapid or worm-like movements of tongue

restlessness or need to keep moving (severe)

shuffling walk

stiffness of arms and legs

trembling and shaking of fingers and hands

twisting movements of body

uncontrolled chewing movements

uncontrolled movements of the arms and legs

Less common

Blurred vision or other eye problems

difficult urination

fainting

skin discoloration

skin rash

Rare

Hot, dry skin or lack of sweating

increased blinking or spasms of eyelid

muscle weakness

sore throat and fever

uncontrolled twisting movements of neck, trunk, arms, or legs

unusual bleeding or bruising

unusual facial expressions or body positions

yellow eyes or skin

Symptoms of overdose

Difficulty in breathing (severe)

dizziness (severe)

drowsiness (severe)

muscle trembling, jerking, stiffness, or uncontrolled movements (severe)

small pupils

unusual excitement

unusual tiredness or weakness (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

decreased sweating

dizziness, lightheadedness, or fainting

drowsiness (mild)

dryness of mouth

increased appetite and weight

increased sensitivity of skin to sunlight (skin rash, itching, redness or other discoloration of skin, or severe sunburn)

stuffy nose

Less common

Changes in menstrual period

decreased sexual ability

swelling of breasts (in males and females)

unusual secretion of milk

After you stop taking this medicine your body may need time to adjust, especially if you took this medicine in high doses or for a long time. If you stop taking it too quickly, the following withdrawal effects may occur and should be reported to your doctor:

Dizziness

nausea and vomiting

stomach pain

trembling of fingers and hands

uncontrolled, continuing movements of mouth, tongue, or jaw

Although not all of the side effects listed above have been reported for all thioxanthenes, they have been reported for at least one of them. However, since these medicines are very similar, any of the above side effects may occur with any of them.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.