Navane (Oral)

Thiothixene is used to treat a mental condition called schizophrenia. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check how you are doing at regular visits to ensure that this medicine is working properly. Blood tests may be necessary to look for unwanted effects. You may also need regular eye tests while using this medicine.

This medicine may cause tardive dyskinesia (a movement disorder). Contact your doctor immediately if you notice any of the following symptoms while using this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Stop using this medicine and contact your doctor immediately if you experience any of the following symptoms: convulsions (seizures), difficulty breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be signs of a serious condition called neuroleptic malignant syndrome (NMS).

Thiothixene can temporarily decrease the number of white blood cells in your blood, which increases the risk of getting an infection. If possible, avoid contact with people who have infections. Contact your doctor immediately if you think you may be getting an infection or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause dizziness, difficulty thinking, or trouble controlling body movements. Make sure you know how this medicine affects you before you drive, operate machines, or do anything else that requires alertness, coordination, or clear thinking.

This medicine will increase the effects of alcohol and other CNS depressants (medications that cause drowsiness or decreased alertness). Some examples of CNS depressants include antihistamines or medications for allergies or colds; sedatives, tranquilizers, or sleeping medications; prescription pain medications, including narcotics; medications for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Consult your doctor before taking any of these while using this medicine.

You may get overheated more easily while using this medicine. Be mindful of this if you are exercising or if the weather is hot. Drinking water may help. If you become too hot and feel dizzy, weak, tired, confused, or nauseous, try to cool down. Call your doctor if you cannot cool down and your symptoms persist.

Do not take other medications unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks of the medicine against its benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

The use of thiothixene in children younger than 12 years old is not recommended.

Geriatric

There is no information available on how age affects the effects of thiothixene in older patients. However, this medicine should not be used for behavioral problems in older adults with dementia.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together despite possible interactions. If you are taking this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may adjust the other medicines you are taking.

• Bromopride
• Metoclopramide
• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Amantadine
• Apomorphine
• Buprenorphine
• Bupropion
• Clozapine
• Codeine
• Dihydrocodeine
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Lithium
• Methacholine
• Methadone
• Oxycodone
• Quetiapine
• Remifentanil
• Revefenacin
• Scopolamine
• Secretin Human
• Tapentadol
• Tiotropium
• Zotepine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Betel Nut

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods, as interactions may occur. Using alcohol or tobacco with some medicines can also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact your use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (e.g., agranulocytosis, leukopenia, neutropenia) or
• Central nervous system depression (severe drowsiness or loss of consciousness) or
• Circulatory collapse (shock-like state)—This medicine should not be used in patients with these conditions.

• Breast cancer, prolactin-dependent or
• Eye or vision problems (e.g., pigmentary retinopathy, lenticular pigmentation) or
• Heart or blood vessel disease or
• Hyperprolactinemia (high prolactin in the blood) or
• Liver disease or
• Neuroleptic malignant syndrome (NMS), history of or
• Seizures, history of—Use with caution. This medicine may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• unusual tiredness or weakness
• wheezing

Incidence not known

• Abdominal or stomach pain
• back, leg, or stomach pains
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• bloody, black, or tarry stools
• blurred vision
• chest pain
• chills
• clay-colored stools
• confusion
• convulsions
• cough or hoarseness
• dark urine
• difficulty with breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• fever with or without chills
• general body swelling
• general feeling of tiredness or weakness
• headache
• high fever
• high or low blood pressure
• inability to move the eyes
• inability to sit still
• increased blinking or spasms of the eyelid
• increased sweating
• lightheadedness
• lip smacking or puckering
• loss of appetite
• loss of balance control
• loss of bladder control
• lower back or side pain
• mask-like face
• nausea or vomiting
• need to keep moving
• nosebleeds
• overactive reflexes
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• rapid weight gain
• restlessness
• seizures
• severe muscle stiffness
• shuffling walk
• slowed movements
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sticking out of the tongue
• sweating
• swollen glands
• tic-like (jerky) movements of the head, face, mouth, and neck
• tingling of the hands or feet
• tiredness
• trembling and shaking of the fingers and hands
• trouble with breathing, speaking, or swallowing
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unexplained bleeding or bruising
• unpleasant breath odor
• unusual bleeding or bruising
• unusual facial expressions
• unusual weight gain or loss
• unusually pale skin
• vomiting of blood
• yellowing of the eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness
• depression
• drowsiness
• loss of consciousness
• sudden jerky movements of the body

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:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• constipation
• decreased interest in sexual intercourse
• diarrhea
• dry mouth
• extreme thirst
• hives or welts
• hyperventilation
• inability to have or keep an erection
• increased appetite
• increased sensitivity of the skin to sunlight
• increased sweating
• increased thirst
• increased weight
• irritability
• loss in sexual ability, desire, drive, or performance
• menstrual changes
• nervousness
• redness or other discoloration of the skin
• severe sunburn
• sleeplessness
• stopping of menstrual bleeding
• stuffy nose
• swelling of the breasts or unusual milk production
• trouble with sleeping
• unable to sleep
• watering of mouth

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.

In the U.S.

• Navane

Available Dosage Forms:

• Capsule

Therapeutic Class: Antipsychotic

Chemical Class: Thioxanthene

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of this medicine 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 this medicine. 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 oral dosage form (capsules):For schizophrenia: Adults and teenagers 12 years of age and older—At first, 2 milligrams (mg) three times per day or 5 mg two times per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day. Children younger than 12 years of age—Use is not recommended.

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• What drugs cause tardive dyskinesia?