Navane: Uses, Side Effects and Dosage

What is NAVANE used for?

• NAVANE is used to treat schizophrenia and other psychotic disorders in adults.

How does NAVANE work?

NAVANE belongs to a group of medicines called antipsychotics, which affect chemicals in the brain that allow nerve cells to talk to each other (neurotransmitters). These chemicals are called dopamine and serotonin. NAVANE appears to work by changing the balance of dopamine and serotonin in your body.

What are the ingredients in NAVANE?

Medicinal ingredients: Thiothixene

Non-medicinal ingredients: Corn starch, FD&C red # 3, FD&C yellow #6, gelatin (bovine), lactose, magnesium stearate, silicon dioxide, sodium lauryl sulphate, titanium dioxide.

NAVANE comes in the following dosage forms:

Capsules: 5mg

Serious Warnings and Precautions

• Elderly Patients with Dementia: There is an increased risk of death when antipsychotic medications, such as NAVANE, are used in elderly patients with dementia. NAVANE is not to be used if you are older than 60 years of age and have dementia.
• Neuroleptic Malignant Syndrome (NMS) is a rare, life-threatening neurological disorder. It has been linked with the use of antipsychotic medications, including NAVANE. Symptoms of NMS include high fever, unusual stiffness of the muscles, disorder of your consciousness, sweating and fast heart rate. If you think you have NMS, seek medical attention right away.

Do not use NAVANE if:

• You are allergic to thiothixene, or to any of the ingredients in NAVANE
• You are allergic to other phenothiazines
• You have a medical condition known as pheochromocytoma (a tumor of the adrenal gland)
• You have a severe heart or blood vessel disorder
• You have severe kidney problems
• You have had brain damage
• You have a liver disease
• You have a blood cell disorder such as anemia, low white blood cell counts, or low platelets
• You have drowsiness, slow breathing, weak pulse

• You have decreased alertness caused by taking certain medications or drinking alcohol

• You are going to receive anesthesia in the spine or for a region (such as an arm, leg or the lower part of your body)
• You are under 12 years old

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NAVANE. Talk about any health conditions or problems you may have, including if you:

• Have heart disease, a history of heart problems or blood vessel problems
• Have a history of stroke, or are at risk for stroke
• Regularly drink alcohol; you should not take NAVANE if you are under the effects of alcohol

• Have risk factors for developing blood clots such as:

  • A family history of blood clots
  • Are 65 years of age or older
  • Are a smoker
  • Are overweight
  • Have had a recent major surgery (such as a hip or knee replacement)
  • Are not able to move due to air travel or other reasons
  • Take oral birth control (“The Pill”)
• Are taking any medications that make you drowsy.
• Have low levels of potassium or magnesium in your blood
• Have or are at risk of having an eye condition called glaucoma
• Have a condition called prostatic hypertrophy
• Have Parkinson’s Disease
• Have a history of seizures or convulsive disorders
• Are going through alcohol withdrawal
• Are exposed to extreme heat
• Are using insecticides; NAVANE can increase the toxicity of certain types of insecticides, including insecticides used for farming, treating animals (flea and tick control) and for treating pests around the house and garden. Be cautious if you must use these products while taking NAVANE
• Have high levels of a hormone called prolactin and a condition called hypogonadism

• Are pregnant or think you may be pregnant

• Are breast feeding or plan to breastfeed

Other warnings you should know about:

Driving and Using Machines: NAVANE may affect your mental and/or physical abilities, especially when you first start your treatment, or when your dose is increased. Before you drive or do any tasks that require special attention, wait until you know how you respond to NAVANE. You should be cautious when performing potentially hazardous tasks.

Effects on Newborns: You should not take NAVANE while you are pregnant unless you have talked to your healthcare professional about it. In some cases, babies born to a mother taking NAVANE during pregnancy have symptoms of withdrawal that are severe and require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they:

• Have difficulty breathing
• Are overly sleepy
• Have muscle stiffness, or floppy muscles (like a rag doll)
• Are shaking
• Are having difficulty feeding

Exposure to Sunlight: Skin reactions to the sun have been reported in people taking NAVANE. Where possible, avoid unnecessary exposure to sunlight.

Monitoring and Tests: Your healthcare professional may perform tests before and during your treatment with NAVANE. These may include tests to measure your:

• Body weight
• Blood sugar levels
• Complete blood count and white blood cell count
• Blood pressure
• Liver and kidney function

Severe Constipation: NAVANE may cause you to become severely constipated. Tell your healthcare professional if you have new or worsening constipation, you may need a laxative.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with NAVANE:

• alcohol; NAVANE can add to the effects of alcohol, avoid drinking alcohol while taking NAVANE
• anti-anxiety agents
• antidepressants
• muscle relaxants
• anti-seizure medicines, such as carbamazepine
• high blood pressure medicines, such as guanethidine and guanadrel
• cabergoline, used to treat high levels of prolactin
• metrizamide, used as a contrast agent
• grepafloxacin and sparfloxacin, used to treat bacterial infections
• lithium, used in the treatment of bipolar disorder
• cisapride, used to treat gastric reflux
• atropine-like drugs
• narcotic pain relievers (e.g., codeine)
• drugs used to aid sleep
• drowsiness-causing antihistamines (e.g., diphenhydramine) or other cough and cold medicines; ask your healthcare professional if you are unsure
• other drugs that may make you drowsy

How to take NAVANE:

• Take NAVANE by mouth, exactly as your healthcare professional tells you to
• Even if you feel better, do NOT change your dose or stop taking NAVANE without talking to your healthcare professional
• Try to take NAVANE at the same time each day

Usual dose:

The usual starting dose is 5 mg to 10 mg once a day. Your healthcare professional will slowly increase your dose to 15 mg to 30 mg once a day. Your healthcare professional has decided the best dose for you based on your individual situation but may change your dose depending on your response to the medication.

The maximum recommended dose is 60 mg once a day. Doses up to 60 mg a day can be divided in equal doses and taken twice or three times a day.

Overdose:

Symptoms of an overdose with NAVANE may include:

• agitation,
• confusion,
• drowsiness,
• dizziness,
• muscle stiffness or twitching,
• increased saliva production,
• trouble swallowing,
• weakness,
• loss of balance or coordination,
• fainting.

Missed Dose:

If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double your dose to make up the missed dose.

What are possible side effects from using NAVANE?

These are not all the possible side effects you may have when taking NAVANE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• sweating,
• leaking of urine due to loss of bladder control (urinary incontinence),
• dizziness, drowsiness,
• restlessness, agitation,
• depression,
• cramps,
• dry mouth,
• drooling,
• nasal congestion,
• nausea and vomiting,
• headache,
• menstrual changes,
• change in libido,
• impotence,
• swelling of the breasts and milk production in both men and women,
• weight changes
• blurred vision,
• skin more sensitive to sunburn,
• difficulty sleeping.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store this medication at room temperature between 15 and 30°C away from heat and light. Do not store in the bathroom.

Keep out of reach and sight of children.

If you want more information about NAVANE:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website, at:

  • http://searchlightpharma.com/ or by contacting the sponsor, Searchlight Pharma Inc., at:1 (855) 331-0830

Last Revised May 23, 2023