Navane Capsules 10mg: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NAVANE is used to treat schizophrenia and other psychotic disorders.

What it does:

Navane is an antipsychotic medication which affects chemicals in the brain that allow communication between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how Navane works is unknown. However, it seems to readjust the balance of dopamine and serotonin.

When it should not be used:

You should not use Navane if you have:

• An allergy to thiothixene, to any of its ingredients or to phenothiazines
• A medical condition known as pheochromocytoma (a tumor of the adrenal gland)
• A severe heart or blood vessel disorder
• Severe kidney problems
• Had brain damage
• Liver disease
• A blood cell disorder such as anemia, low white blood cell counts, or low platelets
• Drowsiness, slow breathing, weak pulse

• 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

What the medicinal ingredient is:

Thiothixene

What the nonmedicinal ingredients are:

Corn starch, gelatin (bovine), lactose, magnesium stearate, silicon dioxide, sodium lauryl sulphate, titanium dioxide. The 5mg and 10mg capsules also contain FD&C yellow #6 and FD&C red # 3.

What dosage forms it comes in:

Capsules: 2mg, 5mg and 10mg

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Studies with various medicines of the group to which NAVANE belongs, when used in the elderly patients with dementia, have been associated with an increased rate of death. NAVANE is not indicated in elderly patients with dementia.

BEFORE you use Navane talk to your doctor or pharmacist if:

• You have heart disease, glaucoma or prostatic hypertrophy

• You are addicted to alcohol. You should not take

  Navane if you are under the effects of alcohol.

• You have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives (“The Pill”).

• You are pregnant. Navane should not be used during pregnancy unless your doctor considers the benefits to you markedly outweigh the potential risks to the fetus

• You are taking barbiturates, painkillers , narcotics or, antihistamines or other drugs that make you drowsy.
• You have any allergies to this drug or its ingredients
• You have or ever had a blackout or seizure
• You are breast feeding.

Navane may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, especially during the first few days of therapy. You should be cautious when performing potentially hazardous tasks.

Effects on Newborns:

In some cases babies born to a mother taking Navane during pregnancy have experienced symptoms 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, or are having difficulty feeding.

People who take Navane are cautioned:

• Against exposure to extreme heat
• That drugs such as Navane increase the toxicity of certain types of insecticides ("organophosphorous" insecticides) including insecticides for agriculture (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.
• To avoid unnecessary exposure to sunlight

INTERACTIONS WITH THIS MEDICATION

Navane can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on Navane therapy.

Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products (such as St. John’s Wort), and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Before using Navane, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxants, and medicine for seizures, depression, or anxiety). You should not take Navane if you have drowsiness caused by other medications.

Drugs that may interact with Navane include:

anti-anxiety agents, antidepressants, muscle relaxants, anti-seizure medicine, high blood pressure medicine, cabergoline, metrizamide, guanethidine, guanadrel, grepafloxacin, sparfloxacin, lithium, cisapride, atropine-like drugs, narcotic pain relievers (e.g., codeine), drugs used to aid sleep, drowsiness-causing antihistamines (e.g., diphenhydramine), other drugs that may make you drowsy and carbamazepine.

Many cough-and-cold products contain ingredients that may add a drowsiness effect. Before using cough-and-cold medications, ask your doctor or pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

This list is not complete and there may be other drugs that can interact with Navane.

PROPER USE OF THIS MEDICATION

Take this medication by mouth exactly as prescribed. During the first few days your doctor may gradually increase your dose to allow your body to adjust to the medication. Do not take this more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of serious side effects will be increased. Do not stop taking this drug suddenly without your doctor's approval.

Your doctor will decide which dose is best for you.

Usual dose:

Usual Adult Initial dose: 5 to 10 mg once a day.

Usual adult optimal dose: 15 to 30 mg once a day. This dose could be increased by your physician.

Doses up to 60 mg a day can be divided in equal doses and

given twice or three times a day.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Overdose symptoms may include agitation, and confusion, drowsiness, dizziness, muscle stiffness or twitching, increased salivation, trouble swallowing, weakness, loss of balance or coordination, and fainting.

Missed Dose:

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not double your dose to make up the missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medications, Navane may cause some side effects. These side effects may be minor and temporary. However, some may be serious and need medical attention.

Side effects may include: sweating, urinary incontinence, dizziness, drowsiness, restlessness, agitation, depression, cramps, seizures, 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 and blurred vision, your skin may become more sensitive to sunburn, or you may have difficulty sleeping.

If any of these affects you severely, tell your doctor.

Your doctor should check your body weight before starting Navane and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting Navane. They will monitor blood sugar, your liver and the number of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being treated.

If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism you may be at increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

This is not a complete list of side effects. For any unexpected effects while taking Navane, contact your doctor or pharmacist.

HOW TO STORE IT

Store this medication at room temperature between 15 and 30 oC away from heat and light. Do not store in the bathroom. Keep this and all medications out of the reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

-------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.ECI2012.net

or by contacting the sponsor, ERFA Canada 2012 Inc., at: 1-800-922-3133

Last revised: December 19, 2012.