What Latuda is used for and how to use it
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Latuda - Consumer Medicine Information

Manufacture: Sunovion Pharmaceuticals Inc.
Country: Canada
Condition: Bipolar Disorder, Schizophrenia
Class: Atypical antipsychotics
Form: Tablets
Ingredients: lurasidone hydrochloride, carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, Opadry (hypromellose, polyethylene glycol, and titanium dioxide), pregelatinized starch; 80 mg tablet also contains: FDandC Blue No.2 Aluminum Lake and yellow ferric oxide.

About this medication

What the medication is used for:

LATUDA (lurasidone hydrochloride) is used to treat the symptoms of schizophrenia.

Schizophrenia is characterized by symptoms such as:

  • hearing, seeing, or sensing things that are not there
  • suspiciousness, mistaken beliefs
  • incoherent speech and behavior, and
  • emotional flatness.

People with this condition may also feel depressed, guilty, anxious, or tense.

LATUDA is also used to treat the symptoms of depression associated with bipolar disorder such as:

  • sadness
  • loss of interest and enjoyment
  • lack of energy
  • change in appetite
  • sleep disturbance, and
  • difficulty concentrating.

LATUDA is not a cure for your condition, but it can help manage your symptoms.

Your doctor may have prescribed LATUDA for another reason.

Ask your doctor if you have any questions about why LATUDA has been prescribed for you.

A Reminder: This medicine has been prescribed only for you. Never give it to anyone else.

What it does:

LATUDA belongs to a class of medicines called atypical antipsychotics.

Antipsychotic medications affect the chemicals that allow communication between nerve cells (neurotransmitters). Illnesses that affect the brain, such as schizophrenia or bipolar depression, may be due to certain chemicals in the brain being out of balance. These imbalances may cause some of the symptoms you may be experiencing. Doctors and scientists are not sure what causes these imbalances to occur. Exactly how LATUDA works is unknown. However, it seems to adjust the balance of chemicals called dopamine and serotonin.

When it should not be used:

Do not take LATUDA if you have had any allergic reaction to LATUDA or any of the ingredients listed in the “What the nonmedicinal ingredients are” section of this leaflet.

Do not take LATUDA if you are taking drugs that affect significantly the way LATUDA is metabolised in your body: a strong CYP3A4 inhibitor (for example, ketoconazole) or a strong CYP3A4 inducer (for example, rifampin).

What the medicinal ingredient is:

lurasidone hydrochloride

What the nonmedicinal ingredients are:

LATUDA contains the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, Opadry (hypromellose, polyethylene glycol, and titanium dioxide), pregelatinized starch; 80 mg tablet also contains: FDandC Blue No.2 Aluminum Lake and yellow ferric oxide.

What dosage forms it comes in:

20 mg, 40 mg, 80 mg, and 120 mg tablets

Warnings and precautions

Serious Warnings and Precautions
Various medicines of the group to which LATUDA belongs have been associated with an increased rate of death when used in elderly patients with dementia. LATUDA is not indicated in elderly patients with dementia.

BEFORE you use LATUDA, talk to your doctor or pharmacist if you:

  • are taking any other medicines (prescriptions or over the counter medicines)
  • are pregnant, think you are pregnant, or plan to become pregnant
  • are breastfeeding or plan to breastfeed
  • are an elderly patient suffering from dementia (loss of memory and other mental abilities)
  • exercise vigorously or work in hot or sunny places
  • have high blood sugar or a history of diabetes
  • have a history of kidney or liver problems
  • have involuntary, irregular muscle movements, especially in the face or tongue
  • suffer from abnormal (high) blood pressure or have rapid heart beat and a drop in pressure when getting up
  • suffer from heart disease or have a family history of heart disease, stroke, or "mini" stroke
  • have a history of any problems with the way your heart beats (arrhythmias) or if you are taking any medicines that may have an impact on the way your heart beats; or have a condition known as QT prolongation
  • 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, take oral contraceptives ("The Pill")
  • have or have had breast cancer
  • have pituitary tumours
  • drink alcohol or use street drugs
  • have ever had fainting, blackouts, or seizures
  • work with hazardous machinery or drive a motorized vehicle
  • have a history of low blood cell counts

Effects on Newborns:

In some cases, babies born to a mother taking LATUDA 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.

Other cautions:

Because some people experience drowsiness, you should not drive or operate machinery until you are reasonably certain that LATUDA does not affect your ability to carry out these activities.

Some people may faint, or experience symptoms such as light- headedness and dizziness, especially when getting up from a lying or sitting position. This is more likely to happen if you are elderly and also in the early stages of treatment or following dose increases. This will usually pass on its own but if it does not, tell your doctor.

Since medications of this type may interfere with the ability of the body to adjust to heat, it is best to avoid becoming overheated or dehydrated (for example, with vigorous exercise or exposure to extreme heat) while taking LATUDA.

Interactions with this medication

Tell all doctors, dentists, and pharmacists who are treating you that you are taking LATUDA.

As well, be sure to tell them about any other medications - prescription, non-prescription, or alternative - that you are taking or plan to take.

Inform your doctor if you start or stop taking any of the following medications:

  • ketoconazole, itraconazole, ritonavir, and other medicines that may increase the level of LATUDA in your blood and should not be taken while you are receiving LATUDA
  • rifampin, phenobarbital, phenytoin, and other medicines that may decrease the effect of LATUDA and should not be used while you are receiving LATUDA
  • diltiazem, erythromycin, fluconazole, verapamil, and other medicines that may increase the level of LATUDA in your blood as your doctor may have to change your dose of LATUDA
  • medicines used to treat problems with your heart beat (antiarrhythmics) or medicines that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (drugs to treat infections)

The effects of alcohol could be made worse while taking LATUDA. It is recommended that you do not drink alcohol while taking LATUDA.

You should avoid consuming grapefruit, grapefruit juice, or products containing grapefruit extract while receiving LATUDA.

Proper use of this medication

Usual dose:

Schizophrenia:

The usual starting dose is 40 mg once a day.

Depression Associated with Bipolar Disorder:

The usual starting dose is 20 mg once a day alone or in combination with lithium or valproate.

The most important thing about taking LATUDA is to take it exactly the way your doctor has prescribed it, every day. You should check with your doctor or pharmacist if you are not sure. Your doctor has decided on the best dosage for you based on your individual situation. Your doctor may increase or decrease your dose depending on your response.

LATUDA should be taken with food (at least 350 calories independent of fat content) and swallowed whole with water.

It is best to take LATUDA at the same time each day.

If you have moderate liver problems, your daily dose of LATUDA should not be more than 80 mg. If you have severe liver problems, your daily dose of LATUDA should not be more than 40 mg.

If you have moderate or severe kidney problems, your daily dose of LATUDA should not be more than 80 mg.

Do not give LATUDA to anyone else. Your doctor has prescribed it for you and your condition. LATUDA is not for use in children under 18 years of age.

Missed Dose:

If you miss a dose by a few hours, take it as soon as possible. If most of the day has passed, skip that dose and wait to take your next scheduled dose at the regular time. DO NOT DOUBLE THE DOSE PRESCRIBED TO YOU TO MAKE UP FOR A MISSED DOSE.

Overdose:

If you have taken more LATUDA tablets than your doctor has recommended (or if someone else has taken some of your LATUDA tablets), contact your regional Poison Control Centre and talk to your doctor right away or go to your nearest hospital emergency department. Take the medication package with you.

Side effects and what to do about them

Like other medicines, LATUDA can cause some side effects. These side effects are likely to be minor and temporary. However, some may be serious and need medical attention.

The most common side effects of LATUDA in patients with schizophrenia are:

  • drowsiness/sleepiness
  • feeling of restlessness (akathisia)
  • abnormal movements, tremor, muscle stiffness, slowing of movement
  • nausea

The most common side effects of LATUDA in patients with depression associated with bipolar disorder are:

  • feeling of restlessness (akathisia)
  • abnormal movements, tremor, muscle stiffness, slowing of movement.

The following other side effects may also happen in some people who take LATUDA:

  • Symptoms of an allergic reaction including rash, itching, flushing, and/or inflammation of the mouth and/or skin (see also SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM).
  • Increase in the amount of sugar (glucose) in the blood (hyperglycemia). Symptoms of high blood sugar can include feeling very thirsty and/or hungry, needing to urinate more than usual, feeling weak or tired, feeling sick to your stomach, feeling confused, fruity smelling breath.
  • Decreased blood pressure. Symptoms of decreased blood pressure can include lightheadedness or fainting when rising too quickly from a sitting or lying position.

The following may also occur with LATUDA, and may be seen in routine blood testing:

  • decrease in the amount of white blood cells
  • increase in the amount of hormone prolactin in the blood which:
    • in women, may lead to swelling of breasts and unexpected production of breast milk and changes in the regularity of monthly periods; and
    • in men, may lead to diminished sexual function and breast enlargement

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

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

Your doctor should take blood tests before starting LATUDA. They will monitor blood sugar 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.

You should tell your doctor if you notice any symptoms that worry you, even if you think the problems are not connected with the medicine or are not listed here.

Serious side effects, how often they happen and what to do about them

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking
drug and
seek
immediate
Only
if
severe
In all
cases
CommonNew or worsening
constipation
UncommonInvoluntary
movements
mainly of your
face or tongue
(tardive
dyskinesia)
Sudden weakness
or numbness of
he face, arms, or
egs and slurred
speech or vision
problems, even if
or a short period
of time
Feeling faint, or
dizzy, or lose
consciousness, or
feel a change in
the way your
heart beats
(palpitations)
Difficulty
swallowing
RarePronounced
muscle stiffness or
inflexibility with
high fever, rapid
or irregular
heartbeat,
sweating, state of
confusion, or
reduced
consciousness
(Neuroleptic
Malignant
Syndrome)
Seizure (loss of
consciousness
with
uncontrollable
shaking)
Symptoms of a
severe allergic
reaction such as
swelling of the
mouth, face, lips,
or tongue, and
may include
difficulty
breathing
Blood clots:
swelling, pain and
redness in an arm
or leg that can be
warm to touch.
You may develop
sudden chest pain,
difficulty
breathing, and
heart palpitations.
Very dark (“tea
coloured”) urine,
muscle
tenderness, and/or
aching
(rhabdomyolysis)
Long-lasting
(greater than 4
hours in duration)
and painful
erection of the
penis

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

How to store it

Store at room temperature (15 – 30oC).

The expiry date of this medicine is printed on the package label.Do not use the medicine after this date. Keep 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:
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  • 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 0701D
      Ottawa, Ontario
      K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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.sunovion.ca or by contacting the sponsor, Sunovion Pharmaceuticals Canada Inc. at: 1-866-260-6291