Lithane: Uses, Side Effects and Dosage

What is LITHANE used for?

LITHANE is used to treat manic episodes in adults who suffer from manic-depressive disorders (bipolar disorder). A manic episode includes symptoms such as:

• feeling invincible or an all-powerful inflated self-esteem,
• having racing thoughts, easily losing train of thought,
• overreacting to what you see or hear,
• speeding-up your activities,
• talking very quickly, too loudly, or more than usual,
• needing less sleep,
• having poor judgment,
• severe irritability.

LITHANE is also used as a long-term treatment in adults with bipolar disorder (with a strong history of mania) to prevent or reduce further episodes of mania and depression.

Serious Warnings and Precautions

• LITHANE is a medicine for which small increases in dose or blood concentration can lead to lithium toxicity. It is also known as a lithium overdose. This means that toxic side effects can occur at doses close to the prescribed dose. Your healthcare professional will need to monitor your blood levels of lithium to find the best dose for you.
• Certain medical conditions can increase your risk of lithium toxicity. Your healthcare professional will decide if LITHANE is right for you by carefully assessing your medical condition. This includes body weight checks, electrocardiogram (ECG), blood and/or urine tests.
• After a manic episode, usually within a week, your healthcare professional may rapidly decrease your dose of LITHANE. This is because your lithium tolerance may decrease after a manic episode and taking your usual dose may lead to lithium toxicity.

• Stop taking LITHANE and seek immediate medical help if you think you have taken too much

  LITHANE or if you experience the following symptoms of lithium toxicity:

  • lack of muscle control, diarrhea, vomiting, shaking, muscle weakness, lack of energy or sleepiness.

• You may find it helpful to tell a relative or close friend that you are taking LITHANE. Ask them to:

  • read this leaflet; and
  • tell you if they notice any signs of lithium toxicity while you are taking LITHANE.

How does LITHANE work?

LITHANE belongs to a group of medicines called antimanic agents. LITHANE modifies the transport of sodium in nerves and muscle cells. Exactly how LITHANE works is unknown. However, it seems to treat manic episodes and prevent the symptoms of mania and depression in people with manic-depressive disorders.

What are the ingredients in LITHANE?

Medicinal ingredients: Lithium carbonate

Non-medicinal ingredients: Gelatin

LITHANE comes in the following dosage forms:

Capsules: 150 mg and 300 mg

Do not use LITHANE if:

• you are allergic to lithium or any other ingredients in LITHANE or its packaging.
• you have severe heart or kidney problems.
• you have a condition that causes severe weakness or frailty.
• you are severely dehydrated.
• you have low blood sodium, or have a condition that requires you to have a diet low in sodium.
• you have or have had brain damage.

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

• have an infection with fever.
• have or have had heart problems, including an abnormal heart beat.
• have or have had thyroid problems.
• have been told you have low blood calcium.
• suffer from excessive vomiting, diarrhea, or sweating.
• take haloperidol or other antipsychotic medicines (used to treat serious mental and emotional disorders, including schizophrenia and other psychotic disorders).
• take diuretics, also known as “water pills” (used to treat high blood pressure and other heart problems).
• are pregnant, think you might be pregnant, or plan to become pregnant.
• are breastfeeding.

Other warnings you should know about:

LITHANE may cause serious side effects, including:

• Thyroid problems: The thyroid is a butterfly-shaped gland located at the front of your neck.

  LITHANE can cause an enlarged thyroid, also known as a goiter. Tell your healthcare professional if you notice your thyroid getting bigger while taking LITHANE. They may prescribe you small doses of thyroid hormones to help stop further growth or shrink your thyroid. If you have taken LITHANE for a long time, the goiter may disappear on its own after you stop taking LITHANE.

• Hypercalcemia (high blood calcium): Taking LITHANE for a long time may cause high levels of calcium in the blood. This can also be accompanied with a hormone disorder known as hyperparathyroidism. This is a condition where your parathyroid glands, which are located behind the thyroid, create too much parathyroid hormone in the blood. This can lead to other medical problems.
• Encephalopathic syndrome (a rare neurological disorder): Rare cases of encephalopathic syndrome have been reported in patients taking lithium with haloperidol, an antipsychotic medicine. This syndrome can lead to permanent brain damage. Your healthcare professional will closely monitor you if you take lithium with an antipsychotic medicine.
• Kidney problems: LITHANE may cause frequent urination, and other kidney problems that may affect how the kidney work. This may occur in patients taking LITHANE for a long time.

See the Serious side effects and what to do about them table for more information on these and other serious side effects.

Diet and hydration:

• While taking LITHANE:

  • do not make sudden changes to your salt (sodium) intake. Discuss any changes to your salt intake with your healthcare professional before making them.
  • drink plenty of fluids, especially during periods of prolonged or intense exercise. This is to ensure your body is able to properly get rid of the lithium in your blood.
• Low-sodium diets and dehydration may affect the level of lithium in your blood, leaving you at risk for lithium toxicity. If you have been suffering from excessive vomiting, sweating or diarrhea, you may need more salt and fluids. Talk to your healthcare professional if this happens.

Pregnancy and birth control:

• You should use a highly effective birth control method while taking LITHANE (males and females).

• LITHANE should not be taken during pregnancy or by women who could become pregnant unless:

  • no other appropriate therapy exists; and
  • your healthcare professional has determined the expected benefits outweigh the possible risks to your baby.
• Tell your healthcare professional right away if you become pregnant or think you might be pregnant while taking LITHANE. They will discuss the specific risks with you and decide if you should continue taking LITHANE, or use other treatments instead.

Breast-feeding: LITHANE can pass into breast milk and harm a breastfed baby. LITHANE should not be taken during breast-feeding unless your healthcare professional has determined the expected benefits outweigh the possible risks to your baby.

Adults (65 years of age or older): You may be more susceptible to side effects while taking LITHANE, even at prescribed doses.

Check-ups and testing: Your healthcare professional may do check-ups and tests before you start LITHANE and during your treatment. These tests may include:

• blood tests to monitor:

  • the amount of lithium in your blood
  • the health of your kidneys, thyroid and parathyroid glands
  • the amount of electrolytes (sodium and calcium) in your blood

• urine tests to monitor:

  • your hydration level
  • the health of your kidneys
• electrocardiogram (ECG) tests to monitor the health of your heart.
• body weight checks to monitor any weight gain.
• mental status checks to monitor your mental health.

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 LITHANE:

• medicines used to treat high blood pressure or other heart problems such as:

  • diuretics, also known as “water pills”.
  • Angiotensin Converting Enzyme (ACE) inhibitors (e.g., benazepril, captopril, enalapril or lisinopril).
  • calcium channel blockers (e.g., verapamil, diltiazem, amlodipine, felodipine, nifedipine).
  • a beta blocker called propranolol.
  • methyldopa.

• medicines used to treat serious mental and emotional disorders, including schizophrenia and other psychotic disorders. These include:

  • haloperidol.
  • phenothiazines (e.g., prochlorperazine, chlorpromazine, thioridazine, perphenazine, fluphenazine).
• medicines used to treat seizures (e.g., carbamazepine, phenytoin).
• medicines used to cause short-term paralysis during surgery (e.g., succinylcholine, pancuronium).
• medicines used to treat depression (e.g., selective serotonin reuptake inhibitors (SSRI) such as fluvoxamine, fluoxetine, citalopram and sertraline; tricyclic antidepressants).

• Non-steroidal anti-inflammatory Drugs (NSAIDs), used to relieve pain and reduce inflammation

  (e.g., ibuprofen, naproxen, diclofenac, celecoxib).

• theophylline, used to treat asthma and other lung diseases.
• potassium iodide, used to treat an overactive thyroid and to protect the thyroid gland from the effects of radiation.

• diazepam, used to treat anxiety, alcohol withdrawal and seizures.

• sodium bicarbonate, used to reduce stomach acid and treat heartburn.
• urea, used to treat low blood sodium.
• mazindol, used to suppress the appetite.
• low-sodium diets.

How to take LITHANE:

• Take LITHANE by mouth. Swallow capsules with a glass of water, if needed.
• Take LITHANE exactly as your healthcare professional has told you. Your healthcare professional will prescribe you the lowest dose possible needed for your treatment.
• Never take more than you are told. This may cause you serious harm or even death.

Usual dose:

• The dose prescribed to you will depend on your medical condition. Your healthcare professional will tell you how much and how often to take LITHANE.
• During your treatment, your healthcare professional will check if LITHANE is working for you and if it is causing you any unwanted effects. They may change your dose depending on the amount of lithium in your blood and how your respond to LITHANE.
• After a manic episode, usually within a week, your healthcare professional may rapidly decrease your dose. This is to avoid unwanted effects.

Overdose:

Signs of an overdose with LITHANE may include:

• lack of coordination or muscle control, shaking, muscle weakness or twitching,
• feeling sluggish, lack of energy,
• sleepiness,
• loss of appetite, vomiting,
• diarrhea.

If these signs occur, stop taking LITHANE and get immediate medical help.

If you think you, or a person you are caring for, have taken too much LITHANE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, skip it and take your next dose as scheduled. Do not take two doses at once to make up for the missed dose.

What are possible side effects from using LITHANE?

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

• upset stomach
• nausea
• muscle weakness
• vertigo (feeling like you are spinning)
• feeling dazed
• shaky hands
• sleepiness
• feeling thirsty or dehydrated
• need to urinate more often than usual
• dry mouth
• swelling of the hands, wrists, ankles or feet
• loss of bladder control
• inability to control bowel movements
• slurred speech
• feeling restless
• abdominal pain
• weight changes
• dehydration
• drying and thinning of hair, hair loss
• itchy or dry skin
• worsening of psoriasis (a skin condition)

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 between 15°C and 30°C.
• Keep out of reach and sight of children.

If you want more information about LITHANE:

• 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 websitewww.searchlightpharma.ca, or by calling 1-647-945-9762.

Last Revised SEP 21, 2022