Apo-Lithium Carbonate: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is APO-LITHIUM CARBONATE used for?

APO-LITHIUM CARBONATE is used to treat manic episodes in adults who suffer from manic-depressive disorders (bipolar disorder).

APO-LITHIUM CARBONATE 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.

How does APO-LITHIUM CARBONATE work?

APO-LITHIUM CARBONATE belongs to a group of medicines called antimanic agents. APO-LITHIUM CARBONATE modifies the transport of sodium in nerves and muscle cells. Exactly how APO-LITHIUM CARBONATE 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 APO-LITHIUM CARBONATE?

Medicinal ingredient: Lithium Carbonate

Non-medicinal ingredients: D&C red #28, D&C yellow #10 (150 mg only), FD&C red #40, FD&C yellow #6 (300 mg only), gelatin, talc and titanium dioxide. The edible black printing ink on the capsule shell contains the non-medicinal ingredient black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

APO-LITHIUM CARBONATE comes in the following dosage forms:

Capsules; 150 mg and 300 mg

Do not use APO-LITHIUM CARBONATE if:

• you are allergic to lithium carbonate or any of the other ingredients in APO-LITHIUM CARBONATE.
• you have a condition that causes severe weakness or frailty.
• you are severely dehydrated.
• you have severe kidney disease.
• you have severe heart disease.
• you have low levels of sodium in the blood or have a condition that requires you to have a diet low in sodium.
• you are taking diuretics, also known as “water pills” (used to treat high blood pressure and other heart problems).
• you have or have had brain damage.

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

• have or had heart problems.
• have or had kidney problems or reduced kidney function.
• have or previously had a thyroid disease.
• are pregnant, think you might be pregnant, or plan to become pregnant.
• are breast-feeding or trying to breast-feed.
• are 65 years of age or older.
• take haloperidol or other antipsychotic medicines (used to treat serious mental and emotional disorders, including schizophrenia and other psychotic disorders).

Other warnings you should know about:

Driving and Using Machines: Before you drive or do tasks that require special attention, wait until you know how you respond to APO-LITHIUM CARBONATE.

APO-LITHIUM CARBONATE may cause serious side effects, including:

• Hypercalcemia (high blood calcium): Taking APO-LITHIUM CARBONATE 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: APO-LITHIUM CARBONATE may cause frequent urination, and other kidney problems that may affect how the kidney work. This may occur in patients taking APO-LITHIUM CARBONATE for a long time.
• Drug Rash with Eosinophilia and Systemic Syndrome (DRESS): Serious skin reactions, that can be fatal, can happen in people taking APO-LITHIUM CARBONATE. These reactions include Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Get medical help right away if you develop a rash at any time while you are taking APO-LITHIUM CARBONATE.

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

Pregnancy: If you take APO-LITHIUM CARBONATE during pregnancy, your baby is at risk for health issues, such as heart problems kidney problems and low blood sugar. APO-LITHIUM CARBONATE should not be taken during pregnancy or by people 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 APO-LITHIUM CARBONATE. Your healthcare professional will discuss the risks with you and decide if you should continue taking APO-LITHIUM CARBONATE.

Breast-feeding: APO-LITHIUM CARBONATE can pass into breast milk. APO-LITHIUM CARBONATE should not be taken during breast-feeding unless your healthcare professional has determined the expected benefits outweigh the possible risks to your baby.

Diet and hydration: While taking APO-LITHIUM CARBONATE:

• 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, or infection with a fever, you may need more salt and fluids. Talk to your healthcare professional if this happens.

Check-ups and testing: Your healthcare professional may do check-ups and tests before you start APO-LITHIUM CARBONATE 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.
• a physical examination.

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 APO-LITHIUM CARBONATE:

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

  • diuretics, also known as water pills
  • Angiotensin Converting Enzyme (ACE) Inhibitors
  • calcium channel blockers such as verapamil and diltiazem
  • methyldopa

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

  • haloperidol
  • phenothiazines such as chlorpromazine
• medicines used o treat seizures such as carbamazepine and phenytoin
• medicines used to treat depression such as selective serotonin inhibitors (fluoxetine, fluvoxamine and sertraline) and tricyclic antidepressants
• Non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and reduce inflammation
• medicines called bronchodilators that make breathing easier, such as theophylline and aminophylline
• potassium iodide, used to treat an overactive thyroid and to protect the thyroid gland from the effects of radiation
• amphetamines, a stimulant medicine that is used to treat ADHD
• sodium bicarbonate, used to reduce stomach acid and treat heartburn
• mazindol, used to suppress the appetite
• low-sodium diets
• tetracyclines, used to manage and treat bacterial infections
• sodium-glucose cotransporter 2 inhibitor, used to lower blood sugar
• neuromuscular blocking agents, used to relax muscles for anesthesia
• high and low sodium chloride (salt) diets

How to take APO-LITHIUM CARBONATE:

• Take APO-LITHIUM CARBONATE exactly as your healthcare professional has told you.
• Do not stop taking your dose or change your dose without talking to your healthcare professional. Never take more than you are told. This may cause you serious harm or even death.

• Take APO-LITHIUM CARBONATE with food. Swallow the capsules whole. Do not break or chew the capsules.

Usual dose

• Your healthcare professional will tell you how much and how often to take APO-LITHIUM CARBONATE. Your dose will depend on:

  • your medical condition
  • your age
  • your weight
  • if you have kidney problems

• During your treatment, your healthcare professional will check if APO-LITHIUM CARBONATE is working for you and if it is causing you any unwanted side effects. They

  • -LITHIUM CARBONATE depending on the amount of lithium in your blood and how you respond to APO-LITHIUM CARBONATE.
• After a manic episode, usually within a week, your healthcare professional may rapidly decrease your dose. This is to avoid unwanted side effects.

Overdose:

Some of the signs of an overdose (lithium toxicity) could be:

• diarrhea
• drowsiness
• lack of coordination
• loss of appetite
• muscle weakness
• nausea or vomiting
• slurred speech
• trembling
• blurred vision
• clumsiness or unsteadiness
• confusion
• convulsions (seizures)
• dizziness
• increase in amount of urine
• ringing in the ears
• trembling (severe)

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 APO-LITHIUM CARBONATE?

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

• abdominal pain
• altered taste
• diarrhea
• need to urinate more often than usual
• feeling thirsty or dehydrated
• loss of appetite
• nausea
• sensation of spinning (vertigo)
• feeling tired or sleepy
• trembling of hands
• vomiting
• muscle weakness
• feeling sleepy or dazed
• dry mouth
• drying and thinning of hair or hair loss
• weight changes
• headache
• worsening of psoriasis (a skin condition)
• itchy or dry skin
• swelling of the hands, wrists, ankles or feet
• feeling restless
• feeling dazed or dizzy

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 at room temperature between 15°C and 30°C, away from heat and direct light.
• Do not store in a humid place, such as a bathroom.
• Keep in a well closed container.
• Keep out of reach and sight of children.
• Do not dispose of medications down the sink, in the toilet or in household garbage.
• Ask your healthcare professional on how to dispose of medications that are no longer needed or have expired.

If you want more information about APO-LITHIUM CARBONATE:

• 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 (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: JUL 24, 2024