Eskalith (Oral)

Lithium is used to treat mania that occurs with bipolar disorder (manic-depressive illness). It is also taken daily to lower how often and how severe manic episodes are. People with manic-depressive illness have extreme mood swings, which can include feeling very excited or manic (for example, experiencing unusual anger, irritability, or a false sense of well-being) to feeling depressed or sad.

It is not clear how lithium helps stabilize mood, but it does affect the central nervous system. It helps you gain better control over your emotions and manage life’s challenges more effectively.

It is important for you and your family to understand all the effects of this medicine. These effects can vary based on your specific condition, how you respond to the medication, and the dose of lithium you take. You should also know when to reach out to your doctor if you experience any issues with the medication.

This medicine is available only with a prescription from your doctor.

It is very important for your doctor to check your or your child's progress during regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you might be pregnant while using the medicine, tell your doctor right away.

Call your doctor immediately if you have diarrhea, vomiting, drowsiness, muscle weakness, tremors, unsteadiness, or any other issues with muscle control or coordination. These may be signs of lithium toxicity.

Make sure your doctor knows if you have a heart disorder called Brugada syndrome. Brugada syndrome can be life-threatening and requires immediate medical attention. Call your doctor or the emergency department right away if you experience a fast, pounding, or uneven heartbeat, unexplained fainting, lightheadedness, or trouble breathing after using this medicine.

This medicine may cause pseudotumor cerebri (increased pressure in the brain). Call your doctor immediately if you have blurred or double vision, dizziness, eye pain, severe headache, or nausea and vomiting.

Encephalopathic syndrome (brain problem) may occur in patients using this medicine along with a medicine to treat mental illness (e.g., chlorpromazine [Thorazine®], clozapine [Clozaril®], fluphenazine [Prolixin®], haloperidol [Haldol®], perphenazine [Trilafon®], risperidone [Risperdal®], thioridazine [Mellaril®]). Check with your doctor right away if you have any of the following symptoms while using this medicine: fever, confusion, drowsiness, difficulty speaking, uncontrolled body movements, or unusual tiredness or weakness.

Check with your doctor immediately if you experience anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or if you see or hear things that are not there. These may be signs of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine may cause some people to feel dizzy, drowsy, or less alert than usual. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Use extra care in hot weather and during activities that make you sweat heavily, such as hot baths, saunas, or exercising. If you have an infection or illness that causes heavy sweating, vomiting, diarrhea, shakiness, or muscle weakness, check with your doctor immediately. Losing too much water and salt from your body could lead to serious side effects from this medicine.

Do not go on a diet to lose weight and do not make major changes to your diet without first checking with your doctor. Improper dieting could cause the loss of too much water and salt from your body and could lead to serious side effects from this medicine.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, the chances of using the medication must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this drug or any other drugs. As well tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lithium extended-release tablets in children younger than 12 years of age or lithium capsules, solution, and tablets in children younger than 7 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of lithium have not been performed in the geriatric population. Nevertheless, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving lithium.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this drug during breastfeeding. Weigh the potential benefits against the potential risks before using this medicine while breastfeeding.

Interactions with Medications

Although certain medications should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medication, it is especially important that your healthcare professional know if you are using any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Acetazolamide
• Acetophenazine
• Alacepril
• Alclofenac
• Alfentanil
• Almotriptan
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anileridine
• Aspirin
• Azilsartan Medoxomil
• Azosemide
• Bemetizide
• Benazepril
• Bendroflumethiazide
• Benzhydrocodone
• Benzphetamine
• Benzthiazide
• Bexagliflozin
• Bromfenac
• Bromperidol
• Brompheniramine
• Bufexamac
• Bumetanide
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Canagliflozin
• Candesartan Cilexetil
• Canrenoate
• Captopril
• Carprofen
• Celecoxib
• Chlorothiazide
• Chlorpheniramine
• Chlorpromazine
• Chlorprothixene
• Chlorthalidone
• Choline Salicylate
• Cilazapril
• Citalopram
• Clomipramine
• Clonixin
• Clozapine
• Cocaine
• Codeine
• Cyclobenzaprine
• Dapagliflozin
• Desipramine
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Dihydrocodeine
• Diphenoxylate
• Dipyrone
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Droxicam
• Duloxetine
• Eletriptan
• Empagliflozin
• Enalapril
• Enalaprilat
• Eprosartan
• Ertugliflozin
• Escitalopram
• Ethacrynic Acid
• Ethopropazine
• Ethylmorphine
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenbufen
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flupenthixol
• Fluphenazine
• Flurbiprofen
• Fluvoxamine
• Fosinopril
• Frovatriptan
• Furazolidone
• Furosemide
• Gepirone
• Granisetron
• Haloperidol
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Ibuprofen
• Imipramine
• Indapamide
• Indomethacin
• Iproniazid
• Irbesartan
• Isocarboxazid
• Ketobemidone
• Ketoprofen
• Ketorolac
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lisinopril
• Lofepramine
• Lorcaserin
• Lornoxicam
• Losartan
• Loxapine
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melperone
• Meperidine
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metolazone
• Metronidazole
• Milnacipran
• Mirtazapine
• Moclobemide
• Moexipril
• Molindone
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nalbuphine
• Naproxen
• Naratriptan
• Nefazodone
• Nepafenac
• Nialamide
• Nicomorphine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olanzapine
• Olmesartan Medoxomil
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Palonosetron
• Papaveretum
• Parecoxib
• Paregoric
• Paroxetine
• Penfluridol
• Pentazocine
• Periciazine
• Perindopril
• Perphenazine
• Phenelzine
• Phenylbutazone
• Piketoprofen
• Pimozide
• Pipamperone
• Pipotiazine
• Piretanide
• Piritramide
• Piroxicam
• Polythiazide
• Pranoprofen
• Procarbazine
• Prochlorperazine
• Proglumetacin
• Promazine
• Promethazine
• Propyphenazone
• Proquazone
• Protriptyline
• Quinapril
• Ramipril
• Rasagiline
• Remifentanil
• Remoxipride
• Risperidone
• Rizatriptan
• Rofecoxib
• Safinamide
• Salicylic Acid
• Salsalate
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Salicylate
• Sotagliflozin
• Spirapril
• Spironolactone
• St John's Wort
• Sufentanil
• Sulindac
• Sulpiride
• Sumatriptan
• Suprofen
• Tapentadol
• Telmisartan
• Tenoxicam
• Thiopropazate
• Thioproperazine
• Thioridazine
• Thiothixene
• Tianeptine
• Tiapride
• Tiaprofenic Acid
• Tilidine
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Torsemide
• Tramadol
• Trandolapril
• Tranylcypromine
• Trichlormethiazide
• Trifluoperazine
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Valdecoxib
• Valsartan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zofenopril
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Using this medication with any of the following medications may cause an increased risk of certain adverse effects, but using both drugs may be the best treatment for you. If both medications are prescribed together, your clinician may change the dose or how frequently you use one or both of the drugs.

• Calcitonin
• Carbamazepine
• Cisplatin
• Diltiazem
• Lactulose
• Mazindol
• Phenytoin
• Semaglutide
• Succinylcholine
• Verapamil
• Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following is typically not advised, but may be unavoidable in some cases. If used together, your physician may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Issues

The presence of other medical issues may affect the use of this drug. Make sure you inform your doctor if you have any other medical problems, especially:

• Brugada syndrome (heart disorder), or family history of or
• Decreased urination or
• Diarrhea, prolonged or
• Infection, serious with fever or
• Kidney disease or
• Sweating, prolonged or
• Vomiting, prolonged—May raise risk for serious side effects.

• Dehydration, serious or
• Heart or blood vessel disease or
• Hyponatremia (low sodium in the blood) or
• Kidney disease, severe or
• Muscle weakness, serious or
• Weakened physical condition—Should not be used in patients with these conditions.

• Encephalopathic syndrome (brain disease) or
• Goiter or other thyroid problems or
• Nervous system issues—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Confusion, poor memory, or lack of awareness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• frequent urination
• increased thirst
• slow heartbeat
• stiffness of the arms or legs
• troubled breathing (especially during hard work or exercise)
• unusual tiredness or weakness
• weight gain

Rare

• Blue color and pain in the fingers and toes
• coldness of the arms and legs
• dizziness
• eye pain
• headache
• noise in the ears
• vision problems

Incidence not known

• Blurred vision
• burning feeling in the chest or stomach
• chills
• cloudy urine
• cough
• decreased urination
• difficulty in speaking
• drooling
• dry mouth
• eyeballs bulge out of the eye sockets
• fever
• flushed, dry skin
• fruit-like breath odor
• general feeling of illness
• increase in heart rate
• increased hunger
• increased urination
• indigestion
• irregular heartbeat, recurrent
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lightheadedness
• loss of balance control
• loss of strength or energy
• muscle pain or weakness
• muscle trembling, jerking, or stiffness
• paleness or cold feeling in the fingertips and toes
• rapid breathing
• restlessness or agitation
• shakiness and unsteady walk
• shuffling walk
• sore throat
• stomach pain or upset
• sugar in the urine
• sunken eyes
• swelling of the ankles or wrists
• tenderness in the stomach area
• tingling or pain in the fingers or toes when exposed to the cold
• tremor
• twisting movements of the body
• twitching
• uncontrolled jerking or twisting movements of the hands, arms, or legs
• uncontrolled movements, especially of the face, neck, and back
• unexplained weight loss
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, or feeling of sluggishness
• unusually strong reflexes
• wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

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

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acne or skin rash
• bloated feeling or pressure in the stomach
• change in or loss of taste
• decreased interest in sexual intercourse
• diarrhea
• drying and thinning of hair
• excess air or gas in the stomach or bowels
• full feeling
• inability to have or keep an erection
• increased watering of the mouth
• loss in sexual ability, desire, drive, or performance
• passing gas
• salivary gland swelling
• tooth pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Eskalith
• Eskalith-CR
• Lithobid

Available Dosage Forms:

• Tablet, Extended Release
• Capsule
• Tablet
• Solution

Therapeutic Class: Antimanic

Take this medicine exactly as directed by your doctor. Do not take more or less of it, do not take it more or less often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. You should talk to your doctor if you have any questions.

You might have to take this medicine for several weeks before you begin to feel better. Talk to your doctor if you have any questions.

Make sure that your doctor knows if you are on a low-sodium or low-salt diet. Too little salt in your diet could lead to serious side effects.

Talk to your doctor about the correct amount of fluid to take with this medicine. Some people need to drink extra fluid every day with lithium.

Swallow the extended-release tablet whole. Do not break, crush, or chew it.

Measure the oral solution with a marked measuring spoon, oral syringe, or medicine cup. A regular teaspoon may not measure the correct amount of medicine.

There are several different forms of lithium. The dose for each is different and they are used at different times of the day. Do not change the type of medicine you take without talking to your doctor first.

In order for lithium to work properly, it must be taken every day in regularly spaced doses as ordered by your doctor. This is necessary to keep a constant amount of lithium in your blood. To help keep the amount constant, do not miss any doses and do not stop taking the medicine even if you feel better.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, solution, and tablets): For acute mania: Adults and children 7 years of age and older weighing more than 30 kilograms (kg)—600 milligrams (mg) or 10 milliliters (mL) 2 to 3 times a day. Your doctor may adjust your dose as needed. Children 7 years of age and older weighing 20 kg to 30 kg—600 mg to 1500 mg or 10 mL to 25 mL given in divided doses per day. Your doctor may adjust your dose as needed. Children 7 years of age and older weighing less than 20 kg—Use and dose must be determined by your doctor. Children younger than 7 years of age—Use is not recommended. For long-term treatment of mania: Adults and children 7 years of age and older weighing more than 30 kilograms (kg)—300 mg to 600 mg or 5 mL to 10 mL 2 to 3 times a day. Your doctor may adjust your dose as needed. Children 7 years of age and older weighing 20 kg to 30 kg—600 mg to 1200 mg or 10 mL to 20 mL given in divided doses per day. Your doctor may adjust your dose as needed. Children 7 years of age and older weighing less than 20 kg—Use and dose must be determined by your doctor. Children younger than 7 years of age—Use is not recommended.

• For oral dosage form (extended-release tablets): For acute mania: Adults and children 12 years of age—900 milligrams (mg) 2 times a day, or 600 mg 3 times a day. Children younger than 12 years of age—Use is not recommended. For long-term treatment of mania: Adults and children 12 years of age—600 milligrams (mg) 2 times a day, or 3 times a day up to 1200 mg per day. Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• What is a proper diet to go on with lithium?