Lithium Carbonate 300mg Capsules

The precise mechanism of action of lithium in bipolar disorder is not fully understood. It is thought to exert its therapeutic effects through multiple mechanisms, including: modulation of neurotransmitter systems (e.g., serotonin, norepinephrine, dopamine), inhibition of inositol monophosphatase (leading to depletion of inositol and disruption of phosphoinositide signaling), inhibition of glycogen synthase kinase-3 beta (GSK-3β), and effects on ion transport (e.g., sodium-potassium ATPase). These actions collectively contribute to mood stabilization.

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Rapid breathing or heartbeat
+ Abnormal heartbeat or very severe stomach pain
+ Nausea, vomiting, or feeling extremely sleepy
+ Shortness of breath or feeling very tired or weak
Signs of thyroid problems, such as:
+ Weight changes
+ Feeling nervous, excitable, restless, or weak
+ Hair thinning or depression
+ Eye or neck swelling
+ Difficulty focusing or trouble with heat or cold
+ Menstrual changes or shakiness
+ Excessive sweating
Signs of fluid and electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness
+ Increased thirst or seizures
+ Feeling very tired or weak
+ Decreased appetite or difficulty urinating
+ Dry mouth, dry eyes, or severe stomach upset
Other serious side effects, such as:
+ Bloating or diarrhea
+ Dizziness or giddiness
+ Difficulty walking or controlling body movements
+ Twitching, balance problems, or trouble swallowing or speaking
+ Muscle weakness or feeling sluggish
+ Uncontrolled eye movements
+ Mood changes or fever
+ Hallucinations (seeing or hearing things that are not there)
+ Memory problems or loss
+ Restlessness or shortness of breath
+ Sudden weight gain or swelling in the arms or legs
+ Unexplained weight changes
+ Loss of bladder or bowel control
+ Sexual problems

Common Side Effects

Most people experience few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor if they bother you or do not go away:

Feeling dizzy, sleepy, tired, or weak
Upset stomach or decreased appetite
Stomach pain or excessive saliva production
Gas or dry mouth
Headache or dry, thin, or falling hair
* Joint pain or changes in taste

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Dehydration (fluid loss)
+ Heart disease
+ Kidney disease
+ Low sodium levels in your blood
+ Severe illness or weakness
A specific heart condition called Brugada syndrome, or if you have ever fainted without knowing the reason
A family history of Brugada syndrome or sudden death before the age of 45
* If you are taking medications for blood pressure or heart problems, as your doctor may need to monitor your blood work more closely

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

Until you know how this medication affects you, avoid driving and other activities that require alertness. If you are advised to follow a low-salt diet, notify your doctor, as this can impact how your body processes lithium. Additionally, consult your doctor before consuming alcohol.

Certain conditions, such as fever, infection, vomiting, diarrhea, or excessive sweating, can alter the levels of this medication in your blood. If you experience any of these conditions, inform your doctor promptly. It is also crucial to stay hydrated, especially in hot weather or during physical activity, to prevent fluid loss.

Monitor your body for signs of high blood sugar, including confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. If you notice any of these symptoms, report them to your doctor.

There is a rare risk of a heart condition called Brugada Syndrome, which can increase the risk of sudden death. Although this condition is often undiagnosed, it is essential to discuss this potential risk with your doctor. In some cases, people taking this medication with other drugs, such as haloperidol, have experienced rare brain problems, which can lead to long-term brain damage. Consult your doctor about this potential risk.

A severe and potentially life-threatening condition called serotonin syndrome can occur, especially when taking certain other medications. Seek immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea or vomiting, or a severe headache.

This medication can also cause increased pressure in the brain and swelling in the eyes, leading to vision problems, including loss of vision. If you experience a severe headache, ringing in the ears, or vision problems such as blurred vision, double vision, or loss of vision, contact your doctor immediately.

If you notice signs of kidney problems, such as difficulty urinating, changes in urine output, bloody, brown, or foamy urine, shortness of breath, cough, or swelling in the face, feet, or hands, seek medical attention promptly.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication can harm an unborn baby, so a pregnancy test may be required before starting treatment. If you become pregnant or are planning to become pregnant, inform your doctor immediately. Additionally, if you are breastfeeding or plan to breastfeed, consult your doctor, as this medication can pass into breast milk and potentially harm your baby.

• Thiazide diuretics (e.g., hydrochlorothiazide): Increase lithium reabsorption, leading to increased lithium levels and toxicity.
• Loop diuretics (e.g., furosemide): Can increase or decrease lithium levels; monitor closely.
• NSAIDs (e.g., ibuprofen, naproxen, celecoxib): Decrease renal clearance of lithium, leading to increased lithium levels and toxicity.
• ACE inhibitors (e.g., lisinopril, enalapril): Decrease renal clearance of lithium, leading to increased lithium levels and toxicity.
• Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan): Decrease renal clearance of lithium, leading to increased lithium levels and toxicity.
• Metronidazole: Can increase lithium levels and toxicity.
• Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, MAOIs): Increased risk of serotonin syndrome.
• Calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of neurotoxicity (ataxia, tremor, nausea, vomiting, diarrhea) even at therapeutic lithium levels.
• Phenytoin: Can increase lithium levels and neurotoxicity.
• Carbamazepine: Increased risk of neurotoxicity (ataxia, tremor, nausea, vomiting, diarrhea) even at therapeutic lithium levels.

• Caffeine: May increase lithium excretion, potentially lowering lithium levels.
• Theophylline: May increase lithium excretion, potentially lowering lithium levels.
• Sodium-containing products (e.g., high sodium diet, IV saline): Can increase lithium excretion, potentially lowering lithium levels.
• Sodium-depleting conditions (e.g., dehydration, excessive sweating, vomiting, diarrhea): Can decrease lithium excretion, leading to increased lithium levels and toxicity.
• Antipsychotics (e.g., haloperidol, clozapine): Increased risk of neurotoxicity, especially with haloperidol.
• Methyldopa: Can increase lithium levels and toxicity.
• Topiramate: May increase lithium levels.

• Acetazolamide: May increase lithium excretion.
• Urea: May increase lithium excretion.

• Signs of lithium toxicity (nausea, vomiting, diarrhea, tremor, ataxia, slurred speech, confusion, lethargy, muscle weakness, seizures, coma)
• Signs of hypothyroidism (fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss)
• Signs of nephrogenic diabetes insipidus (polyuria, polydipsia)
• Changes in mood or behavior (for efficacy and relapse)

Lithium is classified as Pregnancy Category D. It crosses the placenta and has been associated with an increased risk of congenital malformations, particularly Ebstein's anomaly (a rare heart defect), though the absolute risk is lower than previously estimated. Use during pregnancy should be carefully weighed against the risks of untreated bipolar disorder. If used, monitor lithium levels closely as they can fluctuate significantly during pregnancy.

Lithium is excreted into breast milk in significant amounts (milk-to-plasma ratio typically 0.3-0.5). The American Academy of Pediatrics considers lithium to be a drug for which the effect on the nursing infant is unknown but may be of concern. Most guidelines recommend avoiding breastfeeding if possible due to potential infant toxicity (lethargy, hypotonia, cyanosis, ECG changes, thyroid suppression). If breastfeeding is chosen, close monitoring of infant for signs of toxicity and regular infant lithium levels, renal function, and thyroid function are essential.

Generally not recommended for children under 12 years due to limited safety and efficacy data. If used, it should be under specialist supervision, with careful individualized dosing based on weight and frequent monitoring of serum levels, renal, and thyroid function. Higher incidence of side effects like tremor and polyuria/polydipsia may be observed.

Elderly patients often have reduced renal clearance, leading to higher lithium levels at standard doses and an increased risk of toxicity. Start with lower doses (e.g., 300 mg once or twice daily) and titrate slowly based on serum levels and clinical response. More frequent monitoring of renal function, thyroid function, and lithium levels is crucial. They are also more susceptible to neurotoxic side effects.

• Lithium has a narrow therapeutic index; small changes in dose or fluid/sodium balance can lead to toxicity.
• Consistency is key: Patients should take lithium at the same time each day and maintain consistent fluid and sodium intake.
• Educate patients thoroughly on signs of toxicity and the importance of hydration and consistent sodium intake.
• Always draw lithium levels 10-12 hours after the last dose (trough level) to ensure accurate interpretation.
• Be vigilant for drug interactions, especially with diuretics, NSAIDs, ACE inhibitors, and ARBs, which can significantly increase lithium levels.
• Long-term lithium use can cause renal impairment (e.g., chronic interstitial nephritis) and hypothyroidism; regular monitoring is essential.
• Consider extended-release formulations for better adherence and potentially fewer peak-related side effects.

• Valproate (Divalproex sodium)
• Carbamazepine
• Lamotrigine
• Atypical antipsychotics (e.g., olanzapine, quetiapine, risperidone, aripiprazole, lurasidone) for acute mania or maintenance in bipolar disorder.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.