Lithium Carbonate 600mg Capsules

The precise mechanism of action of lithium in treating bipolar disorder is not fully understood. It is thought to exert its therapeutic effects through multiple mechanisms, including: 1) Modulation of ion transport (e.g., sodium, potassium, calcium) across cell membranes, affecting neuronal excitability. 2) Inhibition of inositol monophosphatase (IMPase), leading to depletion of inositol and disruption of phosphoinositide signaling pathways (second messenger systems). 3) Inhibition of glycogen synthase kinase-3 beta (GSK-3β), an enzyme involved in various cellular processes, including neuronal plasticity, mood regulation, and cell survival. 4) Modulation of neurotransmitter systems (e.g., serotonin, norepinephrine, dopamine, GABA) and neurotrophic factors.

Urgent 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 or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of too much acid in the blood (acidosis), including:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Abnormal heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of thyroid problems, such as:
+ Weight changes
+ Feeling nervous, excitable, restless, or weak
+ Hair thinning
+ Depression
+ Eye or neck swelling
+ Difficulty focusing
+ Sensitivity to heat or cold
+ Menstrual changes
+ Shakiness
+ Sweating
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Urination problems (difficulty starting or stopping urine flow, or changes in urine output)
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Other severe side effects, including:
+ Bloating
+ Diarrhea
+ Dizziness or lightheadedness
+ Difficulty walking
+ Trouble controlling body movements, twitching, or balance problems
+ Swallowing or speaking difficulties
+ Muscle weakness
+ Feeling sluggish
+ Uncontrolled eye movements
+ Mood changes
+ Fever
+ Hallucinations (seeing or hearing things that are not there)
+ Memory problems or loss
+ Restlessness
+ 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 or seek medical attention if they bother you or persist:

Feeling dizzy, sleepy, tired, or weak
Upset stomach
Decreased appetite
Stomach pain
Excessive saliva production
Gas
Dry mouth
Headache
Dry or thin hair
Hair loss
Changes in taste
* Joint pain

Reporting Side Effects

This is not an exhaustive list of potential 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, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
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 high blood pressure or heart problems, as you may require more frequent blood tests to monitor your condition

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 whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

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 understand 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 lead to abnormal heart rhythms and increase the risk of sudden death. Although this condition may have been present before taking the medication, it is essential to discuss this with your doctor. In some cases, people taking this medication with other drugs like haloperidol have experienced rare brain problems, which can lead to long-term brain damage. Consult your doctor about this potential risk.

A 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, rapid or irregular heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea or vomiting, or a severe headache.

In rare cases, this medication can 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 to confirm that you are not pregnant. If you become pregnant while taking this medication, 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.

• Not explicitly contraindicated with specific drugs, but extreme caution/avoidance with drugs that significantly impair renal function or cause severe electrolyte imbalance.

• Thiazide diuretics (e.g., hydrochlorothiazide): Increase lithium reabsorption, leading to increased lithium levels and toxicity.
• NSAIDs (e.g., ibuprofen, naproxen, celecoxib): Decrease renal lithium clearance, leading to increased lithium levels and toxicity. Aspirin and sulindac may have less effect.
• ACE inhibitors (e.g., lisinopril, enalapril) and ARBs (e.g., losartan, valsartan): Can decrease renal lithium clearance, leading to increased lithium levels and toxicity.
• Loop diuretics (e.g., furosemide): Can increase or decrease lithium levels; monitor closely.
• Sodium-depleting agents (e.g., excessive sweating, diarrhea, vomiting, low sodium diet): Increase lithium reabsorption and risk of toxicity.
• Serotonergic agents (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol): Increased risk of serotonin syndrome.
• Calcium channel blockers (e.g., verapamil, diltiazem): May increase risk of neurotoxicity (ataxia, tremor, nausea, vomiting) even at therapeutic lithium levels.
• Antipsychotics (e.g., haloperidol, olanzapine): Increased risk of neurotoxicity, extrapyramidal symptoms, and potentially irreversible encephalopathic syndrome (rare, but reported with haloperidol).

• Metronidazole: May increase lithium levels.
• Phenytoin: May increase or decrease lithium levels; monitor.
• Carbamazepine: Increased risk of neurotoxicity (ataxia, tremor) even at therapeutic levels of both drugs.
• Neuromuscular blockers (e.g., succinylcholine): Lithium may prolong the effects of neuromuscular blockers.
• Caffeine: May increase lithium excretion, potentially lowering levels.

• Theophylline: May increase lithium excretion, potentially lowering levels.

• Signs of lithium toxicity (nausea, vomiting, diarrhea, tremor, ataxia, slurred speech, confusion, lethargy, muscle weakness, seizures)
• Changes in mood or behavior (recurrence of manic/depressive symptoms)
• Signs of hypothyroidism (fatigue, weight gain, cold intolerance, dry skin)
• Signs of nephrogenic diabetes insipidus (polyuria, polydipsia)

Lithium is classified as Pregnancy Category D due to evidence of human fetal risk. It is associated with an increased risk of congenital malformations, particularly cardiac anomalies (e.g., Ebstein's anomaly), especially with first-trimester exposure. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus, and after careful discussion with the patient.

Lithium is excreted into breast milk at concentrations 30-100% of maternal serum levels. Due to the potential for serious adverse effects in the nursing infant (e.g., lethargy, hypotonia, cyanosis, ECG changes, hypothyroidism), breastfeeding is generally not recommended while taking lithium. If breastfeeding is considered essential, close monitoring of infant lithium levels, renal function, and thyroid function is necessary.

Generally not recommended for children under 12 years due to limited safety and efficacy data. In adolescents, use requires careful consideration, individualized dosing, and close monitoring of serum levels, renal function, and thyroid function due to potential for increased sensitivity and adverse effects.

Elderly patients may be more sensitive to the effects of lithium and are at increased risk for toxicity due to age-related decline in renal function and changes in body composition. Lower starting doses and slower titration are recommended. More frequent monitoring of serum lithium levels, renal function, and thyroid function is essential.

• Lithium has a narrow therapeutic index; careful monitoring of serum levels is critical to avoid toxicity.
• Maintain consistent hydration and salt intake to prevent fluctuations in lithium levels.
• Educate patients thoroughly on signs of toxicity and the importance of adherence and monitoring.
• Consider extended-release formulations for better tolerability and once or twice daily dosing.
• Be vigilant for drug interactions, especially with diuretics, NSAIDs, ACEIs, and ARBs, which can significantly increase lithium levels.
• Long-term lithium use can lead to renal impairment (e.g., chronic interstitial nephritis, nephrogenic diabetes insipidus) and hypothyroidism; regular monitoring is essential.
• Lithium can cause benign leukocytosis; do not confuse with infection.
• In cases of suspected toxicity, immediately hold lithium, assess hydration status, and obtain urgent lithium level, electrolytes, and renal function tests.

• Valproate (Divalproex sodium)
• Carbamazepine
• Lamotrigine
• Atypical antipsychotics (e.g., olanzapine, quetiapine, risperidone, aripiprazole)
• Combination therapy (e.g., lithium + antipsychotic)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.