Lithium Carbonate ER 300mg Tablets

Lithium's precise mechanism of action is not fully understood but is thought to involve multiple neurotransmitter systems and intracellular signaling pathways. It affects ion transport across cell membranes, alters the metabolism of inositol phosphates (inhibiting inositol monophosphatase), and modulates the activity of glycogen synthase kinase-3 (GSK-3). These actions lead to stabilization of mood, reduction of manic symptoms, and prevention of depressive episodes.

Serious Side Effects: Seek Medical Help Immediately

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 medical attention right away:

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
+ Excessive 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 serious side effects, such as:
+ 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: 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. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Dehydration (fluid loss)
+ Heart disease
+ Kidney disease
+ Low sodium levels in your blood
+ Severe illness or weakness
Specific heart conditions, such as Brugada syndrome, or if you have ever fainted without a known 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 you may require more frequent blood tests.

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 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 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.

Be aware of the 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, such as haloperidol, have experienced rare brain problems, which can result in 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 symptoms such as 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.

Monitor your kidney function and report any signs of kidney problems to your doctor, including difficulty urinating, changes in urine output, bloody, brown, or foamy urine, shortness of breath, cough, or swelling in the face, feet, or hands.

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, notify your doctor immediately. Additionally, if you are breastfeeding or plan to breastfeed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.

• Thiazide diuretics (e.g., hydrochlorothiazide): Increased 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.
• Calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of neurotoxicity (ataxia, tremor, nausea, vomiting) even at therapeutic lithium levels.
• Serotonergic agents (e.g., SSRIs, SNRIs, triptans): Increased risk of serotonin syndrome (though less direct interaction than with other serotonergic drugs, caution advised).

• Antipsychotics (e.g., haloperidol, olanzapine): Increased risk of neurotoxicity, especially with haloperidol (irreversible encephalopathy reported).
• Methyldopa: Increased lithium levels and toxicity.
• Phenytoin: Increased lithium levels and toxicity.
• Carbamazepine: Increased risk of neurotoxicity (ataxia, tremor, confusion) even at therapeutic lithium levels.
• Sodium-depleting agents (e.g., excessive sweating, diarrhea, vomiting): Can increase lithium levels due to increased renal reabsorption.
• Caffeine: May increase lithium excretion, potentially lowering lithium levels.

• Xanthines (e.g., theophylline): May increase lithium excretion, potentially lowering lithium levels.
• Acetazolamide: May increase lithium excretion, potentially lowering lithium levels.

• Early signs of toxicity: Nausea, vomiting, diarrhea, fine tremor, muscle weakness, lethargy, polyuria, polydipsia.
• Moderate to severe toxicity: Coarse tremor, ataxia, slurred speech, confusion, nystagmus, hyperreflexia, muscle fasciculations, seizures, coma, cardiac arrhythmias, renal failure.

Lithium is classified as Pregnancy Category D due to evidence of human fetal risk. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Lithium is excreted into breast milk in significant amounts. Due to the potential for serious adverse effects in the nursing infant (e.g., lethargy, hypotonia, cyanosis, ECG changes, hypothermia, diabetes insipidus-like syndrome), breastfeeding is generally not recommended while on lithium. If breastfeeding is considered essential, close monitoring of infant lithium levels and clinical status is required.

Not generally recommended for children under 12 years due to limited safety and efficacy data. If used in adolescents, extreme caution, lower initial doses, and close monitoring of serum levels, renal function, and adverse effects are necessary. Long-term effects on growth and development are not fully established.

Elderly patients may be more sensitive to lithium's effects and more prone to toxicity due to age-related decline in renal function and changes in body composition. Lower initial doses and slower titration are recommended. Close monitoring of serum lithium levels, renal function, and signs of toxicity is essential. Target serum levels may be lower (e.g., 0.4-0.8 mEq/L).

• Lithium has a narrow therapeutic index; careful monitoring of serum levels is critical to prevent toxicity.
• Maintain consistent fluid and salt intake to avoid fluctuations in lithium levels.
• Educate patients thoroughly on signs of toxicity and the importance of adherence to monitoring appointments.
• Consider long-term renal and thyroid monitoring due to potential for chronic effects (e.g., chronic kidney disease, hypothyroidism).
• Extended-release formulations may improve adherence and reduce peak-related side effects (e.g., tremor, GI upset) compared to immediate-release.
• Avoid concomitant use with NSAIDs, ACE inhibitors, ARBs, and thiazide diuretics due to significant risk of lithium toxicity.

• Valproate (Divalproex sodium)
• Carbamazepine
• Lamotrigine
• Atypical antipsychotics (e.g., quetiapine, olanzapine, 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 and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, 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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.