Lithium Carbonate ER 450mg Tablets

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) Alteration of ion transport (sodium, potassium, calcium) across cell membranes in nerve and muscle cells. 2) Modulation of neurotransmitter systems, particularly serotonin and norepinephrine, and to a lesser extent, dopamine. 3) Inhibition of inositol monophosphatase, leading to depletion of inositol and disruption of phosphoinositide signaling pathways, which are involved in second messenger systems. 4) Neuroprotective effects and promotion of neurogenesis.

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), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular 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, such as:
+ 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 or changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Other severe 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

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 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 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 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 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 placed on a low-salt diet, notify your doctor, as this can alter how your body processes lithium. Additionally, consult your doctor before consuming alcohol.

Certain conditions, such as fever, infection, vomiting, diarrhea, or excessive sweating, can affect the levels of this medication in your blood. If you experience any of these conditions, inform your doctor promptly.

In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you notice signs of high blood sugar, such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, report them to your doctor.

A rare heart condition called Brugada Syndrome has been associated with this medication. Although this condition may have been present before taking the medication, it is crucial to discuss this with your doctor, as it can increase the risk of sudden death. 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.

There is a risk of a severe and potentially life-threatening condition called serotonin syndrome, which may be increased if you are taking certain other medications. Seek immediate medical attention if you experience symptoms such as 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 has been associated with increased pressure in the brain and swelling in the eye, which can lead 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, and 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.

• Thiazide diuretics (e.g., hydrochlorothiazide): Significantly increase lithium levels due to increased renal reabsorption of lithium.
• NSAIDs (e.g., ibuprofen, naproxen, celecoxib): Can increase lithium levels by reducing renal clearance.
• ACE inhibitors (e.g., lisinopril, enalapril): Can increase lithium levels by reducing renal clearance.
• Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan): Can increase lithium levels by reducing renal clearance.
• Metronidazole: Can increase lithium levels.
• Serotonergic agents (e.g., SSRIs, SNRIs, triptans, tramadol): Increased risk of serotonin syndrome.
• Calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of neurotoxicity (ataxia, tremor, nausea, vomiting).
• Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): Prolongation of neuromuscular blockade.
• Antipsychotics (e.g., haloperidol, chlorpromazine): Increased risk of neurotoxicity, especially with high doses or in combination with lithium.

• Loop diuretics (e.g., furosemide): May increase or decrease lithium levels; monitor closely.
• Potassium-sparing diuretics (e.g., spironolactone, amiloride): May increase lithium levels.
• Caffeine: May decrease lithium levels due to increased renal excretion.
• Theophylline: May decrease lithium levels due to increased renal excretion.
• Sodium-depleting conditions (e.g., dehydration, excessive sweating, low sodium diet, vomiting, diarrhea): Increase lithium levels.
• Acetazolamide: May increase lithium excretion, leading to decreased lithium levels.
• Sodium bicarbonate: May increase lithium excretion, leading to decreased lithium levels.
• Topiramate: May increase lithium levels and risk of neurotoxicity.
• Carbamazepine: Increased risk of neurotoxicity (ataxia, tremor, nausea, vomiting) even with therapeutic levels of both drugs.

• Antacids: No significant interaction.
• Oral contraceptives: No significant interaction.

• Signs of lithium toxicity (nausea, vomiting, diarrhea, coarse tremor, ataxia, slurred speech, lethargy, muscle weakness, confusion, seizures, arrhythmias)
• 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 (recurrence of manic or depressive symptoms)

Lithium is classified as Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Close monitoring of maternal lithium levels is crucial due to fluid shifts.

Lithium is excreted into breast milk at concentrations 30-100% of maternal serum levels. Due to the risk of toxicity in the infant (lethargy, hypotonia, cyanosis, ECG changes, poor feeding, diabetes insipidus-like syndrome), breastfeeding is generally not recommended. If breastfeeding is chosen, close monitoring of infant for signs of toxicity and infant lithium levels is essential.

Use in children under 12 years is generally not recommended due to limited data and potential for toxicity. For children >6 years with bipolar disorder, use is off-label and requires careful individualized dosing, close monitoring of serum levels, renal function, and thyroid function. Risk of long-term renal and thyroid effects is a concern.

Elderly patients are more susceptible to lithium toxicity due to age-related decline in renal function and reduced total body water. Lower doses are typically required, and serum lithium levels should be maintained at the lower end of the therapeutic range (e.g., 0.4-0.8 mEq/L). Close monitoring of renal function, thyroid function, and serum lithium levels is essential. Increased risk of neurotoxicity and cognitive impairment.

• Lithium has a narrow therapeutic index; small changes in dose or fluid/sodium balance can lead to toxicity.
• Always obtain trough lithium levels (12 hours post-dose) for accurate interpretation.
• Educate patients thoroughly on the importance of consistent fluid and sodium intake, and to report any signs of dehydration or illness.
• Be vigilant for drug interactions, especially with diuretics, NSAIDs, ACE inhibitors, and ARBs, which can significantly increase lithium levels.
• Long-term lithium use requires regular monitoring of renal and thyroid function due to potential for chronic kidney disease and hypothyroidism.
• Consider the extended-release formulation for patients experiencing GI upset or requiring once-daily dosing for adherence.
• Lithium can cause benign leukocytosis; do not confuse with infection unless other signs are present.

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

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.