Lithium Carbonate 300mg Tablets

Lithium's precise mechanism of action is not fully understood but is thought to involve multiple cellular processes. It affects ion transport (e.g., sodium, potassium, calcium) across cell membranes, influences neurotransmitter systems (e.g., serotonin, norepinephrine, dopamine, acetylcholine), and modulates second messenger systems (e.g., inositol monophosphatase, glycogen synthase kinase-3 (GSK-3)). These actions lead to stabilization of mood, reduction of manic symptoms, and prevention of mood swings.

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 medical attention immediately:

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
+ Abnormal heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Feeling extremely sleepy
+ Shortness of breath
+ Feeling very 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
+ Trouble with heat or cold
+ Menstrual changes
+ Shakiness
+ Sweating
Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Difficulty urinating or changes in urine production
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Other severe side effects, such as:
+ Bloating
+ Diarrhea
+ Dizziness or lightheadedness
+ Trouble walking
+ Difficulty controlling body movements, twitching, or balance problems
+ Trouble swallowing or speaking
+ Muscle weakness
+ Feeling sluggish
+ Difficulty controlling 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. However, many people experience no side effects or only mild ones. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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 possible 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 allergic reaction and its symptoms.
Certain health conditions, including:
+ Dehydration (fluid loss)
+ Heart disease
+ Kidney disease
+ Low salt 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
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 closer monitoring of your blood work

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 existing health conditions and medications. 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 potential risk of a heart condition called Brugada Syndrome, which can increase the risk of sudden death. Although this condition is rare, it is essential to discuss this with your doctor, especially if you have a pre-existing heart condition. In rare cases, brain problems have occurred in individuals taking this medication in combination with other drugs, such as haloperidol. These brain problems can lead to long-term damage, so it is crucial to discuss this with your doctor.

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

Raised pressure in the brain and swelling in the eye can occur, 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 for signs of kidney problems, 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 notice any of these symptoms, contact your doctor 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.

• Diuretics (thiazide, loop): Increased 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.
• ACE inhibitors (e.g., lisinopril, enalapril): Decrease renal lithium clearance, leading to increased lithium levels and toxicity.
• Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan): Decrease renal lithium clearance, leading to increased lithium levels and toxicity.
• Metronidazole: Can increase lithium levels and risk of toxicity.
• Serotonergic agents (e.g., SSRIs, SNRIs, triptans, tramadol): Increased risk of serotonin syndrome (rare, but possible with lithium).
• Calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of neurotoxicity (ataxia, tremor, nausea, vomiting) even at therapeutic lithium levels.
• Phenytoin: Increased risk of neurotoxicity (ataxia, confusion, tremor) without significant change in lithium levels.
• Carbamazepine: Increased risk of neurotoxicity (ataxia, tremor, nausea, vomiting) without significant change in lithium levels.

• Caffeine: May increase lithium excretion, potentially lowering lithium levels.
• Theophylline: May increase lithium excretion, potentially lowering lithium levels.
• Sodium bicarbonate: May increase lithium excretion, potentially lowering lithium levels.
• Acetazolamide: May increase lithium excretion, potentially lowering lithium levels.
• Haloperidol: Increased risk of neurotoxicity (encephalopathic syndrome) in some patients, though this interaction is debated.
• Antipsychotics (other): Increased risk of extrapyramidal symptoms or neuroleptic malignant syndrome (NMS) when co-administered with lithium.

• Sodium intake changes: Significant changes in dietary sodium intake can affect lithium levels (high sodium -> lower lithium; low sodium -> higher lithium).
• Dehydration: Can increase lithium levels and risk of toxicity.

• Increased thirst (polydipsia)
• Increased urination (polyuria)
• Fine hand tremor
• Nausea, vomiting, diarrhea
• Muscle weakness
• Drowsiness, lethargy
• Slurred speech
• Ataxia (uncoordinated movements)
• Confusion
• Blurred vision
• Dizziness
• Seizures
• Arrhythmias
• Hypothyroidism symptoms (fatigue, weight gain, cold intolerance, dry skin, constipation)

Lithium is classified as Pregnancy Category D due to potential risks to the fetus. It should generally be avoided, especially during the first trimester, unless the potential benefits outweigh the risks. If used, careful monitoring of maternal lithium levels and fetal cardiac anomalies (e.g., Ebstein's anomaly) is crucial.

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

Use in children under 12 years is generally not recommended due to limited safety and efficacy data. In adolescents and children >6 years with severe bipolar disorder, it may be used under specialist supervision with careful dose titration and monitoring of serum levels and side effects. Renal function should be closely monitored.

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 more frequent monitoring of serum lithium levels, renal function, and thyroid function is essential. Start low and go slow with dosing.

• 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 monitoring.
• Educate patients thoroughly on the importance of consistent fluid and sodium intake, and signs of toxicity.
• Be vigilant for drug interactions, especially with diuretics, NSAIDs, ACE inhibitors, and ARBs, which can significantly increase lithium levels.
• Hypothyroidism and nephrogenic diabetes insipidus are common long-term side effects requiring regular monitoring.
• Consider extended-release formulations for better tolerability and once or twice daily dosing.
• 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, Aripiprazole, Risperidone)
• Combination therapy (e.g., lithium + atypical antipsychotic)

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.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.