Lithium Carbonate 150mg Capsules

Manufacturer GLENMARK PHARMACEUTICALS Active Ingredient Lithium Capsules and Tablets(LITH ee um) Pronunciation LITH ee um KAR bo nate
WARNING: This drug may cause severe side effects at doses that are close to the normal dose. Rarely, this may include death. Do not take more of this drug than you are told. You will have blood tests to check the level of this drug in your blood. There are many signs of too much lithium in the blood. Closely read the part in this leaflet which lists when to call your doctor. @ COMMON USES: It is used to treat bipolar disorder. It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antimanic agent; Mood stabilizer
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Pharmacologic Class
Alkali metal
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Pregnancy Category
Category D
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FDA Approved
Apr 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lithium is a medication used to help stabilize mood, primarily for people with bipolar disorder. It helps reduce the intensity and frequency of manic episodes and can also help prevent depressive episodes. It's important to take it exactly as prescribed and have regular blood tests to ensure the dose is right for you.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize this side effect. Maintain a consistent salt intake from day to day. Additionally, follow your doctor's advice on the types of liquids to drink and the amount of liquid to consume while taking this medication.

Storing and Disposing of Your Medication

To ensure the quality and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or inquire about potential drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you're unsure about what to do if you miss a dose, consult your doctor for advice.
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Lifestyle & Tips

  • Maintain consistent fluid intake (8-12 glasses of water daily) to prevent dehydration, which can increase lithium levels and toxicity.
  • Maintain consistent sodium intake; avoid drastic changes in diet (e.g., very low sodium diets) as this can affect lithium levels.
  • Avoid excessive caffeine intake, as it can lower lithium levels.
  • Avoid alcohol, as it can worsen mood symptoms and contribute to dehydration.
  • Inform all healthcare providers, including dentists, about lithium use.
  • Carry a medical alert card or wear a medical alert bracelet.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 300 mg 2-3 times daily (immediate release) or 300 mg twice daily (extended release). Adjust to achieve target serum levels.
Dose Range: 600 - 2100 mg

Condition-Specific Dosing:

acuteMania: Initial: 600 mg three times daily (IR) or 900 mg twice daily (ER). Target serum level: 0.8-1.2 mEq/L.
maintenance: Initial: 300 mg 2-3 times daily (IR) or 300 mg twice daily (ER). Target serum level: 0.6-1.0 mEq/L.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not routinely recommended below 12 years; if used, dosing is highly individualized based on weight and serum levels. Initial: 15-20 mg/kg/day in divided doses. Target serum level: 0.6-1.2 mEq/L.
Adolescent: Similar to adult dosing, individualized based on weight and serum levels. Initial: 300 mg 2-3 times daily (IR) or 300 mg twice daily (ER). Target serum level: 0.6-1.2 mEq/L.
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Dose Adjustments

Renal Impairment:

Mild: Reduce dose by 25-50% or extend dosing interval. Monitor serum levels closely.
Moderate: Reduce dose by 50-75% or extend dosing interval. Monitor serum levels closely.
Severe: Contraindicated or use with extreme caution and significant dose reduction (e.g., 75% or more). Monitor serum levels daily.
Dialysis: Lithium is dialyzable. Dosing post-dialysis is complex and requires close monitoring of serum levels. Typically, a supplemental dose is needed after each dialysis session.

Hepatic Impairment:

Mild: No specific dose adjustment required, as lithium is not hepatically metabolized.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.
Confidence: Medium

Pharmacology

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Mechanism of Action

The precise mechanism of action of lithium in treating bipolar disorder is not fully understood, but it is thought to involve multiple neurotransmitter systems and intracellular signaling pathways. It affects ion transport across cell membranes, alters the metabolism of neurotransmitters (e.g., serotonin, norepinephrine, dopamine), and modulates second messenger systems (e.g., inositol monophosphatase, glycogen synthase kinase-3 (GSK-3)). These actions contribute to its mood-stabilizing effects.
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Pharmacokinetics

Absorption:

Bioavailability: Nearly 100%
Tmax: 0.5-3 hours (immediate release); 4-6 hours (extended release)
FoodEffect: Food may delay absorption slightly but does not significantly affect the extent of absorption. Taking with food may reduce GI upset.

Distribution:

Vd: 0.7-1.0 L/kg (similar to total body water)
ProteinBinding: <1%
CnssPenetration: Limited and slow penetration across the blood-brain barrier, reaching equilibrium with plasma after 6-24 hours.

Elimination:

HalfLife: 18-36 hours (longer in elderly and renal impairment)
Clearance: Primarily renal clearance, proportional to creatinine clearance.
ExcretionRoute: Renal (95% via kidneys)
Unchanged: >95%
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Pharmacodynamics

OnsetOfAction: 5-14 days for full therapeutic effect in acute mania, though some effects may be seen earlier.
PeakEffect: Weeks for full mood stabilization.
DurationOfAction: Dependent on half-life and continued dosing; effects persist as long as therapeutic levels are maintained.

Safety & Warnings

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BLACK BOX WARNING

Lithium toxicity is closely related to serum lithium levels and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available. Patients should be instructed to recognize early symptoms of lithium toxicity and to discontinue the drug and notify their physician if such symptoms appear.
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Side Effects

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 experience 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
+ Irregular heartbeat
+ Severe stomach pain, nausea, 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 concentrating
+ 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 (difficulty starting or stopping urine flow, or changes in urine output)
+ Dry mouth
+ Dry eyes
+ Severe nausea 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

Other Side Effects

Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, 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

Reporting Side Effects

This is not a complete 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.
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Seek Immediate Medical Attention If You Experience:

  • Early signs of toxicity: Nausea, vomiting, diarrhea, fine tremor, muscle weakness, drowsiness, thirst, increased urination.
  • Moderate to severe toxicity: Coarse tremor, ataxia (unsteady gait), slurred speech, confusion, blurred vision, ringing in ears, muscle twitching, seizures, coma.
  • Signs of hypothyroidism: Unusual tiredness, weight gain, constipation, feeling cold, dry skin, hair loss.
  • Signs of kidney problems: Swelling in ankles/feet, changes in urination (e.g., urinating more often, especially at night).
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Before Using This Medicine

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 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 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.
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Precautions & Cautions

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 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 be cautious in hot weather or during physical activity, drinking plenty of fluids to prevent dehydration.

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 risk of a specific heart condition, known as Brugada Syndrome, which may be associated with this medication. Although rare, this condition can lead to abnormal heart rhythms and increase the risk of sudden death. Discuss this potential risk with your doctor. In some cases, brain problems have occurred in individuals taking this medication in combination with other drugs, such as haloperidol. These brain problems can be severe and potentially lead to long-lasting damage. Consult your doctor about this potential risk.

A severe and potentially life-threatening condition called serotonin syndrome can occur, particularly if you are 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.

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, coughing, 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, 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.
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Overdose Information

Overdose Symptoms:

  • Severe nausea, vomiting, and diarrhea
  • Coarse tremor
  • Ataxia (loss of coordination)
  • Slurred speech
  • Confusion, stupor, coma
  • Muscle twitching or fasciculations
  • Hyperreflexia
  • Seizures
  • Cardiac arrhythmias
  • Hypotension
  • Renal failure

What to Do:

Immediately seek emergency medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment may involve gastric lavage, whole bowel irrigation, fluid and electrolyte correction, and in severe cases, hemodialysis to remove lithium from the body.

Drug Interactions

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Major Interactions

  • 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) & ARBs (e.g., losartan, valsartan): Decrease renal lithium clearance, leading to increased lithium levels and toxicity.
  • 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).
  • Antipsychotics (e.g., haloperidol, chlorpromazine): Increased risk of neurotoxicity, including encephalopathic syndrome (fever, rigidity, confusion, extrapyramidal symptoms).
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Moderate Interactions

  • 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 levels.
  • Theophylline: May increase lithium excretion, potentially lowering levels.
  • Phenytoin: May increase lithium levels or cause neurotoxicity.
  • Carbamazepine: Increased risk of neurotoxicity (ataxia, tremor, nausea, vomiting) even at therapeutic levels of both drugs.
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Minor Interactions

  • Sodium intake changes: Significant changes in dietary sodium can affect lithium levels (high sodium -> lower lithium; low sodium -> higher lithium).

Monitoring

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Baseline Monitoring

Serum Lithium Level

Rationale: To establish baseline and guide initial dosing, ensuring therapeutic but non-toxic levels.

Timing: Before initiation, then 5-7 days after initiation or dose change (trough level, 12 hours post-dose).

Renal Function (BUN, Creatinine, eGFR)

Rationale: Lithium is primarily renally excreted; impairment increases toxicity risk. Long-term use can cause renal damage.

Timing: Before initiation.

Thyroid Function (TSH)

Rationale: Lithium can cause hypothyroidism.

Timing: Before initiation.

Electrolytes (Sodium, Potassium, Calcium)

Rationale: Electrolyte imbalances can affect lithium levels and toxicity. Lithium can affect calcium metabolism.

Timing: Before initiation.

ECG

Rationale: Lithium can cause cardiac conduction abnormalities (e.g., T-wave flattening/inversion).

Timing: Before initiation, especially in patients with pre-existing cardiac disease or risk factors.

Weight/BMI

Rationale: Lithium can cause weight gain.

Timing: Before initiation.

Pregnancy Test (for females of childbearing potential)

Rationale: Lithium is Category D in pregnancy.

Timing: Before initiation.

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Routine Monitoring

Serum Lithium Level

Frequency: Every 3-6 months (maintenance); more frequently during dose adjustments or illness.

Target: 0.6-1.0 mEq/L (maintenance); 0.8-1.2 mEq/L (acute mania)

Action Threshold: >1.5 mEq/L (mild toxicity), >2.0 mEq/L (moderate-severe toxicity); adjust dose if outside target range.

Renal Function (BUN, Creatinine, eGFR)

Frequency: Every 6-12 months, or more frequently if clinically indicated or with risk factors.

Target: Normal range for age/sex

Action Threshold: Significant decline in GFR; consider dose adjustment or alternative treatment.

Thyroid Function (TSH)

Frequency: Every 6-12 months.

Target: Normal range

Action Threshold: Elevated TSH; consider thyroid hormone replacement.

Electrolytes (Sodium, Calcium)

Frequency: Annually, or more frequently if clinically indicated.

Target: Normal range

Action Threshold: Significant abnormalities; investigate cause and manage.

Weight/BMI

Frequency: Every 3-6 months.

Target: Stable

Action Threshold: Significant weight gain; consider dietary counseling or alternative treatment.

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Symptom Monitoring

  • Signs of lithium toxicity (tremor, nausea, vomiting, diarrhea, ataxia, slurred speech, confusion, muscle weakness, drowsiness, polyuria, polydipsia)
  • Signs of hypothyroidism (fatigue, weight gain, constipation, cold intolerance, dry skin)
  • Signs of renal dysfunction (changes in urination, edema)
  • Changes in mood or behavior (return of manic or depressive symptoms)

Special Patient Groups

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Pregnancy

Lithium is classified as Pregnancy Category D due to potential risks to the fetus, particularly during the first trimester. Use should be carefully weighed against the benefits, and alternative treatments should be considered.

Trimester-Specific Risks:

First Trimester: Increased risk of Ebstein's anomaly (a rare congenital heart defect) in the fetus, though the absolute risk is low. Other cardiac and non-cardiac malformations have also been reported.
Second Trimester: Lower risk of major malformations compared to the first trimester, but continued exposure may lead to fetal effects such as polyhydramnios, fetal goiter, and neonatal toxicity.
Third Trimester: Risk of neonatal toxicity (floppy infant syndrome, hypotonia, lethargy, poor feeding, cyanosis, cardiac arrhythmias, diabetes insipidus-like syndrome) if exposed near term. Close monitoring of the neonate is required.
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Lactation

Lithium is excreted into breast milk in significant amounts (Lactation Risk L4 - possibly hazardous). Breastfeeding is generally not recommended due to the risk of toxicity in the infant. If breastfeeding is chosen, close monitoring of infant for signs of toxicity (lethargy, hypotonia, poor feeding, cyanosis) and regular infant serum lithium levels are crucial.

Infant Risk: High risk of infant toxicity (lethargy, hypotonia, cyanosis, poor feeding, cardiac effects, nephrogenic diabetes insipidus-like symptoms).
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Pediatric Use

Not routinely recommended for children under 12 years due to limited safety and efficacy data. If used, dosing must be highly individualized based on weight and close monitoring of serum levels, renal function, and thyroid function is essential. Children may be more susceptible to adverse effects.

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Geriatric Use

Elderly patients may have reduced renal clearance, leading to higher lithium levels and increased risk of toxicity at lower doses. Start with lower doses and titrate slowly. More frequent monitoring of serum lithium levels, renal function, and thyroid function is recommended. They may also be more susceptible to neurotoxic effects.

Clinical Information

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Clinical Pearls

  • Lithium has a narrow therapeutic index; small changes in dose or fluid/sodium balance can lead to toxicity.
  • Consistency is key: Advise patients to maintain consistent fluid and sodium intake.
  • Always obtain trough lithium levels (12 hours post-dose) for accurate interpretation.
  • Educate patients thoroughly on early signs of toxicity and when to seek medical attention.
  • Long-term lithium use can cause nephrogenic diabetes insipidus (polyuria, polydipsia) and hypothyroidism; monitor for these conditions.
  • Avoid concomitant use with NSAIDs, ACE inhibitors, ARBs, and thiazide diuretics unless absolutely necessary and with very close monitoring of lithium levels.
  • Consider extended-release formulations for better tolerability and once-daily dosing, which may improve adherence.
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Alternative Therapies

  • Valproate (Divalproex sodium)
  • Carbamazepine
  • Lamotrigine
  • Atypical antipsychotics (e.g., olanzapine, quetiapine, risperidone, aripiprazole)
  • Electroconvulsive Therapy (ECT) for severe or refractory cases.
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (150mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, contact your doctor immediately. It's essential to use your medication responsibly: do not share it with others, and never take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read it carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, promptly call your local poison control center or seek immediate medical attention. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.