Ketoconazole 200mg Tablets
WARNING: This drug is not for use to treat certain types of fungal infections. This includes fungal infections of the skin, nails, or brain. Talk with the doctor.This drug must only be used when other drugs cannot be used or have not worked. Talk with your doctor to be sure that the benefits of this drug are more than the risks.Severe and sometimes deadly liver problems like the need for a liver transplant have happened with this drug. Some people did not have a raised chance of liver problems before taking this drug. Most of the time, but not always, liver problems have gone back to normal after this drug was stopped. Call your doctor right away if you have signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light- colored stools, throwing up, or yellow skin or eyes. Blood tests will be needed to watch for any liver problems. Talk with your doctor.Taking this drug with certain other drugs may raise the risk of a severe and sometimes deadly abnormal heartbeat (prolonged QT interval). Do not take this drug if you are taking any of these drugs: Cisapride, disopyramide, dofetilide, dronedarone, lurasidone, methadone, pimozide, quinidine, or ranolazine. @ COMMON USES: It is used to treat fungal infections. It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antifungal
Pharmacologic Class
Imidazole antifungal; Azole antifungal
Pregnancy Category
C
FDA Approved
Jun 1981
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketoconazole is an antifungal medication used to treat serious fungal infections inside the body. It works by stopping the growth of the fungus. Due to serious side effects, it is usually only used when other antifungal medicines have not worked or cannot be used.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Important Interactions and Precautions
Do not take antacids within 1 hour before or 2 hours after taking your medication. If you are also taking antacids, cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine, consult with your doctor. You may need to take your medication with an acidic drink, such as non-diet cola.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are 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 is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Important Interactions and Precautions
Do not take antacids within 1 hour before or 2 hours after taking your medication. If you are also taking antacids, cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine, consult with your doctor. You may need to take your medication with an acidic drink, such as non-diet cola.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are 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 is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take this medication exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor, even if you feel better.
- Take ketoconazole with food to help your body absorb it better.
- Avoid taking antacids, H2-blockers (like ranitidine, famotidine), or proton pump inhibitors (like omeprazole, pantoprazole) at the same time as ketoconazole, as they can reduce its absorption. If you must take them, separate doses by at least 2 hours, or consult your doctor for specific instructions.
- Avoid alcohol while taking this medication, as it can increase the risk of liver problems.
- Be aware of the many drug interactions. Always inform your doctor and pharmacist about all medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
200 mg once daily for 1-6 months, depending on infection type and response. May be increased to 400 mg once daily for severe infections.
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
Systemic Fungal Infections (e.g., Blastomycosis, Coccidioidomycosis, Histoplasmosis, Chromomycosis, Paracoccidioidomycosis):
200 mg once daily, may be increased to 400 mg once daily for severe or rapidly progressive infections. Treatment duration varies from 6 weeks to 6 months or longer, depending on the infection and clinical response. Oral ketoconazole is NOT indicated for fungal meningitis due to poor CNS penetration. Oral ketoconazole is NOT indicated for superficial fungal infections.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for routine use due to safety concerns. Limited data for severe systemic infections: 3.3 to 6.6 mg/kg/day as a single daily dose.
Adolescent:
Not recommended for routine use due to safety concerns. Dosing similar to adults for severe systemic infections if other options are not feasible.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment generally needed.
Moderate:
No dosage adjustment generally needed.
Severe:
No dosage adjustment generally needed, as ketoconazole is minimally excreted by the kidneys.
Dialysis:
Not significantly removed by hemodialysis. No supplemental dose needed.
Hepatic Impairment:
Mild:
Use with caution. Monitor liver function closely.
Moderate:
Contraindicated due to risk of severe hepatotoxicity.
Severe:
Contraindicated due to risk of severe hepatotoxicity.
Pharmacology
Mechanism of Action
Ketoconazole inhibits the fungal cytochrome P450 enzyme 14Îą-demethylase, which is responsible for the demethylation of lanosterol to ergosterol. Ergosterol is a vital component of the fungal cell membrane. Inhibition of ergosterol synthesis leads to increased fungal cell membrane permeability, leakage of cellular contents, and ultimately fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (approximately 75% in healthy individuals, but significantly reduced with achlorhydria or use of acid-reducing agents).
Tmax:
1-2 hours
FoodEffect:
Absorption is enhanced when taken with food, especially fatty meals. Requires an acidic environment for dissolution and absorption; absorption is significantly decreased by antacids, H2-blockers, and proton pump inhibitors.
Distribution:
Vd:
Approximately 0.15-0.2 L/kg
ProteinBinding:
Approximately 99% (primarily to albumin)
CnssPenetration:
Limited (does not achieve therapeutic concentrations in CSF, not indicated for fungal meningitis)
Elimination:
HalfLife:
Biphasic: initial phase 2 hours, terminal phase 8 hours (dose-dependent)
Clearance:
Not well characterized, primarily hepatic
ExcretionRoute:
Primarily biliary excretion into feces (approximately 57%), with a small amount excreted in urine (approximately 13%)
Unchanged:
Less than 1% in urine
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within days to weeks, depending on the infection.
PeakEffect:
Not directly applicable as an acute effect; relates to sustained antifungal activity.
DurationOfAction:
Antifungal effects persist as long as therapeutic concentrations are maintained.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
HEPATOTOXICITY: Oral ketoconazole has been associated with a risk of serious hepatotoxicity, including cases leading to liver transplantation or death. Some cases have occurred in patients with no obvious risk factors. Liver function tests should be performed prior to and at frequent intervals during treatment. QT PROLONGATION AND DRUG INTERACTIONS: Oral ketoconazole can cause QT prolongation and may lead to life-threatening ventricular arrhythmias such as Torsades de Pointes. It is also a potent inhibitor of cytochrome P450 3A4 (CYP3A4) and can significantly increase plasma concentrations of drugs metabolized by this pathway, leading to increased risk of adverse events, including QT prolongation. Concomitant use with certain drugs is contraindicated.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 help 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 a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Dizziness
Chest pain
Abnormal sensations, such as burning, numbness, or tingling
Swelling in the arms or legs
Unexplained bruising or bleeding
Sensitivity to bright lights
Change in tongue color
Changes in menstrual period
Fever or chills
Muscle pain or weakness
Hair loss
Abnormal heartbeat (prolonged QT interval), which may cause:
+ Fast heartbeat
+ Irregular heartbeat
+ Fainting
This medication may also lower testosterone levels, leading to:
Enlarged breasts
Erectile dysfunction
Low sperm count
Testosterone levels typically return to normal after stopping the medication. If you experience any of these effects, contact your doctor.
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 experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Constipation
Diarrhea
Stomach pain
Upset stomach or vomiting
Headache
Changes in appetite
Trouble sleeping
Feeling nervous or excitable
Feeling sleepy
Feeling tired or weak
Dry mouth
Change in taste
Gas
* Flushing
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.
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 help 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 a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Dizziness
Chest pain
Abnormal sensations, such as burning, numbness, or tingling
Swelling in the arms or legs
Unexplained bruising or bleeding
Sensitivity to bright lights
Change in tongue color
Changes in menstrual period
Fever or chills
Muscle pain or weakness
Hair loss
Abnormal heartbeat (prolonged QT interval), which may cause:
+ Fast heartbeat
+ Irregular heartbeat
+ Fainting
This medication may also lower testosterone levels, leading to:
Enlarged breasts
Erectile dysfunction
Low sperm count
Testosterone levels typically return to normal after stopping the medication. If you experience any of these effects, contact your doctor.
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 experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Constipation
Diarrhea
Stomach pain
Upset stomach or vomiting
Headache
Changes in appetite
Trouble sleeping
Feeling nervous or excitable
Feeling sleepy
Feeling tired or weak
Dry mouth
Change in taste
Gas
* Flushing
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.
Seek Immediate Medical Attention If You Experience:
- Signs of liver problems: unusual tiredness, loss of appetite, nausea, vomiting, yellowing of your skin or eyes (jaundice), dark urine, pale stools, or pain in the upper right part of your stomach.
- Signs of adrenal insufficiency: extreme tiredness, weakness, dizziness, lightheadedness, nausea, vomiting, or loss of appetite.
- Signs of heart problems: fast or irregular heartbeat, dizziness, or fainting.
- Any new or worsening symptoms.
Before Using This Medicine
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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the safety and efficacy of the medication.
Any medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. Certain medications, such as those used to treat high cholesterol, migraines, mood disorders, and other conditions, may interact with this drug and should be avoided. There are many medications that are contraindicated with this drug, so it is crucial to disclose all medications you are taking.
If you are breastfeeding, as this medication is not recommended for use during breastfeeding. You should not breastfeed while taking this drug.
This is not an exhaustive list of all potential drug interactions or health problems that may be relevant to your treatment with this medication. Therefore, it is vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Before starting, stopping, or changing the dose of any medication, you must consult with your doctor to ensure it is safe to do so in conjunction with this drug.
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the safety and efficacy of the medication.
Any medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. Certain medications, such as those used to treat high cholesterol, migraines, mood disorders, and other conditions, may interact with this drug and should be avoided. There are many medications that are contraindicated with this drug, so it is crucial to disclose all medications you are taking.
If you are breastfeeding, as this medication is not recommended for use during breastfeeding. You should not breastfeed while taking this drug.
This is not an exhaustive list of all potential drug interactions or health problems that may be relevant to your treatment with this medication. Therefore, it is vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Before starting, stopping, or changing the dose of any medication, you must consult with your doctor to ensure it is safe to do so in conjunction with this drug.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly undergo blood tests and other laboratory examinations as instructed by your doctor to monitor your condition. Do not exceed the prescribed duration of treatment, as this may increase the risk of developing a secondary infection. It is recommended to avoid consuming alcohol during treatment with this drug. There is a potential risk of developing high cholesterol associated with this medication; if you have concerns, discuss them with your doctor. If you are pregnant or planning to become pregnant, consult your doctor to weigh the benefits and risks of using this drug during pregnancy.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Headache
- Dizziness
- Severe liver damage (delayed onset)
What to Do:
In case of overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). There is no specific antidote. Treatment is supportive and symptomatic, including gastric lavage and activated charcoal if ingestion is recent.
Drug Interactions
Contraindicated Interactions
- Cisapride
- Dofetilide
- Dronedarone
- Eplerenone
- Ergot alkaloids (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine)
- Felodipine
- Fesoterodine
- Irinotecan
- Isavuconazonium
- Ivabradine
- Lercanidipine
- Lovastatin
- Lurasidone
- Midazolam (oral)
- Nisoldipine
- Pimozide
- Quinidine
- Ranolazine
- Rivaroxaban
- Sertindole
- Simvastatin
- Solifenacin
- Tolvaptan
- Triazolam
- Vardenafil
Major Interactions
- Antacids, H2-receptor antagonists, Proton Pump Inhibitors (PPIs) - significantly reduce absorption
- Warfarin (increased anticoagulant effect)
- Cyclosporine, Tacrolimus, Sirolimus (increased immunosuppressant levels)
- Digoxin (increased digoxin levels)
- Phenytoin (altered phenytoin and ketoconazole levels)
- Rifampin, Isoniazid, Nevirapine, Phenobarbital (decreased ketoconazole levels)
- Oral hypoglycemics (increased hypoglycemic effect)
- Calcium channel blockers (e.g., amlodipine, verapamil, nifedipine - increased levels)
- Corticosteroids (e.g., methylprednisolone, dexamethasone - increased levels)
- HIV protease inhibitors (e.g., indinavir, ritonavir - altered levels)
- Non-sedating antihistamines (e.g., terfenadine, astemizole - risk of QT prolongation, though these are largely withdrawn)
- Colchicine (increased colchicine levels, toxicity)
- Everolimus, Temsirolimus (increased mTOR inhibitor levels)
- Fentanyl (increased fentanyl levels, respiratory depression)
- Salmeterol (increased salmeterol levels, cardiovascular effects)
- Alprazolam (increased alprazolam levels)
- Buspirone (increased buspirone levels)
- Carbamazepine (altered carbamazepine and ketoconazole levels)
- Eletriptan (increased eletriptan levels)
- Eplerenone (increased eplerenone levels, hyperkalemia)
- Halofantrine (QT prolongation)
- Quetiapine (increased quetiapine levels)
- Repaglinide (increased repaglinide levels, hypoglycemia)
- Saxagliptin (increased saxagliptin levels)
- Sildenafil, Tadalafil (increased PDE5 inhibitor levels)
- Tolterodine (increased tolterodine levels)
- Vincristine, Vinblastine (increased vinca alkaloid levels, neurotoxicity)
Moderate Interactions
- Paroxetine (increased paroxetine levels)
- Theophylline (increased theophylline levels)
- Metformin (potential for increased metformin levels)
- Statins (other than lovastatin/simvastatin, e.g., atorvastatin - increased risk of myopathy)
- Oral contraceptives (reduced efficacy of oral contraceptives, increased ketoconazole levels)
- Caffeine (increased caffeine levels)
- Omeprazole (increased omeprazole levels)
- Tramadol (increased tramadol levels)
- Zolpidem (increased zolpidem levels)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Liver Function Tests (LFTs): AST, ALT, alkaline phosphatase, bilirubin
Rationale: To establish baseline liver function due to the risk of severe hepatotoxicity.
Timing: Prior to initiation of therapy.
Electrocardiogram (ECG) with QTc interval
Rationale: To assess baseline cardiac conduction due to the risk of QT prolongation and torsades de pointes.
Timing: Prior to initiation of therapy.
Adrenal function assessment (e.g., morning cortisol)
Rationale: To assess for baseline adrenal insufficiency, as ketoconazole can cause adrenal suppression.
Timing: Prior to initiation of therapy, especially in patients with pre-existing adrenal conditions or on corticosteroids.
Routine Monitoring
Liver Function Tests (LFTs): AST, ALT, alkaline phosphatase, bilirubin
Frequency: Weekly for the first month, then monthly or more frequently if clinically indicated.
Target: Within normal limits or stable from baseline.
Action Threshold: Discontinue ketoconazole if ALT or AST levels increase to 3-5 times the upper limit of normal, or if any signs/symptoms of hepatotoxicity develop. Consider discontinuation if bilirubin increases.
Signs and symptoms of hepatotoxicity
Frequency: Daily patient self-monitoring and at each clinical visit.
Target: Absence of symptoms.
Action Threshold: Immediately discontinue ketoconazole and seek medical attention if symptoms such as unusual fatigue, anorexia, nausea, vomiting, jaundice, dark urine, pale stools, or abdominal pain occur.
Signs and symptoms of adrenal insufficiency
Frequency: At each clinical visit.
Target: Absence of symptoms.
Action Threshold: Monitor for symptoms like fatigue, weakness, anorexia, nausea, vomiting, hypotension. Consider adrenal function testing if suspected.
Drug interaction assessment
Frequency: Continuously throughout therapy.
Target: Avoid contraindicated drugs; manage other interactions.
Action Threshold: Adjust doses of interacting drugs or avoid concomitant use as per guidelines.
Symptom Monitoring
- Unusual fatigue
- Anorexia
- Nausea
- Vomiting
- Jaundice (yellowing of skin or eyes)
- Dark urine
- Pale stools
- Abdominal pain
- Fever
- Rash
- Dizziness
- Lightheadedness
- Palpitations
- Shortness of breath
- Swelling of ankles/feet
- Weakness
Special Patient Groups
Pregnancy
Category C. Studies in animals have shown adverse effects on the fetus (teratogenicity, embryotoxicity). There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects observed in animal studies.
Second Trimester:
Risk of fetal exposure and potential adverse effects.
Third Trimester:
Risk of fetal exposure and potential adverse effects.
Lactation
L3 (Moderately Safe). Ketoconazole is excreted into breast milk. While the amount is generally low, potential for adverse effects on the infant (e.g., gastrointestinal upset, liver effects) exists. Weigh the benefits of breastfeeding against the potential risks to the infant. Monitor the infant for adverse effects.
Infant Risk:
Low to moderate risk. Monitor for GI upset, rash, or jaundice.
Pediatric Use
Oral ketoconazole is generally not recommended for pediatric patients due to the risk of severe hepatotoxicity and adrenal suppression. Its use should be reserved for severe systemic fungal infections where other, safer antifungals are ineffective or contraindicated, and only under strict medical supervision.
Geriatric Use
No specific dosage adjustment is required based solely on age. However, elderly patients may have reduced hepatic function or be on multiple medications, increasing the risk of adverse effects and drug interactions. Monitor liver function and for adverse effects closely.
Clinical Information
Clinical Pearls
- Oral ketoconazole has a Black Box Warning for severe hepatotoxicity and drug interactions leading to QT prolongation. Its use is highly restricted and generally reserved for serious systemic fungal infections when other first-line antifungals are not tolerated or are contraindicated.
- Always perform baseline and regular monitoring of liver function tests (LFTs) and assess for signs/symptoms of hepatotoxicity.
- Requires an acidic environment for absorption; instruct patients to take with food and avoid concomitant use with antacids, H2-blockers, or PPIs. If acid-reducing agents are necessary, consider taking ketoconazole with an acidic beverage (e.g., cola) and separating doses.
- Potent inhibitor of CYP3A4, leading to numerous significant drug interactions. Thoroughly review patient's medication list for potential interactions.
- Can cause adrenal insufficiency; monitor for symptoms and consider baseline cortisol levels in at-risk patients.
- Not effective for fungal meningitis due to poor CNS penetration.
- Not indicated for superficial fungal infections (e.g., dermatophytosis, candidiasis) due to safety risks; topical formulations are available for these conditions.
Alternative Therapies
- Fluconazole (for candidiasis, cryptococcosis, coccidioidomycosis)
- Itraconazole (for histoplasmosis, blastomycosis, aspergillosis, sporotrichosis)
- Voriconazole (for aspergillosis, candidiasis, scedosporiosis, fusariosis)
- Posaconazole (for prophylaxis of invasive fungal infections, oropharyngeal candidiasis)
- Amphotericin B (conventional or lipid formulations - for severe, life-threatening systemic fungal infections)
- Echinocandins (e.g., caspofungin, micafungin, anidulafungin - for candidiasis, aspergillosis)
Cost & Coverage
Average Cost:
$50 - $200 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization due to safety concerns and restricted use)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.