Cipro 250mg Tablets

Manufacturer BAYER Active Ingredient Ciprofloxacin Tablets(sip roe FLOKS a sin) Pronunciation sip roe FLOKS a sin
WARNING: This drug may cause severe side effects like irritated or torn tendons; nerve problems in the arms, hands, legs, or feet; and nervous system problems. These can happen alone or at the same time. They can happen within hours to weeks after starting this drug. Some of these effects may not go away, and may lead to disability or death.The chance of irritated or torn tendons is greater in people over the age of 60; heart, kidney, or lung transplant patients; or people taking steroid drugs. Tendon problems can happen as long as several months after treatment. Call your doctor right away if you have pain, bruising, or swelling in the back of the ankle, shoulder, hand, or other joints. Call your doctor right away if you are not able to move or bear weight on a joint or if you hear or feel a snap or pop.Call your doctor right away if you have signs of nerve problems. These may include not being able to handle heat or cold; change in sense of touch; or burning, numbness, tingling, pain, or weakness in the arms, hands, legs, or feet.Call your doctor right away if you have signs of nervous system problems. These may include anxiety, bad dreams, trouble sleeping, change in eyesight, dizziness, feeling confused, feeling nervous or agitated, feeling restless, hallucinations (seeing or hearing things that are not there), new or worse behavior or mood changes like depression or thoughts of suicide, seizures, or very bad headaches.Do not take if you have myasthenia gravis. Very bad and sometimes deadly breathing problems have happened with this drug in people who have myasthenia gravis.For some health problems, this drug is only for use when other drugs cannot be used or have not worked. Talk with the doctor to be sure that the benefits of this drug are more than the risks. @ COMMON USES: It is used to treat or prevent bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Fluoroquinolone; DNA gyrase inhibitor; Topoisomerase IV inhibitor
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Pregnancy Category
C
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FDA Approved
Oct 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ciprofloxacin is an antibiotic used to treat various bacterial infections. It works by stopping the growth of bacteria. It's important to take it exactly as prescribed and to finish the entire course of treatment, even if you feel better.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow these instructions carefully:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions closely.
Take your medication at the same time every day.
You can take your medication with or without food.
Swallow your medication with a full glass of water.
Avoid taking your medication with dairy products, such as milk or yogurt, or calcium-rich juices. However, if you are taking a full meal that contains these products, you can take your medication with the meal.
If you take certain other medications, you may need to take this medication at a different time. Be sure to take this medication at least 2 hours before or 6 hours after taking any antacids, didanosine, lanthanum, sucralfate, quinapril, bismuth, sevelamer, multivitamins, or other products that contain magnesium, calcium, aluminum, iron, or zinc.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Swallow your medication whole; do not chew or crush it.
Some tablet strengths may have a score line, which allows you to split the tablet in half if needed for your dose. If you need to split your tablet, only split it along the score line.

Storing and Disposing of Your Medication

To ensure the safety and effectiveness of your medication:

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe place, 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 by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
If it is less than 6 hours until your next scheduled dose, skip the missed dose and take your next dose at the regular time.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take with plenty of fluids to prevent crystal formation in urine.
  • Avoid taking antacids, iron supplements, zinc supplements, or dairy products (milk, yogurt) within 2 hours before or 6 hours after taking ciprofloxacin, as they can reduce its absorption.
  • Avoid excessive exposure to sunlight or artificial UV light (tanning beds) as ciprofloxacin can increase sensitivity to light.
  • Limit caffeine intake as ciprofloxacin can increase caffeine levels in the body.
  • Avoid alcohol if it causes stomach upset or other adverse effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by infection type and severity, e.g., 250 mg to 750 mg orally twice daily.
Dose Range: 250 - 750 mg

Condition-Specific Dosing:

Uncomplicated UTI: 250 mg PO BID for 3 days
Complicated UTI/Pyelonephritis: 500 mg PO BID for 7-14 days
Acute Sinusitis: 500 mg PO BID for 10 days
Chronic Bacterial Prostatitis: 500 mg PO BID for 28 days
Lower Respiratory Tract/Skin/Bone/Joint Infections: 500-750 mg PO BID for 7-14 days
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Pediatric Dosing

Neonatal: Not established (generally avoided)
Infant: Not established (generally avoided)
Child: 10-20 mg/kg PO BID (max 750 mg/dose) for specific severe infections (e.g., complicated UTI, pyelonephritis, anthrax, cystic fibrosis exacerbations).
Adolescent: 10-20 mg/kg PO BID (max 750 mg/dose) for specific severe infections (e.g., complicated UTI, pyelonephritis, anthrax, cystic fibrosis exacerbations).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 50 mL/min)
Moderate: Reduce dose by 50% or extend interval (e.g., 250-500 mg q12h for CrCl 30-50 mL/min)
Severe: Reduce dose by 50% or extend interval (e.g., 250-500 mg q24h for CrCl < 30 mL/min)
Dialysis: Administer after dialysis on dialysis days. For hemodialysis/CAPD, 250-500 mg q24h.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: Not well studied; monitor closely.

Pharmacology

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Mechanism of Action

Ciprofloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to inhibition of bacterial DNA synthesis and ultimately bacterial cell death.
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Pharmacokinetics

Absorption:

Bioavailability: 70-80%
Tmax: 1-2 hours
FoodEffect: Food delays Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 2-3 L/kg
ProteinBinding: 20-40%
CnssPenetration: Limited (CSF levels 10-40% of plasma)

Elimination:

HalfLife: 3-5 hours
Clearance: Not available (variable)
ExcretionRoute: Renal (glomerular filtration and tubular secretion), Fecal
Unchanged: 50-70% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: 12 hours (due to BID dosing)

Safety & Warnings

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BLACK BOX WARNING

Fluoroquinolones, including ciprofloxacin, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Discontinue ciprofloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with a known history of myasthenia gravis. Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions, reserve ciprofloxacin for use in patients who have no alternative treatment options for uncomplicated urinary tract infections, acute bacterial exacerbation of chronic bronchitis, and acute sinusitis.
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Side Effects

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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Chest pain or pressure
Shortness of breath
Shakiness or tremors
Difficulty walking
Vaginal itching or discharge
White patches in the mouth (oral thrush)
Sunburn
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Muscle pain or weakness
Difficulty focusing or memory problems
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, causing severe health problems that may not be reversible, and potentially leading to death. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem. Contact your doctor immediately if you experience:
+ Stomach pain or cramps
+ Very loose, watery, or bloody stools
A rare but severe problem with the aorta (the main blood vessel that comes out of the heart) has been reported in some patients, especially older adults, within 2 months of taking this medication. This can cause severe bleeding and potentially lead to death. Seek medical help immediately if you experience:
+ Sudden, severe pain in the stomach, chest, or back that does not go away

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Upset stomach or vomiting
Headache
Other side effects not listed here

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:

  • Sudden pain, swelling, or bruising around a joint (especially ankle, heel, shoulder, elbow, wrist) - could be tendon rupture.
  • Numbness, tingling, burning, or weakness in arms or legs - could be nerve damage.
  • Confusion, hallucinations, depression, anxiety, or unusual thoughts/behaviors.
  • Severe or watery diarrhea, especially if bloody, with fever or stomach cramps.
  • Chest pain, rapid or irregular heartbeat, fainting.
  • Severe rash, blistering, or peeling skin.
  • Yellowing of skin or eyes, dark urine (signs of liver problems).
  • Any new or worsening muscle weakness (if you have myasthenia gravis).
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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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Certain heart conditions, such as:
+ Long QTc on electrocardiogram (ECG) or abnormal heartbeat
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (weak heart)
+ Recent heart attack
Nerve problems or tendon problems, including:
+ Previous tendon irritation or tears while taking this medication or similar drugs
Aortic aneurysm (ballooning or bulging of the aorta) or risk factors for this condition, including:
+ Other blood vessel problems
+ High blood pressure
+ Certain health conditions like Marfan syndrome or Ehlers-Danlos syndrome
Medications that can cause abnormal heart rhythms (prolonged QT interval). Consult your doctor or pharmacist if you are unsure.
Concurrent use of specific medications, including:
+ Duloxetine
+ Theophylline
+ Tizanidine
+ Zolpidem
* Breast-feeding: Do not breast-feed while taking this medication and for at least 2 days after the last dose.

This list is not exhaustive. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor.
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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. This will help ensure they are aware of any potential interactions or effects.

Until you know how this medication affects you, avoid driving and other activities that require you to be alert. Additionally, be aware that this drug may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and lab personnel that you are taking this medication.

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition. It is also important to be aware of the risk of high and low blood sugar associated with this medication. Low blood sugar has occurred, particularly in people with diabetes who are taking medications that lower blood sugar, such as insulin. In severe cases, low blood sugar can lead to coma or even death. Therefore, it is essential to monitor your blood sugar levels as directed by your doctor and report any signs of high or low blood sugar, including:

Breath that smells like fruit
Dizziness
Fast breathing
Fast heartbeat
Feeling confused or sleepy
Feeling weak
Flushing
Headache
Unusual thirst or hunger
Passing urine more often
* Shaking or sweating

Do not take this medication for longer than prescribed, as this can increase the risk of a second infection. If you consume products containing caffeine, such as tea, coffee, cola, or chocolate, or take medications that contain caffeine, inform your doctor.

Be aware that this medication can increase your risk of sunburn, so it is essential to avoid excessive sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize your risk.

Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.

Although rare, this medication can cause severe and potentially life-threatening side effects, including muscle or joint problems, kidney or liver damage, blood disorders, and other complications. If you have any concerns or questions, discuss them with your doctor.

This medication can also cause a type of abnormal heartbeat known as prolonged QT interval. If you experience a fast or irregular heartbeat, or if you faint, seek medical attention immediately.

If you notice any signs of liver problems, such as dark urine, tiredness, decreased appetite, stomach pain or nausea, light-colored stools, vomiting, or yellowing of the skin or eyes, contact your doctor right away.

If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication with caution, as the risk of joint problems may be higher in children.

If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Tremor
  • Headache
  • Tiredness
  • Seizures
  • Abdominal pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Renal impairment (crystalluria, hematuria)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. Gastric lavage may be considered. Maintain adequate hydration. Hemodialysis or peritoneal dialysis is not effective in removing ciprofloxacin.

Drug Interactions

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Contraindicated Interactions

  • Tizanidine (risk of significant hypotension and sedation)
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Major Interactions

  • QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics)
  • Corticosteroids (increased risk of tendinitis and tendon rupture)
  • Warfarin (increased anticoagulant effect, elevated INR)
  • Cyclosporine (increased nephrotoxicity)
  • Phenytoin (altered phenytoin levels)
  • Methotrexate (increased methotrexate toxicity)
  • Clozapine (increased clozapine levels and toxicity)
  • Ropinirole (increased ropinirole levels)
  • Sildenafil (increased sildenafil levels)
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Moderate Interactions

  • Multivalent cations (e.g., aluminum, magnesium, calcium, iron, zinc, sucralfate) - significantly reduce ciprofloxacin absorption; separate administration by at least 2 hours before or 6 hours after.
  • NSAIDs (increased risk of CNS stimulation and seizures)
  • Oral hypoglycemics (e.g., glyburide) - risk of dysglycemia (hypo- or hyperglycemia)
  • Theophylline (increased theophylline levels and toxicity)
  • Caffeine (decreased caffeine clearance)
  • Omeprazole (reduced ciprofloxacin absorption)
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Minor Interactions

  • Probenecid (decreased renal clearance of ciprofloxacin)

Monitoring

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Baseline Monitoring

Culture and Sensitivity

Rationale: To confirm susceptibility of the infecting organism to ciprofloxacin.

Timing: Prior to initiation of therapy

Renal Function (CrCl, SCr)

Rationale: To determine appropriate dosing, especially in patients with pre-existing renal impairment.

Timing: Prior to initiation of therapy

Electrolytes (K+, Mg2+)

Rationale: To assess risk of QT prolongation, especially in patients with cardiac risk factors.

Timing: Prior to initiation of therapy (if cardiac risk factors present)

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Routine Monitoring

Renal Function (SCr, CrCl)

Frequency: Periodically, especially in patients with impaired renal function or prolonged therapy.

Target: Maintain within patient's baseline or adjusted for impairment.

Action Threshold: Significant decline warrants dose adjustment.

Blood Glucose

Frequency: Regularly, especially in diabetic patients.

Target: Maintain within target range.

Action Threshold: Significant hypo- or hyperglycemia warrants intervention and potential drug discontinuation.

INR (if on warfarin)

Frequency: Frequently, especially at initiation and dose changes.

Target: Maintain within therapeutic range.

Action Threshold: INR outside range warrants warfarin dose adjustment.

Signs of Tendinopathy/Neuropathy/CNS effects

Frequency: Daily patient assessment.

Target: Absence of symptoms.

Action Threshold: Presence of symptoms warrants immediate discontinuation.

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Symptom Monitoring

  • Tendon pain, swelling, inflammation, or rupture (especially Achilles tendon)
  • Numbness, tingling, burning, or weakness (signs of peripheral neuropathy)
  • Confusion, hallucinations, depression, anxiety, insomnia, dizziness, seizures
  • Severe or persistent diarrhea (may indicate C. difficile infection)
  • Chest pain, palpitations, fainting (signs of QT prolongation/arrhythmia)
  • Muscle weakness (especially in patients with myasthenia gravis)
  • Joint pain or swelling (especially in pediatric patients)

Special Patient Groups

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Pregnancy

Generally avoided unless the potential benefit justifies the potential risk to the fetus. Animal studies show some evidence of arthropathy. Human data are limited but generally reassuring for first-trimester exposure, but risk cannot be excluded.

Trimester-Specific Risks:

First Trimester: Limited human data, no clear evidence of increased major birth defects, but animal data show arthropathy. Use only if clearly needed.
Second Trimester: Potential for arthropathy in the fetus, though human data are limited.
Third Trimester: Potential for arthropathy in the fetus, though human data are limited.
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Lactation

Ciprofloxacin is excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., arthropathy, alteration of gut flora), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Moderate risk (L3). Potential for arthropathy, changes in gut flora. Monitor infant for gastrointestinal disturbances (diarrhea, candidiasis) and joint issues.
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Pediatric Use

Generally not recommended as first-line due to risk of arthropathy (damage to cartilage in weight-bearing joints). Reserved for specific severe infections where benefits outweigh risks (e.g., complicated UTI, pyelonephritis, anthrax, cystic fibrosis exacerbations).

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Geriatric Use

Increased risk of tendinitis/tendon rupture, QT prolongation, and CNS effects (e.g., confusion, hallucinations). Dose adjustment required for age-related decline in renal function. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Ciprofloxacin is a broad-spectrum antibiotic, but its use should be reserved for appropriate indications due to the risk of serious adverse effects and to combat antimicrobial resistance.
  • Always advise patients to stay well-hydrated to prevent crystalluria.
  • Emphasize the importance of separating ciprofloxacin from multivalent cation-containing products (antacids, iron, dairy) by several hours.
  • Educate patients on the signs and symptoms of tendinopathy, peripheral neuropathy, and CNS effects, and instruct them to discontinue the drug and seek medical attention immediately if these occur.
  • Consider alternative antibiotics for uncomplicated infections where fluoroquinolones are not the only option, especially given the FDA's strengthened warnings.
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Alternative Therapies

  • Other Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin)
  • Beta-lactam antibiotics (e.g., Amoxicillin, Cephalexin, Ceftriaxone)
  • Macrolide antibiotics (e.g., Azithromycin, Clarithromycin)
  • Tetracyclines (e.g., Doxycycline)
  • Aminoglycosides (e.g., Gentamicin, Tobramycin)
  • Sulfonamides (e.g., Trimethoprim/Sulfamethoxazole)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 250mg)
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, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its use. It is important to 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, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek emergency medical attention right away. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care.