Cipro 500mg 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
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Pregnancy Category
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 that fights bacterial infections. It works by stopping the growth of bacteria. It is used to treat various infections like urinary tract infections, respiratory infections, skin infections, and bone infections.
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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.
You can take it with or without food.
Drink a full glass of water with your medication.
However, do not take it with dairy products like milk or yogurt, or with calcium-rich juices. If you are having a meal that includes these products, you can take your medication with the meal.
If you are taking other medications, your doctor may advise you to take this medication at a different time. Specifically, take this medication at least 2 hours before or 6 hours after taking antacids, didanosine, lanthanum, sucralfate, quinapril, bismuth, sevelamer, multivitamins, or other products that contain magnesium, calcium, aluminum, iron, or zinc.

Continuing Your Medication

Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

Swallow the tablets whole; do not chew or crush them.
Some tablet strengths have a score line, which allows you to split the tablet in half if needed for your dose. Only split the tablet along the score line.

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. Consult your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember.
If it is almost time for your next dose (less than 6 hours away), skip the missed dose and return to your regular dosing schedule.
Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take exactly as prescribed, do not skip doses or stop early, even if you feel better.
  • Avoid taking antacids, sucralfate, dairy products, calcium-fortified juices, or mineral supplements (iron, zinc, magnesium, calcium) within 2 hours before or 6 hours after taking ciprofloxacin, as they can reduce absorption.
  • Drink plenty of fluids to prevent crystal formation in the urine.
  • Avoid excessive exposure to sunlight or artificial UV light (tanning beds) as ciprofloxacin can increase sensitivity to light. Use sunscreen and wear protective clothing.
  • Limit caffeine intake as ciprofloxacin can increase caffeine levels in your body.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication, e.g., 250-750 mg orally twice daily
Dose Range: 250 - 750 mg

Condition-Specific Dosing:

Uncomplicated Urinary Tract Infection: 250 mg PO BID for 3 days
Complicated Urinary Tract Infection/Pyelonephritis: 500 mg PO BID for 7-14 days
Lower Respiratory Tract Infections: 500-750 mg PO BID for 7-14 days
Skin and Skin Structure Infections: 500-750 mg PO BID for 7-14 days
Bone and Joint Infections: 500-750 mg PO BID for 4-6 weeks
Inhalational Anthrax (post-exposure): 500 mg PO BID for 60 days
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Pediatric Dosing

Neonatal: Not established (generally avoided)
Infant: Not established (generally avoided)
Child: 10-20 mg/kg/dose PO BID (max 750 mg/dose) for specific indications (e.g., complicated UTI, inhalational anthrax, cystic fibrosis exacerbations) when benefits outweigh risks.
Adolescent: 10-20 mg/kg/dose PO BID (max 750 mg/dose) for specific indications, or adult dosing if weight-appropriate.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl >50 mL/min)
Moderate: 250-500 mg q12h (CrCl 30-50 mL/min)
Severe: 250-500 mg q18-24h (CrCl <30 mL/min)
Dialysis: Administer after dialysis; 250-500 mg q24h (hemodialysis or peritoneal dialysis)

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: Not well studied; use with caution

Pharmacology

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Mechanism of Action

Ciprofloxacin is a fluoroquinolone antibacterial agent. It 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 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 AUC (extent of absorption). Dairy products and mineral supplements significantly reduce absorption.

Distribution:

Vd: 2-3 L/kg
ProteinBinding: 20-40%
CnssPenetration: Limited (increased with inflamed meninges)

Elimination:

HalfLife: 3-5 hours
Clearance: Primarily renal (glomerular filtration and tubular secretion), some non-renal clearance
ExcretionRoute: Renal (urine), Fecal
Unchanged: 60-70% (renal), 15-20% (fecal)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours)
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 the 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. Fluoroquinolones have been associated with an increased risk of aortic aneurysm rupture or dissection. In patients at increased risk for aortic aneurysm, use Ciprofloxacin only when there are no other treatment options available. Dysglycemia, including both hypoglycemia and hyperglycemia, has been reported with fluoroquinolone use. Monitor blood glucose in diabetic patients.
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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

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 right away:

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
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
Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes

Important: A severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or very loose, watery, or bloody stools, contact your doctor immediately.

Rare but Serious Condition: A rare but severe problem with the main blood vessel that comes out of the heart (aorta) has been reported in some patients, especially older adults, within 2 months of taking this medication. This can cause severe bleeding and even death. If you experience sudden, severe pain in the stomach, chest, or back that does not go away, seek medical help immediately.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. 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:

Diarrhea
Upset stomach or vomiting
Headache

Reporting 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:

  • New or worsening pain, swelling, or bruising around a joint (especially the heel, ankle, or shoulder) - could indicate tendon damage.
  • Numbness, tingling, burning pain, or weakness in your arms or legs - signs of nerve damage.
  • Dizziness, confusion, hallucinations, seizures, or severe changes in mood or behavior.
  • Severe, watery diarrhea or bloody stools (even weeks after stopping the medication) - could be C. difficile infection.
  • Sudden, severe pain in your chest, stomach, or back - could be an aortic aneurysm.
  • Any signs of an allergic reaction: rash, hives, difficulty breathing, swelling of face/lips/tongue/throat.
  • Yellowing of skin or eyes, dark urine, severe stomach pain (signs of liver problems).
  • Unusual bruising or bleeding.
  • Changes in blood sugar levels (especially if diabetic).
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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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Abnormal heart rhythms, such as a prolonged QTc interval on an electrocardiogram (ECG), or other irregular heartbeats
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (a weakened heart)
+ Recent heart attack
+ Nerve problems or tendon problems
+ Previous tendon irritation or tears, especially if you have taken this medication or similar drugs in the past
+ Aortic aneurysm (a bulging or ballooning of the aorta, the main blood vessel that carries blood from the heart) or an increased risk of developing this condition, which may be associated with other blood vessel problems, high blood pressure, or certain health conditions like Marfan syndrome or Ehlers-Danlos syndrome
Medications that may cause abnormal heart rhythms, specifically those that can prolong the QT interval. There are many drugs that can cause this effect, so it is crucial to ask your doctor or pharmacist if you are unsure.
Concurrent use of certain medications, including:
+ Duloxetine
+ Theophylline
+ Tizanidine
+ Zolpidem
* If you are breastfeeding, as you should not breastfeed while taking this medication and for at least 2 days after your last dose.

This list is not exhaustive, and 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. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

Caution with Daily Activities

Until you know how this medication affects you, avoid driving and engaging in other activities that require you to be alert. This will help prevent accidents and ensure your safety.

Lab Tests and Monitoring

This medication may affect the results of certain lab tests. Be sure to inform all of your healthcare providers and lab workers that you are taking this medication. If you are taking this medication for an extended period, your doctor may recommend regular blood work to monitor your condition.

Blood Sugar Control

Medications like this one can cause changes in blood sugar levels. If you have diabetes and are taking medications to lower your blood sugar, such as insulin, you may be at risk for low blood sugar. Symptoms of high or low blood sugar include:

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

If you experience any of these symptoms, contact your doctor immediately. It is also essential to monitor your blood sugar levels as directed by your doctor.

Duration of Use

Do not take this medication for longer than prescribed by your doctor. Taking it for an extended period can increase the risk of a second infection.

Caffeine Interactions

If you take medications that contain caffeine or consume products with caffeine, such as tea, coffee, cola, or chocolate, inform your doctor. This can help prevent any potential interactions.

Sun Protection

This medication can increase your risk of sunburn. To protect yourself, avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.

Fluid Intake

Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Rare but Serious Side Effects

In rare cases, 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.

Abnormal Heartbeat

This medication can cause a type of abnormal heartbeat known as prolonged QT interval. If you experience a fast heartbeat, an irregular heartbeat, or fainting, contact your doctor immediately.

Liver Problems

If you experience any symptoms of liver problems, such as dark urine, tiredness, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor right away.

Age-Related Precautions

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

Pregnancy and Breastfeeding

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

Overdose Symptoms:

  • Dizziness
  • Confusion
  • Headache
  • Tremors
  • Hallucinations
  • Seizures
  • Renal impairment (crystalluria)

What to Do:

In case of overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is symptomatic and supportive. Gastric lavage may be performed. Maintain adequate hydration.

Drug Interactions

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Contraindicated Interactions

  • Tizanidine (significant increase in tizanidine levels, hypotension, somnolence)
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Major Interactions

  • QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) - increased risk of QT prolongation and Torsades de Pointes
  • Warfarin - increased INR and bleeding risk
  • Theophylline - increased theophylline levels and toxicity (due to CYP1A2 inhibition)
  • Methotrexate - increased methotrexate levels and toxicity
  • Cyclosporine - increased cyclosporine levels and nephrotoxicity
  • Phenytoin - altered phenytoin levels
  • NSAIDs (non-steroidal anti-inflammatory drugs) - increased risk of CNS stimulation and seizures (especially with high doses of ciprofloxacin)
  • Sildenafil, Tadalafil, Vardenafil - increased PDE5 inhibitor levels
  • Duloxetine - increased duloxetine levels (CYP1A2 inhibition)
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Moderate Interactions

  • Polyvalent cations (e.g., antacids containing aluminum, magnesium, calcium; iron, zinc supplements, sucralfate, didanosine buffered tablets/oral solution) - reduced ciprofloxacin absorption due to chelation. Separate administration by at least 2-6 hours.
  • Caffeine - decreased caffeine clearance
  • Ropinirole - increased ropinirole levels (CYP1A2 inhibition)
  • Clozapine - increased clozapine levels (CYP1A2 inhibition)
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Minor Interactions

  • Metoclopramide - accelerates ciprofloxacin absorption (no change in AUC)
  • Probenecid - increases ciprofloxacin levels (inhibits renal tubular secretion)

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To guide initial dosing and identify patients at risk for accumulation.

Timing: Prior to initiation of therapy

Liver function tests (LFTs)

Rationale: To assess baseline hepatic status, especially in patients with pre-existing liver disease.

Timing: Prior to initiation of therapy (if clinically indicated)

Electrocardiogram (ECG)

Rationale: To assess baseline QT interval, especially in patients with risk factors for QT prolongation or on concomitant QT-prolonging medications.

Timing: Prior to initiation of therapy (if clinically indicated)

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Routine Monitoring

Renal function (CrCl)

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

Target: Maintain appropriate CrCl for dosing

Action Threshold: Adjust dose if CrCl declines

Blood glucose

Frequency: Periodically, especially in diabetic patients or those with risk factors for dysglycemia

Target: Normal glycemic range

Action Threshold: Manage hypoglycemia/hyperglycemia; consider discontinuing ciprofloxacin if severe

INR (if on warfarin)

Frequency: Frequently, especially during initiation and dose changes

Target: Therapeutic INR range for indication

Action Threshold: Adjust warfarin dose as needed

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Symptom Monitoring

  • Tendon pain, swelling, or inflammation (especially Achilles tendon)
  • Numbness, tingling, burning, pain, or weakness in extremities (peripheral neuropathy)
  • Dizziness, confusion, hallucinations, seizures, tremors, anxiety, depression, suicidal thoughts (CNS effects)
  • Severe watery diarrhea, abdominal pain, fever (C. difficile-associated diarrhea)
  • Rash, blistering, peeling skin (severe cutaneous adverse reactions)
  • Joint pain or swelling (arthralgia)
  • Muscle weakness (exacerbation of myasthenia gravis)
  • Chest, back, or abdominal pain (aortic aneurysm/dissection)
  • Palpitations, fainting (QT prolongation/arrhythmia)
  • Unusual bruising or bleeding

Special Patient Groups

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Pregnancy

Category C. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown arthropathy and skeletal abnormalities, but human data are limited and do not consistently show increased risk of major birth defects.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies show potential for cartilage damage.
Second Trimester: Limited human data; animal studies show potential for cartilage damage.
Third Trimester: Limited human data; animal studies show potential for cartilage damage.
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Lactation

L3 (Moderately safe). Ciprofloxacin is excreted into breast milk. While the risk of arthropathy in the infant is considered low, monitor the infant for gastrointestinal disturbances (e.g., diarrhea, candidiasis) and potential effects on developing cartilage.

Infant Risk: Low risk of serious adverse effects, but theoretical risk of arthropathy. Monitor for GI upset.
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Pediatric Use

Generally not recommended as first-line therapy due to the risk of arthropathy (cartilage damage) in weight-bearing joints. Use is reserved for specific severe infections (e.g., complicated UTI/pyelonephritis, inhalational anthrax, cystic fibrosis exacerbations) where the benefits outweigh the risks and alternative therapies are not suitable.

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Geriatric Use

Increased risk of tendon disorders (tendinitis and rupture), peripheral neuropathy, CNS effects, QT prolongation, and aortic aneurysm/dissection. Dose adjustment is necessary for renal impairment, which is more common in the elderly. Use with caution and monitor closely.

Clinical Information

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Clinical Pearls

  • Ciprofloxacin should be taken at least 2 hours before or 6 hours after antacids, sucralfate, or products containing iron, zinc, calcium, magnesium, or aluminum.
  • Counsel patients on the serious and potentially irreversible adverse effects, including tendinitis/tendon rupture, peripheral neuropathy, and CNS effects. Instruct them to discontinue the drug and seek medical attention immediately if these symptoms occur.
  • Patients should be advised to avoid excessive sun exposure due to photosensitivity.
  • Monitor blood glucose in diabetic patients due to the risk of dysglycemia (hypoglycemia or hyperglycemia).
  • Complete the full course of therapy, even if symptoms improve, to prevent the development of antibiotic resistance.
  • Ciprofloxacin is a potent CYP1A2 inhibitor, leading to significant interactions with drugs like theophylline and tizanidine.
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Alternative Therapies

  • Other fluoroquinolones (e.g., Levofloxacin, Moxifloxacin)
  • Beta-lactam antibiotics (e.g., Penicillins, Cephalosporins, Carbapenems)
  • Aminoglycosides (e.g., Gentamicin, Tobramycin)
  • Macrolides (e.g., Azithromycin, Clarithromycin)
  • Tetracyclines (e.g., Doxycycline)
  • Sulfonamides (e.g., Trimethoprim/Sulfamethoxazole)
  • Depending on the specific infection and susceptibility patterns.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (500mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 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 is a valuable resource that provides important information. 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, we encourage you 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 seeking help, be prepared to provide details about the overdose, including the amount taken and the time it occurred.