Moxifloxacin 400mg Tablets

Manufacturer DR.REDDY'S Active Ingredient Moxifloxacin Tablets(moks i FLOKS a sin) Pronunciation moks i 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 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
Dec 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Moxifloxacin is an antibiotic used to treat certain 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 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, with or without food. However, if you take certain other medications, you may need to take this medication at a different time.

It's essential to take this medication at least 4 hours before or 8 hours after taking antacids, certain forms of didanosine, quinapril, sucralfate, multivitamins, or products containing magnesium, aluminum, zinc, or iron. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

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. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who can also inform you 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 less than 8 hours until your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Stay well-hydrated while taking this medication.
  • Avoid excessive exposure to sunlight or artificial UV light (tanning beds) as moxifloxacin can increase sensitivity to light. Use sunscreen and wear protective clothing.
  • Do not take antacids, sucralfate, iron, zinc, or multivitamins within 4 hours before or 8 hours after taking moxifloxacin, as they can reduce its absorption.
  • Avoid strenuous exercise if you experience any tendon pain or swelling, and contact your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 400 mg orally once daily
Dose Range: 400 - 400 mg

Condition-Specific Dosing:

Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg orally once daily for 5 days
Acute Bacterial Sinusitis: 400 mg orally once daily for 10 days
Community-Acquired Pneumonia: 400 mg orally once daily for 7-14 days
Uncomplicated Skin and Skin Structure Infections: 400 mg orally once daily for 7 days
Complicated Skin and Skin Structure Infections: 400 mg orally once daily for 7-21 days
Complicated Intra-abdominal Infections: 400 mg orally once daily for 5-14 days
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Pediatric Dosing

Neonatal: Not established (generally not recommended due to risk of arthropathy)
Infant: Not established (generally not recommended due to risk of arthropathy)
Child: Not established (generally not recommended due to risk of arthropathy, except for specific severe infections like anthrax or plague where benefits outweigh risks)
Adolescent: Not established (generally not recommended due to risk of arthropathy, except for specific severe infections like anthrax or plague where benefits outweigh risks)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed (Moxifloxacin is not significantly removed by hemodialysis or continuous ambulatory peritoneal dialysis)

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Use with caution; pharmacokinetic data are limited in patients with severe hepatic impairment (Child-Pugh Class C). No specific dose adjustment recommendations.

Pharmacology

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Mechanism of Action

Moxifloxacin is a fluoroquinolone antibacterial agent that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to DNA strand breaks and bacterial cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: 0.5 to 4 hours
FoodEffect: Food does not significantly alter the absorption of moxifloxacin. It can be taken with or without food.

Distribution:

Vd: 1.7 to 2.7 L/kg
ProteinBinding: Approximately 50%
CnssPenetration: Limited (achieves concentrations in CSF, but generally lower than plasma)

Elimination:

HalfLife: Approximately 12 hours
Clearance: Not available (total body clearance is approximately 12 L/hr)
ExcretionRoute: Renal (urine) and fecal (bile/feces)
Unchanged: Approximately 20% in urine, 25% in feces
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Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose)
PeakEffect: Within 0.5 to 4 hours post-dose
DurationOfAction: 24 hours (due to once-daily dosing)
Note: Moxifloxacin exhibits concentration-dependent bacterial killing, with AUC/MIC and Cmax/MIC being the primary pharmacodynamic parameters correlating with efficacy.

Safety & Warnings

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BLACK BOX WARNING

Fluoroquinolones, including moxifloxacin, 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 moxifloxacin immediately and avoid the use of fluoroquinolones in patients who experience any of these serious adverse reactions. Fluoroquinolones may exacerbate muscle weakness in persons with myasthenia gravis. Avoid moxifloxacin in patients with a known history of myasthenia gravis. Because fluoroquinolones, including moxifloxacin, have been associated with serious adverse reactions, reserve moxifloxacin for use in patients who have no alternative treatment options for acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, and uncomplicated skin and skin structure infections.
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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
+ 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 kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high or low blood sugar, including:
+ Fruity-smelling breath
+ Dizziness
+ Rapid breathing
+ Rapid heartbeat
+ Confusion
+ Sleepiness
+ Weakness
+ Flushing
+ Headache
+ Unusual thirst or hunger
+ Frequent urination
+ Shaking
+ Sweating
Chest pain or pressure
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Shortness of breath
Shakiness
Difficulty walking
Vaginal itching or discharge
White patches in the mouth
Muscle pain or weakness
Difficulty focusing
Memory problems or loss

Severe Skin Reaction (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis)

A severe skin reaction may occur, causing serious health problems that may not be reversible and can be life-threatening. Seek medical help immediately if you experience:

Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in the mouth, throat, nose, or eyes

Diarrhea and C. Diff-Associated Diarrhea (CDAD)

Diarrhea is a common side effect of antibiotics. However, a severe form called CDAD may occur, which can lead to life-threatening bowel problems. If you experience:

Stomach pain
Cramps
Very loose, watery, or bloody stools

contact your doctor right away. Do not treat diarrhea without consulting your doctor.

Abnormal Heartbeat (Prolonged QT Interval)

This medication may cause an abnormal heartbeat. Seek medical help immediately if you experience:

Rapid heartbeat
Irregular heartbeat
Fainting

Aortic Problems

A rare but severe problem with the main blood vessel that comes out of the heart (aorta) may occur within 2 months of taking this medication, especially in older patients. This can lead to severe bleeding and even death. If you experience:

Sudden, severe pain in the stomach, chest, or back that does not go away

contact your doctor right away.

Other Side Effects

All medications can cause side effects, but many people experience no side effects or only minor ones. If you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor:

Upset stomach
Diarrhea

This is not an exhaustive list of side effects. If you have questions or concerns, contact your doctor.

Reporting Side Effects

You can 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 inflammation in any joint or tendon (especially Achilles, shoulder, hand)
  • Numbness, tingling, burning, or weakness in your arms or legs
  • Dizziness, confusion, hallucinations, or seizures
  • Severe or persistent diarrhea, especially if it contains blood or mucus
  • Rash, hives, or other signs of an allergic reaction (e.g., swelling of face, lips, tongue, or throat; difficulty breathing)
  • Palpitations, irregular heartbeat, or fainting spells
  • Blurred vision or any other changes in vision
  • Severe abdominal, chest, or back pain (possible aortic aneurysm/dissection)
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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 other abnormal heart rhythms
+ Slow heartbeat
+ Low potassium or magnesium levels
Recent heart attack
History of nerve problems or tendon problems
Previous experiences with tendon irritation or tears while taking this medication or similar drugs
Presence of an aortic aneurysm (a bulging or ballooning of the aorta, the main blood vessel that comes out of the heart) or risk factors for this condition, including:
+ Other blood vessel problems
+ High blood pressure
+ Certain health conditions like Marfan syndrome or Ehlers-Danlos syndrome
Use of medications to treat abnormal heart rhythms
Use of medications that can cause prolonged QT interval, a type of abnormal heart rhythm. Many drugs can interact with this medication, so it is crucial to ask your doctor or pharmacist if you are unsure.

To ensure your safety, it is vital to disclose all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

As well as any health problems you have. Your doctor and pharmacist need this information to verify that it is safe for you 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.
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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. Until you understand how this drug affects you, avoid driving and other activities that require alertness.

Regular blood tests and other laboratory assessments, as directed by your doctor, are crucial to monitor your condition. Some individuals may also need to undergo electrocardiogram (ECG) checks to evaluate their heart rhythm. Be aware that medications like this one can cause fluctuations in blood sugar levels, leading to hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). This is particularly concerning for people with diabetes who are taking medications that lower blood sugar, such as insulin, as severe hypoglycemia can result in coma or even death. Adhere to your doctor's instructions for checking your blood sugar levels.

Do not exceed the prescribed duration of treatment, as this may increase the risk of developing a secondary infection. Additionally, be cautious when exposed to sunlight, as this medication can increase your susceptibility to sunburn. To minimize this risk, avoid direct sun exposure, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.

Adequate hydration is important; drink plenty of non-caffeinated fluids unless your doctor advises you to restrict your fluid intake. 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 concerns or questions, discuss them with your doctor.

If you are over 60 years old, use this medication with caution, as you may be more prone to experiencing side effects. This medication is not approved for use in children, as it may increase the risk of joint and tendon problems. However, your child's doctor may determine that the benefits of treatment outweigh the risks; consult with their doctor if you have questions.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Exaggerated adverse effects such as QTc prolongation
  • CNS effects (e.g., seizures, confusion)
  • Gastrointestinal upset (e.g., nausea, vomiting)

What to Do:

In case of overdose, contact a poison control center immediately. Call 1-800-222-1222. Treatment is symptomatic and supportive. ECG monitoring is recommended due to the potential for QT prolongation. Hemodialysis or peritoneal dialysis are not effective in removing moxifloxacin.

Drug Interactions

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Contraindicated Interactions

  • Class IA antiarrhythmics (e.g., quinidine, procainamide)
  • Class III antiarrhythmics (e.g., amiodarone, sotalol)
  • Other drugs known to prolong the QT interval (e.g., cisapride, erythromycin, antipsychotics, tricyclic antidepressants)
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Major Interactions

  • Antacids containing magnesium or aluminum, sucralfate, iron supplements, zinc supplements, multivitamins (reduce absorption of moxifloxacin; administer moxifloxacin at least 4 hours before or 8 hours after these agents)
  • Corticosteroids (increased risk of severe tendon disorders, including rupture)
  • NSAIDs (increased risk of CNS stimulation and convulsive seizures)
  • Warfarin (potential for increased anticoagulant effect, monitor INR)
  • Antidiabetic agents (e.g., insulin, sulfonylureas) (potential for dysglycemia, including hypoglycemia and hyperglycemia)
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Moderate Interactions

  • Probenecid (may decrease renal excretion of moxifloxacin, leading to increased plasma concentrations)
  • Didanosine (DDI) (chelation, similar to antacids)
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Minor Interactions

  • No specific minor interactions commonly cited as clinically significant.

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess baseline QT interval, especially in patients with known QTc prolongation, uncorrected hypokalemia/hypomagnesemia, or those receiving other QTc-prolonging drugs.

Timing: Prior to initiation, if risk factors for QTc prolongation are present.

Renal and Hepatic Function Tests

Rationale: Although dose adjustment is generally not needed, baseline assessment is prudent in patients with pre-existing impairment.

Timing: Prior to initiation, if clinically indicated.

Blood Glucose

Rationale: For diabetic patients, due to risk of dysglycemia.

Timing: Prior to initiation.

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Routine Monitoring

Symptoms of Tendonitis/Tendon Rupture

Frequency: Daily during therapy and for several months post-therapy

Target: Absence of pain, swelling, inflammation, or inability to bear weight/move affected joint.

Action Threshold: Discontinue moxifloxacin immediately and avoid exercise if symptoms occur.

Symptoms of Peripheral Neuropathy

Frequency: Daily during therapy

Target: Absence of pain, burning, tingling, numbness, or weakness.

Action Threshold: Discontinue moxifloxacin immediately if symptoms occur.

Symptoms of CNS Effects

Frequency: Daily during therapy

Target: Absence of dizziness, confusion, hallucinations, seizures, or increased intracranial pressure.

Action Threshold: Discontinue moxifloxacin if severe CNS symptoms occur.

Blood Glucose (for diabetics)

Frequency: Regularly, as per usual diabetes management, with increased vigilance

Target: Individualized glycemic targets

Action Threshold: Manage hypoglycemia/hyperglycemia as per standard protocols; consider discontinuing moxifloxacin if severe dysglycemia occurs.

ECG (QTc interval)

Frequency: As clinically indicated, especially if new risk factors emerge or symptoms of arrhythmia occur.

Target: QTc < 450 ms (men), < 470 ms (women)

Action Threshold: Discontinue moxifloxacin if QTc prolongation occurs or if patient develops symptoms of arrhythmia.

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Symptom Monitoring

  • Tendon pain, swelling, inflammation, or rupture (especially Achilles, shoulder, hand)
  • Numbness, tingling, burning, pain, or weakness (signs of peripheral neuropathy)
  • Dizziness, lightheadedness, confusion, hallucinations, seizures, tremors, restlessness, insomnia, depression
  • Severe or persistent diarrhea (possible Clostridioides difficile-associated diarrhea)
  • Rash, hives, itching, swelling of face/throat, difficulty breathing (signs of hypersensitivity reaction)
  • Palpitations, irregular heartbeat, fainting (signs of QTc prolongation/arrhythmia)
  • Vision changes (e.g., blurred vision, loss of vision)
  • Severe abdominal pain, back pain, or chest pain (possible aortic aneurysm/dissection)

Special Patient Groups

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Pregnancy

Moxifloxacin is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development (e.g., skeletal abnormalities, reduced fetal weight) at doses higher than human therapeutic doses.

Trimester-Specific Risks:

First Trimester: Potential for skeletal abnormalities observed in animal studies. Use only if clearly needed.
Second Trimester: Limited human data. Animal data suggest potential for cartilage damage, though relevance to human fetal cartilage is uncertain.
Third Trimester: Limited human data. Potential for cartilage damage in the developing fetus, though relevance to human fetal cartilage is uncertain.
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Lactation

Moxifloxacin is excreted into human breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., arthropathy, effects on 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: L3 (Moderately safe). Potential risks include alteration of infant gut flora, diarrhea, and theoretical risk of cartilage damage. Monitor infant for gastrointestinal disturbances (e.g., diarrhea, candidiasis) and rash.
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Pediatric Use

Not routinely recommended for pediatric patients (<18 years of age) due to the risk of irreversible arthropathy (damage to cartilage in weight-bearing joints) observed in juvenile animals. Use is generally restricted to specific severe infections (e.g., anthrax, plague) where the benefits outweigh the risks and no other suitable alternatives are available.

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Geriatric Use

Elderly patients are at increased risk for severe tendon disorders (including rupture), QTc prolongation, and aortic aneurysm/dissection when taking fluoroquinolones. Exercise caution and monitor closely. Renal dose adjustment is generally not needed based on age alone, but consider overall renal function.

Clinical Information

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Clinical Pearls

  • Always consider the Black Box Warning for fluoroquinolones; reserve moxifloxacin for conditions where no alternative treatment options are available, especially for acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, and uncomplicated skin and skin structure infections.
  • Counsel patients to report any tendon pain, swelling, or inflammation immediately and to discontinue the drug and avoid exercise if these symptoms occur.
  • Advise patients about the risk of peripheral neuropathy and CNS effects, and to discontinue the drug if these symptoms develop.
  • Be aware of the risk of QTc prolongation; avoid use in patients with known QTc prolongation, uncorrected hypokalemia/hypomagnesemia, or those taking other QTc-prolonging drugs.
  • Moxifloxacin has excellent tissue penetration, including respiratory tract, skin, and intra-abdominal tissues.
  • Unlike some other fluoroquinolones, moxifloxacin does not require dose adjustment for renal impairment, which can be an advantage in patients with kidney disease.
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Alternative Therapies

  • Other fluoroquinolones (e.g., levofloxacin, ciprofloxacin) - with similar class warnings.
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins)
  • Macrolide antibiotics (e.g., azithromycin, clarithromycin)
  • Tetracyclines (e.g., doxycycline)
  • Clindamycin
  • Metronidazole (for anaerobic infections)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$300 per 30 tablets (400mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.