Moxifloxacin 400mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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)
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)
Moderate Interactions
- Probenecid (may decrease renal excretion of moxifloxacin, leading to increased plasma concentrations)
- Didanosine (DDI) (chelation, similar to antacids)
Minor Interactions
- No specific minor interactions commonly cited as clinically significant.
Monitoring
Baseline Monitoring
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.
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.
Rationale: For diabetic patients, due to risk of dysglycemia.
Timing: Prior to initiation.
Routine Monitoring
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.
Frequency: Daily during therapy
Target: Absence of pain, burning, tingling, numbness, or weakness.
Action Threshold: Discontinue moxifloxacin immediately if symptoms occur.
Frequency: Daily during therapy
Target: Absence of dizziness, confusion, hallucinations, seizures, or increased intracranial pressure.
Action Threshold: Discontinue moxifloxacin if severe CNS symptoms occur.
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.
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.
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
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:
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.
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.
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
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.
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)
Cost & Coverage
General Drug Facts
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.