MAXEVA 400 MG 10TAB

Indications

Approved Uses

Community-acquired pneumonia, acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, uncomplicated skin and skin structure infections, complicated skin and skin structure infections, complicated intra-abdominal infections

Off-Label Uses

May be used as part of combination regimens for multidrug‑resistant tuberculosis and some non‑tuberculous mycobacterial infections (off‑label, specialist‑directed).

Dosage & Administration

Dosing by Condition

Community-acquired pneumonia: 400mg once daily for 7-14 days; Acute bacterial sinusitis: 400mg once daily for 7 days; Acute bacterial exacerbation of chronic bronchitis: 400mg once daily for 5 days; Uncomplicated skin and skin structure infections: 400mg once daily for 7 days; Complicated skin and skin structure infections: 400mg once daily for 7-21 days; Complicated intra-abdominal infections: 400mg once daily for 5-14 days

Initial Dose

400 mg once daily.

Maintenance Dose

400 mg once daily.

Maximum Dose

400 mg once daily.

Children's Dosage

Not approved for children under 18 years of age for systemic use due to risk of joint and cartilage damage.

Dose Adjustment Notes

No dose adjustment is required in renal impairment (including dialysis). No dose adjustment is required in mild to moderate hepatic impairment (Child‑Pugh A/B); avoid/use with caution in severe hepatic impairment due to limited data and potential risk (not a routine dose-adjustment scenario). No adjustment is required based on age alone.

How to Take

Swallow the 400 mg film‑coated tablet whole with water; may be taken with or without food, once daily at the same time each day. Separate from products containing polyvalent cations (Al/Mg antacids, sucralfate, iron, zinc, multivitamins) by taking moxifloxacin at least 4 hours before or at least 8 hours after these agents.

Side Effects

Common Side Effects

Nausea, diarrhea, headache, dizziness (and vomiting can occur).

Side Effect Frequency

Common (1-10%): nausea, diarrhea, dizziness, headache, vomiting; also commonly reported: abdominal pain/dyspepsia and increased liver enzymes (ALT/AST). Serious reactions (rare/uncommon): QT prolongation/arrhythmia risk, tendinopathy/tendon rupture, peripheral neuropathy, severe hypersensitivity, C. difficile-associated diarrhea, hepatotoxicity, CNS effects (e.g., seizures/psychosis).

Safety & Warnings

Contraindications

Hypersensitivity to moxifloxacin/other quinolones; concomitant use with drugs known to prolong the QT interval (e.g., Class IA/III antiarrhythmics) and/or patients with congenital/acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia/heart failure or history of symptomatic arrhythmias (per labeling precautions/contraindications).

Warnings & Precautions

Key warnings/precautions: QT prolongation (avoid in high-risk patients and with QT-prolonging drugs; correct hypokalemia); tendinitis/tendon rupture (higher risk with age, steroids, transplant-stop at first tendon symptoms); peripheral neuropathy (stop if symptoms occur); CNS effects/seizures (caution in seizure disorders); severe hypersensitivity and severe skin reactions; C. difficile diarrhea; hepatotoxicity; exacerbation of myasthenia gravis; dysglycemia (esp. diabetics); (class) aortic aneurysm/dissection risk in at-risk patients; photosensitivity is less prominent with moxifloxacin but advise sun caution if reactions occur.

Age Restriction

Not approved under 18 years.

Driving Warning

Caution advised; may cause dizziness, CNS effects that can impair driving/operating machinery.

Drug Interactions

Drug Interactions

Chelation interactions: antacids/sucralfate/multivitamins or supplements containing Al/Mg/Fe/Zn reduce absorption (separate dosing). QT-prolonging drugs (including Class IA/III antiarrhythmics, certain antipsychotics, TCAs, macrolides) increase arrhythmia risk. Warfarin may increase anticoagulant effect (monitor INR). Corticosteroids increase tendon rupture risk. NSAIDs may increase CNS stimulation/seizure risk.

Interaction Severity

MAJOR: Concomitant QT‑prolonging drugs (e.g., class IA/III antiarrhythmics, certain antipsychotics, TCAs, some macrolides) due to additive QT prolongation/torsades risk. MODERATE: Warfarin (monitor INR/bleeding), systemic corticosteroids (increased tendinopathy/rupture risk), NSAIDs (may increase CNS stimulation/seizure risk). MINOR/CLINICALLY IMPORTANT ADMINISTRATION: Antacids/sucralfate/iron/zinc/multivitamins (reduced absorption-manage by dose separation).

Food Interaction

No clinically meaningful food restriction; may be taken with or without food.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children under 18 years of age for systemic use due to risk of joint and cartilage damage.

Elderly

Standard adult dosing; exercise caution due to increased risk of tendon rupture, QT prolongation, and CNS effects in elderly patients

Kidney Impairment

No adjustment needed.

Liver Impairment

No dose adjustment for mild to moderate hepatic impairment (Child-Pugh A or B); avoid/use not recommended in severe hepatic impairment (Child-Pugh C) or significant hepatic dysfunction, particularly with risk of QT prolongation.

Storage & Patient Advice

Storage Conditions

Do not store above 30°C (store below 30°C).

Missed Dose

Take the missed dose as soon as remembered on the same day; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Complete the prescribed course unless a serious adverse reaction occurs; stop moxifloxacin and seek medical care immediately if tendon pain/swelling, neuropathy symptoms, severe rash/allergy, severe diarrhea, or significant CNS effects occur.

Overdose

Symptoms may include GI upset, dizziness/CNS effects (including seizures), and QT prolongation/arrhythmias. Management: supportive care, consider activated charcoal if recent ingestion, correct electrolytes, and perform ECG monitoring; no specific antidote.

Patient Counseling

Take once daily at the same time, with or without food; swallow whole with water. Separate from Al/Mg antacids, sucralfate, iron, zinc, or multivitamins (take moxifloxacin ≥4 hours before or ≥8 hours after). Complete the full course. Stop and seek care urgently for tendon pain/swelling, new numbness/tingling/burning (neuropathy), severe/persistent diarrhea, rash, or palpitations/fainting (QT). Use caution with driving if dizzy; inform clinicians about heart rhythm problems, myasthenia gravis, seizure history, and warfarin use; avoid unnecessary sun exposure if photosensitivity occurs.

Monitoring Requirements

No routine lab monitoring is required for most patients, but monitor/assess ECG (QT) in patients with risk factors or on QT‑prolonging drugs; monitor glucose in diabetics; monitor for tendinopathy, peripheral neuropathy, CNS effects, and severe diarrhea (C. difficile); check LFTs if symptoms of hepatic injury occur and monitor INR if on warfarin.

Pharmacology

Mechanism of Action

Inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, which are essential enzymes for DNA replication, transcription, repair, and recombination, leading to bacterial cell death.

Onset of Action

Peak plasma concentration occurs about 1-3 hours after an oral dose; clinical improvement in susceptible infections is typically seen within 48-72 hours.

Duration of Effect

Approximately 24 hours (supports once‑daily dosing).

Half-Life

Approximately 12 hours (range ~11-15 hours).

Bioavailability

Approximately 90% (about 85-92%).

Metabolism

Hepatic metabolism mainly via Phase II conjugation (glucuronidation and sulfation); not metabolized by CYP450 enzymes.

Excretion

Eliminated via both feces and urine as unchanged drug and metabolites; roughly ~20% excreted unchanged in urine and ~25% unchanged in feces, with the remainder as conjugated metabolites (e.g., sulfate/glucuronide).

Protein Binding

Approximately 45% (often cited ~45-50%).

Product Information

Available Dosage Forms

Film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: 400mg moxifloxacin as hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Spectrum

Broad-spectrum

Antibiotic Class

Fluoroquinolone

Legal Disclaimer - Al Mujtama Pharmacy The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment. Al Mujtama Pharmacy assumes no legal or medical liability for: Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist Any discrepancy between the information provided and the product's package insert or SFDA guidelines Any misuse of medication resulting from personal interpretation of the content displayed Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication. By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation. Your health is a trust - always consult your doctor first.