Melitase (ANTIBACTERIALS)

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Melitase (ANTIBACTERIALS)

Property Description
Active ingredient Levofloxacin
Form Tablets, Solution for Infusion, Ophthalmic Solution
Pharmacological class Fluoroquinolone Antibiotic
Common use Elimination of Bacterial Infections
Origin Synthetic

What Type of Medicine is Melitase (Levofloxacin)?

Melitase is a synthetic pharmaceutical preparation whose single active ingredient is Levofloxacin, a potent Fluoroquinolone Antibiotic. This medication is specifically developed to eliminate susceptible systemic bacterial infections throughout the body.

The active component, Levofloxacin, is a highly focused and pure S-(-) enantiomer, distinguishing it from older, racemic quinolones. This single-entity product is generally designated as a Prescription-only medicine (Rx). The compound’s structure is a chiral fluorinated carboxyquinolone, a classification that supports its broad-spectrum capability against diverse microbial pathogens.

Composition and General Purpose of This Antibacterial Agent

The primary purpose of Melitase is the effective destruction and resolution of bacterial infections via its bactericidal mode of action. The medication is supplied in multiple dosage forms to provide therapeutic versatility, including oral tablets, a sterile solution for infusion for intravenous administration, and an ophthalmic solution (eye drops) for localized, topical use.

This range of forms facilitates multiple routes of administration—Oral, Intravenous, and Ophthalmic—ensuring the active substance can be effectively delivered where needed. The high bioavailability of Levofloxacin indicates that the body can absorb and utilize the drug systemically. Its fundamental therapeutic principle relies on interfering with vital bacterial replication enzymes, ensuring the destruction of pathogens.

Regulatory References

  1. WHO Essential Medicines List
  2. Levofloxacin on WHO Essential Medicines List

What side effects are possible with Melitase (ANTIBACTERIALS)?

Possible Side Effects and Safety Information

This section describes the officially documented adverse effects and safety characteristics of Melitase (Levofloxacin) based strictly on government regulatory sources. This information is descriptive and not intended as clinical advice or usage instruction.

Adverse reactions are classified according to frequency and the affected System-Organ Class (SOC) as defined in regulatory documents such as the Summary of Product Characteristics (SmPC) and FDA labeling.

Frequency-Classified Adverse Reactions

  • Common: Adverse effects observed in up to 10 out of 100 people primarily include Gastrointestinal Disorders (e.g., diarrhea, nausea) and Nervous System Disorders (e.g., headache, dizziness). An increase in hepatic enzymes is also classified as common.
  • Uncommon: Reactions seen in up to 10 out of 1,000 people involve additional effects like vomiting, abdominal pain, insomnia, anxiety, and dermatological effects such as rash and pruritus.
  • Rare: Effects documented at this frequency, such as convulsions, paresthesia (tingling), and tendon disorders, involve more sensitive systems.

Documented Serious Safety Constraints

Official regulatory labeling highlights several serious adverse reactions. These include the risk of Tendon Rupture, which may occur during or after the completion of therapy, and Peripheral Neuropathy, which can manifest as sensory or sensorimotor nerve damage. Severe Hepatic Reactions (liver damage) and the development of Clostridioides difficile-associated Diarrhea (CDAD) are also listed as serious safety concerns associated with this class of antibacterial agent.

Population-Specific Safety Considerations

Specific constraints are defined for certain patient groups. The risk of tendon rupture is noted to be increased in older adults, particularly those also receiving corticosteroid therapy. Furthermore, regulatory documents explicitly state that the use of Levofloxacin is restricted in the pediatric population (individuals under 18 years of age) due to the documented risk of irreversible lesions in weight-bearing joints.

Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information

Feature Official Regulatory Statement
Documented overdose presentations Central nervous system effects including dizziness, confusion, tremor, and convulsions (seizures). Gastrointestinal effects such as nausea are also noted.
Physiological systems affected Central Nervous System (CNS), Cardiovascular System (QT interval), and the Renal System.
Population-specific overdose notes Patients with impaired renal function are at a higher risk of increased systemic concentrations and potential toxicity following overdose.

Required Emergency Action

In the event of an acute overdosage or if severe symptoms such as confusion or convulsions occur, regulatory authorities mandate the following actions:

Classification Official Regulatory Statement
Severity classification Overdose may result in severe cardiac effects (QT prolongation, potential for Torsades de Pointes) and Acute renal failure.
Emergency-response statements Seek emergency medical attention immediately. Management includes symptomatic and supportive treatment.
Overdose-context constraints No specific antidote is known. Procedures such as gastric lavage and administration of activated charcoal are described to reduce systemic absorption. ECG monitoring is necessary due to the documented cardiac risks.

The regulatory documents establish that an acute overdose of Levofloxacin presents risks primarily involving the neurological and cardiovascular systems, along with the potential for kidney injury. Since no specific antidote is known, official instructions mandate that medical help be sought immediately to provide intensive supportive care, including decontamination procedures and continuous ECG monitoring.

Therapeutic Uses of Melitase (ANTIBACTERIALS)

What Melitase (Levofloxacin) Treats: Main Uses and Benefits

Melitase is commonly used across conditions where functional stability becomes affected, helping to address symptoms related to acute or episodic changes. It is relevant in clinical scenarios characterized by periods of heightened symptoms.

This medication is applied in addressing significant infections, including Community-Acquired Pneumonia, Acute Pyelonephritis (kidney infection), complicated and uncomplicated Urinary Tract Infections (UTI), Chronic Bacterial Prostatitis, and Skin and Skin Structure Infections (SSSI). The medication plays a role in managing symptoms that interfere with daily comfort, such as high fever, systemic imbalance, and symptoms related to inflammatory states.


Quick Fact: Relief for Systemic Discomfort
Melitase is commonly used to help with groups of symptoms that appear suddenly, such as fever and systemic imbalance, assisting with maintaining functional stability during episodes of discomfort.

Regulatory References

  1. DailyMed label information published by the National Library of Medicine (NIH)

Eligibility and Restrictions for Use

Melitase, containing the fluoroquinolone Levofloxacin, is subject to specific regulatory limitations regarding its use in certain populations. Adherence to these rules is mandatory and based on official government labeling.

Populations for Whom Use is Contraindicated

Melitase is contraindicated and must not be used by patients with a known hypersensitivity to Levofloxacin, any other quinolones, or excipients in the formulation. It is also contraindicated in patients with a history of epilepsy, a history of tendon disorders related to previous fluoroquinolone administration, pregnant women, and breastfeeding women [SmPC 4.3, 4.6]. The general use of this drug is also contraindicated in children and growing adolescents.

Age-Related and Condition-Specific Eligibility

Population Eligibility Status (Regulatory) Restriction/Conditional Use
Adults (ge 18 years) Generally Approved Approved for all labeled indications [FDA Label 1.1].
Pediatric Patients Restricted/Contraindicated Generally restricted to limited, severe infections (e.g., Anthrax, Plague) in patients ge 6 months of age [FDA Label 2.2].
Older Adults (ge 60 years) Use with Caution Increased risk of tendon disorders; caution advised, especially with concurrent corticosteroids [SmPC 4.4].
Renal Impairment Conditional Use Dosage must be adjusted in patients with creatinine clearance le 50 mL/min [SmPC 5.3].

Use should also be avoided in patients with a history of Myasthenia Gravis (MG) [FDA Label 5.2]. Conditional use applies to those with risk factors for QT interval prolongation or a history of solid organ transplants.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section details officially documented interaction information for Melitase (Levofloxacin) based on authoritative government regulatory sources.

Classification Interacting Agents / Classes Constraint / Required Monitoring
Contraindicated Drugs that Prolong the QT Interval (e.g., Dronedarone, Pimozide, Thioridazine) Avoid co-administration due to heightened risk of QT prolongation and severe arrhythmia.
Absorption-Reducing Multivalent Cation-Containing Products (Antacids, Sucralfate, Iron salts, Zinc salts, Didanosine) Mandatory Time Separation: Must be taken at least two hours before or after oral Levofloxacin administration to prevent reduced absorption.
Pharmacodynamic Corticosteroids Increased risk of tendinitis and tendon rupture, particularly in older patients and those with renal impairment.
Pharmacodynamic Antidiabetic Agents (e.g., Insulin, Glyburide) Requires careful monitoring of blood glucose due to the risk of dysglycemia (hypoglycemia or hyperglycemia).
Clearance-Altering Probenecid, Cimetidine Reduce Levofloxacin's renal clearance (by approx 35% and approx 24% respectively), indicating competition in tubular secretion.
Pharmacodynamic Vitamin K Antagonists (e.g., Warfarin) Enhanced anticoagulant effect, requiring close monitoring of Prothrombin Time (PT) or INR.
Pharmacodynamic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) May increase the risk of CNS stimulation and convulsive seizures.

Connection to the overall interaction profile:

Regulatory documents define this drug's interaction profile through clear prohibitions (QT-prolonging drugs) and timing constraints (chelation agents) necessary to manage exposure. The profile also highlights pharmacodynamic risk augmentations with agents like corticosteroids and antidiabetic drugs, emphasizing population-specific susceptibility to certain adverse outcomes.

Mechanism of Action

Melitase (Levofloxacin) acts as a high-affinity inhibitor against two essential bacterial enzymes: DNA Gyrase and Topoisomerase IV. This action prevents the enzymes from completing their critical task of repairing and managing the bacterial chromosome structure, stabilizing the enzymes onto the DNA strands to form a lethal cleavage complex. This molecular interference targets core mechanisms essential for bacterial genetic viability. The stabilization of the cleavage complex leads to the accumulation of widespread, irreparable double-strand DNA breaks (DSBs) within the bacterial genome. This destructive process immediately halts the cell's ability to replicate, transcribe, or repair itself, resulting in a rapid, self-destruct mechanism known as bactericidal cell lysis. This cascade leads to the systemic reduction of the viable microbial load. The function of this bactericidal mechanism is inherently limited by bacterial genetics. The mechanism is functionally constrained when bacteria acquire mutations in the Quinolone Resistance Determining Regions (QRDR) of the target enzymes, reducing Levofloxacin's binding affinity. Additionally, the drug can be actively excluded from the bacterial interior by overexpressed efflux pumps, preventing it from reaching the necessary inhibitory concentration to stabilize the lethal complex.

Dosage and Administration Information

How to use Melitase (Levofloxacin) — Administration Guidelines

Melitase (Levofloxacin) is administered based on established clinical parameters. The medication is supplied for Oral (tablets, solution), Intravenous (IV) infusion, and Ophthalmic (topical eye solution) administration, with the systemic forms being bioequivalent for completing a course of therapy.

Systemic dosing is typically administered once daily (every 24 hours), with dosage ranging from 250 mg to 750 mg, depending on the specific condition as determined by the prescriber. Treatment durations vary significantly, from short courses of 3 days (Uncomplicated UTI) up to 60 days (e.g., Anthrax post-exposure prophylaxis).


Administration Conditions and Adjustments

Administration Property Standard Administration Protocol
Oral Intake Tablets may be taken without regard to food; Oral Solution should be taken 1 hour before or 2 hours after a meal.
Mineral/Cation Separation Oral formulations are typically taken at least 2 hours before or 2 hours after administering products containing multivalent cations (e.g., aluminum/magnesium antacids, iron supplements, sucralfate).
IV Infusion Rate This form is intended for slow intravenous infusion only. A 500 mg dose involves a minimum of 60 minutes, and a 750 mg dose involves a minimum of 90 minutes of infusion time.
Dose Adjustment Rule Dose adjustment is utilized for adult patients with renal impairment (Creatinine Clearance < 50 mL/min), involving a dose reduction or interval extension. No adjustment is indicated for hepatic impairment.
Missed Dose Rule If a systemic dose is missed, it is generally taken as soon as remembered. If it is almost time (e.g., less than 8 hours) until the next dose, the missed dose is skipped to maintain the schedule and prevent double dosing.

These administration parameters describe the delivery method, timing, and dosage modification protocols associated with the use of Levofloxacin.

Recent Clinical Evidence

Research evidence / Overview of Studies for Melitase (Levofloxacin)

Evidence for Use in Respiratory and Systemic Infections

Research exploring the use of Melitase for conditions like Community-Acquired Pneumonia (CAP) and Hospital-Acquired Pneumonia (HAP) involves comparative studies, including Randomized Controlled Trials (RCTs). These studies were designed to measure clinical outcomes, reporting data like the rate of clinical success and the rate of microbiological eradication (elimination of the identified bacteria). The studies examined groups of adult patients with varying degrees of illness severity, from mild cases to those requiring intravenous administration.

Evidence for Use in Urinary Tract and Kidney Infections

Melitase has been evaluated in clinical trials for treating complicated Urinary Tract Infections (cUTI) and Acute Pyelonephritis (a kidney infection). Studies focused on key outcomes, specifically tracking the microbiological eradication of the bacterial pathogens and the corresponding clinical response measured after treatment. Evidence for these indications is generally categorized as High-level, but the findings are tracked in the context of the broader trend of rising bacterial resistance. Scientific surveillance of pathogen susceptibility is relevant, as research data continue to emerge regarding clinical patterns related to this class of drugs against resistance trends.

Studies in Special Populations and Extended Observation

Studies monitored how the drug was observed in various groups, including pediatric patients (children) for certain serious infections. Subsequent accumulating clinical data in humans has informed the specific, limited regulatory approval for use in children over six months old. Research also specifically includes older adult populations in dedicated studies.

Most initial clinical trials focus on short-term outcomes. Data on the durability of the clinical response months or years after the infection is resolved are limited for many indications, and long-term patterns are not fully established outside of specific disease contexts.

Key Studies & References

  1. Levofloxacin - StatPearls - NCBI Bookshelf (FDA Approved Indications)
  2. A Multicenter, Double-Blind Study to Compare the Safety and Efficacy of Levofloxacin to That of Ciprofloxacin in the Treatment of Chronic Prostatitis (NCT00236808)

Frequently Asked Questions (FAQ)

Common questions about Melitase (ANTIBACTERIALS) (FAQ)


Q: Does Melitase interact with common pain relievers like ibuprofen or acetaminophen?

Official documents state that taking Melitase with non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, may increase the potential for central nervous system effects like seizures. Regulatory sources do not specifically list acetaminophen as a known drug interaction with this antibacterial.


Q: What should I look out for that might be a serious, but rare, side effect of Melitase?

The official product information describes that serious, but rare, effects to look out for include signs of tendon rupture, such as sudden pain, swelling, or inflammation near a joint. Peripheral neuropathy, which is damage to the nerves, can also occur, presenting as pain, burning, tingling, or weakness.


Q: What are the signs of an allergic reaction to Melitase?

Official information sources note that signs of a serious allergic reaction can include a rash, hives, or swelling of the face, lips, tongue, or throat. Experiencing difficulty breathing is also described as a potential sign of hypersensitivity to the drug.


Q: Does Melitase interact with any herbal supplements or vitamins?

Regulatory documents focus on substances that contain multivalent cations, such as iron or zinc supplements, which must be separated from oral Melitase by at least two hours to prevent reduced absorption. Official drug information does not provide a comprehensive list regarding every possible interaction with herbal supplements.


Q: Is it possible to have an overdose on Melitase, and what are the symptoms?

According to official product labels, symptoms described in cases of overdose primarily relate to the central nervous system. These effects can include confusion, tremors, or convulsions. Overdose may also be associated with problems related to the heart's rhythm, which is known as QT prolongation.


Q: Can Melitase interact with blood pressure medication?

Official documents note that Melitase is known to interact with certain medicines that prolong the QT interval (a heart rhythm measurement). This group includes certain medications that may be prescribed for heart conditions or high blood pressure, and their use is contraindicated (should not be used).


Q: Is it true that Melitase can change the way certain lab test results appear?

Regulatory documentation indicates that Melitase use can potentially lead to certain lab results appearing inaccurate. Specifically, it may cause false-positive results during urine screening for opiates. It is also noted to interfere with some laboratory tests used to detect Mycobacterium tuberculosis.


Q: Are the reported side effects of Melitase temporary or permanent?

Studies and official information indicate that certain severe adverse effects, such as peripheral neuropathy (nerve damage) and tendon rupture, may be irreversible. However, most other side effects are generally reported to be reversible following the discontinuation of the drug.


Q: Does Melitase have any known interaction with oral contraceptives?

Regulatory information indicates that no clinically significant interaction has been found between Melitase and oral contraceptive agents.


Q: Can Melitase be used to treat viral infections like the flu?

Melitase is officially indicated only for the treatment of susceptible bacterial infections as defined in the official labeling. It is not approved or intended for use against infections caused by viruses, such as the common cold or the flu.


Q: Is Melitase considered a broad-spectrum or narrow-spectrum antibacterial?

According to authoritative health sources, Melitase is described as a broad-spectrum antibacterial. This means it has activity against a wide variety of different types of bacteria.


Q: Can Melitase cause issues with sleep or insomnia?

Insomnia (difficulty sleeping) is documented in the official safety profile as an uncommon adverse effect. This means it has been reported in clinical studies but occurs in a limited percentage of patients.


Q: How quickly is Melitase eliminated from the body?

Pharmacokinetic studies, which describe how the body handles the drug, are documented in official labels. They indicate that the drug has a mean terminal elimination half-life of approximately six to eight hours in patients with normal kidney function.


Q: Is there a risk of antibiotic resistance developing with the use of Melitase?

Official labeling includes a warning that utilizing an antibacterial when a bacterial infection is not confirmed can potentially increase the risk of developing drug-resistant bacteria. This is noted in the official labeling alongside the drug's approved uses.


Q: Does Melitase affect blood sugar levels in people with diabetes?

Regulatory documents state that Melitase has the potential to cause changes in blood glucose levels, a condition known as dysglycemia. This includes the possibility of both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia).


Q: Why are there different strengths of Melitase tablets?

Official dosing tables indicate that the prescribed strength and duration of the tablets are determined by the specific type and severity of the bacterial infection being treated.


Q: Is Melitase available as a generic medicine?

Authoritative sources confirm that the active ingredient in Melitase, which is Levofloxacin, is available as a generic medicine in the United States and several other regions globally.


Q: Does Melitase affect the gut microbiome?

Like many antibacterials, Melitase can affect the natural balance of bacteria within the gut. Official safety warnings explicitly mention the risk of Clostridioides difficile-associated diarrhea (CDAD), which is a serious condition resulting from a major disturbance of the gut bacteria.

How should Melitase (ANTIBACTERIALS) be stored and disposed of?

Storage and Disposal of Melitase (Levofloxacin)

Official regulatory guidelines mandate specific conditions for storing and disposing of Melitase, which vary by dosage form.

Storage Conditions:

  • Oral Forms (Tablets/Solution): Store at controlled room temperature, 20 C to 25 C. Protection from moisture and excessive heat is required. Keep the product in its original container.
  • IV Solution: Store at 25 C; do not freeze.
  • Stability: The oral solution must be discarded 14 days after opening.

Disposal and Safety:

Melitase must be stored out of the sight and reach of children. Unused or expired medicine should be returned via a drug take-back program. If a program is unavailable, follow federal guidelines by mixing the drug with an unappealing substance, placing it in a sealed container, and disposing of it in the trash. Do not flush the product.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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