L-Cin-OZ

There is no image.

Treatment option:

Medically reviewed

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 L-Cin-OZ

Property	Description
Active Ingredients	Levofloxacin, Ornidazole
Form	Tablet, Oral Suspension
Pharmacological Class	Fluoroquinolone Antibiotic, Nitroimidazole Antiprotozoal
Common Use	Treatment of mixed bacterial and parasitic infections
Origin	Synthetic

What Type of Medicine is L-Cin-OZ?

L-Cin-OZ is a synthetic, fixed-dose combination medication classified as a broad-spectrum antimicrobial agent, designed for oral route administration in the form of a tablet or oral suspension. It is structurally defined as a single pharmaceutical preparation that simultaneously delivers the two distinct active compounds, Levofloxacin and Ornidazole. This specific two-drug structure is clinically recognized for providing enhanced therapeutic efficacy compared to single-agent therapies when addressing infections of uncertain or mixed etiology.

Composition and Pharmacological Class of L-Cin-OZ

The core of L-Cin-OZ is its composition, leveraging Levofloxacin, an established antibiotic, and Ornidazole, an antiprotozoal agent. Levofloxacin belongs to the fluoroquinolone antibiotic class, while Ornidazole is categorized as a nitroimidazole antimicrobial. This deliberate combination establishes the product's comprehensive therapeutic scope, specifically targeting scenarios requiring intervention against both bacterial and parasitic components. The established fluoroquinolone classification for Levofloxacin validates its foundational role in antimicrobial therapy.

General Purpose of the Combination Therapy

The general purpose of the L-Cin-OZ combination is to provide powerful, systemic coverage against a diverse range of microbial and parasitic infections throughout the body. The medication utilizes its dual mechanism of action to address common clinical scenarios where an infection may be caused by both bacteria and protozoa concurrently. By combining the strengths of the two agents, the preparation ensures that the underlying cause of infection is comprehensively targeted, offering a robust defense beyond what a single-class drug could typically achieve.

Regulatory References

What side effects are possible with L-Cin-OZ?

Possible Side Effects and Safety Information

This section outlines the officially documented safety profile, including possible adverse reactions and restrictions associated with this medication.

Serious and Potentially Irreversible Adverse Reactions

L-Cin-OZ contains a fluoroquinolone antibiotic component (Ofloxacin), a class associated with a Boxed Warning by major regulatory agencies. This warning highlights the risk of serious, disabling, and potentially irreversible side effects that can affect multiple body systems:

Musculoskeletal and Connective Tissue: Inflammation and rupture of tendons (tendonitis and tendon rupture), most commonly the Achilles tendon. This risk is higher in the elderly (over 60), patients with kidney impairment, or those taking corticosteroid medicines.
Nervous System (Peripheral and Central): Disabling, long-lasting peripheral neuropathy (numbness, tingling, pain, or weakness in the extremities) and central nervous system effects such as seizures, psychosis, severe confusion, hallucinations, and suicidal thoughts.

Other Clinically Significant Reactions

Reported adverse effects categorized by body system include:

Gastrointestinal: Common events include nausea, vomiting, diarrhea, and abdominal pain. Severe cases of antibiotic-associated colitis (e.g., Clostridioides difficile-associated diarrhea) have been reported.
Hypersensitivity: Severe, sometimes fatal, allergic reactions (anaphylaxis) and severe skin reactions (e.g., Stevens-Johnson syndrome, Toxic Epidermal Necrolysis) have been documented.
Cardiac: The drug can prolong the QT interval, requiring caution in patients with pre-existing heart conditions or those taking other medications that affect heart rhythm.

Safety Restrictions and Contraindications

Regulatory documents stipulate that this medicine must not be used (is contraindicated) in patients with:

A known history of allergy or hypersensitivity to the drug's components or any other quinolone or nitro-imidazole antibiotics.
A history of tendon disorder related to previous fluoroquinolone treatment.
Known epilepsy or conditions that lower the seizure threshold.
Pregnancy and breast-feeding.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for an overdose of L-Cin-OZ (Levofloxacin and Ornidazole) is defined by the documented risks associated with its two components. Overdose manifestations are generally characterized as an extreme exaggeration of known adverse effects.

Documented Manifestations and Severe Outcomes

Category	Officially Documented Manifestation
Neurological Effects	Confusion, agitation, tremor, hallucinations, and the potential for convulsive seizures from the Levofloxacin component. Headache and somnolence (sleepiness) are also noted.
Cardiovascular Risk	The most serious documented outcome is prolongation of the QT interval on the electrocardiogram, which carries the risk of life-threatening cardiac arrhythmias.
Gastrointestinal Effects	Manifestations include severe nausea, vomiting, and gastric mucosal erosions.

Official Emergency Actions and Management

Regulatory authorities mandate that emergency medical attention must be sought immediately for any suspected overdose. Because no specific antidote is known for either active component, management is strictly defined as symptomatic and supportive treatment.

Required procedural measures documented in regulatory labeling include ECG monitoring due to the cardiovascular risk and maintaining adequate hydration. If convulsions or seizures occur, the use of diazepam is a specified supportive measure. Special caution is warranted in patients with pre-existing conditions that predispose them to seizures or QT prolongation.

Therapeutic Uses of L-Cin-OZ

L-Cin-OZ is applied across domains where additional symptomatic support is needed due to the presence of both certain bacterial and protozoal activity. The combination's use is generally aimed at addressing a broad range of symptoms associated with these specific activities. This class of medication is specifically used for the management of symptoms related to diarrhea and dysentery caused by mixed infections.

The medication is considered relevant for easing symptoms associated with conditions that involve episodic or fluctuating manifestations, such as certain gastrointestinal infections, gynaecological discomfort, and skin and soft tissue conditions. It is applied during phases of increased distress or discomfort when symptoms become temporarily overwhelming.

“This combination supports the patient during difficult episodes by easing distress and contributing to improved day-to-day comfort during symptomatic periods.”

This approach supports the management of symptoms linked to infections involving multiple pathogen types. By helping to ease the overall symptom burden, it assists with maintaining functional stability when symptoms interfere with routine activities.

Quick Fact: Supports the management of symptoms related to Systemic Imbalance

Eligibility and Restrictions for Use

This section outlines the officially documented population eligibility and non-eligibility rules for L-Cin-OZ, a fixed-dose combination containing Levofloxacin (a fluoroquinolone) and Ornidazole (a nitroimidazole).

Populations for Whom Use is Prohibited (Contraindications)

Category	Status	Regulatory Basis
Hypersensitivity	Contraindicated	Allergy to Levofloxacin, Ornidazole, any other Fluoroquinolones, or Nitroimidazole derivatives is prohibited.
Age Restriction	Contraindicated	Not recommended for children and growing adolescents (typically under 18 years) due to the risk of joint cartilage damage.
Tendon History	Contraindicated	Patients with a history of tendon disorders related to previous Fluoroquinolone use must not use this medicine.
Neuromuscular Disorders	Contraindicated	Patients with Myasthenia Gravis or conditions like Epilepsy and CNS disorders that lower the seizure threshold are prohibited from use.

Populations Requiring Conditional or Restricted Use

Category	Status	Restriction Context
Reproductive Status	Not Recommended	Use is generally not recommended during pregnancy or breastfeeding as components are known to pass into breast milk or carry fetal risk.
Organ Impairment	Caution Required	Patients with severe renal impairment often require close monitoring, as well as those with severe hepatic impairment.
Older Adults ( ge 60 years)	Caution Required	Use requires caution due to an increased risk of tendon damage and effects on the QT interval (heart rhythm).
Comorbidities	Caution Required	Use must be closely monitored in patients with Diabetes Mellitus (risk of blood sugar disturbances) and in those with pre-existing risk factors for Aortic Aneurysm or QT prolongation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for L-Cin-OZ (Levofloxacin and Ornidazole) establishes specific interaction patterns and use constraints. The interaction profile is structured around drug–drug and drug–substance effects that require either timing separation or complete avoidance.

Key Pharmacokinetic and Administration-Timing Constraints

Interacting Product Category	Official Interaction Outcome	Administration Rule (Timing/Restriction)
Multivalent Cation-Containing Products (Antacids, Sucralfate, Iron/Zinc supplements)	Significantly decreases the absorption and bioavailability of Levofloxacin.	Oral Levofloxacin must not be taken within 2 hours before or 2 hours after these products.
Probenecid and Cimetidine	Reduce the renal clearance of Levofloxacin, resulting in increased plasma exposure of Levofloxacin.	Use with caution, as stated in regulatory documents.

Documented Pharmacodynamic Interactions and Substance Restrictions

Interacting Substance/Class	Official Interaction Outcome	Restriction/Constraint
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)	May cause a pronounced lowering of the cerebral seizure threshold.	Use with caution; risk noted in official documentation.
Vitamin K Antagonists (e.g., Warfarin)	Both Levofloxacin and Ornidazole enhance the anticoagulant effects.	Coagulation tests (PT/INR) require close monitoring.
Alcohol (Ethanol)	Risk of a disulfiram-like reaction (with Ornidazole component).	Must not be ingested during treatment and for several days after discontinuation.
Corticosteroids	Concomitant use with Levofloxacin increases the risk of tendinopathy and tendon rupture.	This risk is further increased in geriatric patients.

The profile includes mandatory constraints for avoidance of alcohol and specific timing separation for multivalent cation products. Regulatory bodies advise on monitoring or caution when L-Cin-OZ is used with other CNS-active drugs or agents that affect cardiac rhythm.

Mechanism of Action

How L-Cin-OZ Works: The Dual-Action Mechanism

Inhibition of DNA Maintenance in Aerobic Bacteria

This primary mechanism is executed by Levofloxacin, which functions as an enzyme inhibitor within susceptible aerobic bacteria. It targets and prevents the proper functioning of essential bacterial enzymes, DNA Gyrase and Topoisomerase IV, which are critical for maintaining the structural integrity and replication of the bacterial chromosome. The resultant accumulation of double-stranded DNA breaks causes a lethal interruption of all vital cellular processes, resulting in the bactericidal effect against these oxygen-dependent pathogens.

Chemically Driven DNA Destruction in Anaerobes and Protozoa

The second, distinct mechanism involves Ornidazole, whose action is unique to organisms existing in low-oxygen states, such as anaerobic bacteria and protozoa. The drug is chemically activated by microbial nitroreductase enzymes inside these cells, generating highly toxic, reactive free radicals. These radicals immediately initiate a chemical attack that fragments the pathogens' DNA and critical macromolecules. This process is inherently cytotoxic, resulting in the physiological eradication of oxygen-sensitive pathogens, contributing to the biological clearance of diverse microbial populations.

Dosage and Administration Information

L-Cin-OZ is administered exclusively via the oral route using the film-coated tablet formulation. The standard regimen involves taking one fixed-dose tablet Twice Daily (BID), with doses ideally separated by approximately 12 hours. This treatment is prescribed as a short course, typically lasting between 5 and 10 days.

Administration Procedure

The tablet should be swallowed whole with a full glass of water and may be taken with or without food. It is crucial to adhere to two key constraints:

Cation Separation: The dose must not be taken within a two-hour period before or after ingesting products that contain multivalent cations, such as iron supplements, zinc, or antacids (containing aluminum or magnesium).
Course Completion: The full prescribed duration must be adhered to, even upon early resolution of symptoms, and the treatment is generally restricted to adult patients.

Dosing Adjustments

In specific patient populations, the standard dosing requires modification. For patients with impaired renal function (based on creatinine clearance), a reduction in dose or an extension of the dosing interval is necessary. Similarly, for those with severe hepatic impairment, adjustment to the dosing interval is typically mandated. If a dose is missed, it should be taken when remembered, unless it is close to the time for the next scheduled dose, in which case the missed dose should be skipped.

Recent Clinical Evidence

Research evidence / Overview of studies for L-Cin-OZ

Evidence for Use in Mixed Gastrointestinal Infections

The research base for L-Cin-OZ, which combines the active ingredients Levofloxacin and Ornidazole, was studied for its application in conditions such as acute gastrointestinal infections. These are conditions characterized by fluctuating or episodic manifestations where both bacterial and protozoal pathogens are often suspected, such as diarrhea and dysentery. The evidence includes controlled investigations, notably Randomized Controlled Trials (RCTs), that research examined by was compared against single-agent monotherapies or other standard treatments in controlled trials for these types of infections.

The studies were designed to measure whether the germs responsible for these conditions involving periods of heightened symptoms were eliminated, known as microbiological clearance. Additionally, researchers observed in the study populations how quickly outcomes related to physical discomfort and the outcomes reflecting daily functioning or activity level evolved. Findings describe patterns observed in the studies where the combination was associated with specific rates of microbiological clearance. Research does not determine whether an individual will respond similarly to the group averages observed in these trials.

Scientific Studies on the Combination's Structure

To support the use of this fixed-dose combination, researchers studies explored the fundamental behavior of the two drugs when they are taken simultaneously. This involves in vitro laboratory studies that research describes the combined antimicrobial action against various organisms. These studies contribute to the broader evidence landscape by describing the observed activity of the combination.

A crucial part of the scientific analysis involved Pharmacokinetic/Pharmacodynamic (PK/PD) analyses. These studies were evaluated in order to understand how the body processes Levofloxacin and Ornidazole together—specifically, how they are absorbed, distributed, and eliminated. Data show patterns related to the speed at which each drug reaches its target level in the body.

Key Research Limitations and Uncertainties

Scientific discourse and regulatory reviews have identified several limitations in the evidence base for this fixed-dose combination. One significant point of discussion concerns a reported pharmacokinetic mismatch between the two component drugs. This means that the optimal timing for taking Levofloxacin and Ornidazole may differ, which has been cited in regulatory reviews as raising scientific questions when they are combined into a single dosage form.

Furthermore, evidence quality varies across studies, and sometimes the conclusions rely on comparative evidence is lacking between this specific L-Cin-OZ formulation and standard mono-therapies or other combination products. While the combination was studied for specific applications, the overall certainty remains low regarding the full clinical rationale for combining these two drugs in a fixed dose, and research is ongoing in this broader area.

Frequently Asked Questions (FAQ)

Common questions about L-Cin-OZ (FAQ)

Q: What is the expected duration of treatment with L-Cin-OZ?

Official prescribing information describes this medicine as a short-course treatment, typically listing a duration between 5 and 10 days.

Q: What are the most common side effects of L-Cin-OZ?

Regulatory documents indicate that the most commonly reported adverse events are generally gastrointestinal in nature. These can include stomach discomfort, nausea, vomiting, diarrhea, and abdominal pain.

Q: Does L-Cin-OZ cause drowsiness or affect driving?

The components of this medication are associated with documented central nervous system effects, such as dizziness and drowsiness. For this reason, regulatory documents advise caution regarding activities that require full mental alertness, such as driving or operating machinery, due to these potential effects.

Q: Can L-Cin-OZ affect blood sugar levels?

Yes, official regulatory labeling notes that Levofloxacin, one of the medicine’s components, has been associated with disturbances in blood glucose control. This effect can potentially lead to both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia), particularly in patients with pre-existing diabetes.

Q: What is the purpose of the black box warnings associated with L-Cin-OZ (if applicable to its component)?

A Boxed Warning is the highest level of caution required by regulatory bodies to communicate serious risks. Its purpose is to alert patients and prescribers to documented adverse effects that are disabling, serious, or potentially irreversible, such as those affecting the tendons or the nervous system.

Q: What happens if I miss a dose of L-Cin-OZ?

The official instruction for a missed dose is included in the prescribing information. It states that the dose should be taken when remembered, unless the time is near the next scheduled dose, in which case the regulatory guidance is to skip the missed dose and take the next scheduled dose.

Q: What should I do if I accidentally take two doses of L-Cin-OZ?

Official regulatory documents address situations of accidental over-ingestion. They advise immediately contacting emergency medical services or a designated poison control center if more than the prescribed amount of medicine is taken.

Q: What precautions should be taken if I have kidney problems and need to take L-Cin-OZ?

Official information indicates that for patients with impaired kidney function, dose or dosing interval adjustments are commonly specified. These modifications account for the body’s ability to process and clear the medicine.

Q: What is the difference between L-Cin-OZ and a single-ingredient antibiotic?

L-Cin-OZ is officially described as a fixed-dose combination, containing two active ingredients. This dual structure is intended to provide broad coverage against both bacteria (via the antibiotic component) and protozoa (via the antiprotozoal component).

Q: Can L-Cin-OZ affect my sleep?

Regulatory documents list difficulty sleeping, specifically insomnia, as a potential adverse reaction. This is associated with the central nervous system effects documented for this class of medication.

Q: Is L-Cin-OZ an over-the-counter medicine?

This medication is documented within official regulatory prescribing information and labeling, such as that provided by the FDA or other national health authorities. This type of documentation is exclusively applied to prescription-only medicines.

Q: Are there any known long-term effects of taking L-Cin-OZ?

Regulatory warnings highlight the risk of certain serious side effects that are described as being disabling and potentially irreversible, such as peripheral neuropathy. These effects are considered long-lasting or permanent in some cases.

Q: What is the recommended time of day to take L-Cin-OZ?

Regulatory information emphasizes that doses should be separated by approximately 12 hours. A schedule that is often achieved by taking the medicine at the same time each day to maintain consistent levels in the body.

Q: Why do official documents describe certain precautions when using L-Cin-OZ?

Official documents describe precautions to inform patients and prescribers about documented risks and potential drug-drug or drug-substance interactions, ensuring the drug is used under the conditions studied.

Q: How is L-Cin-OZ generally classified by medical authorities?

Medical authorities classify L-Cin-OZ as a broad-spectrum antimicrobial agent. Its dual composition includes two distinct pharmacological classes: a fluoroquinolone antibiotic and a nitroimidazole antiprotozoal.

Q: Can L-Cin-OZ cause changes in mood or behavior?

Regulatory warnings include information regarding central nervous system effects. These can sometimes involve changes in mental status, such as confusion and hallucinations, and in severe instances, psychosis or suicidal thoughts.

Q: What should I know about drug resistance and L-Cin-OZ?

Official warnings state that not completing the full, prescribed duration of treatment is associated with an increased risk of developing drug resistance in the infection-causing organisms.

How should L-Cin-OZ be stored and disposed of?

How to Store and Dispose of L-Cin-OZ

L-Cin-OZ must be stored according to official regulatory specifications to maintain the stability of its Levofloxacin and Ornidazole components. The required conditions are strictly defined in labeling provided by government health authorities.

Storage Requirements

Condition	Requirement
Temperature	Store at controlled room temperature, 20 C to 25 C (68 F to 77 F).
Protection	Keep the medicine protected from light and moisture and generally do not freeze.
Container	Keep the product in its original, tightly closed container.

Disposal Instructions

Disposal must follow documented regulatory procedures for unused or expired medication. The preferred method is to utilize an official drug take-back program or designated collection site. If a take-back option is not available, the product should be mixed with an unappealing substance, placed in a sealed container, and discarded in the household trash. The medication must not be flushed down a toilet or poured down a sink.