Overview of Oflocine 200

Oflocine 200 is a synthetic pharmaceutical preparation containing the fluoroquinolone antibiotic Ofloxacin and is used as a broad-spectrum anti-infective agent against susceptible bacteria.

Property	Description
Active Ingredient	Ofloxacin
Form	Film-coated tablet (Oral)
Pharmacological Class	Fluoroquinolone Antibiotic
General Purpose	Bactericidal anti-infective agent
Origin	Synthetic

Oflocine 200: Definition and Core Composition

Oflocine 200 is a specific synthetic medicine whose primary component is the active ingredient Ofloxacin at a controlled strength of 200 mg. This medication is provided exclusively as a film-coated tablet designed for oral administration. As a single-ingredient product, its pharmacological profile is determined solely by the compound Ofloxacin (C18H20FN3O4), which is a product of chemical synthesis, distinguishing it from naturally derived agents. The tablet formulation uses standard pharmaceutical excipients as its base to ensure the accurate and effective delivery of the Ofloxacin component into the body. Ofloxacin is clinically recognized for its reliable bioavailability when administered orally, a factor often considered in treatment protocols.

Classification and General Therapeutic Purpose

The Oflocine 200 medicine is classified as an antibiotic, belonging specifically to the fluoroquinolone antibiotic group, which is a key class of quinolone agents. This classification defines its function as a broad-spectrum anti-infective agent. Ofloxacin is recognized as an essential medicine, affirming its globally established role in managing various bacterial infections. The general therapeutic purpose is rooted in its ability to exert a potent bactericidal effect. By directly interfering with the essential internal processes that allow susceptible bacteria to multiply, the medicine effectively eliminates pathogens and helps the body clear the underlying bacterial infection, making it a typical choice in scenarios requiring systemic bacterial clearance.

Regulatory References

What side effects are possible with Oflocine 200?

Possible Side Effects and Safety Information

The safety profile of Oflocine 200 is based strictly on regulatory documents and includes adverse reactions categorized by their frequency and the body system affected (System-Organ Class).

Adverse Reactions by Frequency and System-Organ Class

Adverse reactions are documented as:

Uncommon (e.g., headache, dizziness, nausea, agitation, diarrhea, vomiting, skin rash, pruritus).
Rare (e.g., anxiety, depression, psychoses, paresthesia, tremor, tendon disorders, arthralgia, myalgia, elevated liver enzymes).
Very Rare (e.g., anaphylactic/anaphylactoid reactions, convulsions, peripheral sensory or sensorimotor neuropathy, acute renal failure, tendon rupture).
Not Known (frequency cannot be estimated): Hepatic failure, aortic aneurysm and dissection.

Serious and Clinically Significant Adverse Reactions

The regulatory profile highlights serious reactions that may be irreversible or disabling. These include:

Peripheral Neuropathy: Pain, burning, tingling, numbness, and/or weakness, potentially leading to long-term disability.
Musculoskeletal and Connective Tissue Effects: Tendinopathy and tendon rupture (e.g., Achilles tendon), arthralgia, and myalgia. The risk is elevated in elderly patients and with concomitant corticosteroid use.
Central Nervous System Effects: Severe reactions include convulsions, psychoses, depression, suicidal ideation, and acute psychiatric episodes.
Cardiac Events: Potential for QT interval prolongation and Torsades de pointes.
Liver and Gastrointestinal: Acute hepatic failure (potentially fatal) and pseudomembranous colitis.

Safety Considerations and Restrictions

Regulatory documents define specific populations and conditions where use requires caution:

Population-Specific Caution: Caution is advised in elderly patients, patients with pre-existing conditions like epilepsy, myasthenia gravis, or a known risk for QT interval prolongation, and those with renal or hepatic impairment.
Avoidance of Concomitant Use: Specific drugs (e.g., corticosteroids, Class IA/III antiarrhythmics) must be avoided or used with great caution due to increased risk of toxicity or adverse interactions.
Photosensitivity: Patients must strictly avoid excessive exposure to strong sunlight or artificial UV radiation.

Overdose and Emergency Response

Overdose Manifestations and Complications

Overdose of Oflocine 200 (Ofloxacin) is primarily defined by documented effects on the Central Nervous System (CNS) and the gastrointestinal tract. Acute CNS manifestations cited in regulatory documents include symptoms such as dizziness, confusion, tremors, and the potential for convulsive seizures. Gastrointestinal effects, including nausea and vomiting, are also commonly associated with excessive intake.

The drug’s official profile notes the risk of ECG QT interval prolongation, a serious electrical abnormality that requires specialized ECG monitoring once a patient is under clinical observation. This potential for cardiotoxicity underscores the need for continuous oversight.

Emergency Actions and Management

Immediate medical attention must be sought for any suspected overdose or upon the manifestation of severe CNS or cardiac symptoms. If a patient experiences convulsive seizures, regulatory guidance mandates that the medication be discontinued immediately.

Management is symptomatic and supportive, as no specific antidote is known. Procedures to reduce systemic absorption, such as gastric lavage or the administration of activated charcoal, may be undertaken if the ingestion was recent. Furthermore, patients with severe renal impairment are noted as a population with potentially reduced excretion, which may increase the risk of drug accumulation and toxicity following overdose.

Therapeutic Uses of Oflocine 200

What Oflocine 200 Treats: Main Uses and Benefits

Oflocine 200 is applied across domains where additional symptomatic support is needed, particularly in conditions characterized by periods of heightened symptoms. This medicine is commonly used to help manage symptoms associated with infections in the urinary tract, respiratory tract, and skin structures. This assistance is often relevant during phases where the patient experiences heightened discomfort, helping to address symptoms that may appear suddenly or intensify over time.

The medication assists with maintaining functional stability by easing the overall symptom load. “It helps patients cope more steadily with difficult episodes,” ensuring symptomatic relief when discomfort becomes momentarily overwhelming. This supportive role is critical in clinical settings marked by temporary physiological imbalance.


Quick Fact:	Relief for Physical Discomfort

Oflocine 200 is used for managing conditions associated with acute or disruptive episodes, supporting general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Oflocine 200 (Ofloxacin) eligibility is determined by official regulatory bodies based on age, physiological state, and pre-existing medical conditions. Use is generally permitted for adults with susceptible bacterial infections.

Contraindicated Populations

Use is absolutely prohibited for the following groups, as stated in regulatory labeling:

Patients with hypersensitivity to ofloxacin or any other quinolone antibiotic.
Patients with epilepsy or a history of seizure disorders.
Individuals with a history of tendon disorders (e.g., tendinitis, rupture) related to previous fluoroquinolone use.
Breastfeeding women, as the drug is excreted in human milk.
Patients with Myasthenia Gravis, due to the risk of exacerbating muscle weakness.

Age and Condition Restrictions

Category	Eligibility Status
Pediatric Population	Not Recommended or Contraindicated (typically under 18 years) due to risks to developing joints.
Pregnancy	Not Recommended; FDA assigns a Pregnancy Category C.
Renal Impairment	Conditional Use; dosage adjustment is required for patients with impaired kidney function.
Older Adults	Special Caution is required due to increased risk of tendon injury and the likelihood of reduced renal function.

Conditional use also applies to patients with specific risk factors, including those with severe hepatic impairment, G-6-PD deficiency, risk factors for QT prolongation, or a history of organ transplantation.

What should I know about interactions with other medicines?

Oflocine 200 can interact with several medicinal products and substance categories, primarily through interference with absorption or by altering drug effects in the body.

Significant Interaction Categories:

Cation-Containing Products: Oral absorption of Oflocine is significantly reduced by the simultaneous intake of products containing divalent or trivalent cations, which form insoluble complexes. This includes antacids (containing aluminum, magnesium, calcium), sucralfate, iron salts, and zinc supplements. A mandatory timing requirement exists: these products should not be taken within the two-hour period before or after Oflocine.
Drugs Affecting the Heart Rhythm (QTc Prolongation): The co-administration of Oflocine with other medicines known to prolong the QT interval (e.g., certain antiarrhythmics, tricyclic antidepressants, and macrolides) should be avoided or used with caution due to the risk of an additive effect on the heart rhythm.
Agents Lowering Seizure Threshold: Concomitant use with drugs such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), particularly fenbufen, or theophylline may increase the risk of central nervous system stimulation and convulsions.
Systemic Corticosteroids: The concurrent use of corticosteroids significantly increases the risk of tendon disorders, including tendon rupture.
Anticoagulants and Antidiabetics: Close monitoring of coagulation tests is necessary when Oflocine is administered with warfarin or other Vitamin K antagonists, as the effect of the anticoagulant may be increased. For diabetic patients, Oflocine combined with oral hypoglycemic agents or insulin requires careful blood glucose monitoring due to a risk of hypoglycemia.

Mechanism of Action

ℓ Dual Inhibition of Bacterial DNA Enzymes

Oflocine 200 (Ofloxacin) operates by directly inhibiting two critical bacterial enzymes, DNA Gyrase (Topoisomerase II) and Topoisomerase IV, which are vital for maintaining the structure and integrity of the pathogen's genetic material. The drug blocks the function of these unique microbial targets by stabilizing a cleavage complex, resulting in the rapid and widespread accumulation of catastrophic double-strand DNA breaks.

Induction of Irreversible Pathogen Cell Death

The resulting genetic damage initiates an overwhelming, irreversible cellular process that culminates in the complete destruction of the bacterial cell. This specific action progresses beyond simple growth prevention to induce a bactericidal effect, which induces the rapid reduction of the viable pathogen population.

️ Constraints by Efflux and Target Mutation

The mechanism's effectiveness is constrained when bacteria develop mutations in the target enzymes, which reduce the drug's binding affinity, or when they activate efflux pumps that actively expel Ofloxacin from the cell interior. These bacterial adaptations lead to a reduction in intracellular drug concentration, which can prevent the initiation of the cell-death cascade, contributing to the elimination of the bacterial population from the affected system.

Dosage and Administration Information

How to Use Oflocine 200

The administration of Oflocine 200, an oral film-coated tablet, is governed by official prescribing information concerning dosage, frequency, and specific intake conditions.

Administration Scope	Official Guideline
Route and Form	The medicine is taken orally. The 200 mg tablet is manufactured to be divisible into equal doses, if required for the prescribed regimen.
Dosing Schedule	The standard adult daily dose generally ranges from 200 mg to 800 mg. Daily doses exceeding 400 mg must be administered as two separate, divided doses at approximately equal intervals. Daily doses up to 400 mg may be taken once daily, preferably in the morning.
Timing with Meals	The tablet may be taken with or without food; patients are advised to drink plenty of fluids during the course of treatment.
Timing Restrictions	To avoid reduced absorption, the tablet must not be taken within two hours before or after ingesting preparations that contain multivalent metallic ions, such as aluminum, iron, or magnesium salts (e.g., antacids or supplements).
Population Adjustment	Dosage adjustment is necessary for patients with impaired renal function (creatinine clearance <50 mL/min) to ensure proper drug clearance and prevent accumulation. No other specific dose adjustment is typically required for older adults beyond that determined by renal function.
Duration and Missed Dose	The treatment course should not exceed two months. If a dose is missed, it is instructed to skip the missed dose and not double up if it is almost time for the next scheduled intake.

Resulting Procedural Structure

Official step sequence:

The tablet is consistently administered via the oral route, with attention to the precise daily dosage and the required divided frequency for doses over 400 mg.
Intake of the medicine is flexible concerning meals but requires simultaneous consumption of sufficient fluids.
A mandatory two-hour interval must separate the tablet from mineral-containing products to safeguard systemic absorption.
The overall protocol is subject to modification based on the patient's kidney function to maintain the intended drug concentration.

Connection to the overall use protocol (2–4 sentences): These principles define the standardized, label-based approach for using Oflocine 200 in clinical practice, governing the proper route and preparation, the required timing protocols, and the necessary adjustments for individuals with reduced renal function. This structural guidance ensures consistent adherence to the approved regimen over the specified treatment duration.

Recent Clinical Evidence

Research evidence / Overview of studies for Oflocine 200

Evidence for Use in Systemic Bacterial Infections

Oflocine 200 was studied for its use as an anti-infective agent in several bacterial conditions, including infections affecting the urinary tract, respiratory tract, and skin structures. The regulatory acceptance of this medicine is based on an evidence base that includes Controlled Clinical Trials. These trials were conducted to gather data required for review by bodies like the US Food and Drug Administration (FDA).

The trials included patients who had been diagnosed with these susceptible bacterial infections. Researchers monitored outcomes related to systemic or functional imbalance caused by the bacteria. The studies evaluated whether the targeted bacteria were eliminated—an outcome known as microbiological clearance. Research also studied clinical response, which means researchers monitored outcomes related to physical discomfort during the study period. Findings describe patterns observed in the studies related to the clearance of the specific pathogens and the evolution of patients' infection symptoms.

Focus of Studies: Microbiological and Clinical Endpoints

Clinical research primarily focused on two types of evidence: microbiological clearance and clinical response. The studies explored clinical response, which involves tracking how symptoms evolved in the observed populations. These outcomes linked to inflammatory or irritative states and outcomes reflecting daily functioning were measured by researchers during treatment and immediate follow-up. This research provides insight into short-term changes observed in some studies when the medicine was studied for conditions involving periods of heightened symptoms.

Long-Term Research and Follow-up Data

Most of the foundational evidence used for the initial regulatory review involved studies where follow-up durations were limited. These trials focused on the necessary period required to assess the immediate post-treatment outcome. Because of this focus, long-term effects are not fully established. There is limited information for long-term outcomes regarding the durability of the anti-infective effect or patterns of infection recurrence over extended periods.

Evidence in Specialized Patient Groups

The results apply only to the populations studied in the primary clinical trials. Research so far indicates that specific data regarding the use of Oflocine 200 in certain specialized groups may be limited. For example, data for certain groups remain insufficient, particularly for pediatric patients (children), as studies often focus on the adult population. Evidence can be limited for older adults who may have other underlying health issues (comorbidities).

Frequently Asked Questions (FAQ)

Common questions about Oflocine 200 (FAQ)

Q: Is Oflocine 200 the same kind of drug as Ciprofloxacin or Levofloxacin?

Official documents state that Oflocine 200 (Ofloxacin), Ciprofloxacin, and Levofloxacin are all categorized as fluoroquinolone antibiotics. This means they belong to the same medicinal class, sharing a common mechanism of action against bacteria. However, they are distinct agents.

Q: Is Oflocine 200 effective against viral infections like the common cold or flu?

Oflocine 200 is classified as a bactericidal agent, meaning its primary function is to eliminate susceptible bacteria. Regulatory documents indicate the medicine is not labeled for use against viruses. Therefore, it is not used to treat illnesses caused by viruses, such as the common cold or the flu.

Q: What is 'peripheral neuropathy' and is it associated with Oflocine 200?

Peripheral neuropathy is officially described as a condition characterized by damage to the nerves located outside the brain and spinal cord. It is an adverse reaction associated with Oflocine 200. Symptoms described in the official label include pain, burning, tingling, numbness, and/or weakness in the extremities.

Q: Can Oflocine 200 cause diarrhea that lasts even after the full course is finished?

Official adverse reaction reports indicate that diarrhea, including severe forms like pseudomembranous colitis, can potentially occur during or after the completion of treatment with Oflocine 200. Official information indicates this is a reported possibility even after the full medication course has been completed.

Q: Are there different versions or strengths of Oflocine (like 400mg) available?

The official labeling for Oflocine indicates the medicine is manufactured in various strengths for oral use. These typically include a 200 mg tablet and a 400 mg tablet. These different strengths are available to accommodate various prescribed daily doses.

Q: What are the reported signs of tendon problems or rupture related to Oflocine 200?

Regulatory documents advise that signs of tendon injury include pain, swelling, inflammation, or tear of the affected tendon. Regulatory guidance states that the drug must be discontinued if symptoms of tendon injury appear.

Q: Can taking Oflocine 200 lead to trouble sleeping or nightmares?

Official adverse reaction lists for Oflocine 200 include insomnia (difficulty sleeping) as a reported side effect in the Uncommon category. This indicates that some patients have experienced trouble sleeping while taking the medication. Nightmares are not consistently listed in the core documents.

Q: What are the signs of a severe allergic reaction to Oflocine 200?

Official warnings describe severe hypersensitivity reactions as potentially including signs like swelling of the face, throat, and tongue. They can also involve difficulty breathing or the development of a widespread, severe rash. These types of severe hypersensitivity reactions are medically serious events.

Q: How long after stopping Oflocine 200 can tendon problems still appear?

The official drug label states that tendon problems, including rupture, can occur during treatment and up to several months after Oflocine 200 therapy has been stopped. This indicates that the risk period extends beyond the end of the treatment course.

Q: Is it generally safe to consume alcohol in moderation while taking Oflocine 200?

Regulatory documents do not list a specific formal contraindication for consuming alcohol while taking Oflocine 200. However, the official labeling includes general warnings regarding potential central nervous system effects. Caution is typically noted due to the possibility that alcohol may potentiate or increase these effects.

Q: Can Oflocine 200 be taken with common cold and sinus relief products?

Oflocine 200's known interactions focus on products containing multivalent cations (which can reduce absorption) and drugs affecting the QT interval or seizure threshold. Caution is typically noted because components found in some cold and sinus relief products, such as multivalent cations or certain CNS-acting drugs, have documented interactions with Oflocine 200.

Q: Is a change in the ability to taste or smell a known side effect?

Yes, official documents list dysgeusia (a change in the ability to taste) as a reported adverse reaction for Oflocine 200. This is classified as a sensory side effect that has been observed in clinical populations.

Q: Is Oflocine 200 an option for someone who has an allergy to penicillin?

Regulatory documents classify Oflocine 200 as a fluoroquinolone, a chemical group entirely unrelated to penicillin. An allergy to penicillin does not inherently prohibit the use of Oflocine 200.

Q: Are there any specific lifestyle restrictions besides sun exposure while on Oflocine 200?

Official documents emphasize the need to avoid excessive sun exposure due to the risk of photosensitivity. Additionally, caution is noted regarding strenuous physical activity due to the heightened risk of tendon injury.

Q: Is it possible to experience eye irritation or dryness while using Oflocine 200?

Yes, official side effect lists for Oflocine 200 include reports of ocular irritation or burning. This is a reported adverse reaction that has been observed in patients.

Q: What does research evidence say about Oflocine 200’s use for long-term prostate infections?

Official indications include the treatment of prostatitis (prostate infection) caused by susceptible organisms. While this is an approved use, the recommended treatment course for Oflocine 200 is generally limited to a maximum of two months. The evidence is based on outcomes within the approved treatment period.

Q: Is Oflocine 200 used for sexually transmitted infections (STIs)?

Official indications in some regulatory bodies include the treatment of certain infections, such as those caused by susceptible organisms like Neisseria gonorrhoeae. These organisms are involved in some sexually transmitted infections (STIs). Use is determined based on the specific pathogen and location of the infection.

Q: Why are fluoroquinolones like Oflocine 200 considered a drug class of special concern?

Official regulatory communications, such as the FDA's Boxed Warning, explicitly state that this drug class is associated with the risk of disabling and potentially irreversible serious adverse reactions. These reactions involve tendons, peripheral nerves, and the central nervous system, which explains the heightened regulatory concern and warnings.

Q: What are the early signs of potential serious side effects that require immediate attention?

Regulatory patient information describes the first signs of serious reactions as including pain/swelling (tendon), numbness/tingling (nerve), or sudden changes in mood or thinking (CNS effects).

How should Oflocine 200 be stored and disposed of?

How to Store and Dispose of Oflocine 200 (Ofloxacin Tablets)

Oflocine 200 must be stored under specific regulatory conditions to maintain its stability. The tablets should be kept at Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F), with brief excursions allowed up to 30 C.

Required Storage Conditions

Environment: Protect the medicine from freezing, direct light, and excessive moisture.
Container: The tablets must be kept in their closed container.
Child Safety: It is a mandatory requirement to keep Oflocine 200 out of the sight and reach of children.

Disposal Instructions

Unused or expired Oflocine 200 must be disposed of properly. Patients should ask a healthcare professional or pharmacist how to dispose of unused medicine, or follow local regulations. The tablets should not be kept once they are no longer needed.

Oflocine 200