Brakke

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Brakke

Method of action: Antiprotozoal

Treatment option:

Medically reviewed

Marina Burgos

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 Brakke

Quick Facts

Property Description
Active Ingredients Ofloxacin and Ornidazole
Form Oral Tablet
Pharmacological Class Combination Antibiotic / Broad-Spectrum Antimicrobial
General Purpose To eliminate susceptible bacteria and protozoa
Origin Synthetic

What Type of Medicine is Brakke? (Identity and Classification)

Brakke is defined as a synthetic, prescription-only Combination Antibiotic and Broad-Spectrum Antimicrobial provided in an Oral Tablet form. It is intended for systemic treatment, meaning the active compounds are absorbed into the bloodstream to target internal infections. This formulation, combining Ofloxacin and Ornidazole, is used for addressing infections potentially involving mixed aerobic and anaerobic pathogens.

The strategic pairing of agents from different pharmacological classes allows for broader microbial coverage compared to single-agent therapies. This positioning is common for formulations designed to address the scope of treatment against diverse microbial causes.


Composition: Ofloxacin and Ornidazole (Ingredients and Synergy)

The composition of Brakke includes two primary active ingredients: Ofloxacin and Ornidazole. Ofloxacin is classified as a synthetic fluoroquinolone antibacterial, while Ornidazole is a synthetic nitroimidazole derivative. This dual inclusion enables the formulation to address pathogens with distinct cellular structures.

This medicine attacks pathogens through two separate, simultaneous mechanisms. Ofloxacin targets vulnerable bacteria, and Ornidazole is active against certain protozoa (single-celled parasites) and anaerobic bacteria. The final preparation uses solid excipients to form a stable, orally administered tablet.


General Purpose and Dual Action Benefit (High-Level Function)

The primary purpose of Brakke is to eliminate susceptible microorganisms responsible for causing an infection. It achieves this general therapeutic goal through its bactericidal (killing bacteria) and protozoacidal (killing protozoal cells) effects.

This dual action benefit makes the medicine applicable for managing complex or mixed infections—those where the illness may be caused by a combination of different types of susceptible bacteria and/or protozoa simultaneously. The combination works to halt the progression of the underlying microbial illness by attacking diverse microbial populations with two potent, independent mechanisms.

What side effects are possible with Brakke?

Possible Side Effects and Safety Information

The official safety profile of Brakke (Ofloxacin and Ornidazole) reflects the documented risks associated with its two distinct components, classified by frequency and the body system affected, consistent with regulatory guidelines.

Frequency-Classified Adverse Reactions

The most frequently reported adverse reactions, classified as Uncommon (occurring in fewer than 1 in 100 people) in regulatory documentation, often relate to the Gastrointestinal and Nervous System systems. These may include nausea, vomiting, abdominal pain, diarrhoea, headache, dizziness, and insomnia.

Reactions classified as Rare or Very Rare include psychotic reactions, peripheral neuropathy, convulsions, and effects on the blood such as agranulocytosis.

Serious Adverse Reactions

Regulatory sources emphasize the risk of Serious Adverse Reactions (SARs). These include tendon rupture and severe tendonitis, which may occur within the first 48 hours of use or several months after discontinuation. Other documented SARs include acute liver failure, severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome), and potentially irreversible peripheral sensorimotor neuropathy.

Population-Specific Safety Notes

The label specifies safety constraints for certain groups. Older adults (aged over 60) and patients concurrently taking corticosteroids have a documented increased risk of tendon damage. Diabetic patients should be aware of the risk of dysglycaemia (abnormal blood sugar levels). Caution is also advised in patients with underlying liver impairment due to the risk of severe liver injury.

Overdose and Emergency Response

An overdose of Brakke (Ofloxacin and Ornidazole) is officially documented by regulatory authorities as a serious event requiring immediate action. The official prescribing information indicates that an acute overdose primarily affects the Central Nervous System (CNS) and gastrointestinal systems, often presenting as an intense exacerbation of expected adverse effects. Documented manifestations include CNS disturbances such as confusion, drowsiness, dizziness, tremor, slurred speech, and severe coordination impairments, alongside nausea and vomiting.

Regulators cite the potential for severe outcomes, including seizures and, rarely, kidney failure. Due to the gravity of these documented risks, immediate medical help must be sought for any suspected overdose. Urgent medical attention is required, and official instructions mandate contacting a National Poisons Information Centre and proceeding immediately to the nearest Accident and Emergency Centre.

It is officially stated that no specific antidote is known for this combination medicine. Consequently, the management of an acute overdose is limited to providing supportive and symptomatic treatment. For instance, specific procedural steps documented in official labeling note that the administration of Diazepam may be required if cramps occur during the overdose scenario.

Therapeutic Uses of Brakke

What Brakke Treats: Main Uses and Benefits

Brakke (Ofloxacin and Ornidazole) is generally used in clinical settings that involve acute or unstable symptom patterns caused by susceptible microorganisms. This combination is relevant for the empirical symptomatic management associated with mixed aerobic-anaerobic infections across several domains. The medication is applied in clinical scenarios where additional symptomatic support is needed, primarily for conditions involving acute episodes in the genitourinary and pelvic tracts, intra-abdominal infection, and diarrhea of mixed infections in adults.

This medicine is commonly used to help with symptom clusters that may become intense or disruptive, such as localized pain, fever, inflammation, and abnormal discharge. In symptomatic management, the medication assists with addressing the primary cause and contributes to improved comfort during episodes of heightened discomfort.

“The combination plays a role in managing symptoms across diverse microbial challenges, supporting the easing of symptoms associated with complex infections where a combination of susceptible organisms may be present.”


Quick Fact: Supportive Management for Acute Discomfort

Brakke is applicable in conditions marked by heightened symptoms, offering supportive relief when manifestations interfere with daily comfort. It may be part of symptomatic management across diverse sites, including the gastrointestinal tract, lungs, pelvis, and skin/soft tissues.

Regulatory References

  1. Rwanda FDA product monograph

Eligibility and Restrictions for Use

Who can and cannot use Brakke?

Eligibility for Brakke (Ofloxacin and Ornidazole) is defined by strict population limitations established in official regulatory documents. Use of this combination medicine is primarily approved for adults.


Populations That Must Not Use Brakke (Contraindications)

The medicine is absolutely contraindicated in several groups due to potential risks:

  • Age and Development: Use is prohibited for children and adolescents (individuals under 18 years of age).
  • Reproductive Status: It must not be used during pregnancy or while breastfeeding.
  • Medical History: Patients with a history of epilepsy, any Central Nervous System (CNS) disorder associated with a lowered seizure threshold, or tendon disorders related to previous fluoroquinolone use are excluded.
  • Comorbid Conditions: Individuals with severe hepatic impairment (liver damage) or G6PD deficiency are strictly contraindicated.

Use Restrictions and Cautions

Certain populations may be eligible but require restricted use or specific caution:

  • Kidney Function: Patients with renal impairment are eligible only if the dosage is formally adjusted by a healthcare provider.
  • Older Adults: Elderly patients require careful use due to an increased risk of tendonitis and tendon rupture.
  • Hypersensitivity: Anyone with a known allergy to Ofloxacin, Ornidazole, or any related drug class (fluoroquinolones, nitroimidazoles) must not use this medicine.

What should I know about interactions with other medicines?

Timing and Absorption Requirements

Brakke is subject to pharmacokinetic interference from substances that contain metal cations. Co-administration with Antacids (aluminum or magnesium), Sucralfate, Didanosine (chewable/buffered tablets), and preparations containing Iron, Zinc, or Calcium may substantially reduce Ofloxacin absorption through chelation. Regulatory documents mandate a minimum separation of two hours before or after taking Brakke when administering these agents to prevent reduced systemic exposure.

Pharmacodynamic and Clearance Interactions

Official regulatory profiles note interactions that increase the risk of specific effects. The combination carries a documented risk of potentiating the anticoagulant effect when co-administered with Vitamin K antagonists (e.g., Warfarin). Similarly, combining Brakke with agents that lower the seizure threshold, such as Theophylline or certain Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), carries an official risk of additive neurotoxicity. Agents that reduce renal tubular clearance (e.g., Probenecid and Cimetidine) can result in a pharmacokinetic increase in Ofloxacin exposure.

Substance Restrictions

Alcohol consumption is strictly restricted during the entire course of treatment and for a specified period after discontinuation. Due to the Ofloxacin component's profile, co-administration is restricted or contraindicated with medicines known to prolong the QT interval, owing to the official risk of additive cardiac toxicity.

Mechanism of Action

The function of Brakke is defined by two distinct, independent mechanisms targeting the core survival processes of different microbial types. This combination results in a broad and complementary disruption of essential pathogen systems.

Blocking Microbial DNA Replication (Ofloxacin)

This mechanistic domain involves the fluoroquinolone ingredient, Ofloxacin, which acts as an inhibitor of two bacterial enzymes, DNA Gyrase and Topoisomerase IV. These enzymes are critical for unwinding and repairing the bacterial genetic code during replication. Ofloxacin binds to and stabilizes the complex between the enzyme and cleaved DNA, physically preventing the DNA from being resealed. This process results in the rapid accumulation of irreversible double-strand DNA breaks, which forces the cessation of all essential cellular functions, resulting in the lysis and destruction of the susceptible aerobic bacterial cell.


Chemical Destruction via Free Radical Generation (Ornidazole)

The second domain utilizes the nitroimidazole ingredient, Ornidazole, which is activated only within the low-oxygen, low-redox environment characteristic of anaerobic bacteria and protozoa. Inside these specific cells, Ornidazole undergoes an enzymatic reduction, creating highly unstable and reactive nitro-free radicals. These cytotoxic radicals chemically attack and fragment the pathogen's DNA and other vital macromolecules. This non-specific, chemical destruction provides the protozoacidal and bactericidal action against oxygen-intolerant species, adding a second, distinct microbial population to the drug's activity profile.

Dosage and Administration Information

How Brakke is Used: Administration Guidelines

Brakke, an oral tablet containing Ofloxacin 200 mg and Ornidazole 500 mg, is administered for systemic treatment according to established usage patterns. The primary method of use is focused on maintaining a fixed concentration of both active ingredients within the body for a specified duration.

The standard adult regimen involves taking one tablet twice daily (B.I.D.), resulting in a total daily intake of Ofloxacin 400 mg and Ornidazole 1000 mg. The treatment course is typically established to last for 5 to 10 days, with the specific duration determined by the type of condition being addressed.

Administration Instructions

  • Tablet Handling: The film-coated tablet must be swallowed whole with a sufficient quantity of water, and must not be crushed or chewed.
  • Food Relationship: The administration of Brakke is flexible and may occur with or without food.
  • Drug Separation: To prevent potential interference with absorption, the tablet should not be taken within the two-hour period before or the two-hour period after consuming mineral antacids or preparations containing metal ions, such as iron, aluminum, or zinc.

Population-Specific Considerations

The standard dosing schedule requires adjustment when a patient has certain forms of renal impairment or severe hepatic impairment, as the body's ability to clear the components of the medicine is altered in these conditions. These modifications are necessary to ensure appropriate levels of the drug are maintained throughout the course of use.

Recent Clinical Evidence

Research evidence / Overview of Studies for Brakke

The body of research supporting the clinical evaluation of the combination medicine Brakke (Ofloxacin and Ornidazole) is derived from controlled studies, clinical trials, and pharmacological investigations. This section describes the types of studies that have explored this combination, the outcomes monitored, and what remains uncertain in the existing evidence, focusing only on the official clinical scenarios.


Evidence for Use in Mixed Infections in the Genitourinary / Pelvic Tract

Research has examined the use of this combination in comparative randomized controlled trials (RCTs) and clinical case series. These studies were applied in research contexts involving fluctuating or unstable symptoms in adult women experiencing mixed bacterial and protozoal infections in the genitourinary and pelvic areas. Researchers monitored short-term outcomes related to inflammatory states and the measured clearance of the suspected infectious organisms. Some trials described patterns observed in the short-term achievement of clinical changes, such as symptom relief, and reported rates of microbiological clearance at the end of the treatment period. However, evidence is limited regarding the durability of response or recurrence patterns beyond the short follow-up periods typically used in these studies.


Evidence for Use in Intra-Abdominal Infection

The evidence for this indication includes comparative RCTs and pharmacological studies exploring the combination’s role against the diverse mix of pathogens often found in intra-abdominal infections. Researchers monitored clinical change rates, outcomes related to systemic or functional imbalance, and the rates of microbiological clearance that were measured for both aerobic and anaerobic/protozoal pathogens. The evidence describes the rationale for combining these agents when addressing conditions characterized by fluctuating or episodic manifestations. The documented studies contain limited information concerning long-term outcomes or recurrence rates following the use of this combination in this setting.


Research Gaps and Areas of Uncertainty

This summary highlights key limitations in the existing evidence base. Evidence quality varies across studies, particularly for broad indications like mixed diarrhea, where findings were mixed. The research describes a lack of large, centralized RCTs conducted by major international regulators specifically for the fixed Ofloxacin-Ornidazole combination. Furthermore, comparative evidence is lacking against established alternative dual therapies in high-quality studies for some approved indications. Since follow-up durations were limited, the long-term effects are not fully established.

Studies help show what has been observed so far in specific groups of patients. Research provides context but not individual predictions—the findings describe group patterns, not personal outcomes. This evidence highlights what is knownand what is still uncertain.

Key Studies & References Ornilox (Ornidazole 500mg & Ofloxacin 200mg Tablets) - Summary of Product Characteristics (SmPC)

Frequently Asked Questions (FAQ)

Common questions about Brakke (FAQ)

Q: What is the main reason doctors prescribe Brakke?

The official purpose of Brakke is its dual action in eliminating both susceptible bacteria and protozoa. This combination is recognized for treating complex or mixed infections in approved areas. These areas include infections in the genitourinary/pelvic tract and intra-abdominal infections.

Q: How quickly does Brakke start working after I begin taking it?

Pharmacological data indicates that the Ofloxacin component is absorbed relatively quickly after dosing. Maximum concentrations of Ofloxacin in the bloodstream are generally achieved within one to two hours after taking the tablet.

Q: If I miss a dose of Brakke, what should I do?

Official regulatory information typically addresses a missed dose by stating the conditions under which it may be taken. Generally, if it is almost time for the next scheduled dose, the missed dose is skipped to avoid doubling the dose.

Q: Is it normal to feel a little dizzy when first starting Brakke?

Dizziness is listed as an uncommon adverse reaction in the official product information. The medicine's profile includes the potential for drowsiness or dizziness to occur.

Q: Does Brakke need to be taken at the exact same time every day?

The standard regimen is defined as 'twice daily' (B.I.D.) to ensure a stable concentration of the active ingredients is maintained in the body. This spaced administration pattern helps to ensure a stable drug concentration is maintained throughout the treatment course.

Q: Is Brakke considered a long-term treatment or short-term?

According to official administration guidelines, the treatment course is typically short-term. The duration is generally established to last for 5 to 10 days, depending on the condition being addressed.

Q: Does taking Brakke cause weight gain or loss?

Weight gain is not commonly listed as an adverse reaction in official product information. However, unexplained weight loss has been noted as a symptom associated with dysglycaemia (abnormal blood sugar levels), which is a specific risk for diabetic patients taking the medicine.

Q: Are there any common foods or drinks that interact with Brakke?

The tablet may be taken with or without food. However, official product information advises that the tablet should not be taken within two hours before or after consuming antacids or preparations containing metal ions like iron, aluminum, or zinc.

Q: Does Brakke affect how birth control pills work?

Information from health bodies indicates that the quinolone component (Ofloxacin) is not typically restricted for use with combined hormonal contraceptives. Information from health bodies does not typically indicate a general restriction or interaction with oral birth control for this class of medicine.

Q: Is it safe to take over-the-counter pain relievers like ibuprofen with Brakke?

Regulatory documents note that combining this medicine with certain agents that lower the seizure threshold carries a risk. This includes Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and the combination may lead to additive neurotoxicity.

Q: What happens if I suddenly stop taking Brakke?

Regulatory information indicates the medicine is intended for use for the entire treatment time as prescribed to help ensure the infection is cleared. For patients who have experienced adverse neurological effects, these symptoms have been reported to resolve after the drug’s discontinuation.

Q: Is Brakke safe for older adults (seniors)?

Older adults are eligible for treatment, but official safety information advises careful use. This is due to a documented increased risk of tendon damage, specifically tendinitis and tendon rupture.

Q: What is the general difference between the benefits and risks of Brakke?

The benefit of Brakke is its purpose in eliminating susceptible bacteria and protozoa through a dual action. This function is balanced against documented risks, which include serious adverse reactions such as tendon rupture, severe tendonitis, and acute liver failure.

Q: Will Brakke change my mood or energy levels?

Rare adverse reactions documented in official information include psychotic reactions. Other central nervous system (CNS) effects noted in the drug class include anxiety, depression, confusion, and insomnia, which can affect mood and energy.

Q: What should I watch out for that signals a serious side effect from Brakke?

Serious adverse reactions may include signs such as pain, swelling, or inflammation of the tendons, often appearing in the first 48 hours. Other serious signs include a severe rash or yellowing of the skin or eyes, which may signal acute liver failure.

Q: How is Brakke different from a supplement?

Brakke is defined in official documents as a synthetic, prescription-only combination antibiotic and broad-spectrum antimicrobial. This classification distinguishes it from non-prescription dietary supplements.

Q: Can I drive or operate machinery while on Brakke?

Official product information advises caution regarding activities that require full mental alertness. This warning is based on the potential for the medicine to cause dizziness or drowsiness.

Q: Is there a risk of allergic reactions with Brakke?

The medicine is contraindicated in patients with any known allergy to its components or related drug classes. Official reports indicate that serious allergic reactions have been documented, sometimes following the first dose.

Q: What kind of studies were done on Brakke before it was approved?

The clinical evaluation is supported by controlled studies, pharmacological investigations, and clinical trials. Research specifically includes comparative randomized controlled trials (RCTs) used to examine the combination’s use in approved indications.

Q: Does Brakke have a 'black box' warning, and what does that mean?

The Ofloxacin component belongs to a class of antibiotics associated with a Boxed Warning, which is the FDA’s strongest warning. This warning highlights the risk of disabling and potentially permanent side effects involving tendons, muscles, nerves, and the central nervous system.

Q: Is there a generic version of Brakke available?

The Ofloxacin component is a widely available generic medication. The specific Ofloxacin/Ornidazole fixed-dose combination is also widely available in generic formulations across many countries.

Q: Can I take Brakke if I have a history of heart issues?

Caution is advised for patients with heart conditions. Co-administration is restricted with other medicines known to prolong the QT interval due to an official risk of cardiac toxicity.

Q: What common supplements should I avoid while taking Brakke?

Official documents state that the tablet should be separated by two hours from preparations containing metal ions. This includes common supplements like multivitamins that contain Iron, Zinc, or Calcium.

Q: If I have mild side effects, is that normal when taking Brakke?

Commonly reported adverse reactions, such as nausea, headache, and dizziness, are often described as mild. These effects are generally noted to be mild and may resolve over the course of treatment.

Q: Will Brakke show up on a standard drug test?

Official information notes that the Ofloxacin component of the medicine might produce false-positive results. This can specifically occur on certain urine screening tests for opiates.

Q: Is there a cumulative effect with Brakke over time?

The Ofloxacin component has a half-life profile that allows for estimation of drug accumulation. Pharmacological data can be used to estimate the drug’s concentration at a steady-state after multiple doses.

Q: Do I need to get regular blood tests while on Brakke?

Monitoring parameters noted in pharmacological literature include checks of liver function, kidney function (creatinine concentrations), and blood sugar levels. These checks are advised, particularly for diabetic patients taking the medicine.

Q: Why do some people say Brakke is a 'last resort' medication?

Official guidance from the FDA advises restricting the fluoroquinolone class (which includes Ofloxacin) for certain uncomplicated infections. These medicines are sometimes reserved for cases where other treatment options are not available due to the risk of serious adverse effects.

Q: Are there different forms or strengths of Brakke available?

Brakke is defined as an Oral Tablet containing a fixed dose of Ofloxacin 200, mg and Ornidazole 500, mg. Official documentation defines only this specific strength and oral form.

Q: Can I take other prescription medications while taking Brakke?

Regulatory documents note that co-administration can increase the risk of specific effects with certain drug classes. These include Vitamin K antagonists, agents that lower the seizure threshold, and medicines that reduce renal clearance.

How should Brakke be stored and disposed of?

How to Store and Dispose of Brakke?

Storage

Brakke tablets should be kept in their original container, tightly closed. Store the medication at or below 30 C (approximately 86 F), which generally corresponds to a cool, dry place. Protection from excessive moisture and light is essential to maintain the tablet's stability and efficacy. Keep this and all medicines out of the sight and reach of children and pets to prevent accidental ingestion or misuse.

Disposal

Proper disposal of unused or expired Brakke is important for safety and environmental protection. It should not be disposed of in household trash or poured down a sink or toilet, as active pharmaceutical ingredients can contaminate the water supply. The recommended method is to use a drug take-back program, if one is available in your area, such as a community pharmacy drop-off or an authorized DEA collector event. If a take-back program is unavailable, consult local waste management guidelines for safe disposal instructions.

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

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