OFFBACT-M Suspension – Ofloxacin 50 mg + Metronidazole 100 mg/5 mL

OFFBACT-M Suspension by Amcare Pharmaceuticals is an oral suspension containing Ofloxacin 50 mg + Metronidazole Benzoate 100 mg per 5 mL, as specified on the provided product image.

The combination provides antibacterial activity from ofloxacin, a fluoroquinolone, together with metronidazole, which has activity against susceptible anaerobic bacteria and certain protozoa. The combination should be used only when the clinical indication supports coverage by both components.

Composition of OFFBACT-M Suspension

Each 5 mL contains:

• Ofloxacin IP – 50 mg
• Metronidazole Benzoate IP – 100 mg

Product Details

Note: The supplied image does not show a pack volume, flavour, colour, or excipient list, so these details have not been added.

Uses of OFFBACT-M Suspension

OFFBACT-M contains two antimicrobial agents with different mechanisms and spectra.

It may be prescribed by a healthcare professional when treatment requires activity against susceptible bacterial organisms, including anaerobic organisms, and/or selected protozoal infections.

Ofloxacin

Ofloxacin is a fluoroquinolone antibacterial used against susceptible bacterial infections. Its activity includes several Gram-negative and Gram-positive organisms, depending on susceptibility. However, fluoroquinolones carry important safety warnings and should be used only when clinically appropriate.

Metronidazole

Metronidazole is active against susceptible anaerobic bacteria and certain protozoa. Approved uses include infections such as amebiasis and selected anaerobic bacterial infections.

Important Antibiotic Stewardship Information

This combination should not be used routinely for every episode of diarrhoea or gastrointestinal upset. Antibiotics are appropriate only when a bacterial or protozoal infection is suspected or confirmed and the organisms are expected to be susceptible.

How OFFBACT-M Works

Ofloxacin

Ofloxacin is a fluoroquinolone antibacterial. It inhibits bacterial enzymes involved in DNA replication and repair, primarily DNA gyrase and topoisomerase IV, interfering with essential bacterial DNA processes.

Metronidazole

Metronidazole is a nitroimidazole antimicrobial. In susceptible anaerobic microorganisms, it is reduced to active metabolites that damage DNA and interfere with nucleic-acid synthesis, resulting in antimicrobial activity.

Combination Action

The two components have different antimicrobial mechanisms:

Ofloxacin → bacterial DNA gyrase/topoisomerase inhibition

Metronidazole → DNA damage in susceptible anaerobic organisms

This provides complementary antimicrobial coverage when both aerobic/facultative bacterial and anaerobic/protozoal coverage is clinically appropriate.

Dosage and Administration

The dosage of OFFBACT-M Suspension should be determined by the treating physician according to:

• Patient’s age and body weight
• Type and severity of infection
• Suspected or confirmed organism
• Kidney and liver function
• Other medicines being used
• Clinical response

Do not self-medicate or determine the dose solely from the concentration on the bottle.

Administration

• Shake the suspension thoroughly before each dose.
• Measure the prescribed quantity using a suitable oral measuring device.
• Give exactly according to the physician’s instructions.
• Complete the prescribed course unless the healthcare professional advises otherwise.

Important Pediatric Consideration

The product image depicts a child, but the image alone does not establish that this formulation is approved for all pediatric age groups.

Ofloxacin systemic prescribing information states that safety and effectiveness in patients below 18 years have not been established for its oral tablet formulation, with important musculoskeletal safety concerns in juvenile animals. Therefore, pediatric use of an ofloxacin-containing oral suspension should be specifically determined by a qualified healthcare professional.

Possible Side Effects

Possible adverse effects may arise from either component.

Ofloxacin-related effects

• Nausea
• Diarrhea
• Abdominal discomfort
• Headache
• Dizziness
• Insomnia

More serious fluoroquinolone-associated reactions include tendon disorders, peripheral neuropathy and central nervous system effects.

Metronidazole-related effects

• Nausea
• Vomiting
• Abdominal discomfort
• Diarrhea
• Headache
• Metallic taste

Metronidazole can also rarely cause neurological effects such as peripheral neuropathy or encephalopathy, particularly with prolonged exposure.

Seek medical attention for severe or persistent adverse effects.

Precautions and Warnings

Ofloxacin-Related Warnings

Ofloxacin belongs to the fluoroquinolone class, which carries warnings for potentially serious reactions including:

• Tendinitis and tendon rupture
• Peripheral neuropathy
• Central nervous system effects
• Exacerbation of myasthenia gravis

Patients should seek medical advice promptly if tendon pain/swelling, numbness, tingling, burning, weakness or significant neurological symptoms occur.

Metronidazole-Related Warnings

Metronidazole can cause neurological adverse effects, including peripheral neuropathy and, rarely, encephalopathy or seizures. New neurological symptoms require prompt medical evaluation.

Alcohol Interaction

Alcohol and products containing propylene glycol should be avoided during metronidazole treatment and for at least 3 days after completion, because a disulfiram-like reaction can occur, including abdominal cramps, nausea, vomiting, headache and flushing.

Hypersensitivity

Do not use in patients with known hypersensitivity to ofloxacin, other quinolones, metronidazole or other nitroimidazole derivatives.

Drug Interactions

Inform the doctor about all medicines, vitamins and supplements being taken.

Potentially important interactions include:

• Antacids containing aluminium or magnesium
• Iron or mineral supplements
• Warfarin and other oral anticoagulants
• Medicines affecting the QT interval
• Certain antidiabetic medicines
• Disulfiram
• Lithium
• Certain medicines metabolized through hepatic enzyme pathways

Ofloxacin absorption can be reduced by polyvalent cations such as aluminium, magnesium, iron and zinc. Metronidazole has clinically important interactions with warfarin, disulfiram, lithium and alcohol/propylene glycol.

Storage

Store OFFBACT-M Suspension according to the storage instructions printed on the specific product packaging.

General precautions:

• Keep the bottle tightly closed.
• Store away from excessive heat and moisture.
• Shake well before use.
• Keep out of reach of children.

If the product is supplied as a ready-to-use suspension, do not add water unless the product label specifically instructs you to do so.

Why Choose OFFBACT-M by Amcare Pharmaceuticals?

OFFBACT-M Suspension provides:

• Ofloxacin 50 mg/5 mL
• Metronidazole Benzoate 100 mg/5 mL
• Two complementary antimicrobial components
• Convenient oral suspension dosage form
• Clearly specified pharmaceutical composition
• Product from Amcare Pharmaceuticals