OFFBACT-MZ Suspension – Ofloxacin 50 mg + Metronidazole 120 mg + Simethicone 10 mg/5 mL

OFFBACT-MZ Suspension by Amcare Pharmaceuticals is an oral suspension containing Ofloxacin, Metronidazole Benzoate and Simethicone. According to the provided product image, each 5 mL contains Ofloxacin 50 mg, Metronidazole Benzoate 120 mg and Simethicone 10 mg.

The formulation combines antimicrobial components with simethicone, an antiflatulent ingredient commonly used for the symptomatic relief of gas and bloating.

Composition of OFFBACT-MZ Suspension

Each 5 mL contains:

• Ofloxacin IP – 50 mg
• Metronidazole Benzoate IP – 120 mg
• Simethicone IP – 10 mg

Product Details

Uses of OFFBACT-MZ Suspension

OFFBACT-MZ contains two antimicrobial agents with different activity profiles, together with simethicone for symptomatic gas relief.

Ofloxacin

Ofloxacin is a fluoroquinolone antibacterial used against susceptible bacterial infections. Because of its important safety warnings, fluoroquinolones should be used only when clinically appropriate.

Metronidazole

Metronidazole is active against susceptible anaerobic bacteria and certain protozoa. It is used for specific bacterial and parasitic infections depending on the clinical diagnosis.

Simethicone

Simethicone is an antiflatulent used to relieve symptoms associated with intestinal gas.

Important Note

The presence of three ingredients does not mean OFFBACT-MZ should be used for every episode of diarrhoea, stomach upset or abdominal discomfort. The antimicrobial components should be prescribed only when an appropriate bacterial or protozoal infection is suspected or confirmed.

How OFFBACT-MZ Works

Ofloxacin

Ofloxacin inhibits bacterial enzymes involved in DNA replication and repair, particularly DNA gyrase and topoisomerase IV. This interferes with bacterial DNA processes and produces an antibacterial effect.

Metronidazole

Metronidazole is reduced within susceptible anaerobic microorganisms to active metabolites that damage DNA and interfere with nucleic-acid synthesis. This produces antimicrobial activity against susceptible anaerobic bacteria and certain protozoa.

Simethicone

Simethicone acts locally in the gastrointestinal tract as an antifoaming agent, helping gas bubbles coalesce and facilitating their passage. It is used for symptomatic relief of gas-related discomfort.

Dosage and Administration

The dosage of OFFBACT-MZ Suspension should be determined by a qualified healthcare professional based on:

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

Do not calculate the dose solely from the concentration shown on the bottle.

Administration Instructions

• Shake the suspension well before each dose.
• Measure the prescribed quantity using a calibrated oral dosing device.
• Do not use an ordinary household spoon for accurate dosing.
• Administer exactly as directed by the physician.

Proper measurement and shaking of oral suspensions are important for consistent dosing.

Important Pediatric Consideration

Although the product image contains children’s imagery, this does not by itself establish approval or safety for every pediatric age group.

Ofloxacin systemic prescribing information states that safety and effectiveness in patients under 18 years have not been established for its oral tablet formulation and identifies important musculoskeletal concerns in younger patients. Therefore, an ofloxacin-containing suspension should be used in children only when specifically prescribed and medically supervised.

Possible Side Effects

Possible adverse effects may result from any of the three components.

Ofloxacin

Possible effects include:

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

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

Metronidazole

Possible effects include:

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

Neurological reactions such as peripheral neuropathy, encephalopathy or seizures have also been reported.

Simethicone

Simethicone is generally used for symptomatic gas relief and acts locally in the gastrointestinal tract. Follow the prescribed dosage and seek medical advice if symptoms persist or worsen.

Precautions and Warnings

Ofloxacin-Related Warnings

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

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

Patients should promptly report tendon pain/swelling, numbness, tingling, burning, weakness or significant neurological symptoms.

Metronidazole-Related Warnings

Metronidazole has been associated with neurological effects, including peripheral neuropathy, encephalopathy and convulsive seizures. New or unusual neurological symptoms require medical evaluation.

Alcohol Interaction

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

Allergic Reactions

Patients with known hypersensitivity to ofloxacin, other quinolones, metronidazole or other nitroimidazole derivatives should inform their healthcare professional before treatment.

Drug Interactions

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

Potentially important interactions include:

• Antacids containing aluminium or magnesium
• Iron and mineral supplements
• Warfarin and other oral anticoagulants
• Medicines that may affect cardiac rhythm
• Disulfiram
• Lithium
• Certain medicines affecting blood glucose

Metronidazole can potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, while disulfiram can produce serious psychiatric reactions when used with metronidazole.

Storage

Store OFFBACT-MZ Suspension according to the storage conditions printed on the specific product label.

General precautions:

• Keep the bottle tightly closed.
• Store away from excessive heat and moisture.
• Shake well before each use.
• Keep out of reach of children.
• Do not use beyond the labelled expiry date.

Why Choose OFFBACT-MZ by Amcare Pharmaceuticals?

OFFBACT-MZ Suspension provides:

• Ofloxacin 50 mg/5 mL
• Metronidazole Benzoate 120 mg/5 mL
• Simethicone 10 mg/5 mL
• Combination oral suspension dosage form
• Antimicrobial components with complementary activity
• Simethicone for gas-related symptom relief
• Pharmaceutical product from Amcare Pharmaceuticals