Norfloxacin 400mg Tablets IP available from trusted pharmaceutical manufacturers

An Overview of Norfloxacin 400mg Tablets IP Manufacturer Insights

Norfloxacin is a synthetic antibiotic belonging to the fluoroquinolone class that is primarily used to treat bacterial infections, particularly those affecting the urinary tract, gastrointestinal tract, and certain other tissues. The formulation known as Norfloxacin 400mg Tablets IP (Indian Pharmacopoeia) is one of the most common dosages available on the market, designed to be effective in combating susceptible bacterial strains. Here, we explore the key aspects of Norfloxacin 400mg tablets, their therapeutic uses, manufacturing standards, and safety considerations.

Therapeutic Uses

Norfloxacin is effective against a broad spectrum of Gram-negative bacteria, including Escherichia coli and other organisms that are responsible for urinary tract infections (UTIs). It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication. In addition to treating UTIs, Norfloxacin can be used to manage certain types of gastroenteritis, such as those caused by Campylobacter species and Shigella.

The recommended dosage of Norfloxacin typically involves taking one tablet of 400mg twice daily, preferably before meals, and is generally prescribed for a duration that may vary depending on the type and severity of the infection. It is crucial for patients to adhere to the prescribed regimen to ensure the complete eradication of the infection and to prevent antibiotic resistance.

Manufacturing Standards

The production of Norfloxacin 400mg Tablets IP adheres to stringent pharmaceutical manufacturing standards, which are established to ensure the safety, efficacy, and quality of medications. In India, the manufacturing process must comply with the guidelines set by the Central Drugs Standard Control Organization (CDSCO) and the Indian Pharmacopoeia.

1. Raw Material Inspection All raw materials must be tested for purity and potency to ensure they meet required specifications.

2. Formulation Development The formulation of Norfloxacin involves the careful selection of excipients that aid in the stability and bioavailability of the active ingredient.

3. Production The tablets are produced in controlled environments to minimize contamination risks. Automated processes help maintain consistency in dosage and formulation.

4. Quality Control Each batch undergoes rigorous testing that includes dissolution tests, disintegration tests, and stability studies to ensure that the tablets meet quality standards throughout their shelf life.

5. Packaging and Labeling Proper packaging is not only essential for physical protection but also for maintaining the drug's integrity. The labeling must comply with regulatory requirements, providing essential information including dosage, indications, contraindications, and possible side effects.

Safety Considerations

While Norfloxacin is generally well-tolerated, like all medications, it may cause side effects. Common side effects include gastrointestinal disturbances, dizziness, and headache. More severe reactions can occur, such as tendonitis or tendon rupture, particularly in elderly patients or those with existing tendon issues. As a precaution, patients are advised to stay well-hydrated and avoid excessive exposure to sunlight due to potential photosensitivity.

Moreover, it is crucial for healthcare providers to assess the patient's medical history before prescribing Norfloxacin, especially for those with a history of seizures, kidney disease, or known allergies to fluoroquinolones.

Conclusion

Norfloxacin 400mg Tablets IP represent a vital tool in the medical community's arsenal against bacterial infections, particularly in the urinary tract. The drug's effectiveness, combined with rigorous manufacturing standards, ensures that patients receive a quality product that adheres to safety guidelines. However, it remains vital for healthcare professionals and patients alike to be aware of the potential risks and to use Norfloxacin judiciously to combat the growing concern of antibiotic resistance. Through ongoing education and adherence to prescribed therapies, Norfloxacin can continue to provide benefits in managing bacterial infections effectively.